Reclassification Petition of the medical devices associated with Product Code OAY from Karl Storz SE and Co KG. (Docket no. FDA-2022-P-2644).

Division of Dockets Management
U.S. Food and Drug Administration,
5630 Fishers Lane, Room 1061,
Rockville, MD 20857.
Oslo, 8 March 2023
Reclassification Petition of the medical devices associated with Product Code OAY
from Karl Storz SE and Co KG
(Docket no. FDA-2022-P-2644)
Dear Madam/Sir:
Photocure ASA (Photocure) supports and appreciates the initiative of Karl Storz to request
reclassification of medical devices associated with Product Code OAY as outlined in our
comment dated 25th November 2022. In light of new information, Photocure is submitting a
second comment in support of the request for reclassification.
Photocure is the NDA holder of Cysview (hexaminolevulinate hydrochloride); the drug product
that is approved for use in combination with Karl Storz Photodynamic Diagnostic D-Light C
(PDD) System, classified under the Product Code OAY.
1 This use of the PDD System in
combination with Cysview is also referred to as blue light cystoscopy or BLC.
As further detailed below, Karl Storz, the only manufacturer with approved OAY devices,
recently informed Photocure about the cessation of production of one of the two types of OAY
devices subject to potential reclassification.
2 This device is widely relied on for the care of US
patients today. We thus respectfully urge FDA to prioritize reclassification of OAY devices and
complete this reclassification as expeditiously as possible to help remedy this critical situation.
Patient access to a device that serves an important and unique role in enhancing patient
health now clearly depends on urgent action by FDA to facilitate US market entry by new
device suppliers. Such action directly aligns with the mission of the FDA Center for Devices
and Radiological Health (CDRH) “… to protect and promote the public health. We assure that
patients and providers have timely and continued access to safe, effective, and high-quality
medical devices …”3
The Karl Storz PDD System consists of two different cystoscope configurations: rigid and
flexible. In general, the flexible PDD System is routinely used in doctors’ offices or in
ambulatory surgical care and is used for diagnosis and surveillance of bladder cancer patients
including tumor fulguration and biopsies, while rigid cystoscopes are used in an operating

1
“Drugs@FDA.”
2
“Photocure ASA: Results for the Fourth Quarter of 2022.”
3 Center for Devices and Radiological Health, “CDRH Mission, Vision and Shared Values.”
Hoffsveien 4 | 0275 Oslo | Norway | P +47 22 06 22 10 | F +47 22 06 22 18 | www.photocure.com
room setting for transurethral resection of bladder tumors (TURBTs). Rigid PDD-assisted
TURBT is an advanced surgical intervention that cannot be performed in the doctor’s office,
requires use of an operating room, and the administration of general anesthesia, all of which
place a burden on the patient, reduces expediency of diagnosis, adds expense, and increases
the likelihood of adverse events, especially as many bladder cancer patients are elderly and
often frail. For these reasons, a rigid PDD System is not a replacement for the flexible PDD
System.
New information as of late February 2023:
Recently, Karl Storz has shared with Photocure that there is a high risk that manufacturing of
all further new flexible PDD systems will be on an indefinite hold due to supply chain
challenges. Specifically, the current supplier of the flexible PDD system’s critical fiber optic
bundle is discontinuing production of the component.
This development urgently accelerates the need for access to approved devices as bladder
cancer patients appropriate for surveillance with flexible cystoscopes will have no access to
this important, FDA-approved technology which is endorsed by major bladder cancer
guidelines.
4
The reclassification and subsequent reduction in the regulatory burden for these medical
devices is expected to increase the availability of the PDD technology to physicians and
patients as we believe that more manufactures will seek to enter the US market. Photocure
believes that additional manufacturers entering the market also has potential to lower the cost
of flexible PDD equipment, given the expected increase in competition. As of today, the single
source situation for PDD Systems in the U.S., including flexible equipment, increases the risk
that patients will not have access to the technology, hence unsatisfactory diagnostics and
surveillance, and suboptimal management of their cancer.
Adverse impacts to patient health with reduced availability of flexible PDD devices:
Non-muscle invasive bladder cancer is prevalent in the US population and primarily managed
by urologists. The disease is characterized by high recurrence rates and requires long-term,
often life-long, surveillance with repeated cystoscopies and TURBTs to detect recurrence and
avoid or delay progression to muscle in