PDE PHOTODYNAMIC EYE

K110480 · Hamamatsu Photonics K.K. · OWN · Jan 13, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K110480
• Device Name: PDE PHOTODYNAMIC EYE
• Applicant: Hamamatsu Photonics K.K.
• Product Code: OWN · Gastroenterology, Urology
• Decision Date: Jan 13, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The PDE is an imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic, micro-, reconstructive and organ transplant surgeries.

Device Story

PDE is an intraoperative fluorescent imaging system used by surgeons to assess blood flow and tissue perfusion. The system consists of a camera unit, controller, and remote controller. During surgery, indocyanine green (ICG) is injected intravenously into the patient. The camera unit, which contains infrared LEDs and a CCD camera, illuminates the surgical site with infrared light to excite the ICG fluorescence. The CCD camera captures the resulting fluorescent images, which are processed by the controller and displayed on an external video monitor. Surgeons use these real-time visual images to evaluate blood vessel patency and tissue perfusion in free flaps and transplants. This adjunctive information assists in clinical decision-making during reconstructive procedures, potentially improving surgical outcomes by confirming tissue viability.

Clinical Evidence

No clinical trials were conducted for this submission. Evidence consists of 5 years of clinical use in Japan without reported adverse events and a review of published literature confirming the device's safety and efficacy in assessing blood flow and tissue perfusion during surgery. Bench testing included electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and LED safety (IEC 60825-1).

Technological Characteristics

System comprises a camera unit (CCD sensor, infrared LEDs), controller, and remote controller. Operates via infrared excitation of intravenous ICG. Connectivity includes video output to external monitors/recorders. Complies with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and IEC 60825-1 (Class 1 LED product).

Indications for Use

Indicated for intraoperative visual assessment of blood flow and tissue perfusion in patients undergoing plastic, micro-, reconstructive, and organ transplant surgeries, utilizing intravenous indocyanine green (ICG) as a contrast agent.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• SPY Imaging System SP2000 (K063345)
• SPY Fluorescent Imaging System SP2001 (K073130)

Submission Summary (Full Text)

{0}------------------------------------------------

K110480

JAN 1 3 2012

## 510(k) Summary PDE

Submitter Name: Hamamatsu Photonics K.K.

Submitter Address: 812 Joko-cho, Higashi-ku, Hamamatsu City, 431-3196, JAPAN

Contact Person: Susumu Suzuki

Phone Number: [phone]

Fax Number: [phone]

Date Prepared: February 17, 2011

Device Trade Name: PDE

Device Common Name: Fluorescent Angiographic System

Product Code: IZI

Classification: Class II

Predicate Devices: Novadaq Technologies Inc.'s SPY Imaging System SP2000 (K063345) and SPY Fluorescent Imaging System SP2001 (K073130)

- Device Description: The PDE is an imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic, micro-, reconstructive and organ transplant The PDE is intended for intraoperative visual surgeries. assessment of blood vessels and related tissue perfusion, by enabling surgeons to observe fluorescent images of blood vessels and related tissue perfusion. Indocyanine green (ICG) is injected intravenously into patients. Infrared light-emitting diodes (LEDs) are used to excite the fluorescence of ICG and illuminate the regions of a patient's body to be observed. A charge coupled device (CCD) camera captures the fluorescent image that is used to assess the blood vessels and related tissue perfusion.
The PDE consists of the following components: Camera Unit, Controller, and Remote Controller. The Camera Unit contains a CCD camera and LED light sources and is used either by hand or attaching it to a mechanical arm. The Controller receives the video

Page ① of ②

{1}------------------------------------------------

signal of the fluorescent image from the Camera Unit and outputs the processed fluorescent image to the external video monitor and recorder. Adjustments of the fluorescent image are possible either by the Camera Unit or the Remote Controller.

- The PDE is an imaging system used in capturing and viewing Intended Use: fluorescent images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic, micro-, reconstructive and organ transplant surgeries.
- Performance data: The following electrical, performance, and clinical tests have been conducted with the PDE and are described in the 510(k) submission. All tests demonstrate that the device functions as intended.
- 1. Electrical per IEC 60601-1.
- 2. Electromagnetic Compatibility per IEC 60601-1-2.
- 3. Light Emitting LED Product per IEC 60825-1 (Class1 LED product).

4. The PDE has been sold and used clinically for 5 years in Japan without any adverse events. A review of the published literature concludes that the device worked as intended by safely assessing the blood flow and related tissue perfusion during surgeries.

Substantial Equivalence: The predicate devices are Novadag Technologies Inc.'s SPY Imaging System SP2000 (K063345) and SPY Fluorescent Imaging System SP2001 (K073130). The intended use, indications for use, and the principles of operation of the PDE and its predicate devices are the same. The PDE and the predicate devices have similar technological characteristics, and any minor differences do not raise different questions of safety or efficacy, as confirmed by Hamamatsu's testing and validation activities described in this submission. All devices function as cameras allowing surgeons to view fluorescent images of blood flow and evaluation of tissue perfusion with the use of indocyanine green. Further, the PDE is at least as safe and effective as the predicate devices. This leads to the conclusion of substantial equivalence between the PDE and SPY Imaging System SP2000 and SPY Fluorescent Imaging System SP2001. The Substantial Equivalence Comparison chart is found in Section XIII.

Page (2) of (2)

Page 5

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JAN 1 3 2012

Hamamatsu Photonics, K.K. % Hyman, Phelps & McNamara, P.C. Mr. Jeffrey K. Shapiro 700 13th Street, N.W., Suite 1200 Washington, District of Columbia 20005

Re: K110480

Trade/Device Name: PDE Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: Class II Product Code: OWN Dated: January 11, 2012 Received: January 12, 2012

Dear Mr. Shapiro:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

{3}------------------------------------------------

Page 2 - Mr. Jeffrey K. Shapiro

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use Form

510(k) Number (if known): K110480

Device Name: PDE

Indications for Use:

The PDE is an imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic, micro-, reconstructive and organ transplant surgeries.

## Over-The-Counter Use Prescription Use _ X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off Office of Device Evaluation Center for Devices and Radiological Health 510(k)

Neil RP Odom for mkm

(Division Sign-Off) Page 1 of 1 Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110480

Pge ① of ①

Page 2