The Pde-neo is an imaging system used in capturing 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 Description

The pde-neo 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. The pde-neo is intended for intraoperative visual 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 anatomy 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-neo 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 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.

AI/ML Overview

This document describes the 510(k) summary for the pde-neo, a fluorescent angiographic system.

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy). Instead, the performance evaluations focus on functional aspects, safety, and image quality comparison to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Conformance to IEC 60601-1-2 (Electromagnetic Compatibility)	Successfully completed.
Conformance to IEC 60601-1 (General Requirements for Safety)	Successfully completed.
Conformance to IEC 60825-1 (Safety for laser products)	Successfully completed.
Functional testing of camera lens (focus rotation)	Successfully completed to evaluate the angle of rotation required to focus the image.
Image quality analogous to predicate device	A study of image quality was successfully completed to demonstrate that the quality of fluorescence images obtained from the predicate and proposed pde-neo devices are substantially equivalent.
Software operates as intended	Verification testing of the proposed device software was performed to demonstrate that the software operates as intended.
Substantial Equivalence to predicate device (K110480 - Hamamatsu's PDE)	The intended use, indications for use, fundamental scientific technology, and principles of operation are the same. Minor differences do not raise different questions of safety or efficacy. The pde-neo is at least as safe and effective as the predicate device. This leads to the conclusion of substantial equivalence. The proposed pde-neo offers enhancements such as color visualization, pseudo-color display, adjustable camera focus, and integrated white LEDs for illumination, which are considered improvements rather than safety/efficacy concerns.

2. Sample size used for the test set and the data provenance:

Test set sample size: Not explicitly stated for image quality or functional testing. The "study of image quality" is mentioned but without the number of images or cases.
Data provenance: Not specified. Given that Hamamatsu Photonics K.K. is the submitter in Japan, the data likely originates from Japan, but it's not confirmed whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The image quality study is mentioned but lacks details on human expert involvement or ground truth establishment.

4. Adjudication method for the test set:

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted or reported. This device is not an AI-assisted diagnostic tool in the sense of providing automated interpretations or predictions that would require such a study. It's an imaging system providing visual information to the surgeon.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

A standalone algorithm-only performance study was not explicitly reported or necessary for this device type. The device provides visual information for human interpretation, not automated diagnostic outputs. The "software verification" indicated that the software operates as intended but doesn't describe an algorithm's standalone performance in a medical context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The document does not explicitly define the type of ground truth used. For the "image quality study," the implication is that images from the new device were compared against those from the predicate device to establish "substantial equivalence" in quality, likely based on visual assessment.

8. The sample size for the training set:

There is no mention of a "training set" as this device does not appear to employ machine learning or AI that would require one for its primary function.

9. How the ground truth for the training set was established:

Not applicable, as no training set for machine learning/AI is described.

Summary

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510(k) Summary pde-neo (K133719)

Submitter Name:	Hamamatsu Photonics K.K.
Submitter Address:Contact Person:	812 Joko-cho, Higashi-ku, Hamamatsu City, 431-3196, JAPANSusumu Suzuki
Phone Number:	+81-53-431-0124
Fax Number:	+81-53-431-0148
Date Prepared:	March 20, 2014
Device Trade Name:	pde-neo
Device Common Name:	Fluorescent Angiographic System
Product Code:	IZI
Classification:	Fluorescent Angiography Systems have been classified as Class IIaccording to 21 C.F.R. § 892.1600
Predicate Device:	Hamamatsu's PDE (K110480)
Device Description:	The pde-neo is an imaging system used in capturing and viewingfluorescent images for the visual assessment of blood flow, as anadjunctive method for the evaluation of tissue perfusion, and relatedtissue-transfer circulation in tissue and free flaps used during plastic,micro-, reconstructive, and organ transplant surgeries. The pde-neo isintended for intraoperative visual assessment of blood vessels and relatedtissue perfusion by enabling surgeons to observe fluorescent images ofblood vessels and related tissue perfusion. Indocyanine green (ICG) isinjected intravenously into patients. Infrared light-emitting diodes(LEDs) are used to excite the fluorescence of ICG and illuminate theregions of a patient's anatomy to be observed. A charge coupled device(CCD) camera captures the fluorescent image that is used to assess theblood vessels and related tissue perfusion.The pde-neo consists of the following components: Camera Unit,Controller, and Remote Controller. The Camera Unit contains a CCDcamera and LED light sources and is used either by hand or attaching itto a mechanical arm. The Controller receives the video signal of thefluorescent image from the Camera Unit and outputs the processedfluorescent image to the external video monitor and recorder.Adjustments of the fluorescent image are possible either by the CameraUnit or the Remote Controller.The proposed pde-neo differs from the cleared PDE in that:

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I } The proposed pde-neo allows the user the option to visualize the outward appearance of the target area in color with no fluorescence, as compared to the predicate PDE's black-and-white fluorescence image only. The proposed pde-neo uses a color CCD, rather than the blackand-white CCD used in the predicate PDE. By changing the optical filters placed in front of the CCD device, one can switch the color image and the black-and-white fluorescence image displayed on the monitor.

The proposed pde-neo allows the user the option to display the fluorescence image in a pseudo-color form as compared to black-andwhite (monochrome) display only with the predicate PDE. Ambient infrared light can sometimes cause the outer edges of the fluorescence image to be less clearly identifiable compared to the center of the image. Using the pseudo-color display, the intensity of the fluorescence is displayed in color (rather than brightness in the monochrome display), thereby allowing the clinician to see the outer area of the fluorescence area in a different manner.
The proposed pde-neo allows the clinician to observe the fluorescence image from a closer distance by adjusting the camera focus, which enables viewing of larger and smaller images, if necessary.
The proposed pde-neo includes six white LEDs on the front of the Camera Unit to illuminate the field of observation. During the observation of ICG fluorescence, the shadowless lamp that would otherwise illuminate the target area needs to be turned off because it contains a large amount of infrared light. Though normal overhead lights can be kept turned on, the field of observation may become dim. Since the white LED light does not interfere in the fluorescence image, it helps the clinician to observe the field with the naked eye while the shadowless lamp is turned off.

The pde-neo 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.
The pde-neo has been tested to support conformance with the following Performance data: applicable standards:
· IEC 60601-1-2, Medical Electrical Equipment Part 1-2: Electromagnetic Compatibility - Requirements and Tests 09/09/2008;
· IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 10/31/2005; and
· IEC 60825-1, Safety for laser products Part 1: Equipment classification, requirements and user's guide, 1993 + A1 (1997) + A2 (2001).

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Also, the following testing was completed to verify performance of the device:

. Functional testing of the camera lens was successfully completed to evaluate the angle of rotation required in order to focus the image; and
A study of image quality was successfully completed to . demonstrate that the quality of fluorescence images . obtained from the predicate and proposed pde-neo devices are substantially equivalent.

Lastly, verification testing of the proposed device software was performed to demonstrate that the software operates as intended.

The intended use, indications for use, fundamental scientific Substantial Equivalence: technology, and the principles of operation of the proposed pde-neo and the predicate PDE (K110480) are the same. The pde-neo and the predicate PDE have similar technological characteristics, and the minor differences do not raise different questions of safety or efficacy, as confirmed by the information described in this submission. Both the proposed and predicate devices function as cameras, allowing surgeons to view fluorescent images of blood flow and evaluate tissue perfusion with the use of indocyanine green. Further, the pde-neo is at least as safe and effective as the predicate device. In Hamamatsu's opinion, this leads to the conclusion of substantial equivalence between the proposed pde-neo and the predicate PDE.

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Public Health Service

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

March 27, 2014

Hamamatsu Photonics K.K. C/O Jeffrey K. Shapiro 700 13th ST, NW Suite 1200, Washington, DC 20005

Re: K133719

Trade/Device Name: Pde-neo Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: Class II Product Code: IZI, OWN Dated: December 26, 2013 Received: December 27, 2013

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 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

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Page 2 - Mr. Jeffrey K. Shapiro

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Felipe Aguel

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K133719

Device Name Pde-neo

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

: Date: 2014.03.27 10:53 3:14 -04'00'

FORM FDA 3881 (1/14)

Regulation Number and Section

§ 892.1600 Angiographic x-ray system.

(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.