(112 days)
Not Found
No
The summary describes a standard imaging system with image processing capabilities, but there is no mention of AI, ML, or related concepts like training or test sets for algorithmic performance.
No.
The device is described as an "imaging system" used for visual assessment and observation, which indicates a diagnostic rather than therapeutic purpose.
Yes
The device is used for the visual assessment of blood flow and tissue perfusion, which are diagnostic indicators for evaluating tissue health and circulation.
No
The device description explicitly lists hardware components such as a Camera Unit (containing a CCD camera and LED light sources), a Controller, and a Remote Controller. The system relies on capturing and processing fluorescent images using these physical components.
Based on the provided information, the Pde-neo is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Pde-neo's Function: The Pde-neo is an imaging system that works in vivo (within the living body). It uses fluorescent imaging to visualize blood flow and tissue perfusion directly on the patient during surgery. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "visual assessment of blood flow... as an adjunctive method for the evaluation of tissue perfusion... in tissue and free flaps used during plastic, micro-, reconstructive, and organ transplant surgeries." This is a direct visualization technique performed on the patient.
Therefore, the Pde-neo falls under the category of medical devices used for imaging and visualization in vivo, not for the analysis of in vitro specimens.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
IZI, OWN
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.
Mentions image processing
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluorescent images
Anatomical Site
tissue and free flaps used during plastic, micro-, reconstructive, and organ transplant surgeries.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Hamamatsu's PDE (K110480)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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, JAPAN |
| Susumu 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 II |
| according 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 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.
The proposed pde-neo differs from the cleared PDE in that: |
:
.
:
1
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).
Page 2 of 3
2
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.
3
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
4
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
5
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)
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.
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)