(82 days)
Not Found
No
The document describes standard image processing for displaying visible and near-infrared images, but there is no mention of AI, ML, or any algorithms that would interpret, analyze, or enhance the images beyond basic processing for display. The focus is on the hardware and the ability to capture and display fluorescence.
No.
The device is used for imaging and visualization during surgery, not for treatment or therapy.
Yes.
The device's intended use is to provide real-time endoscopic visible and near-infrared fluorescence imaging to enable surgeons to visually assess vessels, blood flow, tissue perfusion, and major extra-hepatic bile ducts. This assessment is a form of diagnosis, as it helps identify and characterize anatomical structures and processes.
No
The device description explicitly lists multiple hardware components including an endoscopic video processor/illuminator, surgical laparoscopes, a camera head, and a flexible light guide cable. While it includes image processing, it is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The PINPOINT system is used for real-time imaging within the human body during surgery.
- The intended use is for visualization during surgery. The system provides visual information to the surgeon about vessels, blood flow, tissue perfusion, and bile ducts. It does not analyze biological samples outside the body to diagnose a condition or monitor a patient's health status.
- The device description focuses on imaging hardware and its function. It describes the components used to capture and display images from within the body.
While the system uses an imaging agent (ICG) that is injected into the patient, the device itself is not performing a diagnostic test on a biological sample. It's a surgical imaging tool.
N/A
Intended Use / Indications for Use
The PINPOINT Endoscopic Fluorescence Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging.
The PINPOINT System enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the PINPOINT System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, IZI
Device Description
The PINPOINT Endoscopic Fluorescence Imaging System (PINPOINT, PINPOINT System) is comprised of an endoscopic video processor/ illuminator (VPI which is capable of providing visible and near-infrared illumination to a surgical laparoscope, surgical laparoscopes optimized for visible (VIS) and near-infrared (NIR) illumination and imaging, a camera head that is also optimized for visible and near-infrared imaging, and a flexible light quide cable. The following laparoscope models are included as part of the PINPOINT System: SC9100, SC9104, SC9130, SC9131, SC9134, SC9144, SC9504, SC9534 and SC9544. These are the major components of the PINPOINT System.
During surgical procedures, PINPOINT may be operated to provide visualization similar to that provided by conventional imaging systems used in surgical endoscopy. The area of interest is illuminated with visible light from the illuminator and the resulting reflected light is imaged by the camera and displayed on the video monitor. When used with the VIS-only laparoscopes, the System is only capable of the conventional mode of visualization described herein.
To provide NIR fluorescence imaging, PINPOINT is used with the imaging agent, indocvanine green (ICG). The patient is injected with ICG imaging agent. The ICG fluoresces when illuminated through the laparoscope with NIR excitation light from the VPI, and the fluorescence response is then imaged with the camera, processed and displayed on an HD video monitor.
When used with a VIS/NIR laparoscope, PINPOINT can operate to provide illumination and imaging of both visible light and ICG fluorescence images simultaneously.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic visible light, Near-infrared fluorescence imaging
Anatomical Site
Vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons performing minimally invasive surgery in a hospital operating room.
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)
Animal testing using a porcine model validated the in vivo fluorescence imaging capability of the PINPOINT System. It was demonstrated that the proposed modification to the PINPOINT System is substantially equivalent to the predicate device in terms of safety, effectiveness and performance.
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.
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
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 20, 2016
Novadaq Technologies Inc. Jen Pendlebury Director of Regulatory Affairs 8329 Eastlake Drive. Unit 101 Burnaby, British Columbia Canada V5A 4W2
Re: K161792
Trade/Device Name: Pinpoint Endoscopic Fluorescence Imaging System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ, IZI Dated: August 25, 2016 Received: August 26, 2016
Dear Jen Pendlebury:
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
1
Part 807): labeling (21 CFR Part 801): medical device reporting (reporting of medical devicerelated adverse events) (21 CFR Part 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 Parts 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
Christopher J. Ronk -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161792
Device Name
PINPOINT Endoscopic Fluorescence Imaging System
Indications for Use (Describe)
The PINPOINT Endoscopic Fluorescence Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging.
The PINPOINT System enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the PINPOINT System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
| 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)
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Section 6 - 510(k) Summary
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR § 807.92.
| Trade Name: | PINPOINT Endoscopic Fluorescence Imaging System |
|---|---|
| Device Model Number: | PC9000 |
| Common Name: | Endoscope Video Imaging System |
| Classification: | 21 CFR § 876.1500 |
| Classification Name: | Laparoscope, General & Plastic Surgery; Angiographic X-ray |
| System | |
| Product Code: | GCJ; IZI |
| Classification: | Class II |
| Manufacturer: | Novadaq Technologies Inc. |
| 8329 Eastlake Drive, Unit 101 | |
| Burnaby, British Columbia | |
| Canada V5A 4W2 | |
| Contact Name: | Jen Pendlebury |
| Director of Regulatory Affairs | |
| Tel: (905) 629-3822 ext. 205 | |
| Fax: (905) 249-0656 | |
| Date 510(k) Summary Prepared: | June 29, 2016 |
| Predicate Devices: | PINPOINT Endoscopic Fluorescence Imaging System (K150956) |
| (Novadaq Technologies Inc.) |
Device Description:
The PINPOINT Endoscopic Fluorescence Imaging System (PINPOINT, PINPOINT System) is comprised of an endoscopic video processor/ illuminator (VPI) which is capable of providing visible and near-infrared illumination to a surgical laparoscope, surgical laparoscopes optimized for visible (VIS) and near-infrared (NIR) illumination and imaging, a camera head that is also optimized for visible and near-infrared imaging, and a flexible light quide cable. The following laparoscope models are included as part of the PINPOINT System: SC9100, SC9104, SC9130, SC9131, SC9134, SC9144, SC9504, SC9534 and SC9544. These are the major components of the PINPOINT System.
During surgical procedures, PINPOINT may be operated to provide visualization similar to that provided by conventional imaging systems used in surgical endoscopy. The area of interest is illuminated with visible light from the illuminator and the resulting reflected light is imaged by the
4
camera and displayed on the video monitor. When used with the VIS-only laparoscopes, the System is only capable of the conventional mode of visualization described herein.
To provide NIR fluorescence imaging, PINPOINT is used with the imaging agent, indocvanine green (ICG). The patient is injected with ICG imaging agent. The ICG fluoresces when illuminated through the laparoscope with NIR excitation light from the VPI, and the fluorescence response is then imaged with the camera, processed and displayed on an HD video monitor.
When used with a VIS/NIR laparoscope, PINPOINT can operate to provide illumination and imaging of both visible light and ICG fluorescence images simultaneously.
Proposed Indications for Use of the PINPOINT System:
The PINPOINT Endoscopic Fluorescence Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging.
The PINPOINT System enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the PINPOINT System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
Summary of Technological Characteristics of the PINPOINT System and Predicate Device
Based on the technological characteristics and fundamental scientific premise, the PINPOINT System (PC900) has been determined to be substantially equivalent to the predicate device, the PINPOINT Endoscopic Fluorescence Imaging System (K150956). Both systems use the same technology and mode of imaging to provide real-time endoscopic visible and NIR fluorescence imaging during minimally invasive surgical procedures. These systems utilize the same mode of imaging - visible and near infrared fluorescence imaging, with ICG as the imaging agent, used in the hospital operating room. All of these systems have the same integral components - a light source console and a light cable for outputting light, a camera control unit for processing NIR and VIS light images, a coupler attached to the laparoscope and a camera head, and a laparoscope for VIS and NIR light illumination and imaging. The proposed PINPOINT laparoscopes are substantially equivalent to the existing PINPOINT laparoscopes (K150956) with minor modification to provide users with an alternative laparoscope.
Non-Clinical Performance Testing of the PINPOINT System
The PINPOINT System was designed and developed by Novadaq Technologies Inc. (NOVADAQ), in accordance with the applicable requirements and standards to establish performance and safety of the device. Device safety and performance were verified by tests conducted by NOVADAQ and accredited third party laboratories.
The PINPOINT System was tested in accordance with IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance. IEC 60601-1-2:2007 Medical Electrical Equipment - Part 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility - Requirements and tests conformance testing was also conducted on the PINPOINT System and test results showed that PINPOINT conforms
5
to the applicable requirements. PINPOINT was also tested in accordance with IEC 60601-2-18:2009 Medical Electrical Equipment – Part 2: Particular reguirements for the basic safety and essential performance of endoscopic equipment, and has demonstrated conformance to the standard. Conformance of PINPOINT with IEC 60825:2007 Safety of laser products – Part 1: Equipment classification and requirements was assessed by Underwriters Laboratories Inc. (UL) and showed that PINPOINT is a Class 3R laser device with internal maximum Class 4 laser radiation.
Animal testing using a porcine model validated the in vivo fluorescence imaging capability of the PINPOINT System.
Conclusions
It has been demonstrated in this Special 510(k) submission that the proposed modification to the PINPOINT System is substantially equivalent to the predicate device in terms of safety, effectiveness and performance. This determination is based on the proposed and predicate devices having the same indications for use, technological characteristics and principle of operation. The device modification to the PINPOINT Endoscopic Fluorescence Imaging System outlined in this summary raises no issues related to its safety and effectiveness.