(410 days)
Not Found
No
The summary describes a system for real-time visible and near-infrared fluorescence imaging during surgery. While it mentions image processing, there is no mention of AI, ML, or any related concepts like training sets, test sets, or performance metrics typically associated with AI/ML algorithms. The focus is on the hardware components and the imaging modalities.
No
The device is an imaging system used to visualize internal structures during surgery, not to treat a disease or condition. Its purpose is diagnostic/visualization, aiding the surgeon, not providing therapy.
Yes
The device provides "real time endoscopic visible and near-infrared fluorescence imaging" and enables "visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts". This capability to visualize internal structures for assessment fits the definition of a diagnostic device.
No
The device description explicitly lists hardware components such as an endoscopic video processor/illuminator, surgical laparoscopes, a camera head, and a flexible light guide cable.
Based on the provided information, the PINPOINT Endoscopic Fluorescence Imaging System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- PINPOINT's Function: The PINPOINT system is used during surgery to visualize structures within the body in real-time using fluorescence imaging. It does not analyze samples taken from the patient.
- Intended Use: The intended use clearly states it's for "real time endoscopic visible and near-infrared fluorescence imaging" to visualize vessels, blood flow, tissue perfusion, and bile ducts during minimally invasive surgery.
- Device Description: The description details an imaging system with a laparoscope, camera, and light source used for direct visualization within the body.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing biological specimens.
Therefore, the PINPOINT Endoscopic Fluorescence Imaging System falls under the category of a surgical imaging system, not an IVD.
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
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 guide cable. The following laparoscope models are included as part of the PINPOINT System: SC9100, SC9104, SC9130, SC9131, SC9134 and SC9144. 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, indocyanine 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 (NIR) fluorescence imaging
Anatomical Site
vessels, blood flow and related tissue perfusion, 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 / 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)
Non-Clinical Performance Testing:
The PINPOINT System was designed and developed by Novadag 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 testing was also conducted on the PINPOINT System and test results showed that PINPOINT conforms to the applicable requirements. PINPOINT was also tested in accordance with IEC 60601-2-18:2009 Medical Electrical Equipment – Part 2: Particular requirements 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.
Clinical Performance Data:
A clinical evaluation based on a clinical literature search and reported clinical adverse event information from post-market surveillance was considered appropriate to evaluate the performance and safety of the PINPOINT System. It was concluded to objectively verify the continued clinical safety and performance of NOVADAQ'S Fluorescence Imaging devices, including the PINPOINT System.
Data presented in the clinical evaluation report provides evidence to support the safety and performance claims for the PINPOINT System. Additionally, results from a clinical study and case reports utilizing the PINPOINT System and published in the Journal of Gastrointestinal Surgerv and in Surgical Innovation and Int! J Sur Case Reports, respectively, together with findings from the most recent literature search are enclosed to support the expanded Indications for Use of PINPOINT (see section 20, Performance Testing - Clinical, for the summary of the relevant clinical literature reports). Findings demonstrated that no new concerns related to the safety and effectiveness of the device have been introduced.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SPY Scope Intra-Operative Imaging System/ PINPOINT (K091515), Da Vinci Firefly Imaging System (K141077), Stryker Infrared Light Source and SafeLight Cable (K142310)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 23, 2016
Novadaq Technologies Inc. Ms. Jen Pendlebury Director of Regulatory Affairs 8329 Eastlake Drive Unit 101 Burnaby, British Columbia Canada V5A 4W2
Re: K150956
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: May 13, 2016 Received: May 16, 2016
Dear Ms. 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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
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 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 yours,
Jennifer R. Stevenson -A
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) K150956
Device Name
PINPOINT Endoscopic Fluorescence Imaging System (PC9000)
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Section 5 - 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: | May 12, 2016 |
| Predicate Devices: | SPY Scope Intra-Operative Imaging System/ PINPOINT |
| (K091515) | |
| (Novadaq Technologies Inc.) |
Da Vinci Firefly Imaging System (K141077) (Intuitive Surgical
Inc.)
Stryker Infrared Light Source and SafeLight Cable (K142310)
(Stryker Endoscopy) |
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 guide cable. The following
4
laparoscope models are included as part of the PINPOINT System: SC9100, SC9104, SC9130, SC9131, SC9134 and SC9144. 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, indocyanine 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 Devices
Based on the technological characteristics and fundamental scientific premise, the PINPOINT System (PC9000) has been determined to be substantially equivalent to the predicate devices. the SPY Intra-Operative Imaging System/PINPOINT (K091515), as well as the da Vinci Firefly Imaging System (K141077) and the Stryker IRF Light Source and SafeLight Cable (K142310). PINPOINT is substantially equivalent to the SPY Scope Intra-Operative Imaging System (SC8000), as 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. PINPOINT is also substantially equivalent to the da Vinci Firefly Imaging System (K141077) and to the Stryker IRF Light Source and SafeLight Cable (K142310). Both systems and PINPOINT utilize very similar technology and rely on the same scientific premise – they are endoscopic video imaging systems which are used for high definition visible light and NIR fluorescence imaging during minimally invasive surgery. All of 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.
5
Performance Data:
Non-Clinical Performance Testing of the PINPOINT System
The PINPOINT System was designed and developed by Novadag 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 testing was also conducted on the PINPOINT System and test results showed that PINPOINT conforms to the applicable requirements. PINPOINT was also tested in accordance with IEC 60601-2-18:2009 Medical Electrical Equipment – Part 2: Particular requirements 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.
Clinical Performance Data
A clinical evaluation based on a clinical literature search and reported clinical adverse event information from post-market surveillance was considered appropriate to evaluate the performance and safety of the PINPOINT System. It was concluded to objectively verify the continued clinical safety and performance of NOVADAQ'S Fluorescence Imaging devices, including the PINPOINT System.
Data presented in the clinical evaluation report provides evidence to support the safety and performance claims for the PINPOINT System. Additionally, results from a clinical study and case reports utilizing the PINPOINT System and published in the Journal of Gastrointestinal Surgerv and in Surgical Innovation and Int! J Sur Case Reports, respectively, together with findings from the most recent literature search are enclosed to support the expanded Indications for Use of PINPOINT (see section 20, Performance Testing - Clinical, for the summary of the relevant clinical literature reports). Findings demonstrated that no new concerns related to the safety and effectiveness of the device have been introduced.
Conclusions
It has been demonstrated in this 510(k) submission that the PINPOINT System, with the expanded Indications for Use, is substantially equivalent to the predicate devices discussed herein and there are no issues related to its safety or effectiveness. The additional performance data and scientific literature from a recent literature search supports the expanded Indications of the device, and further validates the well-established safety profile of NOVADAQ'S imaging systems.