(266 days)
Camera System: The Camera System is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ endoscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the Camera System are general surgeons, gynecologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
NIR FI Light Source: The NIR FI Light Source and NIR FI Light Guide are indicated for use to provide real-time endoscopic visible and nearinfrared fluorescence imaging. The NIR FI Light Source and NIR FI Light Guide enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the NIR FI Light Source and NIR FI Light Guide is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
The individual components of the subject device, SCHOELL Y's NIR FI System, form a system to provide real-time endoscopic visible imaging (wight light imaging, WLI) and near-infrared (NIR) illumination and imaging (fluorescence imaging, FI) using indocyanine green (ICG):
- Camera System suitable for processing and recordings visible light images as well as NIR images. The Camera System consists of a Camera Control Unit (CCU) and a Camera Head for connection to a fiberoptic scope;
- . Light Source and Light Guide for use with a fiberoptic scope for emitting light within the visible spectrum as well as in the NIR spectrum to cause fluorescence;
- . Fiberoptic Laparoscope suitable for visible light and NIR light illumination and imaging;
The imaging agent (ICG) is not provided by SCHOELLY as part of the subject system.
The submitted information does not contain a study that proves the device meets the acceptance criteria in the format requested. The document primarily focuses on establishing substantial equivalence to a predicate device for regulatory clearance. It describes general performance testing conducted, but not in the context of specific acceptance criteria and detailed study results as typically found in clinical trials or dedicated performance studies for AI/ML devices.
However, based on the provided text, I can extract information related to the device and the types of testing performed to support its regulatory clearance.
Here's an attempt to structure the available information, noting where specific details (like acceptance criteria, sample sizes, ground truth establishment, or expert involvement for performance scores) are not explicitly present in the provided document:
Device Name: Near-Infrared (NIR) Fluorescence Imaging (FI) System: Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance (e.g., specific sensitivity, specificity, accuracy targets). Instead, it relies on demonstrating compliance with recognized standards and substantial equivalence to a predicate device.
| Performance Aspect | Acceptance Criteria (Implicit from regulatory context) | Reported Device Performance |
|---|---|---|
| Reprocessing Validation | Compliance with FDA 2015 guidance, AAMI TIR12:2010, AAMI TIR30:2011(R)2016, ANSI/AAMI/ISO 17665-1:2006 (R)2013, ISO 17664:2017. | "These tests demonstrated that the device successfully passed cleaning, drying and sterilization validations according to the instructions in the user manual." |
| Software Documentation | Compliance with FDA's 2005 Guidance for Software, IEC 62304:2006/A1:2016 (MODERATE Level of Concern). | "Software documentation for a MODERATE Level of Concern device is provided in support of the proposed device... The software lifecycle, including software documentation and validation, is managed in accordance with IEC 62304:2006/A1:2016..." (Implies compliance). |
| Electrical Safety Testing | Compliance with IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 and IEC 60601-2-18:2009. | "The NIR FI System was assessed for conformity with, and was found to comply with, the relevant requirements of IEC 60601-1:2005... and IEC 60601-2-18:2009..." |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2:2014. | "The NIR FI System was assessed for conformity with, and was found to comply with, the relevant requirements of IEC 60601-1-2:2014..." |
| Non-Clinical Performance | Substantial equivalence to predicate device (Stryker AIM System) and meeting design input requirements for endoscopic white light and NIR fluorescence imaging. | "Non-Clinical performance test data demonstrate that the proposed NIR FI System performs substantially equivalent to the Stryker predicate AIM System and that the design output meets the design input requirements for endoscopic white light and near-infrared fluorescence imaging." (No specific quantitative metrics for imaging performance are disclosed in this summary). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of evaluating a dataset for AI performance. The performance data mentioned refers to engineering and quality system validation tests. No information is provided regarding the origin (country, retrospective/prospective) of specific data sets used for validating imaging performance beyond general statements about "non-clinical performance test data."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable based on the provided text. The document does not describe a study involving expert readers establishing ground truth for a test set to assess AI performance. The focus is on the device's technical specifications and safety/effectiveness in a comparative context to a predicate device.
4. Adjudication Method for the Test Set
Not applicable. As no human expert evaluation of a test set for AI performance is described, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC study is mentioned. The document primarily focuses on demonstrating substantial equivalence to a predicate device through technical comparisons and compliance with standards, rather than a study comparing human readers with and without AI assistance.
6. If a Standalone (Algorithm Only) Performance Study Was Done
The device described is a medical imaging system (hardware and integrated functionality for visible and NIR fluorescence imaging), not a standalone AI algorithm. Therefore, a standalone algorithm performance study as typically understood for AI/ML software is not applicable here. The "Non-Clinical Performance Testing" refers to the system as a whole.
7. The Type of Ground Truth Used
For the "Non-Clinical Performance Testing," the "ground truth" implicitly refers to the expected performance characteristics based on an existing predicate device and the design input requirements for endoscopic white light and near-infrared fluorescence imaging. The document does not specify an external "ground truth" like pathology, expert consensus on images, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. The document does not describe the development or training of an AI algorithm with a training set. The device is an imaging system, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no mention of a training set or AI algorithm training, the establishment of ground truth for such a set is not discussed.
Summary of Non-Inclusion:
The provided document is a 510(k) summary for a medical device (an imaging system) seeking clearance based on substantial equivalence. It is not a report on a clinical or performance study evaluating an AI/ML algorithm against specific performance metrics with independent test sets and expert ground truth. Therefore, many of the requested details, particularly those related to AI/ML study design (sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies), are not present in the given text. The "Performance Data" section details compliance with recognized safety, software, and reprocessing standards, and general non-clinical performance demonstrations for substantial equivalence.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 23, 2023
Schoelly Fiberoptic GmbH % Pamela Papineau Regulatory Affairs Consultant (Alternate Application Contact) Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, Massachusetts 01432
Re: K221591
Trade/Device Name: Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ, FET, OWN, FCW Dated: January 24, 2023 Received: January 27, 2023
Dear Pamela Papineau:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
{1}------------------------------------------------
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jianting Wang -S
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K221591
Device Name
Near-Infrared (NIR) Fluorescence Imaging (FI) System: Camera Control Unit, Camera Head to be coupled to a fiberoptic scope); NIR FI Light Source
Indications for Use (Describe)
Camera System:
The Camera System is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ endoscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the Camera System are general surgeons, gynecologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
NIR FI Light Source:
The NIR FI Light Source and NIR FI Light Guide are indicated for use to provide real-time endoscopic visible and nearinfrared fluorescence imaging. The NIR FI Light Source and NIR FI Light Guide enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the NIR FI Light Source and NIR FI Light Guide is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (6/20)
{3}------------------------------------------------
23 May 2022 NIR FI System
005 510(k) Summary - K221591
A. GENERAL INFORMATION
| 510(k) Sponsor: | Schoelly Fiberoptic GmbH |
|---|---|
| Address: | Robert-Bosch-Str. 1 – 379211 DenzlingenGermany |
| FDA Registration Number: | 8043903 |
| Telephone Number: | +49-7666-980-0 |
| Fax Number: | +49-7666-908-380 |
| Contact Person: | Dr. Sandra Baumann |
| Date Prepared: | 23 May 2022 |
B. DEVICE IDENTIFICATION
The subject device is the SCHOELL Y Near-Infrared (NIR) Fluorescence Imaging (FI) System that is specifically comprised of the flowing components:
| Trade Name | Camera System(Camera Control Unit, Camera Head to be coupled to afiberoptic scope) |
|---|---|
| Common Name | Video Camera(Camera Control Unit, Camera Head to be coupled to afiberoptic scope) |
| Classification Name | Laparoscope, General & Plastic SurgeryEndoscopic Video Imaging System/Component,Gastroenterology-Urology |
| Product Code | GCJFET |
| Regulation Number | 21 CFR 876.1500 |
| Regulation Name | Endoscope and accessories |
| Device Classification | Class II |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panels | General & Plastic SurgeryGastroenterology/Urology |
| Trade Name | NIR FI Light Source |
|---|---|
| Common Name | Light Source, Illuminator |
| Classification Name | Confocal Optical Imaging1 |
{4}------------------------------------------------
| Light Source, Fiberoptic, Routine2 | |
|---|---|
| Product Code | OWN1 |
| FCW2 | |
| Regulation Number | 21 CFR 876.1500 |
| Regulation Name | Endoscope and accessories |
| Device Classification | Class II |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panels | General & Plastic Surgery1 |
| Gastroenterology/Urology2 |
1 when used for assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extrahepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using NIR Fluorescence Imaging 2 when used to emit light in the visible range of the spectrum to support standard endoscopic imaging
Indications for Use
Camera System
The Camera System is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ endoscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection. Laparoscopically assisted hysterectomy. Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the Camera System are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
NIR FI Light Source
The NIR FI Light Source and NIR FI Light Guide are indicated for use to provide real-time endoscopic visible and near-infrared fluorescence imaging. The NIR FI Light Source and NIR FI Light Guide enable surgeons to perform minimally invasive surgery using standard endoscope visual 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 and common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the NIR FI Light Source and NIR FI Light Guide is intended for use with standard-of-care white light and, when indicated, intraoperative
{5}------------------------------------------------
cholangiography. The devices are not intended for standalone use for biliary duct visualization.
C. PREDICATE DEVICE
The predicate device is the STRYKER AIM (Advanced Imaging Modality) System:
| 510(k) Sponsor: | Stryker Endoscopy |
|---|---|
| 510(k) Number: | K182160 |
The predicate device is specifically comprised of the flowing components:
| Trade Name | 1688 4k Camera System(1688 Camera Control Unit; 1688 AIM 4K CameraHead, C-Mount; 1688 AIM 4K Camera Head withIntegrated Coupler; AIM 4K Coupler, 20mm, C-Mount) |
|---|---|
| Common Name | 3-Chip Video Camera(Camera Control Unit, Camera Head and accessories tobe coupled to a fiberoptic scope) |
| Classification Name | Laparoscope, General & Plastic Surgery |
| Product Code | GCJ |
| Regulation Number | 21 CFR 876.1500 |
| Regulation Name | Endoscope and accessories |
| Device Classification | Class II |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panels | General & Plastic Surgery |
| Trade Name | L11 LED Light Source with Advanced Imaging Modality |
|---|---|
| Common Name | Light Source, Illuminator |
| Classification Name | Confocal Optical Imaging1Light Source, Fiberoptic, Routine2Fiberoptic light ureteral catheter3 |
| Product Code | OWN1FCW2FCS3 |
| Regulation Number | 21 CFR 876.1500121 CFR 876.40202,3 |
| Regulation Name | Endoscope and accessories |
{6}------------------------------------------------
| Device Classification | Class II |
|---|---|
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panels | General & Plastic Surgery1Gastroenterology/Urology2, 3 |
Indications for Use
1688 4K Camera System with Advance Imaging Modality
The 1688 Video Camera is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ endoscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectorny, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the 1688 Video Camera are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
L11 LED Light Source with Advanced Imaging Modality
The L11 AIM Light Source and SafeLight™ Cable are indicated for use to provide real-time endoscopic visible and near-infrared fluorescence imaging. The L11 AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual 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 and common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the L11 AIM Light Source and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
The L11 AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
{7}------------------------------------------------
D. REFERENCE DEVICE
SCHOELLY's TipVision™ Videoscope System serves as a reference device in this submission:
| 510(k) Sponsor: | Schoelly Fiberoptic GmbH |
|---|---|
| 510(k) Number: | K201617 |
The reference device is specifically comprised of the flowing components:
| Trade Name | EleVision™ HD 2 Camera Control Unit |
|---|---|
| Common Name | Camera Control Unit |
| Classification Names | Endoscopic Video Imaging System/Component |
| Product Codes | FET |
| Regulation Numbers | 21 CFR 876.1500 |
| Regulation Name | Endoscope and accessories |
| Device Classification | Class II |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panels | Gastroenterology/Urology |
| Trade Name | TipVision™ Videoscope |
|---|---|
| Common Name | Video Laparoscope(Camera Head) |
| Classification Names | Laparoscope, Gynecologic (and Accessories)Laparoscope, General & Plastic Surgery |
| Product Codes | HET, GCJ |
| Regulation Numbers | 21 CFR 884.172021 CFR 876.1500 |
| Regulation Name | Endoscope and accessories |
| Device Classification | Class II |
| Regulation Medical Specialty | Obstetrics/GynecologyGastroenterology/Urology |
| Review Panels | Obstetrics / GynecologyGeneral & Plastic Surgery |
{8}------------------------------------------------
Indications for Use:
The TipVision™ 0°/30° Videoscopes and the other EleVision™ / TipVision™ components are indicated for visualization during general laparoscopy, gynecological laparoscopy, urological laparoscopy, and video-assisted minimally invasive thoracic surgical procedures.
SCHOELLY's Schoelly Laparoscope serves as a further reference device in this submission:
| 510(k) Sponsor: | Schoelly Fiberoptic GmbH |
|---|---|
| 510(k) Number: | K143221 |
| Trade Name | Schoelly Laparoscope |
|---|---|
| Common Name | Laparoscope |
| Classification Names | Laparoscope, General & Plastic Surgery |
| Product Codes | GCJ |
| Regulation Numbers | 21 CFR 876.1500 |
| Regulation Name | Endoscope and accessories |
| Device Classification | Class II |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panels | General & Plastic Surgery |
Indications for Use:
The Schoelly Laparoscope is indicated for examination of body cavities, hollow organs, and canals, and using additional accessories, to perform various diagnostic and therapeutic procedures.
E. DEVICE DESCRIPTION
The individual components of the subject device, SCHOELL Y's NIR FI System, form a system to provide real-time endoscopic visible imaging (wight light imaging, WLI) and near-infrared (NIR) illumination and imaging (fluorescence imaging, FI) using indocyanine green (ICG):
- Camera System suitable for processing and recordings visible light images as well as NIR images. The Camera System consists of a Camera Control Unit (CCU) and a Camera Head for connection to a fiberoptic scope;
- . Light Source and Light Guide for use with a fiberoptic scope for emitting light within the visible spectrum as well as in the NIR spectrum to cause fluorescence;
- . Fiberoptic Laparoscope suitable for visible light and NIR light illumination and imaging;
The imaging agent (ICG) is not provided by SCHOELLY as part of the subject system.
{9}------------------------------------------------
F. INDICATIONS FOR USE
Camera System:
The Camera System is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ arthroscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectorny, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the Camera System are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
NIR FI Light Source:
The NIR FI Light Source and NIR FI Light Guide are indicated for use to provide real-time endoscopic visible and near-infrared fluorescence imaging. The NIR FI Light Source and NIR FI Light Guide enable surgeons to perform minimally invasive surgery using standard endoscope visual 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 and common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the NIR FI Light Source and NIR FI Light Guide is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
G. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Styrker's predicate device, the AIM (Advanced Imaging Modality) System, was cleared in K182160. A detailed comparison of the proposed and predicate system is provided in the substantial equivalence table below. SCHOELLY's TipVision™ Videoscope System cleared in K201617 is cited as a reference device in this submission because it represents an example of a camera system with Product Code FET (endoscopic video imaging system/component) for use in different application fields (not just laparoscopy) and relying on basically the same image processing options for real-time endoscopic visible imaging as the Camera System of the subject device does. The TipVision™ Videoscope System does not include near-infrared fluorescence imaging capability and features an integrated camera head (Videoscope) instead of a camera head connected to a fiberoptic scope.
{10}------------------------------------------------
| Attribute | Proposed SystemSCHOELLY's NIR FISystem(current submission) | Predicate SystemStyrker's AIM(Advanced ImagingModality) System(K182160) | Similarities andDifferences |
|---|---|---|---|
| Intended Use | Endoscopic visible andnear-infrared lightillumination and imaging | Endoscopic visible andnear-infrared lightillumination and imaging | Same |
| Indications for Use | NOTE 1 | NOTE 2 | Camera System: SameLight Source: Same;Light source of subjectdevice comprises asubset of the indicationsfor use of the predicatedevice since subjectdevice is not intended totransilluminate the ureterduring open orlaparoscopic surgicalprocedures |
| Imaging Modes | White LightNIR - fluorescence | White LightNIR – fluorescenceNIR - transillumination | Same;Subject device comprisesa subset of imagingmodes as compared topredicate device sincesubject device is notintended totransilluminate the ureterduring open orlaparoscopic surgicalprocedures |
| Safety Standards | IEC 60601-1IEC 60601-2-18IEC 60601-1-2IEC 60825-1 | IEC 60601-1IEC 60601-2-18IEC 60601-1-2IEC 60825-1 | Same |
| System Components | Camera System,Light Source and LightGuide,Laparoscopes | Camera System;Light Source andSafeLight Cable;Laparoscope;IRIS Ureteral Kit;Imaging Agent Kits | Same;Subject systemcomprises a subset ofcomponents as comparedto predicate system sinceimaging agents kits arenot within the scope ofdelivery of the subjectsystem |
| Use Environment | Hospital, Operating room | Hospital, Operating room | Same |
| Camera System | |||
| Principles of Operation | Via an optical scope, light is transferred to imaging sensors of the camera system and the optical signal is transferred into an electrical signal. Imaging sensors acquire a continuous stream of image data which is further processed for proper viewing on displays. | Via an optical scope and coupler, light is transferred to imaging sensors of the camera system and the optical signal is transferred into an electrical signal. Imaging sensors acquire a continuous stream of image data which is further processed for proper viewing on displays. | Same |
| Image Sensor | CMOS image sensor | CMOS image sensor | Same |
| Image Processing / Video Output | Digital | Digital | Same |
| Data record and storage | Capture images and video recordings to USB or recordings to remote device | Capture images and video recordings to remote device | Similar |
| Resolution | up to 3840 x 2160 | up to 3840 x 2160 | Same |
| Resprocessing | Camera head released for manual or automated cleaning and sterilization | Camera head released for manual or automated cleaning and sterilization | Same |
| Light Source | |||
| Principles of Operation | An electronic driver controls Red/Green/Blue LEDs & a near-infrared laser diode which are combined through. dichroic mirrors and projected onto an output light collimator. A fiber output bundle can be inserted into the light source to couple light to the distal end and into an endoscope. | An electronic driver controls Red/Green/Blue LEDs & a near-infrared laser diode which are combined through. dichroic mirrors and projected onto an output light collimator. A fiber output bundle can be inserted into the light source to couple light to the distal end and into an endoscope. | Same |
| Light Source / Laser | RGB LEDsInfrared Laser | RGB LEDsInfrared Laser | Same |
| Automatic light control | yes | yes | Same |
Table 15.1: Technological Characteristics Comparison Table
{11}------------------------------------------------
{12}------------------------------------------------
NOTE 1:
Camera System:
The Camera System is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, simuscopy, and plastic surgery whenever a laparoscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectorny, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectorny, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectorny, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the Camera System are general surgeons, gynecologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
NIR FI Light Source:
The NIR FI Light Source and NIR FI Light Guide are indicated for use to provide real-time endoscopic visible and nearinfrared fluorescence imaging. The NIR FI Light Source and NIR FI Light Guide enable surgeons to perform minimally invasive surgery using standard endoscope visual 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 and common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the NIR FI Light Guide is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
NOTE 2:
1688 4K Camera System with Advance Imaging Modality:
The 1688 Video Camera is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectorny, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectorny, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the 1688 Video Camera are general surgeons, gynecologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
L11 LED Light Source with Advanced Imaging Modality:
The L11 AIM Light Source and SafeLightTM Cable are indicated for use to provide real-time endoscopic visible and near-infrared fluorescence imaging. The L11 AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual 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 and common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the L11 AIM Light Source and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
{13}------------------------------------------------
The L11 AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
Differences in technological characteristics do not raise different questions of safety and effectiveness.
H. PERFORMANCE DATA
The following performance testing has been performed for the subject device:
Reprocessing validation
Reprocessing validations were designed and conducted in accordance with FDA's 2015 guidance (including Appendix E revised June 2017) Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.
Cleaning studies were designed and performed in accordance with AAMI TIR12:2010 Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers, AAMI TIR30:2011(R)2016 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable devices.
Sterilization studies were designed and performed in accordance with AAMI TIR12:2010 Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers, and ANSVAAMI/ISO 17665-1:2006 (R)2013 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. Cleaning and sterilization processes are defined in the device labeling per ISO 17664:2017 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices.
These tests demonstrated that the device successfully passed cleaning, drying and sterilization validations according to the instructions in the user manual.
Software Documentation
Software documentation for a MODERATE Level of Concern device is provided in support of the proposed device per FDA's 2005 Guidance for the Content of Premarket Submissions for Software Contained in Medical Device. The software lifecycle, including software documentation and validation, is managed in accordance with IEC 62304:2006/A1:2016 Medical Device Software -Software Life Cycle Processes.
Electrical Safety Testing
The NIR FI System was assessed for conformity with, and was found to comply with, the relevant requirements of IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 (ed. 3.1, including the US deviations) Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance.
{14}------------------------------------------------
The NIR FI System was assessed for conformity with, and was found to comply with, the relevant requirements of IEC 60601-2-18:2009 (ed. 3): Medical Electrical Equipment, Part 2: Particular Requirements for the Basic Safety and Essential Performance of Endoscopic Equipment.
Electromagnetic Compatibility Testing
The NIR FI System was assessed for conformity with, and was found to comply with, the relevant requirements of IEC 60601-1-2:2014 (ed. 4) Medical Electrical Equipment, Part 1-2: General Requirements for Safety – Collateral standard: Electromagnetic Compatibility – Requirements and Tests.
Non-Clinical Performance Testing
Non-Clinical performance test data demonstrate that the proposed NIR FI System performs substantially equivalent to the Stryker predicate AIM System and that the design output meets the design input requirements for endoscopic white light and near-infrared fluorescence imaging.
CONCLUSION I.
Based on a comparison of the proposed SCHOELLY NIR FI System and the Stryker predicate AIM System in terms of indications for use, physical and technological characteristics, and performance specifications the SCHOELLY NIR FI System raises no new issues of safety and effectiveness and is substantially equivalent to the predicate device.
§ 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.