(86 days)
The 1688 Video Camera is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ arthroscope/ sinuscope/ sinuscope is indicated for use. The 1688 Video Camera is indicated for adults and pediatric patients.
The 1688 4K Camera System with Advanced Imaging Modality is an endoscopic camera system that produces live video in the surgical field during surgical endoscopic procedures. The system is sensitive in the visible and infrared spectrum. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible endoscopes, which are attached to the camera head. The 1688 4K Camera System consists of three main components: (1) a camera control unit (CCU); (2) a camera head with an integral cable that connects to the CCU; and (3) a coupler for attaching an endoscope to the camera head.
The provided document does not contain information about acceptance criteria and a study that proves a device meets acceptance criteria related to performance metrics like accuracy, sensitivity, or specificity for a specific medical condition.
Instead, the document is a 510(k) Premarket Notification from the FDA for a Stryker 1688 4K Camera System with Advanced Imaging Modality. This notification focuses on demonstrating substantial equivalence to a previously cleared predicate device (K211202) for an endoscopic camera system used in various surgical procedures.
The "Performance Data" section (Page 6) describes testing completed to ensure the device meets safety, electromagnetic compatibility, cleaning, disinfection, sterilization, software integrity, usability, and general bench/animal performance standards. These are regulatory compliance tests, not a clinical study to prove the device's diagnostic or therapeutic efficacy against specific performance criteria related to a disease state.
Here's a breakdown of what is provided regarding acceptance criteria (for regulatory compliance) and the "study" (referring to the testing performed):
1. Table of Acceptance Criteria and the Reported Device Performance:
| Test | Acceptance Criteria (Method) | Reported Device Performance |
|---|---|---|
| Electrical Safety | ANSI/AAMI ES60601-1:2005 + A1:2012, IEC 60601-2-18:2009, IEC 60601-1-6:2010 + A1:2013 | Pass |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2014 | Pass |
| Cleaning | AAMI TIR30:2011 (R2016), ISO/TS 15883-5:2005 | Pass |
| Disinfection | AAMI TIR12:2020, ISO 17664:2017, EN ISO 15883-2:2009 | Pass |
| Sterilization | AAMI TIR12:2020, AAMI ST79:2017, ISO 17664:2017, ISO 14937:2009, ISO 17665-1:2006 | Pass |
| Software | IEC 62304:2006/AMD1:2015 | Pass |
| Usability | IEC 62366-1:2020 | Pass |
| Performance - Bench | In accordance with design input specifications | Pass |
| Performance - Animal | In accordance with device user needs | Pass |
2. Sample size used for the test set and the data provenance:
- The document does not provide details on specific sample sizes for each test in the "Performance Data" section. It lists the standards followed.
- Data provenance (e.g., country of origin, retrospective/prospective) and clinical test sets are not applicable to the compliance testing described. The "Animal" performance test suggests in vivo testing, but no details on animal models, sample size, or specific outcomes are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the tests are for regulatory compliance (e.g., electrical safety, software standards, cleaning validation) rather than evaluating performance against a diagnostic 'ground truth' established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for the types of compliance tests listed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The device is an endoscopic camera system, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a camera system, not an AI algorithm. Its performance is as an imaging tool used by surgeons.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" for these tests are the requirements and specifications outlined in the referenced standards (e.g., electrical safety limits, sterilization efficacy, software bug-free operation).
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device requiring a training set for an algorithm.
9. How the ground truth for the training set was established:
- Not applicable.
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November 4, 2021
Stryker Marlene Fraga Staff Regulatory Affairs Specialist, Software Interoperability 5900 Optical Court San Jose, California 95138
Re: K212511
Trade/Device Name: 1688 4K Camera System with Advanced Imaging Modality Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ, GWG Dated: August 6, 2021 Received: August 10, 2021
Dear Marlene Fraga:
We have reviewed vour 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/cdrb/ofdocs/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.
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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 and Part 809: 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 (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,
Long Chen, PhD Assistant Director Non-Light Based Energy Devices DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality
Enclosure
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Indications for Use
510(k) Number (if known)
K212511
Device Name 1688 4K Camera System with Advanced Imaging Modality (AIM)
Indications for Use (Describe)
The 1688 Video Camera is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ arthroscope/ sinuscope/ sinuscope is indicated for use. The 1688 Video Camera is indicated for adults and pediatric patients.
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, 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 1688 Video Camera are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, neurosurgeons and urologists.
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) |
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510(k) Summary
Submitter:
| Applicant: | Stryker Endoscopy5900 Optical CourtSan Jose, CA 95138 |
|---|---|
| Contact Person: | Marlene FragaStaff Regulatory Affairs Specialist, Software InteroperabilityEmail: marlene.fraga@stryker.com |
| Date Prepared: | August 6, 2021 |
Subject Device:
| Name of Device: | 1688 4K Camera System with Advanced Imaging Modality | |
|---|---|---|
| Common orUsual Name | 3-chip Video Camera | |
| ClassificationName: | Laparoscope, General and Plastic Surgery (21 C.F.R. §876.1500)Endoscope, Neurological (21 C.F.R. §882.1480) | |
| Regulatory Class: | II | |
| Product Code: | GCJGWG | |
| 510(k) ReviewPanel: | General & Plastic SurgeryNeurology |
Predicate Device(s):
| 1688 4K Camera System with Advanced Imaging Modality | K211202 |
|---|---|
| ------------------------------------------------------ | --------- |
NOTE: The predicate device has not been subject to a design-related recall.
Device Description:
The 1688 4K Camera System with Advanced Imaging Modality is an endoscopic camera system that produces live video in the surgical field during surgical endoscopic procedures. The system is sensitive in the visible and infrared spectrum. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible endoscopes, which are attached to the camera head. The 1688 4K Camera System consists of three main components: (1) a camera control unit (CCU); (2) a camera head with an integral cable that connects to the CCU; and (3) a coupler for attaching an endoscope to the camera head.
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Indications for Use:
| Subject Device | Predicate Device |
|---|---|
| 1688 4k Camera SystemThis Submission | 1688 4K Camera System(K211202) |
| Intended Use:Endoscopic white light and near-infrared illumination andimaging during endoscopic procedures. | Intended Use:Same as subject device |
| Indications for Use:The 1688 Video Camera is indicated for use in generallaparoscopy, nasopharyngoscopy, ear endoscopy,sinuscopy, neurosurgery and plastic surgery whenever alaparoscope/ endoscope/ arthroscope/ sinuscope isindicated for use. The 1688 Video Camera is indicated foradults and pediatric patients. | Indications for Use:Same as subject device |
| A few examples of the more common endoscope surgeriesare Laparoscopic cholecystectomy, Laparoscopic herniarepair, Laparoscopic appendectomy, Laparoscopic pelviclymph node detection, Laparoscopically assistedhysterectomy, Laparoscopic and thorascopic anterior spinalfusion, Anterior cruciate ligament reconstruction, Kneearthroscopy, Small joint arthroscopy, Decompressionfixation, Wedge resection, Lung biopsy, Pleural biopsy,Dorsal sympathectomy, Pleurodesis, Internal mammaryartery dissection for coronary artery bypass, Coronaryartery bypass grafting where endoscopic visualization isindicated and Examination of the evacuated cardiacchamber during performance of valve replacement. | |
| The users of the 1688 Video Camera are general andpediatric surgeons, gynecologists, cardiac surgeons,thoracic surgeons, plastic surgeons, orthopedic surgeons,ENT surgeons, neurosurgeons and urologists. |
Comparison of Technological Characteristics with the Predicate Device:
| Item | Subject Device | Predicate Device |
|---|---|---|
| 1688 4K Camera System(This Submission) | 1688 4K Camera System(K211202) | |
| Manufacturer | Stryker | Stryker |
| Imaging Modes | White LightNear-infrared – fluorescenceNear-infrared – transillumination | Same as subject device |
| Item | Subject Device1688 4K Camera System(This Submission) | Predicate Device1688 4K Camera System(K211202) |
| Safety Standards | IEC 60601-1IEC 60601-1-6IEC 60601-2-18IEC 60601-1-2 | Same as subject device |
| Principles ofOperations | Via an optical endoscope andcoupler, light is projected from alight source onto one or morecomplementary metal oxidesemiconductor image sensorswhich acquire a continuousstream of image data. The imagedata is processed to provide avideo stream that is then sent to adisplay for viewing. | Same as subject device |
| Modes of Operation | Alternate Frame processingSimultaneous Frame processing | Same as subject device |
| Image Sensor | CMOS image sensor | Same as subject device |
| Image Processing/Video Output | Digital | Same as subject device |
| Resolution | 4K (up to 3840 x 2160) | Same as subject device |
| Frame Rate | 60 frames per second | Same as subject device |
| Camera SystemComponents | Camera Control UnitCamera Head(s) – Standard,Integrated, Inline, Pendulum,AutoclaveCoupler(s) – AIM 4K, AIM 4KAutoclave | Camera Control UnitCamera Head(s) – Standard,Integrated, Inline, PendulumCoupler(s) – AIM 4K |
| CompatibleProcessing Methods | Cleaning Manual & AutomatedDisinfection (optional) Thermal Disinfection | Same as subject deviceManual Disinfection |
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Performance Data:
Testing was completed in accordance with the following:
| Test | Method | Result |
|---|---|---|
| Electrical Safety | ANSI/AAMI ES60601-1:2005 + A1:2012IEC 60601-2-18:2009IEC 60601-1-6:2010 + A1:2013 | Pass |
| ElectromagneticCompatibility (EMC) | IEC 60601-1-2:2014 | Pass |
| Cleaning | AAMI TIR30:2011 (R2016)ISO/TS 15883-5:2005 | Pass |
| Disinfection | AAMI TIR12:2020ISO 17664:2017EN ISO 15883-2:2009 | Pass |
| Sterilization | AAMI TIR12:2020AAMI ST79:2017ISO 17664:2017ISO 14937:2009ISO 17665-1:2006 | Pass |
| Software | IEC 62304:2006/AMD1:2015 | Pass |
| Usability | IEC 62366-1:2020 | Pass |
| Performance - Bench | In accordance with design input specifications | Pass |
| Performance - Animal | In accordance with device user needs | Pass |
NOTE: The 1688 4K Camera System is not patient contacting; therefore, biocompatibility testing was not required to support the determination of substantial equivalence. Additionally, the device modifications to the 1688 4K Camera System do not require clinical studies to support the determination of substantial equivalence.
Conclusions:
The 1688 4K Camera System is substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to the predicate devices. There are no different issues of safety and/or effectiveness introduced by the 1688 4K Camera System.
§ 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.