(25 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 text describes a 510(k) submission for the Stryker 1688 4K Camera System with Advanced Imaging Modality (AIM). This submission focuses on administrative updates and confirms substantial equivalence to a previously cleared device (K211202).
Based on the provided information, the request for a detailed description of acceptance criteria, study details, and performance for this particular 510(k) submission (K220895) cannot be fully met because the document explicitly states:
"The 510(k) submission was not re-reviewed." (page 0)
"Please note that CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading." (page 1)
"Additionally, the device modifications to the 1688 4K Camera System do not require clinical studies to support the determination of substantial equivalence." (page 7)
Therefore, the provided document does not contain a study explicitly designed to prove that the current modified device (K220895) meets specific acceptance criteria based on human reader performance, ground truth establishment, or clinical effectiveness studies.
The document states that substantial equivalence is based on the previous 1688 4K Camera System (K211202) and that the current submission primarily addresses minor modifications and regulatory updates.
However, I can extract the information that is available about the performance data provided for this submission (K220895), which relates to software verification.
Here's the available information extracted from the provided text, recognizing the limitations mentioned above:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Method | Reported Device Performance (Result) |
|---|---|---|
| Software Verification | IEC 62304:2015 | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" sample size in the context of clinical or diagnostic performance evaluation, as it explicitly states that clinical studies were not required for this submission. The software verification test would likely involve testing various software modules and functionalities, but sample sizes for such engineering tests are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical or diagnostic performance study requiring expert ground truth establishment was conducted for this specific 510(k) submission.
4. Adjudication method for the test set
Not applicable, as no clinical or diagnostic performance study requiring adjudication was conducted for this specific 510(k) submission.
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
Not applicable. The document states that the device modifications did not require clinical studies. Also, the device is an endoscopic camera system, not explicitly an AI-assisted diagnostic tool for interpretation that would typically necessitate an MRMC study comparing human readers with and without AI assistance in this context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a camera system used by human surgeons for visualization during endoscopic procedures. While it has an "Advanced Imaging Modality," the focus of this submission is on the camera system itself, not a standalone AI algorithm for diagnosis or interpretation. The document explicitly says "clinical studies to support the determination of substantial equivalence" were not required.
7. The type of ground truth used
Not applicable for this submission in the context of clinical performance. The "ground truth" for the software verification would be the expected behavior and outcomes defined by the IEC 62304:2015 standard.
8. The sample size for the training set
Not applicable. The document does not describe the development or training of an AI model that would require a dedicated training set. The referenced "Advanced Imaging Modality" (AIM) is mentioned as part of the camera system but no details regarding specific AI model training are provided in this submission summary.
9. How the ground truth for the training set was established
Not applicable, as no AI model training specific to this submission's evaluation is described.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue and white.
April 22, 2022
Stryker Marlene Fraga Sr. Staff, Regulatory Affairs Specialist, Software Interoperability 5900 Optical Court San Jose, California 95138
Re: K220895
Trade/Device Name: 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ, GWG
Dear Marlene Fraga:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 22, 2022. Specifically, FDA is updating this SE Letter to add a secondary product code as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Purva Pandya, OHT4: Office of Surgical and Infection Control Devices, at 240-402-9979, purva.pandva@fda.hhs.gov.
Sincerely,
Purva U. Pandya -S
Purva Pandya, D.Eng. 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
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Image /page/1/Picture/0 description: The image shows 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.
April 22, 2022
Stryker Marlene Fraga Sr. Staff, Regulatory Affairs Specialist, Software Interoperability 5900 Optical Court San Jose, California 95138
Re: K220895
Trade/Device Name: 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130) Regulation Number: 21 CFR 21 C.F.R. §876.1500 Regulation Name: Laparoscope, General And Plastic Surgery Regulatory Class: Class II Product Code: GCJ
Dated: March 24, 2022 Received: March 28, 2022
Dear Marlene Fraga:
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.
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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); 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 mediation-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,
Purva U. Pandya -S
Purva Pandya, D.Eng. 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
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Indications for Use
510(k) Number (if known)
K220895
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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stryker
510(k) Summary K220895
Submitter:
| Applicant: | Stryker Endoscopy5900 Optical CourtSan Jose, CA 95138 |
|---|---|
| Contact Person: | Marlene FragaSr. Staff Regulatory Affairs Specialist, Software InteroperabilityEmail: marlene.fraga@stryker.com |
| Date Prepared: | March 24, 2022 |
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 |
|---|---|
| ------------------------------------------------------ | --------- |
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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stryker
Indications for Use:
| Subject Device | Predicate Device |
|---|---|
| 1688 4K Camera System | 1688 4K Camera System |
| This Submission | (K211202) |
| Intended Use: | Intended Use: |
| Endoscopic white light and near-infrared illumination and imagingduring endoscopic procedures. | Same as subject device |
| Indications for Use: | Indications for Use: |
| The 1688 Video Camera is indicated for use in general laparoscopy,nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery andplastic surgery whenever a laparoscope/ endoscope/ arthroscope/sinuscope is indicated for use. The 1688 Video Camera is indicatedfor adults and pediatric patients. | Same as subject device |
| A few examples of the more common endoscope surgeries areLaparoscopic cholecystectomy, Laparoscopic hernia repair,Laparoscopic appendectomy, Laparoscopic pelvic lymph nodedetection, Laparoscopically assisted hysterectomy, Laparoscopic andthorascopic anterior spinal fusion, Anterior cruciate ligamentreconstruction, Knee arthroscopy, Small joint arthroscopy,Decompression fixation, Wedge resection, Lung biopsy, Pleuralbiopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary arterydissection for coronary artery bypass, Coronary artery bypass graftingwhere endoscopic visualization is indicated and Examination of theevacuated cardiac chamber during performance of valve replacement. | |
| The users of the 1688 Video Camera are general and pediatricsurgeons, gynecologists, cardiac surgeons, thoracic surgeons, plasticsurgeons, orthopedic surgeons, ENT surgeons, neurosurgeons andurologists. |
Comparison of Technological Characteristics with the Predicate Device:
| Item | Subject Device1688 4K Camera System(This Submission) | Predicate Device1688 4K Camera System(K211202) |
|---|---|---|
| Manufacturer | Stryker | Stryker |
| Imaging Modes | White LightNear-infrared – fluorescenceNear-infrared – transillumination | Same as subject device |
| Camera System Components | Camera Control Unit | Camera Control Unit |
| Camera Head(s) – Standard,Integrated, Inline, Pendulum,Autoclave1 | Camera Head(s) – Standard,Integrated, Inline, Pendulum | |
| Coupler(s) – AIM 4K, AIM 4KAutoclave1 | Coupler(s) – AIM 4K | |
| Principles of Operations | Via an optical endoscope andcoupler, light is projected from alight source onto one or more | Same as subject device |
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stryke
| Item | Subject Device | Predicate Device |
|---|---|---|
| 1688 4K Camera System(This Submission) | 1688 4K Camera System(K211202) | |
| complementary metal oxidesemiconductor image sensors whichacquire a continuous stream of imagedata. The image data is processed toprovide a video stream that is thensent to a display for viewing. | ||
| Safety Standards | IEC 60601-1IEC 60601-1-6IEC 60601-2-18IEC 60601-1-2 | 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/ VideoOutput | 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 Control UnitSoftware | Version: 4.0.19 | Version: 4.0.18 |
¹ AIM 4K Autoclave Camera Head and Coupler were previously cleared under K212511 on November 4, 2021 as part of the 1688 4K Camera System.
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Performance Data:
The following performance data were provided in support of the substantial equivalence determination:
| Test | Method | Result |
|---|---|---|
| Software Verification | IEC 62304:2015 | 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.