(29 days)
Not Found
No
The document describes a standard endoscopic camera system with image processing, but there is no mention of AI, ML, or related concepts. The performance studies listed are standard tests for medical devices, not AI/ML model validation.
No.
The device is a video camera system used for visualization during surgical endoscopic procedures, not for delivering therapy.
No
The device is described as an "endoscopic camera system that produces live video in the surgical field during surgical endoscopic procedures." Its "Intended Use" lists various surgical procedures where it provides visualization. It does not state that it is used to diagnose a condition, but rather to aid in surgical intervention.
No
The device description explicitly states it is an "endoscopic camera system" consisting of a camera control unit, camera head, and coupler, which are all hardware components. While it includes image processing, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The 1688 Video Camera is an endoscopic camera system used to provide live video of the surgical field during surgical procedures. It visualizes internal structures directly, not by analyzing samples taken from the body.
- Intended Use: The intended use clearly describes its application in various surgical procedures (laparoscopy, endoscopy, etc.) for visualization purposes.
- Device Description: The description focuses on the components of a camera system designed for capturing images within the body.
The device's function and intended use are focused on direct visualization during surgery, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The 1688 Video Camera 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 hysterectorny, 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
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 scopes, 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 (integrated or standard); and (3) a coupler for attaching an endoscope to the camera head.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic visible and near-infrared light illumination and imaging during surgical endoscopic procedures.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The users of the 1688 Video Camera are general surgeons, gynecologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
Prescription Use
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)
Performance Testing: Locking Knob Actuation Torque, Rotating Endobody Torque, Pendulum Focus Ring Torque, Optical Compliance, Coupler Transmission - Pass
Electrical Testing: ANSI AAMI ES60601-1:2005 + A1:2012, IEC 60601-1-6:2010 + A1:2013, IEC 60601-2-18:2009 - Pass
EMC Testing: IEC60601-1-2:2014 - Pass
Software Verification: IEC 62304:2015 - Pass
Cleaning & Disinfection: AAMI TIR 12:2010, AAMI TIR 30:2011, ASTM E2314:2014, ISO 17664:2017 - Pass
Sterilization: AAMI TIR 12:2010, AAMI TIR 17:2008, AAMI ST58:2013, AAMI ST77:2013, ISO 17664:2017, ISO 14937:2009 - Pass
The 1688 4K Camera System does not require clinical studies to support the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image shows the logo for 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 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.
Stryker April Malmborg Director, Regulatory Affairs 5900 Optical Ct San Jose, California 95138
Re: K200310
Trade/Device Name: 1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: February 4, 2020 Received: February 6, 2020
Dear April Malmborg:
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.
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
1
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,
Jessica Mavadia-Shukla 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)
Device Name
1688 4K Camera System with Advance Imaging Modality
Indications for Use (Describe)
The 1688 Video Camera 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 hysterectorny, 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, 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.
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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3
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R Part 807.92(c).
Submitter:
| Applicant: | Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | April Malmborg, RAC
Director, Regulatory Affairs
Phone: (408) 754-2473
Facsimile: (408) 754-2598
Email: april.malmborg@stryker.com |
| Date Prepared: | February 4, 2020 |
Subject Device:
| Name of Device: | 1688 4K Camera System with Advance Imaging Modality |
|---|---|
| Common or | |
| Usual Name | 3-chip Video Camera |
| Classification | |
| Name: | Laparoscope, General and Plastic Surgery (21 C.F.R. §876.1500) |
| Regulatory Class: | II |
| Product Code: | GCJ |
| 510(k) Review | |
| Panel: | General & Plastic Surgery |
Predicate Device(s):
| 1688 4K Camera System with Advance Imaging Modality | K182160 |
|---|---|
| ----------------------------------------------------- | --------- |
NOTE: The predicate devices have 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 scopes, 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 (integrated or standard); and (3) a coupler for attaching an endoscope to the camera head.
4
Indications for Use:
The 1688 Video Camera 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 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 1688 Video Camera are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
| Item | Subject Device | Predicate Device |
|---|---|---|
| 1688 4K Camera System | 1688 4K Camera System | |
| Manufacturer | Stryker | Same as subject device |
| Submission Reference | Current Submission | K182160 |
| Intended Use | Endoscopic visible and near- | |
| infrared light illumination and | ||
| imaging during surgical endoscopic | ||
| procedures | Same as subject device | |
| Indications for Use | NOTE 1 | Same as subject device |
| Imaging Modes | White Light | |
| Near-infrared – fluorescence | ||
| Near-infrared - transillumination | Same as subject device | |
| Safety Standards | IEC 60601-1 | |
| IEC 60601-2-18 | ||
| IEC 60601-1-2 | Same as subject device | |
| Principles of Operation | Via an optical scope and coupler, | |
| light is projected onto one or more | ||
| complementary metal oxide | ||
| semiconductor image sensors which | ||
| acquire a continuous stream of | ||
| image data. The image data is | ||
| processed to provide a video stream | ||
| that is then sent to a display for | ||
| viewing. | 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 to3840 x 2160) | Same as subject device |
| Frame Rate | 60 frames per second | Same as subject device |
| System Components | Camera Control Unit | |
| Camera Head(s): Standard, | ||
| Integrated, and Pendulum | ||
| Coupler | Camera Control Unit | |
| Camera Head(s): Standard & Integrated | ||
| Coupler |
Comparison of Technological Characteristics with the Predicate Device:
5
NOTE 1: The 1688 Video Camera is indicated for use in general laparoscopy, nasopharyngoscopy, 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 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 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.
Performance Data:
The following performance data were provided in support of the substantial equivalence determination.:
| Test | Method/ Rationale | Results |
|---|---|---|
| Performance Testing | Locking Knob Actuation Torque | |
| Rotating Endobody Torque | ||
| Pendulum Focus Ring Torque | ||
| Optical Compliance | ||
| Coupler Transmission | Pass | |
| Electrical | ANSI AAMI ES60601-1:2005 + A1:2012 | |
| IEC 60601-1-6:2010 + A1:2013 | ||
| IEC 60601-2-18:2009 | Pass | |
| EMC | IEC60601-1-2:2014 | Pass |
| Software Verification | IEC 62304:2015 | Pass |
| Cleaning & Disinfection | AAMI TIR 12:2010 | |
| AAMI TIR 30:2011 | ||
| ASTM E2314:2014 | ||
| ISO 17664:2017 | Pass | |
| Sterilization | AAMI TIR 12:2010 | |
| AAMI TIR 17:2008 | ||
| AAMI ST58:2013 | ||
| AAMI ST77:2013 | ||
| ISO 17664:2017 | ||
| ISO 14937:2009 | Pass |
NOTE: The 1688 4K Camera System does not require clinical studies to support the determination of substantial equivalence.
Conclusions:
The 1688 4K Camera System with Advance Imaging Modality is substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to the predicate device. There are no new issues of safety and/or effectiveness introduced by the 1688 4K Camera System with Advance Imaging Modality when used as instructed.