(102 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms. The performance studies focus on standard electrical and usability testing, not AI/ML model validation.
No.
The document describes a camera system for visualization during surgical procedures, not a device that directly treats or prevents disease.
No
Explanation: The device description states that the 1788 4K Camera System is an endoscopic camera system that produces live video in the surgical field during surgical endoscopic procedures. Its intended use is described for various surgical procedures to provide visualization, not to diagnose a condition.
No
The device description explicitly states it consists of hardware components: a camera control unit (CCU), a camera head, and a coupler. The performance studies also include hardware-specific testing like "Flash Event Elimination" and "Light Transmission."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The 1788 4K Camera System is an endoscopic camera system that provides live video of the surgical field during surgical procedures. It is used for visualization within the body, not for examining specimens outside the body.
- Intended Use: The intended use clearly states its application in various surgical procedures where visualization is needed. It does not mention any analysis of biological samples.
Therefore, the 1788 4K Camera System falls under the category of a surgical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in general laparoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ arthroscope/ sinuscope/ sindicated for use. The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in adults and pediatric patients.
A few examples of the more common endoscope surgeries are Laparoscopic cholecystectorny, Laparoscopic hernia repair, Laparoscopic appendectorny, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectorny, Laparoscopic 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.
Product codes
GCJ
Device Description
The 1788 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, infrared spectrums. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible to the camera head. The 1788 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical image
Anatomical Site
Not Found
Indicated Patient Age Range
adults and pediatric patients.
Intended User / Care Setting
general and pediatic surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons and urologists.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was designed and developed in accordance with applicable requirements and stablish performance and safety of the subject device (1788 4K Camera System with Advanced Imaging Modality System), These include performance bench testing (Flash Event Elimination, Minimum Focus Distance, Light Transmission, Camera Head Image Size, CH to CCU Button Activation Timing and Pendulum CH Flip), software function testing executed in accordance with IEC 62304:2015, Medical device software - Software life-cycle processes (FDA recognized voluntary consensus standard: 13-79) as well as EMC and Electrical Safety testing in accordance with IEC 60601-1-2:2014+A1:2020, Medical Electrical Equipment – Part 1-2: General reguirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and Tests (FDA-recognized voluntary consensus standard: 19-36) and IEC TR 60601-4-2 Edition 1.0 2016-05, Medical Electrical Equipment – Part 4-2: Guidance and interpretation - Electromagnetic immunity; performance of medical electrical equipment and medical electrical systems (FDArecognized voluntary consensus standard: 19-19), ANSI AAMI ES 60601-1:2005 + A2:2021, Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance (FDA recognized voluntary consensus standard: 19-46), IEC 60601-1-6:2010+A1:2013+A2:2020, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (FDA-recognized voluntary consensus standard: 5-132) and IEC 60601-2-18:2009, Medical electrical equipment – Part 2-18 : Particular requirement (FDA-recognized voluntent (FDA-recognized voluntary consensus standard: 9-1 14). Verification and validation testing successfully completed that the device conform with recognized safety standards, design input specifications, user needs and intended uses.
The subject devices do not require clinical studies to support the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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.
January 9, 2024
Stryker Endoscopy Mrs. Michelle Stephens Senior Staff Regulatory Affairs Specialist 5900 Optical Court San Jose, California 95138
Re: K233327
Trade/Device Name: 1788 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 Dated: September 29, 2023 Received: December 15, 2023
Dear Mrs. Michelle Stephens:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
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-devices/deviceadvice-comprehensive-regulatory-assistance/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.
Tanisha L. Hithe Tanisha L. J 2024.01.09 Hithe -S 18:31:34 -05'00'
Tanisha Hithe, MS 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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
1788 4K Camera System with Advanced Imaging Modality
Indications for Use (Describe)
The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ endoscope/ arthroscope/ sinuscope is indicated for use. The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in 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, 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 1788 4K Camera System with Advanced Imaging Modality are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT/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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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4
| 510(k) #: | K233327 |
|---|---|
| ----------- | --------- |
| 510(k) Summary | Prepared on: 2023-12-15 | |
|---|---|---|
| -- | ---------------- | ------------------------- |
| Contact Details | 21 CFR 807.92(a)(1) |
|---|---|
| Applicant Name | Stryker Endoscopy |
| Applicant Address | 5900 Optical Court San Jose CA 95138 United States |
| Applicant Contact Telephone | 904-608-1262 |
| Applicant Contact | Mrs. Michelle Stephens |
| Applicant Contact Email | michelle.stephens@stryker.com |
| Device Name | 21 CFR 807.92(a)(2) |
|---|---|
| Device Trade Name | 1788 4K Camera System with Advanced Imaging Modality |
| Common Name | Endoscope and accessories |
| Classification Name | Laparoscope, General & Plastic Surgery |
| Regulation Number | 876.1500 |
| Product Code | GCJ |
| Legally Marketed Predicate Devices | |
|---|---|
| ------------------------------------ | -- |
| 21 CFR 807.92(a)(3) | |
|---|---|
| -- | --------------------- |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K231854 | Advanced Imaging Modality (AIM) System (1788 4K Camera Sys | GCJ |
Device Description Summary
The 1788 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, infrared spectrums. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible to the camera head. The 1788 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.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(4)
The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in general laparoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ arthroscope/ sinuscope/ sindicated for use. The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in adults and pediatric patients.
A few examples of the more common endoscope surgeries are Laparoscopic cholecystectorny, Laparoscopic hernia repair, Laparoscopic appendectorny, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectorny, Laparoscopic 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 1788 4K Camera System with Advanced Imaging Modality are general and pediatic surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons and urologists.
Indications for Use Comparison
5
The subject device, the 1788 4K Camera System with AlM, has the same intended use as the predicate device.
Technological Comparison
21 CFR 807.92(a)(6)
The 1788 4K Camera System has the same technological characteristics as the 1788 4K Camera System with the addition of the optical shutter to the 1788 4K Pendulum Urology Camera Head and those necessary to support the addition of the optical shutter.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Non-clinical testing was designed and developed in accordance with applicable requirements and stablish performance and safety of the subject device (1788 4K Camera System with Advanced Imaging Modality System), These include performance bench testing (Flash Event Elimination, Minimum Focus Distance, Light Transmission, Camera Head Image Size, CH to CCU Button Activation Timing and Pendulum CH Flip), software function testing executed in accordance with IEC 62304:2015, Medical device software - Software life-cycle processes (FDA recognized voluntary consensus standard: 13-79) as well as EMC and Electrical Safety testing in accordance with IEC 60601-1-2:2014+A1:2020, Medical Electrical Equipment – Part 1-2: General reguirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and Tests (FDA-recognized voluntary consensus standard: 19-36) and IEC TR 60601-4-2 Edition 1.0 2016-05, Medical Electrical Equipment – Part 4-2: Guidance and interpretation - Electromagnetic immunity; performance of medical electrical equipment and medical electrical systems (FDArecognized voluntary consensus standard: 19-19), ANSI AAMI ES 60601-1:2005 + A2:2021, Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance (FDA recognized voluntary consensus standard: 19-46), IEC 60601-1-6:2010+A1:2013+A2:2020, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (FDA-recognized voluntary consensus standard: 5-132) and IEC 60601-2-18:2009, Medical electrical equipment – Part 2-18 : Particular requirement (FDA-recognized voluntent (FDA-recognized voluntary consensus standard: 9-1 14). Verification and validation testing successfully completed that the device conform with recognized safety standards, design input specifications, user needs and intended uses.
The subject devices do not require clinical studies to support the determination of substantial equivalence.
The 1788 4K Camera System with Advanced Imaging Modality has the same intended use and indications for use, and fundamental technology as the predicate device. In summary, 1788 4K Camera System with Advanced Imaging Modality are the same or similar with respect to safety and effectiveness to the legally marketed predicate device.