(101 days)
No
The document describes a standard video camera system for endoscopic procedures, focusing on image capture and transmission. There is no mention of AI, ML, or advanced image processing beyond basic video display.
No
The device is a video camera used for visualization during surgical procedures, not for direct treatment or therapy. It aids in the performance of therapy but does not provide it.
No
The device is described as a video camera used to view surgical sites for visualization during endoscopic procedures, not to diagnose a condition.
No
The device description clearly states it is a "Video Camera" system with a "system control unit (CCU)" and a "camera head," indicating it is a hardware device with associated software.
Based on the provided information, the Stryker 1488 HD Video Camera with Infrared Compatibility is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside of the living body (in vitro).
- Device Function: The Stryker 1488 HD Video Camera is used to visualize internal anatomical structures during surgical procedures. It captures optical images directly from the surgical site within the patient's body.
- Intended Use: The intended use clearly describes its application in various surgical procedures for visualization, not for analyzing specimens.
Therefore, the device's function and intended use fall under the category of a surgical imaging device used for direct visualization within the body, not for in vitro testing of specimens.
N/A
Intended Use / Indications for Use
The Stryker 1488 HD Video Camera with Infrared Compatibility is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic anterior spinal fusion, anterior cruciate ligament reconstruction, knee arthroscopy, shoulder 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 Stryker 1488 HD Video Camera with Infrared Capability are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
The Stryker 1488 HD Video Camera with Infrared Compatibility is an endoscopic camera system that is used to produce still and video images 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 system consists of a camera control unit (CCU) and a camera head with an integral cable that connects to the CCU.
Product codes
GCJ
Device Description
The Stryker 1488 HD Video Camera with Infrared Compatibility (hereafter referred to as “proposed device”) is used to view endoscopic surgical sites on video monitors. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible scopes that are attached to the camera head using an optical coupler or by direct connection. The system is sensitive in the visible and infrared spectrum. The system control unit (CCU) and a camera head with an integral cable that connects to the CCU. The camera will provide a high quality image while remaining lightweight and easy to use. The system is intended to be used in orthopedic, laparoscopic, endoscopic, urological, microscopic, sinuscopic and plastic surgery and in dentistry, cardiology and wherever endoscopic procedures are deemed appropriate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT 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)
The proposed device was tested for performance in accordance with internal design specifications and with the applicable performance standards. Risk analysis was carried out, and subsequently design verification/validation activities and corresponding acceptance criteria were identified and performed in accordance with the risk analysis assessment.
Electrical safety and electromagnetic compatibility testing was performed in accordance to IEC 60601-1:2005 and IEC 60601-1-2:2007, respectively. Testing indicates that the proposed device conforms to the aforementioned voluntary standards.
The software validation activities were performed in accordance with IEC 62304:2006/AC: 2008 as well as the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
The sterilization validation testing activities were performed in accordance with ISO 14937:2009 as described in Section 11, Device Description.
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
Stryker® 1488 HD Video Camera with Infrared Compatibility, Traditional 510(k)
DEC 1 6 2013
1. General Information
| 510(k) Sponsor | Stryker Endoscopy |
|---|---|
| Address | 5900 Optical Court |
| San Jose, CA 95138 | |
| FDA Registration Number | 2936485 |
| Correspondence Person | Lifei Liu |
| Associate Regulatory Affairs Manager | |
| Stryker Endoscopy | |
| Contact Information | Email: lifei.liu@stryker.com |
| Phone: (408) 754-2315 |
IMMAR
Device Identification 2.
Proposed Device:
| Proprietary Name | Stryker 1488 HD Video Camera with Infrared Compatibility |
|---|---|
| Common Name | 3-Chip Video Camera |
| Classification Name | Laparoscope, General and Plastic Surgery |
| Regulation Number | 21 CFR 876.1500 |
| Product Code | GCJ |
| Regulatory Class | II |
| Predicate Device: | ||
|---|---|---|
| Proprietary Name | Stryker Model 888 Video Camera |
|---|---|
| Common Name | 3-Chip Video Camera |
| Premarket Notification | K983566 |
| Classification Name | Laparoscope, General and Plastic Surgery |
| Regulation Number | 21 CFR 876.1500 |
| Product Code | GCJ |
| Regulatory Class | II |
3. Device Description
The Stryker 1488 HD Video Camera with Infrared Compatibility (hereafter referred to as "proposed device") is used to view endoscopic surgical sites on video monitors. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible scopes that are attached to the camera head using an optical coupler or by direct connection. The system is sensitive in the visible and infrared spectrum. The system control unit (CCU) and a camera head with an integral cable that connects to the CCU. The camera will provide a high quality image while remaining lightweight and easy to use. The system is intended to be used in orthopedic, laparoscopic, endoscopic, urological, microscopic, sinuscopic and plastic surgery and in dentistry, cardiology and wherever endoscopic procedures are deemed appropriate.
4. Indications for Use
The Stryker 1488 HD Video Camera with Infrared Compatibility is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic
1
Stryker® 1488 HD Video Camera with Infrared Compatibility, Traditional 510(k)
appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectorny, laparoscopic & thorascopic anterior spinal fusion, anterior cruciate ligament reconstruction, knee arthroscopy, shoulder 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 Stryker 1488 HD Video Camera with Infrared Compatibility are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons and urologists.
5. Intended Use
The Stryker 1488 HD Video Camera with Infrared Compatibility is an endoscopic camera system that is used to produce still and video images 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 system consists of a camera control unit (CCU) and a camera head with an integral cable that connects to the CCU.
Technological Comparison 6.
The proposed device has the same technological characteristics as the predicate device in the following areas:
- . Operating principle
- Software architecture .
- Electrical characteristics .
- . Mechanical characteristics
- Performance characteristics .
- . Energy source
7. Performance Testing
The proposed device was tested for performance in accordance with internal design specifications and with the applicable performance standards. Risk analysis was carried out, and subsequently design verification/validation activities and corresponding acceptance criteria were identified and performed in accordance with the risk analysis assessment.
Electrical safety and electromagnetic compatibility testing was performed in accordance to IEC 60601-1:2005 and IEC 60601-1-2:2007, respectively. Testing indicates that the proposed device conforms to the aforementioned voluntary standards.
The software validation activities were performed in accordance with IEC 62304:2006/AC: 2008 as well as the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
The sterilization validation testing activities were performed in accordance with ISO 14937:2009 as described in Section 11, Device Description.
While no device specific guidance document from FDA was applicable to the proposed device, Stryker Endoscopy has chosen to comply with the following voluntary standards, which are recognized consensus standards for the product code GCJ:
| Standard | Title of Standard |
|---|---|
| IEC 60601-2-18: 2009 | Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
2
| ISO 8600-1: 2005 | Optics and photonics -- Medical endoscopes and endotherapy devices -- Part
1: General requirements |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 8600-4: 1997 | Optics and optical instruments -- Medical endoscopes and certain accessories
-- Part 4: Determination of maximum width of insertion portion |
| ISO 8600-3: 1997 +
Amendment 1 | Optics and optical instruments - Medical endoscopes and endoscopic
accessories Part 3: Determination of field of view and direction of view of
endoscopes with optics |
| ISO 8600-5: 2005 | Optics and photonics - Medical endoscopes and endotherapy devices - Part
5: Determination of optical resolution of rigid endoscopes with optics |
| ISO 8600-6: 2005 | Optics and photonics - Medical endoscopes and endotherapy devices - Part
6: Vocabulary |
Stryker® 1488 HD Video Camera with Infrared Compatibility, Traditional 510(k)
8. Conclusion
The Stryker 1488 HD Video Camera with Infrared Compatibility has the following similarities as compared to its predicated device:
- Identical indications for use, .
- Same Intended Use .
- Same technological characteristics .
In conclusion, the proposed device raises no new questions of safety and effectiveness as compared to its predicate device. Therefore, the proposed device is substantially equivalent to the predicate device Stryker Model 888 Video Camera.
3
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Stryker Endoscopy Lifei Liu 5900 Optical Court San Jose, California 95138
December 16, 2013
Re: K132785
Trade/Device Name: Stryker 1488 HD Video Camera with Infrared Compatibility Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: November 18, 2013 Received: November 19, 2013
Dear Lifei Liu:
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. The general controls provisions of the Act include requirements for annual registration. Ilsting 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Lifei Liu
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joshua C. Nipper -S
Binita Ashar, MD, MBA, FACS Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Stryker® 1488 HD Video Camera with Infrared Compotibility, Traditional 510(k) INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K132785
Device Name: Stryker 1488 HD Video Camera with Infrared Compatibility
Indications for Use:
The Stryker 1488 HD Video Camera with Infrared Compatibility is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic anterior spinal fusion, anterior cruciate ligament reconstruction, knee arthroscopy, shoulder 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 Stryker 1488 HD Video Camera with Infrared Capability are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
Over-The-Counter Use != ... AND/OR Prescription Use X (21 CFR 801 Subpart C) " (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) for BSA Division of Surgical Devices
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510(k) Number K132785