(38 days)
Not Found
No
The document describes a standard endoscopic camera system and does not mention any AI or ML capabilities.
No.
The device is an endoscopic camera system used for visualization during surgery, not for direct therapeutic intervention. Its function is to view surgical sites, which aids in performing surgical procedures, but it does not treat or cure conditions itself.
No
The device is an endoscopic camera system used for visualization during surgical procedures, not for making diagnoses.
No
The device description explicitly states that the system consists of hardware components including a Camera Control Unit (CCU), a Coupler, and a Camera Head. It also mentions sterilization of the Coupler and Camera Head, which are physical components.
Based on the provided information, the Stryker Precision HD Camera System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done in vitro (in a lab setting, outside the body).
- Stryker Precision HD Camera System Function: This device is an endoscopic camera system used for direct visualization of internal anatomical sites during surgical procedures. It captures optical images from within the body.
The intended use and device description clearly indicate that this system is used for surgical visualization in vivo (within the living body), not for testing specimens in vitro.
N/A
Intended Use / Indications for Use
The Stryker Precision HD Camera System 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 listed below.
- laparoscopic cholecystectomy
- laparoscopic hernia repair
- laparoscopic appendectomy
- laparoscopic pelvic lymph node dissection
- laparoscopically assisted hysterectomy
- laparoscopic and 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
- examination of the evacuated cardiac chamber during performance of valve replacement
The users of the 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 Stryker Precision HD Camera Systems (hereafter referred to as "proposed device") is an endoscopic camera system that is used together with an endoscope to view endoscopic surgical sites on video monitors. The system consists of a Camera Control Unit (CCU), a Coupler, and a Camera Head with an integral cable that connects to the CCU. 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. Sterilization of the Coupler and Camera Head is required before use. The Coupler and Camera Head can be sterilized using steam sterilization.
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
The users of the camera are 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 Precision HD Camera System was tested for performance in accordance with internal design specification and with the applicable performance standards.
Electrical safety and electromagnetic compatibility testing was performed in accordance to the standards listed below. Testing indicates that the proposed device conforms to these standards.
- ANSI/AAMI ES60601-1:2005+A2 (R2012) + A1- Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
- IEC60601-1-2:2007 - Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility - Requirements and Tests,
- IEC60601-2-18:2009 Medical Electrical Equipment Part 2-18: Particular Requirements for the Basic Safety and Essential Performance of Endoscopic Equipment
Software was developed, tested, and verified per FDA guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and IEC 62304:2006 - Medical Device Software - Software Life Cycle Processes. The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could result in minor injury to the patient or operator.
The cleaning instructions provided in the labeling for reusable components were validated. Sterilization validation testing activities were performed in accordance with ISO 14937:2009- Sterilization of Health Care Products — General Requirements for Characterization of a Sterilizing Agent and the Development. Validation and Routine Control of a Sterilization Process for Medical Devices.
Bench performance testing was conducted to ensure that the device functioned as intended and met design specifications and acceptance criteria. Bench testing included video compatibility, DVI compliance, and system compatibility. Test results obtained verified the safety and effectiveness of the devices per design specifications and applicable standards.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of a stylized eagle or bird with three human profiles incorporated into its design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 23, 2014
Stryker Endoscopy Mr. Dave Yungvirt Third Party Review Group, LLC 45 Rockefeller Plaza, Suite 2000 New York, New York 10111
Re: K142603
Trade/Device Name: Stryker Precision HD Camera System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GJC Dated: October 9, 2014 Received: October 10, 2014
Dear Ms. Yungvirt:
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, 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 801); medical device reporting (reporting of medical
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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.
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142603
Device Name
Stryker Precision HD Camera System
Indications for Use (Describe)
The Stryker Precision HD Camera System 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 listed below.
- · laparoscopic cholecystectomy
- · laparoscopic hernia repair
- · laparoscopic appendectomy
- laparoscopic pelvic lymph node dissection
- · laparoscopically assisted hysterectomy
- · laparoscopic and 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
- · examination of the evacuated cardiac chamber during performance of valve replacement
The users of the camera are general surgeons, gynecologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
Image /page/3/Picture/1 description: The image shows the Stryker logo in black and white. The logo is a stylized wordmark with a bold, sans-serif font. The registered trademark symbol is located to the right of the word "Stryker".
510(k) SUMMARY
1) General Information
| 510(k) Sponsor | Stryker Endoscopy |
|---|---|
| Address | 5900 Optical Court |
| San Jose, CA 95138 | |
| FDA Registration Number | 2936485 |
| Correspondence Person | Angela Wong |
| Staff Regulatory Affairs Analyst | |
| Stryker Endoscopy | |
| Contact Information | Email: angela.wong @ stryker.com |
| Phone: (408) 754-2737 | |
| Date Prepared | 10 September 2014 |
2) Proposed Device
| Proprietary Name | Stryker Precision HD Camera System |
|---|---|
| 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 |
3) Predicate Device
| Proprietary Name | Stryker 1488 HD Video Camera with Infrared Compatibility |
|---|---|
| Common Name | 3-Chip Video Camera |
| Premarket Notification | K132785 |
| Classification Name | Laparoscope, General and Plastic Surgery |
| Regulation Number | 21 CFR 876.1500 |
| Product Code | GCJ |
| Regulatory Class | II |
4
4) Device Description
The Stryker Precision HD Camera Systems (hereafter referred to as "proposed device") is an endoscopic camera system that is used together with an endoscope to view endoscopic surgical sites on video monitors. The system consists of a Camera Control Unit (CCU), a Coupler, and a Camera Head with an integral cable that connects to the CCU. 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. Sterilization of the Coupler and Camera Head is required before use. The Coupler and Camera Head can be sterilized using steam sterilization.
ട്) Indication for Use
The Stryker Precision HD Camera System 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 listed below.
- laparoscopic cholecystectomy
- laparoscopic hernia repair
- laparoscopic appendectomy ●
- . laparoscopic pelvic lymph node dissection
- laparoscopically assisted hysterectomy
- laparoscopic and 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 ●
- examination of the evacuated cardiac chamber during performance of valve ● replacement
The users of the camera are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
5
Stryker® Precision HD Camera System. 510(k) Summary
6) Comparison of Technological Characteristics with the Predicate Device
The Stryker Precision HD Camera System has the same technological characteristics and design as the predicate device except the following features:
- a) A change in sterilization method Uses steam sterilization method
- b) A change in sensor technology within the camera head Uses Charge-coupled device (CCD) sensor
- c) Modification to the surgical mode selection on the CCU's interface touchscreen -It should be noted that the Stryker Precision HD Camera System does not include "Infrared" surgical mode selection on its interface touchscreen but it is sensitive to Infrared band. The proposed device maintains its Infrared capability by displaying the Infrared light as red image when used with Stryker Infravision Illuminator.
All other technological characteristics of both proposed and predicate devices are identical. Both devices consist of three main components: a camera head, a coupler, and a Camera Control Unit (CCU). Both devices receive optical image from a variety of scopes that are attached to the camera head via coupler and use image sensor to convert optical image into electronic signal. Both camera heads feature a button keypad for controlling of the device itself and the connected video peripheral devices. Both camera systems are sensitive to specific IR band.
The Camera Control Unit (CCU) of both devices contains software and acts as the control center of the device. The CCU of both devices contains a touchscreen with graphical user interface (GUI). The touchscreen menu of both devices has pre-defined surgical mode selections menu to allow users to optimize camera setting base on different surgical specialties.
The CCU of both devices is not intended to enter the sterile field, and should not be sterilized. The camera head and coupler of both devices are reusable devices and shall be sterilized prior to the first use and after every subsequent use.
7) Performance Data
The Precision HD Camera System was tested for performance in accordance with internal design specification and with the applicable performance standards.
Electrical safety and electromagnetic compatibility testing was performed in accordance to the standards listed below. Testing indicates that the proposed device conforms to these standards.
6
Stryker® Precision HD Camera System. 510(k) Summary
- . ANSI/AAMI ES60601-1:2005+A2 (R2012) + A1- Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
- . IEC60601-1-2:2007 - Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility - Requirements and Tests,
- IEC60601-2-18:2009 Medical Electrical Equipment Part 2-18: Particular ● Requirements for the Basic Safety and Essential Performance of Endoscopic Equipment
Software was developed, tested, and verified per FDA guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and IEC 62304:2006 - Medical Device Software - Software Life Cycle Processes. The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could result in minor injury to the patient or operator.
The cleaning instructions provided in the labeling for reusable components were validated. Sterilization validation testing activities were performed in accordance with ISO 14937:2009- Sterilization of Health Care Products — General Requirements for Characterization of a Sterilizing Agent and the Development. Validation and Routine Control of a Sterilization Process for Medical Devices.
Bench performance testing was conducted to ensure that the device functioned as intended and met design specifications and acceptance criteria. Bench testing included video compatibility, DVI compliance, and system compatibility. Test results obtained verified the safety and effectiveness of the devices per design specifications and applicable standards.
8) Conclusion
Base on the indication of use, technological characteristic, performance testing and comparison to the predicate device, the Stryker Precision HD Camera System raises no new questions of safety and effectiveness as compared to the predicate device and is substantially equivalent to the predicate devices in terms of safety, efficacy and performance.