(115 days)
Not Found
7205292, 7205208
No
The document describes a standard video camera system for endoscopy and explicitly states that it does not mention AI, DNN, or ML.
No
This device is for visualization and illumination during endoscopic procedures, not for direct therapeutic intervention or treatment.
No
This device is used for visualization during surgical procedures to provide illumination and allow visualization, not for diagnosing conditions.
No
The device description explicitly lists hardware components such as a camera control unit, camera head, illuminator, and light guides, indicating it is a hardware system with video capabilities, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for endoscopic surgical procedures to provide illumination and visualization of internal body structures. This is a surgical tool used in vivo (within the living body).
- Device Description: The description reinforces its use in surgical procedures by mating with endoscopes to allow visualization and supplying light to the surgical site.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the living body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
Therefore, the Smith & Nephew Images Digital 3-Chip Color Video Camera System and its components are surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
Smith & Nephew Images Digital 3-Chip Color Video Camera System, illuminators, video components and accessories are indicated for use in endoscopic surgical procedures to provide illumination and allow visualization of articular cavities, body cavities, hollow organs and canals when used in conjunction with an appropriately indicated endoscope.
Additionally, the Smith & Nephew Images Digital 3-Chip Color Video Camera System, consisting of the D-3 Camera Control Unit (REF. 7205292), PEEK Camera Head (REF. 7205208), Smith & Nephew Images Illuminator and Smith & Nephew Images liquid or fiberoptic light guide is indicated for use in endoscopic surgical procedures in the thoracic cavity when used in conjunction with an appropriately indicated thoracoscope.
Product codes
GCJ
Device Description
The Smith & Nephew Images Digital 3-Chip Color Video Camera and Video components mate with the endoscope to allow for visualization during various surgical procedures.
Smith & Nephew Images Illuminators, Light Guides and accessories are designed to supply light to the surgical site through the endoscope. The light guides mate to the endoscope and light source with instrument specific adapters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
articular cavities, body cavities, hollow organs and canals, thoracic cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
current product offerings from Smith & Nephew as well as video components, surgical cameras, illuminators and accessories manufactured by Snowden Pencer DSP, Stryker Endoscopy and Olympus.
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
Endoscopy Division
Smith & Nephew, Inc. 160 Dascomb Road, Andover, MA 01810 U.S.A Telephone: 508-749-1000 Telefax: 508-749-1599
510(k) Summary Smith & Nephew Images Digital 3-Chip Color Video Camera, Illuminators, Video Components and Accessories
Smith = Nephew
OCT 2 4 1997
1972471
Substantial Equivalence
The Smith & Nephew Images Surgical Camera, Illuminators, Video Components and Accessories are substantially equivalent in both design and intended use to surgical cameras, video components and illumination products offered by Snowden Pencer DSP, Strvker Endoscopy and Olympus.
The Video Components, Surgical Cameras, Illuminators and accessories for all of the above referenced manufacturers mate with an endoscope to allow for visualization during various surgical procedures. The Illuminators, Light Guides and accessories mate to the endoscope and deliver light to the surgical site.
Predicate Device:
The predicate devices for this submission are the current product offerings from Smith & Nephew as well as video components, surgical cameras, illuminators and accessories manufactured by Snowden Pencer DSP, Stryker Endoscopy and Olympus.
Summary of Device Function:
The Smith & Nephew Images Digital 3-Chip Color Video Camera and Video components mate with the endoscope to allow for visualization during various surgical procedures.
Smith & Nephew Images Illuminators, Light Guides and accessories are designed to supply light to the surgical site through the endoscope. The light guides mate to the endoscope and light source with instrument specific adapters.
Intended Use of Device:
Smith & Nephew Images Digital 3-Chip Color Video Camera System, illuminators, video components and accessories are indicated for use in endoscopic surgical procedures to provide illumination and allow visualization of articular cavities, body cavities, hollow organs and canals when used in conjunction with an appropriately indicated endoscope.
Additionally, the Smith & Nephew Images Digital 3-Chip Color Video Camera System, consisting of the D-3 Camera Control Unit (REF. 7205292), PEEK Camera Head (REF. 7205208), Smith & Nephew Images Illuminator and Smith & Nephew Images liguid or fiberoptic light guide is indicated for use in endoscopic surgical procedures in the thoracic cavity when used in conjunction with an appropriately indicated thoracoscope.
1
Comparison of Technological Characteristics of Predicate Devices:
The basic design and function of the Smith & Nephew Images Surgical Camera, Illuminators, Video Components and Accessories are unchanged compared to information provided in previous submissions. All electromechanical equipment complies with UL544, EN 55011, IEC 601-1 and IEC 601-2-18. The Smith & Nephew Images Digital 3-Chip Color Video Camera Head complies with the appropriate electrical safety standards for use in the thoracic cavity. Smith & Nephew Images Surgical Camera, Illuminators, Video Components and Accessories are substantially equivalent in both design and intended use to surgical cameras, video components and illumination products offered by Snowden Pencer DSP, Stryker Endoscopy and Olympus.
Webnak Conne
Deborah Connors Regulatory Affairs Department
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 1997
Ms. Deborah J. Connors Regulatory Affairs Specialists Smith & Nephew, Inc. 160 Dascomb Road Andover, Massachusetts 01810
Re: K972471
Trade Name: Smith & Nephew Endoscopy Images Digital 3-Chip Color Video Camera, Illuminators, Video Components and Accessories Regulatory Class: II Product Code: GCJ Dated: September 23, 1997 Received: September 24, 1997
Dear Ms. Connors:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the devices, 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.
If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Deborah J. Connors
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number :
Device Name : Smith & Nephew, Inc., Endoscopy Division Images Digital 3-Chip Color Video Camera, Illuminators, Video Components and Accessories
Indications for Use :
Smith & Nephew Images Digital 3-Chip Color Video Camera System, illuminators, video components and accessories are indicated for use in endoscopic surgical procedures to provide illumination and allow visualization of articular cavities, body cavities, hollow organs and canals when used in conjunction with an appropriately indicated endoscope.
Additionally, the Smith & Nephew Images Digital 3-Chip Color Video Camera System, consisting of the D-3 Camera Control Unit (REF. 7205292), PEEK Camera Head (REF. 7205208), Smith & Nephew Images Illuminator and Smith & Nephew Images liquid or fiberoptic light guide is indicated for use in endoscopic surgical procedures in the thoracic cavity when used in conjunction with an appropriately indicated thoracoscope.
(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K972471 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-the-Counter |
|---|---|---|
| X |
(Optional Format 1-2-96)