SONY DXC-LS1 COLOR VIDEO CAMERA

K980279 · Sony Medical Electronics Co. · GCJ · Apr 24, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980279
• Device Name: SONY DXC-LS1 COLOR VIDEO CAMERA
• Applicant: Sony Medical Electronics Co.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Apr 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Sony DXC-LS1 Color Video Camera is intended for use in capturing video images for display and storage in applications such as surgery, microsurgery, endoscopy, dentistry and microscopy.

Device Story

The Sony DXC-LS1 is a color video camera designed for medical environments where space is limited. It captures optical video images using Hyper HAD Charge-Coupled Device (CCD) image sensors. The device functions as part of a system including lenses, adaptors, and cables to facilitate image acquisition for display, recording, and printing. It is used by clinicians in settings such as operating rooms, dental offices, and microscopy labs. The output provides visual information to assist healthcare providers in performing and documenting surgical, microsurgical, endoscopic, and dental procedures. The device benefits patients by enabling high-resolution visualization and documentation of medical interventions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Color video camera utilizing Hyper HAD Charge-Coupled Device (CCD) image sensors. Features a compact form factor for space-limited applications. System includes various lenses, adaptors, and cables. No specific software algorithm or connectivity standards mentioned.

Indications for Use

Indicated for capturing video images for display and storage during medical procedures including surgery, microsurgery, endoscopy, dentistry, and microscopy.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Sony DXC-750MD Color Video Camera (K884343)
• Sony DXC-101/102 Series Color Video Camera (K884343)

Submission Summary (Full Text)

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# APR 2 4 1998

# 510(k) SUMMARY FOR SONY DXC-LS1 COLOR VIDEO CAMERA

K980279

## Applicant: 1.

Sony Medical Systems Division Sony Electronics Inc. 1 Sony Drive Park Ridge, NJ 07656

Anthony John Kefalos Contact Person: 201-358-4330 Telephone:

Date Prepared: January 22, 1998

### Device Name 2.

| Proprietary Name: | Sony DXC-LS1 Color Video Camera |
|------------------------|-------------------------------------------------------------------------------|
| Common/Usual Name: | Color Video Camera |
| Classification Status: | Surgical Camera and Accessories; and Dental<br>Operative Unit and Accessories |

### Predicate Devices 3.

Sony DXC-750MD Color Video Camera Sony Medical Systems Division K884343

Sony DXC-101/102 Series Color Video Camera Sony Medical Systems Division K884343

#### Device Description 4.

The Sony DXC-LS1 is a progression in the DXC line of cameras. The DXC-LS1 is designed specifically for applications where space is limited. A comprehensive system of adaptors, lenses, cables and other accessories is available. These

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accessories enable the camera to be used in various medical applications including surgery, microsurgery, endoscopy, dentistry and microscopy, and other general medical procedures involving reproduction of video images.

#### Intended Use 5.

The Sony DXC-LS1 Color Video Camera is intended for use in capturing video images for display and storage in applications such as surgery, microsurgery, endoscopy, dentistry and microscopy.

#### Technological Characteristics Q.

The DXC-LS1 Color Video Camera is intended as an addition to the Sony video camera product line. The DXC-LS1 has the same general purpose and function a s the predicate devices identified above. These cameras are intended to be used to capture medical images for display, recording and printing. The primary difference between the Sony DXC-LS1 Color Video Camera and the substantially equivalent devices is the higher resolution and smaller size for use where space is critical. Also, the Charge-Coupled Device (CCD) image sensors used in the DXC-LS1 employ the Hyper HAD technology.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 4 1998

Ms. Cynthia A. Sinclair ·Senior Staff Consultant Sony Medical Electronics Company c/o Medical Device Consultant, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Re: K980279 Trade Name: Sony DXC-LS1 Color Video Camera Regulatory Class: II Product Code: GCJ Dated: January 22, 1998 January 26, 1998 Received:

Dear Ms. Sinclair:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general-controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device 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 requirement, as set forth in the Quality System Requlation (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 In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission 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.

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# Page 2 - Ms. Sinclair

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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510(k) Number (if known): K980279

Device Name:_Sony DXC-LS1 Color Video Camera

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Indications For Use:

The Sony DXC-LS1 Color Video Camera is intended for use in capturing video images for I inc Don't 2110 22 - 2011 as surgery, microsurgery, microsurgery, endoscopy, dentistry and microscopy.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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