CARDIOVATIONS PORTABLE VIDEO SYSTEM

K032339 · ETHICON, Inc. · GCJ · Aug 8, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K032339
• Device Name: CARDIOVATIONS PORTABLE VIDEO SYSTEM
• Applicant: ETHICON, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Aug 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

The CardioVations Portable Video System is intended to be used as an accessory in any endoscopic procedures that require a viewing distance up to 2 inches (5cm), when used with many rigid B-Style (32mm diameter eyecup) endoscopes.

Device Story

CardioVations Portable Video System is a self-contained endoscopic accessory providing visualization for procedures requiring viewing distances up to 2 inches. System components include a battery-powered Video System Controller (worn by user under sterile gown), camera heads (NTSC or PAL) with integrated light source and umbilical cable, and a heads-up display or standard monitor. User connects sterilized camera/light source to a rigid B-style endoscope; circulating nurse connects cable to controller. User performs manual focus and white balance via push-and-lock button. Controller provides power to camera/light source. Device benefits include portability compared to cart-mounted systems. Output is a video image displayed for the clinician to guide endoscopic procedures.

Clinical Evidence

Bench testing only. Pre-clinical evaluation assessed essential performance characteristics, specifically the ability to produce quality video images (color, clarity, brightness, contrast). Results concluded image quality is comparable to the predicate device. Compliance with electrical safety standards IEC 60601-1-2 and IEC 60601-2-18 was verified.

Technological Characteristics

Portable endoscopic video system. Components: battery-powered controller (lithium-ion), camera head with integrated light source, umbilical cable, and display. Connectivity: wired connection between camera head and controller. Sterilization: camera head, light source, and cable are sterilizable. Power: rechargeable battery. Form factor: wearable controller. Standards: IEC 60601-1-2, IEC 60601-2-18.

Indications for Use

Indicated for use as an accessory in endoscopic procedures requiring a viewing distance up to 2 inches (5cm) when used with rigid B-style (32mm diameter eyecup) endoscopes.

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.

Submission Summary (Full Text)

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## SECTION 8

# SUMMARY OF SAFETY AND EFFECTIVENESS

| 510(k) Summary of<br>Safety and<br>Effectiveness | Information supporting claims of substantial equivalence,<br>as defined under the Federal Food, Drug and Cosmetic Act<br>respecting safety and effectiveness is summarized below.<br>For the convenience of the Reviewer, this summary is<br>formatted in accordance with the Agency's final rule<br>"...510(k) Summaries and 510(k) Statements..." (21 CFR<br>807) and can be used to provide a substantial equivalence<br>summary to anyone requesting it from the Agency. |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Peter Cecchini<br>Manager, Regulatory Affairs<br>ETHICON, Inc.<br>Rt. #22, West<br>Somerville, NJ 08876-0151<br>Telephone: [phone] |
| Date | July 24, 2003 |
| Device Name | Classification Name: Accessory to an endoscope<br>Common Name: Endoscopic Camera System<br>Proprietary Name: CardioVations Portable Video System |
| Device<br>Description | The CardioVations Portable Video System is a self<br>contained system that is used as an endoscopic accessory to<br>provide visualization during any endoscopic procedure that<br>requires a viewing distance up to 2 inches (5 cm), when |
| | Continued on next page |
| Device<br>Description<br>(Con't) | used with many B-style eyecup rigid endoscopes. The<br>system consists of the following components:<br><br>• Video System Controller (Pack)<br>• Camera Heads (PAL, NTSC) with Light Source<br>and Cable (Umbilical)- as one unit<br>• Heads-up Display (serves as a monitor or can be<br>connected to a monitor).<br>• Battery Charger and Universal Power Supply |
| | There are three main components of the Cardio Vations<br>Portable Video System. These components are the Video<br>System Controller (camera control unit) that is powered by<br>a lithium ion rechargeable battery pack and worn by the<br>user under the sterile gown, a Video Display (Heads-Up<br>Video Display or standard monitor display) description and<br>camera head (two, NTSC or PAL) and compact light source<br>and cable. Only the camera head, light source and<br>connection cable can be sterilized. |
| | The Video System Controller provides power to the camera<br>head and light source through the umbilical cable. The<br>camera and light source is connected to an endoscope for<br>visualization. In use, the camera, light source and cable are<br>brought to the sterile field after being sterilized. The user<br>connects them to a sterile endoscope and passes the cable<br>off to a circulating nurse using appropriate sterile<br>technique. The circulating nurse connects the cable to the<br>control unit and turns the power on. The user then focuses<br>the camera and white balances the unit by pressing the push<br>and lock white balance button. The camera control unit<br>and batteries are designed to be reused indefinitely, while<br>the camera head can be reused 34 times before it needs to<br>be replaced. |
| Intended Use | The CardioVations Portable Video System is intended to be<br>used as an accessory in any endoscopic procedures that<br>require a viewing distance up to 2 inches (5cm), when used<br>with many rigid B-Style (32mm diameter eyecup)<br>endoscopes. |
| Indications Statement | The CardioVations Portable Video System is designed to<br>be used as an accessory in any endoscopic procedures that<br>require a viewing distance up to 2 inches (5cm), when used<br>with many rigid B-Style (32mm diameter eyecup)<br>endoscopes. |
| Technological<br>Characteristics | The new device has similar technological characteristics<br>as the predicate device. Both the new and the predicate<br>device are video cameras intended as endoscopic<br>accessories. Both devices can be connected to a monitor to<br>provide visualization of the surgical field. The new device<br>is battery operated with a portable camera controller that<br>can be worn by the user. The predicate device is powered<br>by line voltage and the controller is mounted on a cart in<br>the operating room. |
| Performance Data<br>for New Device | The CardioVations Portable Video System will be tested<br>compliance with the electrical standards, International<br>Electrotechnical Commission, IEC 60601-1-2 and IEC<br>60601-2-18, Particular Requirements for Safety of<br>Endoscopic Equipment. |
| | Pre-clinical testing was conducted to demonstrate that the<br>CardioVations Portable Video System performed as<br>clinically intended. In a pre-clinical evaluation , the<br>essential performance characteristic assessed was the<br>ability of the system to produce a quality video image in<br>terms of color, clarity, brightness and contrast. The results<br>of the testing concluded that video image quality of the new<br>device is comparable to the predicate device. |
| Conclusion | Based on the 510(k) summaries and 510(k) statements (21<br>CFR 807) and the information provided herein, we<br>conclude that the new device is substantially equivalent to<br>the Predicate Devices under the Federal Food, Drug, and<br>Cosmetic Act. |

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## SUMMARY OF SAFETY AND EFFECTIVENESS (Continued)

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# SUMMARY OF SAFETY AND EFFECTIVENESS (Continued)

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 8 2003

Ethicon, Inc. c/o Mr. Robert Mosenkis President Citech 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298

Re: K032339

Trade/Device Name: CardioVations Portable Video System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: July 28, 2003 Received: July 29, 2003

Dear Mr. Mosenkis:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.

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Page 2 - Mr. Robert Mosenkis

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE

| 510(k) Number (if known): | K032339 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | CardioVations Portable Video System |
| Indications for Use: | The CardioVations Portable Video System is designed to be used<br>as an accessory in any endoscopic procedures that require a<br>viewing distance up to 2 inches (5cm), when used with many rigid<br>B-style (32mm diameter eyecup) endoscopes. |

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

> Prescription Use _ (Per 21 CFR 801.109)

OR

Over-The Counter Use

(Optional Format 1-2-9G)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

CardioVations Portable Video systems) Num ETHICON, Inc

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