ENDOSCOPIC CAMERA TC804/C4

K014158 · World of Medicine Lemke GmbH · GCJ · Mar 14, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K014158
• Device Name: ENDOSCOPIC CAMERA TC804/C4
• Applicant: World of Medicine Lemke GmbH
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Mar 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Endoscopic Camera TC804/C4 is intended to attach to standard endoscopes to permit visualization of body cavities, hollow organs and canals during endoscopic procedures. It also may be attached to a microscope. The endoscopic image can be displayed on any standard video monitor.

Device Story

Endoscopic Camera TC804/C4 is a 3-CCD camera system comprising a camera control unit (CCU), camera head, connecting objectives, cables, and adapters. Device attaches to standard endoscopes or microscopes to capture visual data from body cavities, hollow organs, and canals. Captured images are transmitted to standard video monitors for real-time viewing by clinicians during endoscopic procedures. System features programmable head buttons and ring-focus adjustment for ambidextrous use. Device assists physicians in visualizing internal anatomy, facilitating diagnostic or surgical decision-making. Used in clinical settings where endoscopic visualization is required.

Clinical Evidence

Bench testing only. Compliance with IEC 601-1, IEC 601-1-2, EN 55011, and UL2601-1 standards confirmed. No clinical data provided.

Technological Characteristics

3-CCD camera system; includes CCU, camera head, and 30mm/25mm/zoom objectives. Features ring-focus and programmable buttons. Operates via standard electrical power. Complies with IEC 601-1, IEC 601-1-2, EN 55011, and UL2601-1 safety standards.

Indications for Use

Indicated for visualization of body cavities, hollow organs, and canals during endoscopic or microscopic procedures in patients undergoing such examinations.

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

• Karl Storz Endovision Tricam, Model 20221101 (202) (K950862)
• Circon MicroDigital IP 6.2 (K914883)
• Image Technologies SteriCam, Coupler-Drape and TrowView Imaging System (K983567)

Submission Summary (Full Text)

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K014158

# MAR 1 4 2002

### 510(K) SUMMARY Endoscopic Camera TC804/C4

#### I. Submitter:

WORLD OF MEDICINE Lemke GmbH Danziger Strasse 21 82194 Groebenzell Germany

#### II. Device Names:

- 1. Classification Name:
- Common or Usual Name: 2.
- 3. Proprietary Name:

Accessory to an Endoscope Endoscopic Camera Endoscopic Camera TC804/C4

#### III. Classification:

Class II. This device is described in 21 C.F.R. § 876.1500. The product code for the device is GCJ.

#### IV. Predicate Devices:

- Karl Storz Endovision Tricam, Model 20221101 (202) (K950862) .
- Circon MicroDigital IP 6.2 (K914883) coup inst. S �
- Image Technologies SteriCam, Coupler-Drape and TrowView Imaging . System (K983567)

#### Intended Use: V.

The Endoscopic Camera TC804/C4 is intended to attach to standard endoscopes to permit visualization of body cavities, hollow organs and canals during endoscopic procedures. It also may be attached to a microscope. The endoscopic image can be displayed on any standard video monitor.

#### VI. Device Description:

The Endoscopic Camera TC804/C4 is a 3-CCD camera, which consists of a camera control unit (CCU), a camera head, various connecting objectives, cables and adapters. The Endoscopic Camera TC804/C4 takes the image through standard endoscopes that would be normally seen with the naked eye, and displays it on any standard video monitor. The camera head is supplied with a standard 30 mm endofocus objective but may also be used with a 25 mm or zoom objective. The device is programmable by two head key bottons and is equipped with a ring-focus for both right-handed and left-handed users.

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### 510(K) SUMMARY Page -2- / -2-

#### VII. Substantial Equivalence:

The Endoscopic Camera TC804/C4 described in this notification is similar in design and construction to the Endovision Tricam, Model 20221101 (202) (K950862) manufactured by Karl Storz Imaging, Inc., the MicroDigital IP 6.2 (K914883) manufactured by Circon Corporation and the device Image Technologies SteriCam, Coupler-Drape and TrowView Imaging System (K983567).

The Endoscopic Camera TC804/C4 and the predicate devices are all intended to permit visualization of body cavities, hollow organs and canals during endoscopic procedures. The camera head of the Endoscopic Camera TC804/C4 and the predicate devices is designed to attach to standard, commercially available, endoscopes and the endoscopic image in the proposed and predicate devices can be displayed on any standard video monitor.

The differences between the proposed and predicate devices are limited to picture quality and handling convenience.

Accordingly, WORLD OF MEDICINE Lemke GmbH believes that the proposed new device, the Endoscopic Camera TC804/C4, is substantially equivalent to the predicate devices currently on the market.

### VIII. Performance Data:

The Endoscopic Camera TC804/C4 complies with the International Standard IEC 601-1. IEC 601-1-2. the European Standard EN 55011 and conforms to the Medical Device Directive 93/42 EEC. The device will be tested in accordance with UL2601-1.

Signed:

S. Raab

Susanne Raab Official Correspondent

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 a stylized representation of a caduceus, a symbol often associated with medicine and healthcare, featuring a staff with a serpent entwined around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2002

World of Medicine Lemke GMBH c/o Susanne Raab Regulatory Consultant 91 Trowbridge Street Cambridge, Massachusetts 02138

Re: K014158

Trade Name: Endoscopic Camera TC804/C4 Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: December 17, 2001 Received: December 19, 2001

Dear Ms. Raab:

We have reviewed your Section 510(k) premarket 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, 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 (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.

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Page 2 - Ms. Susanne Raab

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

iriam C. Provost

Col 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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## STATEMENT OF INDICATIONS FOR USE

| APPLICANT: | |
|------------|--|
|------------|--|

WORLD OF MEDICINE Lemke GmbH

510(K) NUMBER (if known):

DEVICE NAME:

Endoscopic Camera TC804/C4

KO14168

INDICATIONS FOR USE:

The Endoscopic Camera TC804/C4 is intended to attach to standard endoscopes to permit visualization of body cavities, hollow organs and canals during endoscopic procedures. It also may be attached to a microscope. The endoscopic image can be displayed on any standard video monitor.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 C.F.R. § 801.109)

(Optional Format 1-2-96)

Miriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number K0114/58