MICROENDOSCOPE, MINIATURIZED BIOPSY SCOPE

K983527 · Dofi Technologies, Inc. · GCJ · Jan 19, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K983527
• Device Name: MICROENDOSCOPE, MINIATURIZED BIOPSY SCOPE
• Applicant: Dofi Technologies, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jan 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

Use for visualization inside the human body to view surgical procedure(s), by physician.

Device Story

The Miniature Endo/Laparoscope is a medical visualization device used by physicians to view soft tissue inside the human body during surgical procedures. It is inserted through natural orifices or surgical incisions to provide internal visualization. The device functions as an endoscope/laparoscope, allowing the practitioner to observe the surgical site directly. It is intended for use in clinical or surgical settings. The device is physically identical to the predicate device, with minor miniaturization changes that do not impact safety or effectiveness.

Clinical Evidence

No clinical data provided; substantial equivalence is based on physical and technological comparison to the predicate device.

Technological Characteristics

Miniature endoscope/laparoscope for soft tissue visualization. Device utilizes standard endoscopic optical/mechanical technology. Materials, biocompatibility, and manufacturing processes are stated to be identical to the predicate device. No specific software, energy source, or connectivity features are described.

Indications for Use

Indicated for medical practitioners needing visualization of soft tissue, either through a natural orifice or incision.

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

• Solos Endoscopy (K983538)

Reference Devices

• K936857
• K935834
• Omega (K91109C)
• Candela Laser (K910732)
• Fujinon
• Olympus
• Baxter
• Stryker
• Linyatec
• Karl Storz
• Pentax

Submission Summary (Full Text)

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## JAN 1 9 1999

### DOFI COMMUNICATIONS provides the following 510(k) Summary:

We have taken the terminology from the Reference Manual-"Pre-market Notification 510(k): Regulatory Requirements for Medical Devices" (FDA 92-4158).

### Summarv

DOFI Communications confirms that the Miniature Endo/Laparoscope listed in this 510(k) is IDENTICAL in every way to the device marketed by Solos Endoscopy under K983538 and therefore this device is Substantially Equivalent, in terms of physical characteristics, to the legally marketed devices already in commercial distribution, These other devices are made/marketed by Solos Endoscopy, Inc., Mitsubishi Inc. America, and no less than 20 other companies with similar devices with very similar characteristics. These other devices now under commercial distribution are K936857. and K935834. Others with very similar characteristics are listed and under commercial distribution by Omega under K91109C and Candela Laser under K910732. Other manufacturer's, such as, but not limited to; Fujinon, Olympus, Baxter, Stryker, Linyatec, Karl Storz et al, market similar devices and are cited in this document as having similar and verv comparable products

The design of SOLOS ENDOSCOPY made/marketed endoscope K983538 is identical in every way as the scope approved for intended uses that are listed in this document. The assessment of this device, from DOFI COMMUNICATIONS', point of view is as follows: The physical characteristics, except for miniaturization, are identical as the approved device and this predicate device has been accepted with respect to: performance specifications, composition, intended use, technology employed, biocompatibility, manufacturing, QC, physical testing, etc. These above minor changes have no impact on the safe use and/or effectiveness of the device.

For information purposes and completeness DOFI COMMUNICATIONS has also cited the other legally marketed devices ie: (Olympus, Pentax, etc.), in this filing to illustrate the wide, general use of many other similar devices. This wide use has led to the safe use of the device in many practitioner's hands for the same intended use-Use for visualization inside the human body to view surgical procedure(s), by physician.'

DOFI COMMUNICATIONS, therefore, contends there is Substantial Equivalence of the device and the device's Intended Uses.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 9 1999

Mr. Tony Anthony President and Chief Executive Officer DOFI Communications, Inc. 150 West 51st Street, Suite 1108 New York. New York 10019

Re: K983527

> Trade Name: Miniature Endo/Laparoscope Regulatory Class: II Product Code: GCJ Dated: December 22, 1998 Received: January 11, 1999

Dear Mr. Anthony:

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, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) 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 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 - Mr. Tony Anthony

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 regulation (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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Page 1 of 1

# 510(k) #: K983527

Device Name: Miniature Endo/Laparoscope

## Indications for Use:

The Indications for this device use is for medical practitioner needing visualization of soft tissue, either through a natural orifice or incision.

## Intended Use:

'Use for visualization inside the human body to view surgical procedure(s), by physician. '

Prescription Use
(Per 21 CFR 801.109)

ccelo

(Divisio Division of General Restor 510(k) Number