DAVLITE MICROENDOSCOPE & ACCESSORIES

K020310 · Davlite Technologies · GCJ · Mar 20, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K020310
• Device Name: DAVLITE MICROENDOSCOPE & ACCESSORIES
• Applicant: Davlite Technologies
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Mar 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

This device is to be used by a physician for viewing an interior cavity of the human body through either a natural opening or incision.

Device Story

Davlite Microendoscope is a semi-rigid fiberscope designed for visualization of interior human body cavities. System consists of a reusable microendoscope and a single-use sheath. Device is provided non-sterile and requires sterilization by the physician prior to use. Operated by physicians in clinical settings to view internal anatomy through natural orifices or surgical incisions. Provides direct optical visualization to assist in diagnostic or procedural guidance.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material similarities to predicate devices.

Technological Characteristics

Semi-rigid fiberscope; includes single-use sheath and reusable microendoscope component. Requires sterilization prior to use.

Indications for Use

Indicated for use by physicians to visualize interior human body cavities via natural openings or incisions.

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

• Acueity Microendoscope (Viaduct) (K011189)
• Solos Endoscope (K932987)

Submission Summary (Full Text)

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Davlite Technologies

MAR 2 0 2002

# Summary of Safety and Effectiveness

Trade Name:

The Davlite Microendoscope

Manufacturer Information:

Davlite Technologies 37 Kris Allen Drive Holden, MA 01520

Contact: David A. McNally Phone: [phone] Fax: [phone] E-mail: [e-mail]

Establishment Registration Number: Form FDA 2891 submitted January 21, 2002 (copy next page)

## FDA Device Classification:

| Standard Product Nomenclature: | Laparoscope, General & Plastic Surgery |
|--------------------------------|----------------------------------------|
| Device Description: | Endoscope and Accessories |
| Medical Specialty: | General & Plastic Surgery |
| Product Code: | GCJ |
| Device Class: | 2 |
| 510(K) Exempt? | No |
| Regulation Number | 876.1500 |

## Intended Use and Product Description:

The Davlite Microendoscope will be labeled for the intended use of:

This device is to be used by a physician for viewing an interior cavity of the human body through either a natural opening or incision.

The Davlite Microendoscope is a semi-rigid fiberscope with a single use sheath and a re-useable (reposable) microendoscope. The microendoscope is provided and labeled nonsterile. The microendoscope must be sterilized prior to use. (See instructions for cleaning and sterilization).

# Substantial Equivalence:

Establishment of equivalence is based on similarities of intended use, design, and materials, physical characteristics and geometry between the Davite Microendoscope and Acueity Microendoscope (Viaduct) (K011189) and Solos Endoscope (K932987) among other marketed visualization products.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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 image of an eagle with its wings spread, formed by three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 2 0 2002

Davlite Technologies Mr. David A. McNally President 37 Kris Allen Drive Holden, Massachusetts 01520

Re: K020310

Trade Name: Davlite Microendoscope Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: January 26, 2002 Received: January 29, 2002

Dear Mr. McNally:

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 -- Mr. David McNally .

This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotet notification. The FDA finding of substantial equivalence of your device to a legally prematted 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.

Miriam C. Provost

for 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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Davlite Technologies

# STATEMENT FOR INDICATIONS FOR USE

4070310 510(k) Number:

Device Name: Davlite Microendoscope

Indication for Use:

This device is to be used by a physician for viewing an interior cavity of the human body through either a natural opening or an incision.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Over-the-Counter Use Yes No NO Prescription Use YES or (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number_K0203/D (Division Sign-Off)_

> 020310 510(k) Number: