DESIGNS FOR VISION FIBEROPTIC LIGHT

K032283 · Designs For Vision, Inc. · GDB · Aug 20, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K032283
• Device Name: DESIGNS FOR VISION FIBEROPTIC LIGHT
• Applicant: Designs For Vision, Inc.
• Product Code: GDB · Gastroenterology, Urology
• Decision Date: Aug 20, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Designs for Vision Fiberoptic Light is indicated for use in surgery and medical applications where high intensity illumination is required.

Device Story

Device provides high-intensity illumination for surgical and medical procedures. System comprises 150-watt light source, fiberoptic cables, and fiberoptic headsets. Headsets available in coaxial, bifurcated, or focusable configurations. Light source features continuous illumination adjustment and 3200 K color temperature output. Used in surgical suites by clinicians to provide localized lighting during procedures. Benefits include improved visualization of surgical sites.

Clinical Evidence

Bench testing only. Testing performed to demonstrate electrical safety and electromagnetic compatibility characteristics.

Technological Characteristics

150-watt light source; fiberoptic cable and headset delivery system; 3200 K color temperature; continuous illumination adjustment; coaxial, bifurcated, or focusable headset designs.

Indications for Use

Indicated for use in surgery and medical applications requiring high intensity illumination. No specific patient population, age, or gender restrictions defined.

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

• Designs for Vision Daylite Xenon Light Source (K013880)
• Cuda Products Corporation M300 Light Source (K981962)

Submission Summary (Full Text)

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# 510(k) Summary For Designs for Vision, Inc. Designs for Vision Fiberoptic Light

#### 1. SPONSOR

Designs for Vision, Inc. 760 Koehler Avenue Ronkonkoma, NY 11779

Contact Person: Gordon Perry Telephone: [phone]

Date Prepared: July 23, 2003

#### 2. DEVICE NAME

| Proprietary Name: | Designs for Vision Fiberoptic Light |
|----------------------|-------------------------------------------|
| Common/Usual Name: | Surgical Lights |
| Classification Name: | Surgical Lights/Routine Fiberoptic Lights |

#### 3. PREDICATE DEVICES

| Designs for Vision Daylite Xenon Light Source | K013880 |
|-----------------------------------------------|---------|
| Cuda Products Corporation M300 Light Source | K981962 |

#### DEVICE DESCRIPTION 4.

The Designs for Vision Fiberoptic Light is composed of a high intensity light source, fiberoptic cables, and fiberoptic headsets. The Designs for Vision headsets have been marketed since the early 1970s with a long history of safe use in the surgical suite. The headsets are coaxial, bifurcated, or focusable designs.

The light source includes a chuck for fiberoptic cable attachment. The Light source provides a 150-watt power output and contains a continuous illumination level adjustment, which provides 3200 K color temperature light.

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# ડ. INTENDED USE

The Designs for Vision Fiberoptic Light is indicated for use in surgery and medical applications where high intensity illumination is required.

# TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The Designs for Vision Fiberoptic Light device has the same intended use as the predicate devices and similar technological characteristics. They all consist of Light Sources supplying fiberoptic illuminators with illumination for headlights.

# PERFORMANCE TESTING 7.

Testing has been performed which demonstrates the electrical safety and electromagnetic compatibility characteristics of the Designs for Vision Fiberoptic Light.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 0 2003

Designs for Vision, Inc. c/o Ms. Mary McNamara-Cullinane Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Re: K032283

Trade/Device Name: Designs for Vision Fiberoptic Light Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GDB Dated: July 23, 2003 Received: July 25, 2003

Dear Ms. McNamara-Cullinane:

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 - Ms. Mary McNamara-Cullinane

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 vours.

Sincerely yours,

Mark N. Milliken

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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KO32283 510(k) Number (if known):

Device Name: Designs for Vision Fiberoptic Light

Indications for Use:

The Designs for Vision Fiberoptic Light is indicated for use in surgery and medical applications where high intensity illumination is required

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Millikan

eral, Restorative and Neurological I

510(k) Number K032283

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Special 510(k) Premarket Notification Designs for Vision Fiberoptic Light

July 23, 2003

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