DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER

K993089 · Deroyal Cardiovascular, Inc. · FTA · Oct 14, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K993089
• Device Name: DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER
• Applicant: Deroyal Cardiovascular, Inc.
• Product Code: FTA · General, Plastic Surgery
• Decision Date: Oct 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

Intended Use

The DeRoyal Right Handle and Adapter are intended to be used as accessories to a surgical lamp. The universal adapter is used to attach the light handle to the surgical lamp when necessary while the light handle is used to position the lamp to the desired area without contaminating the gloved hand.

Device Story

Device consists of disposable rigid light handle and universal adapter; used as surgical lamp accessory. Handle features protective shield at base to prevent gloved hand contact with non-sterile surfaces; shield foldable for storage. Adapter facilitates attachment to surgical lamp. Operated by surgical staff in OR to position light for illumination of surgical field. Benefits include maintenance of sterile field and ease of lamp adjustment.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: Plastic polymers (handle), aluminum (adapter). Design: Rigid, disposable, includes protective shield. Sterility: Sterile. Connectivity: None. Software: None.

Indications for Use

Indicated for use as accessories to a surgical lamp to facilitate positioning of the lamp while maintaining a sterile field by preventing contamination of the gloved hand.

Regulatory Classification

Identification

A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

Special Controls

*Classification.* Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Predicate Devices

• Charles Polo & Co.
• Devon Industries

Submission Summary (Full Text)

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K993089

# OCT 1 4 1999

### DeRoyal Industries, Inc.

## DeRoyal Disposable Rigid Light Handle and Adapter

### 510(k) Summary

### Summary of the Safety and Effectiveness Information Upon Which An Equivalence Determination Could Be Based

### SUBMITTER INFORMATION

DeRoyal Industries, Inc. NAME: ADDRESS: 200 DeBusk Lane Powell, TN 37849

TELEPHONE: CONTACT: DATE OF PREPARATION: [phone] Lois Marsh September 15, 1999

## DEVICE NAMES

NAME: COMMON/USUAL NAME: CLASSIFICATION NAME (if known): DeRoyal Disposable Rigid Light Handle and Adapter Surgical Light Handle and Adapter Light, Surgical, Accessories (79FTA)

### PREDICATE OR LEGALLY MARKETED DEVICES

Charles Polo & Co. and Devon Industries

#### DEVICE DESRIPTION

The DeRoyal Disposable Rigid Light Handle and Adapter function in the same manner as predicate devices in that they are intended to be used as accessories to a surgical lamp which are used to position the light for illumination in various areas of the surgical field.

Device Design/ Materials UsedPhysical Properties: The DeRoyal Disposable Rigid Light Handle and Adapter are made of materials commonly used for their purposes. The light handle contains a protective shield at the base which is used to prevent the gloved hand from contaminated surfaces. The protective shield may be folded and attached to the light handle to reduce space needed for packaging and storage.

#### DEVICE INTENDED USE

The DeRoyal Right Handle and Adapter are intended to be used as accessories to a surgical lamp. The universal adapter is used to attach the light handle to the surgical lamp when necessary while the light handle is used to position the lamp to the desired area without contaminating the gloved hand.

#### TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLYMARKETED DEVICE(S)

| Characteristic | DeRoyal Device | Other Devices |
|-------------------------|------------------|------------------|
| Material (Light Handle) | Plastic Polymers | Plastic Polymers |
| Protective Shield | Yes | Yes |
| Rigid | Yes | Yes |
| Universally Adaptable | Yes | Yes |
| Sterility | Sterile | Sterile |
| Disposable | Yes | Yes |
| Packaged | 1 or 2 per Pack | 1 or 2 per Pack |
| Material (Adapter) | Aluminum | Similar |

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Image /page/1/Picture/1 description: The image is a circular seal for the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized image of three human figures, representing the department's focus on health and human well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 4 1999

Ms. Lois Marsh Regulatory Affairs DeRoyal Industries, Inc. 200 DeBusk Lane Powell, Tennessee 37849

Re: K993089

> Trade Name: DeRoyal Disposable Rigid Light Handle and Adapter Regulatory Class: II Product Code: FTA Dated: September 15, 1999 Received: September 16, 1999

Dear Ms. Marsh:

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 (QS) 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 - Ms. Lois Marsh

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 of

## 510(k) Number (if known):

Device Name:

DeRoyal Disposable Rigid Light Handle and Adapter

Indications for Use:

The DeRoyal Disposable Rigid Light Handle and Adapter are indicated for use as accessories to a surgical lamp. The adapter is to be used, when necessary, to attach the light handle to the surgical lamp. The light handle is to be used to position the light without contaminating the gloved hand.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices K993089
510(k) Number.

OR
Over-The-Counter Use

Prescription Use (Per 21 CFR §801.109) OR

Over-The-Counter Use