HAL SCOPE HOLDER SYSTEM

K991548 · Noved Medical · KKX · Jun 23, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K991548
• Device Name: HAL SCOPE HOLDER SYSTEM
• Applicant: Noved Medical
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Jun 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

The HAL Scope Holder System is intended for use during a medical procedure where sterile barrier is required on manipulating / movable arms.

Device Story

HAL Scope Holder System provides sterile barrier for re-usable manipulating arms during medical procedures. Device consists of disposable cover with sterile quick-release scope adapter and sterile drape assembly. Installed over non-sterile re-usable arm prior to procedure to maintain sterile field. Single-use only. Healthcare providers use device to isolate non-sterile equipment from sterile surgical environment, reducing contamination risk to patient.

Clinical Evidence

Bench testing only. Evaluations based on material strength, elongation, and physical handling comparisons to predicate. Barrier testing deemed not applicable per ISO-10993 guidelines.

Technological Characteristics

Polyethylene film construction; heat-sealed tip attachment; Gamma sterilization (10-6 SAL); form, peel, and seal pouch packaging. Mechanical barrier device.

Indications for Use

Indicated for use during medical procedures requiring a sterile barrier on manipulating or movable arms. For single use only.

Regulatory Classification

Identification

A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

Special Controls

*Classification.* Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, 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

• Hydromed Product's Universal Drape

Submission Summary (Full Text)

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JUN 23 1

JUN 2 3 1999

# 510(K) SUMMARY HAL SCOPE HOLDER SYSTEM

| Date: | April 9,1999 |
|------------------------|---------------------------------------------------------------------|
| Owner/Operator: | Noved Medical, Inc. |
| Contact Person: | Mike Griffin<br>Vice President of Operations<br>Noved Medical, Inc. |
| Device Trade Name: | HAL Scope Holder System |
| Common Name: | Surgical Drape |
| Classification Name: | Surgical Drape and Drape Accessories |
| Regulatory Reference : | 79KKX |
| Predicate Device: | Hydromed Product's Universal Drape |

### Description:

The HAL Scope Holder System is used to provide a sterile barrier for re-usable manipulating arm. The disposable cover includes a sterile quick release scope adapter and sterile drape assembly. The device will be installed to an existing re-usable manipulating arm before a medical procedure to act as a barrier between the sterile field and the non-sterile re-usable manipulating arm. The device is single use only and can be used with Noved Medical Universal Arm.

#### Intended Use:

The HAL Scope Holder System is intended for use during a medical procedure where sterile barrier is required on manipulating / movable arms.

## Physical/Technical Comparison:

Technological Comparison: The Noved HAL Scope Holder System is technologically equivalent to the drape marketed by Hydromed Products based on the following:

- Similarity of Materials: Noved Medical drapes are constructed primarily of polyethylene film heat a) sealed to a tip attachment.
- Construction: The predicate device and the HAL Scope Holder System are constructed using b) heat sealed polyethylene film.
- C) Packaging: The HAL Scope Holder System are packaged in form, peel and seal pouches and is sterilized through Gamma sterilization. Both the new device and the predicate device maintain a sterilization assurance level of 10-6 SAL.

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#### Performance Data:

Non-Clinical Evaluations: Based on appearance and handling evaluations, the HAL Scope Holder System is similar to the predicate device.

Clinical Evaluation: Based on the strength and elongation of the polyethylene film used in the HAL Scope Holder System, the material used for the new device was determined to be acceptable. (Data for the predicate device is not available).

Barrier testing was determined not to be applicable for the HAL Scope Holder System. Determination was made after reviewing the Biocompatibility Flow Chart (matrix) included in ISO-10993 guidelines memo dated May 1, 1995.

Conclusion: Based on all physical performance comparisons, the HAL Scope Holder System will function effectively and comparable to the Universal Camera Drape marketed by Hydromed Products.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 23 1999

Mr. Mike Griffin Vice-President of Operations Noved Medical, Incorporated 168 Avenida Del Mar, Suite 120 San Clemente, California 92672

Re : K991548 HALTM Scope Holder System Trade Name: Requlatory Class: II Product Code: KKX Dated: April 9, 1999 Received: May 3, 1999

Dear Mr. Griffin:

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੈਂ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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 Reqister.

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Page 2 - Mr. Griffin

this response to your premarket notification Please note: 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.

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 requlation (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,

Timothy A. Ulatowski

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K991548

Device Name: HAL Scope Holder System

Indication For Use:

The HAL Scope Holder System is intended for use during medical procedure where sterile barrier is required on manipulating/ movable arms.

It is for single use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_

(Per CFR 801.109)

OR

Over the Counter Use

Qlin S. Lin

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