AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)

K031008 · Aesculap · HBA · May 9, 2003 · Neurology

Device Facts

• Record ID: K031008
• Device Name: AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)
• Applicant: Aesculap
• Product Code: HBA · Neurology
• Decision Date: May 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4700
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Aesculap's Neuro Patties are intended for use during surgery to protect nervous tissue, absorb fluids, or stop bleeding during neurological and other general procedures.

Device Story

Aesculap Neuro Patties are rectangular fluid absorption pads used during neurological and general surgery. Constructed from natural woven cotton fiber; available in tight weave (4 or 6 layers) or open gauze-like weave (75). Features include attached suture string for count verification and optional x-ray detectable markers. Used by surgeons in the operating room to protect nervous tissue, absorb fluids, and stop bleeding. Single-use only; non-resterilizable. Packaged in cards of 10, either as single-size sets or procedure-specific kits.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: Natural woven cotton fiber. Dimensions: 4mm-70mm width, 6mm-150mm length. Construction: 4-layer, 6-layer, or gauze-like weave. Features: Suture string for count verification, optional x-ray detectable markers. Single-use, non-sterile (implied by single-use/no-resterilization warning).

Indications for Use

Indicated for patients undergoing neurological or general surgical procedures requiring protection of nervous tissue, fluid absorption, or hemostasis.

Regulatory Classification

Identification

A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.

Predicate Devices

• Codman Surgical Pattie (K880402)
• Pacific Surgical Patties (K993019)

Submission Summary (Full Text)

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510(k) Premarket Notification

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

K031008

| COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034 |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Matthew M. Hull, Sr. Requlatory Affairs Associate<br>800-258-1946 (phone)<br>610-791-6882 (fax)<br>[e-mail] (email) |
| TRADE NAME: | Aesculap Neuro Patties |
| COMMON NAME: | Cottonoid Paddie |
| DEVICE CLASS: | CLASS II |
| PRODUCT CODE: | 84 HBA |
| REGULATION: | 882.4700 |
| REVIEW PANEL: | Neurology |

### INTENDED USE

Aesculap's Neuro Patties are intended for use during surgery to protect nervous tissue, absorb fluids, or stop bleeding during neurological and other general procedures.

# DEVICE DESCRIPTION

Aesculap's Neuro Patties are rectangular fluid absorption pads for use during neurological and/or general procedures. The devices are available in a variety of dimensions, with widths from 4mm to 70mm and lengths from 6mm to 150mm. The material used for the patties is natural woven cotton fiber, this material is available in either a tight weave (neurosorb 4 or 6) or a more open gauze-like weave (neurosorb 75). The neurosorb 4 material consists of 4 layers while neurosorb 6 is constructed with 6 layers, the layers provide different levels of absorbency for surgeon preference. All pattles have a suture string attached for ease in count verification, they are also available with x-ray detectable markers if desired. The patties are packaged 10 per card in either single size sets or in procedure (indication) sets with a variety of sizes. These devices are for single use only and should not be resterilized.

#### PURPOSE FOR SUBMISSION

The purpose for this submission is to gain marketing clearance for the Aesculap Neuro Patties.

# PERFORMANCE STANDARDS

No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.

## SUBSTANTIAL EQUIVALENCE

The Aesculap Neuro Patties described in this premarket notification are substantially equivalent to these predicate devices:

- Codman Surgical Pattie (K880402) •
- Pacific Surgical Patties (K993019) .

is

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 9 2003

Aesculap, Inc. c/o Mr. Stefan Preiss TÜV America, Inc. 1775 Old Highway 8 New Brighton, Minnesota 55112

Re: K031008

Trade/Device Name: Neuro Patties Regulation Number: 21 CFR 882.4700 Regulation Name: Cottonoid Patties Regulatory Class: II Product Code: HBA Dated: April 22, 2003 Received: April 24, 2003

Dear Mr. Preiss:

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. Iisting 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 - Mr. Stefan Preiss

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]. 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) you may obtain. 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,

Muriam C. Provost

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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510(k) Premarket Notification

Aesculap Neuro Patties Page 1 of 1

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K031008

Device Name: Neuro Patties

Indication for Use:

Aesculap's Neuro Patties are intended for use during surgery to protect nervous tissue, absorb fluids, or stop bleeding during neurological and other general procedures.

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_KO31008

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

or Over-the-Counter Use

(per 21 CFR 801.109)

(Optional Format 3-10-98)