AESCULAP NEURO PATTIES

K062406 · Aesculap, Inc. · HBA · Sep 15, 2006 · Neurology

Device Facts

• Record ID: K062406
• Device Name: AESCULAP NEURO PATTIES
• Applicant: Aesculap, Inc.
• Product Code: HBA · Neurology
• Decision Date: Sep 15, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4700
• Device Class: Class 2
• Attributes: Therapeutic

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 surgical procedures. Manufactured from cotton or viscose fibers; available in various dimensions. Features include attached suture string for count verification and optional x-ray detectable markers. Provided sterile or non-sterile for kit packaging; single-use only. Operated by surgeons or surgical staff during procedures to protect nervous tissue, absorb fluids, or achieve hemostasis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Rectangular fluid absorption pads; materials: cotton or viscose fibers; includes suture string for count verification; optional x-ray detectable markers; single-use; provided sterile or non-sterile.

Indications for Use

Indicated for use during surgery to protect nervous tissue, absorb fluids, or stop bleeding during neurological and other general procedures. No specific patient population or contraindications provided.

Regulatory Classification

Identification

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

Predicate Devices

• Aesculap Neuro Patties (K031008)

Submission Summary (Full Text)

{0}------------------------------------------------

K062406

Page 1/

ulap Neuro Patties
(Neurosorb Premium)

SEP 1 5 2006

#### в. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

| COMPANY: | Aesculap ®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Lisa M. Boyle, Regulatory Specialist<br>800-258-1946 (phone)<br>610-791-6882 (fax)<br>[e-mail] (email) |
| TRADE NAME: | Aesculap Neuro Patties |
| COMMON NAME: | Cottonoid Paddie |
| CLASSIFICATION NAME: | Neurosurgical Paddie |
| REGULATION NUMBER: | 882.4700 |
| PRODUCT CODE: | 84 HBA |

### SUBSTANTIAL EQUIVALENCE

Aesculap, Inc. believes that the Neurosorb Premium Patties are substantially equivalent to:

- . Aesculap Neuro Patties (K031008)
## DEVICE DESCRIPTION

Aesculap's Neuro Patties are rectanqular fluid absorption pads for use during neurological and/or general procedures. The devices are available in a variety of dimensions and sizes. The neuro patties are manufactured from either a cotton or viscose fibers. All patties 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 provided sterile or non-sterile (for kit packager), single use only, and should not be resterilized.

### INDICATIONS 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.

# TECHNOLOGICAL CHARACTERISTICS (compared to predicate(s)}

The Neurosorb Premium Pattie will be offered in similar in shapes and sized as the predicate devices. The Neurosorb Premium Paddie is manufactured from viscose, which is the same material as the existing predicate device.

## PERFORMANCE STANDARDS

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

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes extending from its head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP 1 5 2006

Aesculap, Inc. % Ms. Lisa M. Boyle Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K062406

Trade/Device Name: Neuro Patties Regulation Number: 21 CFR 882.4700 Regulation Name: Neurosurgical paddie Regulatory Class: Class II Product Code: HBA Dated: August 17, 2006 Received: August 18, 2006

Dear Ms. Boyle:

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.

{2}------------------------------------------------

Page 2 - Ms. Lisa M. Boyle

This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter will and in your e FDA finding of substantial equivalence of your device to a legally premation for notification of 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 n you desire of Compliance at [phone]. Also, please note the regulation entitled, Contider the Office of Complete 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/industry/support/index.html.

Sincerely yours

Mark N. Melkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Page 1 of 1

#### INDICATIONS FOR USE STATEMENT A.

510(k) Number (if known):

Kda2406

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.

Prescription Use X (per 21 CFR 801.109)

and/or Over-the-Counter Use (21 CFR 897 Subpart C)

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

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

510(k)

002