PACIFIC SURGICAL PATTIES

K993019 · V. Mueller Neuro/Spine · HBA · Mar 30, 2000 · Neurology

Device Facts

• Record ID: K993019
• Device Name: PACIFIC SURGICAL PATTIES
• Applicant: V. Mueller Neuro/Spine
• Product Code: HBA · Neurology
• Decision Date: Mar 30, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pacific Surgical Patties are intended for use in neurosurgical procedures to protect tissue, absorb fluids and stop bleeding. They are supplied to the user in sterile packages. These patties are X-ray detectable and are provided in a variety of sizes necessary to meet clinical needs.

Device Story

Pacific Surgical Patties are sterile, X-ray detectable cotton pads used during neurosurgical procedures. Operated by surgeons or surgical staff, the patties are placed on or near nervous tissue to provide protection, absorb fluids, or assist in hemostasis. The device functions as a passive mechanical barrier and absorbent material. Benefits include tissue protection and fluid management during surgery.

Clinical Evidence

Bench testing only. The device demonstrated fluid absorption capacity of 6.5 times its dry weight and confirmed X-ray detectability.

Technological Characteristics

Manufactured from cotton materials meeting standards equivalent to the predicate device. Features X-ray detectable elements. Provided in various sizes. Sterile.

Indications for Use

Indicated for use in neurosurgical procedures to protect nervous tissue, absorb fluids, or stop bleeding.

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 Patties

Submission Summary (Full Text)

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K993019

## MAR 3 0 2000

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### SECTION 6

### 510(k) STATEMENT

| Submitter Name: | Pacific Surgical Innovations, Inc. |
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| Submitter's Address: | 360 Industrial Road, Unit H<br>San Carlos, CA 94070 |
| Contact Person: | Terry Johnston, President |
| Phone Number: | 650-802-6988 |
| Facsimile Number: | 650-802-0120 |
| Date Prepared: | August 26, 1999 |
| Device Trade Name: | Pacific Surgical Patties |
| Device Common Name: | Cottonoid Pattie |
| Classification Name: | Cottonoid Paddie |
| Predicate Device: | Codman Surgical Patties |
| Device Description: | A cotton pad used during surgery to protect<br>nervous tissue, absorb fluids or stop bleeding. |
| Intended Use: | The Pacific Surgical Patties are intended for use<br>in neurosurgical procedures to protect tissue, absorb<br>fluids and stop bleeding. They are supplied to the<br>user in sterile packages. These patties are X-ray<br>detectable and are provided in a variety of sizes<br>necessary to meet clinical needs. |
| Technological Characteristics<br>and Comparison to Predicate: | The Pacific Surgical Patties are manufactured from<br>equivalent materials meeting the same or similar<br>standards, dimensional specifications and quality<br>conditions as the predicate device. |
| Performance Data: | Pacific Surgical Patties provide X-ray detectable<br>sterile patties that absorb fluids at 6.5 times its dry<br>weight and functions in the same manner as the<br>predicate. |

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Conclusion:

The Pacific Surgical Patties are as safe and effective for its intended use, and meets all regulatory requirements to be found substantially equivalent to the predicate device.

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MAR 3 0 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Terry Johnston President Pacific Surgical Innovations, Inc. 360 Industrial Road, Unit H San Carlos. California 94070

K993019 Re: Trade Name: Surgical Patties Regulatory Class: II Product Code: HBA Dated: March 13, 2000 Received: March 13, 2000

Dear Mr. Johnston:

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 - Mr. Terry Johnston

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 vours,

Nil RP Ogden
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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# K993019

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#### SECTION 5

#### INDICATIONS FOR USE

Device Name:

Pacific Surgical Patties

Indications for Use:

To be used in surgery to protect nervous tissue, absorb fluids, or stop bleeding.

Nro for cmw

(9930

Prescription Use

OR Over the Counter _____________________________________________________________________________________________________________________________________________________________