Intended for 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 Description

Not Found

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Norapad Cottonoid) and does not contain information regarding an AI/ML study. It is a premarket notification for a traditional medical device, comparing it to a predicate device for substantial equivalence, focusing on its intended use, materials, and manufacturing.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details (sample size, data provenance, experts, adjudication, MRMC, standalone), or ground truth, as these concepts are not applicable to the content of this 510(k) submission.

Summary

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K 014268

MAR 2 7 2002

510(K) SUMMARY (as required by 807.92(c))

Submitter of 510(k):	PMI8211 Compton WayMelbourne, FL 32940Phone: 321-751-4307Fax: 321-751-4307
Contact Person:
Date of Summary:	December 2, 2001
Classification Name:	Tape and bandage, Adhesive
Device Name:	Paddie, Cottonoid
Proprietary Name:	Norapad
Regulatory Class:	II
Classification Number:	HBA
Predicate Device:
K993019	Pacific Surgical PattiesPacific Surgical Innovations, Inc

Intended Use:

Intended for 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.

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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 an eagle with its wings spread, depicted in a minimalist, abstract design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 7 2002

Perlei Medical, Inc. c/o Mr. Arthur J. Ward Regulatory and Marketing Services, Inc. 962 Allegro Lane Apollo Beach, Florida 33572

Re: K014268

Trade Name: Norapad Plain Regulation Number: 882.4700 Regulation Name: Cottonoid paddie Regulatory Class: II Product Code: HBA Dated: December 2, 2001 Received: December 27, 2001

Dear Mr. Ward:

We have reviewed your Section 510(k) premarket 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) 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.

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Page 2 - Mr. Arthur Ward

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, «Misbranding by reference to premarket notification» (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Muiam C. Provost

for 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) Number (if known):

Device Name: PMI Norapad

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

4.4

Over-The-Counter Use (Optional Format 1-2-96)

Muriam C. Provost

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

510(k) Number_Ko14268

Regulation Number and Section

§ 882.4700 Neurosurgical paddie.

(a) A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.
(b)
Classification. Class II (performance standards).