NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES

K073576 · Harod Enterprises, Inc. · HBA · Feb 22, 2008 · Neurology

Device Facts

• Record ID: K073576
• Device Name: NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES
• Applicant: Harod Enterprises, Inc.
• Product Code: HBA · Neurology
• Decision Date: Feb 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The neurological sponge is a cotton or rayon pattie used to keep exposed tissue from drying out during surgery. It is used to absorb excess fluids and to protect the tissue from trauma during surgery. It is also used to assist in the gentle suction of fluids.

Device Story

Neurosurgical Paddies/Neurosponges are rectangular pads manufactured from cotton or viscose fibers; used during surgery to prevent tissue desiccation, absorb fluids, protect tissue from trauma, and assist in gentle suction. Devices feature an attached suture string for count verification and an x-ray detectable marker. Used in surgical settings by surgeons. Single-use; supplied sterile or non-sterile for kit packers. Benefit: tissue protection and fluid management during neurosurgical procedures.

Clinical Evidence

No clinical data; bench testing only. Device relies on established history of use since 1979 and equivalence to predicate.

Technological Characteristics

Materials: cotton or viscose/rayon fibers. Form factor: rectangular pads of various sizes (e.g., 0.5"x0.5" to 1"x3"). Features: attached suture string for count verification, x-ray detectable marker. Sterilization: ETO (twice) or E-beam (once).

Indications for Use

Indicated for use during surgery to keep exposed tissue moist, absorb excess fluids, protect tissue from trauma, and assist in gentle fluid suction.

Regulatory Classification

Identification

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

Predicate Devices

• Neurological Sponges (K935883)

Submission Summary (Full Text)

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K073576 Rye 1/2

HE、Inc. 510(k) submission 12/17/2007

Page 5-1 Revised February 11, 2008

Image /page/0/Picture/3 description: The image shows a logo with the letters 'HE' in a bold, blocky font, stacked on top of each other. To the right of the 'E', the letters 'i', 'n', and 'c' are arranged vertically. The entire logo is enclosed within a square border, giving it a clean and modern appearance. The logo is black and white.

## Harod Enterprises

FEU 22 2 2 ...

Personal and Patient Care Products™

4052 Indian Creek Road • Martinez, Georgia 30907 • Phone [phone] • Fax [phone]

## 510(k) Summary

As required by Section 807.92(c) Revised For 510(k) Number K073576

The submitter and owner of the 510(k) is HE, Inc. whose contact information is in the above letterhead. The preparer and contact person during the review process is Norris R. Harod, President of HE, Inc.

This is a Traditional 510(k) submission for a Substantially Equivalent device.

- Common name: . Neurological Pattie and/or Neurosponges
- Trade name: Neuro Patties and/or Neurosponges .
- Classification: ● Name: Neurosurgical Paddie Class II Product code HBA Review panel Neurology Performance Standards NONE issued under Regulation # 882.4700

HE, Inc. and its contract manufacturer have been making the exact same product using the same material suppliers and a 510(k) license from McNeil Healthcare since 2005, but now we need our own 510(k). HE, Inc.'s device has the same intended use and identical technological characteristics as the predicate Neurological Sponges made by McNeil Healthcare, Inc. under K935883 and product codes 20501, 20502, 20504, 20505, 20506, and 20507.

A copy of the letter from McNeil Healthcare authorizing the use of their approved Premarket notification K935883 by HE, Inc. and our contract packager is attached. The letter is dated July 16, 2006 and establishes a trail that we are using the same biocompatible materials as our predicate McNeil Healthcare device under K935883. The letter also establishes that we will still be using the same contract packager (Bahia de Palomas), equipment, process and location to make the product as listed in our 510(k) Number K073536 if granted.

Neurosurgical Paddies are used to keep exposed tissue from drying out or to absorb excess fluids and to protect the tissue from trauma during surgery. They are manufactured from either cotton or viscose fibers cut into rectangular pads of various sizes with a suture string attached for ease in count verification and with an x-ray detectable marker sewn to it as an extra precaution. The paddies are normally packaged 10 per count card of a single size and may be sterilized for end use or sold non sterile for kit packers. They are single use items that can be ETO sterilized twice or E-beam sterilized once.

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K073576 Page 2/2

HE. Inc. 510(k) submission 12/17/2007

Page 5-2 Revised February 11, 2008

HE, Inc.'s product will be made from cotton and/or or rayon in sizes and shapes similar to the predicate devices as they have been since 2005 under a 510(k) license. The most commonly used sizes are ½' x ½', ½' x 1", ½" x 3", 1" x 1" and 1" x 3". They will be contract packaged at the same FDA registered facility used in 2007 and ETO sterilized in the cycle and released by the criteria revalidated at our contract sterilizer during 2007. The only thing that will change is that this will be done under HE, Inc.'s 510(k) if granted.

Neurosurgical Paddies have been in use by surgeons since 1979 and are considered a prescription device due to their specialty use. Almost all labeling simply contains the product catalog number, name, size, material used, quantity, and "Rx Only" and "sterile if unopened, undamaged" statements. HE, Inc.'s labeling will contain these same items and/or whatever else may be specified by a relabeler customer.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/13 description: The image shows the logo for the United States Department of Health and 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 overlapping lines that resemble an abstract bird or a symbol representing health and human services.

FEB 22 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Harod Enterprises, Inc. % Mr. Norris R. Harod President 4052 Indian Creek Road Martinez, Georgia 30907

Re: K073576

Trade/Device Name: Neuro Sponge and Neuro Pattie Regulation Number: 21 CFR 882.4700 Regulation Name: Neurosurgical paddie. Regulatory Class: II Product Code: HBA Dated: December 17, 2007 Received: December 19, 2007

Dear Mr. Harod:

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.

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Page 2 – Mr. Norris R. Harod

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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. Millerson

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

Enclosure

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## Statement of Indications for Use HE, Inc. Traditional 510(k) Submission Substantial Equivalence For HBA Neurosurgical Paddies

## HE, Inc. 510 (k) Number K073576

Device Name: Neuro Sponge and Neuro Pattie

Indications For Use: The neurological sponge is a cotton or rayon pattie used to keep exposed tissue from drying out during surgery. It is used to absorb excess fluids and to protect the tissue from trauma during surgery. It is also used to assist in the gentle suction of fluids.

Prescription Use: YES (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use: (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of

Mark A. Melkersen

(Division Sign-C Restorative, Division of Ger and Neurologica

**510(k) Number**