ULTRACELL NEURO SPONGES

K973083 · Ultracell Medical Technologies, Inc. · HBA · Dec 9, 1997 · Neurology

Device Facts

• Record ID: K973083
• Device Name: ULTRACELL NEURO SPONGES
• Applicant: Ultracell Medical Technologies, Inc.
• Product Code: HBA · Neurology
• Decision Date: Dec 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Neuro sponges are used during surgery to protect the brain tissue from dryness, trauma, absorb fluids and act as a filter to aspirate.

Device Story

Ultracell Neuro Sponges are surgical accessories used during neurosurgical procedures. The device functions as a physical barrier to protect brain tissue from desiccation and mechanical trauma, while simultaneously absorbing excess fluids and serving as a filter during suction/aspiration. Used by neurosurgeons in the operating room environment. The device provides a passive, mechanical benefit to the patient by maintaining a moist surgical field and preventing tissue damage during the procedure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Surgical sponge for neurosurgical application. Passive mechanical device. No energy source, software, or complex electronics.

Indications for Use

Indicated for use during surgery to protect brain tissue from dryness and trauma, absorb fluids, and act as a filter during aspiration.

Regulatory Classification

Identification

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

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a bird-like symbol, possibly representing a human figure with outstretched arms, rendered in black lines. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

- 9 1997

Mr. George P. Korteweg Vice President Ultracell Medical Technologies, Inc. 183 Providence New London Turnpike PO Box 326 North Stonington, Connecticut 06359

Re: K973083 Trade Name: Ultracell Neuro Sponges Regulatory Class: II Product Code: HBA Dated: September 30, 1997 Received: October 2, 1997

Dear Mr. Korteweg:

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 requirements , 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

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Page 2 - Mr. George P. Korteweg

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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,

Sincerely, yours,

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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with outstretched arms, resembling a bird in flight. The figure is composed of three curved lines that create the impression of movement and openness. Encircling the figure is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

- 9 1997

Mr. George P. Korteweg Vice President Ultracell Medical Technologies, Inc. 183 Providence New London Turnpike PO Box 326 North Stonington, Connecticut 06359

Re: K973083 Trade Name: Ultracell Neuro Sponges Regulatory Class: II Product Code: HBA Dated: September 30, 1997 Received: October 2, 1997

Dear Mr. Korteweg:

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 requirements , 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

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

Page 2 - Mr. George P. Korteweg

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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,

Sincerely, yours,

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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510(k) Number (if known): ____ k 973083 __

vice Name: Ultracell Neuro Sponge

## Indications For Use:

Neuro sponges are used during surgery to protect the brain tissue from dryness, trauma, absorb fluids and act as a filter to aspirate.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|----------------------------------------------------------------------|
| | <div align="center">(Division Sign-Off)</div> |
| | Division of General Restorative Devices |
| | 510(k) Number <span style="text-decoration:overline;">K973083</span> |

| Prescription Use<br>(Per 21 CFR 801.109) | X | OR | Over-The-Counter Use |
|------------------------------------------|---|----|----------------------|
|------------------------------------------|---|----|----------------------|

(Optional Format 1-2-96)