T-SCIENTIFIC T-PAD

K030334 · T-Scientific, Inc. · QSY · Apr 21, 2003 · SU

Device Facts

• Record ID: K030334
• Device Name: T-SCIENTIFIC T-PAD
• Applicant: T-Scientific, Inc.
• Product Code: QSY · SU
• Decision Date: Apr 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The T-Scientific T-Pad™ is intended for use in the: 1. Local management of bleeding wounds such as lacerations, abrasions, nose bleeds, vascular access site, percutaneous catheters or tubes and surgical debridement, and 2. The promotion of rapid control of bleeding in patients following hemodialysis and in patients on anticoagulation therapy.

Device Story

T-Pad is a soft, non-woven pad composed of poly-N-acetylglucosamine; used for local management of bleeding wounds and rapid hemostasis in hemodialysis or anticoagulated patients. Device functions as a topical dressing to promote bleeding control. Supplied in foil pouch; sterilized via E-beam radiation. Used in clinical settings for wound management.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and material similarity to predicate devices.

Technological Characteristics

Soft, non-woven pad composed of poly-N-acetylglucosamine. Sterilized by E-beam radiation to a 10-6 sterility assurance level (SAL).

Indications for Use

Indicated for local management of bleeding wounds (lacerations, abrasions, nose bleeds, vascular access sites, percutaneous catheters/tubes, surgical debridement) and rapid bleeding control in patients post-hemodialysis or on anticoagulation therapy.

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• Marine Polymer Technologies Syvek Patch (K972914)
• Marine Polymer Technologies Syvek Patch (K984177)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

June 11, 2023

T-Scientific, Inc. Dennis Metcalf Director of Regulatory Affairs and Quality Assurance 1146 Gardencrest Lane Houston, Texas 77077

Re: K030334 Trade/Device Name: T-Pad™ Regulatory Class: Unclassified Product Code: QSY, LYA

Dear Dennis Metcalf:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 21, 2003. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product codes QSY and LYA.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, [e-mail].

Sincerely,

## Julie A. Morabito -S

Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, composed of three curved lines, which is positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the top and left side of the bird symbol.

APR 2 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Dennis Metcalf Director of Regulatory Affairs and Quality Assurance T-Scientific, Inc. 1146 Gardencrest Lane Houston, Texas 77077

Re: K030334

Trade/Device Name: T-PadTM Regulatory Class: Unclassified Product Code: FRO Dated: January 15, 2003 Received: January 31, 2003

Dear Mr. Metcalf:

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 A.ct. 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 - Mr. Dennis Metcalf

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 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" (21CFR Part 807.97) you may obtain. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

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

T-Scientific, Inc.

Confidential

## Statement of Indications for Use IV.

K030334

| Applicant: | T-Scientific, Inc. |
|------------|----------------------|
| | 1146 Gardencrest Ln. |
| | Houston, TX. 77077 |
| | 713-302-0019 |
| | Fax:[phone] |

510(k) Number:

T-Pad™ Device Name:

Indications For Use: The T-Scientific T-Pad™ is intended for use in the:

- 1. Local management of bleeding wounds such as lacerations, abrasions, nose bleeds, vascular access site, percutaneous catheters or tubes and surgical debridement, and
- 2. The promotion of rapid control of bleeding in patients following hemodialysis and in patients on anticoagulation therapy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

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

510(k) Number K030334

Prescription Use

or
Over-the-Counter
(Per 21 CFR 801.109)

(Optional Format 1-2-96)

{4}------------------------------------------------

T-Scientific, Inc.

K030334

Confidential

## 510(k) SUMMARY V.

| Submitted by: | T-Scientific, Inc.<br>1146 Gardencrest Ln.<br>Houston,TX.77077<br>Phone: [phone]<br>Fax: [phone] | APR 21 2003 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Contact Person: | Dennis Metcalf | |
| Date Prepared: | January 15, 2003 | |
| Proprietary Name: | T-Scientific T-Pad™ | |
| Common Name: | Liquid Bandage (KMF) | |
| Classification: | Class I:<br>21 CFR §: | 880.5090 |
| Classification Name: | Liquid Bandage (KMF) | |
| Predicate Device: | Marine Polymer Technologies<br>Marine Polymer Technologies | K972914 Syvek Patch<br>K984177 Syvek Patch |
| Device Description: | The T-Scientific T-Pad™ is a soft, non-woven pad of poly-N-<br>acetylglucosamine. T-Pad™ is packed in a foil pouch and sterilized by E-<br>beam radiation to a 10-6 SAL. | |
| Intended Use: | The T-Scientific T-Pad™ is intended for use in the local management of<br>bleeding wounds such as lacerations, abrasions, nose bleeds, vascular<br>access site, percutaneous catheters or tubes and surgical debridement, and<br>the promotion of rapid control of bleeding in patients following<br>hemodialysis and in patients on anticoagulation therapy. | |
| Technological<br>Characteristics: | The T-Scientific T-Pad™ technological characteristics are the same as the<br>Marine Polymer Technologies predicate devices. The T-Scientific T-Pad™<br>works in the same manner as the approved predicate devices. | |