(80 days)
No
The 510(k) summary describes a physical hemostatic pad and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is intended for the "local management of bleeding wounds" and "promotion of rapid control of bleeding," which are therapeutic actions.
No
The device description and intended use indicate that the T-Scientific T-Pad™ is designed for the local management and promotion of rapid control of bleeding, which are therapeutic functions, not diagnostic ones.
No
The device description clearly states it is a "soft, non-woven pad" and is "packed in a foil pouch and sterilized by E-beam radiation," indicating it is a physical, hardware-based medical device.
Based on the provided information, the T-Scientific T-Pad™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes the device's function as a topical hemostatic agent for managing bleeding wounds and promoting rapid bleeding control. This is a direct therapeutic or procedural application on the patient's body.
- Device Description: The description details a physical pad made of poly-N-acetylglucosamine, designed for direct application to a wound.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening. IVDs typically involve reagents, analyzers, or other components used in a laboratory or point-of-care setting to analyze biological samples.
The T-Scientific T-Pad™ falls under the category of a medical device used for wound management and hemostasis, applied directly to the patient.
N/A
Intended Use / Indications for Use
The T-Scientific T-Pad™ is intended for use in the:
- Local management of bleeding wounds such as lacerations, abrasions, nose bleeds, vascular access site, percutaneous catheters or tubes and surgical debridement, and
- The promotion of rapid control of bleeding in patients following hemodialysis and in patients on anticoagulation therapy.
Product codes
QSY, LYA, FRO
Device Description
The T-Scientific T-Pad™ is a soft, non-woven pad of poly-N-acetylglucosamine. T-Pad™ is packed in a foil pouch and sterilized by E-beam radiation to a 10-6 SAL.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K972914 Syvek Patch, K984177 Syvek Patch
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
N/A
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, Julie.Morabito@fda.hhs.gov.
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 (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) 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 (800) 638-2041 or (301) 443-6597 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.
| Applicant: | T-Scientific, Inc. |
|---|---|
| 1146 Gardencrest Ln. | |
| Houston, TX. 77077 | |
| 713-302-0019 | |
| Fax:281-587-2299 |
510(k) Number:
T-Pad™ Device Name:
Indications For Use: The T-Scientific T-Pad™ is intended for use in the:
-
- Local management of bleeding wounds such as lacerations, abrasions, nose bleeds, vascular access site, percutaneous catheters or tubes and surgical debridement, and
-
- 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.
Confidential
510(k) SUMMARY V.
| Submitted by: | T-Scientific, Inc.
1146 Gardencrest Ln.
Houston,TX.77077
Phone: 713-302-0019
Fax: 281-587-2299 | 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:
21 CFR §: | 880.5090 |
| Classification Name: | Liquid Bandage (KMF) | |
| Predicate Device: | Marine Polymer Technologies
Marine Polymer Technologies | K972914 Syvek Patch
K984177 Syvek Patch |
| Device Description: | The T-Scientific T-Pad™ is a soft, non-woven pad of poly-N-
acetylglucosamine. T-Pad™ is packed in a foil pouch and sterilized by E-
beam radiation to a 10-6 SAL. | |
| Intended Use: | The T-Scientific T-Pad™ is intended for use in the local management of
bleeding wounds such as lacerations, abrasions, nose bleeds, vascular
access site, percutaneous catheters or tubes and surgical debridement, and
the promotion of rapid control of bleeding in patients following
hemodialysis and in patients on anticoagulation therapy. | |
| Technological
Characteristics: | The T-Scientific T-Pad™ technological characteristics are the same as the
Marine Polymer Technologies predicate devices. The T-Scientific T-Pad™
works in the same manner as the approved predicate devices. | |