(98 days)
Not Found
No
The device description and performance studies focus on the physical and functional properties of a hemostatic powder and sponge, with no mention of AI or ML.
Yes
The devices are intended for the temporary treatment of bleeding wounds, which is a therapeutic purpose.
No
This device is a hemostat, intended for the temporary treatment and control of bleeding wounds. It does not perform any diagnostic functions.
No
The device description clearly states it is comprised of physical materials (powder and sponge) and is a topical wound dressing, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "topical dressing for the temporary treatment of moderate to severely bleeding wounds". This describes a device applied externally to the body to control bleeding, not a device used to examine specimens in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details a "sterile, topical wound dressings comprised of plant based polysaccharides" that work by "quickly dehydrate blood cells, resulting in hemoconcentration... leading to clotting". This mechanism of action is a physical interaction with blood at the wound site, not a diagnostic test performed on a sample.
- Lack of Diagnostic Information: The information provided does not mention any analysis of biological samples to provide diagnostic information about a patient's condition.
IVD devices are used to examine specimens such as blood, urine, or tissue in vitro to diagnose diseases, monitor conditions, or screen for health issues. This device's function is purely therapeutic and topical.
N/A
Intended Use / Indications for Use
NexStat® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge are intended for use under the care of a health care professional as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), cuts and lacerations and for the treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. It is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.
Product codes
OSY, LYA, NHB
Device Description
The Hemostasis NexStat® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge are sterile, topical wound dressings comprised of plant based polysaccharides. The hemostatic particles and foam quickly dehydrate blood cells, resulting in hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding.
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
health care professional
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
Comparative hemostasis testing in an animal model demonstrated the devices performed substantially equivalent to predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 and Human Services seal on the left and the FDA acronym followed by the words "U.S. Food & Drug Administration" on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the words in a lighter shade of blue.
July 28, 2023
Hemostasis, LLC c/o Bernard Horwath 5000 Township Parkway St. Paul, Minnesota 55110
Re: K102459
Trade/Device Name: NexStat® Topical Hemostat Powder; NexFoam® Topical Hemostat Sponge Regulatory Class: Unclassified Product Code: OSY, LYA, NHB
Dear Bernard Horwath:
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 December 3, 2010. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product codes QSY, LYA and NHB.
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with outstretched wings, positioned to the right. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged in a circular fashion, following the contour of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Hemostasis, LLC % Mr. Bernard Horwath 5000 Township Parkway St. Paul, Minnesota 55110
DEC - 3 2010
Re: K102459
Trade/Device Name: NexStar® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge Regulatory Class: Unclassified . Product Code: FRO
Dated: October 15, 2010 Received: October 18, 2010
Dear Mr. Horwath:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
2
Page 2 - Mr. Bernard Horwath
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 1000-1150.
If you desire specific advice for your device on our labeling regulation (21 CFR Pan 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1 Lt 800 html br the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Alease note the regulation entitled, "Misbranding by reference to premarket notification" (21)FR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollofre number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For Pete D. Mhomson V
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K102459
NexStat® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge:
Indications for Use:
NexStat® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge are intended for use under the care of a health care professional as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), cuts and lacerations and for the treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. It is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 IF NEEDED)
Concurrence of Office of Device Evaluation (ODE)
Daird Kroneker MXM
(Division Sign OG)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102459
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Page 1/2
510(k) Summary
NexStat® Topical Hemostat Powder NexFoam® Topical Hemostat Sponge
DEC - 3 2010
| Date Prepared: | August 26, 2010 |
|---|---|
| Submitter: | Hemostasis, LLC |
| 5000 Township Parkway | |
| St. Paul, MN 55110 | |
| Telephone: 651- 855-1466 | |
| Fax: 651-855-1465 | |
| Contact: | Mr. Bernard Horwath |
| Hemostasis Regulatory Affairs | |
| 5000 Township Parkway | |
| St. Paul, MN 55110 | |
| Telephone: 651- 361-8041 | |
| Fax: 651-855-1465 | |
| Proprietary Name: | NexStat® Topical Hemostat Powder |
| NexFoam® Topical Hemostat Sponge |
Common/Usual Name: Topical hemostatic particles and foam
Classification Name: Dressing, Pre-Amendment Unclassified Product Code - FRO General and Plastic Surgery
Establishment Registration Number: 10023101
Description:
The Hemostasis NexStat® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge are sterile, topical wound dressings comprised of plant based polysaccharides. The hemostatic particles and foam quickly dehydrate blood cells, resulting in hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding.
Indications for Use:
NexStat® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge are intended for use under the care of a health care professional as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (postoperative, donor sites, dermatological), cuts and lacerations and for the treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. It is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.
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K102459 Page 2/2
Substantial Equivalence:
The Hemostasis NexStat® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge are substantially equivalent to the following predicate devices:
| Manufacturer | Brand Name | 510(k) Number |
|---|---|---|
| Hemostasis, LLC | TraumArrest®/BleedArrest® | K070211 |
| Medafor | HemaDerm™/MPHT™ | K033666 |
NexStat® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge are technically identical hemostats as the predicates and have the same intended use as HemaDerm™/MPH™.
Biocompatibility:
Biocompatibility testing was performed using guidelines of ISO 10993 - Biological Evaluation of Medical Devices and FDA guidance document Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices May 1, 1995 (G95-1). The NexState Topical Hemostat Powder and NexFoam Topical Hemostat Sponge passed biocompatibility requirements for their intended use.
Sterilization:
The NexStat® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge are sterilized using a validated gamma radiation method.
Bench Testing:
Design verification testing was performed on NexStat® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge to demonstrate physical and functional requirements were met.
Performance Testing:
Comparative hemostasis testing in an animal model demonstrated the devices performed substantially equivalent to predicate devices.
Conclusion:
Through the data and information presented, Hemostasis, LLC considers the NexState Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge substantially equivalent to the predicate devices already on the market (cleared by the 510(k) process) in terms of indications for use, scientific technology, design and functional performance and present no new concerns about safety and effectiveness.