(56 days)
Not Found
No
The device description focuses on the material properties and physical mechanism of action (dehydration of blood cells) for hemostasis. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The changes described relate to the manufacturing process of the polysaccharide material.
Yes
The device is intended for the temporary treatment of bleeding wounds, which is a therapeutic purpose.
No
This device is a topical hemostat powder and sponge used to control bleeding from wounds. Its function is therapeutic (to stop bleeding), not diagnostic (to identify a disease or condition).
No
The device is described as a topical wound dressing comprised of physical materials (plant based polysaccharides) and is 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 that the device is a "topical dressing for the temporary treatment of moderate to severely bleeding wounds." This describes a device that is applied directly to the body to control bleeding, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: The description explains that the device is comprised of "plant based polysaccharides" that "quickly dehydrate blood cells, resulting in hemoconcentration... leading to clotting." This mechanism of action is a physical process applied externally to the wound, not a test performed on a biological sample.
- No mention of in vitro testing: There is no mention of the device being used to analyze blood, tissue, or any other biological specimen outside of the body.
IVD devices are specifically designed to be used in vitro (outside the living body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
NexStat® Plus Topical Hemostat Powder and NexFoam® Plus 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 (comma separated list FDA assigned to the subject device)
QSY, LYA, NHB
Device Description
The Hemostasis NexStat® Plus Topical Hemostat Powder and NexFoam® Plus 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.
The NexStat® Plus Topical Hemostat Powder and NexFoam® Plus Topical Hemostat Sponge are identical to the NexStat® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge cleared for market under 510(k) K102459, with the exception of the cross-linking manufacturing process. The cross-linking process for the manufacture of polysaccharide hemostatic particles is being changed for the NexStat® Plus and NexFoam® Plus devices. The new cross linking process utilizes the identical cross linker used in the predicate Medafor MPH® product subject of K033666. All other materials and processes remain the same as NexStat® and NexFoam®. The indications for use remain the same as NexStat® and NexFoam®.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wounds (surgical, donor sites, dermatological), cuts, lacerations, ENT surgical wounds, nosebleeds, skin at percutaneous needle access, vascular access and percutaneous catheter access sites.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility: Biocompatibility testing was performed using the 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 NexStat® Plus Topical Hemostat Powder and NexFoam® Plus Topical Hemostat Sponge passed biocompatibility requirements for their intended use.
Sterilization: The NexStat® Plus Topical Hemostat Powder and NexFoam® Plus Topical Hemostat Sponge are sterilized using a validated gamma radiation method similar to NexFoam to assure a sterility assurance level (SAL) of 10-6.
Bench Testing: Design verification testing was performed on NexStat® Plus Topical Hemostat Powder and NexFoam® Plus Topical Hemostat Sponge to demonstrate physical and functional requirements were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 21, 2023
Hemostasis, LLC Bernard Horwath Regulatory Consultant 4486 Timberline Court Vadnais Heights, Minnesota 55127
Re: K122886
Trade/Device Name: Nexstat® Plus Topical Hemostat Powder and Nexfoam® Plus Topical Hemostat Sponge Regulatory Class: Unclassified Product Code: QSY, 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 November 15, 2012. 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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The text is in all caps.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Hemostatis. LLC % Mr. Bernard Horwath Regulatory Consultant 4486 Timberline Court Vadnais Heights, Minnesota 55127
November 15, 2012
Re: K122886
Trade/Device Name: NexStat® Plus Topical Hemostat Powder and NexFoam® Plus Topical Hemostat Sponge
Regulatory Class: Unclassified Product Code: FRO October 16, 2012 Dated:
October 17, 2012
Dear Mr. Horwath:
Received:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
2
Page 2 - Mr. Bernard Horwath
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 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportaProblem/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 toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K122886 510(k) Number (if known):
NexStat® Plus Topical Hemostat Powder and NexFoam® Plus Topical Hemostat Sponge:
Indications for Use:
NexStat® Plus Topical Hemostat Powder and NexFoam® Plus 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 X (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)
for Mark Melkerson
(Division Sign-Off)
Division of Surgical Devices
510(k) Num
510(k) Number
NexStat® Plus Topical Hemostat Powder and NexFoam® Plus Topical Hemostat Sponge Special 510(k) Hemostasis LLC 8
Sept 19, 2012
4
K122886
p1/2
510(k) Summary
NexStat® Plus Topical Hemostat Powder NexFoam® Plus Topical Hemostat Sponge
Date Prepared:
September 19, 2012
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- 231-1761 Fax: 651-855-1465
Marketed Device:
NexStat® Topical Hemostat Powder NexFoam® Topical Hemostat Sponge
510(k) Clearance: K102459
Proprietary Name
NexStat® Plus Topical Hemostat Powder Modified Device: NexFoam® Plus Topical Hemostat Sponge
Common/Usual Name: Topical hemostatic particles and foam
Classification Name: Dressing, Unclassified Product Code - FRO General and Plastic Surgery
Establishment Registration Number: 3007225047
Description:
The Hemostasis NexStat® Plus Topical Hemostat Powder and NexFoam® Plus 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.
The NexStat® Plus Topical Hemostat Powder and NexFoam® Plus Topical Hemostat Sponge are identical to the NexStat® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge
NexStat® Plus Topical Hemostat Powder and NexFoam® Plus Topical Hemostat Sponge Special 510(k) Hemostasis LLC 10 Sept 19, 2012
NOV 1-5 2012
5
cleared for market under 510(k) K102459, with the exception of the cross-linking manufacturing process. The cross-linking process for the manufacture of polysaccharide hemostatic particles is being changed for the NexStat® Plus and NexFoam® Plus devices. The new cross linking process utilizes the identical cross linker used in the predicate Medafor MPH® product subject of K033666. All other materials and processes remain the same as NexStat® and NexFoam®. The indications for use remain the same as NexStat® and NexFoam®
122886
p22
Indications for Use:
NexStat® Plus Topical Hemostat Powder and NexFoam® Plus 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.
Substantial Equivalence:
The NexStat® Plus Topical Hemostat Powder and NexFoam® Plus Topical Hemostat Sponge are substantially equivalent to the following predicate devices:
- NexStat® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge K102459 �
- Medafor HemaDerm™ MPH® K033666 .
Biocompatibility:
Biocompatibility testing was performed using the 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 NexStat® Plus Topical Hemostat Powder and NexFoam® Plus Topical Hemostat Sponge passed biocompatibility requirements for their intended use.
Sterilization:
The NexStat® Plus Topical Hemostat Powder and NexFoam® Plus Topical Hemostat Sponge are sterilized using a validated gamma radiation method similar to NexFoam to assure a sterility assurance level (SAL) of 10-6.
Bench Testing:
Design verification testing was performed on NexStat® Plus Topical Hemostat Powder and NexFoam® Plus Topical Hemostat Sponge to demonstrate physical and functional requirements were met.
Conclusion:
Through the data and information presented, Hemostasis, LLC considers the NexStat® Plus Topical Hemostat Powder and NexFoam® Plus 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.