(15 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 AI, ML, or any computational processing of data.
Yes
The device is described as a "wound dressing" intended "for the management of bleeding wounds" and for the "temporary treatment of moderate to severely bleeding wounds," which are explicitly therapeutic actions.
No
The device is a wound dressing intended for the management of bleeding wounds to control bleeding, not to diagnose a condition.
No
The device description clearly states the device is comprised of physical materials (modified chitin particles and polysaccharide binders) formed into a foam bandage, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of bleeding wounds and control of bleeding by acting as a topical dressing. This is a direct therapeutic or wound care application, not a diagnostic test performed in vitro (outside the body) on biological specimens.
- Device Description: The description details a physical material (foam bandage) that interacts directly with the wound to promote clotting. It doesn't describe a test or assay that analyzes a sample to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.) to diagnose a condition, monitor a disease, or screen for a specific marker.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to physically help stop bleeding, which is a treatment/management function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Hemostasis, LLC wound dressings are intended for use as topical dressings for the management of bleeding wounds.
Prescription: ExcelArrest™ is indicated for use as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, do noralites, dermatological), cuts and lacerations and is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.
OTC: ExcelArrest™ is indicated for use as a topical dressing on minor bleeding wounds such as cuts, lacerations and abrasions and for minor nose bleeds.
Product codes (comma separated list FDA assigned to the subject device)
QSY, LYA, FRO
Device Description
As described above, the Hemostasis, LLC hemostats are comprised of modified chitin particles and polysaccharide binders. The particles are dissolved in water, poured into appropriate trays and using a lyophylization process, the water is removed to form a foam bandage. Chitin has well known hemostasis properties and when combined with the sodium carboxymethylcellulose and hydroxyethylcellulose binders, has an affinity to hold water. The Hemostasis foam quickly dehydrates blood cells, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding in moderate to severe lacerations.
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)
Comparative testing was performed using a Porcine Model and the devices met the performance criteria.
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 logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 11, 2023
Hemostasis, LLC Corporation % Keith Roberts Technical Business Development 5000 Township Parkway St. Paul, Minnesota 55110
Re: K072900 Trade/Device Name: ExcelArrest™ Foam Hemostat Bandage Regulatory Class: Unclassified Product Code: QSY, LYA
Dear Keith Roberts:
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 October 26, 2007. 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.
Image /page/0/Picture/7 description: The image shows the signature block of Julie A. Morabito, Ph.D., who is listed as an Assistant Director. The signature block includes the office she works in, DHT4B: Division of Infection Control and Plastic Surgery Devices. It also includes OHT4: Office of Surgical and Infection Control Devices, and the Office of Product Evaluation and Quality.
Center for Devices and Radiological Health
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The seal is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hemostasis, LLC Corporation % Mr. Keith Roberts Technical Business Development 5000 Township Parkway St. Paul, MN 55110
OCT 26 2007
Re: K072900
Trade/Device Name: ExcelArrest™ Foam Hemostat Bandage Regulatory Class: Unclassified Product Code: FRO Dated: November 6, 2007 Received: November 11, 2007
Dear Mr. Roberts:
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.
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. Keith Roberts
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Intended Use/ Indications for Use
510(k) Number (if known):
Device Name: Indications for Use:
The Hemostasis, LLC wound dressings are intended for use as topical dressings for the management of bleeding wounds.
Prescription: ExcelArrest™ is indicated for use as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, do noralites, dermatological), cuts and lacerations and is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.
OTC: ExcelArrest™ is indicated for use as a topical dressing on minor bleeding wounds such as cuts, lacerations and abrasions and for minor nose bleeds.
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 OF NEEDED)
Concurrence of Office of Device Evaluation (ODE)
a see and service and superior and consistences
ion Sign-Off Division of General. Resto and Neurological Devices
510(k) Number L072900
4
K072900
page 1/2
510(k) Summary
APPLICANT Hemostasis, LLC Corporation 5000 Township Parkway, St. Paul, MN 55110 Telephone: 651-855-1466 Fax: 651-651-855-1465 Contact: Keith Roberts Title: Technical Business Development
36 2 6 7001
Company Name: Hemostasis, LLC
Classification Name: Dressing, Unclassified, Product Code - FRO
Common/Usual Name: Topical hemostatic foam
Proprietary Name: ExcelArrest™ (Rx) and (OTC) foam,
Establishment Registration Number and Manufacturing Location: To be Assigned Hemostasis, LLC is located at 5000 Township Parkway, St. Paul, MN 55110.
Performance Standards: N/A
Substantial Equivalence: The Hemostasis, LLC ExcelArrest™ foam hemostat is Substantially Equivalent to the Hemostasis, LLC products that were the subject of premarket notification K070211, the Hemcon bandage which was subject of premarket notification K0303946 and the Vascular Solutions bandage which was subject of premarket notification K050511.
DESCRIPTION
As described above, the Hemostasis, LLC hemostats are comprised of modified chitin particles and polysaccharide binders. The particles are dissolved in water, poured into appropriate trays and using a lyophylization process, the water is removed to form a foam bandage. Chitin has well known hemostasis properties and when combined with the sodium carboxymethylcellulose and hydroxyethylcellulose binders, has an affinity to hold water. The Hemostasis foam quickly dehydrates blood cells, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding in moderate to severe lacerations.
INDICATIONS FOR USE
The Hemostasis, LLC wound dressings are intended for use as topical dressings for the management of bleeding wounds.
Prescription: ExcelArrest™ is indicated for use as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative a ) tradities, dermatological), cuts and lacerations and is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.
OTC: ExcelArrest™ foam is indicated for use as a topical dressing on minor bleeding wounds such as cuts, lacerations and abrasions and for minor nose bleeds.
5
K072900
page 2/2
PREDICATE DEVICES
Hemostasis, LLC bandages subject of premarket notification K070211, the Hemcon bandage which was subject of premarket notification K0303946 and the Vascular Solutions bandage which was subject of premarket notification K050511.
BIOCOMPATIBILITY
The classification and applicable testing of the Hemostasis device was determined 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 criteria have been satisfied for biocompatibility.
PORCINE MODEL FOR PERFORMANCE TESTING
Comparative testing was performed using a Porcine Model and the devices met the performance criteria.
The Hemostasis, LLC products will be provided sterile.
CONCLUSION
Through the data and information presented, Hemostasis, LLC considers the devices substantially equivalent to legally marketed predicated devices cited in this Premarket Notification.