(73 days)
Not Found
No
The device description focuses on the material composition and mechanism of action of a plant-based starch hemostatic agent. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The "Not Found" entries for mentions of AI, DNN, ML, training sets, and test sets further support this conclusion.
No.
The device is described as a topical dressing intended for the management and control of bleeding wounds, which classifies it as a hemostat rather than a therapeutic device.
No
The device is a topical dressing intended to manage or treat bleeding wounds. It does not diagnose any condition.
No
The device description clearly states it is comprised of "plant based starch particles" and "starch particles processed into a foam," which are physical materials, 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 wound dressings are for the "management of bleeding wounds" and are applied "topical dressings". This indicates a direct application to the body for a therapeutic or wound management purpose.
- Device Description: The description details the composition of the dressing (plant-based starch particles) and its mechanism of action (dehydrating blood cells to promote clotting). This is a physical or chemical interaction with the wound itself, not an analysis of a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing a sample (blood, urine, tissue, etc.) in vitro (outside the body).
- Providing information about a patient's health status, diagnosis, or monitoring based on sample analysis.
- Any laboratory procedures or equipment typically associated with IVDs.
In summary, the device is a topical wound dressing designed to control bleeding directly on the wound, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
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: TraumArrest™ is indicated for use 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 is also indicated for control of bleeding from the skin at perculaneous needle access, vascular access and percutaneous catheter access sites.
OTC: BleedArrest™ particles and foam are 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)
OSY, LYA
Device Description
As described above, the Hemostasis, LLC hemostats are comprised of plant based starch particles. The particles consist in two forms; one is starch particles and one is starch particles processed into a foam using a lyophylization process and include a polysaccharide binder hydroxypropylmethylcellulose (HPMC). Starch is a polysaccharide that is a well known hemostatic agent due to its ability to hold moisture. The Hemostasis hemostatic particles and foam quickly dehydrate 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
Skin (for percutaneous needle access, vascular access, percutaneous catheter access sites, cuts, lacerations, abrasions, nose bleeds)
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)
Performance studies included biocompatibility testing based on ISO 10993 and FDA guidance G95-1, and comparative testing using a Porcine Model. The devices met the performance criteria in the porcine model.
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 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.
June 11, 2023
Hemostasis, LLC c/o Keith A. Roberts 5000 Township Parkway St. Paul, Minnesota 55110
Re: K070211 Trade/Device Name: TraumArrest™ and BleedArrest (OTC) Regulatory Class: Unclassified Product Code: OSY, LYA
Dear Keith A. 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 April 5, 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.
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 and Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 5 - 2007
Hemostasis, LLC % Mr. Keith A. Roberts 5000 Township Parkway St. Paul, Minnesota 55110
Re: K070211
Trade/Device Name: TraumArrest™ and BleedArrest Regulatory Class: Unclassified Product Code: FRO Dated: January 16, 2007 Received: January 22, 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.
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.
2
Page 2 - Mr. Keith A. Roberts
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
for
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): K070211
Device Name: Indications for Use:
The Hemostasis, LLC wound dressings are intended for use as topical dressings for the management of bleeding wounds.
Prescription: TraumArrest™ is indicated for use 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 is also indicated for control of bleeding from the skin at perculaneous needle access, vascular access and percutaneous catheter access sites.
OTC: BleedArrest™ particles and foam are 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)
8
Revision Sign-Off
(Division Sign-Off) (Division Sign-Orr). Restorative,
Division of General. Restorative, Division of Neurologica. Devices
510(k) Number
4
APR 5 - 2016
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
Company Name: Hemostasis, LLC
Classification Name: Dressing, Unclassified, Product Code - FRO
Common/Usual Name: Topical hemostatic particles and foam
Proprietary Name: TraumArrest™ (Rx) particle and foam and BleedArrest (OTC) particle and 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 TraumArrest™ and BleedArrest particles and foam are substantially equivalent to the Medafor HemaDerm and Bleed-X products which were the subject of premarket notification numbers K033666 and K013225. Hemostasis, LLC believes we have demonstrated that our hemostat devices have performed as well as the above predicate devices. A list of additional predicate devices including their subsequent labeling claims is provided in the summary table titled Matrix of Predicate Devices in Section 12.
COMPARATIVE TESTING OF SUBSTANTIALLY EQUIVALENT DEVICES
Hemostasis, LLC has performed biocompatibility testing on our devices as well as comparative testing using a Porcine Model.
5
DESCRIPTION
As described above, the Hemostasis, LLC hemostats are comprised of plant based starch particles. The particles consist in two forms; one is starch particles and one is starch particles processed into a foam using a lyophylization process and include a polysaccharide binder hydroxypropylmethylcellulose (HPMC). Starch is a polysaccharide that is a well known hemostatic agent due to its ability to hold moisture. The Hemostasis hemostatic particles and foam quickly dehydrate 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: TraumArrest™ is indicated for use 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 is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.
OTC: BleedArrest™ particles and foam are indicated for use as a topical dressing on minor bleeding wounds such as cuts, lacerations and abrasions and for minor nose bleeds.
PREDICATE DEVICE
Medafor HemaDerm and Bleed-X products which were the subject of Premarket Notification numbers K033666 and K013225.
BIOCOMPATIBILITY
The classification and applicable testing of the Hemostasis devices were 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 COMPARATIVE 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.
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CONCLUSION
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Through the data and information presented, Hemostasis, LLC considers the devices r rrough the aquivalent to legally marketed predicated devices cited in this Premarket Notification.
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