(90 days)
The HemoHalt Hemostasis Pad is intended for the local management and rapid control of bleeding (hemostasis): for skin surface puncture sites for vascular procedures, percutaneous catheters and/or tubes; following hemodialysis treatments; for patients on anticoagulation therapy; and for lacerations, and nose bleeds. For use only on external bleeding wounds.
HemoHalt™ Hemostasis Pad is a soft, non-woven pad approximately 5 x 5 x 0.5cm in size, made of chitosan, a polysaccharide heteropolymer of poly-Dglucosamine and poly-N-acetyl-D-glucosamine. The HemoHalt™ Hemostasis Pad will be packaged in a paper surfaced, high barrier foil pouch for single use and terminally sterilized by E-beam radiation.
This document is a 510(k) summary for the HemoHalt™ Hemostasis Pad Wound Dressing. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel AI device. Therefore, much of the requested information cannot be extracted directly from this document.
However, I can provide the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" with numerical thresholds typically seen for new device performance validation studies. Instead, it relies on demonstrating performance that is "as well as or better than" a predicate device.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Hemostasis | Performs "as well as or better than" the predicate device | "performs as well as or better than the predicate" |
| Safety & Safety | No concerns regarding safety or effectiveness | "None of the differences raise any concerns regarding safety or effectiveness" |
| Biocompatibility | Assumed to be acceptable given the predicate comparison, though not explicitly stated as an acceptance criterion | Not explicitly detailed, but implied by the overall conclusion of substantial equivalence. |
| Sterility | Sterility (same as predicate) | Yes, terminal sterilization |
| Packaging | Similar packaging (same as predicate) | Foil pouch, single use |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document states that "In vivo and in vitro tests were performed," but it does not specify the sample sizes (e.g., number of animals for in vivo, number of replicates for in vitro) for these tests.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The studies performed were likely laboratory or animal studies, not human clinical trials requiring expert-established ground truth in the context of diagnostic interpretation.
4. Adjudication method for the test set:
This information is not provided. It's unlikely to be applicable in the context of these types of performance tests (in vivo/in vitro) where human expert adjudication for diagnostic accuracy is not the primary focus.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This document is for a medical device (wound dressing), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant and was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This document is for a medical device (wound dressing), not an AI algorithm. Therefore, "standalone" algorithm performance is not applicable and was not done.
7. The type of ground truth used:
For the in vivo and in vitro tests, the "ground truth" would have been established through objective measurements (e.g., time to hemostasis, blood loss, biocompatibility markers) in experimental settings. The document does not specify the exact metrics or how they were defined as "ground truth."
8. The sample size for the training set:
This document is for a traditional medical device (wound dressing), not an AI/machine learning model. Therefore, there is no "training set" in the AI sense.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI model.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 11, 2023
Vanson-Halosource, Inc. c/o Eric Robinson Vice President of Operations 14716 NE 87th Street Redmond, Washington 98052
Re: K060409 Trade/Device Name: HemoHalt™ Hemostasis Pad Wound Dressing Regulatory Class: Unclassified Product Code: QSY, LYA
Dear Eric Robinson:
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 May 17, 2006. 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 the Assistant Director at DHT4B: Division of Infection Control and Plastic Surgery Devices. It also lists OHT4: Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality, and Center for Devices and Radiological Health. The signature block starts with "Sincerely,", followed by the name and title of the person.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three horizontal lines representing the serpent and staff. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement. The text is in all caps and is evenly spaced around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 7 2006
Vanson-HaloSource % Mr. Eric Robinson Vice President of Operations 14716 NE 87th Street Redmond, Washington, 98052
Re: K060409
Trade/Device Name: HemoHalt™ Hemostasis Pad Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: April 17, 2006 Received: April 19, 2006
Dear Mr. Robinson:
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.
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Page 2 -- Mr. Eric Robinson
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 (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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Herbert Lerner wo
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ___HemoHalt™ Hemostasis Pad Wound Dressing
Indications for Use:
The HemoHalt Hemostasis Pad is intended for the local management and rapid control of bleeding (hemostasis): for skin surface puncture sites for vascular procedures, percutaneous catheters and/or tubes; following hemodialysis treatments; for patients on anticoagulation therapy; and for lacerations, and nose bleeds. For use only on external bleeding wounds.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hubert Penner
Page 1_of 1
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K060409
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K060409 page 1/2
510(k) Summary
1'4Y 17 2005
510(k)'s Owner Name: Vanson HaloSource, Inc. Address: 14716 NE 87th Street, Redmond, WA 98052 Phone Number: 425.881.6464 Fax Number: 425.882.2476 Contact Person: Eric Robinson, VP Operations Date of Preparation: February 14, 2006
Trade Name: HemoHalt™ Hemostasis Pad Wound Dressing Common Name: Wound Dressing Classification: Unclassified Product code: FRO Classification Name: Dressing
Device Description: HemoHalt™ Hemostasis Pad is a soft, non-woven pad approximately 5 x 5 x 0.5cm in size, made of chitosan, a polysaccharide heteropolymer of poly-Dglucosamine and poly-N-acetyl-D-glucosamine. The HemoHalt™ Hemostasis Pad will be packaged in a paper surfaced, high barrier foil pouch for single use and terminally sterilized by E-beam radiation.
Intended Use: The HemoHalt™ Hemostasis Pad is intended for the local management and rapid control of bleeding (hemostasis): for skin surface puncture sites for vascular procedures, percutaneous catheters and/or tubes; following hemodialysis treatments; for patients on anticoagulation therapy; and for lacerations, and nose bleeds. For use only on external bleeding wounds.
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K060409 page 2/2
Summary of Technological Characteristics:
The comparison between the HemoHalt™ Hemostasis Pad Wound Dressing and the predicate device can be summarized as follows. None of the differences raise any concerns regarding safety or effectiveness.
| HemoHalt™ Hemostasis PadWound Dressing | Predicate Device | Comparison | |
|---|---|---|---|
| Intended Use | Intended for the localmanagement and rapid control ofbleeding (hemostasis): for skinsurface puncture sites forvascular procedures,percutaneous catheters and/ortubes; following hemodialysistreatments; for patients onanticoagulation therapy; and forlacerations, abrasions, and nosebleeds. For use only on externalbleeding wounds. | Intended for use under the directionof a health care professional for thefollowing indications: The predicateis indicated for the promotion ofrapid control of bleeding in patientsfollowing hemodialysis and inpatients on anticoagulation therapy.The predicate is indicated for use inthe local management of bleedingwounds such as vascular accesssites, percutaneous catheters ortubes, and surgical debridement. | Same |
| Composition | Chitosan, a polysaccharideheteropolymer of poly-D-glucosamine and poly-N-acetyl-D-glucosamine | polysaccharide homopolymer, poly-N-acetyl-D-glucosamine | Differs insource withsomedifferences instructure |
| PhysicalDimensions | 5 x 5 x 0.5cm | 1.2" x 1.2" (3 x 3 cm) | Differs in size |
| Form | Non-woven | Non-woven | Same |
| Sterile | Yes, terminal sterilization | Yes, terminal sterilization | Same |
| PackagingMaterial | Foil pouch | Foil pouch | Same |
| PackagingType | Single use | Single use | Same |
| Duration ofUse | Short term | Short term | Same |
| Type of Use | Topical | Topical | Same |
Performance Comparison: In vivo and in vitro tests were performed comparing the HemoHalt™ Hemostasis Pad with the predicate. The results indicate that the HemoHalt™ Hemostasis Pad performs as well as or better than the predicate.
N/A