HemaDerm™ is intended for use under the care of a health care professional as a topical dressing for the temporary treatment of severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), minor cuts and lacerations.

HemaDerm™ is intended for use under the care of a health care professional for the local management and control of bleeding from percutaneous needle access, vascular access sites and percutaneous catheters.

Device Description

Medafor. Inc.'s HemaDerm™ consists of dry, sterile, controlled porosity, spherical particles manufactured from purified plant based polysaccharide. The porosity is controlled such that the particles act as molecular sieves excluding large proteins and cells.

The bleeding cessation is accomplished by the rapid dehydration and subsequent hemoconcentration of blood in contact with the particles. The concentration of serum proteins and cells produces a viscous gel. Normal platelet activation and fibrin deposition within the congealed blood produces a clot that limits further bleeding.

AI/ML Overview

This document describes the HemaDerm™ containing Hemadex™ Clotting Beads, a device intended for use as a topical dressing for the temporary treatment of severely bleeding wounds and for the local management and control of bleeding from percutaneous access sites.

Here's an analysis of the provided information regarding acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria in numerical thresholds for performance metrics. Instead, it relies on demonstrating equivalence to predicate devices and showing effectiveness and safety through various studies. The reported performance is qualitative and framed around achieving "accelerated rate of bleeding control" and "effectively control bleeding."

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance (HemaDerm™)
Efficacy	Accelerated rate of bleeding control	"demonstrated an accelerated rate of bleeding control in the presence of the particles"
	Effective control of bleeding	"The device has been shown to effectively control bleeding."
Safety	Biocompatibility	"Biological testing per ISO 10993-1 and FDA G95-1 demonstrates the biological compatibility of HemaDerm™."
	Sterility	"Sterilization validation of the Cobalt-60 gamma irradiation process per AAMI / ANSI / ISO 11137 and EN552 demonstrate a sterility assurance level (SAL) of 1 X 10-6."
Equivalence	Equivalent performance to predicates	"will perform in a manner equivalent and similar to the predicates."
Physiological Appropriateness	Physiologically appropriate	"demonstrated to be procedurally and physiologically appropriate in medical applications."

2. Sample Size Used for the Test Set and Data Provenance:

Human Clinical Investigation: The document mentions "A non-significant risk clinical investigation using human subjects."
- Sample Size: The exact sample size for the human clinical investigation is not specified.
- Data Provenance: The document does not explicitly state the country of origin, but given the 510(k) submission to the FDA, it is highly likely to be prospective data collected within the United States.
Animal Studies: "Animal testing using various animal models."
- Sample Size: The exact sample size for the animal studies is not specified.
- Data Provenance: Not specified, but generally, animal studies for FDA submissions are conducted under controlled conditions, likely prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

Human Clinical Investigation: The study involved a "side by side comparison of HemaDerm™ and a control of normal clotting." The ground truth for bleeding control would likely be established by the healthcare professionals directly observing and managing the wounds.
- Number of Experts: Not specified.
- Qualifications of Experts: Implied to be "health care professional[s]" as the product is intended for use under their care. No specific qualifications (e.g., years of experience, specialty) are provided.

4. Adjudication Method for the Test Set:

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "side by side comparison" in the human clinical investigation suggests direct observation and assessment by the healthcare professionals involved in the study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, an MRMC comparative effectiveness study was not explicitly described. The human clinical investigation mentioned was a "side by side comparison... and a control of normal clotting," which is a comparative study, but not specifically an MRMC study with multiple readers assessing performance against AI assistance.
Effect Size: Not applicable, as an MRMC study with AI assistance was not mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. HemaDerm™ is a medical device (clotting beads), not an AI algorithm. Therefore, there is no "standalone" algorithm performance to assess.

7. The Type of Ground Truth Used:

Human Clinical Investigation: The ground truth for efficacy appears to be based on clinical observation and assessment by healthcare professionals (e.g., direct observation of bleeding cessation, time to hemostasis, comparison to normal clotting). This could be categorized as expert clinical assessment and observation.
Animal Studies: The ground truth for efficacy in animal models would be based on direct observation of bleeding control and potentially other physiological markers within the animal models.
Biocompatibility: Ground truth established against ISO 10993-1 and FDA G95-1 standards (biological compatibility criteria).
Sterilization: Ground truth established against AAMI / ANSI / ISO 11137 and EN552 standards for sterility assurance level.

8. The Sample Size for the Training Set:

Not applicable. HemaDerm™ is a physical medical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As above, HemaDerm™ is a physical medical device.

Summary

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June 11, 2023

Medafor, Inc. Philip B. Jarvi Director, Clinical and Regulatory Affairs 5201 East River Road, # 312 Minneapolis, Minnesota 55421-1035

Re: K021678

Trade/Device Name: HemaDerm™ Containing Hemadex™ Clotting Beads Regulatory Class: Unclassified Product Code: QSY

Dear Philip B. Jarvi:

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 July 12, 2002. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY.

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

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three interconnected profiles facing to the right, resembling human faces or heads. Below the profiles are wavy lines, possibly representing water or fabric.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 12 2002

Medafor, Inc. Philip B. Jarvi Director, Clinical and Regulatory Affairs 5201 East River Road, #312 Minneapolis, Minnesota 55421-1035

Re: K021678

Trade Name: HemaDerm™ Containing Hemadex™ Clotting Beads Regulatory Class: Unclassified Product Code: FRO Dated: May 20, 2002 Received: May 21, 2002

Dear Mr. Jarvi:

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. Philip B. Jarvi

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Celia M. Witten, Ph.D., MD

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 21

5/16/2002

· Applicant: Medafor, Inc.

510(k) Number (if known):

Device name: HemaDerm™

Intended Use/Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sien-Off) Division of General, Restorative and Neurological Devices

510(k) Number K021678

Prescription Use X

Over-The-Counter

(Per 21 CFR 801.109) 1-96)

(Optional Format 1-

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5/16/2002

510(k) Summary of Safety and Effectiveness h.

1. General Company Information
  Page 16

Name:	Medafor, Inc.
Address:	5201 East River RoadSuite 312Minneapolis, MN 55421
Telephone:	763/571-6300
FAX:	763/571-1035
Contact:	Philip B. Jarvi, Director of Regulatory Affairs
Date Prepared:	September 26, 2001

2. General Device Information

Product Name:	HemaDerm™ containing Hemadex™ Clotting Beads
Classification:	Liquid Bandage, Class I (General Controls), Product Code - KME

3. Predicate Devices

Calgon Vestal Labs, Kaltostat Wound Dressing Hemostace, Sorbastace Kendall Hydrophylic Powder Wound Dressing Marine Polymer Technology Healtec and Syvek Patch Dermaphylyx Calcium Alginate Wound Dressing Closure Medical, Liquiderm Liquid Bandage Marine Polymer Technology RDH Bandage Vascular Solutions, Duett Flowable Hemostat Hospal Tipstop Compression Dressing

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P. 2 at 2

4. Description

5. Indications

6. Substantial Equivalence

This section summarizes information about the product and outlines the tests and clinical information we believe will provide sufficient data to support our claims of efficacy and safety.

Medafor, Inc.'s Hemadex® clotting beads consists of dry, sterile, controlled porosity, spherical particles manufactured from purified plant based polysaccharide using an emulsion cross-liking process.

The particles are packaged in single use containers with a moisture-protective laminate outer wrap. The final package is terminally sterilized using gamma irradiation. Contract manufacturers will do both packaging and sterilization, following written contracts with Medafor.

HemaDerm™ will be available for prescription use in sizes from .5 to 10 grams using either a medical grade plastic applicator package or a "peel and pour" laminate pouch.

The hemostatic effect of the particles is produced by the rapid dehydration and subsequent hemoconcentration of blood in contact with the particles. The concentration of serum proteins and cells produces a viscous gel. Normal platelet activation and fibrin deposition within the congealed blood produces a tenacious clot that limits further bleeding.

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Page 18

Biological testing per ISO 10993-1 and FDA G95-1 demonstrates the biological compatibility of HemaDerm™.

Sterilization validation of the Cobalt- 60 gamma irradiation process per AAMI / ANSI / ISO 11137 and EN552 demonstrate a sterility assurance level (SAL) of 1 X 10-6.

Animal testing using various animal models shows the efficacy of HemaDerm™ in the control of bleeding.

A non-significant risk clinical investigation using human subjects in a side by side comparison of HemaDerm™ and a control of normal clotting demonstrated an accelerated rate of bleeding control in the presence of the particles.

The indications is for topical application as an aid in the control of bleeding. This product will be intended for prescription use and labels are worded accordingly.

Medafor, Inc. believes that as a result of the biocompatibility testing, the physical analysis, the animal studies and the human clinical that the HemaDerm™ containing Hemadex™ clotting beads is safe and effective for the control of bleeding wounds and will perform in a manner equivalent and similar to the predicates. The device has been shown to effectively control bleeding. It has been demonstrated to be biocompatible per an internationally recognized standard and it has demonstrated to be procedurally and physiologically appropriate in medical applications.

Regulation Number and Section

N/A