(90 days)
Over the Counter, OTC:
Bleed-X™ is intended as a topical dressing for the local management of bleeding wounds such as minor cuts, lacerations and abrasions.
Prescription, Rx:
Traumadex™ is intended as a topical dressing for the local management of bleeding wounds such as cuts, lacerations and abrasions. Under the care of a health care professional, Traumadex™ may be used for the temporary treatment of severely bleeding wounds such us surgical wounds (post-operative, donor sites, dermatological), cuts, lacerations and traumatic injuries.
Medafor, Inc.'s Bleed-X™ and Traumadex™ 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 plateler activation and fibrin deposition within the congealed blood produces a clot that limits further bleeding.
The given text describes Medafor, Inc.'s Bleed-X™ and Traumadex™ containing Hemadex™ Clotting Beads. Here's an analysis of the acceptance criteria and the studies performed, based only on the provided information:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it refers to the efficacy demonstrated through various studies and concludes that the device is "safe and effective for the control of bleeding wounds and perform in a manner equivalent and similar to the predicates." The reported performance is summarized qualitatively.
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Biological Compatibility | Achieved (per ISO 10993-1 and FDA G95-1) |
| Sterility Assurance Level | Achieved SAL of 1 x 10^-6 (per AAMI/ANSI/ISO 11137 and EN552) |
| Control of Bleeding (Efficacy) | Demonstrated in porcine model and human clinical investigation. Human study showed "accelerated rate of bleeding control in the presence of the particles." |
| Safety | Demonstrated through biocompatibility testing and clinical investigation. |
| Equivalence to Predicate Devices | Believed to be equivalent and similar based on various studies. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: A "non-significant risk clinical investigation using human subjects" was conducted.
- Sample Size: The exact sample size for the human clinical investigation is not specified in the provided text.
- Data Provenance: The study used "human subjects," implying prospective human clinical data. The country of origin is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide any information regarding experts used to establish ground truth or their qualifications for the human clinical investigation.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The human clinical investigation involved a "side by side comparison of Bleed-X™ / Traumadex™ and a control of normal clotting," but it doesn't describe an MRMC design or the effect size of human readers with/without AI assistance (which is not relevant for this device).
6. If a Standalone (Algorithm Only) Performance Study was done
This device is a topical dressing, not an algorithm or AI system. Therefore, a standalone (algorithm only) performance study is not applicable or described.
7. The Type of Ground Truth Used
For the human clinical investigation, the ground truth was likely based on observation of bleeding control and rate of clotting in a "side by side comparison" against "normal clotting." The document states it demonstrated "an accelerated rate of bleeding control."
8. The Sample Size for the Training Set
The document does not mention a training set as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
The document does not mention a training set or how its ground truth would be established, as this is not an AI/ML device.
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Page 19
013225
1 1/28/2001
DEC 2 6 2001
510(k) Summary of Safety and Effectiveness h.
- General Company Information
| 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: | Bleed-XTM and TraumadexTM containing HemadexTM Clotting Beads |
|---|---|
| Classification:KMF | Liquid Bandage, Unclassified (General Controls), Product Code - KMF |
-
- Predicate Devices
Calgon Vestal Labs, Kaltostat Wound Dressing
- Predicate Devices
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
{1}------------------------------------------------
Page 20
4. Description
Meclafor, Inc.'s Bleed-X™ and Traumadex™ 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 ccssation 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 plateler activation and fibrin deposition within the congealed blood produces a clot that limits further bleeding.
5. Indications
Over the Counter, OTC:
Blocd-X™ is intended as a topical dressing for the local management of blocding wounds such as minor cuts, lacerations and abrasions.
Prescription, Rx:
Traumadex™ is intendod as a topical dressing for the local management of bleeding wounds such as cuts, laccrations and abrasions. Under the care of a health care professional, Traumadex™ may be used for the temporary treatment of severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), cuts, lacerations and traumatic injuries.
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 Hemadcx cloting beads consists of dry, sterile, controlled porosity, spherical particles manufactured from purified plant based polysaccharide using an emulsion cross-liking process.
The particles will be packaged in single use containers with a moisture-protective laminate outer wrap. The final package will be terminally sterilized using gamma irradiation. Contract manufacturers will do both packaging and sterilization, following written contracts with Mcdafor.
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Page 21
Contract manufacturers will do both packaging and sterilization, following written contracts with Medafor.
Bleed-XTM will be available for OTC use in sizes from .5 to 10 grams using a medical grade plastic applicator package or a "peel and pour" laminate pouch.
Traumadex™ will be available for prescription use in sizes from 1 to 10 grams using a medical grade plastic applicator.
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.
Biological testing per ISO 10993-1 and FDA G95-1 demonstrates the biological compatibility of Bleed-XTM and TraumadexTM.
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 a porcine model shows the efficacy of Bleed-XTM and Traumadex™ in the control of bleeding.
A non-significant risk clinical investigation using human subjects in a side by side comparison of Bleed-X ™ / Traumadex™ and a control of normal clotting demonstrated an accelerated rare of bleeding control in the presence of the particles.
The initial indications are for topical application as an aid in the control of bleeding. This product will be intended for both prescription and OTC use and labels is worded accordingly.
Medafor, Inc. believes that as a result of the biocompatibility testing, the physical analysis, the animal studics and the human clinical that the Bleed-XTM and Traumadex™ containing Hemadex™ clotung beads are safe and effective for the control of bleeding wounds and 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 upplications.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 6 2001
Medafor, Inc. Mr. Philip B. Jarvi Director of Clinical and Regulatory Affairs 5201 East River Road, #312 Minneapolis, Minnesota 55421-1035
Re: K013225 Trade Name: Traumadex™ and Bleed-X™ containing Hemadex Clotting Beads Regulation Number: 880.5090 Regulation Name: Liquid Bandage Regulatory Class: I Product Code: KMF Dated: November 28, 2001 Received: December 3, 2001
Dear Mr. Jarvi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 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 vours.
Neikhr Ogden
Celia M. Witten, Ph.D., M.D. for
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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12/19/2001
Page 24
Indications for Use Statement
Applicant: Medafor, Inc.
510(k) Number (if known): K013225
Device name: Bleed-X TM and TraumadexTM
Intended UseAndications for Use:
Over the Counter, OTC:
Bleed-X™ is intended as a topical dressing for the local management of bleeding wounds such as minor cuts, lacerations and abrasions.
Prescription, Rx:
Traumadex™ is intended as a topical dressing for the local management of bleeding wounds such as cuts, lacerations and abrasions. Under the care of a health care professional, Traumadex™ may be used for the temporary treatment of severely bleeding wounds such us surgical wounds (post-operative, donor sites, dermatological), cuts, lacerations and traumatic injuries.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
NRe for cmw
Division Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number K013225
Prescription Use /
OR
Over-The-Counter $\nearrow$
(Per 21 CFR 801.109) 1-86)
(Optional Format 1-
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.