(52 days)
Not Found
Not Found
No
The device description focuses on the physical and chemical properties of the polysaccharide particles and their mechanism of action (dehydration and hemoconcentration) for bleeding control. There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
No
This device is described as a topical dressing and hemostatic agent intended to control bleeding, not to diagnose a condition.
No
The device description clearly states it consists of "dry, sterile, controlled porosity, spherical particles manufactured from purified plant based polysaccharide," which is a physical material, 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 HemaDerm™ is a "topical dressing" for the "temporary treatment of severely bleeding wounds" and for the "local management and control of bleeding from percutaneous needle access, vascular access sites and percutaneous catheters." This describes a device applied externally to the body to manage bleeding, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description details a "dry, sterile, controlled porosity, spherical particles manufactured from purified plant based polysaccharide" that work by "rapid dehydration and subsequent hemoconcentration of blood." This mechanism of action is physical and chemical, acting directly on the blood at the site of bleeding, not through in vitro analysis of a sample.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
- Performing tests in a laboratory setting
In summary, HemaDerm™ is a topical hemostatic device used to control bleeding on the body, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
QSY, FRO, KME
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.
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.
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
health care professional
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
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.
Key Metrics
Not Found
Predicate Device(s)
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
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym and the words "U.S. FOOD & DRUG ADMINISTRATION" are in blue.
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
1
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.
2
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
3
Page 21
5/16/2002
· Applicant: Medafor, Inc.
510(k) Number (if known):
Device name: HemaDerm™
Intended Use/Indications for Use:
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.
(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
OR
Over-The-Counter
(Per 21 CFR 801.109) 1-96)
(Optional Format 1-
4
'JUL 12 2002 678
1% 200
5/16/2002
510(k) Summary of Safety and Effectiveness h.
-
- General Company Information
Page 16
- General Company Information
| Name: | Medafor, Inc. |
|---|---|
| Address: | 5201 East River Road |
| Suite 312 | |
| Minneapolis, 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
5
P. 2 at 2
4. 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.
5. Indications
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.
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.
6
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.