No
The device description focuses on the physical and chemical properties of the material and its mechanism of action, with no mention of AI or ML.
Yes.
The device description and intended use clearly state that HemaDerm™ is used for the treatment and control of bleeding, which is a therapeutic function.
No
Explanation: The "Intended Use / Indications for Use" section clearly states that HemaDerm™ is intended as a "topical dressing" for "temporary treatment" of bleeding wounds, not for diagnosing any medical condition. Its function is to control bleeding, which is a therapeutic action, not a diagnostic one.
No
The device description clearly states it is a topical dressing containing physical particles (Microporous Polysaccharide Hemospheres™) that interact with blood to form a clot. This is a physical medical device, not a software-only one.
Based on the provided information, HemaDerm™ is not an In Vitro Diagnostic (IVD) device.
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." This describes a device that is applied directly to the body to achieve a physical effect (stopping bleeding).
- Device Description: The description explains how the device works by physically interacting with blood at the wound site (dehydration, hemoconcentration, clot formation). This is a mechanical/physical mechanism of action, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.) outside of the body, which is a key characteristic of IVD devices. It doesn't provide information about a patient's health status or condition based on testing samples.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. HemaDerm™ does not fit this description.
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 and for the temporary treatment of mild bleeding from topical ENT surgical wounds and nosebleeds.
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, LYA, NHB
Device Description
HemaDerm™ is 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.
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
under the care of a 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K002972, K012532, K984388, K030334, K984177, K984069, K830264, K000108, K972459, K993362
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized eagle. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 11, 2023
Medafor, Inc. c/o Jennifer May Manager, Regulatory Affairs 2700 Freeway Blvd. Suite 800 Minneapolis, Minnesota 55430
Re: K033666 Trade/Device Name: HemaDerm™ Regulatory Class: Unclassified Product Code: QSY, LYA, NHB
Dear Jennifer May:
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 December 17, 2003. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product codes QSY, LYA, and NHB.
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 & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 2003
Medafor, Inc. c/o Jennifer May Regulatory Affairs 2700 Freeway Blvd. Suite 800 Minneapolis, MN 55430
Re: K033666 Trade/Device Name: HemaDerm™ Regulatory Class: Unclassified Product Code: FRO Dated: November 19, 2003 Received: November 21, 2003
Dear Ms. May:
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 - Jennifer May
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 (301) 594-4613. 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,
A kelpi rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
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 and for the temporary treatment of mild bleeding from topical ENT surgical wounds and nosebleeds.
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)
Prescription Use
OR
Over-The-Counter _____________________________________________________________________________________________________________________________________________________________
(Optional Format 1-1-96)
(Per 21 CFR 801.109)
Kunt Baken
(Division Sign(ODF))
Division of Ophthalmic Ear,
Nose and Throat Devices
510(k) Nu
Medafor, Inc. HemaDerm Indications Update page 17 of 17
4
DEC 17 2003
K03366
h. 510(k) Summary of Safety and Effectiveness
1. General Company Information
| Name: | Medafor, Inc. |
|---|---|
| Address: | 2700 Freeway Blvd |
| Suite 800 | |
| Minneapolis, MN 55430 | |
| Telephone: | 763/571-6300 |
| FAX: | 763/571-1035 |
| Contact: | Jennifer May, Manager, Regulatory Affairs |
| Date Prepared: | December 12, 2003. |
2. General Device Information
HemaDerm™ containing MPH (Microporous Polysaccharide Product Name: Hemospheres™ )
Dressing, Unclassified, Product Code - FRO Classification:
3. Predicate Devices
| Manufacturer / Product name |
|---|
| Medafor, Inc. / HermaDerm |
| Xomed, Inc. / MeroGel Control Gel ENT Surgical Dressing |
| Genzyme Corp. / SepraGel Sinus |
| ConvaTec / HA Absorbent Wound Dressing |
| T Scientific / T Pad |
| BioLife / Nosebleed QR powder |
| Marine Polymers / ProDien Patch |
| DeRoyal, Inc. / Single and Double Strung Tonsil Sponges and Double Strung Cylindrical Sponges |
| RITMED, Inc. / Floet Tonsil and Adenoid Sponges |
| Applied Therapeutics, Inc. / Rapid Rhino Nasal Pac with Gel Knit |
| Boston Medical Products / Rhinocell Nasal Packings |
| Les Laboratoires Brothier S.A. / ENTaxis Nasal Packing |
| BIOMATRIX Inc. / Hylasine |
See attached predicate matrix for details.
4. Description
- Description manufactured from purified plant based polysaccharide. The porosity is controlled such that the particles act as molecular sieves excluding large proteins and cells.
5
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 and for the temporary treatment of mild bleeding from topical ENT surgical wounds and nosebleeds.
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
The primary predicate for this submission is the original 510(k) notification for HemaDerm (K021678, cleared July 12, 2002). The product which is the subject of this notification s identical to that product in the following respect:
- Warnings/Precautions/Contraindications 프
- Operating Principles ■
- Performance Specifications
- . Materials
- 1 Manufacturing
- Packaging Materials and Operations 지
- I Sterilization Processing
Other predicates listed in this submission are for the areas of indications and intended use; all but one listed predicate is a prescription devices. Additional predicates for this notification include devices that are used to dress bleeding wounds for the areas addressed by the revised indications, i.e.: topical ear, nose, and throat locations including nosebleeds.
These predicate devices are indicated for use in ear, nose, and throat surgeries and/or for nosebleeds. HemaDerm is substantially equivalent to these products in that it has a similar intended use and indications. The subject predicate devices are made from materials which have demonstrated satisfactory biocompatibility, are highly absorbent, and are sterile single use devices. HemaDerm has also been shown to be biocompatible, absorbent, sterile, and is packaged as a single use device. HemaDerm is different from these predicate devices in that it consists of Medafor's proprietary MPH beads, which have been shown to be safe and effective in earlier testing submitted in previous 510(k) notifications. Because of the similarities in intended uses to these products, Medafor believes that it is substantially equivalent to the predicate devices that have been reviewed, classified and approved or that are exempt from 510(k) submission.
6
| Manufacturer
| Product name | 510(k) | Material | Indications /Description |
|---|---|---|---|
| Medafor, Inc. | |||
| HemaDerm | K021678 | Polysaccharide | 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. | |||
| Xomed | |||
| MeroGel ENT | |||
| Surgical Dressing | K002972 | HYAFF, an ester of | |
| hyaluronic acid | MeroGel Control Gel ENT Surgical Dressing is a dressing and/or stent intended to | ||
| separate tissues of structures compromised by surgical trauma, help control minimal | |||
| bleeding, and act as an adjunct to aid in the natural healing process. The device is | |||
| indicated for use in the ear, nose, and throat, head and neck surgical procedures where an | |||
| open wound dressing and/or stenting material is required including the middle ear and | |||
| external ear canal following myringoplasty, tympanoplasty, canalplasty, stapes and | |||
| mastoid surgery, also for use in the nasal and/or sinus cavities following nasal, sinus, | |||
| and/or throat surgery where separation of tissues or structures is desired. | |||
| Genzyme Hylasine | |||
| (Sepragel Sinus) | K012532 | Derivative hyaluronic | |
| acid | HylaSine is indicated for use in patients undergoing nasal/sinus surgery as a space- | ||
| occupying gel stent to separate and prevent adhesions between mucosal surfaces in the | |||
| nasal cavity, to help control minimal bleeding following surgery or nasal trauma, and to | |||
| prevent lateralization of the middle turbinate during the postoperative period. | |||
| HylaSine, hylan B is a sterile, transparent, viscoelastic gel composed of cross-linked | |||
| polymers of hyaluranon. This hyaluranon is a bioresorbable material that functions to fill | |||
| nasal/sinus cavities following surgery or trauma and to keep mucosal surfaces separate | |||
| during the healing process. During this time, the tamponade effect helps control minimal | |||
| bleeding normally associated with routine sinus surgery. HylaSine leaves the sire of | |||
| placement by natural elimination, or it may aspirated form the cavity earlier at the | |||
| discretion of the physician. | |||
| Convatec HA | |||
| Absorbent Wound | |||
| Dressing R | K984388 | HYAFF 11p75, a | |
| benzyl ester of | |||
| hyaluronic acid | HA Absorbent Wound Dressing R is indicated for use in the management of deep exuding | ||
| wounds, sinuses, and fistulac | |||
| T Scientific T-Pad | K030334 | poly-N-acetyl | |
| glucosamine. | The T-Scientific T-Pad is intended for use in the local management of bleeding wounds | ||
| such as lacerations, abrasions, nose bleeds, vascular access sites, percutaneous catheters or | |||
| tubes and surgical debridement, and the promotion of rapid control of bleeding in patients | |||
| following hemodialysis and in patients on anticoagulation therapy. | |||
| BioLife NoseBleed | |||
| QR Powder | Class 1 | ||
| exempt | potassium salt and | ||
| hydrophilic polymers | For nosebleeds (only in the anterior nasal cavity) and hard to treat areas | ||
| Marine Polymers | |||
| ProDein Patch | K984177 | Polysaccharide/ poly- | |
| n-acetyl glucosamine | ProDein Patch is indicted for use in the local management of bleeding wounds such as | ||
| lacerations, abrasions, and nosebleeds. | |||
| Les Laboratoires | |||
| Brothier S.A. | |||
| ENTAxis Nasal | |||
| Packing | K984069 | calcium alginate | ENTaxis Nasal Packings are intended for nasal epistaxis and as post operative nasal |
| packings. | |||
| DeRoyal, Inc. Single | |||
| and Double Strung | |||
| Tonsil Sponges and | |||
| Double Strung | |||
| Cylindrical Sponges | 510(k) | ||
| exempt; | |||
| unknown, | Gauze covered cotton | ||
| sponge plus Raypaque | |||
| (x-ray detectable | |||
| element) | Tonsil Sponges: The single/double strung tonsil sponge has 15" white memory free cotton | ||
| string. Covered with gauze, the sponge is cotton filled for maximum absorbency and an | |||
| Raypaque element within ensures x-ray detectability. Sterile. | |||
| Double Strung Cylindrical Sponge: Highly absorbent, this cotton sponge is designed for | |||
| tonsil, adenoid and nasal surgery. Designed with an Raypaque element inside, this sponge | |||
| is x-ray detectable. Sterile. | |||
| RITMED, Inc. Floet | |||
| Tonsil and Adenoid | |||
| Sponges | K830264 | Gauze covered super- | |
| absorbent non-woven | |||
| cotton | Gauze covered super-absorbent non-woven cotton. Available sterile. Available double | ||
| strung and stung on count card. All have x-ray element. Sizes include: ½", 7/8", 1", 1 ¼ | |||
| " double strung and ½" x 1", ½ "x 1 ½", ¾" x 1 ½" stung on count card | |||
| Applied | |||
| Therapeutics, Inc. | |||
| Rapid Rhino Nasal | |||
| Pac with Gel Knit | K000108 | PVC catheter with | |
| carboxy- | |||
| methylcellulose as the | |||
| hemostatic material | Rapid Rhino is designed to control epistaxis due to: | ||
| a) Trauma | |||
| b) Post-operative bleeding | |||
| c) Spontaneous epistaxis. | |||
| It is intended to treat minor nasal bleeding. | |||
| Controls minor bleeding via active platelet aggregation, when exposed to blood or fluids. | |||
| Boston Medical | |||
| Products Rhinocell | |||
| Nasal Packings | K972459 | Lint and fiber free | |
| polyvinyl alcohol | |||
| sponge material | For use as a nasal packing to treat epistaxis. | ||
| Superior liquid absorption and wicking characteristics | |||
| BIOMATRIX,Inc. | |||
| Hylasine | K993362 | Sterile, transparent, | |
| viscoelastic gel | |||
| composed f cross- | |||
| linked polymers of | |||
| hyaluronan | The intended use of Hylasone is for use in nasal/sinus cavity as a space-occupying gel | ||
| stent, to separate mucosal surface and to help control minimal bleeding following surgery | |||
| or nasal trauma. Hylasine leaves the site of placement by natural elimination, or it may be | |||
| aspirated from the cavity earlier at the discretion of the physician. |