(87 days)
Not Found
No
The device description and intended use focus on the material composition and function of a wound dressing, with no mention of AI or ML capabilities.
Yes
The device is a wound dressing designed to aid the healing process by maintaining a moist environment, which explicitly supports wound healing for various partial and full thickness wounds.
No
The device description clearly states "HEALADEX-P is a sterile wound-dressing" that "aids the healing process by maintaining a moist environment at the wound site." Its intended use is to cover and protect wounds to facilitate healing, not to diagnose medical conditions or identify the nature of a disease.
No
The device description clearly states that HEALADEX-P is a sterile wound-dressing comprised of physical materials (carboxymethylcellulose, lyophilized formulated porcine plasma, adhesive film, etc.) and is packaged as a physical product. It is not software.
Based on the provided information, the HEALADEX®-P Wound Dressing is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a wound dressing applied to the wound site to provide a moist environment for healing. This is a direct interaction with the body's surface for therapeutic purposes.
- Device Description: The description details the physical components of the dressing and how it functions on the wound.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The HEALADEX-P does not perform any such tests on bodily samples. It is a topical application.
- Anatomical Site: The anatomical site is the "Wound site," which is the external surface of the body. IVDs typically analyze internal samples.
Therefore, the HEALADEX®-P Wound Dressing falls under the category of a medical device used for wound management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
HEALADEX®-P Wound Dressing provides a moist environment that is supportive of wound healing. HEALADEX-P is indicated for dry, light and moderately exudating partial and full thickness wounds such as:
- First and second degree burns
- Severe sunburns
- Superficial injuries, superficial lacerations, cuts, abrasions, incisions/surgical wounds, and skin tears
HEALADEX-P dressing should be used under health care professional direction for the following indications:
- Pressure ulcers, Stage I-IV
- Lower extremity ulcers
- Venous ulcers
- Arterial ulcers
- Ulcers of mixed etiology
- Diabetic ulcers
- Donor sites and skin grafts
- Burns caused by radiation oncology procedures
Product codes (comma separated list FDA assigned to the subject device)
FRO, KGN
Device Description
HEALADEX-P is a sterile wound-dressing comprised of carboxymethylcellulose and lyophilized formulated porcine plasma, which is island mounted on moisture vapor permeable adhesive film dressing sheet coated with acrylic adhesive and a polyurethane protective film. This dressing aids the healing process by maintaining a moist environment at the wound site.
HEALADEX-P dressing is individually packaged in a foil moisture barrier chevron peel pouch appropriately labeled with lot number and expiration date. Five units are packaged into a cardboard box with Instructions for Use (IFU).
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
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Safety testing was conducted in accordance with ISO 10993 Part1 in support of the claim of biocompatibility for this product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
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
KD 63517
1/3
FEB 1 6 2007
HEALADEX®-P 510(k) SUMMARY
(510(K) Summary, Required Under 21 CFR 807.87(h))
COMPANY (APPLICANT) NAME AND ADDRESS
HEALAGENICS 800 West Cummings Park Suite 2900 Woburn, MA. 01801
CONTACT PERSON
Contact Name: Paul Strati, CEO Ph: 781-376-4114 / Fax 781-376-4115 Cell: 781-775-1050
MEDICAL DEVICE INFORMATION
| Proprietary Name | HEALADEX®-P Occlusive Dressing |
|---|---|
| Common Names | Wound Dressing |
| Classification Name | Dressing, Wound and Burn, Hydrogel, with drug or biologic |
DEVICE CLASSIFICATION INFORMATION
Regulatory Class:
Unclassified
Product code:
FRO, KGN
STATEMENT OF SUBSTANTIAL EQUIVALENCE
HEALADEX®-P Dressing is substantially equivalent to the following approved products in indications, and to Gelita-spon Absorbable Gelatin sponge for porcine biomaterial source.
- Nu-Gel Wound Dressing (K983362) manufactured by Johnson & Johnson Medical イ Inc.,
HEALAGENICS®, Inc.
1
Premarket Notification Submission HEALADEX®-P
- Collatek Hydrogel (K022995) manufactured by Biocore Medical Technologies, Inc.) رق イ
- Woun'Dres Collagen Hydrogel Wound Dressing (K991202) manufactured by > Coloplast Corporation
Indications for Use
HEALADEX®-P Wound Dressing provides a moist environment that is supportive of wound healing. HEALADEX-P is indicated for dry, light and moderately exudating partial and full thickness wounds such as:
- First and second degree burns >
-
Severe sunburns
- Superficial injuries, superficial lacerations, cuts, abrasions, > incisions/surgical wounds, and skin tears
HEALADEX-P dressing should be used under health care professional direction for the following indications:
- Pressure ulcers, Stage I-IV V
- Lower extremity ulcers イ
- Venous ulcers イ
- Arterial ulcers イ
- Ulcers of mixed etiology V
- Diabetic ulcers イ
- Donor sites and skin grafts ✔
- Burns caused by radiation oncology procedures V
Device Description and Principles of Operation
HEALADEX-P is a sterile wound-dressing comprised of carboxymethylcellulose and lyophilized formulated porcine plasma, which is island mounted on moisture vapor permeable adhesive film dressing sheet coated with acrylic adhesive and a polyurethane protective film. This dressing aids the healing process by maintaining a moist environment at the wound site.
HEALADEX-P dressing is individually packaged in a foil moisture barrier chevron peel pouch appropriately labeled with lot number and expiration date. Five units are packaged into a cardboard box with Instructions for Use (IFU).
BIOCOMPATIBILITY
HEALAGENICS®, Inc.
2
.
K06317
3/5
Safety testing was conducted in accordance with ISO 10993 Part1 in support of the claim of biocompatibility for this product.
.
·
. . .
: 上一篇: 上一篇:
HEALAGENICS®, Inc.
. ,
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its head facing left and its wings forming three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
HEALAGENICS, Inc. % Mr. Paul Strati CEO 800 West Cummings Park Suite 2900 Woburn, Massachusetts 01801
FEB -16 2007
Re: K063517
Trade/Device Name: HEALADEX®-P Wound Dressing Regulatory Class: Unclassified Product Code: FRO, KGN Dated: November 1, 2006 Received: November 21, 2006
Dear Mr. Strati:
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.
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
4
Page 2 - Mr. Paul Strati
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K063517
Device Name: HEALADEX®-P Wound Dressing
Indications For Use:
HEALADEX®-P Wound Dressing provides a moist environment that is supportive of wound healing. HEALADEX-P is indicated for dry, light and moderately exudating partial and full thickness wounds such as:
-
First and second degree burns
- Severe sunburns
- Superficial injuries, superficial lacerations, cuts, abrasions, incisions/surgical wounds, > and skin tears
HEALADEX-P dressing should be used under health care professional direction for the following indications:
- Pressure ulcers, Stage I-IV
- Lower extremity ulcers >
- V Venous ulcers
-
Arterial ulcers
-
Ulcers of mixed etiology
-
Diabetic ulcers
- Donor sites and skin grafts
- Burns caused by radiation oncology procedures
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
estorative
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (Ob