(328 days)
Not Found
No
The document describes a wound dressing with a physical mechanism for attracting microorganisms and does not mention any computational or data-driven components.
Yes
The device is described as "wound dressing" and is intended for the management of various types of wounds, including scrapes, cuts, sores, burns, post-operative wounds, trauma wounds, ulcers, and fistulas, which aligns with the definition of a therapeutic device.
No
Justification: The device description and intended use indicate it is a wound dressing designed to manage wounds by attracting and capturing microorganisms, not to diagnose medical conditions.
No
The device description clearly states it is a "sterile bandage," indicating a physical, hardware-based medical device. The performance studies also focus on biocompatibility testing of the gel, which is relevant to a physical dressing.
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 the device is for the management of wounds. This involves applying the dressing directly to the wound, which is a topical application for treatment and management, not for diagnosing a condition.
- Device Description: The description focuses on the physical properties of the dressing and its mechanism of action (attracting and capturing microorganisms) in the context of wound care.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the body (like blood, urine, tissue, etc.) to provide information about a person's health status, which is the core function of an IVD.
- Performance Studies: The performance studies focus on biocompatibility and safety when applied to the skin, which is relevant for a wound dressing, not an IVD.
In summary, the Sorbact Gel Wound Dressing is a therapeutic device used for wound management, not a diagnostic device used to test samples from the body.
N/A
Intended Use / Indications for Use
OTC: Sorbact Gel Wound Dressing is intended for use in the management of minor wounds (dry to low exuding) and to attract water repelling germs. The dressing may be used on minor scrapes, cuts, sores and burns.
Rx: Sorbact Gel Wound Dressing is intended for use in the management of dry to low exuding partial to full thickness wounds (including clean, colonized, contaminated or infected wounds). The dressing is indicated for post-operative wounds, trauma wounds, shallow cavity wounds, fistulas, pressure ulcers, diabetic ulcers, and venous ulcers.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Sorbact gel Wound Dressings are sterile bandages that attract and capture water-repelling (hydrophobic) microorganisms.
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
Not Found
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)
Sorbact gel was tested for biocompatibility and the following tests were conducted: Skin Sensitization, Cytotoxicity, Skin Irritation. Sorbact gel passed all tests.
The Sorbact® gel was compared against the original Sorbact wound dressing regarding the ability to bind hydrophobic microbes and water repelling germs. Results of the test were identical for both devices.
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
11 100591 10f Z
JAN 2 4 2011
| JAN 24 20 | |
|---|---|
| 510(k) owner: | Abigo Medical AB |
| Ekonomivagen 5 | |
| Askim, Sweden | |
| +46 31 748 4971 | |
| Contact | |
| Information: | C. G. Bundy Associates, Inc. |
| 435 Rice Creek Terrace NE | |
| Fridley, MN 55432 USA | |
| Phone: 763-574-1976 | |
| Fax: 763-571-2437 | |
| Date of | |
| summary: | February 26, 2010, Revised November 30, 2010 |
| Device Name: | Proprietary Name: Sorbact® gel |
| Common/Classification Name: Wound Dressing | |
| Classification | |
| Regulation: | Unclassified, Class II medical device |
| Product | |
| Code: | FRO |
| Predicate | |
| Device | |
| ldentification: | Sorbact® Wound Dressing, K063059 |
| Device | |
| Description: | Sorbact gel Wound Dressings are sterile bandages that attract and capture |
| water-repelling (hydrophobic) microorganisms. | |
| Intended Use: | OTC: Sorbact Gel Wound Dressing is intended for use in the management of |
| minor wounds (dry to low exuding) and to attract water repelling germs. The | |
| dressing may be used on minor scrapes, cuts, sores and burns. | |
| Rx: Sorbact Gel Wound Dressing is intended for use in the management of dry to | |
| low exuding partial to full thickness wounds (including clean, colonized, | |
| contaminated or infected wounds). The dressing is indicated for post-operative | |
| wounds, trauma wounds, shallow cavity wounds, fistulas, pressure ulcers, | |
| diabetic ulcers, and venous ulcers. |
DL
1/24/11
510(k) Summary
1
2 of 2
Technological characteristics, comparison to predicate device:
Sorbact® Wound Dressings are sterile bandages that attract water-repelling (hydrophobic) microorganisms. The dressings are coated with DACC (dialky) carbamoyl chloride), a hydrophobic (water-repelling) fatty ester acid that atracts and reduces the overall concentration of hydrophobic microbes in a wound each time the dressing is changed. The original Sorbact Wound Dressing has been modified by the addition of a hydrogel. The hydrogel addition allows effective management of low exuding dry wounds and creates a moist wound healing environment.
The Sorbact® gel was compared against the original Sorbact wound dressing regarding the ability to bind hydrophobic microbes and water repelling germs. Results of the test were identical for both devices.
Sorbact gel was tested for biocompatibility and the following tests were conducted:
Skin Sensitization Cytotoxicity Skin Irritation
Sorbact gel passed all tests.
Conclusion: The Sorbact gel has identical features, performance and intended use as the original Sorbact wound dressing. Results of comparative performance testing against the predicate device show that Sorbact® gel is substantially equivalent to devices on the market (cleared by the 510(k) process).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Abigo Medical, AB % C.G. Bundy Associates, Inc. Ms. Constance G. Bundy 435 Rice Creek Terrace Fridley, Minnesota 55432
Re: K100591
Regulatory Class: Unclassified Product Code: FRO Dated: January 11, 2011 Received: January 19, 2011
Dear Ms. Bundy:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading:
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
:
.
JAN 2 4 2011
3
Page 2 - Ms. Constance G. Bundy
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,
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for Bo Dm
N. Molkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): K100591
Device Name: Sorbact® Gel Wound Dressing
Indications for Use:
OTC: Sorbact Gel Wound Dressing is intended for use in the management of minor wounds (dry to low exuding). The dressing may be used on minor scrapes, cuts, sores and burns.
Rx: Sorbact Gel Wound Dressing is intended for use in the management of dry to low exuding partial to full thickness wounds (including clean, colonized, contaminated or infected wounds). The dressing is indicated for post-operative wounds, trauma wounds, shallow cavity wounds, fistulas, pressure ulcers, diabetic ulcers, and venous ulcers.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kaneberkni
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100571