(193 days)
Not Found
No
The summary describes a wound dressing with absorbent and microbe-binding properties, and there is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes.
The device is indicated for the management of various types of wounds, which are considered medical conditions requiring therapeutic intervention.
No
This device is a wound dressing designed for managing exuding wounds, not for diagnosis. Its description focuses on absorption and wound contact, not on identifying medical conditions.
No
The device description clearly describes physical wound dressings made of materials like polyurethane foam, superabsorbent cores, and silicone adhesive, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that Sorbact® Absorbent Dressings are wound dressings applied directly to the wound surface. Their function is to manage wound exudate and bind microbes. This is a topical application and does not involve testing samples taken from the body.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, diagnostic testing, or the use of reagents typically associated with IVDs.
Therefore, Sorbact® Absorbent Dressings fall under the category of wound care devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Sorbact® Foam Gentle Border is inthe management of moderately exuding partial to full thickness wounds (including clean, colonized, or infected wounds): chronic wounds (venous and arterial ulcers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic wounds.
Rx.: Sorbact® Superabsorbent is indicated for use in the management of heavily partial to full thickness wounds (including clean, colonized, contaminated, or infected wounds (venous and arterial ulcers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic wounds.
Product codes
FRO
Device Description
Sorbact® Absorbent Dressings come in two models, Sorbact® Foam Gentle Border and Sorbact® Superabsorbent, for use with moderately or heavily exuding wounds, respectively. Both dressings come in multiple sizes, are sterile (EO), hydrophobic microbe binding, and for single use only. The dressings combine a Sorbact® wound contact layer with absorbent polyurethane foam or a superabsorbent core. The dressings are covered by a semi-permeable polyurethane film or polypropylene non-woven. A fixation border is made of silicone adhesive.
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)
To verify that the device design met its functional performance and safety requirements, representative samples of the device underwent testing.
Bench testing
Performance verification testing (fluid handling tests, packaging tests) Stability testing Sterilization validation testing
Biocompatibility testing
The biocompatibility evaluation of the devices was conducted in accordance with the FDA Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". Testing was performed on representative samples of the devices and included the following tests:
- Cytotoxicity
- Irritation
- Sensitization
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures in profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 1, 2016
ABIGO Medical AB % Ms. Deborah Lavoi Grayeski Senior Project Manager M Squared Associates, Inc. 575 8th Avenue, Suite 1212 New York, New York 10018
Re: K153674
Trade/Device Name: Sorbact Foam Gentle Border, Sorbact Superabsorbent Regulatory Class: Unclassified Product Code: FRO Dated: June 2, 2016 Received: June 6, 2016
Dear Ms. Grayeski:
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
1
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 contact the Division of Industry and Consumer Education 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. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
Radiological Health
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and
Enclosure
2
Indications for Use
510(k) Number (if known) K153674
Device Name Sorbact® Absorbent Dressings (Sorbact® Foam Gentle Border, Sorbact® Superabsorbent )
Indications for Use (Describe)
Rx.: Sorbact® Foam Gentle Border is inthe management of moderately exuding partial to full thickness wounds (including clean, colonized, or infected wounds): chronic wounds (venous and arterial ulcers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic wounds.
Rx.: Sorbact® Superabsorbent is indicated for use in the management of heavily partial to full thickness wounds (including clean, colonized, contaminated, or infected wounds (venous and arterial ulcers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic wounds.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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SECTION 5
510(k) Summary
| I.
| SUBMITTER | |
|---|---|
| Submitter: | ABIGO Medical AB |
| Ekonomivägen 5 | |
| SE-436 33 Askim | |
| Sweden | |
| Phone: +46 31 748 49 50 | |
| Fax: +46 31 68 39 51 | |
| Correspondent Contact: | Deborah Lavoie Grayeski |
| M Squared Associates, Inc. | |
| 575 8th Avenue, Suite 1212 | |
| New York, NY 10018 | |
| USA | |
| Office: 703-562-9800x250 | |
| Mobile: 202-550-7395, Fax: 703-562-9797 | |
| Email: dgrayeski@msquaredassociates.com | |
| Date Prepared: | December 18, 2015 |
| II. | |
| DEVICE | |
| Trade Name: | Sorbact® Absorbent Dressings |
| (Sorbact® Foam Gentle Border, Sorbact® Superabsorbent ) | |
| Common Name: | Wound Dressing |
| Regulatory Class: | Unclassified (Pre-amendment) |
| Review Panel: | General & Plastic Surgery |
| Product Code: | FRO |
| III. | |
| PREDICATE DEVICES | |
| K143151, Cutimed® Sorbact® Wound Dressings, BSN medical GmbH | |
| K063059, Sorbact® Wound Dressings, ABIGO Medical AB |
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DEVICE DESCRIPTION IV.
Sorbact® Absorbent Dressings come in two models, Sorbact® Foam Gentle Border and Sorbact® Superabsorbent, for use with moderately or heavily exuding wounds, respectively. Both dressings come in multiple sizes, are sterile (EO), hydrophobic microbe binding, and for single use only. The dressings combine a Sorbact® wound contact layer with absorbent polyurethane foam or a superabsorbent core. The dressings are covered by a semi-permeable polyurethane film or polypropylene non-woven. A fixation border is made of silicone adhesive.
V. INDICATIONS FOR USE
Rx.: Sorbact® Foam Gentle Border is indicated for use in the management of moderately exuding partial to full thickness wounds (including clean, colonized, contaminated, or infected wounds): chronic wounds (venous and arterial ulcers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic wounds.
Rx.: Sorbact® Superabsorbent is indicated for use in the management of heavily exuding partial to full thickness wounds (including clean, colonized, contaminated, or infected wounds): chronic wounds (venous and arterial ulcers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic wounds.
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| Characteristic | Sorbact® Wound Dressings | Cutimed® Sorbact® Wound Dressings
K143151 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Sorbact® Foam Gentle Border is
indicated for use in the management
of moderately exuding partial to full
thickness wounds (including clean,
colonized, contaminated, or infected
wounds): chronic wounds (venous
and arterial ulcers, diabetic ulcers
and pressure ulcers), postoperative
dehisced wounds and traumatic
wounds.
Sorbact® Superabsorbent is indicated
for use in the management of heavily
exuding partial to full thickness
wounds (including clean, colonized,
contaminated, or infected wounds):
chronic wounds (venous and arterial
ulcers, diabetic ulcers and pressure
ulcers), postoperative dehisced
wounds and traumatic wounds. | Cutimed® Sorbact® Hydroactive is
indicated for use in the management of
low to moderate exuding partial to full
thickness wounds (including clean,
colonized, contaminated, or infected
wounds): chronic wounds (venous and
arterial ulcers, diabetic ulcers and
pressure ulcers), postoperative
dehisced wounds and traumatic
wounds.
Cutimed® Sorbact® Hydroactive B is
indicated for use in the management of
low to moderate exuding partial to full
thickness wounds (including clean,
colonized, contaminated, or infected
wounds): chronic wounds (venous and
arterial ulcers, diabetic ulcers and
pressure ulcers), postoperative
dehisced wounds and traumatic
wounds.
Cutimed® Siltec® Sorbact® is indicated
for use in the management of
moderately to heavily exuding partial to
full thickness wounds (including clean,
colonized, contaminated, or infected
wounds): chronic wounds (venous and
arterial ulcers, diabetic ulcers and
pressure ulcers), postoperative
dehisced wounds and traumatic
wounds. |
| Device Design | | |
| | The Sorbact® Absorbent Dressings
are designed with an acetate fabric
coated with DACC (Sorbact®) in
combination with an absorbent core,
which absorbs and retains wound
exudate. The dressings include a
semi-permeable polyurethane film to
allow vapor and oxygen to penetrate
or water-repellent polypropylene
non-woven. Sorbact® Foam Gentle
Border is also designed with a
silicone adhesive border for fixation. | The Cutimed® Sorbact® Wound
Dressings are designed with an acetate
fabric coated with DACC (Sorbact®) in
combination with an absorbent core,
which absorbs and locks exudate from
the wound, and a transparent semi-
permeable polyurethane film to allow
vapor and oxygen to penetrate the film.
It is also designed with an adhesive
layer for fixation (except the
Hydroactive dressing). |
| Wound Contact
Material | Sorbact® fabric (acetate fabric
coated with dialkyl carbamoyl
chloride, DACC) | Same |
| Exudate Absorption
Material | Polyurethane foam or polyacrylate
superabsorbent particles | Hydropolymer matrix or
superabsorbent polyurethane foam |
| Backing | Polyurethane film or polypropylene
non-woven | Polyurethane film |
| Self-adhesive Border | Yes
(for Sorbact® Foam Gentle Border) | Yes
(for Cutimed® Sorbact® Hydroactive B
and Cutimed® Siltec® Sorbact®) |
| Mechanism of
Action | Used for the management of clean,
colonized, contaminated, or infected
wounds; rapidly absorbs and locks
exudate within an absorbent core;
allows water vapor to evaporate
from the skin to the outside
protecting the skin from maceration | Used for the management of clean,
colonized, contaminated, or infected
wounds; rapidly absorbs and locks
exudate within an absorbent core;
allows water vapor and gases to
evaporate from the skin to the outside
protecting the skin from maceration |
| Sizes | Multiple sizes | Multiple sizes |
| Wear Time | Up to 4 days | Up to 4 days |
| Biocompatible | Yes | Yes |
| Sterilization | Ethylene Oxide (SAL 10-6) | Gamma irradiation (SAL 10-6) for
Cutimed® Sorbact® Hydroactive and
Cutimed® Sorbact® Hydroactive B;
Ethylene Oxide (SAL 10-6) for Cutimed®
Siltec Sorbact® |
| Single Use | Yes | Yes |
| Storage Conditions | Dry and away from sunlight.
For Sorbact® Superabsorbent: below
25°C | Dry, below 25°C |
| Shelf Life | 3 years (Sorbact® Superabsorbent)
5 years (Sorbact® Foam Gentle
Border | 3 years |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.
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7
| Characteristic | Sorbact® Absorbent Dressings | Sorbact® Wound Dressings K063059 |
|---|---|---|
| Other technological | ||
| characteristics: | ||
| Mechanism of action | Sorbact® can bind hydrophobic | |
| microbes based on in vitro testing | ||
| of the following strains: S. aureus, | ||
| S. gordonii, P. aeruginosa, and | ||
| E. coli. When the dressing is | ||
| removed, microbes adhered to the | ||
| dressing will be removed. | Same |
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VII. PERFORMANCE DATA
To verify that the device design met its functional performance and safety requirements, representative samples of the device underwent testing.
Bench testing
Performance verification testing (fluid handling tests, packaging tests) Stability testing Sterilization validation testing
Biocompatibility testing
The biocompatibility evaluation of the devices was conducted in accordance with the FDA Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". Testing was performed on representative samples of the devices and included the following tests:
- Cytotoxicity
- Irritation
- Sensitization ●
VIII. CONCLUSIONS
ABIGO Medical AB considers the Sorbact® Absorbent Dressings to be as safe, as effective, and performing as well as the predicate devices described above. This conclusion is based on the devices' similarities in intended use, design, mechanisms of action, technology, materials and performance.
Note: No clinical information has been submitted