(193 days)
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.
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.
The provided text describes a 510(k) premarket notification for a medical device, specifically Sorbact® Absorbent Dressings (Sorbact® Foam Gentle Border, Sorbact® Superabsorbent). The document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving that the device meets specific acceptance criteria in the context of AI/algorithm performance.
Therefore, many of the requested sections about acceptance criteria, study details, human reader performance, ground truth, and training sets are not applicable to this document as it pertains to a traditional medical device (wound dressing) submission, not an AI/ML-driven diagnostic or assistive device.
However, I can extract the information provided regarding the device's performance, which is primarily focused on bench testing and biocompatibility.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is not an AI/ML device, the concept of "acceptance criteria" for algorithmic performance (e.g., sensitivity, specificity) is not directly applicable. The device's performance is demonstrated through various verification and validation tests as part of its substantial equivalence claim.
| Acceptance Criteria Category (Implied) | Reported Device Performance (as per document) |
|---|---|
| Functional Performance | Met requirements for: |
| - Fluid Handling | Verified |
| - Packaging Integrity | Verified |
| Stability | Verified |
| Sterilization | Validated (Ethylene Oxide, SAL 10-6) |
| Biocompatibility | Passed ISO-10993 tests: |
| - Cytotoxicity | Passed |
| - Irritation | Passed |
| - Sensitization | Passed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for individual bench or biocompatibility tests. The document states "representative samples" were used.
- Data Provenance: Not specified, but generally refers to in vitro lab testing for this type of device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth as typically defined for AI/ML performance (e.g., expert consensus on clinical findings) is not relevant for wound dressings. Bench tests and biocompatibility evaluations follow standardized protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are specific to subjective assessments, typically in clinical studies or image interpretation. These tests are objective laboratory evaluations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a wound dressing, not an AI-assisted diagnostic or interpretation tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a wound dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for the performance of this device is based on established scientific principles and standardized testing methodologies for material properties, fluid absorption, sterility, and biocompatibility, as opposed to clinical "ground truth" established by experts or pathology for diagnostic purposes.
8. The sample size for the training set
Not applicable. The concept of a "training set" is for AI/ML algorithms. This is a physical medical device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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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
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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
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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 ABEkonomivägen 5SE-436 33 AskimSwedenPhone: +46 31 748 49 50Fax: +46 31 68 39 51 |
| Correspondent Contact: | Deborah Lavoie GrayeskiM Squared Associates, Inc.575 8th Avenue, Suite 1212New York, NY 10018USAOffice: 703-562-9800x250Mobile: 202-550-7395, Fax: 703-562-9797Email: 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 DressingsK143151 |
|---|---|---|
| Intended use | Sorbact® Foam Gentle Border isindicated for use in the managementof moderately exuding partial to fullthickness wounds (including clean,colonized, contaminated, or infectedwounds): chronic wounds (venousand arterial ulcers, diabetic ulcersand pressure ulcers), postoperativedehisced wounds and traumaticwounds.Sorbact® Superabsorbent is indicatedfor use in the management of heavilyexuding partial to full thicknesswounds (including clean, colonized,contaminated, or infected wounds):chronic wounds (venous and arterialulcers, diabetic ulcers and pressureulcers), postoperative dehiscedwounds and traumatic wounds. | Cutimed® Sorbact® Hydroactive isindicated for use in the management oflow to moderate exuding partial to fullthickness wounds (including clean,colonized, contaminated, or infectedwounds): chronic wounds (venous andarterial ulcers, diabetic ulcers andpressure ulcers), postoperativedehisced wounds and traumaticwounds.Cutimed® Sorbact® Hydroactive B isindicated for use in the management oflow to moderate exuding partial to fullthickness wounds (including clean,colonized, contaminated, or infectedwounds): chronic wounds (venous andarterial ulcers, diabetic ulcers andpressure ulcers), postoperativedehisced wounds and traumaticwounds.Cutimed® Siltec® Sorbact® is indicatedfor use in the management ofmoderately to heavily exuding partial tofull thickness wounds (including clean,colonized, contaminated, or infectedwounds): chronic wounds (venous andarterial ulcers, diabetic ulcers andpressure ulcers), postoperativedehisced wounds and traumaticwounds. |
| Device Design | ||
| The Sorbact® Absorbent Dressingsare designed with an acetate fabriccoated with DACC (Sorbact®) incombination with an absorbent core,which absorbs and retains woundexudate. The dressings include asemi-permeable polyurethane film toallow vapor and oxygen to penetrateor water-repellent polypropylenenon-woven. Sorbact® Foam GentleBorder is also designed with asilicone adhesive border for fixation. | The Cutimed® Sorbact® WoundDressings are designed with an acetatefabric coated with DACC (Sorbact®) incombination with an absorbent core,which absorbs and locks exudate fromthe wound, and a transparent semi-permeable polyurethane film to allowvapor and oxygen to penetrate the film.It is also designed with an adhesivelayer for fixation (except theHydroactive dressing). | |
| Wound ContactMaterial | Sorbact® fabric (acetate fabriccoated with dialkyl carbamoylchloride, DACC) | Same |
| Exudate AbsorptionMaterial | Polyurethane foam or polyacrylatesuperabsorbent particles | Hydropolymer matrix orsuperabsorbent polyurethane foam |
| Backing | Polyurethane film or polypropylenenon-woven | Polyurethane film |
| Self-adhesive Border | Yes(for Sorbact® Foam Gentle Border) | Yes(for Cutimed® Sorbact® Hydroactive Band Cutimed® Siltec® Sorbact®) |
| Mechanism ofAction | Used for the management of clean,colonized, contaminated, or infectedwounds; rapidly absorbs and locksexudate within an absorbent core;allows water vapor to evaporatefrom the skin to the outsideprotecting the skin from maceration | Used for the management of clean,colonized, contaminated, or infectedwounds; rapidly absorbs and locksexudate within an absorbent core;allows water vapor and gases toevaporate from the skin to the outsideprotecting 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) forCutimed® Sorbact® Hydroactive andCutimed® 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: below25°C | Dry, below 25°C |
| Shelf Life | 3 years (Sorbact® Superabsorbent)5 years (Sorbact® Foam GentleBorder | 3 years |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.
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| Characteristic | Sorbact® Absorbent Dressings | Sorbact® Wound Dressings K063059 |
|---|---|---|
| Other technologicalcharacteristics:Mechanism of action | Sorbact® can bind hydrophobicmicrobes based on in vitro testingof the following strains: S. aureus,S. gordonii, P. aeruginosa, andE. coli. When the dressing isremoved, microbes adhered to thedressing 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
N/A