(84 days)
Not Found
No
The device description and performance studies focus on the physical and biological properties of wound dressings, with no mention of AI or ML technologies.
Yes.
The device is indicated for use in the management of various wounds, including chronic, postoperative, and traumatic wounds, which is a therapeutic purpose.
No
The provided text describes wound dressings used for managing wounds. There is no indication that the device measures, records, or analyzes data to provide diagnostic information about a patient's condition. Its function is therapeutic, not diagnostic.
No
The device description clearly states it is a wound dressing made of physical materials like fabric, hydropolymer matrix, and polyurethane film, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the management of wounds. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details wound dressings designed to absorb exudate and manage the wound environment. This aligns with wound care, not in vitro testing of samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) outside of the body, which is the core function of an IVD. The device interacts directly with the wound.
Therefore, the information provided indicates a wound care product, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 (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 (yenous 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 moderate to heavily exuding partial to full thickness wounds (including clean, colonized, or infected wounds): chronic wounds (venous and arterial ucers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic wounds.
Product codes
FRO
Device Description
Cutimed® Sorbact® Wound Dressings combine Sorbact mesh (Sorbact acetate fabric coated with dialkylcarbamoylchloride - DACC) with a highly absorbent hydropolymer matrix or superabsorbent polyurethane foam and are covered by a semi-permeable polyurethane film. A fixation border is made of a latex free hydrogel or silicone adhesive. The dressings come in three models (Cutimed® Sorbact® Hydroactive, Cutimed® Sorbact® Hydroactive B, Cutimed® Siltec Sorbact®), multiple sizes in each model and are sterile and single use.
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 device design met its functional performance and safety requirements, representative samples of the device underwent testing including bench testing (absorption, MVTR, retention), biocompatibility testing (cytotoxicity, irritation, sensitization, systemic toxicity, implantation, genotoxicity), packaging testing (pouch seal and transportation), sterilization validation testing, and stability testing (AA and real time).
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 features a stylized depiction of an eagle or bird with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2015
BSN medical GmbH % Ms. Marcia Palma NAMSA 4050 Olson Memorial Highway, Suite 450 Minneapolis, Minnesota 55422
Re: K143151
Trade/Device Name: Cutimed® Sorbact® Wound Dressing (Cutimed® Sorbact® Hydroactive, Cutimed® Sorbact® Hydroactive B, Cutimed® Sorbact® Siltec Sorbact) Regulatory Class: Unclassified Product Code: FRO Dated: November 1, 2014 Received: November 4, 2014
Dear Ms. Palma:
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
1
Page 2 - Ms. Marcia Palma
device-related adverse events) (21 CFR 803); 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.
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/ResourcesforYou/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.
for
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S.
Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
. K143151
Device Name
Cutimed® Sorbact® Wound Dressings (Cutimed® Sorbact® Hydroactive, Cutimed® Sorbact® Hydroactive , Cutimed® Siltec Sorbact®)
Indications for Use (Describe)
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 (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 (yenous 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 moderate to heavily exuding partial to full thickness wounds (including clean, colonized, or infected wounds): chronic wounds (venous and arterial ucers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic wounds.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| Submitter: | Martin Spengler, Head of Regulatory Affairs, Legal
Manufacturer Hamburg
BSN medical GmbH
Quickbornstraße 24, Hamburg, 20253 Germany
Phone: +49 (040) 4909-7233
Fax: +49 (040) 4909-5476 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Marcia Palma
Senior Principle Regulatory Consultant, NAMSA
4050 Olson Memorial Hwy, Suite 450 Minneapolis, MN 55422
Telephone: 763.588.9847
Fax: 763-287-3836
Email: mpalma@namsa.com |
| Date Prepared: | January 22, 2015 |
| Trade Name: | Cutimed® Sorbact® Wound Dressings (Cutimed® Sorbact®
Hydroactive, Cutimed® Sorbact® Hydroactive B, Cutimed®
Siltec Sorbact®) |
| Classification: | Unclassified |
| Product Code: | FRO |
| Predicate Device(s): | The subject device is equivalent to the following device:
K063059, Sorbact® Wound Dressings, Abigo Medical AB |
| Device Description: | Cutimed® Sorbact® Wound Dressings combine Sorbact mesh
(Sorbact acetate fabric coated with dialkylcarbamoylchloride -
DACC) with a highly absorbent hydropolymer matrix or
superabsorbent polyurethane foam and are covered by a semi-
permeable polyurethane film. A fixation border is made of a
latex free hydrogel or silicone adhesive. The dressings come in
three models (Cutimed® Sorbact® Hydroactive, Cutimed®
Sorbact® Hydroactive B, Cutimed® Siltec Sorbact®), multiple
sizes in each model and are sterile and single use. |
| Intended Use: | 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 |
--
4
| Comparison to
Predicate: | Product | Cutimed® Sorbact® Wound
Dressings | Predicate:
Sorbact® Wound
Dressings |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Indications for
Use | 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 moderate 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. | Sorbact® Wound
Dressings are
intended for use in
the management
of moderate to
heavily exuding
partial to full
thickness wounds
(including clean,
colonized,
contaminated, or
infected wounds)
and to bind
hydrophobic
microbes. The
dressings are
indicated for post-
operative wounds,
trauma wounds,
shallow cavity
wounds, fistulas,
pressure ulcers,
diabetic ulcers,
and venous ulcers. |
| | | | |
| | Device
Design | 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). | Same |
| | Wound
Contact
Material | Sorbact mesh (Sorbact acetate
fabric coated with
dialkylcarbamoylchloride - DACC) | Same |
| | Exudate
Absorption
Material | Hydropolymer matrix or
polyurethane foam | Non-woven
Viscose |
| | Transparent
Semi-
permeable
backing | Polyurethane film | Same |
| | Self Adhesive
Border | Yes
(Except Cutimed® Sorbact®
Hydroactive) | Same |
| | 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
and gases to evaporate from the
skin to the outside protecting the
skin from maceration | Same |
| | Sizes | Multiple sizes | Same |
| | Wear Time | Up to 4 days | Change at least
twice per week |
| | Sterility | Gamma radiation (SAL 10-6) for
Cutimed® Sorbact® Hydroactive
and Cutimed® Sorbact®
Hydroactive B; EO (SAL 10-6) for
Cutimed® Siltec Sorbact® | Gamma radiation
(SAL 10-6) |
| | Single Use | Yes | Same |
| | Storage
Conditions | Dry, below 25°C | Same |
| | Shelf Life | 3 years | 5 years |
| | Latex Free | Yes | Same |
| | Biocompatible | Yes | Same |
| Functional and
Safety Testing: | To verify that device design met its functional performance and
safety requirements, representative samples of the device | | |
5
·
:
6
| | underwent testing including bench testing (absorption, MVTR,
retention), biocompatibility testing (cytotoxicity, irritation,
sensitization, systemic toxicity, implantation, genotoxicity),
packaging testing (pouch seal and transportation), sterilization
validation testing, and stability testing (AA and real time). |
|-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | BSN medical GmbH considers the Cutimed® Sorbact® Wound
Dressings to be equivalent to the predicate device listed above.
This conclusion is based upon the device's similarities in
intended use, design, mechanisms of action, technology and
materials. |
·