Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact)

Q: Who is the manufacturer of Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact)?

Bsn Medical GmbH filed the 510(k) submission for Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact) (K143151).

Q: What is the FDA product code for Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact)?

FRO. as a Class U device in the SU panel.

Q: What is the regulatory pathway for Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact)?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact)?

Sorbact® Wound Dressings (K063059).

Q: Who can help prepare an FDA 510(k) submission like Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K143151 · Bsn Medical GmbH · FRO · Jan 26, 2015 · SU

Device Facts

Record ID	K143151
Device Name	Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact)
Applicant	Bsn Medical GmbH
Product Code	FRO · SU
Decision Date	Jan 26, 2015
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

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 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, or infected wounds): chronic wounds (venous and arterial ulcers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic wounds.

Device Story

Wound dressing system; combines Sorbact mesh (acetate fabric coated with dialkylcarbamoylchloride - DACC) with absorbent core (hydropolymer matrix or polyurethane foam); covered by semi-permeable polyurethane film; optional latex-free hydrogel or silicone adhesive border. Mechanism: DACC-coated mesh binds hydrophobic microbes; absorbent core manages exudate; semi-permeable film allows gas/vapor exchange to prevent maceration. Used in clinical or home settings for wound management; applied by healthcare providers or patients. Output is physical wound coverage and exudate management; aids healing by reducing microbial load and maintaining moist wound environment.

Clinical Evidence

Bench testing only. Testing included absorption, moisture vapor transmission rate (MVTR), and retention. Biocompatibility testing included cytotoxicity, irritation, sensitization, systemic toxicity, implantation, and genotoxicity. Packaging, sterilization, and stability (accelerated and real-time) testing were also performed.

Technological Characteristics

Wound dressing; Sorbact mesh (DACC-coated acetate fabric); absorbent core (hydropolymer matrix or polyurethane foam); semi-permeable polyurethane film backing; optional hydrogel or silicone adhesive border. Sterile, single-use. Sterilization via gamma radiation or ethylene oxide (EO).

Indications for Use

Indicated for management of partial to full thickness wounds (chronic: venous, arterial, diabetic, pressure ulcers; postoperative dehisced; traumatic) with low to heavy exudate levels, including clean, colonized, contaminated, or infected wounds.

Predicate Devices

Sorbact® Wound Dressings (K063059)

Related Devices

K153674 — Sorbact Foam Gentle Border, Sorbact Superabsorbent · Abigo Medical AB · Jul 1, 2016
K063059 — SORBACT WOUND DRESSING · Abigo Medical AB · Apr 19, 2007
K100591 — SORBACT · Abigo Medical AB · Jan 24, 2011
K240485 — LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use) · Huizhou Foryou Medical Devices Co., Ltd. · Oct 7, 2024
K252167 — Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) · Qingdao Bright Moon Biomedical Materials Co., Ltd. · Dec 19, 2025

Submission Summary (Full Text)

{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. | ·