(147 days)
Not Found
No
The device description and summary of performance studies focus on the material composition and physical properties of the wound dressing, with no mention of AI or ML technologies.
No
The device is a wound dressing used for covering burn wounds and donor sites, which falls under the category of a palliative or supportive device rather than actively treating an underlying condition.
No.
The device is described as a wound dressing used for covering burn wounds and donor sites, which functions as a treatment or protective measure rather than identifying or diagnosing a condition.
No
The device description clearly states it is a wound dressing made from physical materials (silicone membrane, nylon fabric, collagen), indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to cover wounds (burns and donor sites). This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a wound dressing made of silicone, nylon, and collagen. This is a physical barrier and healing aid, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no indication of providing diagnostic information.
Therefore, the BIOBRANE Dressings and BIOBRANE Glove are medical devices, but they fall under the category of wound dressings, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
BIOBRANE Dressings are indicated for:
- Covering clean partial thickness burn wounds
- Split thickness donor sites
BIOBRANE Glove is indicated for:
- Covering clean partial thickness burn wounds of the hand.
Product codes (comma separated list FDA assigned to the subject device)
KGN
Device Description
BIOBRANE Dressing and BIOBRANE Glove are wound dressings made from an ultrathin, semipermeable, perforated silicone membrane that is mechanically bonded to a flexible knitted tri-filament nylon fabric. Denatured porcine dermal collagen is bonded to the silicone-nylon membrane to provide a flexible and conformable dressing with adherence properties and a hydrophilic surface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
BIOBRANE Dressing: All body areas
BIOBRANE Glove: Hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained healthcare professional (HCP) only, Healthcare facility and home use (inpatient and outpatient)
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)
A series of bench performance verification tests and product characterization have been completed to confirm the subject device meets design specifications in support of the performance of BIOBRANE, in addition to demonstrating substantial equivalence to the predicate device of the BIOBRANE II (K901369).
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 17, 2024
Smith & Nephew Medical Limited Andrew Daglish Regulatory Affairs Manager 101 Hessle Road Hull, East Riding of Yorkshire HU3 2BN United Kingdom
Re: K242146
Trade/Device Name: BIOBRANE Dressing; BIOBRANE Glove Regulatory Class: Unclassified Product Code: KGN Dated: July 22, 2024 Received: July 23, 2024
Dear Andrew Daglish:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Mustafa A. Mazher -S
For Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K242146
Device Name BIOBRANE Dressing BIOBRANE Glove
Indications for Use (Describe) BIOBRANE Dressings are indicated for:
- · Covering clean partial thickness burn wounds
- Split thickness donor sites
BIOBRANE Glove is indicated for:
- · Covering clean partial thickness burn wounds of the hand.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K242146 510(k) Summary
| 21 CFR 807.92 (a)(1): Submitter's Information | |
|---|---|
| 510(k) Owner Name | Smith & Nephew Medical Ltd |
| Address | 101 Hessle Road, Hull, HU3 2BN, United Kingdom |
| Establishment | |
| Registration Number | 8043484 |
| Contact Name | Andrew Daglish - Regulatory Affairs Manager |
| Telephone Number | 07890 426317 |
| Date Prepared | 10-Dec-2024 |
| 21 CFR 807.92 (a)(2): Device Information | |
| Device Name | |
| (Trade/Proprietary | |
| Name) | BIOBRANE Dressing |
| BIOBRANE Glove | |
| Common Name | Wound Dressing With Animal-Derived Material(S) |
| Review Panel | General and Plastic Surgery |
| Regulation Number | N/A (Unclassified) |
| Regulatory Class | Unclassified (Pre-amendment) |
| Product Code | KGN |
| 21 CFR 807.92 (a)(3): | |
| Legally marketed | |
| device to which | |
| equivalence is claimed | 510(k) Number: K901369 |
| Device Name: GREEN LABEL BIOBRANE II AND RED LABEL | |
| BIOBRANE II | |
| 21 CFR 807.92 (a)(4): Device Description |
BIOBRANE Dressing and BIOBRANE Glove are wound dressings made from an ultrathin, semipermeable, perforated silicone membrane that is mechanically bonded to a flexible knitted tri-filament nylon fabric. Denatured porcine dermal collagen is bonded to the silicone-nylon membrane to provide a flexible and conformable dressing with adherence properties and a hydrophilic surface.
21 CFR 807.92 (a)(5): Intended Use / Indications for Use
BIOBRANE Dressings are indicated for:
- Covering clean partial thickness burn wounds •
- . Split thickness donor sites
BIOBRANE Glove is indicated for:
- Covering clean partial thickness burn wounds of the hand. .
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| 21 CFR 807.92 (a)(6): Comparison of Technological Characteristics between the Subject and Predicate Devices | |||
|---|---|---|---|
| Product | |||
| Characteristic | Subject Device | ||
| (BIOBRANE, K242146) | Predicate Device | ||
| (BIOBRANE II, K901369) | Substantial Equivalence Decision | ||
| Intended Use | Wound Management | Wound Management | Same |
| Indications for | |||
| Use | BIOBRANE Dressing is indicated for: | ||
| • Covering clean partial thickness burn | |||
| wounds | |||
| • Split thickness donor sites | |||
| BIOBRANE Glove is indicated for: | |||
| • Covering clean partial thickness burn | |||
| wounds of the hand. | RED LABEL BIOBRANE II is indicated | ||
| for: | |||
| • Clean partial thickness burn wounds | |||
| • Donor sites | |||
| GREEN LABEL BIOBRANE II is | |||
| indicated for: | |||
| • Clean partial thickness burn wounds | |||
| • Donor sites | BIOBRANE Dressings specify split | ||
| thickness donor sites and BIOBRANE | |||
| Gloves specify hand sites. The indications | |||
| for use of the subject device are more | |||
| precise within the scope of the predicate | |||
| device's indications for use and the | |||
| indications for use of the subject device | |||
| are substantially equivalent to the | |||
| predicate device. | |||
| Principles of | |||
| operation | Excess fluid can drain from the | ||
| perforations. | Excess fluid can drain from the | ||
| perforations. | Same | ||
| Materials and | |||
| Structure | Silicone membrane, nylon, and collagen | Silicone membrane, nylon, and collagen | Same |
| Porous silicone and nylon knit bi-layer | |||
| sheet with collagen coating | Porous silicone and nylon knit bi-layer | ||
| sheet with collagen coating | Same | ||
| Silicone | |||
| Membrane | |||
| Function | A thin transparent, perforated, | ||
| polymeric film. Creates a film structure | |||
| over the top of the nylon to encase the | |||
| dressing, creating a moist wound- | |||
| healing environment. | A thin transparent, perforated, polymeric | ||
| film. Creates a film structure over the top | |||
| of the nylon to encase the dressing, | |||
| creating a moist wound-healing | |||
| environment. | Same | ||
| Nylon | |||
| Function | A weave of polymeric tri-filament yarn, | ||
| partially embedded into the silicone | |||
| membrane. | A weave of polymeric tri-filament yarn, | ||
| partially embedded into the silicone | |||
| membrane. | Same | ||
| Collagen | |||
| Function | Denatured porcine dermal collagen | ||
| coated to the silicone-nylon dressing. | |||
| The collagen component adheres to the | |||
| fibrin on a clean wound surface and | |||
| adheres the dressing to the wound. | Denatured porcine dermal collagen coated | ||
| to the silicone-nylon dressing. The | |||
| collagen component adheres to the fibrin | |||
| on a clean wound surface and adheres the | |||
| dressing to the wound. | Same | ||
| Principal | |||
| Operator | Trained healthcare professional (HCP) | ||
| only | Trained healthcare professional (HCP) | ||
| only | Same | ||
| Environment of | |||
| Use | Healthcare facility and home use | ||
| (inpatient and outpatient) | Healthcare facility and home use | ||
| (inpatient and outpatient) | Same | ||
| Single-Use or | |||
| Reusable | Single-Use | Single-Use | Same |
| Sterilization | Moist heat | Moist heat | Same |
| Sterility | Sterile, SAL 10-6 | Sterile, SAL 10-6 | Same |
| Shelf Life | 3 years | 3 years | Same |
| Biocompatibility | The device complies with ISO 10993 | The device complies with ISO 10993 | Same |
| Device | |||
| Dimensions | |||
| • Dressing 13cm x 13cm / 5in x 5in | • RED LABEL 13cm x 13cm / 5in x 5in | Same | |
| • Dressing 13cm x 38cm / 5in x 15in | • RED LABEL 13cm x 38cm / 5in x 15in | ||
| • Dressing 25cm x 38cm / 10in x 15in | • RED LABEL 25cm x 38cm / 10in x 15in | ||
| • Dressing 38cm x 50cm / 15in x 20in | • RED LABEL 38cm x 50cm / 15in x 20in | ||
| • Glove Paediatric | • GREEN LABEL Paediatric | ||
| • Glove Small | • GREEN LABEL Small | ||
| • Glove Medium | • GREEN LABEL Medium | ||
| • Glove Large | • GREEN LABEL Large | ||
| Anatomical sites | BIOBRANE Dressing: All body areas | ||
| BIOBRANE Glove: Hand | RED LABEL BIOBRANE II: All body areas | ||
| GREEN LABEL BIOBRANE II: Hand | Same |
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21 CFR 807.92 (b)(1): Brief discussion of nonclinical tests submitted/referenced/ relied on in this submission to determine substantial equivalence
A series of bench performance verification tests and product characterization have been completed to confirm the subject device meets design specifications in support of the performance of BIOBRANE, in addition to demonstrating substantial equivalence to the predicate device of the BIOBRANE II (K901369).
21 CFR 807.92 (b)(2): Brief discussion of clinical tests submitted/referenced/ relied on in this submission to determine substantial equivalence
No clinical data is relied upon in this submission to determine substantial equivalence.
21 CFR 807.92 (b)(3): Conclusions drawn
In establishing substantial equivalence to the predicate device, Smith & Nephew Medical Ltd evaluated the indications for use, principle of operation, materials, technology, product specifications and biocompatibility requirements of the device. Performance testing has been completed to demonstrate that BIOBRANE is substantially equivalent to the predicate device for the intended use.