(147 days)
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.
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.
This document is a 510(k) K242146 premarket notification for the BIOBRANE Dressing and BIOBRANE Glove. It asserts substantial equivalence to the predicate device BIOBRANE II (K901369).
Here's an analysis of the provided information relating to acceptance criteria and device performance:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not provide a table of acceptance criteria with specific performance metrics such as sensitivity, specificity, accuracy, or any quantitative measures for the device's diagnostic or predictive capabilities. This is likely because the device is a wound dressing, not a diagnostic AI/ML device.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through shared characteristics and verification tests. The "acceptance criteria" can be inferred as successful completion of these tests and demonstration that the device's characteristics are similar to the predicate.
| Characteristic / Test | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate | Same |
| Indications for Use | Within scope of predicate's indications | More precise, but substantially equivalent |
| Principles of Operation | Same as predicate | Same |
| Materials and Structure | Same as predicate | Same (Silicone membrane, nylon, collagen) |
| Silicone Membrane Function | Same as predicate | Same |
| Nylon Function | Same as predicate | Same |
| Collagen Function | Same as predicate | Same |
| Principal Operator | Same as predicate | Same (Trained HCP only) |
| Environment of Use | Same as predicate | Same (Healthcare facility and home use) |
| Single-Use or Reusable | Same as predicate | Same (Single-Use) |
| Sterilization | Same as predicate | Same (Moist heat) |
| Sterility | Same as predicate | Same (Sterile, SAL 10-6) |
| Shelf Life | Same as predicate | Same (3 years) |
| Biocompatibility | Complies with ISO 10993 | Complies with ISO 10993 |
| Device Dimensions | Equivalent to predicate sizes | Equivalent to predicate sizes |
| Anatomical sites | Same as predicate | Same |
| Bench Performance Verification Tests | Meets design specifications | Completed and confirm specifications met |
| Product Characterization | Confirms product characteristics | Completed and confirm characteristics |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical data is relied upon in this submission to determine substantial equivalence."
Therefore:
- Sample size for the test set: Not applicable, as no clinical test set was used for substantial equivalence determination.
- Data provenance: Not applicable. The evaluation was based on non-clinical (bench) testing and comparison of technological characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable, as no clinical test set with a ground truth established by experts was used. The substantial equivalence was based on non-clinical data and direct comparison to a predicate device.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or relied upon. This is a wound dressing, not an AI/ML diagnostic device where such studies are typical.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a wound dressing, not an algorithm or software-only device.
7. The Type of Ground Truth Used
Not applicable, as no clinical data or ground truth in the context of diagnostic performance was used. The "ground truth" for this submission is implicitly the established safety and efficacy profile of the legally marketed predicate device (BIOBRANE II, K901369) and the physical/chemical properties assessed through bench testing.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device that requires a training set or ground truth for training.
{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
{3}------------------------------------------------
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
{4}------------------------------------------------
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 |
| EstablishmentRegistration 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/ProprietaryName) | BIOBRANE DressingBIOBRANE 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 marketeddevice to whichequivalence is claimed | 510(k) Number: K901369Device Name: GREEN LABEL BIOBRANE II AND RED LABELBIOBRANE 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. .
{5}------------------------------------------------
| 21 CFR 807.92 (a)(6): Comparison of Technological Characteristics between the Subject and Predicate Devices | |||
|---|---|---|---|
| ProductCharacteristic | Subject Device(BIOBRANE, K242146) | Predicate Device(BIOBRANE II, K901369) | Substantial Equivalence Decision |
| Intended Use | Wound Management | Wound Management | Same |
| Indications forUse | BIOBRANE Dressing is indicated for:• Covering clean partial thickness burnwounds• Split thickness donor sitesBIOBRANE Glove is indicated for:• Covering clean partial thickness burnwounds of the hand. | RED LABEL BIOBRANE II is indicatedfor:• Clean partial thickness burn wounds• Donor sitesGREEN LABEL BIOBRANE II isindicated for:• Clean partial thickness burn wounds• Donor sites | BIOBRANE Dressings specify splitthickness donor sites and BIOBRANEGloves specify hand sites. The indicationsfor use of the subject device are moreprecise within the scope of the predicatedevice's indications for use and theindications for use of the subject deviceare substantially equivalent to thepredicate device. |
| Principles ofoperation | Excess fluid can drain from theperforations. | Excess fluid can drain from theperforations. | Same |
| Materials andStructure | Silicone membrane, nylon, and collagen | Silicone membrane, nylon, and collagen | Same |
| Porous silicone and nylon knit bi-layersheet with collagen coating | Porous silicone and nylon knit bi-layersheet with collagen coating | Same | |
| SiliconeMembraneFunction | A thin transparent, perforated,polymeric film. Creates a film structureover the top of the nylon to encase thedressing, creating a moist wound-healing environment. | A thin transparent, perforated, polymericfilm. Creates a film structure over the topof the nylon to encase the dressing,creating a moist wound-healingenvironment. | Same |
| NylonFunction | A weave of polymeric tri-filament yarn,partially embedded into the siliconemembrane. | A weave of polymeric tri-filament yarn,partially embedded into the siliconemembrane. | Same |
| CollagenFunction | Denatured porcine dermal collagencoated to the silicone-nylon dressing.The collagen component adheres to thefibrin on a clean wound surface andadheres the dressing to the wound. | Denatured porcine dermal collagen coatedto the silicone-nylon dressing. Thecollagen component adheres to the fibrinon a clean wound surface and adheres thedressing to the wound. | Same |
| PrincipalOperator | Trained healthcare professional (HCP)only | Trained healthcare professional (HCP)only | Same |
| Environment ofUse | Healthcare facility and home use(inpatient and outpatient) | Healthcare facility and home use(inpatient and outpatient) | Same |
| Single-Use orReusable | 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 |
| DeviceDimensions | |||
| • 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 areasBIOBRANE Glove: Hand | RED LABEL BIOBRANE II: All body areasGREEN LABEL BIOBRANE II: Hand | Same |
{6}------------------------------------------------
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
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.
N/A