BeneHold™ Surgical Incise Drape with CHG antimicrobial II

K230645 · Avery Dennison Medical , Ltd. · KKX · Oct 25, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K230645
• Device Name: BeneHold™ Surgical Incise Drape with CHG antimicrobial II
• Applicant: Avery Dennison Medical , Ltd.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Oct 25, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

The BeneHold™ Surgical Incise Drape with CHG antimicrobial II is indicated for use as an incise drape with continuous antimicrobial activity (in vitro) from 30 minutes through 4 hours of use against the following organisms: S. aureus, S. epidermidis, E. coli, P. aeruginosa, E. aerogenes, and C. albicans. In vitro testing on the subject drape has also shown continuous antimicrobial activity from 30 minutes through 2.5 hours against E. faecalis and F. oxysporum. It is intended for external use only. Correlation between in vitro results and any clinical event has not been tested.

Device Story

BeneHold™ Surgical Incise Drape with CHG antimicrobial II is a sterile, adhesive surgical drape containing chlorhexidine gluconate (CHG). Applied to patient skin at the surgical site prior to incision; provides a physical barrier and continuous in vitro antimicrobial activity against specified bacteria and fungi. Used in clinical/surgical settings by healthcare professionals. Device functions as a passive antimicrobial barrier; no electronic components or software. Benefits include potential reduction of microbial migration into the surgical wound during procedures.

Clinical Evidence

No clinical data. Evidence consists of in vitro antimicrobial activity testing against S. aureus, S. epidermidis, E. coli, P. aeruginosa, E. aerogenes, C. albicans, E. faecalis, and F. oxysporum. Correlation between in vitro results and clinical outcomes has not been tested.

Technological Characteristics

Surgical incise drape containing chlorhexidine gluconate (CHG) for antimicrobial properties. Adhesive backing for skin application. Passive barrier device. No electronic or software components.

Indications for Use

Indicated for use as a surgical incise drape for patients undergoing surgical procedures requiring an antimicrobial barrier. Intended for external use only.

Regulatory Classification

Identification

A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

Special Controls

*Classification.* Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

October 25, 2023

Avery Dennison Medical Ltd. Elaine Minagh Regulatory Affairs Manager IDA Business Park, Ballinalee Road Longford, Longford N39 DX73 Ireland

Re: K230645

Trade/Device Name: BeneHold™ Surgical Incise Drape with CHG antimicrobial II Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape And Drape Accessories Regulatory Class: Class II Product Code: KKX Dated: September 22, 2023 Received: September 25, 2023

Dear Elaine Minagh:

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"

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(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).

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 (OS) 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.

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.

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 ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

## Bifeng Qian -S

Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and 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)

## K230645

Device Name

BeneHold™ Surqical Incise Drape with CHG antimicrobial II

Indications for Use (Describe)

The BeneHold™ Surgical Incise Drape with CHG antimicrobial II is indicated for use as an incise drape with continuous antimicrobial activity (in vitro) from 30 minutes through 4 hours of use against the following organisms: S. aureus, S. epidermidis, E. coli, P. aeruginosa, E. aerogenes, and C. albicans. In vitro testing on the subject drape has also shown continuous antimicrobial activity from 30 minutes through 2.5 hours against E. faecalis and F. oxysporum. It is intended for external use only. Correlation between in vitro results and any clinical event has not been tested.

Type of Use (*Select one or both, as applicable*)

| <div> <span style="font-size:14px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|----------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:14px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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