BeneHold Surgical Incise Drape with CHG antimicrobial

K202208 · Avery Dennison Belgie Bvba · KKX · Jul 30, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K202208
• Device Name: BeneHold Surgical Incise Drape with CHG antimicrobial
• Applicant: Avery Dennison Belgie Bvba
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Jul 30, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

The BeneHold™ Surgical Incise Drape with CHG is indicated for use as an incise drape with continuous antibacterial activity (in vitro) from 2.5 to 4 hours against the following organisms; S. epidermidis, E. faecalis, E. coli, P. aeruginosa and E. aerogenes. It is intended for external use only. Correlation between in vitro results and any clinical event has not been tested.

Device Story

BeneHold™ Surgical Drape with CHG is a surgical incise drape designed to provide a sterile barrier and continuous in vitro antibacterial activity. The device is applied to the patient's skin at the surgical site prior to incision. It functions by releasing chlorhexidine gluconate (CHG) to inhibit the growth of specific bacteria (S. epidermidis, E. faecalis, E. coli, P. aeruginosa, E. aerogenes) on the skin surface for a duration of 2.5 to 4 hours. Used in clinical surgical settings by healthcare professionals. The device aims to reduce the risk of surgical site contamination by providing an antibacterial environment during the procedure. No clinical correlation between the in vitro antibacterial activity and clinical outcomes has been established.

Clinical Evidence

No clinical data. The device indications are supported by in vitro antibacterial activity testing against specified organisms for 2.5 to 4 hours. The document explicitly states that correlation between in vitro results and any clinical event has not been tested.

Technological Characteristics

Surgical incise drape containing chlorhexidine gluconate (CHG) for antibacterial activity. Class II device (Product Code: KKX).

Indications for Use

Indicated for use as an incise drape providing continuous in vitro antibacterial activity for 2.5 to 4 hours against S. epidermidis, E. faecalis, E. coli, P. aeruginosa, and E. aerogenes. 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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July 30, 2021

Avery Dennison Belgie BVBA Lisa Bartakovics Sr. Global Director, Regulatory Affairs and Ouality Assurance Tieblokkenlaan, 1 Turnhout, Antwerpen 2300 Belgium

Re: K202208

Trade/Device Name: BeneHold™ Surgical Drape with CHG Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical drape and drape accessories Regulatory Class: Class II Product Code: KKX Dated: July 27, 2021 Received: July 27, 2021

Dear Lisa Bartakovics:

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. 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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).

Sincerely,

For Clarence W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

## Indications for Use

510(k) Number (if known) K202208

Device Name BeneHold™ Surgical Drape with CHG

## Indications for Use (Describe)

The BeneHold™ Surgical Incise Drape with CHG is indicated for use as an incise drape with continuous antibacterial activity (in vitro) from 2.5 to 4 hours against the following organisms; S. epidermidis, E. faecalis, E. coli, P. aeruginosa and E. aerogenes.

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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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