BD Alcohol Swab is a single use, sterile device containing 70% Isopropyl alcohol. When used for scrubbing for 5 seconds and allowing drying for 5 seconds, the BD Alcohol Swab disinfects needleless access sites prior to use. It may be used in the home or healthcare facility.

Device Description

The BD Alcohol Swab is a single use, sterile device that is saturated with 70% USP grade Isopropyl alcohol and intended to for needleless access site disinfection.

AI/ML Overview

The BD Alcohol Swab is a single-use, sterile device saturated with 70% USP grade Isopropyl alcohol, intended for needleless access site disinfection. The study described in the 510(k) summary provides insight into its acceptance criteria and performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
4-log reduction in bacteria for medical device disinfecting.	The testing demonstrated that the BD Alcohol Swab met its requirements (implicitly, a 4-log reduction based on the described acceptance criteria) when tested against the specified bacteria on various connectors. This indicates the device achieved or exceeded the 4-log reduction target.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a numerical sample size for the "test set" in terms of how many individual swabs or disinfection events were performed. Instead, it refers to "various connectors" on which the efficacy testing was performed. The data provenance (country of origin, retrospective/prospective) is not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided in the document. The efficacy testing for this device relies on direct microbiological measurements (bacterial reduction) rather than expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. As mentioned above, the assessment is based on direct microbiological measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data. The BD Alcohol Swab is an infection control device, and its efficacy is evaluated through direct microbiological testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to the BD Alcohol Swab. "Standalone performance" usually refers to the performance of an AI algorithm without human involvement. The BD Alcohol Swab is a medical device, not an AI algorithm. Its performance is evaluated directly through its physical and chemical properties and their effect on microorganisms.

7. The Type of Ground Truth Used

The ground truth used was the direct measurement of bacterial reduction on medical device surfaces. This is a quantifiable and objective microbiological outcome.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The BD Alcohol Swab is a physical medical device, not a machine learning model, so there is no "training set" in the context of AI. The efficacy testing described is a performance validation, not a training process.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided, as there is no "training set" for this device. The efficacy testing results are based on laboratory measurements of bacterial load before and after disinfection.

Summary

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510(k) Summary of Safety and Effectiveness

Submitted By:	Avital MerlStaff Regulatory Affairs SpecialistBD Medical - Medical Surgical Systems1 Becton DriveFranklin Lakes, NJ 07417Tel: 201 847 4739Fax: 201 847 5307
Date Prepared:	March 19, 2013
Device Name:	Trade Name:	BD Alcohol Swab
	Common Name:	Alcohol Swab
	Classification:	Unclassified
	Product Code:	80 LKB

Legally marketed predicate devices to which substantial equivalence is being claimed:

K112791- Bard Access Systems'Site-Scrub IPA K111992- Ivera Medical Corporation's Curos™ Port Protector K083508- Excelsior Medical Corporation's SwabCap

Device Description:

The BD Alcohol Swab is a single use, sterile device that is saturated with 70% USP grade Isopropyl alcohol and intended to for needleless access site disinfection.

Intended Use:

The BD Alcohol Swab is a single use, sterile device containing 70% Isopropyl alcohol. When used for scrubbing for 5 seconds and allowing drying for 5 seconds, the BD Alcohol Swab will disinfect needless access sites prior to use. It may be used in the home or healthcare facility.

Comparison with Predicate Devices:

The BD Alcohol Swab has a similar intended use as its predicate device for disinfecting needless access sites within the home or healthcare facility. It is provided sterile and is constructed with the same 70% isopropyl alcohol antimicrobial agent as its predicated devices. It varies in technological characteristics as compared to the predicate devices as the subject device is an alcohol pad and the predicate device contains an alcohol pad-like sponge within a rigid cap design.

Testing:

BD has performed non-clinical performance testing to demonstrate its pre-defined acceptance criteria of a 4-login bacteria reduction for medical device disinfecting. These results were based upon the selection of gram positive and gram negative bacteria. The efficacy testing was performed using the following 6 bacterium on various connectors: Staphylococcus epidermidis, Staphylococcus aureus, Pseudomonas aeruginosa, Kiebsiella pneumoniae, Candida albicans, & Enterococcus faecalis. This testing demonstrated that the BD Alcohol

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Swab met its requirements for its intended use and is as safe and effective as its predicate devices. .

Conclusion:

The analysis and testing performed demonstrate that the BD Alcohol Swab device is substantially equivalent to its predicate devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 20, 2013

Ms. Avital Merl Staff Regulatory Affairs Specialist Becton Dickinson & Company 1 Becton Drive Franklin Lakes, New Jersey 07417-1885

Re: K121655

Trade/Device Name: BD Alcohol Swab Regulation Number: Unclassified Regulation Name: Pad, alcohol, device disinfectant Regulatory Class: Unclassified Product Code: LKB Dated: February 25, 2013 Received: February 26, 2013

Dear Ms. Merl:

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.

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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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

K121655

Device Name:

BD Alcohol Swab

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use . (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Richard C. Chapman 2013.03.19 14:27:13 -04'00'

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Division of Anesthestology, General Hospital Infection Control, Dental Devices

510(k) Number;

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Regulation Number and Section

N/A