The subject Site-Scrub IPA Device is a handheld, sterile, single use device containing isopropyl alcohol (IPA) 70% (v/v) solution. The Site-Scrub IPA Device, by design, provides active mechanical friction and IPA to clean and disinfect surfaces, such as injection ports and female luer hubs, in accordance with 2011 CDC guidelines that recommend for needleless intravascular catheter systems that contamination be minimized by "scrubbing the access port with an appropriate antiseptic (including 70% alcohol) and accessing the port only with sterile devices." The foam design allows for application of the IPA on internal and external surfaces. The Site-Scrub IPA Device has been specifically designed to disinfect female luer hubs and injection ports and has undergone in vitro testing to validate its effectiveness for this purpose. The results of in vitro antimicrobial efficacy testing show the Site-Scrub IPA Device is effective, when used as intended, for significantly reducing (> 4 Log10 or 99.99% reduction) microbial load of the following microbes known to be associated with catheter line-associated blood stream infections (CLABSI) which include: 1. Candida albicans, 2. Candida parapsilosis, 3. Escherichia coli, 4. Pseudomonas aeruginosa, 5. Staphylococcus aureus (MRSA), and 6. Staphylococcus epidermidis (MRSE).

AI/ML Overview

The information provided describes the Site-Scrub IPA Device, a handheld, sterile, single-use device containing 70% (v/v) isopropyl alcohol (IPA) solution, designed for disinfecting injection ports and female luer hubs.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from Device Description)	Reported Device Performance (from Device Description)
Significantly reducing (> 4 Log10 or 99.99% reduction) microbial load of specified microbes associated with CLABSI when used as intended.	In vitro antimicrobial efficacy testing demonstrated effective reduction (> 4 Log10 or 99.99% reduction) of microbial load.

Specific Microbes Mentioned:

Candida albicans
Candida parapsilosis
Escherichia coli
Pseudomonas aeruginosa
Staphylococcus aureus (MRSA)
Staphylococcus epidermidis (MRSE)

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

The document mentions "in vitro testing" to validate effectiveness. However, it does not specify the sample size used for this testing.

Regarding data provenance, the study appears to be in-vitro (laboratory-based) rather than involving human clinical data (retrospective or prospective). The country of origin for the data is not explicitly stated, but the submission is to the US FDA, implying testing was conducted to meet US regulatory requirements, likely within the US or a country with comparable standards.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth. Since the testing is described as "in vitro antimicrobial efficacy testing," the "ground truth" would be established by standard microbiological methods and controls, rather than expert human interpretation of medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable as the described study is "in vitro antimicrobial efficacy testing" and does not involve human readers or complex interpretations that would require an adjudication method like 2+1 or 3+1. The results are based on objective measurement of microbial reduction.

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 done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical cases, and the AI's impact on their performance is evaluated. The Site-Scrub IPA Device is a disinfectant, not an AI-powered diagnostic tool.

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

Since the device is a physical disinfectant and not an algorithm or AI system, the concept of "standalone performance" for an algorithm is not applicable. The device's performance is inherently "standalone" in the sense that it functions physically to disinfect.

7. The Type of Ground Truth Used

The ground truth used for this study is based on in-vitro microbiological cultures and quantitative reduction of microbial load. This is determined by standard laboratory techniques to count colony-forming units (CFUs) or other measures of microbial viability before and after disinfection, compared against controls.

8. The Sample Size for the Training Set

This information is not applicable. The Site-Scrub IPA Device is a physical medical device, not an AI/machine learning algorithm that requires a "training set" of data.

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

This information is not applicable for the same reason as #8.

Summary

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K112791

FEB 2 4 2012

Image /page/0/Picture/2 description: The image shows the logo for BARD ACCESS SYSTEMS. The word "BARD" is in large, bold, sans-serif font on the top line. Below that, the words "ACCESS SYSTEMS" are in a smaller, bold, sans-serif font. The logo is black and white.

510(k) Summary 21 CFR 807.92

Submitter Name:	Bard Access Systems, Inc.
Address:	605 North 5600 WestSalt Lake City, UT 84116
General Provisions
Contact Person:	Lynn M. Kirchoff
Telephone Number:	(801) 522-5636
Fax Number:	(801) 522-5425
Date of Preparation:	December 6, 2011
Subject Device
Trade Name:	Site-Scrub IPA Device
Common Name:	Pad, Alcohol, Device Disinfectant
Classification Name:	Unclassified, pre-amendmentLKB
Predicate Devices
Trade Name:	SwabCap
Classification Name:	Pad, Alcohol, Device Disinfectant
Premarket Notification:	K083508
Manufacturer:	Excelsior Medical Corporation (Neptune, NJ)
Trade Name:	Alcohol Prep Pad
Classification Name:	Pad, Alcohol, Device Disinfectant
Premarket Notification:	K833182
Manufacturer:	Aplicare, Inc. (Meriden, CT)
Device Description	The subject Site-Scrub IPA Device is a handheld, sterile, single usedevice containing isopropyl alcohol (IPA) 70% (v/v) solution. The Site-Scrub IPA Device, by design, provides active mechanical friction and IPAto clean and disinfect surfaces, such as injection ports and female luerhubs, in accordance with 2011 CDC guidelines that recommend forneedleless intravascular catheter systems that contamination beminimized by "scrubbing the access port with an appropriate antiseptic(including 70% alcohol) and accessing the port only with sterile devices."¹The foam design allows for application of the IPA on internal and externalsurfaces.The Site-Scrub IPA Device has been specifically designed to disinfectfemale luer hubs and injection ports and has undergone in vitro testing tovalidate its effectiveness for this purpose. The results of in vitro
Device DescriptionContinued	antimicrobial efficacy testing show the Site-Scrub IPA Device is effective,when used as intended, for significantly reducing (> 4 Log10 or 99.99%reduction) microbial load of the following microbes known to beassociated with catheter line-associated blood stream infections (CLABSI)which include2:1. Candida albicans,2. Candida parapsilosis,3. Escherichia coli,4. Pseudomonas aeruginosa,5. Staphylococcus aureus (MRSA), and6. Staphylococcus epidermidis (MRSE).
Indications forUse/Intended Use	The Site-Scrub IPA Device is intended for use on injection ports andfemale luer hubs as a disinfecting cleaner.
TechnologicalCharacteristics	Technological characteristics of the subject Site-Scrub IPA Device areequivalent with respect to the device's basic design and function to thoseof the predicate devices, Excelsior Medical's SwabCap and the Aplicare,Inc.'s Alcohol Prep Pad. The primary difference between SwabCap andthe subject device is that the Site-Scrub IPA Device is not intended to actas a physical barrier to contamination between line accesses. Othertechnological characteristics of the subject device are comparable to thepredicate devices. Distinguishing differences do not raise new questionsregarding safety or efficacy of the subject device.
Safety &Performance Tests	Verification and validation tests have been performed in accordance withDesign Controls as per 21 CFR §820.30. The following guidancedocuments and standards, in conjunction with internal protocols, wereused to determine appropriate methods for evaluating the performance ofthe device:AAMI/ANSI/ISO 10993-1:2009, Biological Evaluation of MedicalDevices Part 1: Evaluation and Testing, and the FDA ModifiedISO 10993 Test Profile ISO 11137-1:2006, Sterilization of Health Care Products -Radiation- Part 1: Requirements for development, validation, androutine control of a sterilization process for medical devices. ISO 11137-2:2006, Sterilization of health care products -Radiation- Part 2: Establishing the sterilization dose ISO 11137-3:2006, Sterilization of health care products -Radiation - Part 3: Guidance on dosimetric aspects ISO 11607-1:2006, Packaging for Terminally Sterilized MedicalDevices - Part 1: Requirements for materials, sterile barriersystems, and packaging systems
Safety &Performance TestsContinued	• ISO 11607-2:2006, Part 2: Validation Requirements for forming,sealing, and assembly processes• Draft Guidance for Industry and FDA – Premarket Notification[510(k)] Submissions for Medical Devices that IncludeAntimicrobial Agents
	The subject device met all predetermined acceptance criteria derivedfrom the above listed references and demonstrated substantiallyequivalent performance as compared to the cited predicate devices.
Summary ofSubstantialEquivalence	Based on the Indications for Use, technological characteristics, and safetyand performance testing, the subject Site-Scrub IPA Device meets therequirements for its intended use and is as safe, as effective, andperforms as well as or better than the predicate devices cited.

1 2011 Centers for Disease Control Guidelines for the Prevention of Intravascular Catheter-Related Infection.
Accessed July 20, 2011, http://www.cdc.gov/hicpac/Disinfection/

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2 Hidron et al., Antimicrobial Resistant Pathogens Associated with Healthcare-Associated Infections: Annual

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Public Health Service

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

Ms. Lynn M. Kirchoff Associate Director, Regulatory Affairs Bard Access Systems, Inc. 605 North 5600 West Salt Lake City, Utah 84116

FEB 2 4 2012

Re: K112791

Trade/Device Name: Site-Scrub IPA Device Regulation Number: None Regulation Name: Pad, Alèohol, Device Disinfectant Regulatory Class: Unclassified Product Code: LKB Dated: February 7, 2012 Received: February 9, 2012

· Dear Ms. Kirchoff:

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 approvisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, ledging, 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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Page 2 - Ms. Kirchoff

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. or the rot of anyly 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 (reporting of meants as set forth in the quality systems (QS) 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), 11 you debitr bpv://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to Compilance: "Thos; preace now mart 807.97). For questions regarding the reporting of premarter not would the MDR regulation (21 CFR Part 803), please go to au verse events ander the regal/Safety/ReportaProblem/default.htm for the CDRH's http://www.ridall.government.cs/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Tou may obtain other geturers, International and Consumer Assistance at its toll-free Drison (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for Anthony D. Watson

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Bard Access Systems, Inc. Site-Scrub IPA Device Traditional 510(k) Premarket Notification

Indications for Use

510(k) Number (if known):

KI12791

Device Name:

Site-Scrub IPA Device

Indications for Use:

The Site-Scrub IPA Device is intended for use on injection ports and female luer hubs as a disinfecting cleaner.

Prescription Use V (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 IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rld C. Chapman 2/24/12
(Division Sign-Off)

Page 1 of 1

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K112791

Regulation Number and Section

N/A