(151 days)
Not Found
No
The device description and performance studies focus on mechanical friction and chemical disinfection with IPA, with no mention of AI or ML.
No.
This device is intended to disinfect medical surfaces, not to treat a disease or condition in a patient.
No
The device is intended for disinfecting surfaces by reducing microbial load, not for diagnosing conditions or diseases.
No
The device is a physical, handheld device containing a liquid solution and designed for mechanical action, clearly indicating it is not software-only.
Based on the provided information, the Site-Scrub IPA Device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to disinfect injection ports and female luer hubs. This is a direct action on a medical device/surface, not a test performed on a sample taken from the human body to provide information about a physiological state, disease, or condition.
- Device Description: The device is described as a handheld, sterile, single-use device containing IPA for mechanical friction and disinfection. This aligns with a surface disinfectant, not an IVD.
- Performance Studies: The performance studies focus on the device's ability to reduce microbial load on surfaces, which is relevant to disinfection efficacy, not diagnostic accuracy.
- Predicate Devices: The predicate devices listed (SwabCap and Alcohol Prep Pad) are also surface disinfectants, not IVDs.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Site-Scrub IPA Device does not perform this function.
N/A
Intended Use / Indications for Use
The Site-Scrub IPA Device is intended for use on injection ports and female luer hubs as a disinfecting cleaner.
Product codes (comma separated list FDA assigned to the subject device)
LKB
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation tests have been performed in accordance with Design Controls as per 21 CFR §820.30. The following guidance documents and standards, in conjunction with internal protocols, were used to determine appropriate methods for evaluating the performance of the device: AAMI/ANSI/ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile ISO 11137-1:2006, Sterilization of Health Care Products - Radiation- Part 1: Requirements for development, validation, and routine 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 Medical Devices - Part 1: Requirements for materials, sterile barrier systems, and packaging systems; 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 Include Antimicrobial Agents. The subject device met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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: Candida albicans, Candida parapsilosis, Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus (MRSA), and Staphylococcus epidermidis (MRSE).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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 West | |
| Salt 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-amendment | |
| LKB | ||
| 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 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."¹ | ||
| 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 | ||
| Device Description | ||
| Continued | 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 include2: |
- Candida albicans,
- Candida parapsilosis,
- Escherichia coli,
- Pseudomonas aeruginosa,
- Staphylococcus aureus (MRSA), and
- Staphylococcus epidermidis (MRSE). | |
| Indications for
Use/Intended Use | The Site-Scrub IPA Device is intended for use on injection ports and
female luer hubs as a disinfecting cleaner. | |
| Technological
Characteristics | Technological characteristics of the subject Site-Scrub IPA Device are
equivalent with respect to the device's basic design and function to those
of the predicate devices, Excelsior Medical's SwabCap and the Aplicare,
Inc.'s Alcohol Prep Pad. The primary difference between SwabCap and
the subject device is that the Site-Scrub IPA Device is not intended to act
as a physical barrier to contamination between line accesses. Other
technological characteristics of the subject device are comparable to the
predicate devices. Distinguishing differences do not raise new questions
regarding safety or efficacy of the subject device. | |
| Safety &
Performance Tests | Verification and validation tests have been performed in accordance with
Design Controls as per 21 CFR §820.30. The following guidance
documents and standards, in conjunction with internal protocols, were
used to determine appropriate methods for evaluating the performance of
the device:
AAMI/ANSI/ISO 10993-1:2009, Biological Evaluation of Medical
Devices Part 1: Evaluation and Testing, and the FDA Modified
ISO 10993 Test Profile ISO 11137-1:2006, Sterilization of Health Care Products -
Radiation- Part 1: Requirements for development, validation, and
routine 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 Medical
Devices - Part 1: Requirements for materials, sterile barrier
systems, and packaging systems | |
| Safety &
Performance Tests
Continued | • 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 Include
Antimicrobial Agents | |
| | The subject device met all predetermined acceptance criteria derived
from the above listed references and demonstrated substantially
equivalent performance as compared to the cited predicate devices. | |
| Summary of
Substantial
Equivalence | Based on the Indications for Use, technological characteristics, and safety
and performance testing, the subject Site-Scrub IPA Device meets the
requirements for its intended use and is as safe, as effective, and
performs 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/
1
2 Hidron et al., Antimicrobial Resistant Pathogens Associated with Healthcare-Associated Infections: Annual
.
2
and the comments of the comments of
. . . . . . .
and the comments of the comments of the country of
- Sales and the same
and the contraction of the comments of the comments of the comments of
3
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.
4
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
5
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