(288 days)
Not Found
No
The device is a simple alcohol swab for disinfection and the summary contains no mention of AI or ML.
No
The device is described as disinfecting needleless access sites, not treating a disease or condition. Its purpose is to reduce bacteria, which is a PREVENTATIVE measure, not a therapeutic one.
No
The device is described as disinfecting needleless access sites, which is a therapeutic or preventative action, not a diagnostic one. It does not identify or determine the nature of a disease or condition.
No
The device description clearly states it is a "single use, sterile device that is saturated with 70% USP grade Isopropyl alcohol," indicating it is a physical product, not software.
Based on the provided information, the BD Alcohol Swab is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to disinfect needleless access sites prior to use. This is a direct application to a medical device (the access site) on or connected to a patient, not for examining specimens in vitro (outside the body) to provide information about a physiological state, health, or disease.
- Device Description: The description reinforces its use for disinfecting needleless access sites.
- Performance Studies: The performance studies focus on the reduction of bacteria on medical device connectors, which is consistent with a disinfectant for medical devices, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The BD Alcohol Swab's function is to prepare a medical device surface for use, which falls under the category of a disinfectant or antiseptic for medical devices.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
80 LKB
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.
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
home or healthcare facility
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject device was tested for its efficacy against 6 bacterium on various connectors, and it met its requirements for its intended use and is as safe and effective as its predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
4-login bacteria reduction
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
510(k) Summary of Safety and Effectiveness
| Submitted By: | Avital Merl
Staff Regulatory Affairs Specialist
BD Medical - Medical Surgical Systems
1 Becton Drive
Franklin Lakes, NJ 07417
Tel: 201 847 4739
Fax: 201 847 5307 | | MAR 2 0 2013 |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|--------------|
| 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
1
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.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features the department's seal, which includes an abstract symbol resembling an eagle or bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the seal in a circular fashion.
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.
3
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,
Image /page/3/Picture/6 description: The image contains a stylized drawing with illegible text. The text appears to be handwritten and is surrounded by abstract shapes and lines. The drawing is black and white and has a rough, sketchy quality.
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
4
Indications for Use
510(k) Number (if known):
·
Device Name:
BD Alcohol Swab
Indications for Use:
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.
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'
Page 1 of 1
(Division Sign-Off) (Division Sign-On)
Division of Anesthestology, General Hospital Infection Control, Dental Devices
510(k) Number;
21 of 98
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