(248 days)
The B. Braun Antibacterial Ultrasite Valve (Ultrasite Ag) is intended for aspiration, injection or gravity/pump flow of IV fluids upon insertion of a male luer fitting. Not intended for use with power injectors.
The Antibacterial Ultrasite Valve contains a silver based compound which may help to reduce bacterial growth on the surface and within the fluid path of the device.
Testing with Ultrasite Ag Valve demonstrated antibacterial effectiveness against Pseudomonas aeruginosa, Klebsiella pneumoniae, and Enterobacter aerogenes over 96 hours.
The Antibacterial Ultrasite Valve is not intended for use in the treatment of existing infections.
B. Braun's Antibacterial Ultrasite® Valve is an individually packaged, sterile, non-pyrogenic, single use, disposable device. The valve is used as an injection site and requires swabbing to disinfect prior to use. The Antibacterial Ultrasite Valve is a needle free reflux valve or needleless access device intended for IV therapy. The valve is accessed by attaching a male luer fitting.
The Antibacterial Ultrasite Valve contains a silver based compound that is impregnated into the polymeric resin of the device components. The antimicrobial compound is intended to reduce bacterial growth.
The provided document for K073396 describes the Antibacterial Ultrasite® Valve, Ultrasite Ag. This device is a needle-free reflux valve intended for IV therapy, incorporating a silver-based compound to reduce bacterial growth.
Here's an analysis of the acceptance criteria and the study information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Type of Test) | Reported Device Performance |
|---|---|
| Biocompatibility | Tests conducted (details not provided in excerpt) |
| Toxicology | Tests conducted (details not provided in excerpt) |
| Functional Performance | Tests conducted (details not provided in excerpt) |
| Package Integrity | None mentioned beyond "tests conducted" |
| Shipping | Tests conducted (details not provided in excerpt) |
| Microbial Ingress Challenge | Tests conducted (details not provided in excerpt) |
| Antimicrobial Effectiveness | Demonstrated effectiveness against Pseudomonas aeruginosa, Klebsiella pneumoniae, and Enterobacter aerogenes over 96 hours. |
| Neutralization | Tests conducted (details not provided in excerpt) |
| Elution | Tests conducted (details not provided in excerpt) |
Important Note: The provided document is a 510(k) summary, which often summarizes testing without providing granular details of the acceptance criteria (e.g., specific quantitative thresholds for "functional performance" or "biocompatibility") or detailed results beyond a general statement of "demonstrated effectiveness" for the antimicrobial aspect.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the tests aformentioned for the test set or the provenance of the data (e.g., country of origin, retrospective or prospective). It simply states that "The Antibacterial Ultrasite Valve was subjected to a variety of tests."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided in the document. This device is a medical device (intravascular administration set) that undergoes laboratory and performance testing, not human-based interpretive testing that would require expert consensus for ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document, as it pertains to human interpretation tasks.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not conducted or mentioned. This type of study is more relevant for diagnostic imaging or interpretation devices where human readers' performance with and without AI assistance is evaluated.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence, the "Antimicrobial Effectiveness" testing can be considered analogous to "standalone" performance for this device's specific claim. The device itself (the valve with the silver compound) was directly tested for its ability to reduce bacterial growth. This testing was performed independent of human interaction or interpretation beyond laboratory procedures.
7. The Type of Ground Truth Used
For the antimicrobial effectiveness claim, the ground truth was based on microbiological testing results. This typically involves:
- Inoculating the device (or control) with specific bacteria.
- Incubating for a defined period.
- Measuring bacterial viability/reduction compared to control conditions.
- The reduction in bacterial count serves as the "ground truth" for the device's antibacterial efficacy.
For other tests (biocompatibility, functional performance, etc.), the ground truth would be established by validated laboratory methods and predetermined specifications/standards for those types of tests.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This device is a physical medical device, not an AI or machine learning algorithm that requires a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" for this type of device.
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510(k) K073396 Antibacterial Ultrasite Valve, Ultrasite Ag
Response to FDA Request - August 4, 2008 Teleconference August 5, 2008
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) SUMMARY
AUG - 7 2008
| APPLICANT/SUBMITTER: | B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341610-266-0500 | AUG - 7 2008 |
|---|---|---|
| Contact: Rebecca A. StolarickDirector, Regulatory AffairsPhone: 610-596-2536Fax: 610-266-4962E-mail: Rebecca.stolarick@bbraun.com | ||
| DEVICE NAME: | B. Braun Medical Inc. Antibacterial Ultrasite® Valve, Ultrasite Ag | |
| COMMON ORUSUAL NAME: | Needle Free Reflux Valve or Needleless Access Device | |
| DEVICECLASSIFICATION: | Class II, Product Code FPA, Intravascular Administration Set, 21CFR 880.5440 | |
| PREDICATEDEVICES: | B. Braun Medical Inc. Ultrasite Valve 510(k) K955585Elcam Medical Antimicrobial Stopcock 510(k) K053405 | |
| DESCRIPTION: | B. Braun's Antibacterial Ultrasite® Valve is an individually packaged, sterile, non-pyrogenic, single use, disposable device. The valve is used as an injection site and requires swabbing to disinfect prior to use. The Antibacterial Ultrasite Valve is a needle free reflux valve or needleless access device intended for IV therapy. The valve is accessed by attaching a male luer fitting.The Antibacterial Ultrasite Valve contains a silver based compound that is impregnated into the polymeric resin of the device components. The antimicrobial compound is intended to reduce bacterial growth. |
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B. Braun Medical Inc. 510(k) K073396 Antibacterial Ultrasite Valve, Ultrasite Ag Response to FDA Request - August 4, 2008 Teleconference August 5, 2008
Page _________________________________________________________________________________________________________________________________________________________________________
The B. Braun Medical Inc. Antibacterial Ultrasite Valve is INTENDED USE: intended for aspiration, injection or gravity/pump flow of IV fluids upon insertion of a male luer fitting. Not intended for use with power injectors. The Antibacterial Ultrasite Valve contains a silver based compound which may reduce bacterial growth on the surface and within the fluid path of the device. Testing with Ultrasite® Ag Valve demonstrated antibacterial effectiveness against Pseudomonas aeruginosa, Klebsiella pneumoniae, and Enterobacter aerogenes over 96 hours. The Antibacterial Ultrasite® Valve is not intended to treat existing infections. SUBSTANTIAL EQUIVALENCE: The Antibacterial Ultrasite Valve is similar to the predicate device, the currently marketed B. Braun Medical Inc. Ultrasite Valve. The Antibacterial Ultrasite Valve and the Ultrasite Valve are sterile, individually packaged, single use, disposable valves accessed by connecting a male luer fitting. Both are needleless access devices (injection sites) or needle free reflux valves intended for use in IV therapy. The Antibacterial Ultrasite Valve and the Ultrasite Valve have a similar intended use. Both are used for aspiration, injection or gravity/pump flow of IV fluids upon insertion of a male luer fitting. The Antibacterial Ultrasite Valve and the Ultrasite Valve are composed of the same basic materials and components, have the same design and are manufactured using a similar process. The only difference between the Antibacterial Ultrasite Valve and the Ultrasite Valve is the addition of a silver based antimicrobial compound and a lavender colorant. The Antibacterial Ultrasite Valve is also similar to the Elcam Medical Antimicrobial Stopcock. Both devices contain the same silver based antimicrobial compound. The intended use of the antibacterial compound in the Antibacterial Ultrasite Valve is the same as the intended use of the antimicrobial compound in the Elcam Antimicrobial Stopcock, to reduce microbial growth.
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B. Braun Medical Inc. 510(k) K073396 Antibacterial Ultrasite Valve, Ultrasite Ag Response to FDA Request - August 4, 2008 Teleconference August 5, 2008
Page ____________ of _________________________________________________________________________________________________________________________________________________________
The Antibacterial Ultrasite Valve was subjected to a variety of tests to demonstrate substantial equivalence with the two predicate devices and to demonstrate the safety and effectiveness of the proposed device. The following tests were conducted: biocompatibility, toxicology, functional performance, package integrity, shipping, microbial ingress challenge, antimicrobial effectiveness, neutralization, and elution.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a seal for the Department of Health & Human Services - USA. The seal is circular and contains text around the perimeter. In the center of the seal is a symbol that appears to be a stylized representation of a caduceus or a similar emblem associated with health and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 7 2008
Ms. Rebecca A. Stolarick Director, Regulatory Affairs B. Braun Medical Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109
Re: K073396
Trade/Device Name: Antibacterial Ultrasite® Valve, Ultrasite Ag Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: July 23, 2008 Received: July 24, 2008
Dear Ms. Stolarick:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Stolarick
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); good manufacturing practice requirements 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,
Sincerely yours,
Chiu Lin, Ph.D.
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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B. Braun Medical Inc. 5 10(k) K073396 Antibacterial Ultrasite Valve. Ultrasite Ag Response to FDA Request - August 4, 2008 Teleconference August 5, 2008
Page Page of
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Antibacterial Ultrasite® Valve (Ultrasite Ag)
Indications For Use:
The B. Braun Antibacterial Ultrasite Valve (Ultrasite Ag) is intended for aspiration, injection or gravity/pump flow of IV fluids upon insertion of a male luer fitting. Not intended for use with power injectors.
The Antibacterial Ultrasite Valve contains a silver based compound which may help to reduce bacterial growth on the surface and within the fluid path of the device.
Testing with Ultrasite Ag Valve demonstrated antibacterial effectiveness against Pseudomonas aeruginosa, Klebsiella pneumoniae, and Enterobacter aerogenes over 96 hours.
The Antibacterial Ultrasite Valve is not intended for use in the treatment of existing infections.
OR
Prescription Use ___ X (Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clus
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K073396
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.