(331 days)
An extension set to be used as an extension to the intravascular administration set used for fluid delivery through Bard proximally valved catheters. The extension set will connect the IV administration set to the catheter.
The Extension Set is designed for Bard proximally valved catheters and attaches to the end of the catheter hub for use in the administration of fluids. The Extension Set opens the valve to facilitate central venous pressure monitoring and/or blood sampling. Extension Sets are packaged individually for single use for a period no longer than 96 hours.
The provided submission describes non-clinical performance testing for the "Extension Set for Bard® Proximally Valved Catheters." This is a medical device for fluid administration, not an AI/ML powered device, therefore many of the requested categories are not applicable.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Evaluation | Predetermined Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Assembly Leak | No leaks at 43.5 psi minimum (air method used) | Met |
| Gravity Flow | 750 ml/hr minimum | Met |
| Priming Volume | NA, test and report results (results are reported to have been generated though values not specified) | Met |
| Assembly Tensile | Must withstand an axial, static tensile force of 15 N (3.37 lbs) for 15 seconds | Met |
| ISO 594 - 1 & 2 Luer Testing | Must pass acceptance criteria outlined in ISO 594-1 and -2. | Met |
| Aspiration Flow | NA, test and report results (results are reported to have been generated though values not specified) | Met |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for each specific test. The testing is described as "bench performance testing," which implies laboratory-based testing of manufactured devices. There is no information regarding the country of origin of data or whether it was retrospective or prospective, as no human data was involved.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is an extension set for catheters, and the testing involved bench performance criteria, not medical image interpretation or clinical outcomes requiring expert ground truth.
4. Adjudication Method for the Test Set
Not applicable. There was no expert adjudication process described as the testing was non-clinical bench testing against predetermined engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML device, and no MRMC study or human reader performance evaluation was conducted or is relevant for this type of device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is not an algorithmic device. The performance evaluation focuses on the physical properties and functionality of the extension set itself.
7. Type of Ground Truth Used
The "ground truth" for this device's acceptance criteria are established engineering, mechanical, and safety standards and internal protocols (e.g., ISO standards for infusion equipment, Luer fittings, tensile strength requirements, leak integrity, and flow rates).
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned.
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K 102405
Image /page/0/Picture/1 description: The image shows the logo for BARD ACCESS SYSTEMS. The word "BARD" is in large, bold, sans-serif font, with a unique design where the letters are connected and have a slightly angled appearance. Below the word "BARD", the words "ACCESS SYSTEMS" are printed in a smaller, sans-serif font.
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510(k) Summary
21 CFR 807.92(a)
JUL 2 1 2011
Extension Set for Bard® Proximally Valved Catheters
| GeneralProvisions | Submitter Name:Address: | Bard Access Systems, Inc.605 North 5600 WestSalt Lake City, UT 84116 |
|---|---|---|
| Contact Person:Telephone Number:Fax Number:Date of Preparation: | Lynn KirchoffRegulatory Affairs Manager(801) 522-5636(801) 522-5425March 9, 2011 | |
| SubjectDevice | Trade Name:Classification Name: | Extension Set for Bard Proximally Valved CathetersSet, Administration, IntravascularFPA, 21 CFR § 880.5440 Class II |
| PredicateDevice | Trade Name:Classification Name:Premarket Notification:Manufacturer: | IV Extension Set with Needleless Access DeviceSet, Administration, IntravascularFPA, 21 CFR § 880.5440 Class IIK980992Venetec Intl., Inc. now owned by Bard MedicalDivision |
| DeviceDescription | The Extension Set is designed for Bard proximally valved catheters andattaches to the end of the catheter hub for use in the administration of fluids.The Extension Set opens the valve to facilitate central venous pressuremonitoring and/or blood sampling. Extension Sets are packaged individuallyfor single use for a period no longer than 96 hours. | |
| Intended Use | An extension set to be used as an extension to the intravascularadministration set used for fluid delivery through Bard proximally valvedcatheters. The extension set will connect the IV administration set to thecatheter. | |
| Indications ForUse | An extension set to be used as an extension to the intravascularadministration set used for fluid delivery through Bard proximally valvedcatheters. The extension set will connect the IV administration set to thecatheter. | |
| TechnologicalCharacteristics | Technological characteristics of the subject Bard Extension Set are equivalentwith respect to the basic design and function to those of the predicate IVExtension Set with Needleless Access Device. Both the subject and predicatedevice have infusion tubing with ISO compatible luers connections with theexception that the subject device has a cannula on the distal end of thedevice. Differences do not raise any new questions regarding safety andeffectiveness. Accepted scientific methods such as, performance (bench)testing do exist for assessing the effect of the differences in characteristics. | |
| The Bard Extension Set met the bench performance testing requirements ofthe following standards where applicable in conjunction with in-houseprotocols which were used to determine appropriate methods for evaluatingthe performance of the device:ISO 8536-4:2007 :- Infusion equipment for medical use - Part 4:Infusion sets for single use, gravity feed ISO 594-1:1986 :- Conical Fittings with a 6 % (Luer) Taper forSyringes, Needles and Certain Other Medical Equipment - Part 1:General Requirements ISO 594-2:1998 :- Conical Fittings with a 6 % (Luer) Taper forSyringes, Needles and Certain Other Medical Equipment - Part 2:Lock Fittings Guidance for Industry and FDA Review Staff - IntravascularAdministration Sets Premarket Notification Submissions [510(k)],dated April 15, 2005 | ||
| Summary ofNonclincalTesting | Risk management, including a failure modes and effects analysis (FMEA), ofthe subject device was conducted in accordance with ISO 14971:2009,Medical Devices - Risk Management for Medical Devices. No new types ofsafety or efficacy questions were identified for the subject Bard Extension Set.Biocompatibility assessment was conducted on the Bard Extension Set basedon the guidelines presented in blue book memorandum #G95-1 entitled "Useof International Standard ISO-10993, "Biological Evaluation of MedicalDevices Part-1: Evaluation and Testing and ISO 10993-1:2009 - BiologicalEvaluation of Medical Devices Part-1: Evaluation and Testing.The sterility of the Bard Extension Set is assured by using a validatedsterilization method qualified in accordance with ISO 11135-1:2007 :-Sterilization of Healthcare products - Ethylene Oxide- Part 1: Requirementsfor Development, Validation and Routine Control of a Sterilization Process forMedical Devices to a sterility assurance level (SAL) of 10-6. Ethylene Oxideresidual levels resulting from EtO Sterilization are in compliance with ISO10993-7:2008 - Biological Evaluation of Medical Devices- Part 7: EthyleneOxide Sterilization Residuals. The Bard Extension is also tested forpyrogenicity. |
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Summary of Verification Activities
| Summary Results of Verification Testing | |
|---|---|
| Evaluation | Predetermined Acceptance Criteria |
| Assembly Leak | No leaks at 43.5 psi minimum (air methodused) |
| Gravity Flow | 750 ml/hr minimum |
| Priming Volume | NA, test and report results |
| Assembly Tensile | Must withstand an axial, static tensile forceof 15 N (3.37 lbs) for 15 seconds |
| ISO 594 - 1 & 2 LuerTesting | Must pass acceptance criteria outlined inISO 594-1 and -2. |
| Aspiration Flow | NA, test and report results |
Summary of Substantial Equivalence
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Based on the indications for use, technological characteristics, and safety and performance testing, the subject Bard Extension Set met the requirements for its intended use/indications for use and is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available predicate infusion set.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Lynn M. Kirchoff Regulatory Affairs Manager C.R. Bard, Incorporated 605 North 5600 West Salt Lake City, Utah 84116
JUL 21 2011
Re: K102405
Trade/Device Name: Extension Set for Bard Proximally Valved Catheters Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: June 27, 2011 Received: June 29, 2011
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 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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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. 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 (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), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDR H/CDRHOffices/ucm1 1.5809.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.
Antmony D. Orona
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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Indications for Use
510(k) Number (if known):
Device Name:
Extension Set for Bard® Proximally Valved Catheters
Indications for Use:
An extension set to be used as an extension to the intravascular administration set used for fluid delivery through Bard® proximally valved catheters. The extension set will connect the IV administration set to the catheter.
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 IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Richard C. Chayen 7/21/11
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K102405
32
§ 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.