(172 days)
The A6 Luer Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. The A6 Luer Access Device may be used with power injectors at a maximum pressure of 300 psi and a maximum flow rate of 10 mL/sec.
B. Braun's A6 Luer Access Device is a positive displacement valve intended to provide needle-free access to IV gravity sets, pump sets and extension sets for the administration of IV fluids and blood. The piston/valve assembly of the A6 is a 3-piece assembly containing an elastomeric piston with a pre-slit septum, which is housed within a clear, rigid body. The A6 requires swabbing to disinfect prior to insertion of a male Luer connector. The A6 Luer Access Device may be used with power injectors at a maximum pressure of 300 psi and a maximum flow rate of 10 mL/sec. The A6 is individually packaged and is supplied as a sterile, non-pyrogenie, single use, disposable device.
The provided document, K083723, is a 510(k) Pre-Market Notification for the B. Braun Medical Inc. A6 Luer Access Device. It describes the device, its intended use, and claims substantial equivalence to a predicate device. This document is a regulatory submission for a medical device and does not contain a study that proves the device meets specific acceptance criteria in the way that an AI algorithm's performance would be evaluated.
Instead, the submission demonstrates substantial equivalence through a variety of tests. For a device like the A6 Luer Access Device (a physical medical device, not an AI algorithm), "acceptance criteria" are typically defined by recognized standards and internal company specifications for product performance, safety, and effectiveness. The "study" refers to the battery of tests conducted to ensure these criteria are met and to prove substantial equivalence to a predicate device.
Given this context, I will interpret your request to describe the tests conducted and their outcomes as they relate to the "acceptance criteria" for this physical device. Many of your specific points (e.g., sample sizes for test sets in AI, ground truth establishment, expert qualifications, MRMC studies) are not applicable to the type of device and regulatory submission presented in the text.
Here's an interpretation based on the provided text for the A6 Luer Access Device:
Description of Acceptance Criteria and Substantiating "Study" for the A6 Luer Access Device
Since the A6 Luer Access Device is a physical medical device and not an AI algorithm, the concept of "acceptance criteria" and "study" differs from an AI performance evaluation. The submission demonstrates substantial equivalence to a predicate device by meeting various performance, safety, and effectiveness standards through a series of tests.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table with specific numerical acceptance criteria. Instead, it states that the device was subjected to various tests to demonstrate substantial equivalence and verify safe and effective use. The "reported device performance" generally means that the device successfully passed these tests, indicating it met the implicit or explicit performance criteria for each test according to relevant standards or internal specifications.
| Test Category | Implied Acceptance Criteria (Based on typical medical device standards) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Device materials are non-toxic and do not cause adverse biological reactions. | Testing demonstrated compliance, implying no new safety issues relative to predicate. |
| Package Integrity | Packaging maintains sterility and protects the device from damage. | Testing demonstrated compliance. |
| Shipping | Device and packaging withstand shipping stresses without compromise. | Testing demonstrated compliance. |
| Microbial Ingress Challenge | Device prevents microbial entry when accessed and after multiple connections. | Testing demonstrated compliance, ensuring infection control. |
| Performance Tests | Fluid Flow: Handles IV fluid/blood aspiration, injection, gravity/pump flow appropriately.Pressure Resistance: Withstands power injector pressures up to 300 psi.Flow Rate: Maintains flow rates up to 10 mL/sec with power injectors.Luer Compatibility: Ensures proper connection with male Luer connectors. | Testing verified safe and effective use, including specified pressure and flow rate capabilities with power injectors. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (e.g., number of units tested) for each individual test. For a physical device, testing typically involves a statistically relevant number of units to ensure reliability. The data provenance is internal to B. Braun Medical Inc. and is generated through prospective testing conducted by the company or its contractors. No information on country of origin for data is provided, but it's implied to be U.S. based on the applicant's location.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not applicable here. "Ground truth" for physical device testing is established through standardized test methods, calibrated equipment, and objective measurements (e.g., pressure gauges, flow meters, bacterial culture results). Expert opinion might be involved in designing the test protocols or interpreting complex results, but it's not "ground truth" in the AI sense.
4. Adjudication Method for the Test Set
This concept is not applicable here. Performance is determined by objective measurements against predefined pass/fail criteria for each test, not by human adjudication of qualitative results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is relevant to imaging diagnostics or AI algorithms where human readers interpret cases. For a luer access device, comparative effectiveness is shown by demonstrating equivalent functional performance and safety as a predicate device through engineering and biological testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This concept is not applicable as the A6 Luer Access Device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests conducted on the A6 Luer Access Device is established through:
- Standardized Test Methods: Adherence to recognized industry standards (e.g., ISO, ASTM) for medical device performance and safety testing.
- Objective Measurements: Using calibrated instruments to measure parameters like pressure, flow rate, and sterility.
- Biological Endpoints: For biocompatibility and microbial ingress, "ground truth" is determined by established biological safety criteria and microbiological methods.
8. The Sample Size for the Training Set
This concept is not applicable. There is no "training set" for a physical medical device in the context of an AI algorithm. The device is designed, manufactured, and then tested to ensure it meets specifications.
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable as there is no training set. The design specifications and performance requirements for the device are driven by medical necessity, regulatory standards, and the performance characteristics of predicate devices.
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JUN - 5 2009
Page
510(k) SUMMARY
APPLICANT/ SUBMITTER:
CONTACT:
B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109-9341 610-266-0500
Bonnie J. Kincaid, RAC Manager, Regulatory Affairs Phone: 610-596-2970 Fax: 610-266-4962
A6 Luer Access Device
DEVICE NAME:
COMMON OR USUAL NAME:
Needle-free Access Device / Injection Site
DEVICE CLASSIFICATION:
PREDICATE DEVICES:
DESCRIPTION:
Class II per 21 CFR 8880.5440, Intravascular Administration Set, Product Code: FPA
B. Braun Medical Inc. Ultrasite® Valve [for use with power injectors (K031923), previously known as B. Braun Medical Inc. V2 Injection Site (K955585)]
B. Braun's A6 Luer Access Device is a positive displacement valve intended to provide needle-free access to IV gravity sets, pump sets and extension sets for the administration of IV fluids and blood. The piston/valve assembly of the A6 is a 3-piece assembly containing an elastomeric piston with a pre-slit septum, which is housed within a clear, rigid body. The A6 requires swabbing to disinfect prior to insertion of a male Luer connector.
The A6 Luer Access Device may be used with power injectors at a maximum pressure of 300 psi and a maximum flow rate of 10 mL/sec. The A6 is individually packaged and is supplied as a sterile, non-pyrogenie, single use, disposable device.
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510(k) SUMMARY (continued)
INTENDED USE:
The A6 Luer Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. The A6 Luer Access Device may be used with power injectors at a maximum pressure of 300 psi and a maximum flow rate of 10 mL/sec.
Page
SUBSTANTIAL EQUIVALENCE:
The A6 Luer Access Device has the same intended use and function as the predicate device and is similar to the predicate device in design and materials. Both the proposed and predicate devices are needle-free access devices intended for use in IV therapy. The proposed A6 device and the predicate device are sterile, single use adapters that are used as injection sites when accessed by attaching a male Luer connector to the device. Both the proposed and predicate devices provide needle-free injection sites by means of a positive displacement piston/valve mechanism. Both the proposed and predicate devices may be used with power injectors.
The A6 device was subjected to a variety of tests to demonstrate substantial equivalence with the predicate device, including biocompatibility, package integrity, shipping, microbial ingress challenge and a number of performance tests to verify the safe and effective use of the device. This testing demonstrates that there are no differences between the predicate and the proposed device that raise new issues of safety or effectiveness
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 5 2009
Ms. Bonnie J. Kincaid, RAC Manager, Regulatory Affairs B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109-9341
Re: K083723
Trade/Device Name: A6 Luer Access Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: May 28, 2009 Received: June 2, 2009
Dear Ms. Kincaid:
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 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. Kincaid
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/cdrh/comp/ 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/cdrl/mdr/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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Antimony V. anakafer
Susan Runner, D.D.S., MA Acting Division 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 STATEMENT
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Indications for Use:
The A6 Luer Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. The A6 Luer Access Device may be used with power injectors at a maximum pressure of 300 psi and a maximum flow rate of 10 mL/sec.
Prescription Use (Per 21 CFR 801.109) OR
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)
Legal Music for Leor. Colburn 06/05/09
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K08:3723 :
§ 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.