(64 days)
The V3 Valve is a passive anti-needlestick device designed to provide aspiration, injection, or gravity flow of fluids upon insertion of a mate luer-lock fitting.
The V3 Valve is a passive anti-needlestick device designed to provide aspiration, injection, or gravity flow of fluids upon insertion of a male luer-lock fitting.
The provided text describes a 510(k) submission for the "V3 Valve," an intravascular administration set. This submission aims to demonstrate substantial equivalence to previously marketed devices rather than presenting a study with specific acceptance criteria and performance data in the typical sense of a clinical trial for an AI/diagnostic device.
Therefore, many of the requested elements (like acceptance criteria for a study, sample sizes, expert qualifications, MRMC studies, standalone performance, training sets, etc.) are not applicable or not provided in this type of regulatory document.
However, I can extract information related to the device and its intended use, as well as the basis for its safety and effectiveness claims within the context of substantial equivalence.
Here's a breakdown of the available information:
Acceptance Criteria and Device Performance
Since this is a 510(k) submission for a non-AI/diagnostic device, the concept of "acceptance criteria" and "reported device performance" in the typical sense of metrics like sensitivity, specificity, or AUC is not applicable. Instead, the "acceptance criteria" are compliance with established testing procedures and parameters that conform to product design specifications, as detailed for safety and effectiveness.
| Acceptance Criteria (related to device requirements) | Reported Device Performance (as claimed by manufacturer) |
|---|---|
| Material suitability (in accordance with ISO 10993) | Determined to be suitable for intended use |
| Conformity to product design specifications | Met all required release specifications |
| Compliance with Quality Control Test Procedure documents | All finished products tested and meet specifications |
| Physical testing requirements | Satisfied through established testing procedures |
| Visual examination (in-process and finished product) | Performed |
| Substantial equivalence to predicate devices (K941679, K955585) | V3 Valve is equivalent in materials, form, and intended use; no new issues of safety or effectiveness raised. |
| Compliance with general control provisions of the Act (e.g., annual registration, listing, GMP, labeling) | Assumed for marketing approval |
Study Information (Not Applicable/Provided for AI/Diagnostic Devices)
- Sample size used for the test set and the data provenance: Not applicable. This document describes a medical device (valve), not an AI/diagnostic algorithm that would have test sets. The "testing" refers to manufacturing quality control.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the clinical diagnostic sense is established for this device.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" refers to product design specifications, material standards (ISO 10993), and quality control procedures.
- The sample size for the training set: Not applicable. No training set is involved.
- How the ground truth for the training set was established: Not applicable.
Additional Context from the Document:
- Device Name: V3 Valve
- Trade Name: Intravascular Administration Set
- Classification: General Hospital Class II, 80 FPA, Intravascular Administration Set (21 CFR 880.5860)
- Intended Use: "The V3 Valve is a passive anti-needlestick device designed to provide aspiration, injection, or gravity flow of fluids upon insertion of a male luer-lock fitting."
- Predicate Devices:
- Basis for Safety and Effectiveness (as claimed by manufacturer):
- Materials tested in accordance with ISO 10993.
- All finished products are tested against required release specifications, including physical testing and visual examination.
- Physical testing is defined by Quality Control Test Procedure documents that conform to product design specifications.
- Substantial equivalence in materials, form, and intended use to predicate devices, with no new issues of safety or effectiveness raised.
The FDA's letter (JAN - 6 1998) confirms that the device was found "substantially equivalent" for the stated indications for use, allowing it to be marketed. This determination implies that the provided information (including the safety and effectiveness claims based on material testing and quality control) was sufficient for regulatory approval under the 510(k) pathway.
{0}------------------------------------------------
KG 74145
JAN
II. 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90
October 30, 1997 B. Braun Medical, Inc 824 Twelfth Avenue Bethlehem, PA 18018 (610)691-5400
CONTACT: Mark S. Alsberge, Regulatory Affairs Director
PRODUCT NAME: V3 Valve
TRADE NAME: Intravascular Administration Set
CLASSIFICATION NAME:
General Hospital Class II, 80 FPA, Intravascular Administration Set 21 CFR 880.5860
SUBSTANTIAL EQUIVALENCE, TO:
| 510 (k) number | Name | Applicant |
|---|---|---|
| K941679 | Bionector | Vygon Corporation |
| K955585 | V2 Injection Site | B. Braun Medical |
DEVICE DESCRIPTION:
In accordance with section 510 (k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce the V3 Valve. The V3 Valve is a passive anti-needlestick device designed to provide aspiration, injection, or gravity flow of fluids upon insertion of a male luer-lock fitting.
1 The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view.
{1}------------------------------------------------
The term "substantially equivalent" is not applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product.
MATERIAL :
The V3 Valve is composed of materials that have been tested in accordance with ISO 10993 and determined to be suitable for the intended use of this product.
SUBSTANTIAL EQUIVALENCE:
The V3 Valve is equivalent in materials, form, and intended use to our V2 Injection Site currently marketed by B. Braun Medical and covered under K955585. The design of our V3 Valve is very similar to the Bionector Valve marketed by Vygon and covered under K941679. We have included two samples of our V3 Valve and the Bionector Valve by Vygon. There are no new issues of safety or effectiveness raised by the V3 Valve.
SAFETY AND EFFECTIVENESS:
All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product).
The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications.
The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP"s.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 6 1998
Mr. Mark S. Alsberge Requlatory Affairs Director B. Braun Medical, Incorporated 824 Twelfth Avenue 18018 Bethlehem, Pennsylvania
K974145 Re : V3 Valve Trade Name: Regulatory Class: II Product Code: FPA Dated: October 30, 1997 November 3, 1997 Received:
Dear Mr. Alsberge:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
{3}------------------------------------------------
Page 2 - Mr. Alsberge
through 542 of the Act for devices under the Electronic enrough 542 or eno noorol provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Directdr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
510(k) Number (if known):
Valve Device Name:
Indications For Use:
The V3 Valve is a passive anti-needlestick
device designed to provide aspiration, injection, or
gravity flow of fluids upon insertion of a mate
luer-lock fitting.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricia Crescenite
(Division Sign-Off) Division of Dental, Infection Contr and General Hospital D 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.