(49 days)
The SA.ER Multi-Lumen Extension Sets are to be used for the intravascular The SA.ER Multi-Lumen Extension Sets are to be used Icro the intravascular system.
SA.EF Multi-Lumen Extension Set
The provided document is a 510(k) clearance letter from the FDA for a medical device called the "SA.EF Multi-Lumen Extension Set." This letter states that the device is "substantially equivalent" to predicate devices, meaning it doesn't require new clinical studies to prove safety and effectiveness.
Therefore, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way that would be applicable to a new, non-substantially equivalent device or an artificial intelligence/machine learning (AI/ML) device.
The questions you've asked are typically relevant for new devices requiring clinical trials or for AI/ML-driven medical devices that need to demonstrate their performance against a defined ground truth. Since this is a 510(k) clearance based on substantial equivalence, those types of detailed studies, acceptance criteria, and performance metrics are not included in this regulatory document.
However, based on the general information provided, I can state the following regarding your questions, noting that much of the information you requested would not be present in a 510(k) clearance letter:
- A table of acceptance criteria and the reported device performance: Not applicable. The document establishes substantial equivalence, not performance against specific, new acceptance criteria. No performance data is reported.
- Sample size used for the test set and the data provenance: Not applicable. No test set or clinical study data is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment occurred as part of this 510(k) submission.
- 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 a physical medical device, not an AI/ML algorithm.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Vincent L. Vaillancourt President VLV Associates, Incorporated 30-C Ridgedale Avenue East Hanover, New Jersey 07936
SEP 2 9 1997
Re: K972957 SA.EF Multi-Lumen Extension Set Trade Name: Requlatory Class: II Product Code: FPA Dated: August 8, 1997 Received: August 11, 1997
Dear Mr. Vaillancourt:
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 The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, 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
{1}------------------------------------------------
Page 2 - Mr. Vaillancourt
through 542 of the Act for devices under the Electronic Product Radiation Control 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 requlation (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,
U. Alatoush
Timothy A. Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
510(K) Number (if known): K972957
SA.EF Multi-Lumen Extension Set Device Name:
Indications for Use:
The SA.ER Multi-Lumen Extension Sets are to be used for the intravascular The SA.ER Multi-Lumen Extension Sets are to be used Icro the intravascular system.
| ference of CDHR, Office of Device Evaluation (ODE) | |
|---|---|
| -- | ---------------------------------------------------- |
(Division Sign-Off)
| Division of Dental Infection Control, | |
|---|---|
| spital Devices | |
| Number | K972957 |
| Prescription Use: | YES |
| (Per 21 CFR 801.109) | OR Over-The-Counter Use: N/A |
§ 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.