(49 days)
None
Not Found
No
The summary describes a simple medical device (extension set) and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is described as an "Extension Set" for the intravascular system, which suggests it is a component used for delivering substances or taking measurements, rather than directly treating a disease or condition itself. Therapeutic devices are typically those that provide treatment or therapy.
No
The provided text states the device is "to be used for the intravascular system" and describes it as an "Extension Set," which suggests it's for fluid delivery or access rather than diagnosing medical conditions. There is no mention of diagnostic functions.
No
The device description clearly states "Multi-Lumen Extension Set," which is a physical hardware component used in intravascular systems. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the intravascular system." This indicates the device is used within the body, not for testing samples taken from the body.
- Device Description: The description "SA.EF Multi-Lumen Extension Set" suggests a physical device used for fluid delivery or management within the vascular system.
- Lack of IVD Indicators: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's intended use and description do not align with that purpose.
N/A
Intended Use / 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.
Product codes
FPA
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intravascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 |