(25 days)
Not Found
Not Found
No
The summary describes a standard IV fluid administration set with a safety feature for needlestick prevention. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is used for the administration of I.V. fluids to a patient's vascular system, which is a therapeutic intervention.
No
The device is described as being for the administration of I.V. fluids, which is a treatment or therapy, not a diagnostic process.
No
The description clearly indicates the device is for administering I.V. fluids and has a safety feature to prevent needlestick injuries. This implies a physical device (like an IV set with a safety mechanism), not a software-only product.
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 administration of I.V. fluids directly into a patient's vascular system. This is an in vivo (within a living organism) procedure, not an in vitro (outside of a living organism) diagnostic test.
- Device Description: While the description is "Not Found," the intended use clearly points to a device used for direct patient treatment/administration, not for analyzing samples outside the body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing diagnostic tests, or providing information for diagnosis.
Therefore, this device is a medical device used for therapeutic administration, not an IVD.
N/A
Intended Use / Indications for Use
For administration of I.V. fluids from a container to a patient's vascular system. The safety feature of this device aids in the prevention of needlestick injuries.
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
vascular 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized human profiles facing right, stacked on top of each other. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
JAN 2 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
·Mr. Thomas P. Sampogna Acting Director Abbott Laboratories Hospital Products Division D-389K, Bldg J-45 200 Abbott Park Road Abbott Park, Illinois 60064-6133
Re: K030002
Trade/Device Name: Lifeshield Primary IV Set Convertible Pin with Clave L12591 and L12592, L12589, L12593, L12590 Regulation Number: 880.5440 Regulation Name: Intravascular Administration Regulatory Class: II Product Code: FPA Dated: December 31, 2002 Received: January 2, 2003
Dear Mr. Sampogna:
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 such 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 - Mr. Sampogna
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Susan Rnares
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Eyaluation Center for Devices and Radiological Health
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Indications for Use Statement
| 510(k) Number (If known) | |
|---|---|
| Device Name: | Lifeshield Primary IV Set Convertible Pin with Clave L12591 and L12592, L12589, L12593, L12590 |
| Indications For Use: | For administration of I.V. fluids from a container to a patient's vascular system. The safety feature of this device aids in the prevention of needlestick injuries. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------ | -- |
OR
| Over-The Counter Use | |
|---|---|
| ---------------------- | -- |
Patricio Crucente(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number. K030002