(255 days)
No
The device description and intended use are purely mechanical/passive, and there is no mention of AI, ML, or any computational processing.
No.
The device is described as a luer access injection site used for fluid administration and blood sampling, primarily as a needleless connector and a heparin lock, which facilitates medical procedures rather than directly treating a disease or condition.
No
The device is described as a luer access injection site used for fluid administration and blood sampling, as well as a heparin lock. Its purpose is to facilitate needleless access to the vascular path, not to diagnose a condition.
No
The device description clearly states it is a physical luer access injection site consisting of a septum and housing, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for fluid administration and blood sampling through a vascular access device. This is a direct interaction with the patient's circulatory system for therapeutic or diagnostic sample collection purposes, not for testing samples in vitro (outside the body).
- Device Description: The device is a luer access injection site, a physical connector for accessing a vascular path. It doesn't contain reagents, assays, or components designed for analyzing biological samples.
- Lack of IVD Characteristics: The description doesn't mention any analytical function, measurement of analytes, or diagnostic interpretation of results. The performance studies focus on functional and microbiological requirements, not diagnostic accuracy.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device facilitates the collection of a sample, but it doesn't perform the diagnostic test on that sample.
N/A
Intended Use / Indications for Use
The proposed luer access injection site and sets incorporating it will be used with a vascular access device for fluid administration and blood sampling. The luer access injection site can be connected to male luer adapters, (e.g., syringes or sets) to allow needleless access to the vascular path. This device is for use as part of a program to reduce needle-stick injuries and the associated transmission of blood borne pathogens.
Product codes
FPA
Device Description
The subject of this submission is a luer access injection site which will be marketed as a stand-alone device for use as a heparin lock and will also be incorporated into currently marketed solution sets. The proposed injection site consists of a pre-slit synthetic polyisoprene septum and a polyester housing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Performance testing of the proposed luer access injection site has been conducted including microbiological evaluations. A description of the testing along with test results has been provided. All data indicate that the proposed device meets or exceeds all functional and microbiological requirements and thus support its suitability for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ICU Medical Inc. Clave™ Needleless Connector, K970855
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
510(k) Premarket Notification Luer Access Injection Site
JUL 26 1999
510(k) Summary
. ...
Luer Access Injection Site
Submitted by:
Mary Ellen Snyder Senior Manager, Regulatory Affairs Baxter Healthcare Corporation I.V. Systems Division Rt. 120 and Wilson Road Round Lake, IL 60073
Date Prepared:
November 12, 1998
Proposed Device:
Luer Access Injection Site
Predicate Device:
ICU Medical Inc. Clave™ Needleless Connector
Proposed Device Description:
The subject of this submission is a luer access injection site which will be marketed as a stand-alone device for use as a heparin lock and will also be incorporated into currently marketed solution sets. The proposed injection site consists of a pre-slit synthetic polyisoprene septum and a polyester housing.
Statement of Intended Use
The proposed luer access injection site and sets incorporating it will be used with a vascular access device for fluid administration and blood sampling. The luer access injection site can be connected to male luer adapters e.g., syringes or sets, to allow needleless access to the vascular path. This device is for use as part of a program to reduce needle-stick injuries and the associated transmission of blood borne pathogens.
1
Summary of Technological Characteristics of New Device to Predicate Devices
The proposed luer access injection site is similar to the currently marketed ICU Medical Inc. Clave" Needleless Connector, cleared under K970855 and K915571. Both devices are injection ports activated by male luer connectors to allow needleless access to the fluid or vascular path. One key difference between the proposed luer access injection site and the Clave" Connector is the method of operation. The proposed injection site contains a preslit septum which is opened with insertion of a male luer adapter. The septum reseals when the male luer is removed. The Clave™ Connector contains a silicone seal which is depressed, with insertion of the male luer, below the openings of an internal plastic conduit, permitting fluid flow. With disconnection of the silicone seal springs back above the conduit, resealing it and stopping fluid flow. There are no new materials involved in the proposed device. All solution contact materials to be used in the proposed device are identical to materials used in legally marketed devices under comparable conditions of use.
Discussion of Nonclinical Tests and Referenced Studies Reported in Published Literature
Performance testing of the proposed luer access injection site has been conducted including microbiological evaluations. A description of the testing along with test results has been provided. All data indicate that the proposed device meets or exceeds all functional and microbiological requirements and thus support its suitability for use.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design of a human figure with three flowing lines representing the body and head. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA", which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 26 1999
Ms. Mary Ellen Snyder Senior Manager, Regulatory Affairs Baxter Healthcare Corporation I.V. Systems Division Route 120 and Wilson Road Round Lake, Illinois 60073-0490
Re: K984060 Luer Access Injection Site Trade Name: Requlatory Class: II Product Code: FPA Dated: June 23, 1999 Received: June 24, 1999
Dear Ms. Snyder:
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 Requlations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Snyder
Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note ene 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
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use
510(k) Number: Not Available
Device Name: Luer Access Injection Site
Indication for Use: The proposed luer access injection site and sets incorporating it will be used with a vascular access device for fluid administration and blood sampling. The luer access injection site can be connected to male luer adapters, (e.g., syringes or sets) to allow needleless access to the vascular path. This device is for use as part of a program to reduce needle-stick injuries and the associated transmission of blood borne pathogens.
Verl Huband for Pat Cincinti
Prescription Use.
(Per 21 CFR 801. 109)
s:كا10k\ladelect.doc