(255 days)
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.
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.
This submission describes a medical device, a Luer Access Injection Site, and its equivalence to a predicate device. It is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence, not necessarily on detailing rigorous clinical studies with acceptance criteria in the same way a PMA (Premarket Approval) might.
Based on the provided text, here's a breakdown of the requested information, noting what is available and what is not available in this specific document:
Description of the Acceptance Criteria and Study to Prove Device Meets Criteria
The document reports that "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." However, the specific acceptance criteria and detailed study results are not provided in this summary. The submission focuses on substantial equivalence to a predicate device, the ICU Medical Inc. Clave™ Needleless Connector.
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document states that testing was conducted and met requirements, but does not enumerate the specific criteria or the quantitative results against those criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided text. The document mentions "performance testing" and "microbiological evaluations" were conducted, but does not specify sample sizes or the origin of the data. Given the nature of a 510(k) for a device like this, it's highly likely the testing was conducted in a laboratory setting, not with human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and their Qualifications
Not applicable/Not available for this type of device and submission. The testing described (functional and microbiological) would involve laboratory measurements and standards, not human expert interpretation of data or images.
4. Adjudication Method for the Test Set
Not applicable/Not available. As mentioned above, the testing for this type of device does not involve human expert adjudication in the context of clinical interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, not done or not reported. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., medical images). The Luer Access Injection Site is a physical medical device for fluid administration and blood sampling, and its evaluation focuses on functional performance and microbiological integrity, not human interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance assessment was done. The document describes "performance testing" and "microbiological evaluations" conducted on the device itself. This refers to the device's inherent function, independent of a human operator's interpretative skills.
7. The Type of Ground Truth Used
For the performance testing, the "ground truth" would be established by validated laboratory methodologies and industry standards for functional performance (e.g., fluid flow, resealing efficacy, luer compatibility) and microbiological integrity (e.g., sterility, microbial ingress prevention). The document mentions "functional and microbiological requirements," implying a comparison against established benchmarks for these types of devices.
8. The Sample Size for the Training Set
Not applicable/Not available. This device is a physical medical component, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing process would involve engineering specifications and quality control, but not a data-driven training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not available. As there is no AI/ML training set, the concept of establishing ground truth for it does not apply.
{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.
{3}------------------------------------------------
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
§ 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.