(49 days)
This device is intended to be used as a needless injection port that can be attre hed to any standard luer connector. It is a single patient use device that has an access port that can be swabbed and accessed multiple times.
The Filtertek NFC Needlefree Connector is a one-piece design. luer interfacing injection port. It is sterile, nonpyroqenic and packaged in a Tyvek/polyethylene form, fill, and seal package. The materials used to manufacture the Filtertek NFC Needlefree Connector have been tested per tripartite guidelines and are safe for their intended use.
This document is a 510(k) summary for the "Filtertek NFC Needlefree Connector". It outlines the device's intended use and claims substantial equivalence to existing devices.
Here's an analysis based on the provided text, focusing on the requested acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from predicates and general device safety) | Reported Device Performance (from text) |
|---|---|
| Maintain line patency throughout labeled duration of use | "The closure has been tested and has been found to maintain line patency throughout the labeled duration of use." |
| Sterile and nonpyrogenic | "It is sterile, nonpyrogenic..." |
| Materials safe for intended use | "The materials used to manufacture the Filtertek NFC Needlefree Connector have been tested per tripartite guidelines and are safe for their intended use." |
| Sterilization Assurance Level (SAL) of 10^-6 | "The Filtertek NFC Needlefree Connector is sterilized per AAMI quidelines to a 10-6 sterility assurance level." |
| Absence of bacterial endotoxins | "Each production lot is LAL tested per USP guidelines." |
| Substantially equivalent to predicate devices | "The indicated use of the NFC Needlefree Connector is the same or the equivalent of the predicate device named in this submission." |
2. Sample size used for the test set and the data provenance
The document does not explicitly mention a test set sample size or specific data provenance (e.g., country of origin, retrospective/prospective) for validating the performance criteria. The statements regarding performance are general assertions without specific study details.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The filing focuses on substantial equivalence based on design, materials, and established testing guidelines rather than clinical expert evaluation for establishing ground truth for a new, independent test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Given the nature of the device (a needlefree connector) and the type of submission (510(k) for substantial equivalence), a formal adjudication process akin to imaging algorithm validation is not detailed.
5. 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
No. This document describes a medical device (a needlefree connector), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This device is a physical medical component, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's safety and effectiveness is primarily based on:
- Compliance with established industry guidelines and standards: e.g., AAMI guidelines for sterilization, USP guidelines for LAL testing, tripartite guidelines for material safety.
- Demonstrated performance in laboratory tests: "The closure has been tested and has been found to maintain line patency..."
- Substantial equivalence to legally marketed predicate devices: The document repeatedly asserts equivalence to existing devices (Douglas Medical Products Maxcess™ Connector and ICU Medical, Inc Clave™ Connector). The "ground truth" for the predicate devices' safety and effectiveness would have been established through their own regulatory pathways.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. (See point 8).
Summary of Study Type:
This 510(k) filing presents a declaration of substantial equivalence rather than a detailed report of a single, comprehensive clinical or performance study. The "study" here refers to the collection of evidence demonstrating that the device meets safety and effectiveness criteria through adherence to established standards and comparison to predicate devices. The evidence includes:
- Material testing: "tested per tripartite guidelines."
- Functionality testing: "closure has been tested and has been found to maintain line patency."
- Sterilization validation: "sterilized per AAMI quidelines to a 10-6 sterility assurance level."
- Endotoxin testing: "LAL tested per USP guidelines."
These tests and validations are typically performed to demonstrate that the new device performs as expected and is as safe and effective as its predicate counterparts. Specific numerical results, sample sizes for these tests, or expert involvement beyond standard regulatory review are not detailed in this summary.
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JUN 1 8 1998
June 11, 1998
SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act and CFR 807.92.
Trade Name: NFC Needlefree Connector Common Name: Needless injection port or needlefree injection site Classification Name: Intravascular Administration Set
The Filtertek NFC Needlefree Connector is intended to be used as a needleless injection port that can be attached to a luer lock connector. It is intended for single patient use and can be swabbed and then accessed multiple times. The closure has been tested and has been found to maintain line patency throughout the labeled duration of use.
The Filtertek NFC Needlefree Connector is a one-piece design. luer interfacing injection port. It is sterile, nonpyroqenic and packaged in a Tyvek/polyethylene form, fill, and seal package. The materials used to manufacture the Filtertek NFC Needlefree Connector have been tested per tripartite guidelines and are safe for their intended use. The indicated use of the NFC Needlefree Connector is the same or the equivalent of the predicate device named in this submission. The named predicate devices in this submission are Douglas Medical products Maxcess™ Connector currently marketed by Douglas Medical Products under 510(k) #K960661, and the Clave™ Connector currently marketed by ICU Medical, Inc under 510(k) #K915571. The Filtertek NFC Needlefree Connector is sterilized per AAMI quidelines to a 108 sterility assurance level. Each production lot is LAL tested per USP guidelines.
Based on the fact that the Filtertek NFC Connector utilizes similar and equivalent designs and materials as currently legally marketed products, it is safe and effective when used as intended.
By:
Larry Larkin Requlatory Affairs Administrator
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 8 1998
Mr. Larry Larkin 'Requlatory Affairs Administrator Filtertek, Incorporated 11411 Price Road P.O. Box 310 Hebron, Illinois 60034
K981548 Re : Trade Name: NFC Needlefree Connector Model 69960 Regulatory Class: II Product Code: FPA Dated: April 17, 1998 Received: April 30, 1998
Dear Mr. Larkin:
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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 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 through 542 of
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Page 2 - Mr. Larkin
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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 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,
Timothy A. Ulatowski
Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(K) Number (if known): To be assigned
Device Name: NFC Needlefree Connector
Indications For Use:
This device is intended to be used as a needless injection port that can be attre hed to any standard luer connector. It is a single patient use device that has an access port that can be swabbed and accessed multiple times.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device evaluation (ODE)
(Division Sign-Off) 3. Both Division of Dental, Infection of Dental, Infection Control, and General Hospital Devices 510(k) Number_K9Q154 Y
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.