(49 days)
Not Found
No
The summary describes a mechanical needleless connector and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
Explanation: The device is described as a "needless injection port" and a "luer interfacing injection port," intended for accessing standard luer connectors. Its function is to facilitate access rather than directly treat or diagnose a medical condition.
No
Explanation: The device is described as a "needless injection port" and a "luer interfacing injection port" used for accessing standard luer connectors. Its function is to facilitate multiple access to a port, not to diagnose a condition or disease.
No
The device description clearly indicates a physical, hardware-based medical device (needless injection port) made of materials and packaged in a physical form. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a "needless injection port that can be attached to any standard luer connector." This is a device used for administering fluids or medications directly into a patient's bloodstream or other body cavity.
- Device Description: The description reinforces its function as an "injection port" and mentions it's sterile and nonpyrogenic, which are characteristics of devices used for direct patient contact.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are specifically designed to perform tests on samples taken from the human body. This device is designed for direct patient access and fluid delivery.
N/A
Intended Use / Indications for Use
"...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."
"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."
Product codes
FPA
Device Description
"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."
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)
"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 sterilized per AAMI quidelines to a 108 sterility assurance level. Each production lot is LAL tested per USP guidelines."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
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)