(12 days)
Not Found
Not Found
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, or any computational processing.
No
The device is described as a cap for luer ports on medical devices, designed to cover or replace existing port caps. Its function is to seal ports, not to treat or diagnose a medical condition.
No
The device is a cap for luer ports on medical devices, used to cover open ports. Its intended use and description do not mention any diagnostic function, rather it is a protective component.
No
The device description clearly states it is a "sterile Dual Luer Lock Cap" and describes its physical components and function as a cap for luer ports, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to cap luer ports on medical devices. This is a mechanical function related to maintaining sterility and preventing leakage, not for performing tests on samples taken from the human body.
- Device Description: The description focuses on the physical design and function of the cap for covering luer ports. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic, prognostic, or screening information
- Using reagents or assays
- Measuring analytes
The device is a sterile cap for medical device ports, which falls under the category of general medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Dual Luer Lock Cap is intended for use as a cap for male or female luer ports on medical devices such as manifolds, stopcocks or sets.
Product codes
FPA
Device Description
The subject of this submission is a sterile Dual Luer Lock Cap which will be used to cover male or female luer ports on medical devices. The proposed Dual Luer Lock Cap will replace the existing port cap on a number of currently marketed Baxter devices such as sets, stopcocks and manifolds. It will also be sold individually as a replacement cap to cover an open luer port after it has been accessed and is no longer in use. The Dual Luer Lock Cap consists of an integrated design with a male luer lock connection on one end and a female luer lock connection on the other end.
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)
Data regarding the functional performance of the proposed Dual Luer Lock Cap have been generated. A description of the functional testing along with test results has been provided. The data indicate that the proposed cap meets or exceed all functional requirements and support its suitability for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medex Male/Female Luer Lock Plug, B. Braun Blue Cap Dual Function Lock Lock Plug, Abbott Male/Female Sterile Cap
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.
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K981318
510(k) SUMMARY
Dual Luer Lock Cap
Submitted by:
Mary Ellen Snyder Baxter Healthcare Corporation I.V. Systems Division Rte. 120 and Wilson Road Round Lake, IL 60073
Date Prepared:
April 9, 1998
Proposed Device: Dual Luer Lock Cap
Predicate Device:
Medex Male/Female Luer Lock Plug B. Braun Blue Cap Dual Function Lock Lock Plug Abbott Male/Female Sterile Cap
Proposed Device Description:
The subject of this submission is a sterile Dual Luer Lock Cap which will be used to cover male or female luer ports on medical devices. The proposed Dual Luer Lock Cap will replace the existing port cap on a number of currently marketed Baxter devices such as sets, stopcocks and manifolds. It will also be sold individually as a replacement cap to cover an open luer port after it has been accessed and is no longer in use. The Dual Luer Lock Cap consists of an integrated design with a male luer lock connection on one end and a female luer lock connection on the other end.
Statement of Intended Use:
The Dual Luer Lock Cap is intended for use as a cap for male or female luer ports on medical devices such as manifolds, stopcocks or sets.
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Summary of Technological Characteristics of New Device to Predicate Devices
The proposed Dual Luer Lock Cap is similar in design characteristics to several other marketed sterile replacement caps which feature a dual male/female luer connection. These include the Medex Male/Female Luer Lock Plug, the B. Braun Blue Cap Dual Function Lock Lock Plug and the Abbott Male/Female Sterile Cap. It is also similar to the existing port cap on Baxter's MultiPort Manifold.
There are no new materials involved in the proposed device. It is comprised of the same material used to fabricate the current port protector on Baxter's marketed MultiPort Manifold.
Discussion of Nonclinical Tests and Referenced Studies Reported in Published Literature
Data regarding the functional performance of the proposed Dual Luer Lock Cap have been generated. A description of the functional testing along with test results has been provided. The data indicate that the proposed cap meets or exceed all functional requirements and support its suitability for use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 22 1998
Ms. Mary Ellen Snyder Baxter Healthcare Corporation I.V. Systems Division Route 120 and Wilson Road 60073 Round Lake, Illinois
K981318 Re : Dual Luer Lock Cap Trade Name: Requlatory Class: II Product Code: FPA Dated: April 9, 1998 Received: April 10, 1998
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 aqainst 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 Regulations, Title 21, Parts 800 to 895. ਖੇ 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 Reqister. 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 - Ms. Snyder
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 The FDA described in your 510 (k) premarket notification. 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
Director 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) Premarket Notification Dual Luer Lock Cap
Not Available 510(k) Number:
Dual Luer Lock Cap Device Name:
Indication for Use:
Baxter's Dual Luer Lock Cap is intended for use as a cap for male or female luer ports on medical devices such as manifolds, stopcocks or sets.
Patricia Cuccenti
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital, Infection of
510(k) Number K981318
Prescription Use (Per 21 CFR 801.109)
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