(12 days)
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.
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.
Here's an analysis of the provided text regarding the "Dual Luer Lock Cap" and its acceptance criteria and supporting study, formatted as requested.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Requirements (unspecified) | "meets or exceed all functional requirements" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the test set. It mentions "functional testing" was performed, and "data have been generated," but no numbers are provided for the quantity of devices tested.
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a medical device accessory, it is almost certainly a prospective test conducted by the manufacturer for regulatory approval.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not detailed in the provided text. For a device like a luer lock cap, "ground truth" would likely be established by engineering specifications and objective measurements against those specs, rather than expert interpretation (e.g., radiologist consensus).
4. Adjudication Method for the Test Set
This information is not detailed in the provided text. Since the acceptance criteria are functional, adjudication would likely involve comparing test results directly to predefined objective standards, rather than a consensus method among human adjudicators.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not conducted. This type of study is typically relevant for diagnostic imaging AI systems where human readers interpret medical images. The "Dual Luer Lock Cap" is a mechanical medical device, not a diagnostic tool that involves human interpretation of data.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone study was effectively performed, although the term "algorithm" is not applicable here. The device's functional performance was evaluated independently without human intervention influencing the functional outcome itself. The tests would assess properties like seal integrity, connection strength, and material properties.
7. Type of Ground Truth Used
The ground truth used for this device would be based on engineering specifications and objective functional requirements. This includes standards for luer connectivity, sealing capability, material compatibility, and sterilization. The specific details of these functional requirements are not itemized in the summary, but it's implied that the device was tested against such standards.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. Training sets are used for machine learning algorithms. The "Dual Luer Lock Cap" is a physical medical device, not an AI or software product.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" for this physical device, this question is not applicable.
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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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§ 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.