(107 days)
The indicated use of health Line International Corporation's IV Administration Sets and Extensions Sets is for administration of fluids from a container to the patents vascular system.
HLIC's IV Administration Sets covered by this submission are gravity feed Intravascular Administration Sets. They are to be used for administering fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
The provided text is a 510(K) summary for the Health Line International Corporation's (HLIC) IV Administration and Extension Sets. It explicitly states that this is a submission to establish substantial equivalence to predicate devices, not an independent study demonstrating novel performance criteria or the effectiveness of AI.
Therefore, many of the requested elements are not applicable to this document. The device is a physical medical device (IV administration set), not a software or AI-driven diagnostic tool.
Here's the analysis based on the provided text, while also noting the limitations due to the nature of the submission:
1. A table of acceptance criteria and the reported device performance
The submission focuses on substantial equivalence to predicate devices and compliance with existing standards rather than novel performance criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (Baxter K925126 & Baxter K89098) | HLIC IV Administration Sets and Extension Sets are substantially equivalent to Baxter K925126 and K89098. HLIC's spike dimensions are slightly different but more compliant to ISO 8536-4:2004 dimensions. |
| Compliance with ISO 8536-4:2004 (Infusion equipment for medical use - Infusion sets for single use, gravity feed) | HLIC's devices were all compliant with ISO 8536-4:2004. |
| Compliance with ISO 10993 (Biological evaluation of medical devices) | HLIC's devices were all compliant with ISO 10993 requirements. |
| DEHP Free | Product is DEHP free. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical trial data or algorithm evaluation. The "performance data and the safety data" mentioned refer to engineering and biocompatibility testing to demonstrate equivalence and standards compliance, not a clinical study on a patient cohort. Therefore, sample sizes for such tests are not described in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in the context of expert consensus for AI or diagnostic performance is not relevant here. The evaluation relies on standardized tests and comparison to predicate devices, not expert interpretation of outputs.
4. Adjudication method for the test set
Not applicable. There is no human-interpreted "test set" requiring adjudication.
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
Not applicable. This is not an AI device, and no MRMC study was conducted or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
For the purpose of this 510(K) submission, the "ground truth" is established by:
- Predicate device characteristics: The established characteristics and performance of the Baxter IV Administration and Extension Sets.
- International standards: The specifications and requirements outlined in ISO 8536-4:2004 and ISO 10993.
- Engineering and materials testing: Physical, chemical, and biological tests to confirm the device meets predefined technical specifications and safety profiles, ensuring biological compatibility and functional integrity (e.g., flow rates, material strength, sterility).
8. The sample size for the training set
Not applicable. This is not an AI device, and there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or AI model involved.
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MAY 3 1 2006 510(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(K) number is: KC663 2 Device Name:
Proprietary Name: Health Line International Corporation's IV Administration and Extension Sets
Common/Usual Name: Intravascular Administration Sets
Classification:
| Class II: | Per 21 CFR 880.5440 |
|---|---|
| Panel Number: | Panel 88 |
| Product Code: | FPA |
| Predicate Device: |
The HLIC IV Administration Sets are substantially equivalent to Baxter K925126 and the HLIC Extension Sets are substantially equivalent to Baxter K89098 Predicate Devices.
Device Description:
HLIC's IV Administration Sets covered by this submission are gravity feed Intravascular Administration Sets. They are to be used for administering fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
Intended Use
The intended use of health Line International Corporation's IV Administration Sets and Extensions Sets is for the safe and effective administration of fluids from a container to the patents vascular system and/or to draw blood from the patient's vascular system. Product is DEHP free for use on all patient populations The technical characteristics of HLIC's IV Administration Sets and Extension Sets and Baxter's predicate device are substantially equivalent. HLIC's spike dimensions are slightly different from Baxter's predicate devices. HLIC's spike length is more compliant to ISO 8536-4:2004 dimensions than Baxter's predicate devices.
The performance data and the safety data indicated that HLIC's devices are substantially equivalent to Baxter's IV Administration Sets, Extension Sets. And McGaw (B. Braun Needle Free Injection Site Caps. HLIC's devices were all compliant with ISO 8536-4:2004 and ISO 10993 requirements.
Conclusion:
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The following conclusions can be drawn from reviewing the safety and efficacy data of the 510(K) and physical dimensional data all indicated that HLIC's IV Administration Sets and Extension Sets are substantially equivalent to Baxter's predicate devices.
: ·
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.
MAY 3 1 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jack Speer, MS, RAC V.P. Business Development and Regulatory Health Line International Corporation Freeport Center Building E-13 Drive 21 P.O. Box 160435 Clearfield, Utah 84016-0435
Re: K060352
Trade/Device Name: IV Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: May 11, 2006 Received: May 12, 2006
Dear Mr. Speer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Speer
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indication for Use Statement
510(K) Number (K060352) Device Name: IV Administration Set
Indication for Use:
The indicated use of health Line International Corporation's IV Administration Sets and Extensions Sets is for administration of fluids from a container to the patents vascular system.
(Signature
of Verifier)
Jack R. Speer
may 11, 2006
Prescription Use: Yes X (Part 21 CFR 801 Subpart D)
Over The Counter Use AND/OR
No
(21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sign-Off)
ion of Anesthesiology, General Hospital,
action Control, Dental Devices
) Number:
§ 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.