(50 days)
For administration of intravenous fluids to a patient's vascular system utilizing needleless components and an I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. The needleless safety feature may aid in the prevention of needlestick injury.
Sterile single use, non-pyrogenic intravenous fluid administration set: 85 in. (216 cm) long, multiport IV manifold with integrated back check valves, pre-attached needleless injection sites, drip chamber, roller clamps.
The provided text describes the 510(k) summary for the Quest Medical Multiport® Manifold I.V. Set with Swabable Valves. It states that the device is substantially equivalent to a predicate device (Baxter Continu-Flo Solution Set, 2C8930, K003225) based on non-clinical testing.
Here's an analysis of the requested information based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions "acceptable performance of the device" based on "laboratory testing (design verification) using the FDA guidance for Intravascular Administration Sets." However, specific acceptance criteria and detailed quantitative performance metrics are not provided in the given text. The summary only states a qualitative conclusion.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device functions as intended for intravenous fluid administration. | "acceptable performance of the device" |
| Meets standards outlined in FDA guidance for Intravascular Administration Sets. | Device successfully underwent "laboratory testing (design verification) using the FDA guidance for Intravascular Administration Sets." |
| Substantially equivalent to predicate device (Baxter Continu-Flo). | "The technological characteristics of the Multiport IV Set do not differ significantly from the currently marketed Baxter Continu-Flo set. The devices use the same fundamental scientific technology and have the same intended use." |
2. Sample Size Used for the Test Set and Data Provenance:
The document refers to "laboratory testing (design verification)." The specific sample size (N) used for this testing is not mentioned. The data provenance is also not specified beyond being "laboratory testing." It is non-clinical testing, so it's not real-world patient data (retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This is a non-clinical device test. There is no mention of experts being used to establish ground truth in the context of clinical interpretation or diagnosis. The "ground truth" would be the engineering specifications and performance standards defined by the FDA guidance and internal design requirements.
4. Adjudication Method for the Test Set:
As this is non-clinical laboratory testing, adjudication methods typically associated with clinical studies (like 2+1 or 3+1) are not applicable or mentioned. The "adjudication" would refer to the successful meeting of engineering and performance standards during testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The document describes a non-clinical assessment of substantial equivalence, not a clinical study involving human readers or comparative effectiveness with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable to the device described. The Multiport® Manifold I.V. Set is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone performance" in this context is irrelevant.
7. The Type of Ground Truth Used:
For this non-clinical device, the "ground truth" would be the engineering specifications, performance standards, and safety requirements outlined in the FDA guidance for Intravascular Administration Sets and the device's own design documentation. It is not expert consensus, pathology, or outcomes data, as these are related to clinical findings or diagnoses.
8. The Sample Size for the Training Set:
This question is not applicable as the device is a physical medical device and not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
This question is not applicable for the same reasons as #8.
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APR - 7 2004
Section 11
510(k) Summary of Safety and Effectiveness
SUBMITTER INFORMATION: 1.
Submitter's Name: Address:
Telephone: Fax Number: Contact Person: Date Prepared:
- DEVICE INFORMATION: 2. Proprietary Name: Common/Usual Names: Classification:
Quest Medical, Inc. One Allentown Parkway Allen, Texas 75002 972-390-9800 972-390-2881 Kathryn J. Thompson 1 April 2004
Multiport® Manifold I.V. Set with Swabable Valves Intravascular Administration Sets, I.V. Sets Class 11, 21 CFR 880.5440
Baxter Continu-Flo Solution Set, 2C8930, K003225
PREDICATE DEVICE:
-
DEVICE DESCRIPTION: ന്
Sterile single use, non-pyrogenic intravenous fluid administration set: 85 in. (216 cm) long, multiport IV manifold with integrated back check valves, pre-attached needleless injection sites, drip chamber, roller clamps. -
INTENDED USE: 4.
For administration of intravenous fluids to a patient's vascular system utilizing needleless components and an I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF NEW DEVICE TO ട്. PREDICATE DEVICE:
The technological characteristics of the Multiport IV Set do not differ significantly from the currently marketed Baxter Continu-Flo set. The devices use the same fundamental scientific technology and have the same intended use.
NON-CLINICAL TEST CONCLUSIONS: 6.
.The results of laboratory testing (design verification) using the FDA guidance for Intravascular Administration Sets demonstrate acceptable performance of the device.
Replaces pages 28, 29, and 30
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its back, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is in black and white.
Public Health Service
APR - 7 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Quest Medical. Incorporated C/O Mr. Jeremi Peck Responsible Third Party Official Underwriters Laboratories Incorporated 333 Pfingsten Road Northbrook, Illinois 60062
Re: K040385
Trade/Device Name: Multiport® Manifold I.V. Set 3 with Swabable Valves Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: March 16, 2004 Received: March 23, 2004
Dear Mr. Peck:
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. Peck
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 (301) 594-5618. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
for,
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
Enclosure
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SECTION 5 INDICATIONS FOR USE STATEMENT
| 510(k) Number: | |
|---|---|
| Device Name: | Multiport® Manifold I.V. Set with Swabable Valves |
| Indications for Use: | For administration of intravenous fluids to a patient's vascularsystem utilizing needleless components and an I.V. manifoldfor multiple simultaneous intravenous therapy via gravity,syringe, or infusion pump.The needleless safety feature may aid in the prevention ofneedlestick injury. |
(Please do not write below this line-continue on another page if needed)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Prescription Use_ V (Per 21 CFR 801.109)
H
OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
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(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Anesthoology
Infection Control, Dental Devices
510(k) Number: K040385
§ 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.