(197 days)
To provide fluid path connection and flow regulation from fluid delivery set to venipuncture device.
The device is a sterile, nonpyrogenic, single use, I.V. extension set which has flexible tubing that connects to a fluid delivery system by a Luer lock connector, a flow regulator, and flexible tubing that connects to a venipuncture device by a Luer lock connector. A Y-site on the lower length of tubing allows for infusion of medication below the regulator.
The provided document describes the Medcorp Flow I.V. Regulator Extension Set and its substantial equivalence to a predicate device. However, it does not contain the specific details required to fully address all parts of your request, especially regarding a study proving acceptance criteria in the context of an AI/ML device. This document is a 510(k) summary for a traditional medical device, not an AI/ML product.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Flow Rates: Equivalent to predicate device's calibrations | Flow rates are equivalent to those indicated by the calibrations for the predicate device. |
| Toxicity: Nontoxic after manufacturing and sterilization | Toxicity testing indicates the device, after manufacturing and sterilization, is nontoxic. |
| Pyrogenicity: Absence of pyrogens | Pyrogenicity testing supports the claim for the device, which is the same as the claim for the predicate device. |
| Tensile Strength: Acceptable static tensile strength of fittings | Physical testing (static tensile strength of fittings) performed. (No specific threshold or value given, but implied as meeting equivalence) |
Missing Information: Specific numerical thresholds for flow rates, toxicity, pyrogenicity, or tensile strength are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- The document mentions "physical testing (flow rates and static tensile strength of fittings), toxicity testing, and pyrogenicity testing" were performed.
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable to this type of device and study. The testing described (flow rates, toxicity, pyrogenicity, static tensile strength) does not involve expert readers or ground truth in the way it would for an AI/ML diagnostic device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable as there is no expert adjudication process for these types of physical and biological tests.
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/ML device, and no MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests performed can be considered as follows:
- Flow Rates: Measurable physical properties against calibrated standards (likely factory specifications or a reference device).
- Toxicity: Laboratory assays demonstrating non-toxicity according to established standards (e.g., ISO biocompatibility standards).
- Pyrogenicity: Laboratory assays demonstrating absence of pyrogens according to established standards.
- Static Tensile Strength: Measurable physical properties against engineering specifications or established safety limits.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no concept of a "training set." The device is evaluated based on its physical and biological performance directly.
9. How the ground truth for the training set was established
Not applicable.
Summary of Limitations:
The provided document describes a traditional medical device (I.V. extension set) undergoing a 510(k) clearance process. The performance evaluation focuses on physical characteristics (flow rates, tensile strength) and biocompatibility (toxicity, pyrogenicity) compared to a predicate device. This is fundamentally different from the evaluation criteria and study types (e.g., MRMC, standalone algorithm performance, expert consensus on ground truth) typically associated with AI/ML-powered medical devices. Therefore, many of the requested points are not applicable or cannot be answered with the given text.
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K97/004
Image /page/0/Picture/1 description: The image shows the logo for MEDCORP International. The text below the company name reads "A Health Care Export Management Company". The logo is simple and professional, with a focus on the company's name and its mission.
OCT - 2 1997
25612 Stratford Laguna Hills, CA 92653 USA Telephone: 714.582.0313 FAX: 714.582.3747
Attachment 1
510(k) Summarv Medcorp Flow I.V. Regulator Extension Set
| Name and Address: | Medcorp International25612 Stratford PlaceLaguna Hills, CA 92653 |
|---|---|
| Contact Person: | Dave Berberian |
| Phone: | (714) 582-0313 |
| Fax: | (714) 582-3747 |
| Date Prepared: | March 1, 1997 |
| Tradename Name: | Medcorp Flow I.V. Regulator Extension Set |
| Common Name: | I.V. Extension Set |
| Classification Name: | Intravascular Administration Set (per 21 CFR 880.5440) |
Classification Name: Intravascular Administration Set
Predicate Device: DIAL-A-FLOW Regulatory I.V. Extension Set
Description: The device is a sterile, nonpyrogenic, single use, I.V. extension set which has flexible tubing that connects to a fluid delivery system by a Luer lock connector, a flow regulator, and flexible tubing that connects to a venipuncture device by a Luer lock connector. A Y-site on the lower length of tubing allows for infusion of medication below the regulator.
Indicated Use: To provide fluid path connection and flow regulation from fluid delivery set to venipuncture device.
Substantial Equivalence: Medcorp International. believes that the Medcorp Flow I.V. Regulator Extension Set is substantially equivalent to the DIAL-A-FLO Regulator I.V. Extension Set in intended use, labeling, design, components, performance, and biocompatibility. To establish the claim of equivalence to the predicate device, physical testing (flow rates and static tensile strength of fittings), toxicity testing, and pyrogenicity testing) have been performed using the device. The flow rates for the device are equivalent to those indicated by the callbrations for the predicate device. The toxicity testing indicate the device, after manufacturing and sterilization, is nontoxic. Pyrogenicity testing supports the claim for the device which is the same as the claim for the predicate device. Tests support the claim that the proposed device is equivalent to the predicate device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
OCT - 2 1997
Mr. Dave Berberian President Medcorp International 25612 Stratford Laquna Niguel, California 92653
Re: K971004 Medcorp Flow I.V. Regulator Extension Set Trade Name: Requlatory Class: II Product Code: FPA Dated: July 29, 1997 Received: August 1, 1997
Dear Mr. Berberian:
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 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. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
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Page 2 - Mr. Berberian
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 gener 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,
L. Whitlock
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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K97/004
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Medcorp Flow I.V. Regulator Extension Set Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
To provide fluid path connection and flow regulation from fluid delivery set to venipucture device.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patrician Cicerite
(Division Sign-Off) Division of Dental, Infection Control, and General Hosp 510(k) Numb
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use __
§ 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.