K Number
K971004
Device Name
MEDCORP FLOW I.V. REGULATOR EXTENSION SET
Manufacturer
Date Cleared
1997-10-02

(197 days)

Product Code
Regulation Number
880.5440
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To provide fluid path connection and flow regulation from fluid delivery set to venipuncture device.
Device 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.
More Information

DIAL-A-FLOW Regulatory I.V. Extension Set

Not Found

No
The device description and performance studies focus on physical properties and flow regulation, with no mention of AI or ML.

No
Explanation: The device is an I.V. extension set for fluid delivery and flow regulation, not a device intended to treat or cure a disease or condition.

No
The device is described as an I.V. extension set for fluid delivery, with physical properties tested (flow rates, tensile strength, toxicity, pyrogenicity), but no mention of diagnosing conditions.

No

The device description explicitly states it is an "I.V. extension set" with "flexible tubing," "Luer lock connector," and a "flow regulator," all of which are physical hardware components. The performance studies also describe "physical testing."

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "To provide fluid path connection and flow regulation from fluid delivery set to venipuncture device." This describes a device used for delivering fluids into the body, not for testing samples from the body.
  • Device Description: The description details an "I.V. extension set" with tubing, connectors, and a flow regulator. This is consistent with a device used for intravenous fluid administration.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro testing.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for fluid delivery.

N/A

Intended Use / Indications for Use

To provide fluid path connection and flow regulation from fluid delivery set to venipucture device.

Product codes

FPA

Device 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.

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)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

DIAL-A-FLOW Regulatory I.V. Extension Set

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.

0

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 International
25612 Stratford Place
Laguna 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.

1

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

2

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

3

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 __