The Interpore Cross International Manifold with Extension Set is intended to provide multiple access sites into a common fluid path for blood, plasma or solutions. The luer connectors on either end of the stopcock gang allow connection to the Extension Set for fluid transfer (i.e., blood, plasma, or solution).

Device Description

The Interpore Cross Manifold with Extension Set consists of individual stopcocks assembled in series through common luer fittings to form a manifold or stopcock gang. These pre-assembled stopcock gangs provide multiple access sites into a common fluid path for blood, plasma or solutions. The luer connectors on either end of the stopcock gang (Manifold) allow connection to the Extension Set for fluid transfer. The backing plate can be used to attach the stopcock manifold gang to an IV pole.

AI/ML Overview

The provided text describes a 510(k) submission for the "Interpore Cross Manifold With Extension Set." This is a medical device, and the information primarily focuses on its substantial equivalence to a predicate device and its functional performance testing.

Here's an analysis of the provided information, specifically addressing your numbered points:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the device "meets or exceeds all functional requirements," but it does not provide a specific table of acceptance criteria with quantitative metrics nor a detailed report of the device's performance against those metrics. It only lists the types of tests performed.

Acceptance Criterion Category	Reported Device Performance
Ease of Assembly	Meets or exceeds all functional requirements
Unscrewing Torque	Meets or exceeds all functional requirements
Air Leakage	Meets or exceeds all functional requirements
Liquid Leakage	Meets or exceeds all functional requirements
Separation Force	Meets or exceeds all functional requirements
Resistance to Overriding	Meets or exceeds all functional requirements
Pressure Seal Testing	Meets or exceeds all functional requirements
Manifold Flow Rate	Meets or exceeds all functional requirements
Mechanical Security of Stopcock Gangs to Backing Plate	Meets or exceeds all functional requirements

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify the sample size for any of the tests conducted.
Data Provenance: The data was "generated" by Interpore Cross International. The country of origin is not explicitly stated, but the company's address is Irvine, California, USA, suggesting the testing was likely conducted in the USA or under US regulations. The study would be considered prospective as it involves new testing specifically for the 510(k) submission of this device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

This question is not applicable to the type of device and study described. The "Interpore Cross Manifold With Extension Set" is a mechanical fluid transfer device. Its performance is assessed through objective, physical tests (e.g., leakage, flow rate, torque), not through expert interpretation like medical imaging or diagnostic algorithms. Therefore, there's no "ground truth" to be established by experts in the sense of clinical diagnosis or interpretation.

4. Adjudication Method for the Test Set:

Not applicable. As explained above, this study involves objective mechanical testing, not subjective interpretation requiring adjudication among experts.

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 a study of a mechanical fluid transfer device, not an AI-assisted diagnostic tool. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are irrelevant to this document.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is not an algorithm or software. It is a physical medical device.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on objective, quantitative physical measurements against predefined engineering and functional specifications. For example, "air leakage" would have a maximum allowable leakage rate, and the test would verify if the device stays within that limit. This is unlike clinical studies where ground truth might be derived from pathology, expert consensus, or patient outcomes.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its functionality is based on its mechanical design and materials.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As there is no training set for this type of device, this question is irrelevant.

Summary

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JUL 3 | 1998

K982368

Interpore Cross Manifold With Extension Set

Interpore Cross International - Confidential -

510(K) SUMMARY

SUBMITTED BY

Lynn Rodarti Manager, Regulatory Affairs INTERPORE International 181 Technology Drive Irvine, California 92618

(714) 453-3200

Date Submitted: July 2, 1998

CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Classification Name: Stopcock, I.V. Set Common/Usual Name: Stopcock Manifold Product Classification: Class II Proprietary Name: Manifold with Extension Set

PREDICATE DEVICE

Medex Guide-Flo Stopcock Manifold Gangs, Preamendment Device and Baxter Stopcock Manifold Gangs, 510(k) K962531.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

INDICATIONS-FOR-USE

The Interpore Cross International Manifold with Extension Set is intended to provide multiple access sites into a common fluid path for blood, plasma or The luer connectors on either end of the stopcock gang allow solutions. connection to an Extension Set for fluid transfer (i.e., blood, plasma, or solution).

DEVICE DESCRIPTION

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Interpore Cross Manifold With Extension Set

The luer connectors on either end of the stopcock gang (Manifold) allow connection to the Extension Set for fluid transfer. The backing plate can be used to attach the stopcock manifold gang to an IV pole.

COMPARISON TO THE PREDICATE DEVICE

Cross Manifold with Extension Set is technologically The Interpore substantially equivalent to the predicate devices in every respect.

DISCUSSION OF NONCLINICAL TESTS

Data regarding the functional performance of the proposed Manifold have been generated. Testing included ease of assembly, unscrewing torque, air leakage, liquid leakage, separation force, resistance to overriding, pressure seal testing, Manifold flow rate, mechanical security of stopcock gangs to backing plate. The data indicate that the proposed Manifold meets or exceeds all functional requirements and support its suitability for use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

. || "

JUL 31 1998

Ms. Lynn Rodarti Manager, Regulatory Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618

K982368 Re : Manifold with Extension Set Trade Name: Regulatory Class: II Product Code: FMG Dated: July 6, 1998 Received: July 7, 1998

Dear Ms. Rodarti:

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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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 Register. 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. Rodarti

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 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 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 requlation 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,

S. Sutro fer

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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K982368

Page 1 of 1

510(k) Number (if known):

Manifold with Extension Set Device Name:

Indications-For-Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cincenti

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _

Prescription Use
(PER 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.