The Aeroquip SafeStart™ IV Catheter is a sterile, non-pyrogenic, disposable peripheral vascular access catheter intended to provide peripheral venous access per CDC guidelines without the spillage of blood when accessing a vein or artery. It is intended to allow administration of drug and fluids into patients via a standard luer connection. The Aeroquip SafeStart™ IV Catheter permits for any type of intravenous fluid administration (continuous and intermittent) or withdrawal of fluids.

Device Description

The Aeroquip SafeStart™ IV Catheter device is a sterile, non-pyrogenic, disposable, peripheral vascular access catheter. The catheter check valve assembly consists of a catheter tube, a twoway internal check valve, a catheter body and a luer lock interface cap.

AI/ML Overview

This submission (K970669) for the Aeroquip SafeStart™ IV Catheter does not contain the information requested regarding acceptance criteria and studies demonstrating that the device meets those criteria.

The provided text is a 510(k) summary and the FDA's clearance letter for a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance studies against specific acceptance criteria.

Here's why the information is missing from the provided text:

510(k) Submissions Focus on Equivalence: 510(k) applications primarily aim to show that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its absolute safety and effectiveness through rigorous, pre-defined acceptance criteria and extensive performance studies in the way a PMA (Premarket Approval) would.
Device Type: This device is a peripheral vascular access catheter. For such devices, the primary "acceptance criteria" are typically related to biocompatibility, sterility, fluid flow rates, material strength, and safe insertion/removal. These are often validated through standard engineering tests and biocompatibility assessments, rather than complex clinical studies with "ground truth" and "expert consensus" as would be seen for diagnostic AI or imaging devices.
"Study" vs. "Testing": While the device would have undergone various engineering and bench testing (e.g., for flow rate, tensile strength, leak detection, sterilization validation), these are not typically presented as "studies" in the context of comparative effectiveness or accuracy as you've outlined in your request (which are more common for diagnostic AI/imaging devices).
No AI Component: The device described is a physical medical device (IV catheter), not an artificial intelligence (AI) or software-as-a-medical-device (SaMD) product. Therefore, concepts like "human readers improve with AI," "standalone algorithm performance," "ground truth establishment by experts," and "training sets" are not applicable.

Therefore, I cannot populate the requested table or answer the specific questions based on the provided input. The information you're asking for would generally be found in different sections of a regulatory submission (e.g., detailed design verification and validation test reports, biocompatibility reports) or in separate clinical study reports, which are not part of this 510(k) summary.

Summary

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K970669

AUG - | 1997

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 :_______________________________________________________________________________________________________________________________________________

Submitter's Identification: 1.

Aeroquip Medical Products 2323 Green Road Ann Arbor, MI 48105-1530 Contact Person: Ms. Christina L. Thomas, Medical Specialist

Date Summary Prepared: February 20, 1997

Name of the Device: 2.

Aeroquip SafeStart™ IV Catheter

Predicate Device Information: 3.

Critikon PROTECTIV™ manufactured by Critikon Inc. 1)
Low Profile Safsite Y-Site manufactured by B. Braun. 2)

4. Device Description:

Intended Use: પતે

The Aeroquip SafeStart™ IV Catheter permits for any type of intravenous fluid administration (continuous and intermittent) or withdrawal of fluids.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG -- 1 1997

Ms. Susan Goldstein-Falk Official Correspondent Aeroquip Medical Products C/O MDI Consultants, Incorporated 55 Northern Boulevard, Suite 410 Great Neck, New York 11021

Re : K970669 Trade Name: Aeroquip Safestart IV Catheter Requlatory Class: II Product Code: FOZ Dated: May 6, 1997 Received: May 8, 1997

Dear Ms. Goldstein-Falk:

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 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.

lf 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical

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General requlation (21 CFR Part 820) and that, Devices: 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 action. In addition, FDA may publish further announcements in 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 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 regulation (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 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,
K.J. Lilienthal

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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Aeroquip SafeStart™ IV Catheter

Device Mame:

Indications For Use:

The Aeroquip SafeStart™ IV Catheter is a sterile, non-The Aeroquip Sarestart" I v Cacleter access catheter
pyrogenic, disposable peripheral vascular access per CDC quidel intended to provide peripheral venous access per CDC guidelines
intended to provide peripheral venous accessing a vein or intended to provide partpanes of blood when accessing a vein or
hours without the spillage of blood when accessing of drugs and It is intended to allow administration of drugs and artery. into patients via a standard luer connection. fluids

permits for any type The Aeroquip SafeStart™ IV Catheter Seroquip Sarestart IV Cacheler and of . intermittent) or withdrawal of fluids.

(PLEASE:DO NOT WRITE SELOW TEDS LINE - CONTINUE ON ANOTHER. PAGE IS HERDED)

Concerence of CDRS, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

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Ore-The-Court Use

(Optics For at 1-2-96)

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).