C2000 AUTOMATED MANIFOLD KIT by ACIST MEDICAL SYSTEMS, INC.

The C2000 Automated Manifold Assembly Kit is the disposable patient contact intravenous tubing that attaches to Part A via a connector. This kit is contains the patient manifold, saline spike, 3-way pressure stopcock, high pressure line, and a syringe cap. This kit is designed to be connected to the users own pressure monitoring equipment to measure homodynamic waveform.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "C2000 Automated Kit Assembly" (later referred to as "C2000 Automated Manifold Kit") manufactured by ACIST Medical Systems, Inc. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a novel device that requires extensive clinical studies with new acceptance criteria.

Therefore, the document does not contain the information requested in the prompt, as the submission method (510(k)) relies on demonstrating similarity to an already approved device rather than establishing new performance criteria through dedicated studies.

Specifically:

A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on comparing the new device's characteristics (materials, design, operating principle, etc.) to the predicate device, not on meeting specific, de novo clinical performance criteria.
Sample size used for the test set and the data provenance: Not provided. No specific test set or clinical study data proving performance against acceptance criteria is included.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth is mentioned.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this type of study is not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a component of an angiographic injection system, not an algorithm.
The type of ground truth used: Not applicable, as no ground truth establishment is described for performance evaluation.
The sample size for the training set: Not applicable. This device is hardware; there's no mention of a "training set" in the context of an algorithm.
How the ground truth for the training set was established: Not applicable.

Summary of the document's approach:

The submission leverages the "substantial equivalence" pathway, meaning the manufacturer aims to show that their new device is as safe and effective as a legally marketed predicate device (ACIST Angiographic Contrast Management System cleared under K984231). The key arguments for substantial equivalence are based on:

Identical Indications for Use: "The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures."
Similarities in Design and Function: The subject device and predicate device have "The same operating principle; The same basic design; materials; The same manufacturing environment; The same sterilization process; and The same packaging configurations."

The FDA's letter confirms that they "determined the device is substantially equivalent...to legally marketed predicate devices." This determination is based on the comparison provided by ACIST Medical Systems, Inc., rather than new, independent clinical performance studies with specific acceptance criteria as would be typical for de novo device approvals or algorithm-based devices.

Summary

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K052744

0EC 1 6 2005

510(k) Summary

Submitter:	ACIST Medical Systems, Inc7450 Flying Cloud Drive, Suite 150Eden Prairie, MN 55344 USA
Contact Person:	Mr. Al SaalabiVice President of Quality and Regulatory AffairsPhone: (952) 995-9360 FAX: (952) 941-4648Al.saalabi@acistmedical.com
Date Prepared:	September 28, 2005
Trade Name:	C2000 Automated Kit Assembly
ClassificationName andNumber:	Angiographic contrast media injection systems, and its accessories, havebeen classifieds as Class II devices per 21 CFR 870.1650. Noperformance standards have been established under Section 514 of theFood, Drug and Cosmetic Act for these devices.
Product Code:	DXT
Predicate Device	The ACIST Angiographic Contrast Management System cleared underK984231.
Device Description:	The C2000 Automated Manifold Assembly Kit is the disposable patientcontact intravenous tubing that attaches to Part A via a connector. Thiskit is contains the patient manifold, saline spike, 3-way pressurestopcock, high pressure line, and a syringe cap. This kit is designed tobe connected to the users own pressure monitoring equipment tomeasure homodynamic waveform.
Intended Use:	The ACIST Angiographic Injection System is intended to be used forthe controlled infusion of radiopaque contrast media for angiographicprocedures.
Statement ofTechnologicalComparison	The subject device and predicate device have the following similarities.The same indication for use; The same operating principle; The same basic design; materials; The same manufacturing environment; The same sterilization process; and The same packaging configurations.
Conclusion:	In summary, the subject device, as described in this submission is, in theopinion of ACIST Medical, substantially equivalent to the predicatedevice.The subject device, as modified in this submission, is substantiallyequivalent to the predicate device, ACIST Angiographic Contrast ManagementSystem (cleared under K984231.) This conclusion is based upon thesimilarities of the devices in terms of functional design, indication foruse, principles of operation, materials, and performance characteristics.

C2000 Disposable Kit Special 510(k) ACIST Medical Systems, Inc.

Appendix F, Page 2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

OEC 16 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Acist Medical Systems, Inc. c/o Mr. Al Saalabi Vice President of Quality and Regulatory Affairs 7450 Flying Cloud Drive, Suite 150 Eden Prairie, MN 55344

K052744 Re: C2000 Automated Manifold Kit Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector & syringe Regulatory Class: II Product Code: DXT Dated: November 18, 2005 Received: November 21, 2005

Dear Mr. Saalabi:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premainer is substantially equivalent (for the indications
referenced above and have determined the device is substant in interstate referenced above and have decimined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices Amendments for use stated in the encrosulty to regally manced promises of the Medical Device Amendments, or to commerce prior to May 20, 1970, the chance with the provisions of the Federal Food. Drug, devices that have been reclassince in accordance what approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general registration, liging o You may, therefore, market the devreet, seeject of the storest for annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the 7tet merade requirements of the mastern misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) in to existing major regulations affecting your device can
may be subject to such additional controls. This as a see may be subject to such additional controls. Existing major of Sep In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 designer be found in the Code of Peacharting your device in the Federal Register.

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Page 2 - Mr. Al Saalabi

Please be advised that FDA's issuance of a substantial equivalence determination and mean Please be advised that FDA 3 issualted or a bevice complies with other requirements of the Act that FDA has made a decormination that Jour atered by other Federal agencies. You must of ally Federal statutes and regulations and limited to: registration and listing (21 comply with an the Act stequirements, morealing, which and acturing practice requirements as set CFR Part 807), labeling (21 CFR Part 820); and 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 app 1000 1060 forum in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declines our device as described in your Section 510(k) I his letter will anow you to begin manieting your and equivalence of your device to a legally premarket nothleadon: "The PDF intemsgsification 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 If you desire specific davis at (240) 276-0120. Also, please note the regulation entitled, Connact the Office of Oremarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miormational on your respender Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Dmna R. Vochner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Page

510(k) Number (if known): K052744

C2000 Automated Manifold Kit Device Name:

Indications for Use:

The ACIST Angiographic Injection System is intended to be used for the controlled infusion
ing the same of the Samesia procedures The ACIST Anglographic injoction byoma
of radiopaque contrast media for angiographic procedures.

Prescription Use __ X (Per 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dona R. VoLuner

sic Sign-Off) ... Jarsion Ji Cardiovascular Devices

510(k) Number K052744

Regulation Number and Section

§ 870.1650 Angiographic injector and syringe.

(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.