C2000 AUTOMATED MANIFOLD KIT

K052744 · Acist Medical Systems, Inc. · DXT · Dec 16, 2005 · Cardiovascular

Device Facts

• Record ID: K052744
• Device Name: C2000 AUTOMATED MANIFOLD KIT
• Applicant: Acist Medical Systems, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Dec 16, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

Device Story

The C2000 Automated Manifold Assembly Kit is a disposable patient-contact intravenous tubing set used with the ACIST Angiographic Injection System. The kit includes a patient manifold, saline spike, 3-way pressure stopcock, high-pressure line, and syringe cap. It connects to the user's existing pressure monitoring equipment to facilitate hemodynamic waveform measurement during angiographic procedures. The device is intended for use in clinical settings where angiographic contrast media injection is required.

Clinical Evidence

No clinical data provided; substantial equivalence is based on functional design, materials, and performance characteristics.

Technological Characteristics

Disposable intravenous tubing kit including manifold, saline spike, 3-way stopcock, high-pressure line, and syringe cap. Designed for integration with external pressure monitoring equipment. Sterilization and materials are identical to the predicate device.

Indications for Use

Indicated for the controlled infusion of radiopaque contrast media during angiographic procedures. Patient population not specified.

Regulatory Classification

Special Controls

*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.

Predicate Devices

• ACIST Angiographic Contrast Management System (K984231)

Submission Summary (Full Text)

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K052744

## 0EC 1 6 2005

## 510(k) Summary

..

:

| Submitter: | ACIST Medical Systems, Inc<br>7450 Flying Cloud Drive, Suite 150<br>Eden Prairie, MN 55344 USA |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Al Saalabi<br>Vice President of Quality and Regulatory Affairs<br>Phone: [phone] FAX: [phone]<br>[e-mail] |
| Date Prepared: | September 28, 2005 |
| Trade Name: | C2000 Automated Kit Assembly |
| Classification<br>Name and<br>Number: | Angiographic contrast media injection systems, and its accessories, have<br>been classifieds as Class II devices per 21 CFR 870.1650. No<br>performance standards have been established under Section 514 of the<br>Food, Drug and Cosmetic Act for these devices. |
| Product Code: | DXT |
| Predicate Device | The ACIST Angiographic Contrast Management System cleared under<br>K984231. |
| Device Description: | The C2000 Automated Manifold Assembly Kit is the disposable patient<br>contact intravenous tubing that attaches to Part A via a connector. This<br>kit is contains the patient manifold, saline spike, 3-way pressure<br>stopcock, high pressure line, and a syringe cap. This kit is designed to<br>be connected to the users own pressure monitoring equipment to<br>measure homodynamic waveform. |
| Intended Use: | The ACIST Angiographic Injection System is intended to be used for<br>the controlled infusion of radiopaque contrast media for angiographic<br>procedures. |
| Statement of<br>Technological<br>Comparison | The subject device and predicate device have the following similarities.<br>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 the<br>opinion of ACIST Medical, substantially equivalent to the predicate<br>device.<br>The subject device, as modified in this submission, is substantially<br>equivalent to the predicate device, ACIST Angiographic Contrast Management<br>System (cleared under K984231.) This conclusion is based upon the<br>similarities of the devices in terms of functional design, indication for<br>use, 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 [phone]. 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 [phone] or [phone] 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