KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS

K030788 · Geister Medizin Technik GmbH · DWP · Jul 12, 2003 · Cardiovascular

Device Facts

• Record ID: K030788
• Device Name: KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS
• Applicant: Geister Medizin Technik GmbH
• Product Code: DWP · Cardiovascular
• Decision Date: Jul 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4475
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GEISTER vessel dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.

Device Story

GEISTER Vessel Dilators are manual surgical instruments used by surgeons during coronary artery bypass or angioplasty procedures. The device functions as a mechanical tool to physically enlarge or calibrate blood vessels, locate orifices, trace abnormal vessel paths, and measure annulus or lumen diameters. Operated by a physician in a clinical or surgical setting, the dilator provides tactile feedback to the surgeon, assisting in procedural maneuvers. The device does not utilize electronic components, software, or automated processing; it serves as a direct mechanical aid to clinical decision-making and surgical intervention, potentially improving procedural outcomes by ensuring proper vessel sizing and patency.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual surgical instrument; metallic construction; dimensions and form factor designed for vessel dilation and measurement; non-powered; non-sterile or sterile (as per standard surgical instrument processing).

Indications for Use

Indicated for use in patients undergoing coronary artery bypass or angioplasty procedures requiring vessel enlargement, calibration, orifice location, tracing of abnormal vessels, or measurement of annulus and lumen diameters.

Regulatory Classification

Identification

A surgical vessel dilator is a device used to enlarge or calibrate a vessel.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wing shapes. There is also a small star above the bird.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 2003

GEISTER MEDIZINTECHNIK GmbH c/o Mr. Dagmar Maser Business Support International Amstel 320-I Netherlands 1017 AP

Re: K030788

> Trade Name: GEISTER Vessel Dilators Regulation Number: 21 CFR 870.4475 Regulation Name: Surgical vessel dilator Regulatory Class: Class II (two) Product Code: DWP Dated: June 20, 2003 Received: June 23, 2003

Dear Mr. Maser:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Mr. Dagmar Maser

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bram D. Zuckerman, M.D.
Director

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Geister Medizintechnik GmbH

210(K) Interventional Cardiology Devices Branch - HFZ-450

510(k) Number

Device Name

K 030788

Classification/CFR

GEISTER Vessel Dilators

74 DWP / 870.4475

## INDICATIONS FOR USE

GEISTER vessel dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.

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Concurrence of CDRE, Office of Device Evaluation (ODE)

XQeater

(Division Sign-Off)
Division of Cardiovascular Devices
K030788

510(k) Number K030788

Prescription Use
(Per CFR 801 109)

OR

Over-The-Counter Use __

(Optional Format 1-2-95)

08/11/2003