GALIX PACESTAR

K023080 · Galix Biomedical Instrumentation, Inc. · DTE · Jun 11, 2003 · Cardiovascular

Device Facts

• Record ID: K023080
• Device Name: GALIX PACESTAR
• Applicant: Galix Biomedical Instrumentation, Inc.
• Product Code: DTE · Cardiovascular
• Decision Date: Jun 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3600
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The GALIX PaceStar External Paccmaker may be used in any clinical situation in which the use of a temporary pacemaker on a patient provides therapentic or diagnostic value. Specifically, indications for teaporary paccusions include, but are not limited to, the following: - temporary treatment of arrhythmias and heart block . - pro-, intra- and postoperative temporary stimulation of patients undergoing cardiac surgery .

Device Story

External pacemaker pulse generator; provides temporary cardiac stimulation. Used in clinical settings for patients requiring temporary pacing therapy or diagnostics. Device delivers electrical impulses to heart; manages arrhythmias and heart block; supports cardiac surgery patients. Operated by clinicians. Output consists of electrical pacing pulses; assists in maintaining cardiac rhythm; provides therapeutic benefit to patients requiring temporary hemodynamic support.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

External pacemaker pulse generator; Class III device (21 CFR 870.3600). Electrical stimulation delivery system. Specific materials and dimensions not detailed in provided text.

Indications for Use

Indicated for patients requiring temporary cardiac pacing for treatment of arrhythmias, heart block, or pro-, intra-, and postoperative stimulation during cardiac surgery.

Regulatory Classification

Identification

An external pacemaker pulse generator (EPPG) is a prescription device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device, which is used outside the body, is used as a temporary substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. The device may have adjustments for impulse strength, duration, R-wave sensitivity, and other pacing variables.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Appropriate analysis/testing must validate electromagnetic compatibility (EMC) within a hospital environment. (2) Electrical bench testing must demonstrate device safety during intended use. This must include testing with the specific power source ( *i.e.,* battery power, AC mains connections, or both).(3) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following: (i) Testing must demonstrate the accuracy of monitoring functions, alarms, measurement features, therapeutic features, and all adjustable or programmable parameters as identified in labeling; (ii) Mechanical bench testing of material strength must demonstrate that the device and connection cables will withstand forces or conditions encountered during use; (iii) Simulated use analysis/testing must demonstrate adequate user interface for adjustable parameters, performance of alarms, display screens, interface with external devices ( *e.g.* data storage, printing), and indicator(s) functionality under intended use conditions; and(iv) Methods and instructions for cleaning the pulse generator and connection cables must be validated. (4) Appropriate software verification, validation, and hazard analysis must be performed. (5) Labeling must include the following: (i) The labeling must clearly state that these devices are intended for use in a hospital environment and under the supervision of a clinician trained in their use; (ii) Connector terminals should be clearly, unambiguously marked on the outside of the EPPG device. The markings should identify positive (+) and negative (−) polarities. Dual chamber devices should clearly identify atrial and ventricular terminals; (iii) The labeling must list all pacing modes available in the device; (iv) Labeling must include a detailed description of any special capabilities ( *e.g.,* overdrive pacing or automatic mode switching); and(v) Appropriate electromagnetic compatibility information must be included.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 1 2003

GALIX Biomedical Instrumentation c/o Mr. Jordan Gavrielides President 2555 Collins Avenue, Suite C-5 Miami Beach, FL 33140

Re: K023080

Trade Name: PaceStar External Pacemaker Regulation Number: 21 CFR 870.3600 Regulation Name: External Pacemaker Pulse Generator Regulatory Class: Class III (three) Product Code: DTE Dated: March 17, 2003 Received: March 19, 2003

Dear Mr. Gavrielides:

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.

{1}------------------------------------------------

## Page 2 - Mr. Jordan Gavrielides

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 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.

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

Enclosure

{2}------------------------------------------------

| Page_ of | |
|----------|--|
|----------|--|

| 510(k) Number (if known): | K023080 |
|---------------------------|----------------|
| Device Name: | Galix PaceStar |

Indications For Use:

The GALIX PaceStar External Paccmaker may be used in any clinical situation in which the use of a temporary pacemaker on a patient provides therapentic or diagnostic value.

Specifically, indications for teaporary paccusions include, but are not limited to, the following:

- temporary treatment of arrhythmias and heart block .
- pro-, intra- and postoperative temporary stimulation of patients undergoing cardiac surgery .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helartn

ardiovascular Devices

**510(k) Number** K023880

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)