PACE 101H

K970497 · Sulzer Oscor, Inc. · DTE · Jun 4, 1997 · Cardiovascular

Device Facts

• Record ID: K970497
• Device Name: PACE 101H
• Applicant: Sulzer Oscor, Inc.
• Product Code: DTE · Cardiovascular
• Decision Date: Jun 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3600
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The external pacemaker PACE 101 H is designed for temporary stimulation of the heart in case of rhythm disturbances and conduction defects. According to present clinical experience, the instrument is especially suited for stimulation of the heart in the following cases: - treatment of patients before an operation, whereby an implantable pacemaker is being inserted; - treatment of tachyarrhythmia; - treatment of special cases of acute myocardial infarction; - treatment of patients after heart surgery.

Device Story

PACE 101 H is an external pacemaker for temporary cardiac stimulation. Device provides electrical pulses to heart to manage rhythm disturbances and conduction defects. Used in clinical settings (e.g., post-surgery, pre-implant, acute MI) by healthcare professionals. Device delivers stimulation therapy to stabilize heart rate; helps maintain hemodynamic stability in patients with transient cardiac issues. Operation involves setting stimulation parameters to provide temporary pacing support.

Clinical Evidence

No clinical data provided; substantial equivalence based on regulatory review of device design and intended use.

Technological Characteristics

External temporary cardiac pacemaker; provides electrical stimulation for rhythm management. Device is a standalone unit for clinical use. Technical specifications and materials not detailed in provided documentation.

Indications for Use

Indicated for temporary cardiac stimulation in patients with rhythm disturbances or conduction defects, including pre-operative preparation for permanent pacemaker implantation, tachyarrhythmia management, acute myocardial infarction, and post-cardiac surgery recovery.

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)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN 4 1997

Ms. Mila Doskocil
Manager, Regulatory Affairs/Quality Assurance
Oscor Medical Corporation
3816 DeSoto Boulevard
Palm Harbor, Florida 34683

Re: K970497
Trade Name: PACE 101 H; External Pacemaker
Regulatory Class: III
Product Code: 74DTE
Dated: February 7, 1997
Received: February 10, 1997

Dear Ms. Doskocil:

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.

If 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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 regulations.

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Page 2 - Ms. Mila Doskocil

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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05/01/97 15:52 813 9376077 SULZER OSCOR ---> DHHS FDA DCRND 002

Page 1 of 1

510(K) Number: K970497

Device Name: Sulzer Oscar Inc. PACE 101 H External Pacemaker

## Indications for Use:

The external pacemaker PACE 101 H is designed for temporary stimulation of the heart in case of rhythm disturbances and conduction defects. According to present clinical experience, the instrument is especially suited for stimulation of the heart in the following cases:

- treatment of patients before an operation, whereby an implantable pacemaker is being inserted;
- treatment of tachyarrhythmia;
- treatment of special cases of acute myocardial infarction;
- treatment of patients after heart surgery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ (Per 21 CRF 801.109)
(Optional Formal 1-2-96)

OR

Over-The-Counter Use

Thomas J. Callahan
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K970497