(87 days)
Not Found
No
The description focuses on adjustable parameters, automatic modes based on pre-defined logic (like adapting A-V delay or adjusting sensitivity based on measured amplitudes), and standard electronic features. There is no mention of learning, training data, or algorithms that adapt over time based on data, which are characteristic of AI/ML.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device "has applications where such pacing modes are indicated for therapeutic, prophylactic, or diagnostic purposes." It also lists numerous conditions for which the device can be used, such as "Sick Sinus Syndrome" and "Complete heart block," all of which are medical conditions that this device aims to treat or manage. The "Device Description" also mentions its use for "treatment of acute brady-arrhythmia".
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "has applications where such pacing modes are indicated for therapeutic, prophylactic, or diagnostic purposes." Additionally, it mentions that the device "can be used to measure atrial or ventricular voltage stimulation thresholds and determine the approximate P wave potentials sensed... and the approximate R wave potentials sensed." These are diagnostic functions.
No
The device description clearly outlines a physical, battery-operated external cardiac pacemaker with adjustable dials, a liquid crystal display, LEDs, and physical connections for pacing leads and extension cables. It is a hardware device with embedded software, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The PACE 203 / PACE 203H / MODEL 3085 is an external pulse generator/temporary pacemaker. Its primary function is to provide electrical stimulation to the heart for therapeutic, prophylactic, or diagnostic purposes related to cardiac rhythm.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It interacts directly with the heart's electrical system via pacing leads.
- Diagnostic Use: While the device has "diagnostic purposes" listed in its intended use, this refers to its ability to measure electrical potentials (P and R waves) and stimulation thresholds in vivo (within the living body) to help guide pacing therapy, not to perform in vitro diagnostic tests on samples.
Therefore, the PACE 203 / PACE 203H / MODEL 3085 is a therapeutic and diagnostic medical device that operates in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PACE 203 / PACE 203H / MODEL 3085 external pulse generator / dual-chamber temporary pacemaker is designed to be used with cardiac pacing lead systems for temporary atrial or ventricular or A-V sequential pacing. The PACE 203 / PACE 203H / MODEL 3085 has applications where such pacing modes are indicated for therapeutic, prophylactic, or diagnostic purposes.
Specific indications include, but are not limited to, the following: Sick Sinus Syndrome; Bradycardia with congestive heart failure; Complete heart block; Acute myocardial infarction complicated by heart block; Sinus bradycardia; Cardiac arrest with ventricular asystole; Atrial and/or ventricular ectopic arrhythmia; Postoperatively after cardiac surgery; Temporary application during implantation or exchange of permanent pacemaker. Indication for atrial overdrive stimulation (rapid atrial pacing): Supra-ventricular tachycardia. The PACE 203 / PACE 203H / MODEL 3085 can be used to measure atrial or ventricular voltage stimulation thresholds and determine the approximate P wave potentials sensed via the atrial pacing lead electrodes and the approximate R wave potentials sensed via the ventricular pacing lead electrodes.
The XI.TME and XI.RAC Extension Cables are used with external pulse generators / temporary cardiac pacemakers and pacing system analyzers.
Product codes (comma separated list FDA assigned to the subject device)
DTE
Device Description
The PACE 203 / PACE 203H / MODEL 3085 is a dual-chamber external cardiac pacemaker with atrial controlled timing for routine temporary heart stimulation. Synchronous and asynchronous modes of atrial, ventricular and A-V sequential stimulation are available for treatment of acute brady- arrhythmia and for pre-, intra-, and post-operative stimulation of the heart. The stimulation parameters are easily adjustable by rotating dials through a wide range of values.
The PACE 203 / PACE 203H / MODEL 3085 offers the possibility for atrial overdrive stimulation, or rapid atrial pacing, for terminating supra-ventricular tachycardia. The rate of the overdrive stimulation is adjustable within a wide range and is independent of the selected stimulation rate. The overdrive rate can be determined before and changed during overdrive therapy. If required, overdrive stimulation can be initiated with the touch of a button. The overdrive stimulation is indicated optically and acoustically.
The battery operated device can be affixed to the patient's arm by the arm strap included. The housing is protected against accidental liquid spills.
The functional design of the PACE 203 / PACE 203H / MODEL 3085 allows safe and easy operation with regards to all requirements of DDD stimulation.
The PACE 203 / PACE 203H / MODEL 3085 further offers the following features:
• During battery changes, stimulation will be maintained for at least 30 s.
• A non-volatile memory keeps any desired stand-by program ready for use, even if the device is shut off.
• A standard program, which can be individualized, is available for each primary pacing mode.
• An emergency program can be "called up" by pressing an emergency key.
• A burst- and a ramp function are available for atrial overdrive-stimulation.
• An Unlock/Lock button protects against accidental change of the set parameters.
• The set parameters and (error) messages are shown on a liquid crystal display.
• The detection of the intrinsic heart activity as well as the emission of stimulation impulses are shown separately by blinking LEDs for both atrium and ventricle. Additionally, a beep-tone can be switched on whenever desired.
• System malfunctions that occur are indicated optically and acoustically.
• A lead surveillance system indicates interruptions and short circuits.
• When a battery change is required, optical and acoustic alerts are provided.
• During dual chamber pacing, an automatic mode for adapting A-V delay, maximum tracking rate (MTR), and PVARP is available.
• An automatic mode for adjusting the sensitivity in both the atrium and ventricle may be chosen.
• A Pause function is available for easy determination and measurement of the patient's intrinsic heart activity.
The Series XI Extension Cables support proper connection of the PACE 203 / PACE 203H / Model 3085 to various types of pacing lead systems (accessories).
The Series AS Arm Straps ensure proper attachment of the PACE 203 / PACE 203H / Model 3085 to the patient's arm (optional accessory).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary Bench Testing: PACE 203 / PACE 203H / MODEL 3085 and MEDTRONIC MODEL 5330 were subject to bench testing using a simulator. Bench testing compared the performance of both devices against their specifications and determined substantial equivalence. Bench testing also validated safety and effectiveness of the insulated connector terminals matching the protected pins of the Series XI Extension Cables.
Summary Clinical Evaluation: The clinical evaluation validated safety and effectiveness of the PACE 203 / PACE 203H / MODEL 3085. No serious adverse event related to the PACE 203 / PACE 203H / MODEL 3085 occurred during the course of the investigation. The optional AUTO SENSE function reliably tracks P wave and R wave peak amplitudes and adjusts the sensitivities in the atrial and, respectively, ventricular channel accordingly. Based on the recordings obtained, the PACE 203 / PACE 203H / MODEL 3085 provided correct sensing, pacing and A-V sequential demand pacing (DDD) performance without failure.
Conclusion: The results of the bench testing and the clinical evaluation verified the correct function of the PACE 203 / PACE 203H / MODEL 3085, and validated that the PACE 203 / PACE 203H / MODEL 3085 is as safe, as effective, and performs as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K910237, K893633, K970497, K923621
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.3600 External pacemaker pulse generator.
(a)
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.(b)
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.
0
Image /page/0/Picture/1 description: The image shows the text "K020896 page 1 of 4" in a handwritten style. The text appears to be a page number or document identifier. The handwriting is somewhat rough, giving it a casual or informal appearance.
Image /page/0/Picture/2 description: The image shows the logo for OSYPKA MEDICAL. The logo consists of a square with a circle inside it on the left, followed by the text "OSYPKA MEDICAL" in a large, sans-serif font. Below the text is the text "Berlin, Germany • San Diego, California, USA" in a smaller font.
510(k) Summary
Page 1 of 4
510(k) Summary
| Date: | 15 March 2002 | ||
|---|---|---|---|
| Submitter: | Osypka Medical GmbH | ||
| Grossbeerenstrasse 184, 12277 Berlin, Germany | |||
| Contact Person: | Markus Osypka, Ph.D., President | ||
| Osypka Medical, Inc. | |||
| 7463 Draper Avenue, La Jolla, California 92037, USA | |||
| Phone: (858) 459-2312 | Fax: (858) 459-2353 | ||
| Device Trade | |||
| Names: | OSCOR™ | ||
| ST. JUDE MEDICAL™ | |||
| CARDIOTRONIC™ | |||
| Accessories including: | PACE 203™ / PACE 203H™ | ||
| MODEL 3085 | |||
| PACE 203™ | |||
| XI.TME / XI.RAC Extension Cables; | |||
| AS.45 Arm Strap; | |||
| Quick Reference. | and Accessories; | ||
| and Accessories; | |||
| and Accessories; | |||
| Common / | |||
| Usual Names: | Dual-Chamber External Pulse Generator, Dual-Chamber Temporary Cardiac | ||
| Pacemaker; | |||
| Extension Cable, Patient Cable. Arm Strap. | |||
| Classification | |||
| Names: | 870.3600 | ||
| 870.2900 | Pulse-Generator, Pacemaker, External | ||
| Cables, Transducer and Electrode | |||
| Predicate | |||
| Devices: | K910237 | MEDTRONIC™ MODIFIED MODEL 5330 | |
| A-V Demand Pulse Generator | |||
| K893633 | MEDTRONIC™ MODEL 5330 | ||
| External A-V Sequential Demand Pulse Generator | |||
| K970497 | OSCOR™ D-1 / D-3 / D-5 / D-9 / D-10 Extension Cables | ||
| PACE 101H Arm Strap | |||
| K923621 | OSCOR™ DX-2 / D-5 / D-10 Extension Cables | ||
| PACE 100H Arm Strap | |||
| Device | |||
| Description: | The PACE 203 / PACE 203H / MODEL 3085 is a dual-chamber external | ||
| cardiac pacemaker with atrial controlled timing for routine temporary heart | |||
| stimulation. Synchronous and asynchronous modes of atrial, ventricular and | |||
| A-V sequential stimulation are available for treatment of acute brady- | |||
| arrhythmia and for pre-, intra-, and post-operative stimulation of the heart. The | |||
| stimulation parameters are easily adjustable by rotating dials through a wide | |||
| range of values. |
The PACE 203 / PACE 203H / MODEL 3085 offers the possibility for atrial
overdrive stimulation, or rapid atrial pacing, for terminating supra-ventricular
tachycardia. The rate of the overdrive stimulation is adjustable within a wide
range and is independent of the selected stimulation rate. The overdrive rate
can be determined before and changed during overdrive therapy. If required,
overdrive stimulation can be initiated with the touch of a button. The overdrive
stimulation is indicated optically and acoustically. | | |
1
Image /page/1/Picture/0 description: The image shows the logo for OSYPKA MEDICAL. The logo consists of a square with a circle inside on the left, followed by the text "OSYPKA MEDICAL" in a sans-serif font. Below the text is the location "Berlin, Germany • San Diego, California, USA".
| The battery operated device can be affixed to the patient's arm by the arm
| strap included. The housing is protected against accidental liquid spills. |
|---|
| The functional design of the PACE 203 / PACE 203H / MODEL 3085 allows |
| safe and easy operation with regards to all requirements of DDD stimulation. |
| The PACE 203 / PACE 203H / MODEL 3085 further offers the following |
| features: |
| • During battery changes, stimulation will be maintained for at least 30 s. |
| • A non-volatile memory keeps any desired stand-by program ready for |
| use, even if the device is shut off. |
| • A standard program, which can be individualized, is available for each |
| primary pacing mode. |
| • An emergency program can be "called up" by pressing an emergency key. |
| • A burst- and a ramp function are available for atrial overdrive-stimulation. |
| • An Unlock/Lock button protects against accidental change of the set |
| parameters. |
| • The set parameters and (error) messages are shown on a liquid crystal |
| display. |
| • The detection of the intrinsic heart activity as well as the emission of |
| stimulation impulses are shown separately by blinking LEDs for both |
| atrium and ventricle. Additionally, a beep-tone can be switched on |
| whenever desired. |
| • System malfunctions that occur are indicated optically and acoustically. |
| • A lead surveillance system indicates interruptions and short circuits. |
| • When a battery change is required, optical and acoustic alerts are |
| provided. |
| • During dual chamber pacing, an automatic mode for adapting A-V delay, |
| maximum tracking rate (MTR), and PVARP is available. |
| • An automatic mode for adjusting the sensitivity in both the atrium and |
| ventricle may be chosen. |
| • A Pause function is available for easy determination and measurement of |
| the patient's intrinsic heart activity. |
| The Series XI Extension Cables support proper connection of the PACE 203 / |
| PACE 203H / Model 3085 to various types of pacing lead systems |
The Series AS Arm Straps ensure proper attachment of the PACE 203 / PACE 203H / Model 3085 to the patient's arm (optional accessory).
(accessories).
2
Image /page/2/Picture/8 description: The image shows the logo for Osypka Medical. The logo consists of a square with a circle inside on the left, followed by the text "OSYPKA MEDICAL" in a sans-serif font. Below the text is the location of the company, which is "Berlin, Germany • San Diego, California, USA".
K020896
page 3 of
510(k) Summary
Page 3 of 4
| Intended Use: | The PACE 203 / PACE 203H / MODEL 3085 external pulse generator / dual-
chamber temporary pacemaker is designed to be used with cardiac pacing
lead systems for temporary atrial or ventricular or A-V sequential pacing.
The PACE 203 / PACE 203H / MODEL 3085 has applications where such
pacing modes are indicated for therapeutic, prophylactic, or diagnostic
purposes.
Specific indications include, but are not limited to, the following:
Sick Sinus Syndrome; Bradycardia with congestive heart failure; Complete heart block; Acute myocardial infarction complicated by heart block; Sinus bradycardia; Cardiac arrest with ventricular asystole; Atrial and/or ventricular ectopic arrhythmia; Postoperatively after cardiac surgery; Temporary application during implantation or exchange of permanent pacemaker. Indication for atrial overdrive stimulation (rapid atrial pacing): Supra-ventricular tachycardia. The PACE 203 / PACE 203H / MODEL 3085 can be used to measure atrial
or ventricular voltage stimulation thresholds and determine the approximate
P wave potentials sensed via the atrial pacing lead electrodes and the
approximate R wave potentials sensed via the ventricular pacing lead
electrodes. |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technology: | The PACE 203 / PACE 203H / MODEL 3085 and accessories and the
MEDTRONIC MODEL 5330 have the same fundamental technological
characteristics in design, material, and energy source.
The aforementioned devices are stand-alone devices that provide temporary
atrial or ventricular or A-V sequential pacing therapy, including a demand
ventricular pacing function. The aforementioned devices are battery powered
and include defibrillation shock protection and a safety-lock on-off switch.
Indicator lights flash to show atrial and ventricular sensing and atrial and
ventricular pacing functions.
Compared to the MEDTRONIC MODEL 5330, the PACE 203 / PACE 203H /
MODEL 3085 adds the following functions: Atrial sensing (demand atrial pacing); Optional P Wave / R Wave peak amplitude measurements upon a key stroke; Optional AUTO SENSE function; |
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
く . ... ... ...................................................................................................................................................................... . Osypka Medical GmbH . Osypka Medical Gmbh
Grossbeerenstrasse 184 • 12277 Berlin • Germany
Phone +49 (30) 741-6058 • Fax +49 (30) 7479-2507
3
510(k) Summary
Page 4 of 4
| and the destrative development of the di return desire de demande de demande de demande de demande de de de de de de de de de de de de de de de de de de de de de de de de de | ||
|---|---|---|
| . |
- | |
Berlin, Germany · San Diego, California, USA
| • | Continuous display of battery condition during operation; |
|---|---|
| • | After at least 30 minutes of operation, continuous pacing therapy is maintained during a battery change for at least 30 seconds. |
| • | Insulated connector terminals matching the protected pins of the Series XI Extension Cables (meet 21 CFR Part 898 performance standard). |
| Summary Bench Testing: | PACE 203 / PACE 203H / MODEL 3085 and MEDTRONIC MODEL 5330 were subject to bench testing using a simulator. Bench testing compared the performance of both devices against their specifications and determined substantial equivalence. |
| Bench testing also validated safety and effectiveness of the insulated connector terminals matching the protected pins of the Series XI Extension Cables. | |
| Summary Clinical Evaluation: | The clinical evaluation validated safety and effectiveness of the PACE 203 / PACE 203H / MODEL 3085. |
| No serious adverse event related to the PACE 203 / PACE 203H / MODEL 3085 occurred during the course of the investigation. | |
| The optional AUTO SENSE function reliably tracks P wave and R wave peak amplitudes and adjusts the sensitivities in the atrial and, respectively, ventricular channel accordingly. | |
| Based on the recordings obtained, the PACE 203 / PACE 203H / MODEL 3085 provided corrects sensing, pacing and A-V sequential demand pacing (DDD) performance without failure. | |
| Conclusion: | The results of the bench testing and the clinical evaluation verified the correct function of the PACE 203 / PACE 203H / MODEL 3085, and validated that the PACE 203 / PACE 203H / MODEL 3085 is as safe, as effective, and performs as well as the predicate device. |
1
OSYPKA MEDICAL, the company logo, PACE 203, PACE 203H and CARDIOTRONIC are trademarks of OSYPKA MEDICAL GMBH, Berlin (Germany), and OSYPKA MEDICAL, INC., La Jolla, CA. OSCOR is a trademark of OSCOR, INC., Palm Harbor, FL.
ST. JUDE MEDICAL is a trademark of ST. JUDE MEDICAL INC., St. Paul, MN.
MEDTRONIC is a trademark of MEDTRONIC, INC., Minneapolis, MN.
Osypka Medical GmbH Grossbeerenstrasse 184 • 12277 Berlin • Germany Phone +49 (30) 741-6058 • Fax +49 (30) 7479-2507
4
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol that resembles three stylized human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 4 2002
Osypka Medical, Inc. c/o Markus J. Osypka, Ph.D. President 7463 Draper Avenue La Jolla, CA 92037
Re: K020896 Trade Name: Oscor™ Pace 203/203H St. Jude Medical™ Model 3085 Cardiotronic™ Pace 203 XI.TME and XI.RAC Extension Cables Regulation Number: 21 CFR 870.3600 Regulation Name: Pulse Generator, Pacemaker, External Regulatory Class: Class III (three) Product Code: DTE Dated: March 15, 2002 Received: March 19, 2002
Dear Dr. Osypka:
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.
5
Page 2 - Markus J. Osypka, Ph.D.
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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Klat Tille
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
K020896 510(k) Number: OSCOR PACE 203 / PACE 203H Device Names: ST. JUDE MEDICAL MODEL 3085 CARDIOTRONIC PACE 203 XI.TME and XI.RAC Extension Cables
Indications For Use:
The PACE 203 / PACE 203H / MODEL 3085 external pulse generator / temporary pacemaker is designed to be used with cardiac pacing lead systems for temporary atrial or A-V sequential pacing. The PACE 203 / PACE 203H / MODEL 3085 has applications where such pacing modes are indicated for therapeutic, prophylactic, or diagnostic purposes.
Specific indications include, but are not limited to, the following:
- . Sick Sinus Syndrome;
- Bradycardia with congestive heart failure; .
- Complete heart block; .
- Acute myocardial infarction complicated by heart block; .
- . Sinus bradycardia;
- Cardiac arrest with ventricular asystole; .
- Atrial and/or ventricular ectopic arrhythmia; .
- . Postoperatively after cardiac surgery;
- Temporary application during implantation or exchange of permanent pacemaker. .
Indication for atrial overdrive stimulation (rapid atrial pacing):
- Supra-ventricular tachycardia. .
The PACE 203 / PACE 203H / MODEL 3085 can be used to measure atrial or ventricular voltage stimulation thresholds and determine the approximate P wave potentials sensed via the atrial pacing lead electrodes and the approximate R wave potentials sensed via the ventricular pacing lead electrodes.
The XI.TME and XI.RAC Extension Cables are used with external pulse generators / temporary cardiac pacemakers and pacing system analyzers.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109
Or
Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________
Division of Cardiovascular & Respiratory Devices
510(k) Number K020896
(Optional Format 1-2-96)