The Guidant SYNCRUS™ Internal Cardioversion System is indicated for use in post-operative cardiac surgery patients who require temporary atrial or ventricular pacing/sensing and/or atrial cardioversion.

Device Description

The Syncrus System consists of three components:

Three temporary heart wires sutured onto the heart during open-heart surgery. The wires include a unipolar defibrillation heart wire (left atrium), a bipolar pacing/sensing heart wire (right or left ventricle) and a tripolar defibrillation and pacing and sensing heart wire (right atrium).
An attenuator box (External Defibrillator Interface Module EDIM). The EDIM attenuates the delivered energy from a standard, low energy defibrillator by 97% (50 - 360 Joules to 1.3 - 11.5 Joules).
A cardioversion extension cable, which connects the defibrillation heart wires to the EDIM.
The user must supply an external, low-energy defibrillator that is capable of synchronized cardioversion, an external pacemaker, and temporary patient cables to connect the pacemaker to the patient. The Syncrus System is designed to perform the following cardiac rhythm management functions:
Atrial pacing and electrocardiogram sensing
Ventricular pacing and electrocardiogram sensing
Atrial defibrillation using low energy, synchronized cardioversion.

AI/ML Overview

The provided text is a 510(k) summary for the Guidant Syncrus Internal Cardioversion System. It details an acceptance of a Special 510(k) application, which typically focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than explicit acceptance criteria and performance studies in the same way a de novo or PMA application might.

Based on the document, here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) or numerical thresholds that the device had to meet to be deemed acceptable. Instead, the focus of this Special 510(k) is on demonstrating substantial equivalence to a predicate device (Syncrus System K020701).

The "device performance" reported is that the device "met specified requirements" in bench testing, confirming its compatibility with a biphasic defibrillator. However, these "specified requirements" are not detailed in the document.

Acceptance Criteria	Reported Device Performance
Compatibility with biphasic defibrillator (implied)	All bench testing results met specified requirements. The system may be used with a biphasic defibrillator. The EDIM attenuates energy by 97% (50-360 Joules to 1.3-11.5 Joules).
Substantial equivalence to predicate device (K020701)	The subject device is substantially equivalent to the predicate device with regard to intended use, indications, device characteristics, method of use, labeling, materials, and safety features.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "bench testing" was performed. This typically refers to laboratory testing, not human or animal studies with a "test set" in the context of clinical data. Therefore, information about a "sample size" for a test set (e.g., number of patients, cases) or its "data provenance" (country of origin, retrospective/prospective) is not applicable or not provided in this type of submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

As the evaluation was based on bench testing and comparison to a predicate device, there was no "ground truth" to be established by human experts in a clinical context for a "test set" of cases. Therefore, this information is not applicable or not provided.

4. Adjudication Method for the Test Set

Again, given the nature of bench testing and substantial equivalence, a formal "adjudication method" in the clinical sense (e.g., 2+1, 3+1 for resolving discrepancies in expert opinions) for a clinical "test set" is not applicable or not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This question is entirely not applicable. The device described is a medical hardware system (internal cardioversion system), not an AI algorithm designed to assist human readers (e.g., in medical image interpretation). Therefore, an MRMC study or an assessment of AI assistance is irrelevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is also entirely not applicable for the same reasons as point 5. The device is a hardware system, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission was primarily established through:

Bench Testing Results: Verifying the electrical and functional performance of the device components, such as the energy attenuation of the EDIM and compatibility with biphasic defibrillators. The "ground truth" here is the physical and electrical measurements obtained during testing against predefined engineering specifications.
Substantial Equivalence to a Predicate Device: The primary "ground truth" for regulatory approval in a 510(k) is the demonstration that the new device is as safe and effective as a legally marketed predicate device. This involves comparing intended use, indications, device characteristics, method of use, labeling, materials, and safety features.

There was no "expert consensus, pathology, or outcomes data" used to establish ground truth in the context of a clinical study for this 510(k) submission.

8. The Sample Size for the Training Set

Since this involves bench testing and substantial equivalence to a predicate device, there is no "training set" in the context of machine learning. Therefore, the sample size is not applicable or not provided.

9. How the Ground Truth for the Training Set Was Established

As there is no training set, this information is not applicable or not provided.

Summary

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

FEB 1 4 2003 Syncrus System -

Special 510(k)

SECTION 12: 510(k) SUMMARY

This summary of 510(K) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

A. Name, Address, Phone and Fax number of Applicant

Guidant Corporation Cardiac Surgery 3200 Lakeside Drive Santa Clara, CA 95054

Tel: (408) 845-1910 Fax: (408) 845-1855

B. Contact Person Debbie Cogan Requlatory Affairs Associate

C. Date Prepared

December 6, 2002

D. Device Name

Trade Name: Syncrus Internal Cardioversion System Classification Name: ELECTRODE, PACING AND CARDIOVERSION, TEMPORARY, EPICARDIAL Product Classification Code: NHW Device Classification: Class 2 Establishment Registration: 2953148

E. Device Description

The Syncrus System consists of three components:

Three temporary heart wires sutured onto the heart during open-heart . surgery. The wires include a unipolar defibrillation heart wire (left atrium), a bipolar pacing/sensing heart wire (right or left ventricle) and a tripolar defibrillation and pacing and sensing heart wire (right atrium).

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

An attenuator box (External Defibrillator Interface Module EDIM). The EDIM . attenuates the delivered energy from a standard, low energy defibrillator by 97% (50 - 360 Joules to 1.3 - 11.5 Joules).
A cardioversion extension cable, which connects the defibrillation heart wires . to the EDIM.

The user must supply an external, low-energy defibrillator that is capable of synchronized cardioversion, an external pacemaker, and temporary patient cables to connect the pacemaker to the patient. The Syncrus System is designed to perform the following cardiac rhythm management functions:

Atrial pacing and electrocardiogram sensing .
Ventricular pacing and electrocardiogram sensing .
Atrial defibrillation using low energy, synchronized cardioversion. .

F. Intended Use

G. Substantial Equivalence

Guidant proposes that the Syncrus System is substantially equivalent to the Syncrus System (K020701). The subject device is substantially equivalent to the predicate device with regard to intended use, indications, device characteristics, method of use, labeling, materials, and safety feature.

H. Device Testing Results and Conclusions

Guidant Cardiac Surgery performed bench testing to confirm that the Syncrus System may be used with a biphasic defibrillator. All bench testing results met specified requirements.

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 4 2003

Guidant Corporation c/o Ms. Debbie Cogan Regulatory Affairs Associate Guidant Cardiac Surgery 3200 Lakeside Drive Santa Clara, CA 95054

Re: K024071

Trade Name: Guidant Syncrus™ Internal Cardioversion System Regulation Number: 21 CFR 870.3680 Regulation Name: Electrode, Pacing and Cardioversion, Temporary, Epicardial Regulatory Class: Class II (two) Product Code: NHW Dated: January 10, 2003 Received: January 15, 2003

Dear Ms. Cogan:

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 cither 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.

{3}------------------------------------------------

Page 2 -- Ms. Debbie Cogan

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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

VeeertM

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

Enclosure

11 -

{4}------------------------------------------------

STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): K Ω2 4671

Guidant Syncrus™ Internal Cardioversion System Device Name:

Indications For Use:The Guidant SYNCRUS™ Internal Cardioversion System is indicated for use in post-operative cardiac surgery patients who require temporary atrial or ventricular pacing/sensing and/or atrial cardioversion.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use v

OR (Per 21 CFR 801.109) Over-The-Counter Use

(Optional Format 1-2-96)

Quilu Barrn for BDZ

510(k) Number

Regulation Number and Section

§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.

(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.