(66 days)
Not Found
No
The device description focuses on hardware components and basic electrical functions (pacing, sensing, energy attenuation, synchronized cardioversion). There is no mention of AI, ML, algorithms for complex data analysis, or learning capabilities. The performance studies are limited to bench testing of electrical compatibility.
Yes.
The device is used for temporary atrial or ventricular pacing/sensing and/or atrial cardioversion in post-operative cardiac surgery patients, which are therapeutic interventions to manage heart rhythm.
No
The device is described as an Internal Cardioversion System used for temporary pacing, sensing, and atrial cardioversion. It performs cardiac rhythm management functions, rather than diagnosing conditions.
No
The device description clearly outlines hardware components: temporary heart wires, an attenuator box (EDIM), and a cardioversion extension cable. It also requires external hardware like a defibrillator and pacemaker.
Based on the provided information, the Guidant SYNCRUS™ Internal Cardioversion System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Syncrus System Function: The Syncrus System is a device that directly interacts with the patient's heart to provide temporary pacing, sensing, and cardioversion. It is used in vivo (within the living body) to manage cardiac rhythms.
- No Specimen Analysis: The description of the Syncrus System does not mention the analysis of any biological specimens. Its function is to deliver electrical impulses to the heart and sense electrical activity within the heart.
Therefore, the Syncrus System falls under the category of a therapeutic and diagnostic device used directly on the patient, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NHW
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. .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart (left atrium, right or left ventricle, right atrium)
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)
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.
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.
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
§ 870.3680 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.
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
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.
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