(230 days)
Not Found
No
The description focuses on the physical construction and materials of a temporary pacing catheter, with no mention of AI or ML capabilities for sensing, pacing, or any other function.
Yes
The device is indicated for temporary use in ventricular intracardiac pacing and intracardiac sensing, which directly impacts the heart's function and is used for treatment.
No
Explanation: The device is indicated for temporary use in ventricular intracardiac pacing and intracardiac sensing. While sensing can be part of a diagnostic process, the primary stated use is "pacing," which is a therapeutic intervention. The sensing is described in the context of positioning electrodes for pacing, and the device description does not elaborate on using the sensed data for diagnostic purposes beyond determining optimal electrode placement for pacing.
No
The device description clearly details a physical catheter with specific materials, dimensions, and electrodes, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The description clearly states that the INTERIM™ AV Temporary Pacing Catheter is used for "temporary use in ventricular intracardiac pacing and intracardiac sensing." This involves inserting the device into the body (intracardiac) to directly interact with the heart's electrical activity.
- No Specimen Analysis: The device description does not mention the analysis of any biological specimens. Its function is to deliver electrical impulses for pacing and to sense electrical signals within the heart.
Therefore, based on the provided information, the device's function and intended use fall outside the scope of an In Vitro Diagnostic device. It is an invasive medical device used for direct intervention within the body.
N/A
Intended Use / Indications for Use
INTERIM™ AV Temporary Pacing Catheters are indicated for temporary use in ventricular intracardiac pacing and intracardiac sensing in either the atrial or ventricular chambers.
Product codes (comma separated list FDA assigned to the subject device)
LDF
Device Description
The subject device is indicated for temporary use in ventricular intracardiac pacing and intracardiac sensing in either the atrial or ventricular chamber. The catheter consists of radiopaque polymer (PEBAX) tubing encapsulating a braided wire core for optimum torque response. All electrodes, the two atrial ring electrodes and one ventricular ring electrode and a terminal contact tip electrode, are platinum-indium for maximum conductivity. The electrodes terminate at the proximal end of the catheter with 2 mm goldplated pin connectors for connection with the temporary external pacemaker. The INTERIMIM AV Shaped Temporary Pacing Catheter has a Cournand curve at the ventricular tip and a second curve (offset from the Cournand curve by 90°) in the region from 112 mm to 187 mm from the distal tip electrode. This curve or atrial lobe is 20 mm in amplitude and 75 mm wide. The atrial lobe is centered around the atrial ring-electrode pair to conform with the shape of the atrium endocardium. The atrial lobe and the Cournand curve are permanently set by the same manufacturing process which relies only on the PEBAX insulation to maintain the curved shape. No internal stiffening wires are used. The curve is intended to permit positioning of the atrial electrodes in contact or close proximity to the atrial wall for atrial sensing. The Model INT-AV610 is a 6F diameter catheter.
The materials use in the INTERIM™ AV Shaped Temporary Pacing Catheter are: PEBAX® (polyether block amide) thermoplastic insulation, platinum-iridium electrodes, braided stainless steel conductive wire and gold plated pin connectors. Only the PEBAX® insulation and the platinum-iridium electrodes are patient contacting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ventricular intracardiac, atrial chamber, ventricular chamber
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)
Feasibility studies were conducted using a catheter with a similar electrode configuration to that of the subject device. These studies were used to determine the optimal location for the atrial electrodes with regard to atrial sensing potential. Clinical studies using the actual design of the subject device were not performed.
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
Image /page/0/Picture/0 description: The image shows a handwritten word that appears to be "KANITS". The letters are written in a simple, slightly stylized font, with some of the strokes being thicker than others. The overall impression is that of a casual, handwritten note.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitted By: | Cardiac Control Systems, Inc.
3 Commerce Boulevard
Palm Coast, FL. 32164
Telephone: (904) 445-5450
Fax: (904) 445-7226 | | Date Prepared: May 9, 1997
DEC 2 9 1997 | | |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------|--|--|
| Contact Person: | Terry C. McMahon
Vice President, Regulatory Affairs/
Quality Assurance | | | | |
| Device Name: | * | Temporary Cardiac Pacing Catheter
(common name); | | | |
| | * | Temporary Pacemaker Electrode
- 74LDF (classification name); | | | |
| | * | INTERIM™ AV Shaped Temporary Pacing Catheter; Model INT-AV610 | | | |
| Predicate Device: | * | Telectronics (formerly Cordis) Temporary Pervenous with Remote Anode
Market cleared by 510(k) K770214 (03/28/77) | | | |
Indication for Use and Description of Subject Device:
The subject device is indicated for temporary use in ventricular intracardiac pacing and intracardiac sensing in either the atrial or ventricular chamber. The catheter consists of radiopaque polymer (PEBAX) tubing encapsulating a braided wire core for optimum torque response. All electrodes, the two atrial ring electrodes and one ventricular ring electrode and a terminal contact tip electrode, are platinum-indium for maximum conductivity. The electrodes terminate at the proximal end of the catheter with 2 mm goldplated pin connectors for connection with the temporary external pacemaker. The INTERIMIM AV Shaped Temporary Pacing Catheter has a Cournand curve at the ventricular tip and a second curve (offset from the Cournand curve by 90°) in the region from 112 mm to 187 mm from the distal tip electrode. This curve or atrial lobe is 20 mm in amplitude and 75 mm wide. The atrial lobe is centered around the atrial ring-electrode pair to conform with the shape of the atrium endocardium. The atrial lobe and the Cournand curve are permanently set by the same manufacturing process which relies only on the PEBAX insulation to maintain the curved shape. No internal stiffening wires are used. The curve is intended to permit positioning of the atrial electrodes in contact or close proximity to the atrial wall for atrial sensing. The Model INT-AV610 is a 6F diameter catheter.
The materials use in the INTERIM™ AV Shaped Temporary Pacing Catheter are: PEBAX® (polyether block amide) thermoplastic insulation, platinum-iridium electrodes, braided stainless steel conductive wire and gold plated pin connectors. Only the PEBAX® insulation and the platinum-iridium electrodes are patient contacting.
Feasibility studies were conducted using a catheter with a similar electrode configuration to that of the subject device. These studies were used to determine the optimal location for the atrial electrodes with regard to atrial sensing potential. Clinical studies using the actual design of the subject device were not performed.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in black. The symbol is stylized with flowing lines to suggest movement and represents the department's mission related to health and human welfare.
DEC 28 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Terry C. McMahon Vice President, Regulatory Affairs .and Quality Assurance Cardiac Control Systems, Inc. 3 Commerce Boulevard Palm Coast, FL 32164
Re : K971775 INTERIM™ AV Model INT-AV610 Temporary Pacing Catheter Regulatory Class: II (two) Product Code: LDF September 30, 1997 Dated: Received: October 1, 1997
Dear Mr. McMahon:
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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 requlations.
2
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requlation 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows a handwritten word that appears to be "KANITS". The letters are written in a simple, slightly stylized font, with some of the strokes being thicker than others. The overall impression is that of a casual, handwritten note.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitted By: | Cardiac Control Systems, Inc.
3 Commerce Boulevard
Palm Coast, FL. 32164
Telephone: (904) 445-5450
Fax: (904) 445-7226 | | Date Prepared: May 9, 1997
DEC 29 1997 | | | |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-------------------------------------------|--|--|--|
| Contact Person: | | Terry C. McMahon
Vice President, Regulatory Affairs/
Quality Assurance | | | | |
| Device Name: | * | Temporary Cardiac Pacing Catheter
(common name); | | | | |
| | * | Temporary Pacemaker Electrode
- 74LDF (classification name); | | | | |
| | * | INTERIM TM AV Shaped Temporary Pacing Catheter; Model INT-AV610 | | | | |
| Predicate Device: | * | Telectronics (formerly Cordis) Temporary Pervenous with Remote Anode
Market cleared by 510(k) K770214 (03/28/77) | | | | |
Indication for Use and Description of Subject Device:
The subject device is indicated for temporary use in ventricular intracardiac pacing and intracardiac sensing in either the atrial or ventricular chamber. The catheter consists of radiopaque polymer (PEBAX) tubing encapsulating a braided wire core for optimum torque response. All electrodes, the two atrial ring electrodes and one ventricular ring electrode and a terminal contact tip electrode, are platinum-indium for maximum conductivity. The electrodes terminate at the proximal end of the catheter with 2 mm goldplated pin connectors for connection with the temporary external pacemaker. The INTERIMIM AV Shaped Temporary Pacing Catheter has a Cournand curve at the ventricular tip and a second curve (offset from the Cournand curve by 90°) in the region from 112 mm to 187 mm from the distal tip electrode. This curve or atrial lobe is 20 mm in amplitude and 75 mm wide. The atrial lobe is centered around the atrial ring-electrode pair to conform with the shape of the atrium endocardium. The atrial lobe and the Cournand curve are permanently set by the same manufacturing process which relies only on the PEBAX insulation to maintain the curved shape. No internal stiffening wires are used. The curve is intended to permit positioning of the atrial electrodes in contact or close proximity to the atrial wall for atrial sensing. The Model INT-AV610 is a 6F diameter catheter.
The materials use in the INTERIM™ AV Shaped Temporary Pacing Catheter are: PEBAX® (polyether block amide) thermoplastic insulation, platinum-iridium electrodes, braided stainless steel conductive wire and gold plated pin connectors. Only the PEBAX® insulation and the platinum-iridium electrodes are patient contacting.
Feasibility studies were conducted using a catheter with a similar electrode configuration to that of the subject device. These studies were used to determine the optimal location for the atrial electrodes with regard to atrial sensing potential. Clinical studies using the actual design of the subject device were not performed.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized eagle emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The eagle is depicted with flowing lines, suggesting movement and progress.
DEC 28 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Terry C. McMahon Vice President, Regulatory Affairs .and Quality Assurance Cardiac Control Systems, Inc. 3 Commerce Boulevard Palm Coast, FL 32164
Re : K971775 INTERIM™ AV Model INT-AV610 Temporary Pacing Catheter Regulatory Class: II (two) Product Code: LDF September 30, 1997 Dated: Received: October 1, 1997
Dear Mr. McMahon:
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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 requlations.
5
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requlation 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
6
K971775 510(k) Number (if known):
Device Name: INTERIMIN AV Shaped Temporary_Pacing Catheter
Indications For Use:
INTERIM™ AV Temporary Pacing Catheters are indicated for temporary use in ventricular intracardiac pacing and intracardiac sensing in either the atrial or ventricular chambers.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clitshmith
(Division Sign-Off) (Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)