(230 days)
INTERIM™ AV Temporary Pacing Catheters are indicated for temporary use in ventricular intracardiac pacing and intracardiac sensing in either the atrial or ventricular chambers.
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.
The provided document is a 510(k) summary for a medical device called the INTERIM™ AV Shaped Temporary Pacing Catheter, Model INT-AV610. It details the device's description, indications for use, and a comparison to a predicate device. However, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding test sets, ground truth establishment, or comparative effectiveness studies that would typically be performed for an AI/ML powered device.
Based on the content, here's what can be extracted and what is explicitly stated as not performed:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly list quantitative acceptance criteria in a table format for performance metrics. Instead, it relies on substantial equivalence to a predicate device already on the market. The general "performance" indicated is related to the physical design, materials, and a "feasibility study" for optimal electrode placement for atrial sensing.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence | "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." |
| Material Biocompatibility | "Only the PEBAX® insulation and the platinum-iridium electrodes are patient contacting." Materials are listed: PEBAX® (polyether block amide) thermoplastic insulation, platinum-iridium electrodes, braided stainless steel conductive wire, and gold plated pin connectors. Implicitly considered safe and effective due to substantial equivalence. |
| Design/Mechanical | Catheter consists of radiopaque polymer (PEBAX) tubing encapsulating a braided wire core for optimum torque response. Electrodes are platinum-indium for maximum conductivity. Curve is intended for positioning of atrial electrodes in contact or close proximity to the atrial wall for atrial sensing. |
| Substantial Equivalence to Predicate Device | "We have reviewed your Section 510(k) notification... and we have determined the device is substantially equivalent... 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..." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. The document mentions "feasibility studies" but does not specify a sample size for a "test set" in the context of performance evaluation, especially one related to an AI/ML algorithm.
- Data Provenance: Not applicable in the context of AI/ML testing. The "feasibility studies" are mentioned in general terms. No country of origin is specified for these studies, nor whether they were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document does not describe the establishment of ground truth for a test set, as no clinical study or AI/ML algorithm performance evaluation is detailed.
4. Adjudication method for the test set:
- Not applicable. There is no mention of a test set or an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was NOT done. The document explicitly states: "Clinical studies using the actual design of the subject device were not performed." This device is a physical medical instrument, not an AI/ML powered tool that would involve human readers interacting with AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone algorithm performance study was NOT done. This device is a physical medical instrument, not an AI/ML algorithm.
7. The type of ground truth used:
- Not applicable in the AI/ML context. The closest concept might be that the "feasibility studies" determined "optimal location for the atrial electrodes with regard to atrial sensing potential," which implies some form of established physiological understanding or experimental outcome as a "ground truth" for design decisions. This is not the typical "ground truth" used for evaluating AI/ML models (e.g., pathology, outcomes data).
8. The sample size for the training set:
- Not applicable. This document is for a physical medical device, not an AI/ML algorithm that would have a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI/ML algorithm is mentioned.
In summary: This 510(k) submission pertains to a physical temporary cardiac pacing catheter and does not involve AI/ML technology. Therefore, many of the requested details related to AI/ML evaluation (such as test sets, ground truth, MRMC studies, training data) are not present in the document. The device passed regulatory review based on substantial equivalence to an existing predicate device and general feasibility studies for its physical design and function.
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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 BoulevardPalm Coast, FL. 32164Telephone: (904) 445-5450Fax: (904) 445-7226 | Date Prepared: May 9, 1997DEC 2 9 1997 | |||
|---|---|---|---|---|---|
| Contact Person: | Terry C. McMahonVice 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 AnodeMarket 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.
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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.
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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
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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 BoulevardPalm Coast, FL. 32164Telephone: (904) 445-5450Fax: (904) 445-7226 | Date Prepared: May 9, 1997DEC 29 1997 | ||||
|---|---|---|---|---|---|---|
| Contact Person: | Terry C. McMahonVice 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 AnodeMarket 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.
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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
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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)
§ 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.