(67 days)
This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping.
Reprocessed diagnostic electrophysiology catheters are constructed of a hollow polymer shaft approximately 65 to 125 cm in length that terminates with a hand piece or connector. A range of diameters is available; the most clinically utilized sizes are 4 – 7 French. Various configurations of distal platinum alloy electrodes are wired to a proximal connector for bi-directional transmission of electrical signals (pacing and recording). The connector is attached to an interconnecting cable that interfaces with various standard types of sensing, recording, stimulation and pacing equipment. The catheters are available with various distal curves, either fixed or steerable for remote manipulation of the distal tip segment that facilitates precise positioning of the electrode array.
The catheters are also available in a variety of electrode configurations, connector compatibility and torque-transmitting properties that are selected by the clinician based on preference and/or indication. The shaft polymer is manufactured with additives (typically barium sulfate) that enhance the catheter's radiopacity to enable positioning under fluoroscopic guidance. No lumens of catheters reprocessed by Vanguard are open to the patient bloodstream.
Vanguard collects previously used diagnostic EP catheters from healthcare facilities; cleans, inspects, tests, applies a unique serial number, packages, labels, and sterilizes each device for return to the healthcare facility for an additional clinical use.
This document describes a 510(k) submission for reprocessed diagnostic electrophysiology (EP) catheters. It concerns the substantial equivalence of reprocessed devices to their original equipment manufacturer (OEM) counterparts. The validation studies focused on demonstrating that the reprocessed devices perform as intended and are safe and effective, upholding the original technological characteristics and intended use.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics in a typical AI/software device context. Instead, it states that the reprocessed devices were validated to perform as intended and are safe and effective. The acceptance criteria are implicitly linked to maintaining the original device's safety, effectiveness, and technological characteristics after reprocessing.
| Acceptance Criteria Category | Description | Reported Device Performance |
|---|---|---|
| Cleaning Validation | Ensuring the devices are adequately cleaned after single use and before reprocessing to remove biological and other contaminants. | Validation studies demonstrated adequate cleaning. |
| Sterilization Validation | Confirming the reprocessed devices achieve appropriate sterility levels for medical use. | Validation studies demonstrated adequate sterilization. |
| Packaging Validation | Verification that the packaging maintains sterility and device integrity until use. | Validation studies demonstrated adequate packaging. |
| Performance Testing | Assessment that the reprocessed devices maintain the functional performance (e.g., electrical signal transmission, mechanical properties, steerability, radiopacity) of the OEM device. | "Performance testing demonstrate[s] that the reprocessed devices perform as intended." "Vanguard Reprocessed Diagnostic EP Catheters are essentially identical to the Original Equipment Manufacturer (OEM) devices. No changes are made to the device materials or specifications and the reprocessed catheters possess identical technological characteristics." |
| Biocompatibility Testing | Ensuring that the reprocessed materials remain biocompatible and do not elicit adverse reactions in patients. | "Biocompatibility testing demonstrate[s] that the reprocessed devices... are safe and effective." |
| Indications for Use | The reprocessed device must meet the same indications for use as the original device: "temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping." | The reprocessed devices were deemed substantially equivalent for the stated indications for use. |
| Contraindications | The reprocessed device must have the same contraindications as the original device. | Same contraindications as the OEM device apply. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of an AI/software evaluation. The validation described is for reprocessed physical medical devices (catheters). The "sample size" would refer to the number of reprocessed catheters subjected to cleaning, sterilization, packaging, performance, and biocompatibility testing. This specific number is not provided in the document.
Data provenance (e.g., country of origin, retrospective/prospective) is also not specified for the testing. The catheters are collected from "healthcare facilities" without further geographic detail. The nature of the testing is typically prospective (i.e., newly reprocessed devices are tested under controlled conditions).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device and submission. "Ground truth" established by experts is typically relevant for interpretative tasks (e.g., image analysis, diagnosis) in AI/software evaluations. For reprocessed physical devices, "ground truth" relates to objective physical, chemical, and biological measurements and material integrity, not expert interpretation of outputs.
4. Adjudication Method for the Test Set
This information is not applicable to this type of device and submission. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert interpretations, which is not the nature of validation for a physical reprocessed medical device.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses human performance with and without AI assistance and is irrelevant for the validation of a reprocessed physical catheter.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This concept applies to AI algorithms, not reprocessed physical medical devices.
7. The Type of Ground Truth Used
For this device, the "ground truth" is established through:
- Objective Measurements: Directly measuring physical properties (e.g., dimensions, flexibility, electrical conductivity, torque), chemical integrity, and sterility of the reprocessed devices.
- Biological Testing: Biocompatibility tests to ensure safety when in contact with biological systems.
- Performance Specifications: Comparison against the known specifications and performance of the OEM, predicate device.
It is not based on expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic AI systems.
8. The Sample Size for the Training Set
This information is not applicable. This submission concerns a physical medical device, not an AI algorithm utilizing a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. There is no "training set" for this type of device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 2004 NOV
Vanguard Medical Concepts, Inc. c/o Ms. Heather Crawford, RAC Director of Regulatory Affairs 5307 Great Oak Drive Lakeland, FL 33815
Re: K030114 - Supplemental Validation Submission Trade Name: See Enclosed List Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: II (two) Product Code: NLH Dated: January 10, 2003 Received: January 13, 2003
Dear Ms. Crawford:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on March 21, 2003. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 devices in the Federal Register.
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Page 2 - K030114
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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 applicable 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.
The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.
If you desire specific advice for your devices 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,
B.R. Mcmemor for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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Indications for Use
510(k) Number:
Device Name: Vanguard Reprocessed Diagnostic Electrophysiology Catheters
Indications for Use:
This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
sion of Cardiovascular Devices
510(k) Number K030114
Over-the-Counter Use
(Optional Format 1-2-96)
iv
009
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K030114
| Family (Daig) | Catalog # |
|---|---|
| Supreme™ | 401955 |
| Supreme™ | 401954 |
| Supreme™ | 401893 |
| Supreme™ | 401892 |
| Supreme™ | 401891 |
| Supreme™ | 401890 |
| Supreme™ | 401864 |
| Supreme™ | 401863 |
| Supreme™ | 401859 |
| Supreme™ | 401453 |
| Supreme™ | 401451 |
| Supreme™ | 401445 |
| Supreme™ | 401443 |
| Supreme™ | 401442 |
| Supreme™ | 401441 |
| Supreme™ | 401430 |
| Response™ | 401399 |
| Response™ | 401381 |
| Response™ | 401380 |
| Response™ | 401357 |
| Response™ | 401353 |
| Response™ | 401329 |
| Response™ | 401311 |
| Response™ | 401305 |
| Response™ | 401293 |
| Response™ | 401227 |
| Response™ | 401226 |
| Response™ | 401223 |
| Response™ | 401222 |
| Response™ | 401210 |
| Response™ | 401207 |
:
Enclosure - List of devices (31 models)
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MAR 2 1 2003
510(k) Summary of Safety & Effectiveness
| Submitter | Vanguard Medical Concepts, Inc.5307 Great Oak DriveLakeland, FL 33815 |
|---|---|
| Contact | Mike Sammon, Ph.D.Director, Research and Development(863) 904-1628(801) 327-3339 (facsimile)msammon@safe-reuse.com |
| Date | January 10, 2002 |
| Device | Trade Names: Vanguard Reprocessed Diagnostic Electrophysiology (EP) Catheters Common Name: Electrode Recording Catheter, Diagnostic Electrophysiology (EP) Catheter Classification: 21 CFR 870.1220 - Class II - Catheter, Electrode Recording, or Probe, Electrode Recording Product Code DRF |
| PredicateDevices | Daig™ Response™ Fixed Curve Diagnostic Catheters (K002976) Daig™ Supreme™ Fixed Curve Diagnostic Catheters (K002976) Vanguard Reprocessed Diagnostic EP Catheters (K012687, K012688, K022316, K023180) |
| Indications forUse | This catheter is intended for temporary intracardiac pacing and recordingduring electrophysiology studies, e.g. evaluation of arrhythmias or cardiacmapping. |
| Contra-indications | Patients with active systemic infection. Patients with prosthetic valves. Retrograde approach in patients with aortic valve replacement. Transseptal approach in patients with left atrial thrombus or myxoma, or interatrial baffle patch. Diagnostic EP catheters are not intended for electrical ablation. Diagnostic EP catheters are not intended for coronary artery mapping. |
| DeviceDescription | Reprocessed diagnostic electrophysiology catheters are constructed of ahollow polymer shaft approximately 65 to 125 cm in length that terminateswith a hand piece or connector. A range of diameters is available; the mostclinically utilized sizes are 4 – 7 French. Various configurations of distalplatinum alloy electrodes are wired to a proximal connector for bi-directionaltransmission of electrical signals (pacing and recording). The connector isattached to an interconnecting cable that interfaces with various standardtypes of sensing, recording, stimulation and pacing equipment. The cathetersare available with various distal curves, either fixed or steerable for remotemanipulation of the distal tip segment that facilitates precise positioning ofthe electrode array. |
| The catheters are also available in a variety of electrode configurations,connector compatibility and torque-transmitting properties that are selectedby the clinician based on preference and/or indication. The shaft polymer ismanufactured with additives (typically barium sulfate) that enhance thecatheter's radiopacity to enable positioning under fluoroscopic guidance.No lumens of catheters reprocessed by Vanguard are open to the patientbloodstream. | |
| Vanguard collects previously used diagnostic EP catheters from healthcarefacilities; cleans, inspects, tests, applies a unique serial number, packages,labels, and sterilizes each device for return to the healthcare facility for anadditional clinical use. | |
| TechnologicalCharacteristics | Vanguard Reprocessed Diagnostic EP Catheters are essentially identical tothe Original Equipment Manufacturer (OEM) devices. No changes are madeto the device materials or specifications and the reprocessed catheters possessidentical technological characteristics. |
| Test Data | Cleaning, sterilization, and packaging validations; and performance andbiocompatibility testing demonstrate that the reprocessed devices perform asintended and are safe and effective. |
| Conclusion | Based on the information provided herein and the 510(k) "SubstantialEquivalence" Decision Making Process Chart, we conclude that the VanguardReprocessed Diagnostic EP Catheters are substantially equivalent to theirpredicate devices under the Federal Food, Drug and Cosmetic Act. |
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510(k) Summary of Safety & Effectiveness, Continued
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).