(352 days)
This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping.
Diagnostic electrophysiology catheters are constructed of a hollow polymer shaft approximately 92 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 the 5 – 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 deflectable. This allows for remote manipulation of the distal tip segment that facilitates precise positioning of the electrode array.
In addition to a range of diameters, 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 the catheters reprocessed by Vanguard are open to the patient bloodstream.
Vanguard receives previously used diagnostic EP catheters from healthcare facilities; cleans, inspects, tests, refurbishes, repackages and sterilizes the devices; and returns them to the healthcare facility.
This document is a 510(k) summary for Vanguard Reprocessed Diagnostic Electrophysiology (EP) Catheters. The company, Vanguard Medical Concepts, Inc., is seeking to market reprocessed versions of these catheters. The summary states that they are substantially equivalent to currently marketed OEM devices.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific numerical targets. Instead, it broadly states that the reprocessed devices are substantially equivalent to the original equipment manufacturer (OEM) devices and perform as intended. The acceptance criteria are implicitly tied to the performance specifications of new, legally marketed diagnostic EP catheters.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Functionality | Equivalent to new OEM diagnostic EP catheters | Performs as intended (demonstrated by functional/performance testing) |
| Safety | Equivalent to new OEM diagnostic EP catheters (biocompatibility) | Safe and effective (demonstrated by biocompatibility testing) |
| Cleaning | Effective cleaning of previously used devices | Validated |
| Sterilization | Effective sterilization of reprocessed devices | Validated |
| Packaging | Maintains sterility and device integrity | Validated |
| Technological | Identical to currently marketed OEM devices' specifications | Possesses the same technological characteristics |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for the test set in terms of the number of reprocessed catheters or tests performed. It states "functional/performance and biocompatibility testing," but no numbers are provided.
Regarding data provenance:
- The devices are "previously used diagnostic EP catheters from healthcare facilities," so the source of the reprocessed devices is retrospective in terms of their initial use.
- The testing itself is presumably prospective in nature, conducted by Vanguard Medical Concepts after reprocessing.
- The country of origin for the data is not explicitly stated, but given the submission to the U.S. FDA, it is highly likely to be U.S.-based or at least conducted to U.S. standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (experts establishing ground truth) is typically relevant for studies involving subjective assessments or interpretation (e.g., image analysis, clinical diagnosis). For device performance testing of a physical medical device like an EP catheter, "ground truth" is typically established by objective measurement against engineering specifications or established standards.
The document does not mention the use of experts to establish a "ground truth" in the way one might for a diagnostic AI algorithm. Device performance is evaluated against predefined functional and safety parameters, which are usually determined by engineering standards and regulatory requirements for predicate devices.
4. Adjudication Method for the Test Set
Not applicable in the context of this device's performance testing as described. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers/experts in subjective assessment tasks. Performance testing of a physical device against objective criteria usually involves direct measurement and comparison, not expert adjudication in this sense.
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
Not applicable. This is a submission for a reprocessed medical device, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this document.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the reprocessed diagnostic EP catheters is implicitly the original design specifications and performance characteristics of the new, legally marketed OEM predicate devices. The testing aims to demonstrate that the reprocessed devices meet these same established performance and safety benchmarks.
- For functional/performance testing: The ground truth would be the expected electrical, mechanical, and physical parameters of a new catheter.
- For biocompatibility testing: The ground truth would be the established biocompatibility profiles for the materials used in such catheters, ensuring no new risks are introduced by reprocessing.
- For cleaning/sterilization: The ground truth would be established microbiological efficacy standards to ensure complete removal of contaminants and pathogens.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth established for it.
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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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is a stylized symbol consisting of three abstract human profiles facing to the right, with flowing lines above and below them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vanguard Medical Concepts, Inc. c/o Ms. Heather Crawford, RAC Director of Regulatory Affairs 5307 Great Oak Drive Lakeland, FL 33815
NOV 1 2004
Re: K012687 - Supplemental Validation Submission Trade Name: See Enclosed List Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: Il (two) Product Code: NLH Dated: August 13, 2001 Received: August 14, 2001
Dear Ms. Crawford:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on August 1, 2002. 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. Iisting 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 - K012687
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,
Blymmmer 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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K012687
F5-OF-005-PS F5-OL-005-PS F5-QA-005-PS F5-OD-005-PS F6-QL-002-TS F6-QA-002-PS F6-QD-002-PS F6-QF-002-TS F6-QF-002-PS F6-QA-005-TS F6-QF-005-TS F6-QL-005-TS F6-QF-005-PS F6-QL-005-PS F6-QA-005-PS F6-OD-005-PS F6-QA-010-PS F6-QD-010-PS F6-QF-010-PS F6-QL-010-PS D6-10DR-P10-FS D7-DR-252-PS D6-DR-252-PS D7-DR-005-PS D7-08DR-002-RT D6-FR-252-PS D6-08DR-002-FS D6-10DR-P10-RT D7-10DR-P10-RT D6-DR-005-PS D6-08DR-002-RT D7-10DR-P10-FS D6-DR-010-PS D7-08DR-002-FS
Enclosure - List of devices (34 models)
(Biosense Webster)
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Indications for Use -
510(k) Number:
Device Name: Yanguard 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.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012684
iv
.
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510(k) Summary of Safety & Effectiveness
| Submitter | Vanguard Medical Concepts, Inc.5307 Great Oak DriveLakeland, FL 33815 |
|---|---|
| Contact | Mr. Mike Sammon, Ph.D.Director, Research and Development(863) 683-8680, extension 228(801) 327-3339 (facsimile)mikes@safe-reuse.com |
| Date | August 13, 2001 |
| Device | Trade Names: Vanguard Reprocessed Diagnostic Electrophysiology Catheters ⇒ Biosense Webster Diagnostic Electrophysiology Catheters Common Name: Diagnostic Electrophysiology (EP) Catheter Classification: 21 CFR 870.1220 – Class II - Electrode recording catheter or electrode recording probe Product Code DRF |
| Predicate Devices | Biosense Webster and Bard Electrophysiology legally marketed diagnostic EP catheters under various 510(k) premarket notifications. |
| Indications for Use | This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping. |
| Continued on next page |
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510(k) Summary of Safety & Effectiveness, Continued
| 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. |
|---|---|
| DeviceDescription | Diagnostic electrophysiology catheters are constructed of a hollow polymer shaft approximately 92 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 the 5 – 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 deflectable. This allows for remote manipulation of the distal tip segment that facilitates precise positioning of the electrode array. In addition to a range of diameters, 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 the catheters reprocessed by Vanguard are open to the patient bloodstream. Vanguard receives previously used diagnostic EP catheters from healthcare facilities; cleans, inspects, tests, refurbishes, repackages and sterilizes the devices; and returns them to the healthcare facility. |
Continued on next page
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510(k) Summary of Safety & Effectiveness, Continued
| TechnologicalCharacteristics | The Vanguard reprocessed diagnostic EP catheters are essentially identical tothe currently marketed OEM devices. No changes are made to the currentlymarketed device's specifications and they possess the same technologicalcharacteristics. Biocompatibility and performance/functional testingdemonstrate that the devices are equivalent and continue to be safe andeffective for their intended use. |
|---|---|
| Test Data | Cleaning, sterilization and packaging validations; and functional/performanceand biocompatibility testing demonstrates that the reprocessed devicesperform as intended 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 (Biosense Webster Fixed Curve andDeflectable catheters) are substantially equivalent to the predicate devicesunder the Federal Food, Drug and Cosmetic Act. |
§ 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).