(351 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.
The provided document is a 510(k) summary for Vanguard Reprocessed Diagnostic Electrophysiology Catheters. It outlines the safety and effectiveness of reprocessed medical devices compared to their original equipment manufacturer (OEM) counterparts. However, it does not describe acceptance criteria or a study that proves a device meets those criteria in the context of AI/ML performance metrics (e.g., sensitivity, specificity, AUC).
Instead, this document focuses on demonstrating substantial equivalence for reprocessed medical devices, which follows a different set of validation requirements. The "acceptance criteria" and "study" described in the document relate to the validation of the reprocessing procedure itself, ensuring the reprocessed devices perform as intended and are safe for use, similar to new devices.
Therefore, many of the requested items (e.g., sample size for test/training set, number of experts, adjudication method for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission.
Here's an analysis of the information that can be extracted or inferred from the provided text, framed within the context of reprocessed medical device validation:
Acceptance Criteria and Study for Vanguard Reprocessed Diagnostic Electrophysiology Catheters
The document describes the validation of reprocessed single-use diagnostic electrophysiology catheters. The core "acceptance criterion" is demonstrations of substantial equivalence to legally marketed predicate devices, meaning the reprocessed devices are safe and effective for their intended use. The "study" involves various tests to confirm that the reprocessed devices maintain the performance and safety characteristics of the original devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion (for Reprocessed Device) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Technological Characteristics: Essentially identical to OEM, no changes to specifications. | "Vanguard reprocessed diagnostic EP catheters are essentially identical to the currently marketed OEM devices. No changes are made to the currently marketed device’s specifications and they possess the same technological characteristics." (Page 6) |
| Biocompatibility: Safe for patient contact after reprocessing. | "Biocompatibility and performance/functional testing demonstrate that the devices are equivalent and continue to be safe and effective for their intended use." (Page 6) |
| Functional/Performance: Perform as intended after reprocessing. | "Functional/performance testing demonstrates that the reprocessed devices perform as intended and are safe and effective." (Page 6) |
| Cleaning Effectiveness: Free from patient contaminants. | "Cleaning... validations" confirm effectiveness of the cleaning process. (Page 6) |
| Sterilization Assurance: Sterile after reprocessing. | "Sterilization... validations" confirm the sterility of the reprocessed devices. (Page 6) |
| Packaging Integrity: Maintain sterility until use. | "Packaging validations" confirm the integrity of the packaging. (Page 6) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each specific test (e.g., how many catheters were tested for biocompatibility, or functional performance). The document refers to "various models" (21 models listed on Page 3) of catheters being reprocessed and validated.
- Data Provenance: The devices are "previously used diagnostic EP catheters from healthcare facilities" (Page 5). This would imply retrospective data (i.e., used devices collected after patient use). The country of origin of the hospitals/facilities is not specified, but the submission is to the U.S. FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept of "experts establishing ground truth" is not directly applicable in the AI/ML sense to this document. The "ground truth" for reprocessed devices is, by definition, the performance and safety of the original new device. The validation tests (functional, biocompatibility, sterility) are designed to confirm that the reprocessed device meets these established standards, which are based on engineering specifications and regulatory requirements, rather than expert consensus on a diagnostic outcome.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is typically used in reader studies for AI/ML validation. Validation of reprocessed medical devices relies on objective, measurable physical and chemical tests.
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 document is not evaluating AI. It is assessing the substantial equivalence of reprocessed physical medical devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document is not about an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The inherent "ground truth" or benchmark for these reprocessed devices is the performance and safety specifications of the original, new OEM devices. Validation tests (functional, mechanical, material, chemical, biological) are conducted to demonstrate that the reprocessed devices conform to these established benchmarks.
8. The sample size for the training set:
- Not applicable in the AI/ML sense. There is no training set for an algorithm here.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of what the document does provide:
The document describes a regulatory submission (510(k)) to the FDA for reprocessed electrophysiology catheters. The validation provided ("supplemental validation data") aims to demonstrate that these reprocessed devices are substantially equivalent to legally marketed predicate (new) devices. This is achieved through various tests for:
- Cleaning effectiveness
- Sterilization effectiveness
- Packaging integrity
- Biocompatibility
- Functional and performance characteristics (ensuring they operate like the original devices and meet specifications).
The core finding is that the "Vanguard Reprocessed Diagnostic EP Catheters... are substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act" (Page 6), based on the validation data.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. 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: K012688 - 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: 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 July 31, 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 - K012688
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 (QS) 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,
Blimimo 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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K012688
Enclosure - List of devices (21 models)
(Bard Viking)
| 400004 | 400005 | 400006 | 400102 |
|---|---|---|---|
| 400091P | 400044 | 400045 | 400046 |
(Bard Woven)
| 200066 | 200067 | 200068 | 200069 |
|---|---|---|---|
| 200201P | 8567 | 200624 | 200728 |
| 006692P | 002943P | 200202 | 200472 |
| 006245P |
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Indications for Use
Kol2688 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.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012688
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 ⇒ Bard Electrophysiology Diagnostic Electrophysiology CathetersCommon Name: Diagnostic Electrophysiology (EP) CatheterClassification: 21 CFR 870.1220 – Class II - Electrode recording catheter or electrode recording probeProduct 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. |
|---|---|
| Device Description | 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 (Bard Woven Fixed Curve andVikingTM Fixed Curve catheters) are substantially equivalent to the predicatedevices under 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).