(85 days)
This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping.
Explorer 360™ diagnostic electrophysiology catheters are constructed of a 6 French hollow polymer shaft 100 cm in length. The quadripolar catheters are available with various fixed distal curves and electrode spacing configurations. The polymer shaft is manufactured with additives (typically barium sulfate) that enhance its radiopacity during fluoroscopic positioning of the catheter. The platinum alloy electrodes are sealed to the distal catheter and internally wired to a proximal shielded Nexus connector for bi-directional transmission of electrical signals (pacing and recording). The connector is designed to be attached to a compatible instrument cable that interfaces with various standard types of sensing, recording, stimulation, and pacing equipment.
Vanguard receives previously used diagnostic EP catheters from healthcare facilities; cleans, inspects, tests, refurbishes, applies a unique serial number, repackages, and sterilizes the devices; and returns them to the healthcare facility.
This document is a 510(k) summary for the Vanguard Reprocessed Diagnostic Electrophysiology Catheters. It details the reprocessing of single-use devices, specifically EP Technologies™ Explorer 360™ Diagnostic Electrophysiology Catheters. The core of the submission is to demonstrate that the reprocessed devices are substantially equivalent to the original, legally marketed predicate devices.
1. A table of acceptance criteria and the reported device performance:
The document broadly discusses "functional/performance and biocompatibility testing" demonstrating that the reprocessed devices "perform as intended and are safe and effective." However, specific numerical acceptance criteria (e.g., minimum tensile strength, maximum electrical resistance, etc.) and their corresponding reported device performance values are not provided in this 510(k) summary. It states that "No changes are made to the currently marketed device's specifications and they possess the same technological characteristics." This implies that the acceptance criteria are essentially those of the original device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance as intended (e.g., electrical signal transmission, pacing capability, navigation, structural integrity, biocompatibility post-reprocessing) | "Functional/performance and biocompatibility testing demonstrates that the reprocessed devices perform as intended and are safe and effective." |
| "Essentially identical to the currently marketed OEM devices" | "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." |
| Maintenance of original device specifications | Met (implied by "No changes are made") |
2. Sample sizes used for the test set and the data provenance:
The document mentions "cleaning, sterilization, and packaging validations; and functional/performance and biocompatibility testing." However, it does not specify the sample sizes used for these tests. The data provenance (e.g., country of origin, retrospective or prospective) is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This document is for a medical device (catheter) and focuses on its functional and safety aspects after reprocessing, not on diagnostic accuracy based on expert interpretation like an AI imaging device. Therefore, the concept of "experts used to establish ground truth for the test set" is not applicable in the same way. The evaluation would have been performed by engineers and scientists with expertise in medical device testing, manufacturing, microbiology, and biocompatibility.
4. Adjudication method for the test set:
Not applicable, as this is not a study involving human reader interpretation or diagnostic consensus.
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 medical device submission, not an AI or imaging diagnostic study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device submission, not an AI or algorithm-only study. The "standalone" performance here refers to the device itself performing its intended function.
7. The type of ground truth used:
For medical device performance testing, the "ground truth" is typically established through:
- Engineering specifications and standards: The original device's established performance parameters serve as the benchmark.
- Bench testing: Direct measurements of physical, mechanical, and electrical properties.
- Biocompatibility testing: Standardized assays (e.g., cytotoxicity, sensitization, irritation) to ensure no adverse biological reactions.
- Sterilization validation: Ensuring the device meets sterility assurance levels.
- Cleaning validation: Ensuring all biological and chemical contaminants are removed to acceptable levels.
8. The sample size for the training set:
Not applicable. This is a medical device (catheter) submission. There is no AI model being trained, so no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI model.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a symbol that appears to be three stylized human profiles facing to the right.
Public Health Service
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
K022316 - Supplemental Validation Submission Re: Trade Name: Vanguard Reprocessed EPT Explorer™ 360 Diagnostic EP Catheters Models 5291S, 5292S, 5294S, 5433S and 5461S Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Regulatory Class: II (two) Product Code: NLH Dated: July 15, 2002 Received: July 17, 2002
Dear Ms. Crawford:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on October 10, 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 above 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 vour 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 - K022316
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,
B.Zimmerman 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: KO 22 316
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
OR
Over-the-Counter Use
(Per 21 CFR 801.109)
Division of Cardiovascular & Respiratory Devices
510(k) Number K022346
(Optional Format 1-2-96)
iv
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OCT 1 0 2002
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 | July 15, 2002 |
| Device | Trade Names: Vanguard Reprocessed Diagnostic Electrophysiology Catheters⇒ EP Technologies™ Explorer 360™ Diagnostic Electrophysiology CathetersCommon Name: Electrode Recording Catheter, Diagnostic Electrophysiology (EP) CatheterClassification: 21 CFR 870.1220 – Class II - Catheter, Electrode Recording, or Probe, Electrode RecordingProduct Code DRF |
| PredicateDevices | EP Technologies™ Explorer 360™ diagnostic EP catheters legally marketedunder various 510(k) premarket notifications. |
| Indications forUse | This catheter is intended for temporary intracardiac pacing and recordingduring electrophysiology studies, e.g. evaluation of arrhythmias or cardiacmapping. |
| 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 | Explorer 360™ diagnostic electrophysiology catheters are constructed of a 6 French hollow polymer shaft 100 cm in length. The quadripolar catheters are available with various fixed distal curves and electrode spacing configurations. The polymer shaft is manufactured with additives (typically barium sulfate) that enhance its radiopacity during fluoroscopic positioning of the catheter. The platinum alloy electrodes are sealed to the distal catheter and internally wired to a proximal shielded Nexus connector for bi-directional transmission of electrical signals (pacing and recording). The connector is designed to be attached to a compatible instrument cable that interfaces with various standard types of sensing, recording, stimulation, and pacing equipment. |
| Vanguard receives previously used diagnostic EP catheters from healthcare facilities; cleans, inspects, tests, refurbishes, applies a unique serial number, 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 Explorer 360™ diagnostic catheters are essentiallyidentical to the currently marketed OEM devices. No changes are made to thecurrently marketed device's specifications and they possess the sametechnological characteristics. Biocompatibility and performance/functionaltesting demonstrate that the devices are equivalent and continue to be safe andeffective for their intended use. |
|---|---|
| Test Data | Cleaning, sterilization, and packaging validations; and functional/performance and biocompatibility testing demonstrates that the reprocesseddevices perform 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 (EP Technologies™ Explorer 360™Catheters) are substantially equivalent to the predicate devices under theFederal 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).