(79 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 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 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 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 is a 510(k) summary for the Vanguard Reprocessed Diagnostic Electrophysiology (EP) Catheters. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on validation testing.
Here's an analysis of the acceptance criteria and study information:
Key Takeaway: This document does NOT describe the acceptance criteria and the study that proves the device meets them in the context of an AI/ML medical device. Instead, it details the regulatory submission for a reprocessed medical device (electrophysiology catheters), focusing on demonstrating that the reprocessed devices maintain the same safety and effectiveness as new devices.
Therefore, I cannot extract the requested information regarding AI/ML device performance, ground truth, expert adjudication, or MRMC studies from this document. The questions are designed for AI/ML device submissions, which this is not.
However, I can extract information relevant to the type of validation performed for this reprocessed device:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria in the format of an AI/ML performance table (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implicitly that the reprocessed device performs identically to the original equipment manufacturer (OEM) device and is safe and effective.
The reported "device performance" is:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Performance as intended (safe and effective), identical to OEM devices | Cleaning, sterilization, and packaging validations were performed. Performance and biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective. Vanguard Reprocessed Diagnostic EP Catheters are "essentially identical" to OEM devices with "no changes to the device materials or specifications" and possess "identical technological characteristics." |
The following numbered points cannot be answered from the provided text as they pertain to AI/ML device studies, which this document is not about.
- Sample size used for the test set and the data provenance: Not applicable. This is for a reprocessed physical device, not an AI/ML algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model is not relevant here. Device validation involves physical and biological testing.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI/ML device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML context. For this device, "ground truth" would be established via physical, chemical, and biological tests to confirm the device's functionality, cleanliness, sterility, and material integrity compared to the new device specifications and regulatory standards.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
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: K023180 Supplemental Validation Submission Trade Name: Vanguard Reprocessed EPT Polaris™ Dx Diagnostic EP Catheters, Models 5570S. 5572S. 5573S. 5574S. 5577 and 5579 Regulation Number: 21 CFR 870.1220 Regulation Name: Reprocessed Electrode Recording Catheter Regulatory Class: II (two) Product Code: NLH Dated: September 23, 2002 Received: September 24, 2002
Dear Ms. Crawford:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on December 12, 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 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 - K023180
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. Hemmer 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: KO23 180 "
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 V
OR
Over-the-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Stock Number K073 186
Blummenauer
Sign-
00 S
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510(k) Summary of Safety & Effectiveness
| Submitter | Vanguard Medical Concepts, Inc.5307 Great Oak DriveLakeland, FL 33815 | DEC 1 2 2002 |
|---|---|---|
| Contact | Mike Sammon, Ph.D.Director, Research and Development(863) 904-1628(801) 327-3339 (facsimile)msammon@safe-reuse.com | |
| Date | September 23, 2002 | |
| Device | Trade Names: Vanguard Reprocessed Diagnostic Electrophysiology (EP) CathetersCommon Name: Electrode Recording Catheter, Diagnostic Electrophysiology (EP) CatheterClassification: 21 CFR 870.1220 – Class II - Catheter, Electrode Recording, or Probe, Electrode RecordingProduct Code DRF | |
| Predicate Devices | EP Technologies™ Polaris™ Steerable Diagnostic Catheters (K924163)Vanguard Reprocessed Diagnostic EP Catheters (K012687, K012688) | |
| Indications for Use | This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping. | |
| 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. |
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510(k) Summary of Safety & Effectiveness, Continued
| DeviceDescription | Reprocessed diagnostic electrophysiology catheters are constructed of ahollow polymer shaft approximately 92 to 125 cm in length that terminateswith a hand piece or connector. A range of diameters is available; the mostclinically utilized sizes are 5 – 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. |
§ 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).