(219 days)
This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping.
Vanguard reprocessed Livewire diagnostic electrophysiology catheters are constructed of a hollow polymer shaft 5 - 7 French in diameter and 95 to 115 cm in length that terminates with a hand piece. Various configurations of distal platinum alloy electrodes are wired to a proximal connector for bi-directional transmission of electrical signals (pacing and recording). The hand piece 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 steerable distal curves 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 that are selected by the clinician based on preference and/or indication.
The shaft polymer is manufactured with additives (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 collects previously used diagnostic EP catheters from healthcare facilities, and cleans, inspects, tests, applies a unique serial number, packages, labels, and sterilizes each device for return to a healthcare facility for an additional clinical use.
The provided text describes the 510(k) summary for Vanguard Reprocessed Diagnostic Electrophysiology (EP) Catheters. However, it does not contain details about acceptance criteria, specific device performance metrics (beyond "perform as intended"), or a study design with ground truth, sample sizes, or expert adjudication as typically seen in AI/ML device submissions.
The summary focuses on establishing substantial equivalence to a predicate device through:
- Identical technological characteristics: The reprocessed catheters are stated to be "essentially identical" to the Original Equipment Manufacturer (OEM) devices, with "no changes made to the device materials or specifications."
- Performance and biocompatibility testing: This is a general statement.
Given this, I will describe what is available in the text.
Acceptance Criteria and Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Clinical performance and safety equivalent to predicate device | Reprocessed devices perform "as intended" |
| Biocompatibility equivalent to predicate device | Biocompatibility testing demonstrates safety and efficacy |
| Sterilization effectively renders the device sterile | Sterilization validations performed |
| Cleaning effectively prepares the device for reprocessing | Cleaning validations performed |
| Packaging maintains sterility and device integrity | Packaging validations performed |
| Device materials and specifications remain unchanged from OEM | "No changes are made to the device materials or specifications" |
| Radiopacity maintained for fluoroscopic guidance | "Manufactured with additives (barium sulfate) that enhance the catheter's radiopacity" |
Study Details (as inferred from the provided text):
The submission does not detail a study in the context of an AI/ML device submission, but rather a validation of a reprocessed medical device.
- Sample size used for the test set and the data provenance: The document mentions "performance and biocompatibility testing" and "cleaning, sterilization, and packaging validations" but does not specify sample sizes for these tests. The provenance of the data is not mentioned, but it would typically be from laboratory testing and validation rather than clinical or retrospective patient data in this context.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable. Ground truth as typically understood for AI/ML models is not directly established in this context. The "truth" would be determined by whether the reprocessed device meets established engineering and clinical performance specifications.
- 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 a reprocessed medical device, not an AI/ML diagnostic or assistive device.
- If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this medical device's performance would be against engineering specifications, biocompatibility standards, and the performance characteristics of the original predicate device as verified through laboratory testing.
- The sample size for the training set: Not applicable. This is a reprocessed medical device, not an AI/ML model that requires a training set.
- How the ground truth for the training set was established: Not applicable.
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MAR 9 - 2005 510(k) Summary of Safety & Effectiveness
| Submitter | Vanguard Medical Concepts, Inc.5307 Great Oak DriveLakeland, FL 33815 |
|---|---|
| Contact | Heather Crawford, RACDirector, Regulatory Affairs(863) 683-8680 (voice)(863) 683-8703 (facsimile)hcrawford@safe-reuse.com |
| Date | July 29, 2004 |
| 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 NLH |
| PredicateDevices | St. Jude Medical, Daig Division, Livewire™ Steerable Diagnostic Catheters (K022380) |
| Indications forUse | 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 |
1
4
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TD-207
p2/3
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. Patients with acute factors that make the findings unrepresentative of the patient's usual state (i.e. drug toxicity, electrolyte abnormality, acute ischemia). Patients with underlying cardiac disease that increases risk of being unable to terminate induced arrhythmias and that have a high risk of death (i.e. unstable angina, acute myocardial infarction, hemodynamic instability). Diagnostic EP catheters are not intended for electrical ablation. |
|---|---|
| DeviceDescription | Vanguard reprocessed Livewire diagnostic electrophysiology catheters are constructed of a hollow polymer shaft 5 - 7 French in diameter and 95 to 115 cm in length that terminates with a hand piece. Various configurations of distal platinum alloy electrodes are wired to a proximal connector for bi-directional transmission of electrical signals (pacing and recording). The hand piece 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 steerable distal curves 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 that are selected by the clinician based on preference and/or indication.The shaft polymer is manufactured with additives (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 collects previously used diagnostic EP catheters from healthcare facilities, and cleans, inspects, tests, applies a unique serial number, packages, labels, and sterilizes each device for return to a healthcare facility for an additional clinical use. |
Continued on rext page
:
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TD-207+
P 3/2
510(k) Summary of Safety & Effectiveness, Continued
| 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three wing segments, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircles the eagle, indicating the department's name and national affiliation.
MAR 9 - 2005
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
Re: K042074
Trade Name: Vanguard Reprocessed Diagnostic Electrophysiology Catheters (See Enclosed List) Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: NLH Dated: January 12, 2005 Received: January 13, 2005
Dear Ms. Crawford:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is 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 10 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 the device, 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 device is classified (see above) into cither class II (Special Controls) or class III (PMA). it 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 device in the Federal Register.
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Page 2 – Ms. Heather Crawford, RAC
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies 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 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 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,
Bzimimorfor
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 3 -- Ms. Heather Crawford, RAC
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:
List of Model numbers
| St. Jude Daig LiveWire™ Steerable Diagnostic Catheter - 33Models | ||||
|---|---|---|---|---|
| 401939 | 401933 | 401578 | 401580 | 401932 |
| 401940 | 401934 | 401586 | 401581 | - |
| 401938 | 401575 | 401587 | 401582 | - |
| 401941 | 401915 | 401588 | 401904 | - |
| 401600 | 401923 | 401583 | 401905 | - |
| 401603 | 401926 | 401584 | 401914 | - |
| 401572 | 401576 | 401585 | 401908 | - |
| 401606 | 401577 | 401579 | 401918 | - |
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[Indications for Use
510(k) Number (if known): K042074
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.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bimmermo
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K042074
Page 1 of 1
§ 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).