(85 days)
Not Found
Not Found
No
The device description focuses on the physical construction and function of a standard electrophysiology catheter, and there are no mentions of AI, ML, or related concepts in the provided text.
No
The device is intended for temporary intracardiac pacing and recording during electrophysiology studies, which are diagnostic procedures, not therapeutic ones.
Yes
The "Intended Use / Indications for Use" states the catheter is for "evaluation of arrhythmias or cardiac mapping," which are diagnostic procedures. Additionally, the "Device Description" explicitly refers to the devices as "Explorer 360™ diagnostic electrophysiology catheters" and mentions they are used for "bi-directional transmission of electrical signals (pacing and recording)" which supports their role in diagnosis via physiological signal acquisition. The "Predicate Device(s)" also refers to them as "diagnostic EP catheters."
No
The device description clearly details a physical catheter with a polymer shaft, electrodes, and a connector, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Description and Intended Use: The description clearly states that this is a catheter intended for temporary intracardiac pacing and recording during electrophysiology studies. This means it is used inside the body to interact directly with the heart's electrical activity.
The device is an invasive medical device used for diagnosis and potentially treatment (pacing) within the body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping.
Product codes (comma separated list FDA assigned to the subject device)
NLH,DRF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracardiac
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Cleaning, sterilization, and packaging validations; and functional/performance and biocompatibility testing demonstrates that the reprocessed devices perform as intended and are safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
EP Technologies™ Explorer 360™ diagnostic EP catheters legally marketed under various 510(k) premarket notifications.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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
2
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
3
OCT 1 0 2002
510(k) Summary of Safety & Effectiveness
| Submitter | Vanguard Medical Concepts, Inc.
5307 Great Oak Drive
Lakeland, 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 |
| Predicate
Devices | EP Technologies™ Explorer 360™ diagnostic EP catheters legally marketed
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 |
4
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 | 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
5
510(k) Summary of Safety & Effectiveness, Continued
| Technological
Characteristics | The Vanguard reprocessed Explorer 360™ diagnostic 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. Biocompatibility and performance/functional
testing demonstrate that the devices are equivalent and continue to be safe and
effective for their intended use. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test Data | Cleaning, sterilization, and packaging validations; and functional/
performance and biocompatibility testing demonstrates that the reprocessed
devices perform as intended and are safe and effective. |
| Conclusion | Based on the information provided herein and the 510(k) "Substantial
Equivalence" Decision Making Process Chart, we conclude that the Vanguard
Reprocessed Diagnostic EP Catheters (EP Technologies™ Explorer 360™
Catheters) are substantially equivalent to the predicate devices under the
Federal Food, Drug and Cosmetic Act. |