(75 days)
Not Found
No
The device description and intended use are for simple accessory cables used to connect existing medical devices. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as an accessory cable used to connect an electrophysiology catheter to recording/pacing equipment; it does not directly provide therapy.
No
The device is an accessory cable for electrophysiology catheters, designed to connect the catheter to recording/pacing equipment. Its function is to facilitate the connection for diagnostic procedures, not to perform the diagnostic function itself. The "Intended Use" states it connects an electrode catheter to recording/pacing equipment during electrophysiology studies, which are diagnostic studies, but the cable itself is merely a conduit.
No
The device description clearly states it is a physical cable constructed of a polymer shaft with connectors, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to connect an electrode catheter to recording/pacing equipment during electrophysiology studies. This is a direct connection to a medical device used for physiological measurement and intervention within the body.
- Device Description: The device is described as an accessory cable that provides electrical connection and working length for an electrophysiology catheter. It facilitates the function of the catheter and the recording/pacing equipment.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens. It is a component of a system used for in-vivo procedures.
The function of this device is to facilitate the electrical connection for an invasive medical procedure (electrophysiology study), not to perform diagnostic testing on biological samples outside the body.
N/A
Intended Use / Indications for Use
Electrophysiology catheter accessory cables are intended for use during electrophysiology studies to connect an electrode catheter to recording/pacing equipment.
Product codes (comma separated list FDA assigned to the subject device)
DSA
Device Description
Vanguard reprocessed electrophysiology catheter accessory cables are accessories to an appropriate diagnostic catheter. The use of the cable provides a means of electrically connecting the EP catheter to recording/pacing equipment while allowing the catheter to remain in the sterile field and also provides additional working length.
Vanguard reprocessed accessory cables are constructed of a hollow polymer shaft approximately 4 to 7 feet in length that terminates with at each end with a connector. One connector couples with the proximal connector of an electrophysiology catheter; the other connector couples with an extension cable or an electrophysiology console. Various connector types are available at each end to match the appropriate electrophysiology catheter and console.
Vanguard receives previously used accessory cables from healthcare facilities and cleans, inspects, tests, applies a unique serial number, packages, labels, and sterilizes each device for return to the healthcare facility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 performance testing demonstrate 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.
Biosense Webster EP Catheter Accessory Cables (unknown), Daig™ EP Catheter Accessory Cables (K910645), Medtronic EP Catheter Accessory Cables (K894981, K882174)
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
§ 870.2900 Patient transducer and electrode cable (including connector).
(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).
0
| 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 | December 31, 2002 |
| Device | Trade Names: Vanguard Reprocessed Electrophysiology (EP) Catheter Accessory CableCommon Name: Electrode CableClassification: 21 CFR 870.2900 – Class II – Cable, Transducer and Electrode, Patient, (including connector)Product Code DSA |
| Predicate Devices | Biosense Webster EP Catheter Accessory Cables (unknown)Daig™ EP Catheter Accessory Cables (K910645)Medtronic EP Catheter Accessory Cables (K894981, K882174) |
| Indications for Use | Electrophysiology catheter accessory cables are intended for use during electrophysiology studies to connect an electrode catheter to recording/pacing equipment. |
| Contra-indications | None known |
Continued on next page## 510(k) Summary of Safety & Effectiveness
MAR 1 8_2003
V - Page 1 ol 1
Biosense Webster® is a registered trademark of Biosense Webster. Daig™ is a trademark of St. Jude Medical, Inc.
1
510(k) Summary of Safety & Effectiveness, Continued
| Device
Description | Vanguard reprocessed electrophysiology catheter accessory cables are
accessories to an appropriate diagnostic catheter. The use of the cable
provides a means of electrically connecting the EP catheter to
recording/pacing equipment while allowing the catheter to remain in the
sterile field and also provides additional working length. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Vanguard reprocessed accessory cables are constructed of a hollow polymer
shaft approximately 4 to 7 feet in length that terminates with at each end with
a connector. One connector couples with the proximal connector of an
electrophysiology catheter; the other connector couples with an extension
cable or an electrophysiology console. Various connector types are available
at each end to match the appropriate electrophysiology catheter and console. |
| | Vanguard receives previously used accessory cables from healthcare facilities
and cleans, inspects, tests, applies a unique serial number, packages, labels,
and sterilizes each device for return to the healthcare facility. |
| Technological
Characteristics | Vanguard Reprocessed EP Catheter Accessory Cables are essentially identical
to the Original Equipment Manufacturer (OEM) devices. No changes are
made to the device materials or specifications and the reprocessed catheters
possess identical technological characteristics. |
| Test Data | Cleaning, sterilization, and packaging validations and performance testing
demonstrate 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 EP Catheter Accessory Cables are substantially equivalent to
their predicate devices under the Federal Food, Drug and Cosmetic Act. |
V - l'age 2 of 2
Biosense Webster® is a registered trademark of Biosense Webster. Daig™ is a trademark of St. Jude Medical, Inc.
,
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/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 lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
MAR 1 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vanguard Medical Concepts, Inc. c/o Dr. Mike Sammon, Ph.D. Director, Research and Development 5307 Great Oak Drive Lakeland, FL 33815
Re: K030005
Trade Name: Vanguard Reprocessed Diagnostic Electrophysiology Catheter Accessory Cables Regulation Number: 21 CFR 870.2900 Regulation Name: Cable, Transducer and Electrode, Patient, (including connector) Regulatory Class: Class II (two) Product Code: DSA Dated: December 31, 2002 Received: January 2, 2003
Dear Dr. Sammon:
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 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 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 either 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.
3
Page 2 - Mike Sammon, Ph.D.
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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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 vours.
Hobertu
Bram D. Zuckerman, M.D. Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K030005 510(k) Number:
Device Name: Vanguard Reprocessed Electrophysiology Catheter Accessory Cables
Indications for Use:
Electrophysiology catheter accessory cables are intended for use during electrophysiology studies to connect an electrode catheter to recording/pacing equipment.
(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)
Kooooos
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number
(Optional Format 1-2-96)
iv