(64 days)
Not Found
No
The document describes a guidewire for positioning leads and performing measurements, with no mention of AI or ML capabilities.
Yes.
The device is described as having "sensing and stimulation capabilities" and can be used for "Temporary pacing of the left ventricle" and "comparative intraoperative measurements of various pacing sites" to "identify an appropriate pacing site for a LV lead". These functions are directly involved in the treatment or management of a medical condition, making it a therapeutic device.
Yes
The device performs intraoperative tests such as measuring the left ventricular threshold and intracardiac signals, which are diagnostic measurements used to identify an appropriate pacing site.
No
The device description clearly states it is a "transvenous wire with sensing and stimulation capabilities" and a "disposable medical device," indicating it is a physical hardware device, not software only.
Based on the provided information, 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 to provide information for diagnosis, monitoring, or screening.
- Device Function: The VisionWire coronary guide wire is an invasive device used within the body (in the coronary vascular system) for:
- Guiding other devices (pacing leads).
- Performing electrical measurements and temporary pacing in situ.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It interacts directly with the internal anatomy and electrical signals.
Therefore, the VisionWire coronary guide wire falls under the category of an invasive medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VisionWire coronary guidewire is intended for the following applications:
- Its positioning in the coronary vascular system (probing coronary vessel anatomy)
- Connection to an external pacing system analyzer in order to perform the following intraoperative tests in several places e.g. of the coronary sinus:
- Measuring the left ventricular threshold
- Measuring the intracardiac signals
- Temporary pacing of the left ventricle
- As a guidewire for positioning compatible over-the-wire (OTW) pacing leads in the coronary sinus
Product codes
DOX
Device Description
The VisionWire coronary guidewire is a transvenous wire with sensing and stimulation capabilities. The VisionWire is intended to be used to facilitate the positioning of left ventricular (LV) pacing leads, with compatible guidewire lumen, within the coronary venous system during the implantable pulse generator (IPG) or Implantable Cardioverter Defibillator (ICD) for Cardiac Resynchronization Therapy (CRT). The VisionWire is used as a guide to position the over-the-wire (OTW) lead, especially in angled or tortuous veins. Prior to lead positioning, the VisionWire can be used to perform comparative intraoperative measurements of various pacing sites within the coronary venous system. Thus the physician can identify an appropriate pacing site for a LV lead.
The VisionWire coronary quidewire is a disposable medical device designed for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary vascular system, coronary sinus
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
BIOTRONIK, Inc., VisionWire Coronary Guidewire, 510(k)
September 30, 2008
VisionWire Coronary Guidewire 510(k) Premarket Notification
DEC 0 4 2008
GUIDEWIRE 510(K) SUMMARY 1.
Name and Address of Applicant:
BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035
Establishment Registration Number:
1028232
Device Name:
Proprietary Name: Classification: Classification Name: Product Code:
VisionWire Coronary Guidewire Class II (21 CFR 870.1330) Wire, Guide, Catheter DOX
Date Prepared:
September 30, 2008
General Description:
The VisionWire coronary guidewire is a transvenous wire with sensing and stimulation capabilities. The VisionWire is intended to be used to facilitate the positioning of left ventricular (LV) pacing leads, with compatible guidewire lumen, within the coronary venous system during the implantable pulse generator (IPG) or Implantable Cardioverter Defibillator (ICD) for Cardiac Resynchronization Therapy (CRT). The VisionWire is used as a guide to position the over-the-wire (OTW) lead, especially in angled or tortuous veins. Prior to lead positioning, the VisionWire can be used to perform comparative intraoperative measurements of various pacing sites within the coronary venous system. Thus the physician can identify an appropriate pacing site for a LV lead.
The VisionWire coronary quidewire is a disposable medical device designed for single use only.
Predicate Device:
BIOTRONIK proposes the following guidewires and catheter, cleared through 510(k) notification, as the predicate devices for the VisionWire coronary guidewire:
- Guidant's HI-TORQUE WHISPER Guidewires (Models 6726, 6737, 6738, 4482, 4483, 4581, 4586, . 4583, and 4588), #K030019, cleared on 01-24-2003 and HI-TORQUE WHISPER VIEW Guidewire (Model #4631-4639), #K061453, cleared on 06-22-2006
- Medtronic Performr Electrode Catheter, #K964272, cleared on 01-23-1997
Indications for Use:
The VisionWire coronary quidewire is intended for the following applications:
- Its positioning in the coronary vascular system (probing coronary vessel anatomy)
- Connection to an external pacing system analyzer in order to perform the following intraoperative tests in several places e.g. of the coronary sinus:
- ಂ Measuring the left ventricular threshold
- Measuring the intracardiac signals O
- Temporary pacing of the left ventricle 0
- As a guidewire for positioning compatible over-the-wire (OTW) pacing leads in the coronary sinus
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Name and Address of Manufacturing Site:
Brivant Ltd. Parkmore West Business Park Galway, Ireland.
Manufacturer's Establishment Registration Number / Owner's Number: 3006010712 / 9083703
Manufacturing Site Contact Person and Phone Number:
Conan Campbell Quality Engineer Brivant Ltd. Parkmore West Business Park Galway, Ireland (353) 91 358 376
510(k) Contact Person and Phone Number:
Jon Brumbaugh Vice President, Regulatory Affairs and Compliance BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035 (888) 345-0374
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is rendered in black and white, providing a clear and recognizable emblem for the department.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 4 2008
Biotronik, Inc. c/o Mr. Jon Brumbaugh 6024 Jean Road Lake Oswego, Oregon 97035
Re: K082935
Trade/Device Name: VisionWire Coronary Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: September 30, 2008 Received: October 1, 2008
Dear Mr. Brumbaugh:
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.
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
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Page 2 - Mr. Jon Brumbaugh
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 setforth 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
R. lohner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K082935 510(k) Number (if known):
Device Name: VisionWire Coronary Guidewire
Indications for Use:
. :
The VisionWire coronary guide wire is intended for the following applications:
- Its positioning in the coronary vascular system (probing coronary vessel anatomy) ●
- Connection to an external pacing system analyzer in order to perform the following . intraoperative tests in several places e.g. of the coronary sinus:
- o Measuring the left ventricular threshold
- o Measuring the intracardiac signals
- Temporary pacing of the left ventricle o
- As a guide wire for positioning compatible over-the-wire (OTW) pacing leads in the coronary sinus
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)
Page 1 of 1 .
(Division Sign-Off) (Division of Cardiovascular Devices
510(K) Number_K082935
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