(25 days)
Not Found
No
The summary describes a pressure guide wire and associated systems for measuring blood pressure, with no mention of AI or ML capabilities.
No
The device is used to measure pressure for diagnostic purposes and does not provide therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use to measure pressure in blood vessels... during diagnostic angiography and/or any interventional procedures," and that "Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease." This directly indicates its use for diagnostic purposes.
No
The device description explicitly states it is a "steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip," indicating it is a physical hardware device, not software only.
Based on the provided information, the PrimeWire PRESTIGE™ Pressure Guide Wire 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 Function: The PrimeWire PRESTIGE™ Pressure Guide Wire Device is used inside the body to measure pressure directly within blood vessels. It is an invasive device used during diagnostic and interventional procedures.
- Intended Use: The intended use clearly states it's for measuring pressure in blood vessels during procedures, not for analyzing samples taken from the body.
Therefore, the PrimeWire PRESTIGE™ Pressure Guide Wire Device falls under the category of an in vivo diagnostic or therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PrimeWire PRESTIGE™ Pressure Guide Wire Device is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.
Product codes (comma separated list FDA assigned to the subject device)
DOX
Device Description
The PrimeWire PRESTIGE™ Pressure Guide Wire is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The PrimeWire PRESTIGE™ guide wire measures pressure when used with the SmartMap, s5 Family, and ComboMap systems. The PrimeWire PRESTIGE™ guide wire has a diameter of 0.014" (0.36 mm) and is available in lengths of 185 cm and 300 cm, with straight or pre-shaped tips. The PrimeWire PRESTIGE™ guide wire is packaged preconnected to the connector with a torque device to facilitate navigation through the vasculature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels including both coronary and peripheral vessels
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)
Applicable testing was performed in accordance with the Design Verification Plan including a Risk Analysis addressing the impact of modifications to the device and components. The test results indicate the revised product is comparable to the predicate device.
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.
K021209, K070487, Letter to File, Letter to File
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
§ 870.1330 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
Ki00930
SmartWire Pressure Guide Wire Special 510(k)
APR 3 0 2010
510 (K) Summary
PrimeWire PRESTIGE™ Pressure Guide Wire
Date Prepared: April 2, 2010
Submitted by: Volcano Corporation 3661 Valley Centre Dr. Suite 200 San Diego, CA 92130
Contact person: Marilyn Pourazar Director of Regulatory Affairs
Phone number: (858) 720-4116
Facsimile number: (858) 720-0335
PrimeWire PRESTIGETM Pressure Guide Wire Device Name:
| Classification name: | Class | |
|---|---|---|
| > 870.1330 Catheter guide wire | II | |
| > 870.2870 Catheter tip pressure transducer | II |
Predicate Device:
The Volcano PrimeWire PRESTIGE™ Pressure Guide Wire is substantially equivalent to the following:
| 510(k) Number | Product Name | Clearance Date |
|---|---|---|
| K021209 | SmartWire/SmartMap Pressure System | May 17, 2002 |
| K070487 | SmartWire II Pressure Guide Wire | March 16, 2007 |
| Letter to File | PrimeWire Pressure Guide Wire | June 26, 2008 |
| Letter to File | PrimeWire Pressure Guide Wire | April 6, 2009 |
Device Description:
The PrimeWire PRESTIGE™ Pressure Guide Wire is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The PrimeWire PRESTIGE™ guide wire measures pressure when used with the SmartMap, s5 Family, and ComboMap
19
1
systems. The PrimeWire PRESTIGE™ guide wire has a diameter of 0.014" (0.36 mm) and is available in lengths of 185 cm and 300 cm, with straight or pre-shaped tips. The PrimeWire PRESTIGE™ guide wire is packaged preconnected to the connector with a torque device to facilitate navigation through the vasculature.
Intended Use:
The PrimeWire PRESTIGE™ Pressure Guide Wire Device is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.
Device Technological Characteristics and Comparison to Predicate Device:
The Volcano Corporation PrimeWire PRESTIGE™ Pressure Guide Wire Device is substantially equivalent to the predicate devices, Volcano SmartWire II/PrimeWire Pressure Guide Wires.
The modified PrimeWire PRESTIGE™ Pressure Guide Wire Device uses the same fundamental scientific technology and has the same intended use as that of the predicate device.
Performance Data:
Applicable testing was performed in accordance with the Design Verification Plan including a Risk Analysis addressing the impact of modifications to the device and components. The test results indicate the revised product is comparable to the predicate device.
Conclusion:
The Volcano PrimeWire PRESTIGE™ Pressure Guide Wire Device has the same performance specifications, fundamental scientific technology and intended use as that of the predicate devices, Volcano SmartWire II/PrimeWire Pressure Guide Wires.
20
2
Modifications to the device do not raise any new questions regarding safety or efficacy. The performance data and a declaration of conformity with design controls support a determination of continuing substantial equivalence of the modified device to the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles a stylized human figure or bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
APR 3 0 2010
Volcano Corporation c/o Ms. Marilyn Pourazar Director of Regulatory Affairs 3661 Valley Centre Dr., Suite 200 San Diego, CA 92130
Re: K100930
Device Name: PrimeWire PRESTIGE™ Pressure Guide Wire, Models 8185, 8185J, 8300, 8300J Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (Two) Product Code: DOX Dated: April 2, 2010 Received: April 5, 2010
Dear Ms. Pourazar:
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 approvál 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
4
Page 2 - Ms. Marilyn Pourazar
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Singerely yours.
Bram D. Zuckerman, M.D.
Directd Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
PrimeWire PRESTIGETM Pressure Guide Wire Special 510(k)
510(k) Number (if known):
PrimeWire PRESTIGE™ Pressure Guide Wire Device Device Name:
Indications for Use:
The PrimeWire PRESTIGE™ Pressure Guide Wire Device is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.
The intended use and indications for use of the modified device as described in its labeling have not changed. The fundamental scientific technology of the modified device has not changed.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
OR
Over-the-Counter Use
(Per 21 CFR 801.19)
W.M.C.
vision Sian-Off) Division of Cardiovascular Devices
510(k) Numbe