(23 days)
Not Found
No
The summary describes a physical guide wire with sensors and mentions a separate instrument for measurement, but there is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is indicated for use in measuring pressure and blood flow velocities during diagnostic and/or interventional procedures, not for therapeutic intervention itself.
Yes
The intended use explicitly states that the device is used "during diagnostic angiography".
No
The device description clearly states that the device is a "steerable guide wire with a pressure transducer mounted less than 3 cm proximal to the tip and a tip mounted ultrasound transducer." This indicates the presence of physical hardware components beyond just software.
Based on the provided information, the ComboWire™ and ComboTip™ Pressure/Flow Guide Wire is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to measure pressure and blood flow velocities in blood vessels during diagnostic angiography and/or interventional procedures. This is a measurement taken within the living body (in vivo).
- Device Description: The description details a guide wire with sensors designed to be inserted into blood vessels.
- Lack of IVD Characteristics: IVD devices are used to examine specimens taken from the human body (e.g., blood, urine, tissue) outside of the body (in vitro) to provide information for diagnosis, monitoring, or screening. The ComboWire/ComboTip does not perform this function.
Therefore, the ComboWire™ and ComboTip™ Pressure/Flow Guide Wire is an in vivo diagnostic and interventional device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ComboWire™ and ComboTip™ Pressure/Flow Guide Wire is indicated for use to measure simultaneous pressure and blood flow velocities in blood vessels, including coronary and peripheral vessels, during diagnostic angiography and/or interventional procedures.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The ComboWire™/ComboTip™ Pressure/Flow Guide Wire is a steerable guide wire with a pressure transducer mounted less than 3 cm proximal to the tip and a tip mounted ultrasound transducer. The ComboWire/ComboTip measures pressure and flow when used with the ComboMap™ Pressure/Flow Instrument, a class IIa currently marketed device. The ComboWire/ComboTip is currently available in a diameter of 0.014" with a length of 185cm however, additional sensor configurations and wire length will be produced in the future to accommodate customer needs just as has been done with SmartWire, WaveWire and FloWire where up to 10 models are offered. The proximal end of the ComboWire/ComboTip is compatible with the provided ComboWire/ComboTip Connector Cable Assembly. The ComboWire/ComboTip can be torqued using the included 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 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 to evaluate the ComboWire™ and ComboTip™ Pressure/Flow Guide Wire. The test results were found to be acceptable as required by the respective test plans and protocols.
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.
K021219, K905411, K912776, K921563, K972762
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
Volcano Corporation October 18, 2004
NOV 2 4 2004 ComboWire™ Pressure/Flow Guide Wire Family Special 510(k)
510 (K) Summary
ComboWire™/ComboTip™ Pressure/Flow Guide Wire Family of Products
| Date Prepared:
| October 21, 2004 | ||
|---|---|---|
| ------------------------------------ | -- | -- |
Submitted by: Volcano Corporation 2870 Kilgore Rd. Rancho Cordova, CA 95670
Contact person: Lorry W. Huffman Director Regulatory Affairs
Phone number: (916) 638-9404 or (800) 228-4728 ext. 404 Facsimile number: (916) 638-8112
Device Name: ComboWire™ and ComboTip™ Pressure/Flow Guide Wire Family of Products
| Device classification: | Class |
|---|---|
| 870.1330 - Catheter Guide Wire | II |
| 870.2100 - Cardiovascular blood flow meters | II |
| 870.2870 - Catheter tip pressure transducer | II |
| 870.2890 - Vessel occlusion transducer | II |
| 870.2900 - Patient Transducer and Electrical Cable | II |
Predicate Device:
| Predicate
Wires
Product
Name | Predicate
Wires 510(k)
Clearance | Current
Catalog
Numbers |
|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------|-----------------------------------------------------------------------------|
| SmartWire®
BrightWire
(name is used
in certain
European
countries due
to trademark
issues) | K021219 | 6400, 6400J,
6403, 6403J,
6413, 6413J,
7400, 7400J,
7403, 7403J |
| FloWire® | K905411,
K912776,
K921563,
K972762 | 1400, 1400J,
1401, 1401J,
1403, 1403J,
1404, 1404J,
1413, 1413J |
Volcano Therapeutics Inc. purchased the assets of JOMED Inc. who had previously purchased Cardiometrics, Inc. under which K021219, K905411, K912776, K921563 and K972762 were filed.
1
Device Description:
The ComboWire™/ComboTip™ Pressure/Flow Guide Wire is a steerable guide wire with a pressure transducer mounted less than 3 cm proximal to the tip and a tip mounted ultrasound transducer. The ComboWire/ComboTip measures pressure and flow when used with the ComboMap™ Pressure/Flow Instrument, a class IIa currently marketed device. The ComboWire/ComboTip is currently available in a diameter of 0.014" with a length of 185cm however, additional sensor configurations and wire length will be produced in the future to accommodate customer needs just as has been done with SmartWire, WaveWire and FloWire where up to 10 models are offered. The proximal end of the ComboWire/ComboTip is compatible with the provided ComboWire/ComboTip Connector Cable Assembly. The ComboWire/ComboTip can be torqued using the included torque device to facilitate navigation through the vasculature.
Model Numbers and Accessories:
| ComboWire™ Pressure/Flow Guide Wire | Model 9403 |
|---|---|
| ComboTip™ Pressure/Flow Guide Wire | Model 9410 |
Table of Accessories Supplied with Device
| and of the first and and and of the many of the start of the status of the same of the same of the first and
program like for the more a version a comments of the comments of the comments of the comments of the comments of
| Accessories |
|---|
| - Kan K - K - B - - - |
| Torque Device |
| ingle consistential or consisted in consisted in consistent of the consistent of the contract and consideration of the former to the |
| Connector Cable Assembly |
| Particle Production Company Company of Canadian Comments of Canadian Company Company of |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Intended Use:
ComboWire™ and ComboTip™ Pressure/Flow Guide Wire is indicated for use to measure simultaneous pressure and blood flow velocities in blood vessels, including coronary and peripheral vessels, during diagnostic angiography and/or interventional procedures.
Device Technological Characteristics and Comparison to Predicate Device: Currently pressure and flow velocity are measured with separate quide wires (SmartWire® or FloWire®), connected to separate systems (WaveMap® or FloMap"). The ComboWire and ComboMap combine the functionality of both technologies into one system. Material construction, measurement modalities and instrument connections are the same as the predecessor wires. The intended use and the fundamental scientific technology of the SmartWire and FloWire have not been altered and the same fundamental scientific technology has been incorporated into the ComboWire/ComboTip Family of products.
Performance Data:
Applicable testing was performed to evaluate the ComboWire™ and ComboTip™ Pressure/Flow Guide Wire. The test results were found to be acceptable as required by the respective test plans and protocols.
2
Volcano Corporation October 18. 2004
Conclusion:
The ComboWire™ and ComboTip™ Pressure/Flow Guide Wire Family of products have the same intended use and utilize the same fundamental scientific technology as that of the predicate devices. There are no new questions raised regarding safety and efficacy. The information provided in this Special 510(k) submission along with the Declaration of Conformity with Design Controls support a determination of substantial equivalence of the ComboWire™ and ComboTip™ Pressure/Flow Guide Wire Family of products to the predicate devices.
3
Image /page/3/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 2004
Volcano Corporation c/o Ms Lorry W. Huffman Director, Regulatory Affairs 2870 Kilgore Rd. Rancho Cordova, CA 95670
Re: K042996
Trade Name: ComboWire™ and ComboTip™ Pressure/Flow Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: II (two) Product Code: DQX Dated: October 18 , 2004 Received: November 01, 2004
Dear Ms. Huffman:
We have reviewed your Section 510(k) premarket notification of intent to market the device w oneve and have 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 10 rate exaction 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.
4
Page 2 - Ms Lorry W. Huffman
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r read of a reveale 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 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 yours,
B. Zimmerman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
| 510(k) Number (if known): | K042996 |
|---|---|
| --------------------------- | --------- |
ComboWire™ and ComboTip™ Pressure/Flow Guide Wire Device Name:
Indications for Use:
ComboWire™ and ComboTip™ Pressure/Flow Guide Wire is indicated for use to measure simultaneous pressure and blood flow velocities in blood vessels, including coronary and peripheral vessels, during diagnostic angiography and/or interventional procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| ------------------ | --- |
(Per 21 CFR 801.19)
OR
Over-the-Counter Use __________________________________________________________________________________________________________________________________________________________________________
Blhmmmmma
(Division Sign-Off)