(24 days)
Not Found
No
The summary describes a pressure guide wire and associated instruments for measuring blood pressure. There is no mention of AI, ML, or any computational analysis beyond basic pressure measurement. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is used to measure pressure for diagnostic purposes and does not provide therapy.
Yes
The device is described as measuring pressure in blood vessels to provide "hemodynamic information for the diagnosis and treatment of blood vessel disease," explicitly stating its role in diagnosis.
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.
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 to examine these samples outside of the body.
- Device Function: The SmartWire Pressure Guide Wire is used inside the body to directly measure pressure within blood vessels. It is an invasive device used during procedures.
- Intended Use: The intended use clearly states it's for measuring pressure in blood vessels during diagnostic angiography and interventional procedures. This is a direct measurement within the patient's body.
Therefore, based on its function and intended use, the SmartWire Pressure Guide Wire is a medical device used in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SmartWire Pressure Guide Wire 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)
DXQ, DXO
Device Description
The SmartWire II is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The SmartWire measures pressure when used with the SmartMap®, WaveMap®, and ComboMap® Instruments. The SmartWire II is available in a diameter of 0.014" (0.36 mm), lengths of 185 cm and 300 cm, and different tip flexibilities. The SmartWire II is packaged preconnected to the connector with a torque device to facilitate navigation through 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. The new material was tested for biocompatibility according to ISO 10993-1 and the results met the predetermined acceptance criteria.
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.
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
§ 870.2870 Catheter tip pressure transducer.
(a)
Identification. A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.(b)
Classification. Class II (performance standards).
0
Volcano Corporation February 8, 2007
510 (K) Summary SmartWire Pressure Guide Wire
| Dave Prepared: | February 8, 2007 | |
|---|---|---|
| Submitted by: | Volcano Corporation | |
| 2870 Kilgore Rd. | ||
| Rancho Cordova, CA 95670 | ||
| Contact person: | Cynthia Van Duker | |
| Regulatory Affairs Manager | MAR 16 2007 | |
| Phone number: | (916) 231-4510 | |
| Facsimile number: | (916) 638-2647 | |
| Device Name: | SmartWire® Pressure Guide Wire | |
| Classification name: | ➤ 870.1330 Catheter guide wire | Class |
| ➤ 870.2870 Catheter tip pressure transducer | II | |
| II |
Predicate Device:
The Volcano Corporation SmartWire® Pressure Guide Wire is substantially equivalent to the predicate device, Volcano SmartWire® Pressure Guide Wire cleared under K021219 on May 17, 2002.
Device Description:
The SmartWire II is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The SmartWire measures pressure when used with the SmartMap®, WaveMap®, and ComboMap® Instruments. The SmartWire II is available in a diameter of 0.014" (0.36 mm), lengths of 185 cm and 300 cm, and different tip flexibilities. The SmartWire II is packaged preconnected to the connector with a torque device to facilitate navigation through vasculature.
Intended Use:
The SmartWire® Pressure Guide Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography
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1
and/or any interventional procedures. Blood pressure measurements provide homodynamic information for the diagnosis and treatment of blood vessel disease.
Device Technological Characteristics and Comparison to Predicate Device: The Volcano Corporation SmartWire® Pressure Guide Wire is substantially equivalent to the predicate device, Volcano SmartWire® Pressure Guide Wire cleared under K021219 on May 17, 2002. Modifications include changes to the material used in the Guide Wire.
The modified SmartWire® Pressure Guide Wire 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. The new material was tested for biocompatibility according to ISO 10993-1 and the results met the predetermined acceptance criteria.
Conclusion:
The Volcano SmartWire Pressure Guide Wire has the same performance specifications, fundamental scientific technology and intended use as that of the predicate device, Volcano SmartWire Pressure Guide Wire cleared under K021219 on May 17, 2002. 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.
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2
Public Health Service
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 6 2007
Volcano Corporation c/o Ms. Cynthia Van Duker Regulatory Affairs Manager 2870 Kilgore Road Ranch Cordova, CA 95670
Re: K070487
Trade Name: SmartWire™ Pressure Guide Wire Regulation Number: 21 CFR 870.1330 and 870.2870 Regulation Name: Catheter Guide Wire and Catheter Tip Pressure Transducer Regulatory Class: Class II (two) Product Code: DXQ and DXO Dated: February 8, 2007 Received: February 20, 2007
Dear Ms. Van Duker:
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 - Ms. Cynthia Van Duker
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 (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 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.
Bremima for
Bram B. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Volcano Corporation February 8, 2007
510(k) Number (if known):
Device Name: SmartWire Pressure Guide Wire
Indications for Use:
The SmartWire Pressure Guide Wire 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
(Per 21 CFR 801.19)
| Over-the-Counter Use | |
|---|---|
| ---------------------- | -- |
(Division Sign-Off)
Division of Cardiovascular Devices 510ik) Number