(9 days)
The PressureWire Sensor is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary and peripheral blood vessels.
The PressureWire™ Sensor is a 0.014" diameter, 183 or 300 cm long guidewire with a pressure sensor mounted three cm from the distal end and a detachable cable for connection to a programmable diagnostic computer manufactured by the submitter.
The provided document is a 510(k) summary for the PressureWire™ Sensor, a medical device. It does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document focuses on regulatory compliance, specifically demonstrating substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number or qualifications of experts, or adjudication methods for a test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used.
- The sample size for the training set or how its ground truth was established.
This 510(k) summary primarily addresses the regulatory approval process based on similarity to an already approved device (predicate device), rather than presenting a detailed performance study with acceptance criteria.
{0}------------------------------------------------
JUN - 6 2003
Attachment 4
510(k) Summary
This 510(k) summary is submitted in accordance with the requirements in 21 CFR $807.92
| Submitted by: | RADI Medical Systems ABPalmbladsgatan 10SE-754 50 Uppsala, SwedenPhone:(+46) 18161000 |
|---|---|
| Contact Person: | Mats Granlund |
| Date Prepared: | May 26, 2003 |
| Proprietary Name: | PressureWire™ Sensor |
| Common Name: | Pressure Guide Wire |
| Classification Name: | Catheter Guide Wire (870.1330)Catheter Tip Pressure Transducer (870.2870) |
| Predicate Device: | PressureWire™ Sensor 510(k) # K022188 |
Description of the Device: The PressureWire™ Sensor is a 0.014" diameter, 183 or 300 cm long guidewire with a pressure sensor mounted three cm from the distal end and a detachable cable for connection to a programmable diagnostic computer manufactured by the submitter.
Intended Use of the Device: These devices have the same intended use as the predicate PressureWire™ Sensor.
The PressureWire Sensor is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary and peripheral blood vessels.
Technical Characteristics: With exception of the internal dimension modifications, the subject device has the same technological characteristics as the predicate PressureWire™ Sensor.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 6 2003
Radi Medical Systems AB c/o Mr. Mats Granlund Ouality & Regulatory Affairs Manager Palmbladsgatan 10 SE-754 50 Uppsala Sweden
Re: K031662
Trade Name: Pressure Wire™ Sensor Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter tip pressure transducer Regulatory Class: Class II (two) Product Code: DXO Dated: May 26, 2003 Received: May 28, 2003
Dear Mr. Granlund:
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.
{2}------------------------------------------------
Page 2 - Mr. Mats Granlund
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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D.
Director
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Attachment 2
Indication for Use Statement
| 510(k) Number: | K031662 |
|---|---|
| Device Name: | PressureWire™ Sensor |
| Indications for Use: | The PressureWire Sensor is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary and peripheral blood vessels. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
| (Division Sign-Off) | |
|---|---|
| --------------------- | -- |
Division of Cardiovascular Devices
| 510(k) Number | K031662 |
|---|---|
| --------------- | --------- |
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) |
§ 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).