(270 days)
ACS Guidewires, Millar Pressure Measurement System
Not Found
No
The summary describes a physical device (guidewire with a pressure sensor) and its function (measuring blood pressure and facilitating catheter placement). There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies focus on substantial equivalence to predicate devices, not on the performance of an AI/ML model.
No
The device measures blood pressure and facilitates the placement of catheters, which are diagnostic and procedural assistance functions, not therapeutic.
Yes
The device is indicated for the "measurement of blood pressure in the coronary vasculature," which is a diagnostic function used to assess a patient's condition.
No
The device description explicitly states it consists of a guidewire with a pressure sensor and an interface, indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure blood pressure in the coronary vasculature and facilitate the placement of catheters during a medical procedure (PTCA). This is an in vivo (within the living body) application, not an in vitro (outside the living body) diagnostic test performed on samples like blood, urine, or tissue.
- Device Description: The device is a guidewire with a pressure sensor designed to be used directly within the body.
- Anatomical Site: The device is used in the coronary vasculature, which is inside the body.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates directly within the body to provide real-time physiological measurements during a procedure.
N/A
Intended Use / Indications for Use
"The PressureWire™ System is indicated for the measurement of blood pressure in the coronary vasculature and to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA).
Product codes
DQX
Device Description
The RADI Medical Systems PressureWire™ System consists of a guidewire with a nearend mounted pressure sensor and an interface to facilitate connection to an ordinary pressure-monitoring system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary vasculature
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)
Safety and performance testing was performed to demonstrate that the RADI Medical Systems PressureWire™ System is substantially equivalent to the predicate devices.
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.
ACS Guidewires, Millar Pressure Measurement System
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
APR 2 4 1998
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
1972793
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
A. Submitter's Information:
| Name: | Radi Medical Systems AB |
|---|---|
| Address: | Palmbladsgatan 10, S-754 50 Uppsala, Sweden |
| Phone: | 46-18-161000 |
| Fax: | 46-18-161099 |
| Contact Person: | Mats Granlund |
| Date of Preparation: | January 21, 1998 |
B. Device Name:
| Trade Name: | PressureWire™ System including
PressureWire™ Sensor,
PressureWire™ Interface and
PressureWire™ Monitor Cables. |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Transducer, Pressure, Guidewire |
| Classification Names: | Transducer, Pressure, Guidewire |
| Predicate Device Names: | ACS Guidewires
Millar Pressure Measurement System |
D. Device Description:
C.
The RADI Medical Systems PressureWire™ System consists of a guidewire with a nearend mounted pressure sensor and an interface to facilitate connection to an ordinary pressure-monitoring system.
E. Intended Use:
"The PressureWire™ System is indicated for the measurement of blood pressure in the coronary vasculature and to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA).
1
F. Technical Characteristics:
The mechanical properties of the PressureWire™ Sensor are similar to ACS Guidewires. Most of the materials used the construction, which will be in contact with blood, are typical for similar devices. These include stainless steel and platinum alloy. The technical properties of PressureWire™ System are similar to the Millar Pressure Measurement System.
G. Performance Data:
Safety and performance testing was performed to demonstrate that the RADI Medical Systems PressureWire™ System is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 4 1998
Mr. Mats Granlund Quality Manager RADI Medical Systems AB Palmbladsgatan 10 S-754 50 UPPSALA, Sweden
Re: K972793
Trade Name: Pressure Wire™ System with Pressure Wire™ Sensor, Pressure Wire™ Interface and Pressure Wire™ Monitor Cables Requlatory Class: II Product Code: DQX Dated: January 22, 1998 Received: January 26, 1998
Dear Mr. Granlund:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in
3
Page 2 - Mr. Granlund
regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
| 510(k) Number: | K972793 |
|---|---|
| Device Name: | PressureWireTM System with PressureWireTM Sensor, |
| PressureWireTM Interface and PressureWireTM Monitor Cables. | |
| Indications for Use: | "The PressureWireTM System is indicated for the measurement |
| of blood pressure in the coronary vasculature and to facilitate | |
| the placement of balloon dilatation catheters during | |
| percutaneous transluminal coronary angioplasty (PTCA). |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
t
Prescription Use 11 (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1/2/96)
. Ruy
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number _