(270 days)
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).
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.
The provided text is a 510(k) summary for the Radi Medical Systems PressureWire™ System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a robust clinical study as would be expected for a novel AI device. Therefore, much of the requested information (e.g., sample sizes for testing and training, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable or not available in this type of submission.
The document indicates that "Safety and performance testing was performed to demonstrate that the RADI Medical Systems PressureWire™ System is substantially equivalent to the predicate devices." However, it does not provide specific acceptance criteria or detailed results of a study designed to meet those criteria.
Key points from the document regarding "acceptance criteria" and "study":
- Substantial Equivalence: The primary "acceptance criterion" for this 510(k) submission is that the device is "substantially equivalent" to legally marketed predicate devices.
- Predicate Devices: The predicate devices are listed as "ACS Guidewires" and "Millar Pressure Measurement System."
- Performance Data: The document generally states that "Safety and performance testing was performed to demonstrate that the RADI Medical Systems PressureWire™ System is substantially equivalent to the predicate devices."
- Technical Characteristics: It mentions that "The mechanical properties of the PressureWire™ Sensor are similar to ACS Guidewires" and "The technical properties of PressureWire™ System are similar to the Millar Pressure Measurement System." This is the extent of the "performance data" provided. No specific numerical data or detailed study results are given.
Given the nature of this 510(k) summary, which predates modern AI/ML device evaluations, the requested information cannot be fully provided.
Here's a breakdown of the available and missing information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance (from submission) |
|---|---|
| Mechanical Properties: Similar to predicate guidewire. | "The mechanical properties of the PressureWire™ Sensor are similar to ACS Guidewires." |
| Technical Properties: Similar to predicate pressure measurement system. | "The technical properties of PressureWire™ System are similar to the Millar Pressure Measurement System." |
| Biocompatibility: Materials in contact with blood are typical for similar devices. | "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." |
| Overall Performance: Substantially equivalent to predicate devices. | "Safety and performance testing was performed to demonstrate that the RADI Medical Systems PressureWire™ System is substantially equivalent to the predicate devices." |
No specific numerical acceptance criteria (e.g., accuracy, precision, sensitivity, specificity) or detailed study results (means, standard deviations, confidence intervals, p-values) are provided in this summary.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. Substantial equivalence claims often rely on bench testing and comparisons to predicate device specifications, rather than a clinical "test set" in the context of an AI device.
- Data Provenance: Not specified, but likely laboratory/bench data and existing literature on predicate devices. No mention of patient data (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This type of information is not relevant for a 510(k) submission focused on substantial equivalence of a physical medical device, especially not one involving AI. "Ground truth" in this context would likely refer to established engineering standards or performance characteristics of predicate devices, not expert human interpretations of diagnostic data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No human adjudication method would be used for this type of device and submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This device is a physical guidewire with a pressure sensor; it is not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Implicitly: The "ground truth" for demonstrating substantial equivalence would be the established performance specifications and safety profiles of the predicate devices and generally accepted engineering and biocompatibility standards for similar devices. No "expert consensus," "pathology," or "outcomes data" in the AI sense would be used to establish ground truth for this device's performance given the available information.
8. The sample size for the training set:
- Not Applicable. This device does not involve a training set as it is not an AI/ML product.
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set for an AI/ML algorithm is involved.
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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 includingPressureWire™ Sensor,PressureWire™ Interface andPressureWire™ Monitor Cables. |
|---|---|
| Common Name: | Transducer, Pressure, Guidewire |
| Classification Names: | Transducer, Pressure, Guidewire |
| Predicate Device Names: | ACS GuidewiresMillar 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).
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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.
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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
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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
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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 measurementof blood pressure in the coronary vasculature and to facilitatethe placement of balloon dilatation catheters duringpercutaneous transluminal coronary angioplasty (PTCA). |
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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 _
§ 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.