(80 days)
PressureWire® is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary and peripheral blood vessels.
Pressure Wire® is a .014" guidewire with an integrated pressure and temperature sensor, together with a detachable cable for connection to a diagnostic computer.
The provided text describes a 510(k) submission for the PressureWire® device, focusing on its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed performance metrics, or information about a study designed to prove the device meets acceptance criteria in the way typically expected for a medical imaging AI device or diagnostic tool.
Instead, the document states:
- "Biocompatibility and performance testing indicate that PressureWire® satisfies safety and performance requirements of the device specifications and do not raise additional safety issues."
- "On the basis of the testing conducted, it may be concluded that PressureWire® satisfies specified safety and performance requirements."
- "PressureWire® is substantially equivalent to the predicate device."
This indicates that general performance and safety testing was performed, leading to the conclusion of substantial equivalence. The "performance data" mentioned is described broadly without specific quantitative metrics or a study design to meet defined acceptance criteria.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's an attempt to answer based on the absence of the requested information, and what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Satisfies safety requirements | "satisfies safety... requirements" |
| Satisfies performance requirements | "satisfies... performance requirements" |
| Does not raise additional safety issues compared to predicate | "do not raise additional safety issues" |
| Substantially equivalent to predicate in basic material, design, construction, and mechanical performance | "similar in basic material, design, construction and mechanical performance to the predicate device." |
| Effective for intended use (directing catheter, measuring physiological parameters) | (Implied by substantial equivalence and predicate's known use) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. It's likely pre-clinical (bench/in-vitro) and possibly animal testing given the nature of a guidewire, but no details are provided. This is a medical device, not an AI model, so "country of origin of data" in the typical sense for AI data is not relevant here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable/not specified. This is a medical device for physical measurement and guidance, not an imaging diagnostic device requiring expert interpretation for ground truth. Ground truth would likely be established by physical measurements against known standards.
- Qualifications: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not specified. As above, ground truth is likely established by physical measurements, not human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC study was not done, as this is a medical device, not a diagnostic AI intended to assist human readers in interpreting cases.
6. If a Standalone Study Was Done (Algorithm Only Without Human-in-the-Loop Performance)
- Standalone Study: Not applicable in the context of an "algorithm only" study. Performance tests would have been conducted on the device itself (standalone in a physical testing sense) to assess its functional characteristics (e.g., pressure measurement accuracy, steerability, biocompatibility). The document states "Biocompatibility and performance testing indicate..." which implies standalone testing of the device's physical properties.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated but would likely involve:
- Known Physical Standards: For pressure and temperature measurements (e.g., comparison against calibrated sensors).
- Material Science Standards: For biocompatibility and mechanical properties.
- Engineering Specifications: For design, construction, and mechanical performance.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This is a physical medical device, not an AI algorithm that undergoes data-driven training. Device design and validation are based on engineering principles, materials science, and physical testing.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable. As it's not an AI model, there isn't a "training set" in the machine learning sense. The "ground truth" for its development would be established through engineering specifications, material properties, and iterative design and testing.
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K062769
510(k) Summary
| Submitter: | Radi Medical Systems ABPalmbladsgatan 10SE-754 50 Uppsala, SwedenPhone:(+46) 18161000 | DEC - 4 2006 |
|---|---|---|
| Contact: | Mats Granlund | |
| Date Prepared: | September 13, 2006 | |
| Proprietary Name: | PressureWire® | |
| Common Name: | Pressure Guidewire | |
| Classification Name: | Catheter Tip Pressure Transducer (21 CFR 870.2870)Product Code DXO | |
| Predicate Devices: | PressureWire® Sensor, K031662Safe-Cross Deflecting Catheter, K040481 |
Device Description
Pressure Wire® is a .014" guidewire with an integrated pressure and temperature sensor, together with a detachable cable for connection to a diagnostic computer.
Intended Use of the Device:
PressureWire® has the same intended use as the submitter's predicate device. Pressure Wire® is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a vessel. The signal output from the senor is used for calculation and presentation of any physiological parameters, functions or indices based on pressure or temperature, e.g. Fractional Flow Reserve (FFR).
Technological Characteristics:
PressureWire® is similar in basic material, design, construction and mechanical performance to the predicate device. The main modification is that the distal part has been coated with a hydrophilic coating.
Performance Data
Biocompatibility and performance testing indicate that PressureWire® satisfies safety and performance requirements of the device specifications and do not raise additional safety issues.
Conclusion
On the basis of the testing conducted, it may be concluded that PressureWire® satisfies specified safety and performance requirements. PressureWire® is substantially equivalent to the predicate device.
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Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 4 2006
Radi Medical Systems c/o Mats Granlund Director, Quality & Regulatory Affairs Palmbladsgatan 10 Uppsala, Sweden SE-754 50
Re: K062769 Trade/Device Name: PressureWire® Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter tip pressure transduccr Regulatory Class: II Product Code: DXO, DQX Dated: October 25, 2006 Received: October 26, 2006
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 net 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.
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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 (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/cdri/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K062769
Device Name:
Pressure Wire®
Indications for Use:
PressureWire® is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary and peripheral blood vessels.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ision of Cardiovascular Devices
510(k) Number K062769
Page 1 of
§ 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).