The PressureWire Sensor is intended for use in coronary and peripheral blood vessels to measure blood pressure during percutaneous procedures and to facilitate the placement of interventional devices.

Device Description

The PressureWire™ Sensor consists of a pressure sensor mounted steerable guidewire to perform real-time invasive pressure measurement in the vasculature and a detachable cable for connection to RADI Medical Systems PressureWire™ Interface only. The guidewire has an outer diameter of .014" and is 175 cm in length. The pressure sensor is mounted just proximal of the 3 cm shapeable radiopaque tip.

PressureWire™ Sensor is connected to the PressureWire™ Interface via the Interface Cable which has an identification memory chip containing the individual calibration parameters for the sensor.

The readings from the PressureWire™ Sensor and the one measured through a guiding catheter can be used as input for calculation of various indices which require one or two input values e.g. gradient or Fractional Flow Reserve (FFR) etc.

AI/ML Overview

The information provided focuses on the substantial equivalence of the "PressureWire™ Sensor" to a predicate device and does not contain detailed acceptance criteria, a specific study with performance metrics against those criteria, or the other requested study design details.

Here's a breakdown based on the provided text, highlighting the absence of the requested information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in the provided 510(k) summary. The document states a bench test was conducted to show the device "does not clinically significant impact the pressure signal recorded by the catheter."	Bench Test Result: The presence of the PressureWire™ Sensor within a guiding catheter (6 Fr. or greater) does not clinically significantly impact the pressure signal recorded by the catheter.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified.
Data Provenance: Not specified. The study was a "bench test," which typically implies laboratory testing rather than human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The study was a bench test evaluating physical impact on a pressure signal, not an assessment requiring expert ground truth on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept is relevant for studies involving human interpretation or clinical outcomes, not for a bench test of physical properties.

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

No MRMC study was done. This device is a medical guidewire with a pressure sensor, not an AI-powered diagnostic imaging tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone bench test was done. The device's performance (impact on pressure signal) was evaluated independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the bench test, the "ground truth" would be the direct measurement of pressure signals, comparing signals with and without the device's presence to determine the impact. This is not an expert consensus, pathology, or outcomes data, but a direct physical measurement.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, this device is not an AI algorithm requiring a training set.

Summary of Device Performance Justification:

The 510(k) submission for the PressureWire™ Sensor relies heavily on the substantial equivalence to its predicate device (PressureWire™ Sensor (K972793)). The document explicitly states:

"Due to the extreme similarity in design and materials between subject and predicate devices further product performance testing has not been considered necessary."
"The technical characteristics of PressureWire™ Sensor is almost identical with the predicate device."
"The device is almost identical with predicate device and found to be suitable for its intended use."

The only performance data mentioned is a bench test to demonstrate that the presence of the new PressureWire™ Sensor within a guiding catheter does not "clinically significantly impact the pressure signal recorded by the catheter." This test was likely performed to address any potential concerns with the specific embodiment of the new device relative to the predicate, even given the overall similarity. However, no specific quantitative acceptance criteria for this impact are provided, nor are detailed results beyond the qualitative statement of "no clinically significant impact."

Summary

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510(K) SUMMARY 9

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and CFR 21 §807.92.

Submitter's Information:

Name:	RADI Medical Systems AB
Address:	Palmbladsgatan 10, SE-754 50 Uppsala, Swede
Phone/Fax:	+46-18-161000 / +46-18-161099
Contact Person:	Mats Granlund
Date of Preparation:	October 5, 1998
Device Name:
Trade Names:	PressureWire™ Sensor
Common Name:	Pressure Guidewire
Classification Name:	Catheter Guide Wire (870.1330)Catheter Tip Pressure Transducer (870.2870)
Predicate Device Names:	PressureWire™ Sensor (K972793)

Device Description:

PressureWire™ Sensor is connected to the PressureWire™ Interface via the Interface Cable which has an identification memory chip containing the individual calibration parameters for the sensor.

Intended Use:

PressureWire™ Sensor is intended to provide pressure signals from the coronary and peripheral vessels and to guide the positioning of interventional devices.

Technical Characteristics Summary:

The technical characteristics of PressureWire™ Sensor is almost identical with the predicate device.

Performance Data:

Due to the extreme similarity in design and materials between subject and predicate devices further product performance testing has not been considered necessary. A bench test have been conducted to show that the presence of the PressureWire Sensor within a guiding catheter (6 Fr. or greater) does not clinically significant impact the pressure signal recorded by the catheter

Conclusions

The device is almost identical with predicate device and found to be suitable for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a bird or an abstract human figure, composed of three curved lines.

ﺰ

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1099 FEB

Mr. Mats Granlund RADI Medical Systems AB Palmbladsqatan 10, SE-754 50 Uppsala, Sweden

Re : K983506 Pressure Wire™ Sensor Trade Name: Requlatory Class: II Product Code: DQX Dated: December 21, 1998 December 23, 1998 Received:

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, qood manufacturing practice, labeling, and prohibitions aqainst 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to

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Page 2 - Dr. Susan Silavin

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 regulations.

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) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). 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. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

K983506 510(k) Number:

PressureWire™ Sensor Device Name:

Indications for Use: The PressureWire Sensor is intended for use in coronary and peripheral blood vessels to measure blood pressure during percutaneous procedures and to facilitate the placement of interventional devices.

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Obito Uchiha for TJC
(Division Site Off)

(Division Sien-Off) Division of Carciovascular, Respiratory, and Neurological Devices K983506 510(k) Number

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

V Prescription Use

OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

(Optional Format 1/2/96)

Regulation Number and Section

§ 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.