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.

Device Description

The PressureWire™ Sensor consists of a pressure and temperature sensitive sensor mounted on a steerable guidewire to perform real-time invasive physiological measurement in the circulatory system and a detachable cable for connection to a diagnostic computer of the manufacturer's. The detachable cable has an identification memory chip containing the individual calibration parameters for the sensor.

The guidewire has an outer diameter of .014" and comes in two lenghts 183 and 300 cm. The pressure sensor is mounted just proximal of the 3 cm shapeable radiopaque tip.

The signals from the sensor are used for calculation and presentation of any parameters and indices based on temperature and pressure, such as detection of small temperature differences and Fractional Flow Reserve (FFR). By also using the temperature sensitivity in the cables within the device also flow ratios such as Coronary Flow Reserve (CFR) could be derived.

AI/ML Overview

The provided text describes a 510(k) summary for the PressureWire™ Sensor, a medical device used for physiological measurements in the circulatory system. However, the document does not contain information about explicit acceptance criteria or a specific study proving the device meets said criteria in a quantitative manner (e.g., performance metrics, statistical analysis).

Instead, the submission emphasizes that the device is technically identical to its predicate device (K002962) with the exception of a single capacitor. The justification for this change is to improve the device's immunity to disturbing electrical signals, particularly for temperature measurements used in Coronary Flow Reserve (CFR) calculations.

The core of the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting a de novo study with acceptance criteria for a novel device performance claim. Therefore, many of the requested elements for a detailed study description are not available in this document.

Here's an attempt to answer the questions based on the available information, noting where details are missing:

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

Acceptance Criteria	Reported Device Performance
Pressure Signal Linear Working Range: -30 to 300 mmHg	The actual sensor element is a piezo resistive pressure sensor coupled in a Wheatstone bridge. The linear working range for the pressure signals is from -30 to 300 mmHg.
Temperature Signal Linear Working Range: 15 to 42°C	...and for the temperature signals from 15 to 42°C.
Noise Level (due to electrical interference): Not explicitly stated as a quantitative acceptance criteria.	The noise level has decreased tenfold with the incorporation of the capacitor.
Mechanical Principles of Operation: Same as ordinary guidewire.	The mechanical principles of operation are the same as for any ordinary guidewire.

Note: The primary "acceptance criteria" for this 510(k) submission appears to be demonstrating that the modified device performs at least as well as, or better than (in terms of noise reduction), the predicate device, and continues to meet its intended use. Explicit quantitative performance thresholds for characteristics like accuracy or precision are not provided in this summary.

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

This information is not provided in the 510(k) summary. The submission focuses on the technical modification (adding a capacitor) and the resulting impact on noise, rather than a clinical or performance study with a dedicated test set. The claim regarding "tenfold decrease in noise" suggests internal testing, but details are not given.

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)

This information is not provided. As no clinical or expert-reviewed performance study is detailed, the concept of "ground truth" as established by experts for a test set is not applicable here.

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

This information is not provided. Adjudication methods are relevant for studies involving human interpretation or complex evaluations, which are not described in this technical modification summary.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed as described in this document. The PressureWire™ Sensor is a diagnostic device for measuring physiological parameters, not an AI-powered image analysis tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this submission.

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

The device is a sensor that measures physiological parameters. Its function is "standalone" in the sense that it directly measures pressure and temperature. The "calculation and presentation of any parameters and indices based on temperature and pressure, such as detection of small temperature differences and Fractional Flow Reserve (FFR)" are performed by the manufacturer's RADIAnalyzer™, which is mentioned as a concurrent 510(k) submission. The performance of the sensor itself, as a standalone measurement device, is what's being discussed in terms of its operational range and noise reduction.

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

The ground truth for the sensor's performance would primarily relate to its accuracy in measuring pressure and temperature against established physical standards and its ability to reduce electrical noise. However, the specific methodology and "ground truth" used for demonstrating the "tenfold decrease in noise" are not detailed in this summary. It can be inferred that the ground truth would be based on electrical engineering measurements in a controlled environment.

8. The sample size for the training set

This information is not provided. The device is not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The design and modification (adding a capacitor) are based on electrical engineering principles.

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

This information is not applicable/provided. There is no mention of a "training set" in the context of an AI/machine learning algorithm. The "ground truth" for the device's fundamental performance likely refers to physical calibration standards and electrical noise measurements.

Summary

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K022187

p.1/3

SEP 2 4 2002

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, Sweden
Phone/Fax:	+46-18-161000 / +46-18-161099
Contact Person:	Mats Granlund
Date of Preparation:	July 2, 2002
Device Name:
Trade Names:	PressureWire™ Sensor
Common Name:	Pressure Guidewire
Classification Name:	Catheter Guide Wire (870.1330)
	Catheter Tip Pressure Transducer (870.2870)
	Thermodilution probe (870.1915)
Predicate Device Names:	PressureWire™ Sensor (K002962)
	FloWire Doppler Guide wire (K972762)

Device Description:

The guidewire has an outer diameter of .014" and comes in two lenghts 183 and 300 cm. The pressure sensor is mounted just proximal of the 3 cm shapeable radiopaque tip.

Indication for Use:

PressureWire™ Sensor is indicated to direct a catheter through a blood vessel to measure physiological parameters in the coronary and peripheral blood vessels.

Technical Characteristics Summary:

The technical characteristics of PressureWire™ Sensor are identical with the predicate device (K002962) with the exception of a capacitor.

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10 Description

The device is technically identical with the predicate with exception of the capacitor.

10.1 Intended Use

Indications for Use 10.2

The Pressure Wire Sensor is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary and peripheral blood vessels.

10.3 Contraindications

Use of the PressureWire™ Sensor is contraindicated for use in the cerebral vasculature.

10.4 Principles of Operation

For measurements, the PressureWire™ Sensor is connected to the RADIAnalyzer™, which. After calibration of the sensor in saline solution the system is ready for use.

The mechanical principles of operation are the same as for any ordinary guidewire.

Image /page/1/Picture/11 description: The image shows a medical device called a PressureWire. The PressureWire is a thin, flexible wire with a pressure sensor at the tip. It is used to measure blood pressure inside blood vessels. The image also shows a monitor that displays the pressure readings from the PressureWire. The monitor has a screen that shows a graph of the pressure over time.

Figure 10.1 Pressure Wire Sensor connected to RADIAnalyzer

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Composition and Physical Description 10.5

The PressureWire™ Sensor consists of three parts, the sensor, the guidewire, and the torque device. All parts are sterile and for single use only. No changes have been made in the composition apart from the incorporation of the capacitor, which is mounted at the circuit board with in the contact (G), see figure below.

Image /page/2/Figure/3 description: The image shows a diagram of a guidewire with a sensor and a cable. The guidewire has a length of 31 cm, and a sensor with a length of 3 cm. The cable has a length of 200 cm. The diameter of the guidewire is 0.014 inches (0.36mm).

Figure 10.2: Device parts

The guidewire part is available in two lengths (183, 300 cm). The very tip consists of a 3 cm Pt coil distal of the sensor element, and proximal of the sensor element there is a 28 cm stainless steel coil followed by a PTFE coated stainless steel tube, which ends with the male contact. Within the tube and proximal coil there are mainly a core wire and a triple conductor (Micro Cable) for connection between the sensor element and the male contact. The actual sensor element is a piezo resistive pressure sensor coupled in a Wheatstone bridge. The linear working range for the pressure signals is from -30 to 300 mmHg, and for the temperature signals from 15 to 42℃.

The cable is identical with the predicate device with exception of the capacitor, which is incorporated in the connector (female contact) in parallel with a 100kOhm resistor to decrease the impedance of the shield (proximal tube) at high frequencies as well to increase the immunity of the sensor against disturbing signals from surrounding electrical equipment. To decrease the influence from surrounding electrical equipment has become of more importance when the temperature signals are actively used in the CFR calculations. The noise level has decreased tenfold with the incorporation of the capacitor.

(See Attachment III)

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 2002

RADI Medical Systems AB c/o Mr. Mats Granlund Quality Manager Palmbladsgatan 10 SE-754 50 Uppsala Sweden

Re: K022187

Trade Name: PressureWire Sensor Regulation Number: 21 CFR 870.2870 and 870.1915 Regulation Name: Catheter Tip Pressure Transducer and Thermodilution Probe Regulatory Class: Class II (two) Product Code: DXO and KRB Dated: July 2, 2002 Received: July 5, 2002

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.

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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Elias Mallis

Bram D. Zuckernan, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2 Statement of Indications for Use

510(k) Number:	K022187
Device Name:	PressureWire TM Sensor
Indications for Use:	The PressureWire TM Sensor is indicated to direct acatheter through a blood vessel and to measurephysiological parameters in the coronary andperipheral blood vessels

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Elier Malls ·············································································································································································· (CFR 801.109)

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

OR Over-The-Counter Use ______________________________________________________________________________________________________________________________________________________ Prescription Use x (Per 21 CFR 801.109)

(Optional Format 1/2/96)

Regulation Number and Section

§ 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).