PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300

K131452 · St. Jude Medical Systems AB · DXO · Sep 5, 2013 · Cardiovascular

Device Facts

• Record ID: K131452
• Device Name: PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300
• Applicant: St. Jude Medical Systems AB
• Product Code: DXO · Cardiovascular
• Decision Date: Sep 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2870
• Device Class: Class 2

Intended Use

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

Device Story

PressureWire is a 0.014" guidewire with an integrated sensor at the tip; used to direct catheters through vasculature and measure physiological parameters. Device pairs with specific connection cables (PressureWire Certus) or transmitters (PressureWire Aeris). Operated by clinicians in catheterization laboratories; connects to diagnostic computers or hemodynamic recording systems. Modifications include an additional hydrophilic coating supplier and optional palladium coil material for the radiopaque tip. Device provides real-time physiological data to assist clinical decision-making during interventional procedures.

Clinical Evidence

Bench testing only. Verification and validation activities, including mechanical and signal testing, chemical characterization, and biocompatibility, demonstrated that the modified device meets product specifications and performs equivalently to the predicate.

Technological Characteristics

0.014" guidewire with integrated catheter-tip pressure transducer. Features hydrophilic coating and radiopaque tip (option for palladium coil). Connects to external diagnostic computer or hemodynamic recording system via cable or transmitter. Operates as a physiological signal transmitter/receiver.

Indications for Use

Indicated for patients requiring catheter guidance and physiological parameter measurement within the heart, coronary, or peripheral blood vessels.

Regulatory Classification

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.

Predicate Devices

• PressureWire (K113584)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for St. Jude Medical. The logo consists of a 3x3 grid of squares on the left, followed by the text "St. Jude MEDICAL" in a bold, sans-serif font. Below the text, in a smaller font, is the tagline "MORE CONTROL LESS RISK."

St. Jude Medical Systems AB Paimbiadspatan 10 Box 6350, SE-751 35 Uppsala Sweden Tel [phone] Fax [phone]

Corporate ID no: 556335-9446

# 510(k) Summary

This 510(k) summary is submitted in accordance with the requirements in 21 CFR §807.92

| Submitted by: | St. Jude Medical Systems AB<br>Palmbladsgatan 10, Box 6350<br>SE-751 35 Uppsala, Sweden<br>Phone:[phone]<br>Fax: [phone] | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Anna-Lisa Tiensuu | |
| Date Prepared: | May 16, 2013 | SEP 0 5 2013 |
| Proprietary Name: | PressureWire™ | |
| Common Name: | PressureWire™ Guidewire | |
| Classification Name: | Transducer, Pressure, Catheter Tip (870.2870)<br>Wire, Guide, Catheter (870.1330)<br>Transmitters and Receivers, physiological signal,<br>radiofrequency (870.2910) | |
| Predicate Device: | (K113584) PressureWire™ cleared March 2, 2012. | |

### Device Description:

The modified PressureWire™ is essentially a modification of the previously cleared PressureWire™ (K113584). The subject device, The subject and predicate device, PressureWire is a 0.014" guidewire with an integrated sensor element at the tip to enable measurements of physiological parameters. The guidewire is uniquely paired with a specific connection cable for PressureWire Certus or with a specific transmitter for PressureWire Aeris. PressureWire is available in different lengths.

### Indication for Use:

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

### Predicate Device Comparison:

PressureWire was cleared by FDA under 510(k) K113584 on March 2, 2012. The subject device is substantially equivalent to the predicate device in terms of intended use, indication for use, operational characteristics, and fundamental design and technology characteristics. Below list identifies the changes to the subject device.

- Adding an additional supplier of the hydrophilic coating used on the distal tube. .
- . Adding the coil material palladium to the radiopaque tip.

### Testing summary:

A summary of PressureWire™ Design Control Activities with regards to risk analysis and verification and validation activities is provided in this 510k submission. The modifications applies to the corewire and do not change the operational principle. The successful completion of verification activities demonstrates that PressureWire™ meets the required product specifications. Based on passing verification specification criteria for mechanical and signal testing along with chemical characterization and biocompatibility, PressureWire™ performs substantially equivalent to predicate devices.

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St. Jude Medical Systems AB Paimbiadsgatan 10 Box 6350, SE-751 35 Uppsala Sweden Tel [phone] Fax [phone]

Corporate ID no: 556335-9446

#### Substantial Equivalence:

The fundamental scientific technology for the subject device is the same as for predicate device regarding signal transfer, mechanical properties and intended use. Pressure Wire is substantially equivalent to the predicated device in intended use, indication for use, fundamental design and technology, and operating principles. Both devices connect to a diagnostic computer or a catheter laboratory hemodynamic recording system to enable measurements of physiological parameters with minor changes incorporated into the Pressure Wire from the predicate device including:

- Adding an additional supplier of the hydrophilic coating used on the distal tube. .
- . Adding the option to use coil material palladium to the radiopaque tip.

The subject device, PressureWire™, meets the design inputs and raises no new safety or efficacy concerns. PressureWire™ is determined to be substantially equivalent to the presently marketed predicate device, K113584.

#### Conclusion:

Based on the similarities in indication for use, design features and functional features, the modified PressureWire™ is substantially equivalent to the currently marketed predicate device PressureWire™ K113584.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 5, 2013

St. Jude Medical Ms. Anna-Lisa Tiensuu Regulatory Affairs Manager 4 Robbins Rd. Westford, MA 01886

Re: K131452

> Trade/Device Name: PressureWire Certus and Aeris Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter Tip Pressure Transducer Regulatory Class: Class II Product Code: DXO, DRG, DQX Dated: July 23, 2013 Received: July 24, 2013

Dear Ms. Anna-Lisa Tiensuu:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Ms. Anna-Lisa Tiensuu

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): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also. please note the regulation entitled. "Misbranding by reference to premarket notification" (2) CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.hum for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Owen P. Faris -S

for

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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# Indication for Use Statement

| 510(k) Number: | K131452 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | PressureWire™ |
| Indications for Use: | PressureWire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels. |
| Prescription Use | X |
| | OR |
| | Over-The-Counter Use |
| | (Per 21 CFR 801.109) |

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Digitally signed by
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