Zurich Pressure Guidewire System Model 100

K190852 · Zurich Medical, Inc. · DXO · Aug 14, 2019 · Cardiovascular

Device Facts

• Record ID: K190852
• Device Name: Zurich Pressure Guidewire System Model 100
• Applicant: Zurich Medical, Inc.
• Product Code: DXO · Cardiovascular
• Decision Date: Aug 14, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2870
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Zurich Pressure Guidewire System is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a vessel. The signal output of the sensor is used for calculation and presentation of any physiological parameters, functions or indices based on pressure, e.g. Fractional Flow Reserve (FFR).

Device Story

System comprises 0.014" diameter, 180 cm long interventional guidewire with distal pressure sensor and paired battery-powered portable display. Guidewire directs catheters through vessels; sensor measures blood pressure. Signals processed to calculate/display physiological parameters like Fractional Flow Reserve (FFR). Used in catheterization labs; operated by clinicians. Guidewire is single-use, sterile; display is single-use, sterile. Provides real-time hemodynamic data to assist clinical decision-making regarding treatment of intermediate lesions. Benefits include improved diagnostic assessment of coronary/peripheral lesions.

Clinical Evidence

Bench testing only. Includes electromagnetic compatibility (IEC 60601-1-2), electrical safety (AAMI/ANSI ES60601-1), biocompatibility (ISO 10993-1), packaging (ISO 11607-1), sterilization (ISO 11135), human factors (IEC 62366-1), and shelf life (ASTM F1980). Mechanical performance verified via tensile, kink, pushability, torque, flexibility, and fatigue testing. Animal studies conducted under GLP guidelines.

Technological Characteristics

0.014" guidewire with hydrophilic coating and radiopaque coil tip. High-fidelity pressure sensor 3 cm from distal tip. Battery-powered portable display. Connectivity via handle. Sterilization: ISO 11135. Electrical safety: Type CF defibrillation proof. Operating range: 0-300 mmHg. Materials: biocompatible per ISO 10993-1.

Indications for Use

Indicated for measuring physiological parameters in coronary and peripheral blood vessels and the heart, and for directing a catheter through a blood vessel.

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

• St. Jude Medical Systems AB, PressureWire™ Certus™ (K131452)
• Radi Medical Systems AB, RadiAnalyzer™ Xpress (K092105)

Submission Summary (Full Text)

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August 14, 2019

Zurich Medical Inc. % Mark Job Official Correspondent Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K190852

Trade/Device Name: Zurich Pressure Guidewire System Model 100 Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter Tip Pressure Transducer Regulatory Class: Class II Product Code: DXO, DQK, DSK, DQA Dated: June 19, 2019 Received: June 24, 2019

Dear Mark Job:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K190852

## Device Name Zurich Pressure Guidewire System

Indications for Use (Describe)

Zurich Pressure Guidewire System is indicated to measure physiological parameters in the coronary and peripheral blood vessels and in the heart. Zurich Pressure Guidewire System is also indicated to direct a catheter through a blood vessel.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image is a logo for Zurich Medical. The word "ZURICH" is in black, with a blue triangle replacing the dot above the "i". Below "ZURICH" is the word "MEDICAL" in white text on a blue rectangle. The logo is simple and modern, using a clean font and a limited color palette.

6.1.1

## 6.0 510(K) SUMMARY

#### ADMINISTRATIVE INFORMATION 6.1

Date of Summary Preparation:

CONTACT INFORMATION

February 16, 2019

| Sponsor/Manufacturer | Zurich Medical Inc.<br>2405 Xenium Lane N<br>Plymouth, MN 55441<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Kin-Joe Sham<br>COO, Zurich Medical Inc.<br>Phone: [phone] x102<br>Email: [e-mail] |

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Image /page/4/Picture/0 description: The image shows the logo for Zurich Medical. The word "ZURICH" is in black, sans-serif font, with a blue, teardrop-shaped graphic replacing the "U". Below "ZURICH" is the word "MEDICAL" in a larger, blue, sans-serif font. The logo is simple and modern.

#### 6.1.2 DEVICE INFORMATION

| Trade Name | Zurich Pressure Guidewire System Model 100™ |
|-----------------------|----------------------------------------------------------------------------------------|
| Common Name | Zurich Pressure Guidewire System |
| Classification Name | Catheter Tip Pressure Transducer |
| Regulation Number(s): | 870.2870, 870.1330 (interventional guidewire)<br>870.1425, 870.1110 (portable display) |
| Class | II |
| Classification Panel | Cardiovascular |
| Product Code | DXO, DQX (interventional guidewire)<br>DQK, DSK (portable display) |

# 6.2 PREDICATE DEVICES

The Zurich Pressure Guidewire System Model 100™ is substantially equivalent to the following:

- K131452 (Abbott Laboratories) St. Jude Medical Systems AB. PressureWire™ Certus™ ● (interventional guidewire)
- K092105 (Abbott Laboratories) Radi Medical Systems AB, RadiAnalyzer™ Xpress ● (portable display)

### 6.3 DEVICE DESCRIPTION

The Zurich Pressure Guidewire System Model 100™ ("Zurich Pressure Guidewire System") consists of a 0.014" (0.36 mm) diameter, 180 cm long Interventional Guidewire with a high fidelity sensor located immediately beyond the 3 cm shapeable radiopaque tip and a uniquely paired Portable Display. The signals from the sensor can be used to measure blood pressures and calculate Fractional Flow Reserve (FFR). The Guidewire is connected to the Portable Display via the Handle. The distal end has hydrophilic coating. The Portable Display also has an AO Cable that may be used to connect to the Zurich Medical Accessory Cable for AO pressure signal.

# 6.4 INTENDED USE

Zurich Pressure Guidewire System is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a vessel. The signal output of the sensor is used for calculation and presentation of any physiological parameters, functions or indices based on pressure, e.g. Fractional Flow Reserve (FFR).

#### INDICATIONS FOR USE 6.5

Zurich Pressure Guidewire System is indicated to measure physiological parameters in the coronary and peripheral blood vessels and in the heart. Zurich Pressure Guidewire System is also indicated to direct a catheter through a blood vessel.

#### 6.6 TECHNOLOGICAL CHARACTERISTICS

The Zurich Pressure Guidewire System Model 100 is designed for use as an adjunct to conventional angiographic procedures, which identify intermediate lesion(s) to be examined further. FFR is a calculation that has been clinically proven to assist in determining whether to treat or not to treat these intermediate lesions.

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Image /page/5/Picture/1 description: The image contains the logo for Zurich Medical. The word "ZURICH" is in bold, black, sans-serif font, with a blue water droplet shape above the "U". Below "ZURICH" is the word "MEDICAL" in a bold, white, sans-serif font, set against a blue rectangular background. The logo is clean and modern.

The Zurich Pressure Guidewire System Model 100 consists of the following:

- 0.014" standard guidewire ●
- . Pressure sensor located 3 cm proximal to the distal tip
- Disposable battery powered portable display ●

### PERFORMANCE DATA (SUMMARY OF NON-CLINICAL TESTING) 6.7

The Zurich Pressure Guidewire System has been tested and meets all its physical and performance specifications. These include:

- Electromagnetic Compatibility testing per IEC 60601-1-2 Edition 4.0 2014-02
- Electrical Safety testing per AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012 ●
- Biocompatibility testing per ISO 10993-1:2009 for external communicating device with ● short-term contact duration (<24 hours) with circulating blood
- Cytotoxicity O
- O Sensitization
- Irritation O
- Systemic Toxicity O
- Hemolysis -Direct and Indirect Contact O
- Complement Activation O
- Thromboresistance O
- Materials Mediated Pyrogenicity O
- Genotoxicity O
- Packaging Validation per ISO 11607-1:2006 after distribution simulation per ASTM ● D4169-16
- Labeling per FDA General Device Labeling Requirements 21 CFR Part 801 and Unique Device Identification Labeling Requirements 21 CFR Part 830
- Sterilization per ISO 11135:2014 and ISO 10993-7:2008
- Human Factors per IEC 62366-1:2015 ●
- Shelf Life Testing per ASTM F1980-16
- Animal studies were carried out under full GLP guidelines. All requirements were met as . set forth in the study protocols for Zurich Pressure Guidewire System.
- Software Testing and Bench Verification Testing for Interventional Guidewire, Portable Display, and System included:
- Diameter O
- Vascular Device Compatibility O
- Tensile O
- Kink O
- Pushability O
- Torque O
- Flexibility O
- Coating Uniformity and Durability O
- Corrosion O
- Lubricity O
- Fatigue O
- Fracture O
- Dimensional O

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Image /page/6/Picture/1 description: The image contains the logo for Zurich Medical. The word "ZURICH" is in bold, black letters, with a blue teardrop shape above the "U". Below "ZURICH" is the word "MEDICAL" in white letters on a blue rectangle. The logo is simple and modern.

- Particulate O
- O Software verification and validation testing was conducted as recommended in FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005).

The testing showed that the device meets specifications before and after aging, indicating that the device is as safe and effective as the predicate devices. See Section 19 for performance specification details.

#### 6.8 SUBSTANTIAL EQUIVALENCE

Zurich Pressure Guidewire System is substantially equivalent to the presently marketed predicate device, K131452, St. Jude Medical PressureWire Certus Guidewire (interventional guidewire) and K092105 RadiAnalyzer Xpress (portable display) in terms of intended use, indications for use, operational characteristics, and technology characteristics. The Zurich Pressure Guidewire System is as safe and effective as the predicate devices.

One difference is that the portable display for predicate (K092105) is sold separately and can be only used as specified in the portable display intended use. The Zurich Pressure Guidewire System contains both the guidewire and the display therefore there is no need for a separate statement for the portable display. They can only be used together to support the intended use.

The difference in wording of the indications for use is a grammar/readability preference only; i.e. the sentences have been written for readability and preference. This grammar difference is not critical to the intended therapeutic, diagnostic, prosthetic, surgical, or other use of the device and does not affect the safety and effectiveness of the Zurich Pressure Guidewire System when used as labeled.

| Device<br>Characteristics | Zurich<br>Pressure<br>Guidewire<br>System | Predicate<br>K131452 | Predicate<br>K092105 | Comparison<br>Result |
|---------------------------|--------------------------------------------------------|---------------------------------------------------------|----------------------------------------------|----------------------|
| Product Name | Zurich<br>Pressure<br>Guidewire<br>System Model<br>100 | PressureWire<br>Certus<br>(interventional<br>guidewire) | RadiAnalyzer<br>Xpress (portable<br>display) | — |

The comparison between the Subject Device and the predicates is presented below.

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Image /page/7/Picture/0 description: The image shows the logo for Zurich Medical. The word "ZURICH" is in a bold, sans-serif font, with a blue water droplet replacing the dot on the "i". Below "ZURICH" is the word "MEDICAL" in a smaller, sans-serif font, set against a blue rectangle.

| Device<br>Characteristics | Zurich<br>Pressure<br>Guidewire<br>System | Predicate<br>K131452 | Predicate<br>K092105 | Comparison<br>Result |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use of<br>the System<br>(Guidewire and<br>Display) | Zurich<br>Pressure<br>Guidewire<br>System is<br>designed to fit<br>inside a<br>percutaneous<br>catheter for the<br>purpose of<br>directing the<br>catheter<br>through a<br>vessel. The<br>signal output<br>of the sensor is<br>used for<br>calculation<br>and<br>presentation of<br>any<br>physiological<br>parameters,<br>functions or<br>indices based<br>on temperature<br>or pressure,<br>e.g. Fractional<br>Flow Reserve<br>(FFR) | The PressureWire<br>is designed to fit<br>inside a<br>percutaneous<br>catheter for the<br>purpose of<br>directing the<br>catheter through a<br>vessel. The signal<br>output of the<br>sensor is used for<br>calculation and<br>presentation of<br>any physiological<br>parameters,<br>functions or<br>indices based on<br>temperature or<br>pressure, e.g.<br>Fractional Flow<br>Reserve (FFR). | RadiAnalyzer®<br>Xpress is intended<br>for use in<br>catheterization and<br>related<br>cardiovascular<br>specialty<br>laboratories to<br>compute, and<br>display various<br>physiological and<br>blood flow<br>parameters based on<br>the output from one<br>or more electrodes,<br>transducers or<br>measuring devices. | Substantially<br>equivalent to<br>K131452.<br><br>The intended use<br>for K092105 can<br>only be achieved<br>by being<br>connected to<br>K131452.<br><br>The intended use<br>of the Zurich<br>Pressure<br>Guidewire System<br>is the same as the<br>intended use of the<br>two predicates<br>when used<br>together. |
| Device<br>Characteristics | Zurich<br>Pressure<br>Guidewire<br>System | Predicate<br>K131452 | Predicate<br>K092105 | Comparison<br>Result |
| Indications for<br>Use | Zurich<br>Pressure<br>Guidewire<br>System is<br>indicated to<br>measure<br>physiological<br>parameters in<br>the coronary<br>and peripheral<br>blood vessels<br>and in the<br>heart. Zurich<br>Pressure<br>Guidewire<br>System is also<br>indicated to<br>direct a<br>catheter<br>through a<br>blood vessel. | PressureWire™ is<br>indicated to direct<br>a catheter through<br>a blood vessel and<br>to measure<br>physiological<br>parameters in the<br>heart and in the<br>coronary and<br>peripheral blood<br>vessels. | RadiAnalyzer®<br>Xpress is indicated<br>to provide<br>hemodynamic<br>information for use<br>in the diagnosis and<br>treatment of<br>patients that<br>undergo<br>measurement of<br>physiological<br>parameters with<br>PressureWire®. | Substantially<br>equivalent to<br>K131452 but has<br>minor difference<br>in grammar.<br>The indication for<br>use for K092105<br>can only be<br>achieved by being<br>connected to<br>K131452. |
| Device<br>Classification | Class II | Class II | Class II | Same |
| Regulation<br>Number | 21 CFR<br>870.2870 21<br>CFR 870.1330<br>21 CFR<br>870.1425 21<br>CFR 870.1110 | 21 CFR 870.2870<br>21 CFR 870.1330 | 21 CFR 870.1425<br>21 CFR 870.1110 | Same |
| Product Code | DXO, DQX<br>DQK, DSK | DXO, DQX | DQK, DSK | |
| Regulatory<br>Classification<br>Name | Catheter Tip<br>Pressure<br>Transducer,<br>Catheter<br>Guide Wire,<br>Programmable<br>Diagnostic<br>Computer,<br>Blood<br>Pressure<br>Computer | Catheter Tip<br>Pressure<br>Transducer,<br>Catheter Guide<br>Wire, | Programmable<br>Diagnostic<br>Computer,<br>Blood Pressure<br>Computer | Same |
| Device<br>Characteristics | Zurich<br>Pressure<br>Guidewire<br>System | Predicate<br>K131452 | Predicate<br>K092105 | Comparison<br>Result |
| <b>System</b> | | | | |
| Sterility of<br>Guidewire | Single use,<br>disposable,<br>sterile, SAL<br>10-6 | Single use,<br>disposable, sterile<br>SAL 10-6 | — | Same |
| Sterility of<br>Display System | Single use,<br>disposable,<br>sterile, SAL<br>10-6 | — | Reusable, non-<br>sterile | The PD in Zurich<br>Pressure<br>Guidewire System<br>is single use and<br>K092105 is a<br>capital equipment. |
| Shelf Life | 12 months | 24 months | — | Predicate device<br>has extended shelf<br>life. |
| Total Length of<br>Cable | 40 cm<br>Connects to<br>sterile portable<br>display. | 210 cm<br>Connects to non-<br>sterile display. | — | Cord length is<br>indicative of<br>sterile field. |
| <b>Guidewire</b> | | | | |
| Nominal<br>Diameter | 0.014" (0.36<br>mm) | 0.014" (0.36 mm) | — | Same |
| Guidewire<br>Length | 180 cm | 175/300 cm | — | Device length is<br>longer than<br>predicate for same<br>model. |
| Hydrophilic<br>Coating | Hydrophilic<br>coating at<br>distal end | Hydrophilic<br>coating at distal<br>end | — | Same |
| Radiopacity | Radiopaque<br>coil | Radiopaque coil | — | Same |
| Tip Length | 3 cm | 3 cm | — | Same |
| Sensor | Mounted on<br>guidewire | Mounted on<br>guidewire | — | Same |
| <b>Portable Display</b> | | | | |
| Power Source | Battery | — | Electrical main | PD is a single use<br>device and<br>K092105 is a<br>capital equipment. |
| Pressure Range | 0-300 mmHg | — | -30-300 mmHg | Predicate device<br>range is different<br>(-30 to 0 mmHg). |
| Device<br>Characteristics | Zurich<br>Pressure<br>Guidewire<br>System | Predicate<br>K131452 | Predicate<br>K092105 | Comparison<br>Result |
| Electrical | | | | |
| Defibrillation<br>Proof | Type CF | | Type CF | Same |
| Classification | Class II (2-<br>prong power<br>cord) | — | Class I (3-prong<br>power cord) | Difference due to<br>prongs. |
| Operating<br>Voltage | 100-240V~,<br>0.4A, 50/60Hz | — | 100-240Vm 50-<br>60Hz | Same |
| Environmental conditions | | | | |
| Operating<br>Temperature | 15°C-40°C<br>(59°F-104°F) | 15°C-42°C | — | 2°C difference in<br>upper limit for the<br>predicate. |
| Operating<br>Relative<br>Humidity | 30% -75%,<br>non-<br>condensing at<br>40°C | 30 - 75% | — | Same |

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Image /page/8/Picture/0 description: The image shows the logo for Zurich Medical. The word "ZURICH" is in black, with a blue teardrop shape replacing the top left portion of the letter "U". Below "ZURICH" is the word "MEDICAL" in a blue rectangle. The font is sans-serif and appears to be a modern design.

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Image /page/9/Picture/0 description: The image contains the logo for Zurich Medical. The logo consists of the word "ZURICH" in a bold, sans-serif font, with a blue water droplet shape above the "U". Below "ZURICH" is the word "MEDICAL" in a smaller, sans-serif font, set against a blue background. The overall design is clean and modern.

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Image /page/10/Picture/0 description: The image shows the logo for Zurich Medical. The word "ZURICH" is in black, with a blue teardrop shape above the "U". Below "ZURICH" is the word "MEDICAL" in a blue rectangle. The logo is simple and modern.

There are other minor design differences but they do not raise different questions of safety and effectiveness. Performance data demonstrate that the Zurich Pressure Guidewire System is as safe and effective as the predicate devices. Thus, the Zurich Pressure Guidewire System is substantially equivalent.

### 6.9 CONCLUSION

The results of these activities demonstrate that the Zurich Pressure Guidewire System is as safe, as effective, and performs as well as the predicate devices. While there are technological differences between the subject device and the predicates, scientific data shows that the differences do not raise new questions of safety or efficacy. Therefore, the Zurich Pressure Guidewire System Model 100 and predicates, K131452 and K092105, are substantially equivalent.