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.

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Zurich Pressure Guidewire System Model 100. Its purpose is to demonstrate substantial equivalence to existing predicate devices, not primarily to prove performance against specific acceptance criteria for a new clinical indication. Therefore, the document does not contain the detailed information requested regarding acceptance criteria for an AI/device performance study, such as specific metrics (e.g., sensitivity, specificity), sample sizes for test sets, expert adjudication methods, MRMC studies, or detailed ground truth establishment.

The document primarily focuses on:

Device Description and Intended Use: The Zurich Pressure Guidewire System is indicated to measure physiological parameters in coronary and peripheral blood vessels and the heart, and to direct a catheter through a blood vessel.
Comparison to Predicate Devices: It highlights similarities and minor differences in intended use, indications for use, technological characteristics, and physical properties compared to two predicate devices (PressureWire™ Certus™ guidewire and RadiAnalyzer™ Xpress portable display).
Non-Clinical Testing: A summary of non-clinical (bench and animal) testing performed to demonstrate that the device meets its physical and performance specifications and is safe and effective. These tests are primarily related to general medical device safety and functionality (e.g., EMC, electrical safety, biocompatibility, sterility, software verification and validation).

Therefore, I cannot provide a table of acceptance criteria, reported performance, sample sizes for test sets, information on expert ground truth, or details of MRMC studies as these are not present in the provided text for this specific medical device submission.

The document does mention:

Non-Clinical Testing (similar to a standalone performance evaluation in a broader sense):
- The Zurich Pressure Guidewire System has undergone extensive non-clinical testing to meet its physical and performance specifications. This includes electromagnetic compatibility, electrical safety, biocompatibility, packaging validation, labeling compliance, sterilization, human factors, shelf life, animal studies (under GLP guidelines), and various Guidewire/Portable Display/System software and bench verification tests (e.g., diameter, tensile, kink, pushability, torque, flexibility, coating uniformity, corrosion, lubricity, fatigue, fracture, dimensional, particulate).
- Study Proving Device Meets Acceptance Criteria: "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." (Page 6)
- This implies that the "acceptance criteria" here refer to the specifications and requirements outlined by various standards (IEC, AAMI, ISO, ASTM) and FDA guidance for the type of device. The "study" proving it meets these is the sum of all the non-clinical tests mentioned.
- Type of Ground Truth: For non-clinical tests, the "ground truth" is typically derived from physical measurements against established engineering specifications, animal study observations, and compliance with industry standards.
Training Set Information:
- There is no mention of a training set in the context of an AI/machine learning model. This submission is for a physical medical device (pressure guidewire system), not an AI algorithm.

In summary, the provided text does not contain the specific information requested under points 1-9 because the device and its submission type (510(k) for substantial equivalence of a physical device) do not typically involve the kind of AI/algorithm performance studies implied by your questions.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ 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.2405 Xenium Lane NPlymouth, MN 55441Phone: 651-571-0020Fax: 763-477-6357Email: info@zurichmed.com
Submitter:	Kin-Joe ShamCOO, Zurich Medical Inc.Phone: 651-571-0020 x102Email: ksham@zurichmed.com

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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)870.1425, 870.1110 (portable display)
Class	II
Classification Panel	Cardiovascular
Product Code	DXO, DQX (interventional guidewire)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

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

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.

DeviceCharacteristics	ZurichPressureGuidewireSystem	PredicateK131452	PredicateK092105	ComparisonResult
Product Name	ZurichPressureGuidewireSystem Model100	PressureWireCertus(interventionalguidewire)	RadiAnalyzerXpress (portabledisplay)	—

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.

DeviceCharacteristics	ZurichPressureGuidewireSystem	PredicateK131452	PredicateK092105	ComparisonResult
Intended Use ofthe System(Guidewire andDisplay)	ZurichPressureGuidewireSystem isdesigned to fitinside apercutaneouscatheter for thepurpose ofdirecting thecatheterthrough avessel. Thesignal outputof the sensor isused forcalculationandpresentation ofanyphysiologicalparameters,functions orindices basedon temperatureor pressure,e.g. FractionalFlow Reserve(FFR)	The PressureWireis designed to fitinside apercutaneouscatheter for thepurpose ofdirecting thecatheter through avessel. The signaloutput of thesensor is used forcalculation andpresentation ofany physiologicalparameters,functions orindices based ontemperature orpressure, e.g.Fractional FlowReserve (FFR).	RadiAnalyzer®Xpress is intendedfor use incatheterization andrelatedcardiovascularspecialtylaboratories tocompute, anddisplay variousphysiological andblood flowparameters based onthe output from oneor more electrodes,transducers ormeasuring devices.	Substantiallyequivalent toK131452.The intended usefor K092105 canonly be achievedby beingconnected toK131452.The intended useof the ZurichPressureGuidewire Systemis the same as theintended use of thetwo predicateswhen usedtogether.
DeviceCharacteristics	ZurichPressureGuidewireSystem	PredicateK131452	PredicateK092105	ComparisonResult
Indications forUse	ZurichPressureGuidewireSystem isindicated tomeasurephysiologicalparameters inthe coronaryand peripheralblood vesselsand in theheart. ZurichPressureGuidewireSystem is alsoindicated todirect acatheterthrough ablood vessel.	PressureWire™ isindicated to directa catheter througha blood vessel andto measurephysiologicalparameters in theheart and in thecoronary andperipheral bloodvessels.	RadiAnalyzer®Xpress is indicatedto providehemodynamicinformation for usein the diagnosis andtreatment ofpatients thatundergomeasurement ofphysiologicalparameters withPressureWire®.	Substantiallyequivalent toK131452 but hasminor differencein grammar.The indication foruse for K092105can only beachieved by beingconnected toK131452.
DeviceClassification	Class II	Class II	Class II	Same
RegulationNumber	21 CFR870.2870 21CFR 870.133021 CFR870.1425 21CFR 870.1110	21 CFR 870.287021 CFR 870.1330	21 CFR 870.142521 CFR 870.1110	Same
Product Code	DXO, DQXDQK, DSK	DXO, DQX	DQK, DSK
RegulatoryClassificationName	Catheter TipPressureTransducer,CatheterGuide Wire,ProgrammableDiagnosticComputer,BloodPressureComputer	Catheter TipPressureTransducer,Catheter GuideWire,	ProgrammableDiagnosticComputer,Blood PressureComputer	Same
DeviceCharacteristics	ZurichPressureGuidewireSystem	PredicateK131452	PredicateK092105	ComparisonResult
System
Sterility ofGuidewire	Single use,disposable,sterile, SAL10-6	Single use,disposable, sterileSAL 10-6	—	Same
Sterility ofDisplay System	Single use,disposable,sterile, SAL10-6	—	Reusable, non-sterile	The PD in ZurichPressureGuidewire Systemis single use andK092105 is acapital equipment.
Shelf Life	12 months	24 months	—	Predicate devicehas extended shelflife.
Total Length ofCable	40 cmConnects tosterile portabledisplay.	210 cmConnects to non-sterile display.	—	Cord length isindicative ofsterile field.
Guidewire
NominalDiameter	0.014" (0.36mm)	0.014" (0.36 mm)	—	Same
GuidewireLength	180 cm	175/300 cm	—	Device length islonger thanpredicate for samemodel.
HydrophilicCoating	Hydrophiliccoating atdistal end	Hydrophiliccoating at distalend	—	Same
Radiopacity	Radiopaquecoil	Radiopaque coil	—	Same
Tip Length	3 cm	3 cm	—	Same
Sensor	Mounted onguidewire	Mounted onguidewire	—	Same
Portable Display
Power Source	Battery	—	Electrical main	PD is a single usedevice andK092105 is acapital equipment.
Pressure Range	0-300 mmHg	—	-30-300 mmHg	Predicate devicerange is different(-30 to 0 mmHg).
DeviceCharacteristics	ZurichPressureGuidewireSystem	PredicateK131452	PredicateK092105	ComparisonResult
Electrical
DefibrillationProof	Type CF		Type CF	Same
Classification	Class II (2-prong powercord)	—	Class I (3-prongpower cord)	Difference due toprongs.
OperatingVoltage	100-240V~,0.4A, 50/60Hz	—	100-240Vm 50-60Hz	Same
Environmental conditions
OperatingTemperature	15°C-40°C(59°F-104°F)	15°C-42°C	—	2°C difference inupper limit for thepredicate.
OperatingRelativeHumidity	30% -75%,non-condensing at40°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.

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).