(134 days)
Not Found
No
The description focuses on hardware components (guidewire, sensor, display) and basic signal processing for pressure measurement and FFR calculation, with no mention of AI or ML.
No.
The device is indicated to measure physiological parameters and to direct a catheter, which are diagnostic and procedural guidance functions, not therapeutic.
Yes
The device is indicated to "measure physiological parameters" and "measure blood pressures and calculate Fractional Flow Reserve (FFR)", which are diagnostic functions.
No
The device description explicitly states that the system consists of a physical guidewire with a sensor and a portable display, indicating it includes hardware components beyond just software.
Based on the provided information, the Zurich Pressure Guidewire System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Zurich Pressure Guidewire System is used within the body to measure physiological parameters directly in blood vessels and the heart.
- The intended use describes direct measurement within the body. The description clearly states it's used to "measure physiological parameters in the coronary and peripheral blood vessels and in the heart" and "to direct a catheter through a blood vessel." These are in-vivo procedures.
- The device description details an interventional guidewire with a sensor. This is a device designed for use inside the body, not for analyzing samples outside the body.
Therefore, the Zurich Pressure Guidewire System is an in-vivo medical device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DXO, DQK, DSK, DQA
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.
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 ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral blood vessels and in the heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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) | |
|---|---|
| ☑ 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 N
Plymouth, MN 55441
Phone: 651-571-0020
Fax: 763-477-6357
Email: info@zurichmed.com |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Kin-Joe Sham
COO, Zurich Medical Inc.
Phone: 651-571-0020 x102
Email: 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
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 (System | | | | |
| Sterility of
Guidewire | Single use,
disposable,
sterile, SAL
10-6 | Single use,
disposable, sterile
SAL 10-6 | — | Same |
| Sterility of
Display System | Single use,
disposable,
sterile, SAL
10-6 | — | Reusable, non-
sterile | The PD in Zurich
Pressure
Guidewire System
is single use and
K092105 is a
capital equipment. |
| Shelf Life | 12 months | 24 months | — | Predicate device
has extended shelf
life. |
| Total Length of
Cable | 40 cm
Connects to
sterile portable
display. | 210 cm
Connects to non-
sterile display. | — | Cord length is
indicative of
sterile field. |
| Guidewire | | | | |
| Nominal
Diameter | 0.014" (0.36
mm) | 0.014" (0.36 mm) | — | Same |
| Guidewire
Length | 180 cm | 175/300 cm | — | Device length is
longer than
predicate for same
model. |
| Hydrophilic
Coating | Hydrophilic
coating at
distal end | Hydrophilic
coating at distal
end | — | Same |
| Radiopacity | Radiopaque
coil | Radiopaque coil | — | Same |
| Tip Length | 3 cm | 3 cm | — | Same |
| Sensor | Mounted on
guidewire | Mounted on
guidewire | — | Same |
| Portable Display | | | | |
| Power Source | Battery | — | Electrical main | PD is a single use
device and
K092105 is a
capital equipment. |
| Pressure Range | 0-300 mmHg | — | -30-300 mmHg | Predicate device
range is different
(-30 to 0 mmHg). |
| Device
Characteristics | Zurich
Pressure
Guidewire
System | Predicate
K131452 | Predicate
K092105 | Comparison
Result |
| Electrical | | | | |
| Defibrillation
Proof | Type CF | | Type CF | Same |
| Classification | Class II (2-
prong power
cord) | — | Class I (3-prong
power cord) | Difference due to
prongs. |
| Operating
Voltage | 100-240V~,
0.4A, 50/60Hz | — | 100-240Vm 50-
60Hz | Same |
| Environmental conditions | | | | |
| Operating
Temperature | 15°C-40°C
(59°F-104°F) | 15°C-42°C | — | 2°C difference in
upper limit for the
predicate. |
| Operating
Relative
Humidity | 30% -75%,
non-
condensing at
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.
10
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.