LiPPS Analyzer, LiPPS Wire Pressure Guide Wire

K201720 · Beijing Bywave Sensing Medical Technology Co., Ltd. · DQX · Feb 18, 2021 · Cardiovascular

Device Facts

• Record ID: K201720
• Device Name: LiPPS Analyzer, LiPPS Wire Pressure Guide Wire
• Applicant: Beijing Bywave Sensing Medical Technology Co., Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Feb 18, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

LiPPS™ Intravascular Pressure Sensing System is intended to be used in an environment like cathlab and for use in blood vessels, including coronary and peripheral vessels, to measure intravascular pressure during angiography and/or interventional procedures. Pressure measurements are obtained to provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel diseases.

Device Story

The LiPPS™ Intravascular Pressure Sensing System consists of the H2000 LiPPS™ Analyzer and the LiPPS™ Wire Pressure Guide Wire. The system is used in a cathlab environment by clinicians. The sterile, single-use guide wire contains an optical sensor and fiber to measure intravascular blood pressure. Signals are transmitted via an optical cable and connector to the reusable H2000 LiPPS™ Analyzer. The analyzer processes these signals to display real-time pressure curves, numerical values (systolic, diastolic, mean pressure, heart rate), and fractional flow reserve (FFR) values. The system also accepts aortic pressure input from an external transducer to calculate FFR. The output provides hemodynamic data to assist clinicians in diagnosing and treating blood vessel diseases, enabling informed clinical decision-making during interventional procedures.

Clinical Evidence

Bench testing only. Performance verified against IEC 60601-1, IEC 60601-1-2, IEC 60601-2-34, and ISO 11070 standards. Biocompatibility testing conducted per ISO 10993-1 for external communicating devices in contact with circulating blood (<24 hours), including cytotoxicity, sensitization, systemic toxicity, pyrogenicity, hemolysis, and thromboresistance studies.

Technological Characteristics

System comprises a reusable H2000 LiPPS™ Analyzer and a sterile, single-use 0.014" guide wire. Guide wire uses fiberoptic sensing (stainless steel/nitinol core, platinum-nickel alloy coil, PTFE/hydrophilic coating). Analyzer performs signal processing and display. Sterilization via ethylene oxide (ISO 11135). Connectivity includes optical cable/connector and external pressure transducer input. Software developed per IEC 62304.

Indications for Use

Indicated for use in coronary and peripheral blood vessels to measure intravascular pressure during angiography and interventional procedures to provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel diseases.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• OptoWire and OptoMonitor System (K142598)
• PrimeWire PRESTIGE® Plus Pressure Guide Wire (K111395)

Submission Summary (Full Text)

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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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 18, 2021

Beijing Bywave Sensing Medical Technology Co., Ltd. Lizhe Zhang General Manager Room 501, Buildinctg 22, No.12, Juyuan Middle Road, Mapo Town, Shunyi District Beijing, Beijing 101399 China

Re: K201720

Trade/Device Name: LiPPSTM Intravascular Pressure Sensing System Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX, DXO Dated: January 13, 2021 Received: January 21, 2021

Dear Lizhe Zhang:

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.

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

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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,

LT 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) K201720

Device Name

LiPPSTM Intravascular Pressure Sensing System

Indications for Use (Describe)

LiPPS™ Intravascular Pressure Sensing System is intended to be used in an environment like cathlab and for use in blood vessels, including coronary and peripheral vessels, to measure intravascular pressure during angiography and/or interventional procedures. Pressurements are obtained to provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel diseases.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

he-Counter Use (21 CFR 801 Subpart C)

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# Section 5: 510(K) Summary

This summary of 510(K) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1900 and 21 CFR 807.92.

### The assigned 510(K) Number: K201720

#### ડ. 510(K) Summary

#### 5.1. Date of Preparation: 22nd, May, 2020

#### 5.2. Sponsor

Beijing Bywave Sensing Medical Technology Co., Ltd. Room 501, Building 22, No. 12, Juyuan Middle Road, Mapo Town, Shunyi District Beijing, P. R. China Tel: [phone] Fax: [phone]

Contact Person: Lizhe Zhang Position: General Manager Email: [e-mail]

### 5.3. Subject Device Identification

Subject Device Name: LiPPSTM Intravascular Pressure Sensing System Common name: Intravascular Pressure Sensing System Classification Name(s): Catheter Tip Pressure Transducer/ Catheter Guide Wire Product Code: DXO, DQX Regulation Number: 21 CFR 870.2870/ 21 CFR 870.1330 Review Panel: Cardiovascular Classification: II

### 5.4. Predicate Device

510(k) Number: K142598 Device Name: OptoWire and OptoMonitor System Manufacturer: Opsens, Inc. 510(k) Number: K111395 Device Name: PrimeWire PRESTIGE® Plus Pressure Guide Wire Manufacturer: Volcano Corporation

#### 5.5. Indications for use:

LiPPS™ Intravascular Pressure Sensing System is intended to be used in an environment like cathlab and for use in blood vessels, including coronary and peripheral vessels, to measure intravascular pressure during angiography and/or interventional procedures. Pressure measurements are obtained

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to provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel diseases.

#### 5.6. Device Description

The subject device LiPPSTM Intravascular Pressure Sensing System contains H2000 LiPPS™ Analyzer and LiPPS™ Wire Pressure Guide Wire.

The LiPPS™ Wire Pressure Guide Wire is used together with the H2000 LiPPS™ Analyzer in order to measure intravascular pressure. The LiPPS™ Wire contains an optical sensor and an optical fiber to induce the blood pressure and transmit signal. The LiPPS™ Wire can be connected to the analyzer through the companied handle (with an optical cable and an optical connector). The LiPPS™ Analyzer is an electronic signal processing and display units which can process signals received from the LiPPSTM Wire to display intravascular blood pressure and fractional flow reserve (FFR) values, and various connection cables. LiPPS™ Wire and companied handle (with an optical cable and an optical connector) are sterile, single-use devices. The LiPPS™ Analyzer and its accessories are reusable.

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K201720

| Item | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | | |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------|--------------------------------------|
| | LiPPSTM Intravascular<br>Pressure Sensing System | OptoWire and<br>OptoMonitor System<br>(K142598 Opsens, Inc.) | PrimeWire PRESTIGE®<br>Plus Pressure Guide Wire<br>(K111395 Volcano Corp.) | | | |
| Device<br>Common/Usual<br>Name | LiPPSTM Intravascular Pressure<br>Sensing System | Intravascular Pressure<br>Monitoring System | PrimeWire PRESTIGE® Plus<br>Pressure Guide Wire | / | | |
| Device Class | Class II | Class II | Class II | SE | | |
| Product Code/<br>Regulation Number | DXO, DQX<br>21 CFR 870.2870/ 21 CFR<br>870.1330 | DXO, DQX<br>21 CFR 870.2870/ 21 CFR<br>870.1330 | DXO, DQX<br>21 CFR 870.2870/ 21 CFR<br>870.1330 | SE | | |
| Classification<br>Name(s) | Catheter Tip Pressure Transducer<br>Catheter Guide Wire | Catheter Tip Pressure Transducer<br>Catheter Guide Wire | Catheter Tip Pressure Transducer<br>Catheter Guide Wire | SE | | |
| Indications for use | LiPPSTM Intravascular Pressure<br>Sensing System is intended to be<br>used in an environment like cathlab<br>and for use in blood vessels,<br>including coronary and peripheral<br>vessels, to measure intravascular<br>pressure during angiography and/or<br>interventional procedures. Pressure<br>measurements are obtained to<br>provide hemodynamic information,<br>such as fractional flow reserve, for<br>the diagnosis and treatment of<br>blood vessel diseases. | To measure pressure in blood<br>vessels including both coronary<br>and peripheral vessels, during<br>diagnostic angiography and/or<br>other any interventional<br>procedures. Blood pressure<br>measurements provide<br>hemodynamic information, such<br>as fractional flow reserve, for the<br>diagnosis and treatment of blood<br>vessel disease. | The Prime Wire PRESTIGE® Plus<br>Pressure Guide Wire Device is<br>indicated for use to measure<br>pressure in blood vessels including<br>both coronary and peripheral<br>vessels, during diagnostic<br>angiography and/or any<br>interventional procedures. Blood<br>pressure measurements provide<br>hemodynamic information for the<br>diagnosis and treatment of blood<br>vessel disease. | No substantial<br>difference | | |
| Intended use | to measure intravascular pressure | To measure pressure ... during | to measure pressure ... during | Though expressed | | |
| Item | Subject Device<br>LiPPSTM Intravascular<br>Pressure Sensing System | Predicate Device 1<br>OptoWire and<br>OptoMonitor System<br>(K142598 Opsens, Inc.) | Predicate Device 2<br>PrimeWire PRESTIGE®/<br>Plus Pressure Guide Wire<br>(K111395 Volcano Corp.) | Remark | | |
| | during angiography and/or<br>interventional procedures | diagnostic angiography and/or<br>other any interventional<br>procedures. | diagnostic angiography and/or any<br>interventional procedure | in different<br>wording, the<br>subject device has<br>same intended<br>purpose with<br>predicate devices.<br>SE | | |
| System Components | Sterile, disposable guidewire<br>Reusable signal processor /<br>monitor<br>Embedded software<br>Connecting cables | Sterile, disposable guidewire<br>Reusable signal processor /<br>monitor<br>Embedded software<br>Connecting cables | Sterile, disposable guidewire | SE with predicate<br>device K142598.<br>Predicate device<br>K111395 is only a<br>pressure guide<br>wire. | | |
| System Capabilities | Measurement of intravascular<br>blood pressure including FFR. | Measurement of intravascular<br>blood pressure including FFR. | Measurement of intravascular<br>blood pressure and flow including<br>FFR (when used with<br>pressure/flow system) | SE | | |
| Prescription Use | Rx Only | Rx Only | Rx Only | SE | | |
| Pressure Sensing &<br>Signal Transmission<br>Technology | Fiberoptic sensor & fiber bundle<br>embedded in guidewire | Fiberoptic sensor & fiber bundle<br>embedded in guidewire | Hard wired strain gauge<br>embedded in guidewire | No substantial<br>difference | | |
| Sterile, Single Use<br>Patient<br>Contact<br>Component? | Yes –LiPPSTM Wire Pressure<br>Guide Wire | Yes - OptoWire | Yes - PrimeWire Prestige Plus | SE | | |
| Item | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | | |
| | LiPPSTM Intravascular<br>Pressure Sensing System | OptoWire and<br>OptoMonitor System<br>(K142598 Opsens, Inc.) | PrimeWire PRESTIGE®<br>Plus Pressure Guide Wire<br>(K111395 Volcano Corp.) | | | |
| FFR Capability? | Yes | Yes | Yes | SE | | |
| FFR Viewing | Yes | Yes | N/A | SE with predicate<br>device K142598<br>Predicate device<br>K111395 is only a<br>pressure guide<br>wire. | | |
| Basis for FFR<br>Determination | Simultaneous acquisition of 2<br>pressure values: distal pressure<br>from sensor embedded in LiPPSTM<br>Wire Pressure Guide Wire; aortic<br>pressure from external pressure<br>transducer | Simultaneous acquisition of 2<br>pressure values: distal pressure<br>from sensor embedded in<br>OptoWire; aortic pressure from<br>external pressure transducer | Simultaneous acquisition of 2<br>pressure values: distal pressure<br>from sensor embedded in<br>PrimeWire; aortic pressure from<br>external pressure transducer | SE | | |
| Pressure range<br>(analyzer) | -30 to 300mmHg | -30 to 300mmHg | N/A | SE with predicate<br>device K142598<br>Predicate device<br>K111395 is only a<br>pressure guide<br>wire. | | |
| Pressure range<br>(guide wire) | -300 to 300mmHg | -300 to 300mmHg | Unknown | SE | | |
| Accuracy | $\pm$ 1mmHg plus $\pm$ 1% of reading<br>(over the range -30 to 50mmHg) or<br>$\pm$ 1mmHg plus $\pm$ 3% of reading<br>(over the range 50 to 300 mmHg) | $\pm$ 1 mmHg plus $\pm$ 1% of<br>reading (pressure range -30 to 50<br>mmHg)<br>or $\pm$ 3% of reading (pressure | Unknown | SE with predicate<br>device K142598. | | |
| Item | Subject Device<br>LiPPSTM Intravascular<br>Pressure Sensing System | Predicate Device 1<br>OptoWire and<br>OptoMonitor System<br>(K142598 Opsens, Inc.)<br>range 50 to 300 mmHg) | Predicate Device 2<br>PrimeWire PRESTIGE®<br>Plus Pressure Guide Wire<br>(K111395 Volcano Corp.) | Remark | | |
| Zero thermal effect | < 0.3 mmHg / °C | < 0.3 mmHg / °C | < 0.3 mmHg / °C | SE | | |
| Zero drift | < 1 mmHg / h | < 1 mmHg / h | Unknown | SE with predicate<br>device K142598. | | |
| User Interface | Touchscreen, Remote Control,<br>Barcode scanner | Touchscreen | N/A | No substantial<br>difference | | |
| Auto-zeroing | Yes | Yes | N/A | SE with predicate<br>device K142598. | | |
| Real Time Curves | Aortic instantaneous pressure,<br>aortic mean pressure, distal<br>instantaneous pressure, distal mean<br>pressure, Pd/Pa trend curve | Aortic instantaneous pressure,<br>aortic mean pressure, distal<br>instantaneous pressure, distal<br>mean pressure | N/A | No substantial<br>difference | | |
| Real Time<br>Numerical Values | Systolic, diastolic and mean blood<br>pressure (aortic and distal), heart<br>rate, and mean Pd/mean Pa | Mean aortic pressure, mean distal<br>pressure, mean Pd/mean Pa | N/A | No substantial<br>difference | | |
| Recording values | Instantaneous Pa, Pd and Pd/Pa;<br>mean Pa; mean Pd; mean Pd/mean<br>Pa | Instantaneous Pa, Pd and Pd/Pa;<br>mean Pa; mean Pd; mean<br>Pd/mean Pa | N/A | SE with predicate<br>device K142598. | | |
| Minimum Pd/Pa<br>Cursor<br>(Detection of FFR<br>Locus) | Yes | Yes | N/A | SE with predicate<br>device K142598. | | |
| Display Monitor | LCD | LCD | N/A | SE with predicate<br>device K142598. | | |
| Aortic Input | Low Level (5uV/V/mmHg) | High Level (100 mmHg/V) | N/A | Different | | |
| Item | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | | |
| | LiPPSTM Intravascular | OptoWire and | PrimeWire PRESTIGE® | | | |
| | Pressure Sensing System | OptoMonitor System | Plus Pressure Guide Wire | | | |
| | | (K142598 Opsens, Inc.) | (K111395 Volcano Corp.) | | | |
| Aortic Output | Low Level ( $5\mu V/V/mmHg$ ) | No | N/A | Different | | |
| Distal input | LiPPS™ Wire Pressure Guide<br>Wire (optical) | OptoWire (optical) | N/A | SE with predicate | | |
| | | | | device K142598. | | |
| Distal output | Low Level ( $5\mu V/V/mmHg$ ) | Low Level ( $5\mu V /V/mmHg$ ) | N/A | SE with predicate | | |
| | | | | device K142598. | | |
| Guide wire OD | 0.014" | 0.014" | 0.014" | SE | | |
| Guide wire length | 180 cm | 175 cm | 185 cm, 300 cm | Different | | |
| Guide wire material | Stainless Steel; Nitinol | Stainless Steel; Nitinol | Stainless Steel; SS | SE with predicate | | |
| | | | | device K142598. | | |
| Guidewire Coating | PTFE; Hydrophilic coating | Teflon; Silicone | Teflon; GlyDx Hydrophilic<br>coating | No substantial<br>difference | | |
| Guidewire Coating<br>Material | PTFE; Hydrophilic coating…