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.

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.

AI/ML Overview

The provided text is a 510(k) Summary for the LiPPS™ Intravascular Pressure Sensing System, which details the device's characteristics and its comparison to predicate devices to demonstrate substantial equivalence. This document does not describe acceptance criteria for an AI/ML-driven device or a study involving human readers and AI assistance. It focuses on the non-clinical performance and substantial equivalence of a physical medical device (an intravascular pressure sensing system) to existing predicate devices.

Therefore, many of the requested items regarding AI/ML device performance, MRMC studies, ground truth establishment, sample sizes for AI training/testing, and expert adjudication are not applicable to the information provided in this document.

However, I can extract information related to the device's non-clinical performance that is analogous to "acceptance criteria" and "device performance" for a medical device that measures physical parameters.

Based on the provided text, here's what can be extracted and what cannot:

LiPPS™ Intravascular Pressure Sensing System Acceptance Criteria and Performance (Non-Clinical)

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance characteristics of the LiPPS™ Intravascular Pressure Sensing System and compares them to predicate devices to demonstrate substantial equivalence. For a device like this, the "acceptance criteria" are implied by the specifications listed and the successful completion of standard-based testing.

Acceptance Criteria (Implied/Standard-Based)	Reported Device Performance (LiPPS™ Intravascular Pressure Sensing System)
For H2000 LiPPS™ Analyzer:
Compliance with IEC 60601-1:2005+AMD1:2012 (Basic Safety & Essential Performance)	"The test results demonstrated that the proposed device comply with the standard requirements."
Compliance with IEC 60601-1-2:2014 (EMC)	"The test results demonstrated that the proposed device comply with the standard requirements."
Compliance with IEC 60601-2-34:2011 (Invasive Blood Pressure Monitoring Equipment)	"The test results demonstrated that the proposed device comply with the standard requirements."
Software Development and Validation (IEC 62304, FDA Guidance)	"The software embedded in H2000 LiPPS™ Analyzer has been developed, documented and validated in accordance with industry standards and FDA guidance."
Pressure Range (Analyzer)	-30 to 300mmHg
For LiPPS™ Wire Pressure Guide Wire:
Sterilization (EO process)	Validated to 10⁻⁶ SAL in accordance with ISO 11135.
Compliance with ISO 11070:2014 (Sterile single-use intravascular introducers, dilators and guidewires)	"The test results demonstrated that the proposed device comply with the standard requirements."
Pressure Range (Guide Wire)	-300 to 300mmHg
Accuracy	± 1mmHg plus ± 1% of reading (over -30 to 50mmHg) or ± 1mmHg plus ± 3% of reading (over 50 to 300 mmHg)
Zero Thermal Effect	< 0.3 mmHg / °C
Zero Drift	< 1 mmHg / h
Biological Evaluation (ISO 10993-1 classification: External Communicating Device, Circulating Blood, Limited Duration)	All relevant tests (Cytotoxicity, Sensitization, Intracutaneous, Systemic Toxicity, Pyrogen, Hemolysis, Partial Thromboplastin Time, In Vivo Thromboresistance, Complement Activation, Platelet Leukocyte Count) were performed. Results demonstrated compliance.
Physical/Mechanical Properties (Dimensions, Tensile Strength, Torque Strength, Torqueability, Coating Integrity, Particulate, Lubricity, Corrosion Resistance, Kink Resistance, Fracture, Flexing, Tip flexibility, Radiopacity, Optical contrast of Interferogram, Connection/Disconnection)	Tested per ISO 11070:2014. "The test results demonstrated that the proposed device comply with the standard requirements."

2. Sample Size Used for the Test Set and the Data Provenance:

Sample Size: Not explicitly stated as a numerical count of patients or cases. For a medical device like this, "sample size" typically refers to the number of devices or components subjected to specific engineering and biocompatibility tests. These are bench tests and in-vitro/in-vivo biological evaluations.
Data Provenance: The studies are non-clinical (bench testing, in-vitro, and animal studies for biological evaluation). The document does not specify a country of origin for the data (beyond the manufacturer's location in Beijing, China), nor does it describe trials as retrospective or prospective (as these are not clinical trials).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Not Applicable. This is a non-clinical submission for a physical medical device. "Ground truth" in the context of expert consensus is relevant for diagnostic AI/ML devices where human interpretation provides the reference standard. For this device, ground truth is established through standardized measurements and validated test methodologies.

4. Adjudication Method for the Test Set:

Not Applicable. As there are no human readers or diagnostic interpretations involved, there's no need for an adjudication method. Performance is measured against predefined engineering specifications and regulatory standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This document describes a physical medical device for intravascular pressure sensing, not an AI/ML diagnostic tool meant to assist human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not Applicable. While the device has "embedded software," its primary function is direct physical measurement (pressure sensing), not image interpretation or diagnosis via an algorithm that could be evaluated in a standalone manner like an AI application. The software processes signals, displays data, and ensures device functionality, as opposed to making diagnostic inferences.

7. The Type of Ground Truth Used:

For performance metrics (e.g., accuracy, pressure range, zero drift): Measured values against calibrated reference standards using laboratory equipment and controlled environments.
For biological safety: Results from standard biological compatibility tests (e.g., cytotoxicity, hemolysis, pyrogenicity) as defined by ISO 10993 series and USP standards.
For physical/mechanical properties: Measurements and observations against design specifications and ISO 11070 standard limits.

8. The Sample Size for the Training Set:

Not Applicable. This document does not describe an AI/ML device that requires a "training set" in the machine learning sense. The "training" of the device refers to its design, engineering tolerances, and calibration, which are informed by scientific principles and material properties rather than iterative machine learning from a dataset.

9. How the Ground Truth for the Training Set was Established:

Not Applicable. (See #8)

Summary

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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

{1}------------------------------------------------

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,

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)

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)

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: (86)10-82890879 Fax: (86)10-82890879

Contact Person: Lizhe Zhang Position: General Manager Email: zhanglizhe@bws-tech.com

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:

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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.

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K201720

Item	Subject Device	Predicate Device 1	Predicate Device 2	Remark
	LiPPSTM IntravascularPressure Sensing System	OptoWire andOptoMonitor System(K142598 Opsens, Inc.)	PrimeWire PRESTIGE®Plus Pressure Guide Wire(K111395 Volcano Corp.)
DeviceCommon/UsualName	LiPPSTM Intravascular PressureSensing System	Intravascular PressureMonitoring System	PrimeWire PRESTIGE® PlusPressure Guide Wire	/
Device Class	Class II	Class II	Class II	SE
Product Code/Regulation Number	DXO, DQX21 CFR 870.2870/ 21 CFR870.1330	DXO, DQX21 CFR 870.2870/ 21 CFR870.1330	DXO, DQX21 CFR 870.2870/ 21 CFR870.1330	SE
ClassificationName(s)	Catheter Tip Pressure TransducerCatheter Guide Wire	Catheter Tip Pressure TransducerCatheter Guide Wire	Catheter Tip Pressure TransducerCatheter Guide Wire	SE
Indications for use	LiPPSTM Intravascular PressureSensing System is intended to beused in an environment like cathlaband for use in blood vessels,including coronary and peripheralvessels, to measure intravascularpressure during angiography and/orinterventional procedures. Pressuremeasurements are obtained toprovide hemodynamic information,such as fractional flow reserve, forthe diagnosis and treatment ofblood vessel diseases.	To measure pressure in bloodvessels including both coronaryand peripheral vessels, duringdiagnostic angiography and/orother any interventionalprocedures. Blood pressuremeasurements providehemodynamic information, suchas fractional flow reserve, for thediagnosis and treatment of bloodvessel disease.	The Prime Wire PRESTIGE® PlusPressure Guide Wire Device isindicated for use to measurepressure in blood vessels includingboth coronary and peripheralvessels, during diagnosticangiography and/or anyinterventional procedures. Bloodpressure measurements providehemodynamic information for thediagnosis and treatment of bloodvessel disease.	No substantialdifference
Intended use	to measure intravascular pressure	To measure pressure ... during	to measure pressure ... during	Though expressed
Item	Subject DeviceLiPPSTM IntravascularPressure Sensing System	Predicate Device 1OptoWire andOptoMonitor System(K142598 Opsens, Inc.)	Predicate Device 2PrimeWire PRESTIGE®/Plus Pressure Guide Wire(K111395 Volcano Corp.)	Remark
	during angiography and/orinterventional procedures	diagnostic angiography and/orother any interventionalprocedures.	diagnostic angiography and/or anyinterventional procedure	in differentwording, thesubject device hassame intendedpurpose withpredicate devices.SE
System Components	Sterile, disposable guidewireReusable signal processor /monitorEmbedded softwareConnecting cables	Sterile, disposable guidewireReusable signal processor /monitorEmbedded softwareConnecting cables	Sterile, disposable guidewire	SE with predicatedevice K142598.Predicate deviceK111395 is only apressure guidewire.
System Capabilities	Measurement of intravascularblood pressure including FFR.	Measurement of intravascularblood pressure including FFR.	Measurement of intravascularblood pressure and flow includingFFR (when used withpressure/flow system)	SE
Prescription Use	Rx Only	Rx Only	Rx Only	SE
Pressure Sensing &Signal TransmissionTechnology	Fiberoptic sensor & fiber bundleembedded in guidewire	Fiberoptic sensor & fiber bundleembedded in guidewire	Hard wired strain gaugeembedded in guidewire	No substantialdifference
Sterile, Single UsePatientContactComponent?	Yes –LiPPSTM Wire PressureGuide Wire	Yes - OptoWire	Yes - PrimeWire Prestige Plus	SE
Item	Subject Device	Predicate Device 1	Predicate Device 2	Remark
	LiPPSTM IntravascularPressure Sensing System	OptoWire andOptoMonitor System(K142598 Opsens, Inc.)	PrimeWire PRESTIGE®Plus Pressure Guide Wire(K111395 Volcano Corp.)
FFR Capability?	Yes	Yes	Yes	SE
FFR Viewing	Yes	Yes	N/A	SE with predicatedevice K142598Predicate deviceK111395 is only apressure guidewire.
Basis for FFRDetermination	Simultaneous acquisition of 2pressure values: distal pressurefrom sensor embedded in LiPPSTMWire Pressure Guide Wire; aorticpressure from external pressuretransducer	Simultaneous acquisition of 2pressure values: distal pressurefrom sensor embedded inOptoWire; aortic pressure fromexternal pressure transducer	Simultaneous acquisition of 2pressure values: distal pressurefrom sensor embedded inPrimeWire; aortic pressure fromexternal pressure transducer	SE
Pressure range(analyzer)	-30 to 300mmHg	-30 to 300mmHg	N/A	SE with predicatedevice K142598Predicate deviceK111395 is only apressure guidewire.
Pressure range(guide wire)	-300 to 300mmHg	-300 to 300mmHg	Unknown	SE
Accuracy	$\pm$ 1mmHg plus $\pm$ 1% of reading(over the range -30 to 50mmHg) or$\pm$ 1mmHg plus $\pm$ 3% of reading(over the range 50 to 300 mmHg)	$\pm$ 1 mmHg plus $\pm$ 1% ofreading (pressure range -30 to 50mmHg)or $\pm$ 3% of reading (pressure	Unknown	SE with predicatedevice K142598.
Item	Subject DeviceLiPPSTM IntravascularPressure Sensing System	Predicate Device 1OptoWire andOptoMonitor System(K142598 Opsens, Inc.)range 50 to 300 mmHg)	Predicate Device 2PrimeWire PRESTIGE®Plus Pressure Guide Wire(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 predicatedevice K142598.
User Interface	Touchscreen, Remote Control,Barcode scanner	Touchscreen	N/A	No substantialdifference
Auto-zeroing	Yes	Yes	N/A	SE with predicatedevice K142598.
Real Time Curves	Aortic instantaneous pressure,aortic mean pressure, distalinstantaneous pressure, distal meanpressure, Pd/Pa trend curve	Aortic instantaneous pressure,aortic mean pressure, distalinstantaneous pressure, distalmean pressure	N/A	No substantialdifference
Real TimeNumerical Values	Systolic, diastolic and mean bloodpressure (aortic and distal), heartrate, and mean Pd/mean Pa	Mean aortic pressure, mean distalpressure, mean Pd/mean Pa	N/A	No substantialdifference
Recording values	Instantaneous Pa, Pd and Pd/Pa;mean Pa; mean Pd; mean Pd/meanPa	Instantaneous Pa, Pd and Pd/Pa;mean Pa; mean Pd; meanPd/mean Pa	N/A	SE with predicatedevice K142598.
Minimum Pd/PaCursor(Detection of FFRLocus)	Yes	Yes	N/A	SE with predicatedevice K142598.
Display Monitor	LCD	LCD	N/A	SE with predicatedevice 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 GuideWire (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 Hydrophiliccoating	No substantialdifference
Guidewire CoatingMaterial	PTFE; Hydrophilic coating	Teflon; Silicone	Teflon; GlyDx Hydrophiliccoating	No substantialdifference
Guidewire TipConfiguration	Straight, J angled	Straight	Straight, pre-shaped "J"	No substantialdifference
Guide wire CoatingLength andLocation	Hydrophilic coating: 30cm fromthe tipPTFE Coating:145cm starts from5cm from the proximal end	Hydrophilic coating: 32cm fromthe tipPTFE Coating: 145cm from theproximal end	Hydrophilic coating: 27cm fromthe pressure sensorPTFE Coating:155cm from theproximal end	No substantialdifference
Tip Material	Nitinol core wire + Platinumnickel alloy coil	Nitinol core wire + Platinumnickel alloy coil	Nitinol core wire + Platinumnickel alloy coil	No substantialdifference
Tip Flexibility	Straight: 5mm: 2.63, 10mm: 0.73,20mm: 0.35J angled: 5mm: 2.63, 10mm: 0.73,20mm: 0.35	Unknown	Straight: 5mm: 2.62, 10mm: 0.72,20mm: 0.35pre-shaped "J": 5mm: 2.63,10mm: 0.72, 20mm: 0.35	No substantialdifference
Item	Subject Device	Predicate Device 1	Predicate Device 2	Remark
	LiPPSTM IntravascularPressure Sensing System	OptoWire andOptoMonitor System(K142598 Opsens, Inc.)	PrimeWire PRESTIGE®Plus Pressure Guide Wire(K111395 Volcano Corp.)
	Tip Type and Shape	Straight, J angled	Straight		Straight, pre-shaped "J"	SE with predicatedevice K111395.
	Guidewire TipLength	3.0 cm	3.5 cm		3.0 cm	SE with predicatedevice K111395.
	Radiopaque Tip?	Yes	Yes		Yes	SE
Pressure sensor	Optical	Optical	Electrical	SE with predicatedevice K142598.
Accessories withguide wire	Torque deviceHandle (with an optical cable andan optical connector)	Torque deviceHandle (with an OptoWire cableand FOIC optical connector)Gauge factor connector	Torque deviceHandle (with an PrimeWire cable)	SE with predicatedevice K142598.
PackagingConfiguration	The guide wire is in a DHPE coil.The coil, guide wire handle (withan optical cable and an opticalconnector) and torque device areall fixed on a PETG tray. Thewhole product is sealed withinTyvek cover material and polymermaterial. The polymer materialPE50 film. The cover material isTyvek® 1059B of DUPONT.	The guide wire is in a coil. Thecoil, guide wire handle (with withan OptoWire cable and FOICoptical connector), torque deviceand Gauge factor connector areall fixed on a tray. The wholeproduct is sealed within Tyvekcover material and polymermaterial.	The guide wire is in a coil. Thecoil, guide wire handle (with an anPrimeWire cable) and torquedevice are all fixed on a tray. Thewhole product is sealed withinTyvek cover material and polymermaterial.	SE
SterilizationMethod	EO Sterilization	EO Sterilization	EO Sterilization	SE
Shelf Life	2 years	2 years	3 years	SE with predicatedevice K142598.

5.7. Predicate Devices and Subject Device Comparison

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Image /page/6/Picture/0 description: The image shows a logo with a stylized letter 'B' in blue. The 'B' is encircled by a curved shape, also in blue, that gives the impression of movement or rotation. Inside the 'B', there is a small, four-pointed star, adding a touch of detail to the design. The overall impression is clean, modern, and corporate.

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Image /page/7/Picture/0 description: The image shows a blue logo with a stylized letter 'B' in the center. The 'B' is surrounded by a circular shape, also in blue. A diamond shape is embedded within the 'B', adding a touch of elegance to the design. The logo has a gradient effect, with lighter shades of blue at the top and darker shades at the bottom, giving it a three-dimensional appearance.

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Image /page/8/Picture/0 description: The image shows a blue logo with a stylized letter 'B' inside a circular shape. The 'B' is formed by curved lines, and there is a four-pointed star embedded within the letter. The logo has a gradient effect, with darker shades of blue at the bottom and lighter shades at the top, giving it a three-dimensional appearance.

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Image /page/9/Picture/0 description: The image shows a blue logo with a stylized letter 'B' in a rounded shape. Inside the 'B', there is a four-pointed star. The logo has a gradient effect, with the blue color being lighter at the top and darker at the bottom. The overall design is modern and corporate.

K201720

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Image /page/10/Picture/0 description: The image shows a logo with a stylized letter 'B' inside an oval shape. The 'B' is rendered in a gradient of blue, with a darker shade at the bottom and a lighter shade at the top, giving it a three-dimensional appearance. A four-pointed star is embedded within the upper part of the 'B', adding a sparkling effect to the design. The oval shape surrounding the 'B' is also in a similar blue gradient, creating a cohesive and professional look.

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5.8. Non-Clinical Test Conclusion

Bench test were conducted to verify that the subject device met all design specifications, as was Substantially Equivalent (SE) to the predicate device.

H2000 LiPPS™ Analyzer 5.8.1.

The H2000 LiPPS™ Analyzer in subject device is tested per the following standard, to evaluate its performance. The test results demonstrated that the proposed device comply with the standard requirements.

IEC 60601-1:2005+AMD1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements And Tests

IEC 60601-2-34:2011 Medical Electrical Equipment - Part 2-34: Particular Requirements For The Basic Safety, Including Essential Performance, Of Invasive Blood Pressure Monitoring Equipment

The software embedded in H2000 LiPPS™ Analyzer has been developed, documented and validated in accordance with industry standards (IEC 62304 - Medical device software - Software life cycle processes) and FDA guidance (GUIDANCE FOR THE CONTENT OF PRE-MARKET SUBMISSIONS FOR SOFTWARE CONTAINED IN DEVICES).

LiPPS™ Wire Pressure Guide Wire 5.8.2.

The LiPPS™ Wire Pressure Guide Wire in subject device is sterilized to a 10 o SAL using an ethylene oxide process that has been validated in accordance with ISO 11135.

The LiPPS™ Wire Pressure Guide Wire in subject device is tested per the following standard, to evaluate its performance. The test results demonstrated that the proposed device comply with the standard requirements.

ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires The following items are tested:

#	Subject
1	Dimensions
2	Visual Inspection
3	Tensile Strength and Tip Pull
4	Torque Strength (Turns to Failure)
5	Torqueability
6	Coating Integrity
7	Particulate Evaluation
8	Lubricity
9	Corrosion Resistance

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#	Subject
10	Kink Resistance
11	Fracture
12	Flexing
13	Tip flexibility
14	Radiopacity
15	Accuracy
16	Optical contrast of Interferogram
17	Zero drift/ Zero thermal effect/Sensitivity thermal effect
18	Connection / disconnection test

The LiPPS™ Wire Pressure Guide Wire in subject device was assessed against the International Standard ISO 10993-1, "Biological evaluation of medical devices. Part 1. Guidance on selection of tests." The LiPPS™ Wire Pressure Guide Wire in subject device would be classified as an External Communicating Device in contact with the Circulating Blood for a Limited Duration (<24 hours). The following test were performed for any patient / user contacting material which underwent the identical sterilization to the proposed EO sterilization method/facility intended for market release:

Part 1: Pressure Guide Wire (LiPPS Wire, in vivo part)

Test	Standard
Cytotoxicity Study using MTT Method	ISO 10993-5
ISO Guinea Pig Maximization SensitizationTest	ISO 10993-10
ISO Intracutaneous Study in Rabbits	ISO 10993-10
ISO Systemic Toxicity Study in Mice	ISO 10993-11
USP Rabbit Pyrogen Study, MaterialMediated	ISO 10993-11USP41 NF 36 <151>
ASTM Hemolysis Study Direct Contact andIndirect Contact	ISO 10993-4ASTM F756
Partial Thromboplastin Time Study	ASTM F2382
In Vivo Thromboresistance Study in the DogNAVI Mode	ISO 10993-4ASTM F2382
Complement Activation	ISO 10993-4
Platelet Leukocyte Count Study	ASTM F2888

Part 2: Pressure Guide Wire (LiPPS Wire, in vitro part)

Test	Standard
Cytotoxicity Study using MTT Method	ISO 10993-5
ISO Guinea Pig Maximization Sensitization	ISO 10993-10
Test
ISO Intracutaneous Study in Rabbits	ISO 10993-10

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5.9. Substantially Equivalent Conclusion

The subject device, LiPPS™ Intravascular Pressure Sensing System, is determined to be Substantially Equivalent (SE) to the predicate device, in respect of safety and effectiveness.

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
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.(b)
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.