(240 days)
Not Found
No
The description focuses on optical sensing and electronic signal processing for pressure measurement and FFR calculation, with no mention of AI or ML.
No.
The device measures intravascular pressure to provide hemodynamic information for diagnosis and treatment, but it does not directly perform therapy itself.
Yes
The device measures intravascular pressure and provides hemodynamic information such as fractional flow reserve, which is used for the diagnosis of blood vessel diseases.
No
The device description explicitly details hardware components, including a pressure guide wire with an optical sensor and fiber, a handle with an optical cable, and an electronic signal processing and display unit (the Analyzer). This is not a software-only device.
Based on the provided information, the LiPPS™ Intravascular Pressure Sensing System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This examination is performed outside of the living body (in vitro).
- LiPPS™ System Function: The LiPPS™ system directly measures intravascular pressure within the blood vessels of a living patient (in vivo). It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for use in blood vessels to measure intravascular pressure during procedures, providing hemodynamic information for diagnosis and treatment of blood vessel diseases. This is a direct physiological measurement within the body.
Therefore, the LiPPS™ Intravascular Pressure Sensing System falls under the category of a medical device used for physiological measurement and diagnosis in vivo, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
LiPPSTM 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.
Product codes
DOX, DXO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels, including coronary and peripheral vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
cathlab
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)
Bench test were conducted to verify that the subject device met all design specifications, as was Substantially Equivalent (SE) to the predicate device.
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).
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:
- Dimensions
- Visual Inspection
- Tensile Strength and Tip Pull
- Torque Strength (Turns to Failure)
- Torqueability
- Coating Integrity
- Particulate Evaluation
- Lubricity
- Corrosion Resistance
- Kink Resistance
- Fracture
- Flexing
- Tip flexibility
- Radiopacity
- Accuracy
- Optical contrast of Interferogram
- Zero drift/ Zero thermal effect/Sensitivity thermal effect
- 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 ()
- ASTM Hemolysis Study Direct Contact and Indirect Contact (Standard: ISO 10993-4, ASTM F756)
- Partial Thromboplastin Time Study (Standard: ASTM F2382)
- In Vivo Thromboresistance Study in the Dog NAVI Mode (Standard: ISO 10993-4, ASTM F2382)
- Complement Activation (Standard: ISO 10993-4)
- Platelet Leukocyte Count Study (Standard: ASTM F2888)
Part 2: Pressure Guide Wire (LiPPS Wire, in vitro part)
- Cytotoxicity Study using MTT Method (Standard: ISO 10993-5)
- ISO Guinea Pig Maximization Sensitization Test (Standard: ISO 10993-10)
- ISO Intracutaneous Study in Rabbits (Standard: ISO 10993-10)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Pressure range (analyzer): -30 to 300mmHg
- Pressure range (guide wire): -300 to 300mmHg
- Accuracy: ± 1mmHg plus ± 1% of reading (over the range -30 to 50mmHg) or ± 1mmHg plus ± 3% of reading (over the range 50 to 300 mmHg)
- Zero thermal effect:
§ 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.
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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
2
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) | |
|---|---|
| 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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3
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:
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
4
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.
5
| Item | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | ||
|---|---|---|---|---|---|---|
| LiPPSTM Intravascular | ||||||
| Pressure Sensing System | OptoWire and | |||||
| OptoMonitor System | ||||||
| (K142598 Opsens, Inc.) | PrimeWire PRESTIGE® | |||||
| Plus Pressure Guide Wire | ||||||
| (K111395 Volcano Corp.) | ||||||
| Device | ||||||
| Common/Usual | ||||||
| Name | LiPPSTM Intravascular Pressure | |||||
| Sensing System | Intravascular Pressure | |||||
| Monitoring System | PrimeWire PRESTIGE® Plus | |||||
| Pressure Guide Wire | / | |||||
| Device Class | Class II | Class II | Class II | SE | ||
| Product Code/ | ||||||
| Regulation Number | DXO, DQX | |||||
| 21 CFR 870.2870/ 21 CFR | ||||||
| 870.1330 | DXO, DQX | |||||
| 21 CFR 870.2870/ 21 CFR | ||||||
| 870.1330 | DXO, DQX | |||||
| 21 CFR 870.2870/ 21 CFR | ||||||
| 870.1330 | SE | |||||
| Classification | ||||||
| Name(s) | Catheter Tip Pressure Transducer | |||||
| Catheter Guide Wire | Catheter Tip Pressure Transducer | |||||
| Catheter Guide Wire | Catheter Tip Pressure Transducer | |||||
| Catheter Guide Wire | SE | |||||
| Indications for use | LiPPSTM 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. | To measure pressure in blood | |||||
| vessels including both coronary | ||||||
| and peripheral vessels, during | ||||||
| diagnostic angiography and/or | ||||||
| other any interventional | ||||||
| procedures. Blood pressure | ||||||
| measurements provide | ||||||
| hemodynamic information, such | ||||||
| as fractional flow reserve, for the | ||||||
| diagnosis and treatment of blood | ||||||
| vessel disease. | The Prime Wire PRESTIGE® Plus | |||||
| Pressure Guide Wire Device is | ||||||
| indicated for use to measure | ||||||
| pressure in blood vessels including | ||||||
| both coronary and peripheral | ||||||
| vessels, during diagnostic | ||||||
| angiography and/or any | ||||||
| interventional procedures. Blood | ||||||
| pressure measurements provide | ||||||
| hemodynamic information for the | ||||||
| diagnosis and treatment of blood | ||||||
| vessel disease. | No substantial | |||||
| difference | ||||||
| Intended use | to measure intravascular pressure | To measure pressure ... during | to measure pressure ... during | Though expressed | ||
| Item | Subject Device | |||||
| LiPPSTM Intravascular | ||||||
| Pressure Sensing System | Predicate Device 1 | |||||
| OptoWire and | ||||||
| OptoMonitor System | ||||||
| (K142598 Opsens, Inc.) | Predicate Device 2 | |||||
| PrimeWire PRESTIGE®/ | ||||||
| Plus Pressure Guide Wire | ||||||
| (K111395 Volcano Corp.) | Remark | |||||
| during angiography and/or | ||||||
| interventional procedures | diagnostic angiography and/or | |||||
| other any interventional | ||||||
| procedures. | diagnostic angiography and/or any | |||||
| interventional procedure | in different | |||||
| wording, the | ||||||
| subject device has | ||||||
| same intended | ||||||
| purpose with | ||||||
| predicate devices. | ||||||
| SE | ||||||
| System Components | Sterile, disposable guidewire | |||||
| Reusable signal processor / | ||||||
| monitor | ||||||
| Embedded software | ||||||
| Connecting cables | Sterile, disposable guidewire | |||||
| Reusable signal processor / | ||||||
| monitor | ||||||
| Embedded software | ||||||
| Connecting cables | Sterile, disposable guidewire | SE with predicate | ||||
| device K142598. | ||||||
| Predicate device | ||||||
| K111395 is only a | ||||||
| pressure guide | ||||||
| wire. | ||||||
| System Capabilities | Measurement of intravascular | |||||
| blood pressure including FFR. | Measurement of intravascular | |||||
| blood pressure including FFR. | Measurement of intravascular | |||||
| blood pressure and flow including | ||||||
| FFR (when used with | ||||||
| pressure/flow system) | SE | |||||
| Prescription Use | Rx Only | Rx Only | Rx Only | SE | ||
| Pressure Sensing & | ||||||
| Signal Transmission | ||||||
| Technology | Fiberoptic sensor & fiber bundle | |||||
| embedded in guidewire | Fiberoptic sensor & fiber bundle | |||||
| embedded in guidewire | Hard wired strain gauge | |||||
| embedded in guidewire | No substantial | |||||
| difference | ||||||
| Sterile, Single Use | ||||||
| Patient | ||||||
| Contact | ||||||
| Component? | Yes –LiPPSTM Wire Pressure | |||||
| Guide Wire | Yes - OptoWire | Yes - PrimeWire Prestige Plus | SE | |||
| Item | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | ||
| LiPPSTM Intravascular | ||||||
| Pressure Sensing System | OptoWire and | |||||
| OptoMonitor 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 predicate | ||
| device K142598 | ||||||
| Predicate device | ||||||
| K111395 is only a | ||||||
| pressure guide | ||||||
| wire. | ||||||
| Basis for FFR | ||||||
| Determination | Simultaneous acquisition of 2 | |||||
| pressure values: distal pressure | ||||||
| from sensor embedded in LiPPSTM | ||||||
| Wire Pressure Guide Wire; aortic | ||||||
| pressure from external pressure | ||||||
| transducer | Simultaneous acquisition of 2 | |||||
| pressure values: distal pressure | ||||||
| from sensor embedded in | ||||||
| OptoWire; aortic pressure from | ||||||
| external pressure transducer | Simultaneous acquisition of 2 | |||||
| pressure values: distal pressure | ||||||
| from sensor embedded in | ||||||
| PrimeWire; aortic pressure from | ||||||
| external pressure transducer | SE | |||||
| Pressure range | ||||||
| (analyzer) | -30 to 300mmHg | -30 to 300mmHg | N/A | SE with predicate | ||
| device K142598 | ||||||
| Predicate device | ||||||
| K111395 is only a | ||||||
| pressure guide | ||||||
| wire. | ||||||
| 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% of | |||||
| reading (pressure range -30 to 50 | ||||||
| mmHg) | ||||||
| or $\pm$ 3% of reading (pressure | Unknown | SE with predicate | ||||
| device K142598. | ||||||
| Item | Subject Device | |||||
| LiPPSTM Intravascular | ||||||
| Pressure Sensing System | Predicate Device 1 | |||||
| OptoWire and | ||||||
| OptoMonitor System | ||||||
| (K142598 Opsens, Inc.) | ||||||
| range 50 to 300 mmHg) | Predicate Device 2 | |||||
| PrimeWire PRESTIGE® | ||||||
| Plus Pressure Guide Wire | ||||||
| (K111395 Volcano Corp.) | Remark | |||||
| Zero thermal effect | ||||||
| ASTM Hemolysis Study Direct Contact and | ||||||
| Indirect Contact | ISO 10993-4 | |||||
| ASTM F756 | ||||||
| Partial Thromboplastin Time Study | ASTM F2382 | |||||
| In Vivo Thromboresistance Study in the Dog | ||||||
| NAVI Mode | ISO 10993-4 | |||||
| ASTM 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.