(520 days)
The SV600, SV800 Ventilators are intensive care situations for long-term or during transport within a professional healthcare facility. The SV600, SV800 Ventilators are intended to provide ventilation assistance and breathing support for adult and pediatric patients with a minimum body weight of 10 kg (all pediatric subgroups except newborns (neonates)). The SV600, SV800 Ventilators should be operated by properly-trained and authorized medical personnel. This equipment is not suitable for use in an MRI environment.
The SV600 and SV800 Ventilators are pneumatically-driven and electronically-controlled ventilators. The Ventilators consists of a main unit (including pneumatic circuit, electronic system, mechanical structure, display, CO2 module, SpO2 module), trolley and support arm.
This document outlines the substantial equivalence of the Mindray SV600 and SV800 Ventilators to a predicate device (Evita XL Ventilator K083050) and reference devices. The submission focuses on technical comparisons and various types of performance testing to demonstrate safety and effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly provide a table of acceptance criteria with corresponding device performance for specific thresholds. Instead, it states that "The functional and system level testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate." It also notes that the device "meets its accuracy specification and is substantially equivalent to the predicate device."
The closest to "acceptance criteria" are the technical characteristics compared to the predicate and reference devices, and the standards the device was tested against. The "reported device performance" is implied by the statement of compliance with these standards and equivalency to the predicate.
Here's an example of how one might infer "acceptance criteria" from the technical characteristics table:
| Technical Characteristic (Acceptance Criteria - inferred from predicate/reference) | Reported Device Performance (Implied by "Same" or "Similar" comparison and compliance statement) |
|---|---|
| Ventilation Mode: | Compliance: |
| V-A/C: Yes | Same as predicate |
| P-A/C: Yes | Same as predicate |
| PRVC: Yes | Same as predicate |
| V-SIMV: Yes | Same as predicate |
| P-SIMV: Yes | Same as reference device Servo-U (K180098) |
| ... (and so on for all listed modes) | |
| Specifications - Ventilator setting parameter: | |
| TV range (Adult): 100 to 2000 ml (Predicate) | Adult: 100 to 4000 ml (Similar, wider range) |
| TV range (Ped.): 20 to 300 ml (Predicate) | Ped: 20 to 300 ml (Same) |
| O2% range: 21 to 100 vol.% (Predicate) | 21 to 100 vol.% (Same) |
| ... (and so on for all listed parameters) | |
| Biocompatibility: | Compliance: |
| Adherence to ISO 10993-1, ISO 18562-1, -2, -3 | Found to comply |
| Software Verification & Validation: | Compliance: |
| Adherence to FDA Guidance for Premarket Submissions for Software | Was conducted and documentation provided |
| Electromagnetic Compatibility & Electrical Safety: | Compliance: |
| Adherence to ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, ISO 80601-2-12, ISO 80601-2-55, ISO 80601-2-61, AIM Standard 7351731 | Found to comply |
| Bench Testing: | Compliance: |
| Meets accuracy specification compared to predicate | Meets accuracy specification and is substantially equivalent |
| Human Factors Testing: | Compliance: |
| Demonstrates device is safe and effective for intended users, uses and use environments | Was conducted |
2. Sample sized used for the test set and the data provenance
The document mentions "functional and system level testing" and "bench testing" but does not specify the sample sizes for these tests. It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective) for any of the testing. The nature of these tests (bench, functional, system level) generally implies laboratory or simulated environments, rather than patient data from a specific country or clinical setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The testing described (biocompatibility, software, EMC, electrical safety, bench testing) does not typically involve "experts establishing ground truth" in the way a clinical study would. These are generally engineering and performance evaluations against defined specifications and standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically relevant in clinical studies (e.g., for image interpretation or diagnosis) to resolve discrepancies between multiple evaluators. The types of testing described here (functional, system, bench, safety, EMC) do not involve such adjudication.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This document describes a ventilator (hardware and software for life support), not an AI-assisted diagnostic or interpretative device that would typically involve human "readers" or "AI assistance" in that context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not explicitly use the term "standalone" in the context of an algorithm. However, the majority of the testing described (software verification and validation, electromagnetic compatibility, electrical safety, bench testing) are inherently evaluations of the device's performance without continuous human intervention during the test itself, focusing on the device's adherence to specifications and standards. The "human factors testing" mentioned relates to the usability and user interface, ensuring safe and effective interaction for the intended users (medical personnel), rather than a "human-in-the-loop" performance study of an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically understood in clinical or AI performance studies (e.g., pathology for a biopsy, expert consensus for an image diagnosis) is not directly applicable or explicitly stated for the types of testing described. For this device (ventilator), the "ground truth" for its performance is its adherence to:
- Engineering specifications (e.g., flow range, pressure range accuracy)
- Consensus standards (e.g., ISO, IEC for safety, EMC, performance characteristics)
- Functional requirements (e.g., does it deliver the correct ventilation modes)
These are verified through various physical and software tests against known engineering principles and standardized test methods.
8. The sample size for the training set
This information is not applicable/not provided. Ventilators are not typically "trained" using data sets in the way AI/ML algorithms are. This is a traditional medical device whose functionality is based on pre-programmed logic, control algorithms, and pneumatic/electronic design.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reason as point 8.
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Image /page/0/Picture/0 description: The image contains 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 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.
June 16, 2023
Shenzhen Mindray Bio-medical Electronics Co.,LTD. Yanhong Bai Manager Regulatory Affairs, Technical Regulation Department Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan Shenzhen, Guangdong 518057 China
Re: K220107
Trade/Device Name: Mindray SV600 Ventilator, Mindray SV800 Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: June 15, 2023 Received: June 16, 2023
Dear Yanhong Bai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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.
Ethan L. Nyberg -S
for James J. Lee. Ph.D. Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental 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) K220107
Device Name SV600, SV800 Ventilator
Indications for Use (Describe)
The SV600, SV800 Ventilators are intensive care situations for long-term or during transport within a professional healthcare facility. The SV600, SV800 Ventilators are intended to provide ventilation assistance and breathing support for adult and pediatric patients with a minimum body weight of 10 kg (all pediatric subgroups except newborns (neonates)). The SV600, SV800 Ventilators should be operated by properly-trained and authorized medical personnel. This equipment is not suitable for use in an MRI environment.
| 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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510(K) SUMMARY
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Mindray SV600, SV800 Ventilator is provided below.
1. SUBMITTER
| Applicant: | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTDMindray Building, Keji 12th Road South High-tech Industrial Park,Nanshan Shenzhen 518057, P.R. ChinaTel: +86 755 81888998Fax: +86 755 26582680 |
|---|---|
| Contact: | Contact Person: Yanhong Poi |
- Contact Person: Yanhong Bai Contact: Title: Manager Regulatory Affairs Phone: +86 755 81885635 Fax: +86 755 26582680 E-mail: baiyanhong@mindray.com
June 16, 2023 Date Prepared:
2. DEVICE
| Device Trade Name: | SV600, SV800 Ventilator |
|---|---|
| Device Common Name: | Continuous ventilator |
| Classification Name: | 21 CFR 868.5895, Continuous ventilator |
| Regulatory Class: | Class II |
| Primary Product Code: | CBK |
| Panel: | Anesthesiology |
3. PREDICATE DEVICES
Primary predicate:
- K083050 Evita XL Ventilator, Drager Medical AG & Co. KG ●
Secondary predicate:
- . K202405 - BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1), ShenZhen Mindray Bio-Medical Electronics Co., LTD. (Supports CO2 Module and Accessories, SpO2 Module and Accessories)
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REFERENCE DEVICES 4.
Per the FDA Guidance. "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]' issued July 28, 2104, the following reference devices are provided to support substantial equivalence:
- K193228 HAMILTON-G5 Ventilator, HAMILTON MEDICAL AG ●
- K180098 Servo-U Ventilator, Maquet Critical Care AB ●
- K103211 - AVEA Ventilator, CareFusion
- K142679 CARESCAPE R860 Ventilator, GE Healthcare Datex-Ohmeda, Inc. ●
- K201957 A8, A9 Anesthesia System, ShenZhen Mindray Bio-Medical Electronics . Co., Ltd.
DEVICE DESCRIPTION 5.
The SV600 and SV800 Ventilators are pneumatically-driven and electronically-controlled ventilators. The Ventilators consists of a main unit (including pneumatic circuit, electronic system, mechanical structure, display, CO2 module, SpO2 module), trolley and support arm.
INTENDED USE/INDICATIONS FOR USE 6.
The SV600. SV800 Ventilators are intended to be used in intensive care situations for long-term or during transport within a professional healthcare facility. The SV600. SV800 Ventilators are intended to provide ventilation assistance and breathing support for adult and pediatric patients with a minimum body weight of 10 kg (all pediatric subgroups except newborns (neonates)). The SV600, SV800 Ventilators should be operated by properly-trained and authorized medical personnel. This equipment is not suitable for use in an MRI environment.
7. SUBSTANTIAL EQUIVALENCE
Comparison of Indications
Comparing with the primary predicate Evita XL Ventilator (K083050), the indications for use for the subject device SV600, SV800 Ventilators are equivalent.
The BeneVision N Series Patient Monitor modules (Including BeneVision N12, BeneVision N15. BeneVision N17. BeneVision N19. BeneVision N22. BeneVision N1). ShenZhen Mindray Bio-Medical Electronics Co., LTD cleared under K202405 are incorporated into those ventilators with no changes to the modules. This predicate supports the CO2 module and accessories and the SpO2 module and accessories. A more detailed comparison of the features is included in the sections below.
The indications for the BeneVision N Series Patient Monitors modules are the same since the modules are incorporated with no changes in indications into the ventilators.
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As a conclusion, the indications for use of the subject device SV600, SV800 Ventilators is the same as the primary predicate Evita XL Ventilator as cleared in K083050 and the BeneVision N Series Patient Monitors cleared in K202405.
Comparison of Technological Characteristics
The table below compares the key technological feature of the subject devices to the primary predicate device (Evita XL Ventilator (K083050)), secondary predicate devices and reference devices.
| TechnicalCharacteristics | Subject deviceSV600, SV800 VentilatorsShenzhen Mindray Bio-Medical Electronics Co.,Ltd.(Subject device) | Primary predicateEvita XL VentilatorDrager Medical AG &Co. KG(K083050) | Comparison |
|---|---|---|---|
| Ventilation mode | |||
| V-A/C | Yes | CMV+Assist | Same |
| P-A/C | Yes | PCV+Assist | Same |
| PRVC | Yes | CMV+AutoFlow | Same |
| V-SIMV | Yes | SIMV | Same |
| P-SIMV | Yes | Different, same as referencedevice Servo-U(K180098) | |
| PRVC-SIMV | Yes | SIMV+AutoFlow | Same |
| CPAP | Yes | CPAP | Same |
| PSV | Yes | Psupp | Same |
| DuoLevel | Yes | PCV+ | Same |
| APRV | Yes | APRV | Same |
| AMV | Yes | Different, same as referencedevice G5(K193228) | |
| VS | Yes | Different, same as referencedevice G5(K193228) | |
| PSV-S/T | Yes | Different, same as referencedevice G5(K193228) | |
| Apnea Ventilation | Yes | Yes | Same |
| Specifications - Ventilator setting parameter | |||
| TV range | Adu: 100 to 4000 ml | Adu: 100 to 2000 ml | Similar |
| Ped: 20 to 300 ml | Ped: 20 to 300 ml | Same | |
| O2% range | 21 to 100 vol.% | 21 to 100 vol.% | Same |
| f range | 1 to 100 1/min | 0 to 100 1/min | Similar |
| fsimv range | 1 to 60 1/min | 0 to 100 1/min | Similar |
| Subject deviceSV600, SV800 Ventilators | Primary predicateEvita XL Ventilator | ||
| TechnicalCharacteristics | Shenzhen Mindray Bio-Medical Electronics Co.,Ltd.(Subject device) | Drager Medical AG &Co. KG(K083050) | Comparison |
| Tinsp range | 0.1 to 10 s | 0.1 to 10 s | Same |
| I:E range | 10:1 to 1:10 | Different, same as referencedevice Servo-U(K180098) | |
| Tslope range | 0 to 2 s | 0 to 2 s | Same |
| △Pinsp range | Adu: 1 to 100 cmH2O | Adu: 0 to 95 cmH2O | Similar |
| Ped: 1 to 95 cmH2O | Ped: 0 to 95 cmH2O | Similar | |
| PEEP range | 0 to 50 cmH2O | 0 to 50 cmH2O | Same |
| Adu: 0 to 100 cmH2O | Adu: 0 to 95 cmH2O | Similar | |
| △Psupp range | Ped: 0 to 95 cmH2O | Ped: 0 to 95 cmH2O | Same |
| Phigh range | 0 to 95 cmH2O | 0 to 95 cmH2O | Same |
| Plow range | 0 to 50 cmH2O | 0 to 50 cmH2O | Same |
| Thigh range | 0.1 to 30 s | 0.1 to 30 s | Same |
| Tlow range | 0.2 to 30 s | 0.1 to 30 s | Similar |
| Tpause(%) range | OFF, 5% to 60% | Different, same as referencedevice A8, A9(K201957) | |
| Adu: 6 to 180 L/min | Adu: 6-120 L/min | Similar | |
| Flow range | Ped: 6 to 30 L/min | Ped: 6 to 30 L/min | Same |
| F-Trig range | 0.5 to 15 L/min | 0.3 to 15 L/min | Similar |
| P-Trig range | -20 to -1 cmH2O | Different, same as referencedevice Servo-U(K180098) | |
| Exp% range | 1 to 70% | Different, same as referencedevice Servo-U(K180098) | |
| MV% range | 25 to 350% | Different, same as referencedevice G5(K193228) | |
| Specifications - Ventilator monitoring parameter | |||
| TV range | 0 to 6000 ml | 0 to 6000 ml | Same |
| TVspn range | 0 to 6000 ml | 0 to 6000 ml | Same |
| MV range | 0 to 100 L/min | 0 to 120 L/min | Similar |
| MVspn range | 0 to 100 L/min | 0 to 120 L/min | Similar |
| MVleak range | 0 to 100 L/min | 0 to 99 L/min | Similar |
| FiO2 | 15 to 100 vol.% | 15 to 100 vol.% | Same |
| Subject deviceSV600, SV800 Ventilators | Primary predicateEvita XL Ventilator | ||
| TechnicalCharacteristics | Shenzhen Mindray Bio-Medical Electronics Co.,Ltd.(Subject device) | Drager Medical AG &Co. KG(K083050) | Comparison |
| Airway pressure(Ppeak, Pplat,Pmean) range | -20 to 120 cmH2O | -45 to 110 cmH2O | Similar |
| PEEP range | 0 to 120 cmH2O | -45 to 110 cmH2O | Similar |
| ftotal/fspn/fmandrange | 0 to 200 L/min | 0 to 300 L/min | Similar |
| Tinsp range | 0 to 60 s | Different, similar toreference deviceG5(K193228) | |
| I:E range | 99:1 to 1:99 | Different, same as referencedevice G5(K193228) | |
| Leak% range | 0 to 100% | Different, same as referencedevice G5(K193228) | |
| RCexp range | 0 to 10 s | Different, similar toreference deviceG5(K193228) | |
| RSBI range | 0 to 9999 1/(L•min) | 0 to 9999 1/(L•min) | Same |
| WOBtot/WOBvent/ WOBpatrange | 0 to 20 J/L | Different, same as referencedevice AVEA(K103211) | |
| Ri range | 0 to 600 cmH2O/(L/s) | 0 to 600 cmH2O/(L/s) | Same |
| Re range | 0 to 600 cmH2O/(L/s) | Different, same as referencedevice G5(K193228) | |
| Cstat range | 0 to 300 ml/cmH2O | 0 to 300 ml/cmH2O | Same |
| Cdyn range | 0 to 300 ml/cmH2O | Different, same as referencedevice AVEA(K103211) | |
| TVe/IBW range | 0 to 50 mL/kg | Different, similar toreference deviceG5(K193228) | |
| NIF range | -45 to 0 cmH2O | -45 to 0 cmH2O | Same |
| P0.1 range | -20 to 0 cmH2O | -20 to 0 cmH2O | Same |
| PEEPi range | 0 to 80 cmH2O | Yes | Similar |
| PIF range | 0 to 300 L/min | Different, similar toreference deviceG5(K193228) | |
| TechnicalCharacteristics | Subject deviceSV600, SV800 Ventilators | Primary predicateEvita XL Ventilator | Comparison |
| Shenzhen Mindray Bio-Medical Electronics Co.,Ltd.(Subject device) | Drager Medical AG &Co. KG(K083050) | ||
| PEF range | 0 to 180 L/min | - | Different, similar toreference deviceG5(K193228) |
| Specifications - Auxiliary Pressure | |||
| PesI/PesE/Paux2I/Paux2Erange | -40 to 120 cmH2O | - | Different, similar toreference deviceG5(K193228) |
| PtpI/PtpE range | -99 to 99 cmH2O | - | Different, same as referencedevice G5(K193228) |
| ΔPes range | -99 to 99 cmH2O | - | Different, similar toreference deviceAVEA(K103211) |
| Specifications - ATRC | |||
| Tube I.D. | 2.5 to 12 mm | 2.5 to 12 mm | Same |
| Compensate | 1 to 100% | 0 to 100% | Similar |
| Specifications - Sigh | |||
| Type | Pressure sigh | Pressure sigh | Same |
| Δint.PEEP range | OFF, 1 to 40 cmH2O | 0 to 50 cmH2O | Similar |
| Specifications – Apnea Ventilation | |||
| Apnea Ventilation | Yes | Yes | Same |
| Specifications - Intellicycle | |||
| Intellicycle | Yes | - | Different, same as referencedevice G5(K193228) |
| Specifications - Lung Recruitment (SI) | |||
| Pressure Hold | 20 to 60 cmH2O | - | Different, same as referencedevice A8, A9(K201957) |
| Hold Time | 10 to 40 s | - | Different, same as referencedevice A8, A9(K201957) |
| Specifications - Static PV Loop | |||
| Pstart | 0 to 50 cmH2O | 0 to 50 cmH2O | Same |
| Flow | 4 to 15 L/min | 4 to 15 L/min | Same |
| Pmax | 1 to 80 cmH2O | 1 to 80 cmH2O | Same |
| Vlimit | 100 to 2000 ml | 100 to 2000 ml | Same |
| Specifications - Weaning Tools (SBT) | |||
| TechnicalCharacteristics | Subject deviceSV600, SV800 Ventilators | Primary predicateEvita XL Ventilator | Comparison |
| Shenzhen Mindray Bio-Medical Electronics Co.,Ltd.(Subject device) | Drager Medical AG &Co. KG(K083050) | ||
| Type | PSV ventilation | - | Different, same as referencedevice CARESCAPER860(K142679) |
| SBT Criteria | Apnea TimeHigh and low MV alarmHigh and low f alarm | - | Different, same as referencedevice CARESCAPER860(K142679) |
| Specifications - Other Functions | |||
| Manual Breath | Yes | Yes | Same |
| Expiration Hold | Yes | Yes | Same |
| Inspiration Hold | Yes | Yes | Same |
| Nebulization | Yes | Yes | Same |
| O2↑(OxygenEnrichment) | Yes | Yes | Same |
| Suction | Yes | Yes | Same |
| Intrinsic PEEP | Yes | Yes | Same |
| Dynamic lung(PulmoSight) | Yes | - | Different, same as referencedevice G5(K193228) |
| Specifications - Basic Alarm | |||
| High/Low MinuteVolume Alarm | Yes | Yes | Same |
| High/Low TidalVolume Alarm | Yes | Yes | Same |
| High/Low f Alarm | Yes | Yes | Same |
| High/Low FiO2Alarm | Yes | Yes | Same |
| High/Low AirwayPressure Alarm | Yes | Yes | Same |
| Pressure LimitingAlarm | Yes | Yes | Same |
| Continuous AirwayPressure Alarm | Yes | Yes | Same |
| Apnea Alarm | Yes | Yes | Same |
| Specifications - Gas supply | |||
| TechnicalCharacteristics | Subject deviceSV600, SV800 VentilatorsShenzhen Mindray Bio-Medical Electronics Co.,Ltd.(Subject device) | Primary predicateEvita XL VentilatorDrager Medical AG &Co. KG(K083050) | Comparison |
| Pipeline supply | 280 to 650 kPa for O2, Air | 280 to 650 kPa for O2, Air | Same |
| Connector type | DISS body complying withCGA V-5 | DISS body complyingwith CGA V-5 | Same |
| Specifications - Modules | |||
| Specifications -Sidestream CO2Module | Yes | - | Different, same as secondarypredicate BeneVision NSeries PatientMonitors(K202405) |
| Specifications -Mainstream CO2Module | Yes | Yes | Same |
| Specifications -SpO2 Module | Yes | - | Different, same as secondarypredicate BeneVision NSeries PatientMonitors(K202405) |
| "-" means not applicable. |
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Discussion of technological characteristics that are not the same as the predicate device
The differences between the subject device and predicate device are identified in the table above. Many of the differences, when compared to the predicate, are the same or similar to the identified reference devices as noted in the table. Other identified differences are still similar to the predicate device in that the ranges for the parameters are within the ranges of the predicate device, including but not limited to: MV range, MVspn range, △Pinsp range for pediatrics, and airway pressure. Other parameters that are similar, such as MVleak range and △Pinsp range for adults, differ only by a small amount that do not have a clinically meaningful impact.
In conclusion, the subject and predicate have similar technological characteristics and intended uses. Performance testing supports substantial equivalence.
PERFORMANCE DATA 8.
To establish the substantial equivalence of the SV600 Ventilators, Mindray conducted functional and system level testing on the subject device. The testing provided an evaluation of the performance of the device relevant to each of the differences between the subject device and the predicate device. The functional and system level testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate. Mindray has conducted testing to ensure the subject device meets relevant consensus standards. Mindray also conducted human factors testing to demonstrate that the device is safe
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and effective for the intended users, uses and use environments.
Biocompatibility Testing
The SV600 and SV800 Ventilators were assessed for conformity with the relevant requirements of the following standards and found to comply:
- . ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in . healthcare applications - Part 1: Evaluation and testing within a risk management process
- . ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
- . ISO 18562-3:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
Software Verification and Validation Testing
Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Verification of the SV600 and SV800 Ventilators was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product.
Electromagnetic Compatibility and Electrical Safety
The SV600 and SV800 Ventilators were assessed for conformity with the relevant requirements of the following standards and found to comply:
- . ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- AIM Standard 7351731 Rev. 3.00 2021-06-04 Medical Electrical Equipment and . System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard
- IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-1-8 Edition 2.1 2012-11 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
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- . ISO 80601-2-12 Second edition 2020-02 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
- ISO 80601-2-55 Second edition 2018-02 Medical electrical equipment Part 2-55: ● Particular requirements for the basic safety and essential performance of respiratory gas monitors
- . ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02) Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
Bench Testing
To establish the substantial equivalence of the SV600 and SV800 Ventilators, Mindrav conducted functional and system level testing to validate the performance of the devices. The results of the bench testing show that the subject device meets its accuracy specification and is substantially equivalent to the predicate device.
In addition, Mindray has conducted testing to ensure the subject devices meet relevant consensus standards.
- IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical ● equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-1-8 Edition 2.1 2012-11 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- . ISO 80601-2-12 Second edition 2020-02 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
- ISO 80601-2-55 Second edition 2018-02 Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
- . ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02) Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part ● 1: Cones and sockets
- . CGA V-5:2008 (Reaffirmed 2013) Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications)
- . EN 13544-2:2002+A1:2009 Respiratory therapy equipment-Part 2: Tubing and connectors
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- . ASTM F1100-90 (Reapproved 1997) Standard Specification for Ventilator Intended for Use in Critical Care (only Endurance Testing)
CONCLUSION 9.
Based on the detailed comparison of specifications for each of the characteristics to the predicate devices, the performance testing and conformance with applicable standards, the SV600 and SV800 Ventilators can be found substantially equivalent to the predicate device.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).