(520 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on pneumatic and electronic control, not AI/ML capabilities.
Yes
Explanation: The device is described as providing "ventilation assistance and breathing support for adult and pediatric patients," which directly indicates its function in treating a medical condition or ailment.
No
Explanation: The device is a ventilator, which provides respiratory support, not diagnoses conditions. While it includes CO2 and SpO2 modules, these are for monitoring physiological parameters during ventilation, not for diagnosing diseases.
No
The device description explicitly states that the ventilators consist of a main unit including pneumatic and electronic systems, mechanical structure, display, and modules, indicating significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a ventilator for providing ventilation assistance and breathing support to patients. This is a life support device that interacts directly with the patient's respiratory system.
- Device Description: The description details a pneumatically-driven and electronically-controlled ventilator with components like a pneumatic circuit, electronic system, display, etc. These are all consistent with a respiratory support device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are used in vitro (outside the body) to analyze biological samples.
Therefore, the SV600 and SV800 Ventilators are classified as medical devices used for respiratory support, not as In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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.
Product codes
CBK
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult and pediatric patients with a minimum body weight of 10 kg (all pediatric subgroups except newborns (neonates)).
Intended User / Care Setting
Properly-trained and authorized medical personnel within a professional healthcare facility.
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)
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 and effective for the intended users, uses and use environments.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K193228, K180098, K103211, K142679, K201957
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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., LTD
Mindray Building, Keji 12th Road South High-tech Industrial Park,
Nanshan Shenzhen 518057, P.R. China
Tel: +86 755 81888998
Fax: +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.
| Technical
Characteristics | Subject device
SV600, SV800 Ventilators
Shenzhen Mindray Bio-
Medical Electronics Co.,
Ltd.
(Subject device) | Primary predicate
Evita XL Ventilator
Drager 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 reference
device 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 reference
device G5(K193228) |
| VS | Yes | | Different, same as reference
device G5(K193228) |
| PSV-S/T | Yes | | Different, same as reference
device 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 device
SV600, SV800 Ventilators | Primary predicate
Evita XL Ventilator | |
| Technical
Characteristics | 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 reference
device 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 reference
device 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 reference
device Servo-U(K180098) |
| Exp% range | 1 to 70% | | Different, same as reference
device Servo-U(K180098) |
| MV% range | 25 to 350% | | Different, same as reference
device 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 device
SV600, SV800 Ventilators | Primary predicate
Evita XL Ventilator | |
| Technical
Characteristics | 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/fmand
range | 0 to 200 L/min | 0 to 300 L/min | Similar |
| Tinsp range | 0 to 60 s | | Different, similar to
reference device
G5(K193228) |
| I:E range | 99:1 to 1:99 | | Different, same as reference
device G5(K193228) |
| Leak% range | 0 to 100% | | Different, same as reference
device G5(K193228) |
| RCexp range | 0 to 10 s | | Different, similar to
reference device
G5(K193228) |
| RSBI range | 0 to 9999 1/(L•min) | 0 to 9999 1/(L•min) | Same |
| WOBtot/
WOBvent/ WOBpat
range | 0 to 20 J/L | | Different, same as reference
device 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 reference
device 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 reference
device AVEA(K103211) |
| TVe/IBW range | 0 to 50 mL/kg | | Different, similar to
reference device
G5(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 to
reference device
G5(K193228) |
| Technical
Characteristics | Subject device
SV600, SV800 Ventilators | Primary predicate
Evita 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 to
reference device
G5(K193228) |
| Specifications - Auxiliary Pressure | | | |
| PesI/PesE/
Paux2I/Paux2E
range | -40 to 120 cmH2O | - | Different, similar to
reference device
G5(K193228) |
| PtpI/PtpE range | -99 to 99 cmH2O | - | Different, same as reference
device G5(K193228) |
| ΔPes range | -99 to 99 cmH2O | - | Different, similar to
reference device
AVEA(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 reference
device G5(K193228) |
| Specifications - Lung Recruitment (SI) | | | |
| Pressure Hold | 20 to 60 cmH2O | - | Different, same as reference
device A8, A9(K201957) |
| Hold Time | 10 to 40 s | - | Different, same as reference
device 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) | | | |
| Technical
Characteristics | Subject device
SV600, SV800 Ventilators | Primary predicate
Evita XL Ventilator | Comparison |
| | Shenzhen Mindray Bio-
Medical Electronics Co.,
Ltd.
(Subject device) | Drager Medical AG &
Co. KG
(K083050) | |
| Type | PSV ventilation | - | Different, same as reference
device CARESCAPE
R860(K142679) |
| SBT Criteria | Apnea Time
High and low MV alarm
High and low f alarm | - | Different, same as reference
device CARESCAPE
R860(K142679) |
| Specifications - Other Functions | | | |
| Manual Breath | Yes | Yes | Same |
| Expiration Hold | Yes | Yes | Same |
| Inspiration Hold | Yes | Yes | Same |
| Nebulization | Yes | Yes | Same |
| O2↑
(Oxygen
Enrichment) | Yes | Yes | Same |
| Suction | Yes | Yes | Same |
| Intrinsic PEEP | Yes | Yes | Same |
| Dynamic lung
(PulmoSight) | Yes | - | Different, same as reference
device G5(K193228) |
| Specifications - Basic Alarm | | | |
| High/Low Minute
Volume Alarm | Yes | Yes | Same |
| High/Low Tidal
Volume Alarm | Yes | Yes | Same |
| High/Low f Alarm | Yes | Yes | Same |
| High/Low FiO2
Alarm | Yes | Yes | Same |
| High/Low Airway
Pressure Alarm | Yes | Yes | Same |
| Pressure Limiting
Alarm | Yes | Yes | Same |
| Continuous Airway
Pressure Alarm | Yes | Yes | Same |
| Apnea Alarm | Yes | Yes | Same |
| Specifications - Gas supply | | | |
| Technical
Characteristics | Subject device
SV600, SV800 Ventilators
Shenzhen Mindray Bio-
Medical Electronics Co.,
Ltd.
(Subject device) | Primary predicate
Evita XL Ventilator
Drager 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 with
CGA V-5 | DISS body complying
with CGA V-5 | Same |
| Specifications - Modules | | | |
| Specifications -
Sidestream CO2
Module | Yes | - | Different, same as secondary
predicate BeneVision N
Series Patient
Monitors(K202405) |
| Specifications -
Mainstream CO2
Module | Yes | Yes | Same |
| Specifications -
SpO2 Module | Yes | - | Different, same as secondary
predicate BeneVision N
Series Patient
Monitors(K202405) |
| "-" means not applicable. | | | |
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7
8
9
10
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.