Who is the manufacturer of Mindray SV600 Ventilator, Mindray SV800 Ventilator?

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. filed the 510(k) submission for Mindray SV600 Ventilator, Mindray SV800 Ventilator (K220107).

What is the FDA product code for Mindray SV600 Ventilator, Mindray SV800 Ventilator?

CBK. It is classified under 21 CFR 868.5895 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for Mindray SV600 Ventilator, Mindray SV800 Ventilator?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Mindray SV600 Ventilator, Mindray SV800 Ventilator?

Evita XL Ventilator (K083050); BeneVision N Series Patient Monitors (K202405).

Who can help prepare an FDA 510(k) submission like Mindray SV600 Ventilator, Mindray SV800 Ventilator?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Mindray SV600 Ventilator, Mindray SV800 Ventilator

K220107 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · CBK · Jun 16, 2023 · Anesthesiology

Device Facts

Record ID	K220107
Device Name	Mindray SV600 Ventilator, Mindray SV800 Ventilator
Applicant	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Product Code	CBK · Anesthesiology
Decision Date	Jun 16, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5895
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended 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.

Device Story

Pneumatically-driven, electronically-controlled ventilators; provide ventilation assistance and breathing support. Inputs include gas supply and patient physiological data via integrated CO2 and SpO2 modules. Device transforms inputs into controlled ventilation delivery; features include various modes (V-A/C, P-A/C, PRVC, SIMV, CPAP, PSV, DuoLevel, APRV, AMV, VS, PSV-S/T), lung recruitment, and weaning tools. Used in intensive care or transport within professional healthcare facilities; operated by trained medical personnel. Output displayed on integrated screen; provides real-time monitoring of respiratory parameters (e.g., TV, MV, airway pressure, lung mechanics). Output informs clinical decision-making regarding patient respiratory status and weaning. Benefits include continuous respiratory support and monitoring for critically ill patients.

Clinical Evidence

Bench testing only. Functional and system-level testing validated performance against specifications and consensus standards (ISO 80601-2-12, ISO 80601-2-55, ISO 80601-2-61). Human factors testing demonstrated safety and effectiveness for intended users and environments. Biocompatibility, electromagnetic compatibility, and electrical safety testing performed per relevant standards.

Technological Characteristics

Pneumatically-driven, electronically-controlled critical care ventilator. Materials comply with ISO 10993-1 and ISO 18562 series. Features integrated CO2 and SpO2 modules. Connectivity via DISS connectors (CGA V-5). Standards: 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, ASTM F1100-90.

Indications for Use

Indicated for adult and pediatric patients (minimum 10 kg, excluding neonates) requiring ventilation assistance and breathing support in intensive care or during transport within professional healthcare facilities.

Regulatory Classification

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.

Predicate Devices

Evita XL Ventilator (K083050)
BeneVision N Series Patient Monitors (K202405)

Reference Devices

HAMILTON-G5 Ventilator (K193228)
Servo-U Ventilator (K180098)
AVEA Ventilator (K103211)
CARESCAPE R860 Ventilator (K142679)
A8, A9 Anesthesia System (K201957)

Related Devices

K243767 — SV600, SV800 Ventilator · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Aug 28, 2025
K041775 — GE DATEX-OHMEDA ENGSTROM CARESTATION · Datex-Ohmeda, Inc. · Oct 26, 2004
K062710 — GE DATEX-OHMEDA ENGSTROM CARESTATION · Datex-Ohmeda, Inc. · Dec 8, 2006
K060862 — GE DATEX-OHMEDA ENGSTROM CARESTATION · Datex-Ohmeda, Inc. · Jun 5, 2006
K181170 — Trilogy Evo Universal · Respironics, Inc. · Jul 18, 2019

Submission Summary (Full Text)

{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 {2}------------------------------------------------ # 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) | | |-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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) {4}------------------------------------------------ #### 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. {5}------------------------------------------------ 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. | | | | {6}------------------------------------------------ {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 {11}------------------------------------------------ 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 {12}------------------------------------------------ - . 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 {13}------------------------------------------------ - . 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.