SV600, SV800 Ventilator

K243767 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · CBK · Aug 28, 2025 · Anesthesiology

Device Facts

• Record ID: K243767
• Device Name: SV600, SV800 Ventilator
• Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Product Code: CBK · Anesthesiology
• Decision Date: Aug 28, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The SV600, SV800 Ventilator is intended to be used in intensive care situations for long-term or during transport within a professional healthcare facility. The SV600, SV800 Ventilator is intended to provide ventilation assistance and breathing support for adult, pediatric and neonate patients with a minimum body weight of 0.5 kg. The SV600, SV800 Ventilator 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 for intensive care and transport. Inputs include patient respiratory signals via flow sensors, CO2 modules, and SpO2 modules. Device transforms inputs through electronic control system to provide mechanical ventilation; supports various modes (e.g., V-A/C, P-A/C, PRVC, nCPAP, oxygen therapy). Output includes ventilation delivery, monitoring parameters (e.g., TV, MV, airway pressure), and alarms. Operated by trained medical personnel in clinical settings. Healthcare providers use real-time monitoring and alarm data to adjust ventilation settings, optimizing patient respiratory support and gas exchange. Benefits include tailored respiratory assistance for diverse patient populations, including neonates.

Clinical Evidence

Bench testing only. No clinical data provided. Performance validated through functional and system-level testing, biocompatibility testing (ISO 10993 series, ISO 18562 series), electromagnetic compatibility (IEC 60601-1-2), and electrical safety (IEC 60601-1). Human factors testing conducted to ensure safe operation by intended users.

Technological Characteristics

Pneumatically-driven, electronically-controlled ventilator. Includes main unit, trolley, support arm, neonatal flow sensor, CO2/SpO2 modules, and optional backup blower. Connectivity via WiFi. Materials evaluated per ISO 10993 and ISO 18562. Standards: IEC 60601-1, IEC 60601-1-2, ISO 80601-2-12, ISO 80601-2-55, ISO 80601-2-61, ASTM F1100-90.

Indications for Use

Indicated for ventilation assistance and breathing support in adult, pediatric, and neonate patients (minimum weight 0.5 kg) in intensive care or transport within professional healthcare facilities. Contraindicated for use in MRI environments.

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

• Mindray SV600, SV800 Ventilator (K220107)
• BeneVision N Series Patient Monitors (K213799)
• Evita XL Ventilator (K083050)
• Servo-U Ventilator (K180098)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

August 28, 2025

Shenzhen Mindray Bio-medical Electronics Co., LTD.
Li Lei
Manager Regulatory Affairs
Mindray Building, Keji 12th Road South,
Hi-tech Industrial Park, Nanshan
Shenzhen, Guangdong 518057
China

Re: K243767
Trade/Device Name: SV600, SV800 Ventilator
Regulation Number: 21 CFR 868.5895
Regulation Name: Continuous Ventilator
Regulatory Class: Class II
Product Code: CBK
Dated: August 1, 2025
Received: August 1, 2025

Dear Li Lei:

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 (the 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 available 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K243767 - Li Lei
Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K243767 - Li Lei
Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Ethan L. Nyberg -S

Ethan Nyberg, Ph.D.
Assistant Director, Respiratory Devices Team
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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K243767 | |
| Device Name SV600, SV800 Ventilator | |
| Indications for Use (Describe) The SV600, SV800 Ventilator is intended to be used in intensive care situations for long-term or during transport within a professional healthcare facility. The SV600, SV800 Ventilator is intended to provide ventilation assistance and breathing support for adult, pediatric and neonate patients with a minimum body weight of 0.5 kg. The SV600, SV800 Ventilator 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) | |
| 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 [e-mail] | |
| "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." | |

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mindray

Traditional
510(k)
: SV600, SV800 Ventilator

K243767

510(k) Summary

# 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: [phone]
Fax: [phone]

Contact: Contact Person: Li Lei
Title: Manager Regulatory Affairs
Phone: [phone]
Fax: [phone]
E-mail: [e-mail]

Date Prepared: December 3, 2024

# 2. DEVICE

Trade/Device Name: SV600, SV800 Ventilator
Common Name: Continuous Ventilator
Regulation Number: 21 CFR 868.5895
Device Class: Class II
Review Panel: Anesthesiology

# 3. PREDICATE DEVICES

## Primary predicate:

- K220107-Mindray SV600, SV800 Ventilator, ShenZhen Mindray Bio-Medical Electronics CO., LTD.

## Secondary predicate:

- K213799 - 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.
- K083050 - Evita XL Ventilator, Drager Medical AG & Co. KG
- K180098 - Servo-U Ventilator, Maquet Critical Care AB

Page 1 of 19

{5}

mindray

Traditional
510(k)
: SV600, SV800 Ventilator

K243767

510(k) Summary

## 4. 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. The device also includes a neonatal flow sensor and neonatal flow sensor cable, which are used to measure the patient inspiration/expiration flow in neonatal ventilation modes.

## 5. INTENDED USE/INDICATIONS FOR USE

The SV600, SV800 Ventilator is intended to be used in intensive care situations for long-term or during transport within a professional healthcare facility. The SV600, SV800 Ventilator is intended to provide ventilation assistance and breathing support for adult, pediatric and neonate patients with a minimum body weight of 0.5 kg. The SV600, SV800 Ventilator should be operated by properly-trained and authorized medical personnel. This equipment is not suitable for use in an MRI environment.

## 6. SUBSTANTIAL EQUIVALENCE

### Comparison of Indications

Comparing with the primary predicate SV600, SV800 Ventilator(K220107) and Secondary predicate Evita XL Ventilator (K083050) and Servo-U Ventilator (K180098), 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 K213799 are incorporated into thoes ventilators with no changes to the modules. This predicate supports the CO₂ module and accessories, the SpO₂ module and accessories, WiFi Module. 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.

As a conclusion, the indications for use of the subject device SV600, SV800 Ventilators is the same as the primary predicate SV600, SV800 Ventilator as cleared in K220107, secondary predicate Evita XL Ventilator as cleared in K083050, Servo-U Ventilator as cleared in K180098 and the BeneVision N Series Patient Monitors as cleared in K213799.

### Comparison of Technological Characteristics

The table below compares the key technological features of the subject devices to the primary predicate device (SV600, SV800 Ventilator (K220107)) and secondary predicate devices. The

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mindray

Traditional 510(k): SV600, SV800 Ventilator

K243767

510(k) Summary

main differences between the subject device and the primary predicate SV600, SV800 Ventilators are:

1. A neonatal ventilation option has been added including the ventilation mode nCPAP which is specific only to the neonate population.
2. Modifications of certain parameters to support neonates
3. Addition of a neonatal flow sensor.
4. Addition of oxygen therapy.
5. Addition of a backup air supply (blower) (optional).
6. Addition of WiFi communication.
7. Addition of neonate CO2 measurement.
8. Addition of neonate Mindray SpO2 measurement.
9. Addition of Masimo SpO2 and Nellcor SpO2 measurement.
10. Modification of the main control board.
11. Modification of the display.
12. Modification of the structure of the expiratory valve assembly.

| Technical Characteristics | Subject device SV600, SV800 Ventilator Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Subject device) | Primary predicate SV600, SV800 Ventilator Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (K220107) | Comments |
| --- | --- | --- | --- |
| Ventilation mode | | | |
| V-A/C | Yes | V-A/C | Same |
| P-A/C | Yes | P-A/C | Same |
| PRVC | Yes | PRVC | Same |
| V-SIMV | Yes | V-SIMV | Same |
| P-SIMV | Yes | P-SIMV | Same |
| PRVC-SIMV | Yes | PRVC-SIMV | Same |
| CPAP | Yes | CPAP | Same |
| PSV | Yes | PSV | Same |
| DuoLevel | Yes | DuoLevel | Same |
| APRV | Yes | APRV | Same |
| AMV | Yes | AMV | Same |
| VS | Yes | VS | Same |

{7}

mindray

Traditional 510(k): SV600, SV800 Ventilator

K243767

510(k) Summary

| Technical Characteristics | Subject device
SV600, SV800 Ventilator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
(Subject device) | Primary predicate
SV600, SV800 Ventilator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
(K220107) | Comments |
| --- | --- | --- | --- |
| nCPAP | Yes | - | Different, same as secondary predicate device Evita XL(K083050) |
| PSV-S/T | Yes | PSV-S/T | Same |
| Apnea Ventilation | Yes | Yes | Same |
| **Specifications - Ventilator setting parameter** | | | |
| TV range | Adu: 100 to 4000 ml | Adu: 100 to 4000 ml | Same |
| | Ped: 20 to 300 ml | Ped: 20 to 300 ml | Same |
| | Neo: 2 to 100 ml | - | Different, similar to secondary predicate device Servo-U(K180098) |
| O2% range | Adu/Ped: 21 to 100 vol.% | 21 to 100 vol.% | Same |
| | Neo: 21 to 100 vol.% | - | Different, same as secondary predicate device Evita XL(K083050) |
| f range | Adu/Ped: 1 to 100 /min | 1 to 100 /min | Same |
| | Neo: 1 to 150 /min | - | Different, similar as secondary predicate device Evita XL(K083050) |
| fsimv range | Adu/Ped: 1 to 60 /min | 1 to 60 /min | Same |
| | Neo: 1 to 60 /min | - | Different, similar to secondary predicate device Evita XL(K083050) |
| Tinsp range | Adu/Ped: 0.1 to 10 s | 0.1 to 10 s | Same |

Page 4 of 19

{8}

mindray

Traditional 510(k): SV600, SV800 Ventilator

K243767

510(k) Summary

| Technical Characteristics | Subject device
SV600, SV800 Ventilator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
(Subject device) | Primary predicate
SV600, SV800 Ventilator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
(K220107) | Comments |
| --- | --- | --- | --- |
| | Neo: 0.1 to 10 s | - | Different, same as secondary predicate device Evita XL(K083050) |
| I:E range | Adu/Ped: 4:1 to 1:10 | 4:1 to 1:10 | Same |
| | Neo: 4:1 to 1:10 | - | Different, same as secondary predicate device Servo-U(K180098) |
| Tslope range | Adu/Ped: 0 to 2 s | 0 to 2 s | Same |
| | Neo: 0 to 2 s | - | Different, same as secondary predicate device Evita XL(K083050) |
| △Pinsp range | Adu: 1 to 100 cmH_{2}O
Note: when backup air supply works, can set to up to 80cmH_{2}O | Adu: 1 to 100 cmH_{2}O | Same |
| | Ped: 1 to 95 cmH_{2}O
Note: when backup air supply works, can set to up to 80cmH_{2}O | Ped: 1 to 95 cmH_{2}O | |
| | Neo: 1 to 95 cmH_{2}O
Note: when backup air supply works, can set to up to 80cmH_{2}O | - | Different, similar to secondary predicate device Evita XL(K083050) |
| PEEP range | Adu/Ped: 0 to 50 cmH_{2}O | 0 to 50 cmH_{2}O | Same |
| | Neo: 0 to 50 cmH_{2}O | - | Different, same as secondary predicate device Evita XL(K083050) |
| △Psupp range | Adu: 0 to 100 cmH_{2}O | Adu: 0 to 100 cmH_{2}O | Same |

Page 5 of 19

{9}

mindray

Traditional 510(k): SV600, SV800 Ventilator

K243767

510(k) Summary

| Technical Characteristics | Subject device
SV600, SV800 Ventilator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
(Subject device) | Primary predicate
SV600, SV800 Ventilator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
(K220107) | Comments |
| --- | --- | --- | --- |
| | Note: when backup air supply works, can set to up to 80cmH2O | | |
| | Ped: 0 to 95 cmH2O
Note: when backup air supply works, can set to up to 80cmH2O | Ped: 0 to 95 cmH2O | Same |
| | Neo: 0 to 95 cmH2O
Note: when backup air supply works, can set to up to 80cmH2O | - | Different, same as secondary predicate device Evita XL(K083050) |
| Phigh range | Adu/Ped: 0 to 95 cmH2O
Note: when backup air supply works, can set to up to 80cmH2O | 0 to 95 cmH2O | Same |
| | Neo: 0 to 95 cmH2O
Note: when backup air supply works, can set to up to 80cmH2O | - | Different, same as secondary predicate device Evita XL(K083050) |
| Plow range | Adu/Ped: 0 to 50 cmH2O | 0 to 50 cmH2O | Same |
| | Neo: 0 to 50 cmH2O | - | Different, same as secondary predicate device Evita XL(K083050) |
| Thigh range | Adu/Ped: 0.1 to 30 s | 0.1 to 30 s | Same |
| | Neo: 0.1 to 30 s | - | Different, same as secondary predicate device Evita XL(K083050) |
| Tlow range | Adu/Ped: 0.2 to 30 s | 0.1 to 30 s | Same |
| | Neo: 0.2 to 30 s | - | Different, similar to secondary predicate device Evita XL(K083050) |

Page 6 of 19

{10}

mindray

Traditional 510(k): SV600, SV800 Ventilator

K243767

510(k) Summary

| Technical Characteristics | Subject device
SV600, SV800 Ventilator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
(Subject device) | Primary predicate
SV600, SV800 Ventilator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
(K220107) | Comments |
| --- | --- | --- | --- |
| Tpause(%) range | Adu/Ped: OFF, 5% to 60% | OFF, 5% to 60% | Same |
| Flow range | Adu: 6 to 180 L/min | Adu: 6 to 180 L/min | Same |
| | Ped: 6 to 30 L/min | Ped: 6 to 30 L/min | |
| F-Trig range | Adu/ Ped: 0.5 to 15 L/min | 0.5 to 15 L/min | Same |
| | Neo: 0.1 to 5 L/min | - | Different, similar to secondary predicate device Servo-U(K180098) |
| P-Trig range | Adu/ Ped: -20 to -1 cmH_{2}O | -20 to -1 cmH_{2}O | Same |
| | Neo: -20 to -1 cmH_{2}O | - | Different, same as secondary predicate device Servo-U(K180098) |
| Exp% range | Adu/ Ped:1 to 70% | 1 to 70% | Same |
| | Neo: 1 to 70% | - | Different, same as secondary predicate device Servo-U(K180098) |
| MV% range | 25 to 350% | 25 to 350% | Same |
| **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 100 L/min | Same |
| MVspn range | 0 to 100 L/min | 0 to 100 L/min | Same |
| MVleak range | 0 to 100 L/min | 0 to 100 L/min | Same |

Page 7 of 19

{11}

mindray

Traditional 510(k): SV600, SV800 Ventilator

K243767

510(k) Summary

| Technical Characteristics | Subject device
SV600, SV800 Ventilator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
(Subject device) | Primary predicate
SV600, SV800 Ventilator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
(K220107) | Comments |
| --- | --- | --- | --- |
| FiO_{2} | 15 to 100 vol.% | 15 to 100 vol.% | Same |
| Airway pressure (Ppeak, Pplat, Pmean) range | -20 to 120 cmH_{2}O | -20 to 120 cmH_{2}O | Same |
| PEEP range | 0 to 120 cmH_{2}O | 0 to 120 cmH_{2}O | Same |
| ftotal/fspn/fmand range | 0 to 200 /min | 0 to 200 /min | Same |
| Tinsp range | 0 to 60 s | 0 to 60 s | Same |
| I:E range | 99:1 to 1:99 | 99:1 to 1:99 | Same |
| Leak% range | 0 to 100% | 0 to 100% | Same |
| RCexp range | 0 to 10 s | 0 to 10 s | Same |
| RSBI range | 0 to 9999 1/(L·min) | 0 to 9999 1/(L·min) | Same |
| WOBtot/ WOBvent/ WOBpat range | 0 to 20 J/L | 0 to 20 J/L | Same |
| Ri range | 0 to 600 cmH_{2}O/( L/s) | 0 to 600 cmH_{2}O/( L/s) | Same |
| Re range | 0 to 600 cmH_{2}O/( L/s) | 0 to 600 cmH_{2}O/( L/s) | Same |
| Cstat range | 0 to 300 ml/cmH_{2}O | 0 to 300 ml/cmH_{2}O | Same |
| Cdyn range | 0 to 300 ml/cmH_{2}O | 0 to 300 ml/cmH_{2}O | Same |
| TVe/IBW range | 0 to 50 mL/kg | 0 to 50 mL/kg | Same |
| NIF range | -45 to 0 cmH_{2}O | -45 to 0 cmH_{2}O | Same |
| P0.1 range | -20 to 0 cmH_{2}O | -20 to 0 cmH_{2}O | Same |
| PEEPi range | 0 to 80 cmH_{2}O | 0 to 80 cmH_{2}O | Same |
| PIF range | 0 to 300 L/min | 0 to 300 L/min | Same |
| PEF range | 0 to 180 L/min | 0 to 180 L/min | Same |
| **Specifications - O2 Therapy** | | | |
| Flow range | Adu: 10 to 60 L/min | - | Different, similar to secondary predicate device Servo-U(K180098) |
| | Ped: 2 to 25L/min | - | Different, similar to secondary predicate device Servo-U(K180098) |
| | Neo: 2 to 20 L/min | - | Different, similar to secondary predicate device Servo-U(K180098) |

Page 8 of 19

{12}

mindray

Traditional 510(k): SV600, SV800 Ventilator

K243767

510(k) Summary

| Technical Characteristics | Subject device
SV600, SV800 Ventilator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
(Subject device) | Primary predicate
SV600, SV800 Ventilator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
(K220107) | Comments |
| --- | --- | --- | --- |
| | | | device Servo-U
(K180098) |
| **Specifications - Auxiliary Pressure** | | | |
| PesI/PesE/
Paux2I/Paux2E range | -40 to 120 cmH_{2}O | -40 to 120 cmH_{2}O | Same |
| PtpI/PtpE range | -99 to 99 cmH_{2}O | -99 to 99 cmH_{2}O | Same |
| ΔPes range | -99 to 99 cmH_{2}O | -99 to 99 cmH_{2}O | Same |
| **Specifications - ATRC** | | | |
| Tube I.D. | 2.5 to 12 mm | 2.5 to 12 mm | Same |
| Compensate | 1 to 100% | 1 to 100% | Same |
| **Specifications - Sigh** | | | |
| Type | Pressure sigh | Pressure sigh | Same |
| △int.PEEP range | OFF,1 to 40 cmH_{2}O | OFF,1 to 40 cmH_{2}O | Same |
| **Specifications – Apnea Ventilation** | | | |
| Apnea Ventilation | Yes | Yes | Same |
| **Specifications - Intellicycle** | | | |
| Intellicycle | Yes | Yes | Same |
| **Specifications - Lung Recruitment (SI)** | | | |
| Pressure Hold | 20 to 60 cmH_{2}O | 20 to 60 cmH_{2}O | Same |
| Hold Time | 10 to 40 s | 10 to 40 s | |
| **Specifications – Static PV Loop** | | | |
| Pstart | 0 to 50 cmH_{2}O | 0 to 50 cmH_{2}O | Same |
| Flow | 4 to 15 L/min | 4 to 15 L/min | Same |
| Pmax | 1 to 80 cmH_{2}O | 1 to 80 cmH_{2}O | Same |
| Vlimit | 100 to 2000 ml | 100 to 2000 ml | Same |
| **Specifications - Weaning Tools (SBT)** | | | |
| Type | PSV ventilation | PSV ventilation | Same |
| SBT Criteria | Apnea Time | Apnea Time | Same |

Page 9 of 19

{13}

mindray

Traditional 510(k): SV600, SV800 Ventilator

K243767

510(k) Summary

| Technical Characteristics | Subject device
SV600, SV800 Ventilator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
(Subject device) | Primary predicate
SV600, SV800 Ventilator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
(K220107) | Comments |
| --- | --- | --- | --- |
| | High and low MV alarm
High and low f alarm | High and low MV alarm
High and low f alarm | |
| **Specifications - Other Functions** | | | |
| Manual Breath | Yes | Yes | Same |
| Expiration Hold | Yes | Yes | Same |
| Inspiration Hold | Yes | Yes | Same |
| Nebulization | Yes | Yes | Same |
| O_{2}↑
(Oxygen Enrichment) | Yes | Yes | Same |
| Suction | Yes | Yes | Same |
| Intrinsic PEEP | Yes | Yes | Same |
| Dynamic lung
(PulmoSight) | Yes | Yes | Same |
| **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 FiO_{2} 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** | | | |
| Pipeline supply | 280 to 650 kPa for O_{2}, Air | 280 to 650 kPa for O_{2}, Air | Same |
| Connector type | DISS body complying with CGA V-5 | DISS body complying with CGA V-5 | Same |
| **Specifications – Sidestream CO_{2} Module** | | | |

Page 10 of 19

{14}

mindray

Traditional 510(k): SV600, SV800 Ventilator

K243767

510(k) Summary

| Technical Characteristics | Subject device
SV600, SV800 Ventilator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
(Subject device) | Primary predicate
SV600, SV800 Ventilator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
(K220107) | Comments |
| --- | --- | --- | --- |
| Module | External 1-slot Sidestream CO_{2} Module 2.0 | External 1-slot Sidestream CO_{2} Module 2.0 | Same |
| Water trap | DRYLINE II Water trap, Adult/pediatric | DRYLINE II Water trap, Adult/pediatric | Same |
| | DRYLINE II Water trap, Neonate | - | Different, same as secondary predicate device BeneVision N Series Patient Monitors (K213799) |
| Sampling Line | DRYLINE Gas Sampling Line, Neonate 2.5 m | - | Different, same as secondary predicate device BeneVision N Series Patient Monitors (K213799) |
| | DRYLINE Gas Sampling Line, Adult/pediatric 2.5 m | DRYLINE Gas Sampling Line, Adult/pediatric 2.5 m | Same |
| Airway adapter | Dryline airway adapter, straight | Dryline airway adapter, straight | Same |
| | Airway Adapter | Airway Adapter | Same |
| Sample flowrate | Neonate water trap: 90 ml/min | - | Different, same as secondary predicate device BeneVision N Series Patient Monitors (K213799) |
| | Adult/pediatric water trap: 120 ml/min | Adult/pediatric water trap: 120 ml/min | Same |
| Measurement range | 0 mmHg to 150 mmHg | 0 mmHg to 150 mmHg | Same |
| Measurement accuracy | 0 mmHg to 40 mmHg: ±2 mmHg
41 mmHg to 76 mmHg: ±5% of reading
77 mmHg to 99 mmHg: ±10% of reading
100 mmHg to 150 mmHg: ± (3mmHg + 8% of reading) | 0 mmHg to 40 mmHg: ±2 mmHg
41 mmHg to 76 mmHg: ±5% of reading
77 mmHg to 99 mmHg: ±10% of reading
100 mmHg to 150 mmHg: ± (3mmHg + 8% of reading) | Same |
| **Specifications – Mainstream CO_{2} Module** | | | |

Page 11 of 19

{15}

mindray

Traditional 510(k): SV600, SV800 Ventilator

K243767

510(k) Summary

| Technical Characteristics | Subject device
SV600, SV800 Ventilator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
(Subject device) | Primary predicate
SV600, SV800 Ventilator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
(K220107) | Comments |
| --- | --- | --- | --- |
| Module | External 1-slot Mainstream CO_{2} Module | External 1-slot Mainstream CO_{2} Module | Same |
| Sensor | CAPNOSTAT CO_{2} sensor | CAPNOSTAT CO_{2} sensor | Same |
| Airway adapter | Airway adapter, Adult/pediatric | Airway adapter, Adult/pediatric | Same |
| | Airway adapter, Neonate | - | Different, same as secondary predicate device BeneVision N Series Patient Monitors (K213799) |
| Measurement range | 0 mmHg to 150 mmHg | 0 mmHg to 150 mmHg | Same |
| Measurement accuracy | 0 mmHg to 40 mmHg: ±2 mmHg
41 mmHg to 70 mmHg: ±5% of reading
71 mmHg to 100 mmHg: ±8% of reading
101 mmHg to 150 mmHg: ±10% of reading | 0 mmHg to 40 mmHg: ±2 mmHg
41 mmHg to 70 mmHg: ±5% of reading
71 mmHg to 100 mmHg: ±8% of reading
101 mmHg to 150 mmHg: ±10% of reading | Same |
| **Specifications – Mindray SpO_{2} Module** | | | |
| Module | External 1-slot Mindray SpO_{2} module | External 1-slot Mindray SpO_{2} module | Same |
| Cable | 7pin SpO_{2} Cable | 7pin SpO_{2} Cable | Same |
| SpO2 sensor | SpO_{2} sensor, finger-clip, adult | SpO_{2} sensor, finger-clip, adult | Same |
| | SpO_{2} sensor, finger-clip, pediatric | SpO_{2} sensor, finger-clip, pediatric | Same |
| | SpO_{2} sensor, foot, bandage | SpO_{2} sensor, foot, bandage | Different, same as secondary predicate device BeneVision N Series Patient Monitors (K213799) |
| SpO2 Measured parameters | Measurement range: 0 to 100%
Accuracy:70 to 100%: ±2% (adult/pediatric mode)
0% to 69%: Not specified | Measurement range: 0 to 100%
Accuracy:70 to 100%: ±2% (adult/pediatric mode) | Same |

Page 12 of 19

{16}

mindray

Traditional 510(k): SV600, SV800 Ventilator

K243767

510(k) Summary

| Technical Characteristics | Subject device
SV600, SV800 Ventilator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
(Subject device) | Primary predicate
SV600, SV800 Ventilator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
(K220107) | Comments |
| --- | --- | --- | --- |
| | | 0% to 69%: Not specified | |
| | Measurement range: 0 to 100%
Accuracy:
70 to 100%: ±3% (neonate mode)
0% to 69%: Not specified | - | Different, same as secondary predicate device BeneVision N Series Patient Monitors (K213799) |
| PR Measured parameters | Measurement range: 20 to 254 1/min;
Accuracy: ±3 1/min. | Measurement range: 20 to 254 1/min;
Accuracy: ±3 1/min. | Same |
| PI Measured parameters | Range: 0.05 to 20 % | Range: 0.05 to 20 % | Same |
| **Specifications – Masimo SpO2 Module** | | | |
| Module | External 1-slot Masimo SpO2 module | - | Different, same as secondary predicate device BeneVision N Series Patient Monitors (K213799) |
| Cable | RD SET MD 14-05, PC 5 ft
RD SET MD 14-12, Patient Cable 12 ft
RD to LNC Adapter Cable
LNCS to RD Adapter
8pin masimo Cable (RD SET)
8-pin Masimo SpO2 Extension Cable (MASIMOLNCS) | - | Different, same as secondary predicate device BeneVision N Series Patient Monitors (K213799) |
| SpO2 sensor | LNCS DC-I Reusable sensor
LNCS DC-IP Reusable SpO2sensor
LNCS Multisite Reusable sensor
LNCS Neo/Pt disposable sensor
LNCS Neo disposable sensor
LNCS Inf disposable sensor
LNCS Pdtx adhesive sensor
LNCS-Adtx disposable sensor | - | Different, same as secondary predicate device BeneVision N Series Patient Monitors (K213799) |

Page 13 of 19

{17}

mindray

Traditional 510(k): SV600, SV800 Ventilator

K243767

510(k) Summary

| Technical Characteristics | Subject device
SV600, SV800 Ventilator

**Shenzhen Mindray Bio-Medical Electronics Co., Ltd.**
(Subject device) | Primary predicate
SV600, SV800 Ventilator

**Shenzhen Mindray Bio-Medical Electronics Co., Ltd.**
(K220107) | Comments |
| --- | --- | --- | --- |
| | LNCS Adtx disposable sensor
LNCS Pdtx disposable sensor
LNCS DCI reusable sensor
LNCS DCIP reusable sensor
LNCS NeoPt disposable sensor
LNCS Neo disposable sensor
LNCS Inf disposable sensor
RD SET DCI, Adult Reusable Sensor
RD SET DCIP, Pediatric Reusable Sensor
RD Set TC-I SpO2 Reusable Tip-Clip Ear Sensor, 3ft
RD SET Adhesive Sensor
RD SET PDT Adhesive Sensor
RD Set Infant Adhesive Sensor
RD Set Neo Adhesive Sensor
RD Set NeoPt Adhesive Sensor
RD Set NeoPt-500 Non-adhesive sensor | | |
| SpO2 Measured parameters | Range: 1 to 100%
Accuracy:
70% to 100%:
Adult/Pediatric: ±2% (without motion)
Adult/Pediatric: ±3% (with motion)
Neonate: ±3%
1 to 69%: not declaration.
Low Perfusion (Pulse amplitude: >0.02%, Light penetration: >5%): Accuracy: ±2% | - | Different, same as secondary predicate device BeneVision N Series Patient Monitors (K213799) |
| PR Measured parameters | Range: 25 to 240 1/min
Accuracy: | - | Different, same as secondary predicate |

Page 14 of 19

{18}

mindray

Traditional 510(k): SV600, SV800 Ventilator

K243767

510(k) Summary

| Technical Characteristics | Subject device
SV600, SV800 Ventilator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
(Subject device) | Primary predicate
SV600, SV800 Ventilator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
(K220107) | Comments |
| --- | --- | --- | --- |
| | ±3 1/min (without motion)
±5 1/min (with motion) | | device BeneVision N
Series Patient Monitors
(K213799) |
| PI Measured parameters | Range: 0.02 to 20 % | - | Different, same as secondary predicate
device BeneVision N
Series Patient Monitors
(K213799) |
| **Specifications – Nellcor SpO₂ Module** | | | |
| Module | External 1-slot Nellcor SpO₂ module | - | Different, same as secondary predicate
device BeneVision N
Series Patient Monitors
(K213799) |
| Cable | 8-pin, SpO2 extension cable, 2.5m | - | Different, same as secondary predicate
device BeneVision N
Series Patient Monitors
(K213799) |
| SpO2 sensor | Reusable SpO2 sensor, finger-clip, Adult
Reusable Pediatric-Infant SpO2 sensor with wraps, Ped/Infant
Reusable Adult/neonatal SpO2 sensor, adhesive wraps, Adult/Neo
Nellcor MAX-A Disposable SpO2 sensor
Nellcor MAX-P Disposable SpO2 sensor
Nellcor MAX-I Disposable SpO2 sensor
Nellcor MAX-N Disposable SpO2 sensor
Nellcor reusable D-YS SpO2 sensor with wraps | - | Different, same as secondary predicate
device BeneVision N
Series Patient Monitors
(K213799) |
| SpO2 Measured parameters | Range: 0 to 100%
Accuracy: | - | Different, same as secondary predicate
device BeneVision N |

Page 15 of 19

{19}

mindray

Traditional 510(k): SV600, SV800 Ventilator

K243767

510(k) Summary

| Technical Characteristics | Subject device
SV600, SV800 Ventilator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
(Subject device) | Primary predicate
SV600, SV800 Ventilator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
(K220107) | Comments |
| --- | --- | --- | --- |
| | 70% to 100%: Adult/Pediatric: ±2%
Neonate: ±3%
0 to 69%: not declaration. | | Series Patient Monitors (K213799) |
| PR Measured parameters | Range: 20 to 300 1/min
Accuracy: 20 to 250 1/min, ±3 1/min;
251 to 300 1/min: No declaration | - | Different, same as secondary predicate device BeneVision N
Series Patient Monitors (K213799) |
| PI Measured parameters | no declaration | - | Different, same as secondary predicate device BeneVision N
Series Patient Monitors (K213799) |
| *WiFi module* | SX-SDMAC-2832S+ | - | Different, same as secondary predicate device BeneVision N
Series Patient Monitors (K213799) |
| “-” means not applicable. | | | |

In conclusion, the differences in technological characteristics do not raise new questions of safety and effectiveness.

## 7. PERFORMANCE DATA

To establish the substantial equivalence of the SV600 and SV800 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 and effective for the intended users, uses and use environments.

## Biocompatibility Testing

Biocompatibility testing of the SV600, SV800 Ventilator was performed using the following standards:

{20}

mindray

Traditional 510(k): SV600, SV800 Ventilator

K243767

510(k) Summary

- ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- ISO 10993-17 Second edition 2023-09 Biological evaluation of medical devices Part 17: Toxicological risk assessment of medical device constituents
- ISO 10993-18 Second edition 2020-01 Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
- ISO 18562-1 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
- ISO 18562-2 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
- ISO 18562-3 First edition 2017-03 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

EMC and Electrical Safety testing was performed using the following standards::

- IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 MOD) [Including Amendment 2 (2021)]
- IEC 60601-1-2 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and

Page 17 of 19

{21}

mindray

Traditional 510(k): SV600, SV800 Ventilator

K243767

510(k) Summary

essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

- IEEE ANSI USEMCSC C63.27-2021 American National Standard for Evaluation of Wireless Coexistence
- IEC/TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
- 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 2.2 2020-07 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

## Bench Testing

To establish the substantial equivalence of the SV600 and SV800 Ventilators, Mindray 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 demonstrated device performance using the following 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 2.2 2020-07 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

Page 18 of 19

{22}

mindray

Traditional 510(k): SV600, SV800 Ventilator

K243767

510(k) Summary

- 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
- ASTM F1100-90 (Reapproved 1997) Standard Specification for Ventilator Intended for Use in Critical Care (only Endurance Testing)

## 8. CONCLUSION

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.

Page 19 of 19