(267 days)
No
The summary describes a mechanical anesthetic vaporizer with no mention of AI or ML capabilities. The testing focuses on functional performance, safety, and equivalence to a predicate device.
No
The device, an anesthetic vaporizer, delivers desflurane vapor to enrich fresh gas flow in an anesthesia system, which is a supportive function in a medical procedure but does not directly treat a disease or condition itself.
No
Explanation: The V80 Anesthetic Vaporizer is used to deliver anesthesia by enriching fresh gas flow with desflurane vapor; it is not described as assessing a patient's condition or diagnosing a disease.
No
The device description and testing sections clearly indicate this is a hardware device (anesthetic vaporizer) with associated software, not a software-only device.
Based on the provided information, the V80 Anesthetic Vaporizer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to "enrich the fresh gas flow of an anesthesia delivery system with controllable desflurane vapour." This describes a device used in vivo (on a living organism) to deliver medication, not a device used in vitro (outside the body) to examine specimens.
- Device Description: The description reinforces this by stating it "is used to provide desflurane vapour with controllable concentration."
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD device, such as analyzing biological samples (blood, urine, tissue), detecting analytes, or providing diagnostic information based on laboratory tests.
The V80 Anesthetic Vaporizer is a medical device used in the delivery of anesthesia to a patient.
N/A
Intended Use / Indications for Use
V80 Anesthetic Vaporizer is used to enrich the fresh gas flow of an anesthesia delivery system with controllable desflurane vapour.
V80 Anesthetic Vaporizer is intended to be operated only by licensed clinicians and qualified anesthesia personnel who have received adequate training in its use. Anyone unauthorized or untrained must not perform any operation on the anesthetic vaporizer.
V80 Anesthetic Vaporizer cannot be used in mobile vehicles, airplanes, helicopters or ships.
V80 Anesthetic Vaporizer is not suitable for use in an MRI environment.
Product codes
CAD
Device Description
V80 Anesthetic Vaporizer is used to provide desflurane vapour with controllable concentration.
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
Not Found
Intended User / Care Setting
licensed clinicians and qualified anesthesia personnel who have received adequate training in its use.
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)
To establish the substantial equivalence of the V80 Anesthetic Vaporizer, 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.
Biocompatibility Testing:
V80 Anesthetic Vaporizer is categorized as externally communicating, indirect contact with tissue, limited contact duration (≤24 hours).
The biocompatibility tests performed on the subject device including Particulate matter test (ISO 18562-2:2017), Volatile organic compounds (VOCs) test (ISO 18562-3:2017) and Inorganic gases test.
The V80 Anesthetic Vaporizer was assessed for conformity with the relevant requirements of the following standards and found to comply:
- ISO 10993-1 Fifth Edition 2018-08 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 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" Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff". Verification of the V80 Anesthetic Vaporizer was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product.
The level of concern for the V80 Anesthetic Vaporizer software was determined to be Major in that the Software Device is a life-sustaining device that provides vital signs monitoring and alarms for potentially life-threatening situations for which medical intervention is necessary.
The V80 Anesthetic Vaporizer consists of the following two software subcomponents:
-
- Control subsystem
-
- Protection subsystem
Electromagnetic Compatibility and Electrical Safety:
The V80 Anesthetic Vaporizer was assessed for conformity with the relevant requirements of the following standards and found to comply:
- IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION (edition 3.2) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- ANSI AAMI IEC ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & 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 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-6 Edition 3.2 2020-07 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
- 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
Bench Testing:
To establish the substantial equivalence of the V80 Anesthetic Vaporizer, Mindray conducted functional and system level testing on the device. 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.
- ISO 80601-2-13 First edition 2011-08-11 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015) and Amendment 2 (2018)]
- ISO 5360 Fourth edition 2016-02-15 Anaesthetic vaporizers - Agent specific filling systems
Shelf life:
No shelf life is claimed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 868.5880 Anesthetic vaporizer.
(a)
Identification. An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 31, 2024
Shenzhen Mindray Bio-Medical Electronics Co., LTD. Yanhong Bai Manager Regulatory Affairs Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen, Guangdong 518057 China
Re: K240375
Trade/Device Name: V80 Anesthetic Vaporizer (V80) Regulation Number: 21 CFR 868.5880 Regulation Name: Anesthetic Vaporizer Regulatory Class: Class II Product Code: CAD Dated: September 30, 2024 Received: September 30, 2024
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 (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.
1
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 (OS) 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 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-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 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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/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,
Bradley Q. Quinn -S
Bradley Quinn Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240375
Device Name V80 Anesthetic Vaporizer
Indications for Use (Describe)
V80 Anesthetic Vaporizer is used to enrich the fresh gas flow of an anesthesia delivery system with controllable desflurane vapour.
V80 Anesthetic Vaporizer is intended to be operated only by licensed clinicians and qualified anesthesia personnel who have received adequate training in its use. Anyone unauthorized or untrained must not perform any operation on the anesthetic vaporizer.
V80 Anesthetic Vaporizer cannot be used in mobile vehicles, airplanes, helicopters or ships.
V80 Anesthetic Vaporizer is not suitable for use in an MRI environment.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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 V80 Anesthetic Vaporizer 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 Bai
Title: Manager Regulatory Affairs
Phone: +86 755 81885635
Fax: +86 755 26582680
E-mail: baiyanhong@mindray.com | |
| Date Prepared: | Oct 30, 2024 | |
| 2. DEVICE | | |
| Device Trade Name: | V80 Anesthetic Vaporizer | |
| Device Common Name: | Vaporizer, Anesthesia, Non-heated | |
| Classification Name: | 21 CFR 868.5880, Class II, Anesthetic Vaporizer | |
| Regulatory Class: | Class II | |
| Primary Product Code: | CAD | |
3. PREDICATE DEVICES
Primary predicate:
- . K042276 – D-Vapor Anesthetic Vaporizer, Draeger Medical AG & Co KGaA
5
4. REFERENCE DEVICES
- . K000275 – DATEX-OHMEDA TEC 6 PLUS ANESTHETIC VAPORIZER, DATEXOHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA, DATEX-OHMEDA, INC.
- K150167 -V60 Anesthetic Vaporizer, SHENZHEN MINDRAY BIO-MEDICAL . ELECTRONICS CO., LTD.
- 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.
5. DEVICE DESCRIPTION
V80 Anesthetic Vaporizer is used to provide desflurane vapour with controllable concentration.
6. INTENDED USE/INDICATIONS FOR USE
V80 Anesthetic Vaporizer is used to enrich the fresh gas flow of an anesthesia delivery system with controllable desflurane vapour.
V80 Anesthetic Vaporizer is intended to be operated only by licensed clinicians and qualified anesthesia personnel who have received adequate training in its use. Anyone unauthorized or untrained must not perform any operation on the anesthetic vaporizer.
V80 Anesthetic Vaporizer cannot be used in mobile vehicles, airplanes, helicopters or ships.
V80 Anesthetic Vaporizer is not suitable for use in an MRI environment.
7. SUBSTANTIAL EQUIVALENCE
Comparison of Indications
Comparing with the primary predicate D-Vapor Anesthetic Vaporizer (K042276), the indications for use for the subject device V80 Anesthetic Vaporizer is the same.
Comparison of Technological Characteristics
The table below compares the technology characteristics and performance specifications of the subject device V80 Anesthetic Vaporizer to the predicate D-Vapor Anesthetic Vaporizer (K042276).
6
| Technical Characteristics | Technical Characteristics | Subject device
V80 Anesthetic Vaporizer | Primary predicate
D-Vapor Anesthetic Vaporizer |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Shenzhen Mindray Bio-Medical
Electronics Co., Ltd.
(Subject device) | D-Vapor Anesthetic Vaporizer,
Draeger Medical AG & Co
(K042276) |
| Performance | | | |
| Control
parameter | Concentration
setting range | 2vol.% to 18 vol.% | 2vol.% to 18 vol.% |
| | Calibrated setting
concentration | ±0.5vol.% or ±15%rel, the larger
value applies in each case | ±0.5vol.% or ±15%rel, the larger
value applies in each case |
| | Other setting
concentration | ±0.9Vol.% or ±30% rel, which is
greater (at 0.2 to 2L/min);
±0.9Vol.% or ±20% rel, which is
greater (at 2 to 8L/min):
±0.9Vol.% or ±30% rel, which is
greater (at 8 to 15L/min); | ±0.9Vol.% or ±30% rel, which is
greater (at 0.2 to 2L/min);
±0.9Vol.% or ±20% rel, which is
greater (at 2 to 8L/min);
±0.9Vol.% or ±30% rel, which is
greater (at 8 to 15L/min); |
| Flow range | | 0.2 to 15L/min | 0.2 to 15L/min |
| Maximum tilt angle during working | | 10° | 10° |
| Warm-up time at 22 °C | | within 6 min | within 6 min |
| User interface | | | |
| Display Panel | Indicator | Operational | Operational |
| | | No Output | No Output |
| | | Delivery Low | Delivery Low |
| | | Fill Up | Fill Up |
| | | Battery | Battery |
| | Glass tube liquid
level indicator | A sight glass on the front of the
device to visually indicate the
level of agent | A sight glass on the front of the
device to visually indicate the
level of agent |
| | Audio Paused | 120s | 120s |
| Connection to anesthesia delivery system | | | |
| Connection to anesthesia delivery
system | | Selectatec®-compatible plug-in
connectors | Selectatec®-compatible plug-in
connectors |
| Filling system | | | |
| Filling system | | Saf-T-Fill™ | Saf-T-Fill™ |
| Filling volume | | Total:320 mL | Total:300 mL |
| Anesthetic agent loss (24 hours in
storage) | | ≤0.5mL(22°C) | ≤0.5mL(22°C) |
| Anesthetic agent loss (24 hours in
work) | | ≤2.5mL(22°C) | ≤2.5mL(22°C) |
| Technical Characteristics | Subject device
V80 Anesthetic Vaporizer
Shenzhen Mindray Bio-Medical
Electronics Co., Ltd.
(Subject device) | Primary predicate
D-Vapor Anesthetic Vaporizer | |
| Filling time
for one
anesthetic
agent bottle of
Desflurane
(240 mL) | At 22 °C and with
the Vapor not yet
warmed up |