(139 days)
Not Found
No
The description mentions a microprocessor for software control of the heating element, but there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
Yes
The device adds humidity and heat to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance, and this function provides therapeutic benefit to the patient.
No
The device is a heated humidifier used to warm and humidify gases delivered to patients requiring breathing assistance. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it consists of an electrically powered heat controlled with a microprocessor and includes components like a heating element, breathing tubes, and a passive electrical adaptor, indicating it is a hardware device with software control.
Based on the provided text, the inspired™ VHB20 Heated Humidifier is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance or general medical gases." This describes a device used to treat or support a patient's breathing, not to perform tests on samples taken from the body.
- Device Description: The description details a device that heats and humidifies breathing gases and delivers them to the patient via breathing tubes. This aligns with a respiratory support device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or diagnostic testing in the provided text.
Therefore, the inspired™ VHB20 Heated Humidifier is a medical device used for respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The inspired™ VHB20 Heated Humidifier is intended to be used to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance or general medical gases.
The inspired TM VHB20 Heated Humidifier is indicated for use by trained personnel only within a hospital/institutional environment. It is compatible with the Fisher and Paykel MR290 Humidification Chamber (Single Use), RT380 Dual Heated Breathing Circuit and RT265 Dual Heated Infant Breathing Circuit.
Product codes
BTT
Device Description
The subject device, inspired™ VHB20 Heated Humidifier, is indicated to add humidity and heat to the breathing gasses delivered to patients requiring mechanical ventilation or positive pressure breathing assistance.
It consists of an electrically powered heat controlled with a microprocessor to provide software control of the heating element that transfers heat to the water in a chamber.
Breathing tubes enable the humidified gas to be transported to the patient which may also be electrically heated (if connected), by means of a heater-wire placed internally to the tubes, to minimize the loss of humidity. A passive electrical adaptor provides electrical energy from the humidifier to the heater-wire in the breathing circuit. Over-current protection is provided by the SMPS inside the inspired™ VHB20 Heated Humidifier, which incorporates an over-current protection that will be triggered (cut-out) if output power of the SMPS reaches 110% of the rating (100W). The SMPS will recover automatically after fault condition is removed, while the humidifier will restart. This safety feature protects the humidifier from short-circuits in the DC part of the circuit, and prevents voltage and current transients on the heater-wire.
The inspired™ VHB20 Heated Humidifier provides heated and humidified gas with flow rates of 5 to 60 lpm (invasive) and 5 to 120 lpm (non-invasive).
The inspired™ VHB20 Heated Humidifier is a mains powered device that complies with ES60601-1, IEC 60601-1-2, ISO 80601-2-74 and AIM 7351731.
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
Infant to adult patients.
Intended User / Care Setting
trained personnel only within a hospital/institutional environment.
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)
Bench testing was performed to demonstrate:
- Temperature and humidification performance at various flow and temperature settings.
- Electrical safety and EMC.
- Software verification and Validation.
The test results met the applicable standards and are similar to the reported performance of the predicate device.
Biocompatibility testing was performed according to ISO 10993 and ISO 18562. The subject materials were found to meet the applicable requirements for biocompatibility safety for the intended population.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K073706 - Fisher & Paykel MR850 Respiratory Humidifier
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(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 and 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.
December 21, 2022
Vincent Healthcare Products Limited % Paul Dryden Consultant ProMedic Consulting LLC 131 Bay Point Dr NE Saint Petersburg, Florida 33704
Re: K222351
Trade/Device Name: inspired™ VHB20 Heated Humidifier Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory gas humidifier Regulatory Class: Class II Product Code: BTT Dated: August 3, 2022 Received: August 4, 2022
Dear Paul Dryden:
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 Lee, Ph.D. Division 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) K222351
Device Name inspired™ VHB20 Heated Humidifier
Indications for Use (Describe)
The inspired™ VHB20 Heated Humidifier is intended to be used to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance or general medical gases.
The inspired TM VHB20 Heated Humidifier is indicated for use by trained personnel only within a hospital/institutional environment. It is compatible with the Fisher and Paykel MR290 Humidification Chamber (Single Use), RT380 Dual Heated Breathing Circuit and RT265 Dual Heated Infant Breathing Circuit.
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 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) Summarv Page 1 of 6
| Date Prepared: | 19-Dec-22 |
|---|---|
| Vincent Healthcare Products Limited | |
| Flat/RM B2, 7/F., Hang Fung Industrial Building, Phase 2, 2G Hok Yuen Street | |
| Hung Hom, Kowloon Hong Kong | |
| Official Contact: | Patrick Dennis, QA/RA Supervisor |
| Submission Correspondent: | Paul Dryden |
| ProMedic, LLC | |
| 131 Bay Point Dr NE | |
| St. Petersburg, FL 33704 | |
| Proprietary or Trade Name: | inspired™ VHB20 Heated Humidifier |
| Common/Usual Name: | Respiratory gas humidifier |
| Classification Name: | 21CFR 868.5450 |
| Product Code: | BTT |
| Predicate Device: | K073706 - Fisher & Paykel MR850 Respiratory |
| Humidifier | |
| Common/Usual Name: | Respiratory gas humidifier |
| Classification Name: | 21CFR 868.5450 |
| Product Code: | BTT |
Device Description:
The subject device, inspired™ VHB20 Heated Humidifier, is indicated to add humidity and heat to the breathing gasses delivered to patients requiring mechanical ventilation or positive pressure breathing assistance.
It consists of an electrically powered heat controlled with a microprocessor to provide software control of the heating element that transfers heat to the water in a chamber.
Breathing tubes enable the humidified gas to be transported to the patient which may also be electrically heated (if connected), by means of a heater-wire placed internally to the tubes, to minimize the loss of humidity. A passive electrical adaptor provides electrical energy from the humidifier to the heater-wire in the breathing circuit. Over-current protection is provided by the SMPS inside the inspired™ VHB20 Heated Humidifier, which incorporates an over-current protection that will be triggered (cut-out) if output power of the SMPS reaches 110% of the rating (100W). The SMPS will recover automatically after fault condition is removed, while the humidifier will restart. This safety feature protects the humidifier from short-circuits in the DC part of the circuit, and prevents voltage and current transients on the heater-wire.
The inspired™ VHB20 Heated Humidifier provides heated and humidified gas with flow rates of 5 to 60 lpm (invasive) and 5 to 120 lpm (non-invasive).
The inspired™ VHB20 Heated Humidifier is a mains powered device that complies with ES60601-1, IEC 60601-1-2, ISO 80601-2-74 and AIM 7351731.
4
Principle of Operation:
The inspired™ VHB20 Heated Humidifier is a respiratory humidifier that provides a heat source and temperature control to warm a water container, referred as a water chamber, to heat and humidify dry respiratory gases.
Indications for Use:
The inspired™ VHB20 Heated Humidifier is intended to be used to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance or general medical gases.
The inspired™ VHB20 Heated Humidifier is indicated for use by trained personnel only within a hospital/institutional environment. It is compatible with the Fisher and Paykel MR290 Humidification Chamber (Single Use), RT380 Dual Heated Breathing Circuit and RT265 Dual Heated Infant Breathing Circuit.
Patient Population:
Infant to adult patients.
Environments of use:
Hospital/institutional environment
We present the proposed device vs. the predicate in Table 1.
As part of the comparison we will present and discuss the:
- Indications for Use ●
- . Technology and Principle of Operation
- Performance and Specifications .
5
510(k) Summary Page 3 of 6
Table 1 - Comparison - Subject vs. Predicate
| 510(k) Number | Subject Device | K073706 Predicate | Comment |
|---|---|---|---|
| Device Name | Vincent Medical inspiredTM VHB20 Heated Humidifier | Fisher & Paykel MR850 Respiratory Humidifier | |
| Classification No. & Product code | 868.5450 / BTT | 868.5450 / BTT | Similar |
| Indications for Use | The inspiredTM VHB20 Heated Humidifier is intended to be used | ||
| to warm and add humidity to gases delivered to patients requiring | |||
| mechanical ventilation or positive pressure breathing assistance or | |||
| general medical gases. | The Fisher & Paykel Healthcare MR850 humidifier is intended | ||
| to be used to warm and add humidity to gases delivered to | |||
| patients requiring mechanical ventilation or positive pressure | |||
| breathing assistance or general medical gases. | Similar | ||
| The inspiredTM VHB20 Heated Humidifier is indicated for use by | |||
| trained personnel only within a hospital/institutional environment. | |||
| It is compatible with the Fisher and Paykel MR290 | |||
| Humidification Chamber (Single Use), RT380 Dual Heated | |||
| Breathing Circuit and RT265 Dual Heated Infant Breathing | |||
| Circuit. | |||
| Principle of operation | The device has two heating control units and two temperature | ||
| sensors respectively. Water within a humidification chamber is | |||
| heated by the device's heating plate and this temperature is | |||
| controlled by the device with the use of temperature probes. Dry | |||
| medical gases passing through the chamber gain increased humidity | |||
| and heat. The heater wire adaptor supplies current to heater wires | |||
| within breathing tubes that maintain gas temperature travelling to | |||
| patient. Temperature probes measurement temperature and device | |||
| controls chamber temperature to achieve desired gas warmth and | |||
| humidify for patient. | The device has two heating control units and two temperature | ||
| sensors respectively. Water within a humidification chamber is | |||
| heated by the device's heating plate and this temperature is | |||
| controlled by the device with the use of temperature probes. Dry | |||
| medical gases passing through the chamber gain increased | |||
| humidity and heat. The heater wire adaptor supplies current to | |||
| heater wires within breathing tubes that maintain gas temperature | |||
| travelling to patient. Temperature probes measurement | |||
| temperature and device controls chamber temperature to achieve | |||
| desired gas warmth and humidify for patient. | Similar | ||
| Components | The device consists of VHB20 Heated Humidifier, Heater wire | ||
| adaptor and Temperature-humidity data/sensor cable. | The device consists of MR850 Respiratory Humidifier, Heater | ||
| wire adaptor and Temperature probe. | Similar | ||
| Electrical Protection Classification | Class I | Class I | Similar |
| Applied part | Type BF | Type BF | Similar |
| Drip proof | IPX1 | IPX1 | Similar |
| Target population | Infant to adult | Any patient requiring active humidification | Similar |
| Heating Method | Pass over | Pass over | Similar |
| Dimensions (H x D x W) | 159mm x 204mm x 150mm | 140mm × 173mm × 135mm | Similar |
| Weight (without humidification | |||
| chamber) | 1.9kg | 2.8kg | Similar |
| Supply voltage | 110 - 127V | 115V | Similar |
| 510(k) Number | Subject Device | K073706 Predicate | Comment |
| Device Name | Vincent Medical inspired™ VHB20 Heated Humidifier | Fisher & Paykel MR850 Respiratory Humidifier | |
| Supply frequency | 50/60 Hz | 50/60 Hz | Similar |
| Supply current | 3.0A max at 110V | 2.0 A max at 115V | Similar |
| Heater plate power | 150W | 150 W | Similar |
| Heater plate over temperature | |||
| cutout (hardware) | $118 ± 7°C$ | $118 ± 6°C$ | Similar |
| Safety cutoff temperature | |||
| (software control) | $105°C$ | $110°C$ | Similar |
| Heater Wires power supply | 24VDC, 80VA | 22V~, 2.73A max, 60W, 50/60Hz | Similar |
| Temperature control settings | |||
| Airway | |||
| Invasive | Default: $39°C$ | Default: $40°C$ | Similar |
| Range: $35-40°C$ | Range: $35-40°C$ , (Versions 7.22) | ||
| Non-invasive | Default: $34°C$ | Default: $34°C$ | Similar |
| Range: $30-37°C$ | Range: $28-34°C$ , (Versions 7.22) | ||
| Chamber outlet | |||
| Invasive | Default: $36°C$ | Default: | Similar |
| Range: $35-43°C$ | Range: $35.5-42°C$ , (Versions 7.22) | ||
| Non-Invasive | Default: $31°C$ | Default: | Similar |
| Range: $30-32°C$ | Range: $31-36°C$ , (Versions 7.22) | ||
| Display | 2.8-inch - LCD display | 3 digit 14 mm - 7 segment LED | Similar |
| Display Range | 10 - 70°C | 10 - 70°C | Similar |
| Accuracy | $± 2°C$ | $± 0.3°C$ | Similar |
| (in 25 to $45°C$ temperature range) | |||
| Alarms | |||
| High temperature alarm | Invasive mode: Patient-side temperature exceeds $41°C$ | Invasive and Non-invasive mode: | Similar |
| Non-invasive mode: Patient-side temperature exceeds $38°C$ | Displayed temperature exceeds $41°C$ | ||
| or | |||
| Airway temperature exceeds $43°C$ | |||
| Invasive mode: Patient-side temperature 33mg/L | |||
| Non-Invasive - > 10 mg/L | Similar | ||
| Warm-up time | 30 days). We performed the applicable ISO 10993 and ISO 18562. |
Discussion - The subject materials were found to meet the applicable requirements for biocompatibility safety for the intended population.
Substantial Equivalence Conclusion
The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device predicate and reference have been found to substantially equivalent.