LTV2 Series Ventilators

K201082 · Vyaire Medical, Inc. · CBK · Nov 10, 2021 · Anesthesiology

Device Facts

• Record ID: K201082
• Device Name: LTV2 Series Ventilators
• Applicant: Vyaire Medical, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Nov 10, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

LTV2 model 2200 and 2150 ventilators are intended to provide continuous or intermittent ventilator support for the care of the individuals who require mechanical ventilation. The use of environment is for institutional use includes ICU or other hospital environments including intra-hospital transport. The model 2200 can operate with high pressure O2. The model 2150 operates with low pressure oxygen.

Device Story

LTV2 Series Ventilators (models 2200 and 2150) provide continuous or intermittent mechanical ventilation for adult and pediatric patients (≥10 kg). The device uses a touch-turn-touch interface on an LED display to manage ventilation settings, including volume control, pressure control, pressure support, and spontaneous breath types. It features an ultra-sensitive flow trigger to assist with weaning. The model 2200 supports high-pressure O2, while the 2150 supports low-pressure O2. Used in institutional settings (ICU, hospital transport) by trained clinicians. The device mechanically controls breathing gas delivery to support or assist patient respiration. Output includes real-time ventilation parameters and waveforms, enabling clinicians to monitor and adjust therapy to meet patient needs, potentially improving respiratory outcomes.

Clinical Evidence

No clinical studies were conducted. Substantial equivalence is supported by non-clinical bench testing, including electrical safety, mechanical testing, software verification and validation, and waveform verification.

Technological Characteristics

Positive pressure mechanical ventilator. Materials comply with ISO 10993-1. Features include touch-turn-touch LED interface, internal/optional removable battery, and high/low pressure O2 inlets. Connectivity includes VOXP (Ventilator Open XML Protocol). Standards met: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 62304 (software lifecycle), ISO 80601-2-12 (ventilator safety), and ISO 14971 (risk management).

Indications for Use

Indicated for adult and pediatric patients weighing at least 10 kg (22 lbs.) requiring invasive or non-invasive positive pressure ventilation. Supports Assist/Control, SIMV, CPAP, and NPPV modes. Intended for use in professional healthcare facilities, including intra-hospital transport, by qualified personnel under physician direction.

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

• LTV 1200 Ventilator (K060647)
• LTV 1100 Ventilator (K101643)

Reference Devices

• TBird Vela Ventilator (K032451)
• PALMTop PTV Models 8/10 (K070594)
• bellavista 1000/1000e (K183364)

Submission Summary (Full Text)

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Vyaire Medical Inc Colleen Watson Director, Regulatory Affairs 26125 N. Riverwoods Blvd. Mettawa. Illinois 60045

# Re: K201082

Trade/Device Name: LTV2 Series Ventilators Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous ventilator Regulatory Class: Class II Product Code: CBK Dated: November 5, 2021 Received: November 8, 2021

# Dear Colleen Watson:

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.

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Brandon Blakely, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory, and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K201082

Device Name

LTV2 Series Ventilator (LTV2 model 2200 and 2150)

Indications for Use (Describe)

LTV2 model 2200 and 2150 ventilators are intended to provide continuous or intermittent ventilator support for the care of the individuals who require mechanical ventilation. The use environment is for institutional use. Institutional use includes ICU or other hospital environments including intra-hospital transport. The model 2200 can operate with high pressure O2. The model 2150 operates with low pressure oxygen.

Type of Use (Select one or both, as applicable)

| <span style="font-size:120%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------------------------------------------------|
| <span style="font-size:120%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the "Vyaire Medical" logo. The logo features a stylized graphic on the left, consisting of overlapping red and blue shapes. To the right of the graphic is the company name, "Vyaire," in a bold, dark blue font, with the trademark symbol (™) next to it. Below "Vyaire" is the word "MEDICAL" in a smaller, lighter font.

### Summary of Safety and Effectiveness

510k summary complying with 21 CFR 807.92.

## 1. SUBMITTER [21 CFR § 807.92(a)]

VYAIRE MEDICAL INC. 26125 North Riverwoods Blvd. Mettawa, IL 60045. USA

Colleen Watson. MSc. RAC. Contact Person: Alternate Contact Person: Jayme Yamaguchi-Owens

Date Prepared: November 10, 2021

# 2. Device [21 CFR § 807.92(a)(2)]

| Product Name: | LTV2 Series Ventilator (LTV2 model 2200 and 2150) |
|----------------------|-------------------------------------------------------|
| Device Name: | Ventilator, Continuous |
| Common Name: | Continuous or intermittent Ventilator |
| Classification Name: | Ventilator, continuous, facility use (21CFR 868.5895) |
| Regulatory Class: | II |
| Product Code: | CBK |

#### 3. Predicate Device [21 CFR § 807.92(a)(3)]

This submission demonstrates substantial equivalence to the LTV 1200 Ventilator K060647 cleared on May 25th, 2006 and LTV 1100 cleared under K101643 on January 26th, 2011.

| Predicate Device Information | | | |
|------------------------------|----------------------------------------------------|---------------|-----------------|
| Predicate Device | Manufacturer | 510(k) Number | Cleared Device |
| LTV 1200 Ventilator | Pulmonetic Systems, Inc.<br>(Vyaire Medical, Inc.) | K060647 | 25 May 2006 |
| LTV 1100 Ventilator | Carefusion (Vyaire<br>Medical, Inc.) | K101643 | 26 January 2011 |

# Table 1: Predicate Device Information

# Table 2: Reference Device Information

Reference Device Information

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Image /page/4/Picture/0 description: The image shows the Vyaire Medical logo. The logo consists of a stylized letter "V" in blue, followed by the word "Vyaire" in a dark blue sans-serif font. Below the word "Vyaire" is the word "MEDICAL" in a smaller, red sans-serif font. To the left of the letter "V" are two overlapping circles, one red and one blue.

| Predicate Device | Manufacturer | 510(k) Number | Cleared Device |
|----------------------------|--------------------------------------------------------|---------------|-------------------|
| TBird Vela Ventilator | Bird Product Corporation<br>(Vyaire Medical, Inc.) | K032451 | 17 March 2004 |
| PALMTop PTV Models<br>8/10 | Pulmonetic Systems, Inc.<br>(Vyaire Medical, Inc.) | K070594 | 01 August 2007 |
| bellavista 1000/1000e | Imtmedical AG<br>Gewerbestrasse 8<br>Buchs Sg, CH 9470 | K183364 | 13 September 2019 |

#### Device Description [21 CFR § 807.92(a)(4)] 4.

The LTV2 Series ventilator supports adult and pediatric patients weighing at least 10 kg (22 lb) in professional healthcare facilities response with invasive or noninvasive ventilation presets. These settings can be easily refined using the touch-turn-touch interface on the LED display. The ventilator also provides a wide range of ventilation therapies to meet demanding patient needs, including volume control, pressure control, pressure support and spontaneous breath types. Combined with the spontaneous breathing trial function, the ultra-sensitive flow trigger facilitates weaning patients weighing at least 10 kg (22lb).

#### Intended Use [21 CFR § 807.92(a)(5)] 5.

LTV2 model 2200 and 2150 ventilators are intended to provide continuous or intermittent ventilator support for the care of the individuals who require mechanical ventilation. The use of environment is for institutional use includes ICU or other hospital environments including intra-hospital transport. The model 2200 can operate with high pressure O2. The model 2150 operates with low pressure oxygen.

### Indication for use

TheLTV2 Series Ventilators are intended to provide continuous or intermittent ventilatory support for the care of the individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lbs.), who require the following types of ventilatory support:

- . Positive Pressure Ventilation, delivered invasively or non-invasively (via mask).
- . Assist/Control, SIMV, CPAP, and NPPV modes of ventilation.

The ventilator is suitable for use in professional healthcare facilities, including during intrahospital transport.

#### 6. Summary of Substantial Equivalence [21 CFR § 807.92(a)(6)]

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Image /page/5/Picture/0 description: The image shows the logo for Vyaire Medical. The logo consists of two overlapping circles, one red and one blue, followed by the word "Vyaire" in dark blue, with the letters connected in a stylized font. Below "Vyaire" is the word "MEDICAL" in a smaller, lighter font.

The fundamental scientific technology is the same for both proposed and predicate devices. It is based on mechanical control of breathing gas with a predetermined percentage of oxygen to provide control ventilation or to assist patient breathing. The LTV2 Series Ventilators are substantially equivalent to the predicate LTV1200 Ventilator and LTV 1100 regarding safety, design materials and intended use.

The proposed ventilator is designed to operate the same as the predicate devices. Successful test results (electrical safety testing, mechanical testing, software V&V, and waveform verification tests) ensured the proposed ventilator does not raise any different questions of safety and effectiveness. The table below outlines the similarities and differences between the device and predicate device.

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Image /page/6/Picture/0 description: The image shows the Vyaire Medical logo. The logo consists of two overlapping circles, one red and one blue, followed by the word "Vyaire" in a stylized, dark blue font. Below "Vyaire" is the word "MEDICAL" in smaller, light red letters.

| Element of<br>Comparison | Proposed Device<br>LTV2 Series<br>Ventilators<br>(LTV2 2150 & LTV2<br>2200) | Primary<br>Predicate Device<br>LTV 1200 - (K060647) | Secondary<br>Predicate Device<br>LTV 1100 - (K101643) | Discussion of<br>Differences |
|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Intended Use | Intended to provide<br>continuous or<br>intermittent ventilator<br>support for the care of<br>individuals who require<br>mechanical ventilation. | Intended to provide<br>continuous or intermittent<br>ventilator support for the care<br>of individuals who require<br>mechanical ventilation. | Intended to provide<br>continuous or intermittent<br>ventilator support for the<br>care of individuals who<br>require mechanical<br>ventilation. | Same |
| Indications for<br>Use | The LTV2 Series<br>Ventilators are intended<br>to provide continuous<br>or intermittent<br>ventilatory support for<br>the care of the<br>individuals who require<br>mechanical ventilation.<br>The ventilator is a<br>restricted medical<br>device intended for use<br>by qualified, trained<br>personnel under the<br>direction of a physician.<br>Specifically, the<br>ventilator is applicable<br>for adult and pediatric<br>patients weighing at<br>least 10kg (22 lbs.), who<br>require the following<br>types of ventilatory<br>support:<br>Positive Pressure<br>Ventilation,<br>delivered invasively<br>or non-invasively. Assist/Control,<br>SIMV, CPAP, and<br>NPPV modes of<br>ventilation. The ventilator is<br>suitable for use in<br>healthcare institutional<br>settings. | The LTV 1200 ventilator is<br>intended to provide<br>continuous or intermittent<br>ventilatory support for the<br>care of the individuals who<br>require mechanical<br>ventilation. The ventilator is a<br>restricted medical device<br>intended for use by qualified,<br>trained personnel under the<br>direction of a physician.<br>Specifically, the ventilator is<br>applicable for adult and<br>pediatric patients weighing at<br>least 5kg (11 lbs.), who<br>require the following types of<br>ventilatory support:<br>Positive Pressure<br>Ventilation, delivered<br>invasively (via ET tube) or<br>non-invasively (via mask). Assist/Control, SIMV,<br>CPAP, and NPPV modes<br>of ventilation. The ventilator is suitable for<br>use in institutional, home, or<br>transport settings. | The LTV 1100 ventilator is<br>intended to provide<br>continuous or intermittent<br>ventilatory support for the<br>care of the individuals who<br>require mechanical<br>ventilation. The ventilator<br>is a restricted medical<br>device intended for use by<br>qualified, trained<br>personnel under the<br>direction of a physician.<br>Specifically, the ventilator<br>is applicable for adult and<br>pediatric patients weighing<br>at least 5kg (11 lbs.), who<br>require the following types<br>of ventilatory support:<br>Positive Pressure<br>Ventilation, delivered<br>invasively (via ET<br>tube) or non-<br>invasively (via mask). Assist/Control, SIMV,<br>CPAP, and NPPV<br>modes of ventilation. The ventilator is suitable<br>for use in institutional,<br>home, or transport<br>settings. | Same |
| Element of<br>Comparison | Proposed Device<br>LTV2 Series<br>Ventilators<br>(LTV2 2150 & LTV2<br>2200) | Primary<br>Predicate Device<br>LTV 1200 - (K060647) | Secondary<br>Predicate Device<br>LTV 1100 - (K101643) | Discussion of<br>Differences |
| Principles of<br>Operation | Positive pressure<br>mechanical ventilator | Positive pressure mechanical<br>ventilator | Positive pressure<br>mechanical ventilator | Same |
| Patient<br>population | Targeted for adult and<br>pediatric patients<br>weighing at least 10kg<br>(22 lbs.). | Targeted for adult and<br>pediatric patients weighing at<br>least 5kg (11 Ibs.). | Targeted for adult and<br>pediatric patients weighing<br>at least 5kg (11 Ibs.). | Substantial<br>equivalent, increase<br>in lower weight<br>limit |
| Environment | The ventilator is<br>suitable for use in<br>healthcare institutional<br>settings. | The ventilator is suitable for<br>use in institutional, home, or<br>transport settings. | The ventilator is suitable<br>for use in institutional,<br>home, or transport<br>settings. | Substantial<br>equivalent for<br>healthcare<br>institutional<br>settings |
| Compatibility<br>with the<br>environment<br>and other<br>devices; | Storage:<br>Temperature: -20<br>degrees C without<br>relative humidity<br>control to + 60 degrees<br>C at 93% relative<br>humidity, non-<br>condensing. | Storage:<br>Temperature: -20 to<br>+60 degrees C.<br>Humidity: 10% to<br>95% Relative, non-<br>condensing | Storage:<br>Temperature: -20 to +60<br>degrees C. Humidity: 10%<br>to 95% Relative, non-<br>condensing | Substantial<br>equivalent,<br>designed and tested<br>to latest EMC<br>standards |
| | Operating:<br>Temperature:<br>+5 to +40<br>degrees C<br>Humidity: 15%<br>to 95% non- | Operating:<br>Temperature: +5 to<br>+40 degrees C<br>Humidity: 15% to<br>95% non-condensing | Operating:<br>Temperature: +5 to +40<br>degrees C<br>Humidity: 15% to 95%<br>non-condensing | |
| | condensing<br>EMC:<br>IEC 60601-1-2<br>Issue<br>2007/03/30<br>Edition 3 class<br>B for Emissions,<br>Immunity for<br>Life Supporting<br>Equipment | EMC:<br>60601-1-2<br>IEC:2001(E)<br>Sound level: | EMC:<br>60601-1-2 IEC:2001(E)<br>Sound level: | |
| | Sound level:<br>Not exceed 55<br>dBA (RMS) at<br>one meter | Not exceed 50 dBA<br>(RMS) at one meter | Not exceed 50 dBA (RMS)<br>at one meter | |
| Electrical<br>safety | Class II<br>Type BF | Class II<br>Type BF | Class II<br>Type BF | Same |
| Battery | Internal battery<br>Removable battery<br>optional | Internal battery: lower panel<br>door access for trained service<br>technician. | Internal battery: lower<br>panel door access for<br>trained service technician. | Substantial<br>equivalent |
| Element of<br>Comparison | Proposed Device<br>LTV2 Series<br>Ventilators<br>(LTV2 2150 & LTV2<br>2200) | Primary<br>Predicate Device<br>LTV 1200 - (K060647) | Secondary<br>Predicate Device<br>LTV 1100 - (K101643) | Discussion of<br>Differences |
| Internal<br>PEEP/PEEP<br>Compensation | Range: 0-20 cmH2O ± 1<br>cmH2O or 10%,<br>whichever is greater,<br>within 3 breaths.<br>(Mechanical/pneumatic<br>control) | Range: 0-20 cmH2O ± 1<br>cmH2O or 10%, whichever is<br>greater, within 3 breaths.<br>(Mechanical/pneumatic<br>control) | Range: 0-20 cmH2O ± 1<br>cmH2O or 10%, whichever<br>is greater, within 3<br>breaths.<br>(Mechanical/pneumatic<br>control) | Same |
| Bias Flow | Off or 5 to 15 LPM in<br>increments of 1 LPM. | Off or 10 LPM 10% or 1 LPM,<br>whichever is greater | Off or 10 LPM 10% or 1<br>LPM, whichever is greater | Substantially<br>Equivalent<br>(Reference device<br>K032451, K070594) |
| Ventilation<br>Mode | Control Mode<br>Assist/Control Mode<br>SIMV Mode<br>CPAP<br>NPPV<br>Apnea Backup | Control Mode<br>Assist/Control Mode<br>SIMV Mode<br>CPAP<br>NPPV<br>Apnea Backup | Control Mode<br>Assist/Control Mode<br>SIMV Mode<br>CPAP<br>NPPV<br>Apnea Backup | Same |
| Breath types | Pressure Control<br>Volume Control<br>Pressure Support<br>Spontaneous | Pressure Control<br>Volume Control<br>Pressure Support<br>Spontaneous | Volume Control<br>Pressure Support<br>Spontaneous | Same as predicate |
| Breath rate | 0-80 BPM | 0-80 BPM | 0-80 BPM | Same |
| Tidal volume | 50-2,000 mL | 50-2,000 mL | 50-2,000 mL | Same |
| Inspiratory<br>time | 0.3 - 9.9 seconds | 0.3-9.9 sec | 0.3-9.9 sec | Same |
| Pressure<br>control | 4 – 98 cmH20<br>(assist/Control &<br>SIMV/CPAP)<br>Off - 60 cmH2O (NPPV) | 1-99 cmH2O | Pressure control not<br>present | Substantially<br>equivalent |
| Pressure<br>support | 1-60 cmH2O | 1-60 cmH2O | 1-60 cmH2O | Same |
| Sensitivity | Off, 1-9 LPM | Off, 1-9 LPM | Off, 1-9 LPM | Same |
| 02% | 21–100% (LTV2200);<br>oxygen bleed flow (LTV<br>2150 and LTV 2200) | 21-100%; oxygen bleed flow | oxygen bleed flow% | Same as predicate |
| O2 flush | 1-3 min (LTV 2200 only) | 1-3 min…