Who is the manufacturer of LTV2 Series Ventilators?

Vyaire Medical, Inc. filed the 510(k) submission for LTV2 Series Ventilators (K201082).

What is the FDA product code for LTV2 Series Ventilators?

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

What is the regulatory pathway for LTV2 Series Ventilators?

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

What are the predicate devices for LTV2 Series Ventilators?

LTV 1200 Ventilator (K060647); LTV 1100 Ventilator (K101643).

Who can help prepare an FDA 510(k) submission like LTV2 Series Ventilators?

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

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

Indications for 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)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable. 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 {1}------------------------------------------------ 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, 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 {2}------------------------------------------------ # 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) | ☑ 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}------------------------------------------------ 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. (Vyaire Medical, Inc.) | K060647 | 25 May 2006 | | LTV 1100 Ventilator | Carefusion (Vyaire Medical, Inc.) | K101643 | 26 January 2011 | # Table 1: Predicate Device Information # Table 2: Reference Device Information Reference Device Information {4}------------------------------------------------ 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 (Vyaire Medical, Inc.) | K032451 | 17 March 2004 | | PALMTop PTV Models 8/10 | Pulmonetic Systems, Inc. (Vyaire Medical, Inc.) | K070594 | 01 August 2007 | | bellavista 1000/1000e | Imtmedical AG Gewerbestrasse 8 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)] {5}------------------------------------------------ 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. {6}------------------------------------------------ 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 Comparison | Proposed Device LTV2 Series Ventilators (LTV2 2150 & LTV2 2200) | Primary Predicate Device LTV 1200 - (K060647) | Secondary Predicate Device LTV 1100 - (K101643) | Discussion of Differences | |-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | Intended Use | Intended to provide continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. | Intended to provide continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. | Intended to provide continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. | Same | | Indications for Use | The LTV2 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 10kg (22 lbs.), who require the following types of ventilatory support: Positive Pressure Ventilation, delivered invasively or non-invasively. Assist/Control, SIMV, CPAP, and NPPV modes of ventilation. The ventilator is suitable for use in healthcare institutional settings. | The LTV 1200 ventilator is 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 5kg (11 lbs.), who require the following types of ventilatory support: Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). Assist/Control, SIMV, CPAP, and NPPV modes of ventilation. The ventilator is suitable for use in institutional, home, or transport settings. | The LTV 1100 ventilator is 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 5kg (11 lbs.), who require the following types of ventilatory support: Positive Pressure Ventilation, delivered invasively (via ET tube) or non- invasively (via mask). Assist/Control, SIMV, CPAP, and NPPV modes of ventilation. The ventilator is suitable for use in institutional, home, or transport settings. | Same | | Element of Comparison | Proposed Device LTV2 Series Ventilators (LTV2 2150 & LTV2 2200) | Primary Predicate Device LTV 1200 - (K060647) | Secondary Predicate Device LTV 1100 - (K101643) | Discussion of Differences | | Principles of Operation | Positive pressure mechanical ventilator | Positive pressure mechanical ventilator | Positive pressure mechanical ventilator | Same | | Patient population | Targeted for adult and pediatric patients weighing at least 10kg (22 lbs.). | Targeted for adult and pediatric patients weighing at least 5kg (11 Ibs.). | Targeted for adult and pediatric patients weighing at least 5kg (11 Ibs.). | Substantial equivalent, increase in lower weight limit | | Environment | The ventilator is suitable for use in healthcare institutional settings. | The ventilator is suitable for use in institutional, home, or transport settings. | The ventilator is suitable for use in institutional, home, or transport settings. | Substantial equivalent for healthcare institutional settings | | Compatibility with the environment and other devices; | Storage: Temperature: -20 degrees C without relative humidity control to + 60 degrees C at 93% relative humidity, non- condensing. | Storage: Temperature: -20 to +60 degrees C. Humidity: 10% to 95% Relative, non- condensing | Storage: Temperature: -20 to +60 degrees C. Humidity: 10% to 95% Relative, non- condensing | Substantial equivalent, designed and tested to latest EMC standards | | | Operating: Temperature: +5 to +40 degrees C Humidity: 15% to 95% non- | Operating: Temperature: +5 to +40 degrees C Humidity: 15% to 95% non-condensing | Operating: Temperature: +5 to +40 degrees C Humidity: 15% to 95% non-condensing | | | | condensing EMC: IEC 60601-1-2 Issue 2007/03/30 Edition 3 class B for Emissions, Immunity for Life Supporting Equipment | EMC: 60601-1-2 IEC:2001(E) Sound level: | EMC: 60601-1-2 IEC:2001(E) Sound level: | | | | Sound level: Not exceed 55 dBA (RMS) at one meter | Not exceed 50 dBA (RMS) at one meter | Not exceed 50 dBA (RMS) at one meter | | | Electrical safety | Class II Type BF | Class II Type BF | Class II Type BF | Same | | Battery | Internal battery Removable battery optional | Internal battery: lower panel door access for trained service technician. | Internal battery: lower panel door access for trained service technician. | Substantial equivalent | | Element of Comparison | Proposed Device LTV2 Series Ventilators (LTV2 2150 & LTV2 2200) | Primary Predicate Device LTV 1200 - (K060647) | Secondary Predicate Device LTV 1100 - (K101643) | Discussion of Differences | | Internal PEEP/PEEP Compensation | Range: 0-20 cmH2O ± 1 cmH2O or 10%, whichever is greater, within 3 breaths. (Mechanical/pneumatic control) | Range: 0-20 cmH2O ± 1 cmH2O or 10%, whichever is greater, within 3 breaths. (Mechanical/pneumatic control) | Range: 0-20 cmH2O ± 1 cmH2O or 10%, whichever is greater, within 3 breaths. (Mechanical/pneumatic control) | Same | | Bias Flow | Off or 5 to 15 LPM in increments of 1 LPM. | Off or 10 LPM 10% or 1 LPM, whichever is greater | Off or 10 LPM 10% or 1 LPM, whichever is greater | Substantially Equivalent (Reference device K032451, K070594) | | Ventilation Mode | Control Mode Assist/Control Mode SIMV Mode CPAP NPPV Apnea Backup | Control Mode Assist/Control Mode SIMV Mode CPAP NPPV Apnea Backup | Control Mode Assist/Control Mode SIMV Mode CPAP NPPV Apnea Backup | Same | | Breath types | Pressure Control Volume Control Pressure Support Spontaneous | Pressure Control Volume Control Pressure Support Spontaneous | Volume Control Pressure Support 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 time | 0.3 - 9.9 seconds | 0.3-9.9 sec | 0.3-9.9 sec | Same | | Pressure control | 4 – 98 cmH20 (assist/Control & SIMV/CPAP) Off - 60 cmH2O (NPPV) | 1-99 cmH2O | Pressure control not present | Substantially equivalent | | Pressure 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); oxygen bleed flow (LTV 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…

LTV2 Series Ventilators

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Indications for Use

Device Story

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Technological Characteristics

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LTV2 Series Ventilators

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Indications for Use

Device Story

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Reference Devices

Submission Summary (Full Text)

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