(150 days)
No
The document describes a traditional mechanical ventilator with standard modes, monitoring, and alarms. There is no mention of AI, ML, or any advanced algorithms that would suggest their use. The performance studies focus on verifying specifications against standards and requirements, not on evaluating the performance of AI/ML models.
Yes
The primary function of a ventilator is to provide ventilatory support for individuals who require mechanical ventilation, which directly affects a patient's physiological function (breathing) to treat an illness or condition. This clearly falls under the definition of a therapeutic device.
No.
The LTV1000 ventilator is described as a device that provides continuous or intermittent ventilatory support, which is a therapeutic function, not a diagnostic one. While it monitors various respiratory parameters (e.g., peak inspiratory pressure, minute volume), these are for managing the ventilation process, not for diagnosing a patient's medical condition.
No
The device description clearly outlines numerous hardware components including an internal flow generator, electromechanical inspiratory flow valve, oxygen blender, mechanical valves, and a patient circuit with an exhalation valve system, PEEP valve, and flow transducer. While software is mentioned as a component, the device is fundamentally a hardware-based ventilator.
Based on the provided information, the LTV1000 ventilator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for providing mechanical ventilatory support to individuals who require it. This involves directly interacting with the patient's respiratory system to assist with breathing.
- Device Description: The description details a mechanical ventilator that delivers pressurized gas to the patient, monitors respiratory parameters, and has features related to controlling breathing modes and alarms. This is consistent with a life support device used in vivo (within the living body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on biological samples outside of the body to provide diagnostic or other health-related information. The LTV1000 ventilator's function is to directly support a patient's breathing, which is an in vivo application.
N/A
Intended Use / Indications for Use
The LTV1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of 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 (via ET tube) or non-invasively (via mask).
- . Assist/Control, SIMV, or CPAP modes of ventilation.
The ventilator is suitable for use in institutional, home, and transport settings.
Product codes (comma separated list FDA assigned to the subject device)
CBK
Device Description
The LTV 1000 is a self-contained mechanical ventilator suitable for continuous life support in institutional, home, and transport settings. The ventilator is slightly larger than a "laptop computer" and is self-contained in that it can be operated without the need for externally supplied compressed air. The unit may be operated from external AC power through the use of an external AC/DC converter, or may be operated for approximately one hour using an internal rechargeable battery pack.
The following major features are included:
- . Modes: Assist/Control, SIMV, CPAP, Apnea Backup
- Breath Types: Volume Control, Pressure Control, Pressure Support, Spontaneous .
- . Flow Triggering
- . Oxygen Blending
- . PEEP
- Monitors: Calculated Peak Flow, Exhaled Tidal Volume, I:E Ratio, Mean Airway Pressure, Real . Time Airway Pressure, Peak inspiratory Pressure, PEEP, Total Breath Rate, Total Minute Volume
- . Alarms: Apnea, High Pressure Limit, Low Peak Pressure, Low Minute Volume, Disconnect, Low & Lost External Power, Low & Empty Internal Battery, Oxygen Inlet Pressure
The ventilator uses an internal flow generator to provide the pressurized gas source. All breath types are delivered by an electromechanical inspiratory flow valve. An oxygen blender meters oxygen as required to meet the current setting of the O2% control. Mechanical valves are provided internally for overpressure relief and sub-ambient relief functions.
The patient circuit is comprised of a single leg inspiratory tube connected to an exhalation system located proximal to the patient connection. The exhalation valve system will consist of a piloted exhalation valve, a PEEP valve, and a flow transducer combined in a compact package. Additional small bore tubing is included to transmit the flow, pressure and exhalation drive signals.
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
adult and pediatric patients weighing at least 10 kg (22 lbs)
Intended User / Care Setting
qualified, trained personnel under the direction of a physician; institutional, home, and transport settings.
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)
Non clinical test program to establish functional and technical equivalence. Validation activities included running test procedures written to validate the requirements as specified in:
- . System Specification
- . Software Requirements Specification
- . System Hazards Analysis
- ASTM F 1100-90 Standard Specification for Ventilators for Use in Critical Care
- ASTM F 1246-91 Standard Specification for Electrically Powered Home Care Ventilators .
Test procedures were divided into 3 primary categories:
- ASTM tests: Tests that verify the ventilator meets ASTM standards
- Performance Tests: Tests that verify the ventilator meets performance specifications including tolerance and accuracy issues.
- Functional Tests: Tests that verify the ventilator meets behavioral specifications (Primarily Software)
Test procedures were written for individual tests specifying: the requirement being tested, the number of units to be tested, the equipment to be used, test set-up instructions, the data to be recorded. Tests were written to test each parameter over the entire range of operation while varying other relevant parameters such as patient lung condition and environment. For example, the Set Tidal Volume function was tested over its entire range (50 - 2000 ml) and over worst case combinations of the following parameters:
- . Patient Compliance
- Patient Resistance
- . Temperature/Humidity of Patient breathing gas.
- Ventilator Operating Temperature.
A validation report was written that summarizes the results of these tests. The ventilator was found to perform to specifications with exceptions as noted in the validation report. If a parameter was found to be non-compliant, a procedure was described in the report to ensure the anomaly does not present a hazard to the patient or user.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 868.5895 Continuous ventilator.
(a)
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.(b)
Classification. Class II (performance standards).
0
510 K
SUBMITTER
Pulmonetic Systems, Inc 930 S. Mt. Vernon Ave. Suite 100 Colton, CA 92324-3928 Ph. (909) 783-2280 Fax (909) 783-2975 Douglas DeVries Contact Person: November 11, 1998 Date Prepared:
DEVICE NAME
| Trade Name: | LTV 1000 |
|---|---|
| Common Name: | Ventilator |
| Classification Name: | Ventilator, Continuous (Respirator) |
PREDICATE DEVICE
The primary predicate device is the TBird Homecare Ventilator (K981971), manufactured by Bird Products Corp. of Palm Springs, CA.
DESCRIPTION
The LTV1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home, and transport settings, and 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 (via ET tube) or non-invasively (via mask). .
- . Assist/Control, SIMV, or CPAP modes of ventilation.
- Breath types including Volume, Pressure Control, and Pressure Support .
1
The LTV 1000 is a self-contained mechanical ventilator suitable for continuous life support in institutional, home, and transport settings. The ventilator is slightly larger than a "laptop computer" and is self-contained in that it can be operated without the need for externally supplied compressed air. The unit may be operated from external AC power through the use of an external AC/DC converter, or may be operated for approximately one hour using an internal rechargeable battery pack.
The following major features are included:
- . Modes: Assist/Control, SIMV, CPAP, Apnea Backup
- Breath Types: Volume Control, Pressure Control, Pressure Support, Spontaneous .
- . Flow Triggering
- . Oxygen Blending
- . PEEP
- Monitors: Calculated Peak Flow, Exhaled Tidal Volume, I:E Ratio, Mean Airway Pressure, Real . Time Airway Pressure, Peak inspiratory Pressure, PEEP, Total Breath Rate, Total Minute Volume
- . Alarms: Apnea, High Pressure Limit, Low Peak Pressure, Low Minute Volume, Disconnect, Low & Lost External Power, Low & Empty Internal Battery, Oxygen Inlet Pressure
The ventilator uses an internal flow generator to provide the pressurized gas source. All breath types are delivered by an electromechanical inspiratory flow valve. An oxygen blender meters oxygen as required to meet the current setting of the O2% control. Mechanical valves are provided internally for overpressure relief and sub-ambient relief functions.
The patient circuit is comprised of a single leg inspiratory tube connected to an exhalation system located proximal to the patient connection. The exhalation valve system will consist of a piloted exhalation valve, a PEEP valve, and a flow transducer combined in a compact package. Additional small bore tubing is included to transmit the flow, pressure and exhalation drive signals.
INTENDED USE
The LTV1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of 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 (via ET tube) or non-invasively (via mask).
- . Assist/Control, SIMV, or CPAP modes of ventilation.
The ventilator is suitable for use in institutional, home, and transport settings.
2
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS TO THE PREDICATE DEVICE
The following table sets forth a comparison of the major technological characteristics of the TBird Ventilator (K981971), manufactured by Bird Products Corp. of Palm Springs, CA.
| Characteristic | LTV 1000 Vent | Predicate Device | Discussion of Differences and Similarities |
|---|---|---|---|
| Bird TBird Ventilator | |||
| (K981971) | |||
| Compressed Air Source | Internal, Flow Generator driven by a | ||
| brushless DC motor. | Internal, Flow Generator driven by a | ||
| brushless DC motor. | The flow generator is similar in that both devices use | ||
| a rotating element driven by a brushless DC motor. | |||
| The LTV differs in that the flow generator operates | |||
| at a constant speed and is not used to control the | |||
| beginning and end of inspiration as does the | |||
| predicate device. This constant speed operation is | |||
| equivalent to the operation of other ventilators, such | |||
| as the Quantum (K962517) mfg by Healthdyne | |||
| Technologies. | |||
| Inspiratory Flow Control | Variable poppet valve positioned by a | ||
| rotary actuator. | No separate valve, breath control is | ||
| effected through variable speed control | |||
| of the flow generator. | The rotary actuator driven flow control valve used | ||
| on the LTV 1000 is similar to flow valves used on | |||
| other currently marketed ventilators the Servo | |||
| Ventilator 900C ( K811102) mfg by Siemens. Even | |||
| though the 900C is not a home care ventilator, this | |||
| flow control method is approved for use in | |||
| comparable clinical settings. | |||
| Exhalation Valve | External Piloted balloon type. | Internal, diaphragm driven by a linear | |
| actuator. | The external piloted exhalation valve used on the | ||
| LTV 1000 is similar to types used on other currently | |||
| marketed ventilators, for example the Nellcor | |||
| Puritan Bennet LP 10 ventilator, (K905244). |
(
3
| Characteristic | LTV 1000 Vent | Predicate Device
Bird TBird Ventilator
(K981971) | Discussion of Differences and Similarities |
|------------------------|---------------------------------------------------------|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PEEP Valve | External, spring loaded diaphragm
type. | Internal, controlled by closed loop
control of the linear actuator. | The external spring loaded PEEP valve used on the
LTV 1000 is similar to types used on other currently
marketed ventilators, for example the Nellcor
Puritan Bennet LP 10 ventilator, (K905244). |
| Exhalation Flow Xducer | Differential Pressure Type, fixed
orifice. | Differential Pressure Type, variable
orifice. | Transducer is similar. |
| Control System | Microprocessor based analog and
digital electronics. | Microprocessor based analog and
digital electronics. | Control system is similar. |
| Package | Sheetmetal and thermoplastic
elastomer. | Sheetmetal, thermoplastic, and
thermoplastic elastomer. | The LTV 1000 employs a sheetmetal chassis,
protected by elastomeric side panels to provide
enhanced durability. |
| Displays | 7-segment, alpha-numeric, and single
lamp LEDs. | 7-segment, alpha-numeric, and single
lamp LEDs. | Displays are similar |
(
. .
.
(
4
NON-CLINICAL PERFORMANCE TESTING
Pursuant to establishing functional and technical equivalence to the predicate device, a non clinical test program was completed to insure that the device met its stated specifications. Validation activities included running test procedures written to validate the requirements as specified in the following documents:
- . System Specification
- . Software Requirements Specification
- . System Hazards Analysis
- ASTM F 1100-90 Standard Specification for Ventilators for Use in Critical Care
- ASTM F 1246-91 Standard Specification for Electrically Powered Home Care Ventilators .
The test procedures were divided into 3 primary categories:
| ASTM tests | Tests that verify the ventilator meets ASTM standards |
|---|---|
| Performance Tests | Tests that verify the ventilator meets performance specifications including |
| tolerance and accuracy issues. | |
| Functional Tests | Tests that verify the ventilator meets behavioral specifications (Primarily |
| Software) |
Test procedures were written for individual tests specifying: the requirement being tested, the number of units to be tested, the equipment to be used, test set-up instructions, the data to be recorded. In general, test procedures were written to test each parameter over the entire range of operation while varying other relevant parameters such as patient lung condition and environment. For example, the Set Tidal Volume function was tested over its entire range (50 - 2000 ml) and over worst case combinations of the following parameters:
- . Patient Compliance
- Patient Resistance
- . Temperature/Humidity of Patient breathing gas.
- Ventilator Operating Temperature.
A validation report was written that summarizes the results of these tests. The ventilator was found to perform to specifications with exceptions as noted in the validation report. If a parameter was found to be non-compliant, a procedure was described in the report to ensure the anomaly does not present a hazard to the patient or user.
CONCLUSION
The comparison analysis and validation test results demonstrate the device is substantially equivalent to the predicate device and appropriate for the intended use.
5
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three parallel lines that curve and taper to suggest feathers or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 1999
Mr. Douglas DeVries Chief Executive Officer Pulmonetic Systems 930 S. Mt. Vernon Avenue, Suite 100 Colton, CA 92324
Re: K984056 Trade Name: LTV 1000 Regulatory Class: II (two) Product Code: CBK Dated: February 18, 1999 Received: February 23, 1999
Dear Mr. DeVries:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If vour device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements
6
Page 2 - Mr. Douglas DeVries
concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Reqister, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the regulation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please not the regulation entitled, " Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities
7
Page 3 - Mr. Douglas DeVries
under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Athr A. Carlaw L.
/ . Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
STATEMENT OF INTENDED USE
The LTV1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of 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 (via ET tube) or non-invasively (via mask).
- . Assist/Control, SIMV, or CPAP modes of ventilation.
The ventilator is suitable for use in institutional, home, and transport settings.
Ath. A. Cizlowski.
Division Sign-Off) (Division of Cardiovascular, Respiratory, and Neurological Device 510(k) Number
Prescription Use X
(Per 21 CFR 801.109)