(29 days)
No
The summary describes a standard ventilator with a new Spontaneous Breathing Trial (SBT) function, which is a clinical protocol, not an AI/ML technology. There are no mentions of AI, ML, or related concepts.
Yes
The device is a ventilator intended to provide continuous or intermittent ventilatory support, which directly treats or alleviates a medical condition (respiratory failure or inadequacy).
No
The device is a ventilator, which provides respiratory support, and its modification facilitates weaning from ventilation. It does not identify or diagnose a disease or condition.
No
The device description clearly identifies the LTV 1000 as a "ventilator," which is a hardware device that provides mechanical ventilation. The submission describes a software modification (SBT function) to an existing hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Function: The LTV 1000 ventilator is described as a device that provides "continuous or intermittent ventilatory support" for individuals requiring mechanical ventilation. This is a life-support device that directly interacts with the patient's respiratory system.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens (blood, tissue, etc.) from the patient. Its function is to deliver air and control breathing parameters.
Therefore, the LTV 1000 ventilator falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LTV 1000 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 5 kg (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, or CPAP modes of ventilation. ●
- Breath types including Volume, Pressure Control and Pressure Support. ●
The ventilator is suitable for use in institutional, home, or transport settings.
Product codes (comma separated list FDA assigned to the subject device)
CBK
Device Description
The LTV 1000 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 5 kg (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, or CPAP modes of ventilation.
- Breath types including Volume, Pressure Control and Pressure Support. .
The modification intended to be cleared by this submission is:
- The addition of Spontaneous Breathing Trial (SBT) function allowing the clinician to . more easily determine a patient's ability to be weaned from ventilation.
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
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)
Not Found
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.
K981371, K984056, K002881, K010608
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
'JUL 2 9 2005
510(K) SUMMARY 1.
SUBMITTER 1.1
Pulmonetic Systems, Inc. 17400 Medina Road, Suite 100 Minneapolis, Minnesota 55447-1341
| Contact Person: | Robert C. Samec | |
|---|---|---|
| (763) 398-8305 | Telephone | |
| (763) 398-8400 | Facsimile |
1.2 DEVICE / TRADE NAME
Trade Name: LTV 1000 Ventilator
Common Name: Ventilator
Classification Name: Ventilator, Continuous (Respirator) 868.5895
SUBMISSION DATE 1.3
Submission Date: June 28, 2005
DESCRIPTION 1.4
The LTV 1000 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 5 kg (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, or CPAP modes of ventilation.
- Breath types including Volume, Pressure Control and Pressure Support. .
The modification intended to be cleared by this submission is:
- The addition of Spontaneous Breathing Trial (SBT) function allowing the clinician to . more easily determine a patient's ability to be weaned from ventilation.
1
1.5 INTENDED USE
The LTV 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 5 kg (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, or CPAP modes of ventilation.
- Breath types including Volume, Pressure Control and Pressure Support. ●
The ventilator is suitable for use in institutional, home and transport settings.
1.6 EQUIVALENCE TO PREDICATE DEVICE(S)
The LTV 1000 Ventilator listed modifications are substantially equivalent to the following listed devices:
| Predicate Device | 510(k) Clearance | Manufacturer |
|---|---|---|
| LTV 1000 Ventilator | K981371 - Initial clearance for | |
| Institutional and Transport | ||
| settings. | ||
| K984056 - Homecare settings. | ||
| K002881 - Enhancements. | ||
| K010608 - Lap Top Monitor. | ||
| K032226 - 5 kg Patient Application. | Pulmonetic Systems, Inc. | |
| Colton, CA/Mpls., MN | ||
| Engstrom | ||
| Carestation | K041775- Initial clearance | GE Datex-Ohmeda |
The LTV 1000 ventilator, previously cleared for homecare use and for institutional and transport settings, is now being submitted for clearance with the listed modification.
The table on the following pages compares the modification/feature of the LTV to the previously cleared LTV 1000 ventilator
The LTV 1000 ventilator with the modification listed is substantially equivalent to the predicate LTV 1000 (K032226) and the Engstrom Carestation (K041775).
2
| Characteristic
(LTV Modification)
Spontaneous Breathing (SBT) | LTV 1000
(Predicate Device) | Engstrom Carestation
(Predicate Device) | Discussion of Differences and
Similarities |
|---------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Clinicians manually set the CPAP
mode/parameters and alarm
parameters to start breathing
trials. An informational alarm will
appear with two minutes left in
the study and when the trial has
ended. At trial end, the ventilator
will return to the previous mode
and settings. | Clinicians manually set the CPAP
mode/parameters and alarm
parameters to start breathing
trials. An informational alarm will
appear with two minutes left in
the study. At trial end, the
ventilator will return to the
previous mode and settings. | The software application to allow
input presets for CPAP
mode/parameters and alarm
parameters is an addition to the
existing LTV 1000 preset menu
options and does not introduce
any additional or new patient risk
or involve the application of new
technology. |
| | SBT time duration available by
menu selection (15-120 minutes) | SBT time duration available by
menu selection (5-60 minutes) | Longer time duration is provided
at the request of clinicians. |
SUBSTANTIAL EQUIVALENCE SUMMARY TABLE
The LTV 1000 ventilator with the modification listed is substantially equivalent to the predicate LTV 1000 (K03226) and
Engstrom Carestation (K041775).
ﺮ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the eagle.
JUL 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert C. Samec Pulmonetic Systems, Incorporated 17400 Medina Road Suite 100 Minneapolis, Minnesota 55447-1341
Re: K051767
Trade/Device Name: LTV 1000 Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Ventilator Regulatory Class: II Product Code: CBK Dated: June 28, 2005 Received: June 30, 2005
Dear Mr. Samec:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
Page 2 - Mr. Samec
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chiu Lin, Ph.D.
Chiu Lin, Ph.D Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: Ventilator, Continuous (Respirator)
Indications for Use:
The LTV 1000 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 5 kg (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, or CPAP modes of ventilation. ●
- Breath types including Volume, Pressure Control and Pressure Support. ●
The ventilator is suitable for use in institutional, home, or transport settings.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aue Sullion
hesiology, General Hospital.
510(k) Number: K051767
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