(58 days)
Not Found
No
The document describes standard ventilator functions and modifications related to alarms, oxygen monitoring, and pressure compatibility. There is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML mentions.
Yes.
The device provides ventilatory support, which is a therapeutic intervention for individuals who require mechanical ventilation.
No
The device is a ventilator, which provides ventilatory support, and the text does not mention any diagnostic capabilities.
No
The device description clearly states it is a "ventilator," which is a hardware device that provides mechanical ventilation. The modifications described are additions to the functionality of this hardware device, not a standalone software application.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a ventilator for providing mechanical ventilatory support to patients. This is a life-support device that interacts directly with the patient's respiratory system.
- Device Description: The description reinforces that it's a ventilator and details its functions related to delivering air and oxygen to the patient.
- 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 used in vitro (outside the body) to analyze biological samples. This device operates in vivo (within the body) to support respiration.
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 (11lbs.), 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, or transport settings.
Product codes
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 modifications intended to be cleared by this submission are:
- . The addition of a High Breath Rate Alarm to alert operators to a patient's high breath rate condition.
- . The addition of O2 cylinder duration monitoring to provide a reference indicator of the approximate remaining usable time of an external O2 cylinder based on operator entered input parameters.
- The addition of a 100% O₂ flush feature allowing the operator to elevate delivered FIO₂ . for a preset time period.
- The addition of Automatic High O₂ Switchover to alert operators that a high O₂ pressure . source is attached to the ventilator when a low O2 pressure source has been selected. In this condition, the ventilator will switch to a high O2 pressure source mode and set O2 delivery to 21% or room air.
- A change in maximum allowable oxygen input pressure from 70 psig to allow . broader compatibility with institutional oxygen sources.
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 5 kg (11 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the text "K040540" written in black ink. The text is slightly tilted, with the numbers appearing to be handwritten. Below the text, there is a number "1." which is also written in black ink.
510(K) SUMMARY
1.1 SUBMITTER
Pulmonetic Systems, Inc. 17400 Medina Road, Suite 100 Minneapolis, Minnesota 55447-1341
| Contact Person: | Robert C. Samec | Telephone |
|---|---|---|
| (763) 398-8305 | ||
| (763) 398-8400 | Facsmilie |
DEVICE / TRADE NAME 1.2
LTV 1000 Ventilator Trade Name:
Ventilator Common Name:
Classification Name: Ventilator, Continuous (Respirator) 868.5895
SUBMISSION DATE 1.3
Submission Date: April 1. 2004
1,4 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 modifications intended to be cleared by this submission are:
- . The addition of a High Breath Rate Alarm to alert operators to a patient's high breath rate condition.
- . The addition of O2 cylinder duration monitoring to provide a reference indicator of the approximate remaining usable time of an external O2 cylinder based on operator entered input parameters.
1
- The addition of a 100% O₂ flush feature allowing the operator to elevate delivered FIO₂ . for a preset time period.
- The addition of Automatic High O₂ Switchover to alert operators that a high O₂ pressure . source is attached to the ventilator when a low O2 pressure source has been selected. In this condition, the ventilator will switch to a high O2 pressure source mode and set O2 delivery to 21% or room air.
- A change in maximum allowable oxygen input pressure from 70 psig to allow . broader compatibility with institutional oxygen sources.
INTENDED USE 1.5
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.
EQUIVALENCE TO PREDICATE DEVICE(S) 1.6
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 | ||
| T-Bird AVS | K981971 | Bird Products, Palm |
| Springs, CA |
2
The LTV 1000 ventilator, previously cleared for homecare use and for institutional and transport settings, is now being submitted for clearance with the listed modifications.
The table on the following pages compares the modifications/features of the LTV to the previously cleared LTV 1000 ventilator and the T-Bird AVS ventilator.
The LTV 1000 ventilator with the modifications listed is substantially equivalent to the predicate LTV 1000 (K032226) and the T-Bird AVS Ventilator (K981971) manufactured by Bird Products.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, facing left. The eagle is composed of three thick, curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 2004
Mr. Robert C. Samec Vice President-Regulatory Affairs Pulmonetic System, Incorporated 17400 Medina Road Suite 100 Minneapolis, Minnesota 55447
Re: K040540
Trade/Device Name: LTV 1000 Ventilator Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: April 1, 2004 Received: April 2, 2004
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 apper (a) sprovisions 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 (1 will ), it hay ob of of the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Lederal 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. or the receir any 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 and inning (s 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) rins leter 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 (301) 594-4646. 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/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
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): K040540
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 (11lbs.), 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, or transport settings.
Prescription Use X ___________________________________________________________________________________________________________________________________________________________
AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
sthmil
on of Anesthesiology, General Hospital, Infection Control Dental Device
Page 1 of
510(k) Number: K040540