(73 days)
Not Found
No
The document describes modifications to a ventilator, focusing on hardware changes (internal PEEP control, battery accessibility) and software enhancements for setting parameters and modes. There is no mention of AI or ML in the intended use, device description, or the sections specifically checked for AI/ML terms.
Yes
The device is a ventilator intended to provide continuous or intermittent ventilatory support for individuals requiring mechanical ventilation, which directly addresses a health condition.
No
This device is a ventilator, which provides ventilatory support for patients, rather than diagnosing a condition.
No
The device description clearly describes a physical ventilator (LTV 1200) with hardware components and modifications, not solely software.
Based on the provided text, the LTV 1200 ventilator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- LTV 1200 Function: The LTV 1200 ventilator is described as a device that provides mechanical ventilatory support to individuals who require it. It directly interacts with the patient's respiratory system to assist with breathing.
- Lack of Specimen Analysis: The description does not mention the collection, preparation, or analysis of any biological specimens. Its function is entirely focused on delivering air to the patient's lungs.
Therefore, the LTV 1200 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 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilation is a restricted medical device intension of individuals who require incomment venture direction of a physician. Specifically, the ventilator is applicable for adult and petiative weighing at least 5 kg (1 1 lbs), who require the following types of ventilatory support:
- Positive Pressure Yentilation, delivered invasively (via ET tube) or non-invasively (via mask).
Assist/Control, SIMV, CPAP, or NPPV modes of ventilation.
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 1200 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, CPAP, or NPPV modes of ventilation. .
- Breath types including Volume, Pressure Control and Pressure Support. .
The modifications intended to be cleared by this submission are:
- Incorporation of optional internal PEEP control, replacing the optional external 록 mechanical PEEP valve used with the previously cleared LTV 1000 Ventilator.
- 해 The addition of a Low PEEP alarm.
- The addition of optional Patient Setting Control Presets to assist clinicians in initially setting patient ventilation set parameters.
- I The addition of NPPV mode setting enhancements to assist the clinician in setting up NPPV mode ventilation.
- I The addition of externally accessibility to the device internal battery for trained service personnel battery replacement.
- g The designation of the modified LTV 1000 Ventilator as the VIASYS LTV 1200 Ventilator. (Note: The previously cleared Pulmonetic Systems LTV 1000 will continue to be marketed without the modifications listed in this submission).
The LTV 1000 Ventilator, previously cleared for homecare, institutional and transport use is now being submitted for clearance with the listed modifications.
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): 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.
Not Found
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
Ko60647
510(K) SUMMARY
SUBMITTER
MAY 2 5 2006
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
Trade Name: LTV 1200 Ventilator
Common Name: Ventilator
Ventilator, Continuous (Respirator) 868.5895 Classification Name:
SUBMISSION DATE
Submission Date: March 9, 2006
DESCRIPTION
The LTV 1200 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, CPAP, or NPPV modes of ventilation. .
- Breath types including Volume, Pressure Control and Pressure Support. .
The modifications intended to be cleared by this submission are:
- Incorporation of optional internal PEEP control, replacing the optional external 록 mechanical PEEP valve used with the previously cleared LTV 1000 Ventilator.
- 해 The addition of a Low PEEP alarm.
1
- The addition of optional Patient Setting Control Presets to assist clinicians in initially setting patient ventilation set parameters.
- I The addition of NPPV mode setting enhancements to assist the clinician in setting up NPPV mode ventilation.
- I The addition of externally accessibility to the device internal battery for trained service personnel battery replacement.
- g The designation of the modified LTV 1000 Ventilator as the VIASYS LTV 1200 Ventilator. (Note: The previously cleared Pulmonetic Systems LTV 1000 will continue to be marketed without the modifications listed in this submission).
The LTV 1000 Ventilator, previously cleared for homecare, institutional and transport use is now being submitted for clearance with the listed modifications.
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,CPAP, or NPPV 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)
The modified LTV 1000 with the modifications listed is substantially equivalent to the predicate device(s) listed.
Predicate Device | 510(k) Clearance | Manufacturer |
---|---|---|
iVent 201 Portable | ||
Ventilator | K011957 | Versamed Corporation |
2 Blue Hill Plaza | ||
Pearl River, NY 10965 | ||
AVEA Ventilator | K022674 | Bird Products Corporation |
1100 Bird Center Drive | ||
Palm Springs, CA 92262 | ||
LTV 1000 Ventilator | K051767 | Pulmonetic Systems, Inc. |
17400 Medina Road, Suite 100 | ||
Minneapolis, MN 55447 |
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 2006
Mr. Robert C. Samec Vice President-Product Assurance Pulmonetic Systems, Incorporated 17400 Medina Road, Suite 100 Minneapolis, Minnesota 55447-1341
Re: K060647
Trade/Device Name: Ventilator, Continuous (Respirator), Model LTV 1200 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: May 9, 2006 Received: May 10, 2006
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.
3
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 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
4
Indications for Use
510(k) Number (if known):
Device Name: Ventilator, Continuous (Respirator)
Indications for Use:
The LTV 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilation is a restricted medical device intension of individuals who require incomment venture direction of a physician. Specifically, the ventilator is applicable for adult and petiative weighing at least 5 kg (1 1 lbs), who require the following types of ventilatory support:
- Positive Pressure Yentilation, delivered invasively (via ET tube) or non-invasively (via mask).
Assist/Control, SIMV, CPAP, or NPPV modes of ventilation.
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)
Aunselum
Anesthesiology, General Hospital,
Control, Dental Devices
Page of