(87 days)
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No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
Yes
The device is intended to provide "ventilatory support," which is a form of medical treatment to assist or replace breathing for individuals who require mechanical ventilation, thus making it a therapeutic device.
No
Explanation: The device is a ventilator, which is a therapeutic device that provides ventilatory support, not a diagnostic device. Its intended use is to deliver ventilation, not to diagnose a condition.
No
The device is described as a "ventilator," which is a hardware medical device that provides mechanical ventilation. The description does not indicate it is a software component of a ventilator or a standalone software application.
Based on the provided information, the LTV 1000 ventilator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device provides "continuous or intermittent ventilatory support" for patients requiring mechanical ventilation. This is a life-support function directly applied to the patient's respiratory system.
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The LTV 1000 ventilator does not perform this function. It interacts directly with the patient's body to assist with breathing.
Therefore, the LTV 1000 ventilator falls under the category of a medical device used for patient treatment and support, 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.
The ventilator is suitable for use in institutional, home, or transport settings.
Product codes
CBK
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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, or transport settings.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, one behind the other, with a flowing design above them.
OCT 1 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert C. Samec Vice President, Regulatory Affairs/Quality Assurance Pulmonetic Systems, Inc. 17400 Medina Road, Suite 100 Minneapolis, MN 55447
Re: K032226
Trade/Device Name: LTV 1000 Ventilator Regulation Number: 868,5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: July 15, 2003 Received: July 21, 2003
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.
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Page 2 – Mr. Robert C. 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 (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 vours.
Susan Runnells
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
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Indications for Use Statement
| 510(k) Number (if known) | K032226 |
|---|---|
| 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.
The ventilator is suitable for use in institutional, home, or transport settings.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use ✓ (Per 21 CFR 801. 109) | OR | Over-The-Counter Use ________ |
|---|---|---|
| ------------------------------------------------------------------------------------------ | ---- | ------------------------------------------------------------------------------- |
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
| 510(k) Number: | K032226 |
|---|---|
| ---------------- | --------- |