(29 days)
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.
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.
The provided 510(k) summary for the Pulmonetic Systems LTV 1000 Ventilator (K051767) primarily focuses on demonstrating substantial equivalence to predicate devices, particularly regarding a new "Spontaneous Breathing Trial (SBT)" function. This type of submission, for a ventilator modification, does not typically include detailed performance studies with acceptance criteria in the same way an AI/ML device would.
Based on the provided document, here's an analysis concerning acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a table of quantitative acceptance criteria and reported 'performance' in the sense of a diagnostic or predictive device. Instead, it compares characteristics of the modified LTV 1000 Ventilator with its predicate devices to demonstrate equivalence.
| Characteristic (LTV Modification) | Acceptance Criteria (Implied) | Reported Device Performance (LTV 1000 with SBT Function) |
|---|---|---|
| Spontaneous Breathing (SBT) Function | Functionality is comparable to predicate, with beneficial enhancements and no new patient risk or technology. | Software Application: 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. |
| SBT Time Duration | Time duration meets clinician requests (potentially longer). | Offers SBT time duration via menu selection from 15-120 minutes. (Predicate LTV 1000 required manual CPAP mode/parameter setting; Engstrom Carestation offered 5-60 minutes). This longer duration is provided at the request of clinicians. |
| Safety and Risk | No introduction of additional or new patient risk. | The software application "does not introduce any additional or new patient risk or involve the application of new technology." (Comparison to predicate LTV 1000, which required manual CPAP settings and had an alarm for trial end). The predicate Engstrom Carestation also required manual CPAP settings. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This submission is for a modification to a medical device (ventilator software feature), not a diagnostic or AI/ML device that would typically involve a "test set" of patient data for performance evaluation in the way a clinical study would. Therefore, there is no specific sample size, test set, or data provenance mentioned in relation to proving the SBT function's performance. The evaluation is based on engineering design, comparison to predicate devices, and potentially internal validation/verification testing which is not detailed in this public summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. As this is not a diagnostic device relying on expert interpretation for ground truth, there's no mention of experts establishing ground truth for a test set. The statement about "Longer time duration is provided at the request of clinicians" suggests input from medical professionals informed the feature design, but not for establishing ground truth in a performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no test set or adjudication method described in the context of this submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI-assisted diagnostic device, and therefore, no MRMC study or AI assistance effect size is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The device is a ventilator with a software function. The "performance" is inherent to the function's design and operation, not an algorithm providing a diagnostic output independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the traditional sense of a diagnostic performance study. The "ground truth" for the SBT function would be its adherence to engineering specifications, correct implementation of the defined parameters (e.g., timing, mode switching), and safe operation in a simulated or actual clinical environment. This type of validation is typically conducted through internal engineering testing, which is not detailed here but implied by regulatory compliance.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that would require a 'training set'.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.
Summary:
The 510(k) summary for K051767 focuses on demonstrating "substantial equivalence" of a modified ventilator with a new Spontaneous Breathing Trial (SBT) function to previously cleared predicate devices. The "acceptance criteria" here are implicitly tied to ensuring the new function is safe, effective, and performs comparably or superiorly without introducing new risks compared to existing methods or devices. The "study" proving this largely relies on design comparison, engineering assessment of the software modification, and the assertion that it does not introduce new technology or patient risk. It does not involve a clinical performance study with patient data, ground truth establishment, or human reader evaluations as would be expected for a diagnostic or AI/ML device.
{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 forInstitutional and Transportsettings.K984056 - Homecare settings.K002881 - Enhancements.K010608 - Lap Top Monitor.K032226 - 5 kg Patient Application. | Pulmonetic Systems, Inc.Colton, CA/Mpls., MN |
| EngstromCarestation | 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 andSimilarities |
|---|---|---|---|
| Clinicians manually set the CPAPmode/parameters and alarmparameters to start breathingtrials. An informational alarm willappear with two minutes left inthe study and when the trial hasended. At trial end, the ventilatorwill return to the previous modeand settings. | Clinicians manually set the CPAPmode/parameters and alarmparameters to start breathingtrials. An informational alarm willappear with two minutes left inthe study. At trial end, theventilator will return to theprevious mode and settings. | The software application to allowinput presets for CPAPmode/parameters and alarmparameters is an addition to theexisting LTV 1000 preset menuoptions and does not introduceany additional or new patient riskor involve the application of newtechnology. | |
| SBT time duration available bymenu selection (15-120 minutes) | SBT time duration available bymenu selection (5-60 minutes) | Longer time duration is providedat 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
Page of of a
§ 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).