(66 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard ventilation modes and a modification related to breathing circuits.
Yes
The device is a ventilator that provides ventilatory support to individuals requiring mechanical ventilation, which directly addresses a health condition.
No
The device description clearly states its purpose is to "provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation," which is a treatment function, not a diagnostic one.
No
The device description explicitly states it is a "ventilator," which is a hardware device providing mechanical ventilation. The modification described is the addition of heated wire breathing circuit limbs, which are also hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The LTV 1000 ventilator is a mechanical device that provides respiratory support by delivering air to the lungs. It does not analyze biological samples.
- Intended Use: The intended use clearly states it provides "continuous or intermittent ventilatory support" for individuals requiring mechanical ventilation. This is a life-support function, not a diagnostic test.
Therefore, the LTV 1000 ventilator falls under the category of a life-support 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 (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 (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 commercially available heated wire breathing circuit inspiratory/expiratory limbs manufactured and distributed by Allegiance Healthcare Corporation (K000697), as an option to the ventilator breathing circuits specified for use
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.
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
JUN - 3 2004
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 | Facsmilie: |
1.2 DEVICE / TRADE NAME
LTV 1000 Ventilator/Breathing circuits Trade Name:
Common Name: Ventilator
Classification Name: Ventilator, Continuous (Respirator) 868.5895
1.3 SUBMISSION DATE
Submission Date: March 26, 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 modification intended to be cleared by this submission is:
The addition of commercially available heated wire breathing circuit inspiratory/expiratory limbs manufactured and distributed by Allegiance Healthcare Corporation (K000697), as an option to the ventilator breathing circuits specified for use
1
commercially available humidifier with heated wire controller* to provide heated and humidified air under a physicians order/supervision.
*Fisher & Paykel Models: MR 730 (K913368) MR 850 (K020332)
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 | ||
| with breathing | ||
| circuits. | 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 | ||
| Allegiance Airlife | ||
| Heated Ventilator | ||
| Breathing Circuits | K000697 | Allegiance Healthcare |
| Corporation |
The LTV 1000 Ventilator with breathing circuits, 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 page compares the modification of the LTV 1000 breathing circuits to the previously cleared LTV 1000 ventilator/breathing circuits and the Allegiance Airlife Heated Wire Breathing Circuits. Allegiance Healthcare Corporation, the manufacturer of the Airlife Heated Wire
2
Breathing Circuits is the selected supplier for the Heated Wire Breathing Circuit inspiratory/expiratory limbs to be utilized with the LTV 1000 ventilator.
The LTV 1000 ventilator/breathing circuits with the modification listed are substantially equivalent to the EP 1000 ventilator/breathing circuits (K981371) and the Allegiance Airlife Heated the products = r = 1000 (K000697), intended for use with commercially available ventilators.
3
SUBSTANTIAL EQUIVALENCE SUMMARY TABLE
| LTV 1000 with Modification | LTV 1000
(Predicate Device)
(K981371) | Allegiance Airlife Heated Wire
Breathing Circuit Limb(s)
(K000697) Predicate Device | Discussion of Differences and
Similarities |
|-------------------------------------------------------------------------------|-----------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model 15090-001 Heated Circuit
Assy., 6', SPU, Adult w/PEEP | Model 10820 Circuit Assy., 6', SPU,
Adult w/PEEP | RT600-850 Adult Inspiratory Limb,
Heated, 6'. | Airlife Adult Heated Wire Inspiratory
Limb replaces PSI Adult Inspiratory
Limb. |
| Model 15090-002 Heated Circuit
Assy., 6', SPU, Adult PEEPless | Model 10822 Circuit Assy., 6', SPU,
Adult PEEPless | RT600-850 Adult Inspiratory Limb,
Heated, 6'. | Airlife Adult Heated Wire Inspiratory
Limb replaces PSI Adult Inspiratory
Limb. |
| Model 15090-003 Heated Circuit
Assy., 6', SPU, Pediatric w/PEEP | Model 10821 Circuit Assy., 6', SPU.
Pediatric w/PEEP | RT609-856 Pediatric Inspiratory Limb,
Heated, 6'. | Airlife Pediatric Heated Wire
Inspiratory Limb replaces PSI Pediatric
Inspiratory Limb. |
| Model 15090-004 Heated Circuit
Assy., 6' SPU, Pediatric PEEPless | Model 10823 Circuit Assy., 6', SPU,
Pediatric PEEPless | RT609-856 Pediatric Inspiratory Limb,
Heated, 6'. | Airlife Pediatric Heated Wire
Inspiratory Limb replaces PSI Pediatric
Inspiratory Limb. |
| Model 15091-001 Heated Circuit
Assy., 5', SPU, Adult w/ PEEP | Model 10820 Circuit Assy., 6', SPU,
Adult w/PEEP | RT500-853 Adult
Inspiratoty/Expiratory Limbs, Heated,
5'. | Airlife Adult Heated Wire
Inspiratory/Expiratory Limb replaces
PSI Adult Inspiratory/Expiratory Limb.
Length reduced from 6' to 5'. |
| | | | Airlife Adult Heated Wire
Inspiratory/Expiratory Limb replaces
PSI Adult Inspiratory/Expiratory Limb.
Length reduced from 6' to 5'. |
| | | | Airlife Pediatric Heated Wire
Inspiratory/Expiratory Limb replaces
PSI Pediatric Inspiratory/Expiratory
Limb. Length reduced from 6' to 5'. |
| Model 15091-004 Heated Circuit
Assy., 5', SPU, Pediatric PEEPless | Model 10823 Circuit Assy., 6', SPU,
Pediatric PEEPless | RT509-852 Pediatric
Inspiratoty/Expiratory Limbs, Heated,
5'. | Airlife Pediatric Heated Wire
Inspiratory/Expiratory Limb replaces
PSI Pediatric Inspiratory/Expiratory
Limb. Length reduced from 6' to 5'. |
| Model 15092-001 Assy. Heated
Inspiratory Limb Assy., 6', SPU,
Pediatric | Model 10823 Circuit Assy., 6', SPU,
Pediatric PEEPless | RT609-856 Pediatric Inspiratory Limb,
Heated, 6'. | Airlife Pediatric Heated Wire
Inspiratory Limb replaces PSI Pediatric
Inspiratory Limb. |
| Model 15092- 002 Assy. Heated
Inspiratory Limb Assy., 6', SPU, Adult | Model 10820 Circuit Assy., 6', SPU,
Adult w/PEEP | RT600-850 Adult Inspiratory Limb,
Heated, 6'. | Airlife Adult Heated Wire Inspiratory
Limb replaces PSI Adult Inspiratory
Limb. |
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three overlapping wings, symbolizing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
UN - 3 2004
Mr. Robert C. Samec Vice President, Regulatory Affairs Pulmonetic Systems, Incorporated 17400 Medina Road, Suite 100 Minneapolis, Minnesota 55447-1341
Re: K040790
K040770
Trade/Device Name: Modification to LTV 1000 Ventilator/Breathing Circuits Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Il Product Code: CBK Dated: May 24, 2004 Received: May 25, 2004
Dear Mr. Samec:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bectoris in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for tise stated in the encrosure) to regally management date of the Medical Device American's on to commerce prior to May 26, 1970, the enated with the provisions of the Federal Food, Drug, devices that have been recuire in assee approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approvisions of the general controls provisions of the Y ou may, ulciently, market the devices, obly of the courements for annual registration, listing of general controls provisions of the fice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Spccial Controls) or class III (PMA), it If your device is classified (secure) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations liDA m may be subject to such additional controls. Extremgions be found in the Code of Pouchal Ingerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 1127 s issuates or our device complies with other requirements of the Act that FIA has made a decemmances and regulations administered by other Federal agencies. You must
5
Page 2 - Mr. Robert C. Samec
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,
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
6
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 (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
Over-The-Counter Use AND/OR
(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)
Aung Suulum
these sintray, General Hospital. Infection Control, Dental Devices 510(k) Number:
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
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