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.

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

AI/ML Overview

This 510(k) submission (K040790) describes a modification to the LTV 1000 Ventilator, specifically the addition of commercially available heated wire breathing circuits. The submission focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a novel device requiring extensive performance testing against acceptance criteria in the traditional sense. Therefore, the details requested regarding a specific "study that proves the device meets the acceptance criteria" and related metrics are not explicitly provided in this document as it pertains to a new device.

However, based on the provided text, we can infer the implicit "acceptance criteria" and "device performance" in terms of establishing substantial equivalence and the testing methods typically involved for such modifications.

Inferred Acceptance Criteria and Reported Device Performance (Table 1)

Given that this is a 510(k) for a modification focused on incorporating existing, cleared components (heated wire breathing circuits) into a cleared ventilator system, the primary "acceptance criterion" is demonstating that the modified system maintains the safety and effectiveness of the predicate device and the added components when integrated. This is typically achieved through:

Substantial Equivalence: The modified device performs as intended and is as safe and effective as the predicate device(s).
Performance Testing: Verification of critical ventilator parameters and circuit performance within established engineering specifications and relevant standards. This might involve pressure, flow, volume delivery, temperature control (for the heated circuits), and alarm functionality.
Biocompatibility: Ensuring that the materials of the new breathing circuits are biocompatible with patient contact.
Electrical Safety and EMC: Compliance with relevant electrical safety and electromagnetic compatibility standards.

Since the document is a summary for a 510(k), explicit, detailed acceptance criteria values (e.g., "flow rate must be within ±5% of set value") are not laid out, nor are specific performance testing results presented as a report. Instead, the "reported device performance" is implied by the statement of substantial equivalence and the expectation that the combined system meets the performance of its cleared predicate components.

Acceptance Criteria (Implied)	Reported Device Performance (Implied by Substantial Equivalence and K Numbers)
The modified LTV 1000 Ventilator circuit system is substantially equivalent to predicate devices (LTV 1000 Ventilator K981371, Allegiance Airlife Heated Ventilator Breathing Circuits K000697) in terms of safety and effectiveness.	The submission states that the "LTV 1000 Ventilator with 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." This is the core finding of the 510(k) clearance process.
The heated wire breathing circuits (Allegiance Airlife) function as intended to provide heated and humidified air.	The new components (Allegiance Airlife Heated Ventilator Breathing Circuits, K000697) are commercially available and have a prior 510(k) clearance, indicating their individual performance for this function has already been established. The submission details the specific models of the Allegiance Airlife Heated Wire Inspiratory/Expiratory Limbs being incorporated, replacing previous PSI Adult/Pediatric Inspiratory Limbs. The integration with external, commercially available humidifiers (Fisher & Paykel Models: MR 730 (K913368), MR 850 (K020332)) is also noted, implying their established performance.
All specified LTV 1000 Ventilator functions (e.g., ventilation modes, breath types, patient weight range, use settings) are maintained with the modified breathing circuits.	The LTV 1000 Ventilator's core functionalities (Positive Pressure Ventilation, Assist/Control, SIMV, CPAP, Volume, Pressure Control, Pressure Support breath types, for adult/pediatric patients ≥ 5 kg, in institutional/home/transport settings) are explicitly stated to be the same as the predicate device (K981371 and subsequent clearances), and there's no indication that the breathing circuit modification alters these. This is implicit in the substantial equivalence claim.
The device modification does not introduce new safety concerns or risks.	The entire purpose of the 510(k) process for modifications is to ensure that new device safety concerns are not introduced. The discussion of differences and similarities (pages 2-3) confirms the component replacement and length reduction in some circuits, but the substantial equivalence claim implies no new safety concerns. The use of already cleared components (K000697 for the breathing circuits, K913368/K020332 for humidifiers) reinforces this.

Detailed Study Information (Based on 510(k) Modification Context)

Sample Size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a "test set" sample size in terms of patient data. For a 510(k) modification focused on component integration and substantial equivalence, testing would involve engineering verification and validation (V&V) on a sufficient number of device units (physical ventilators with the new circuits) to demonstrate performance against specifications and compliance with standards. The specific number of units tested is not provided in this summary.
- Data Provenance: The data provenance would primarily be from internal engineering and quality testing conducted by Pulmonetic Systems, Inc. on their modified LTV 1000 Ventilator system. Additionally, the pre-existing clearance (K000697) of the Allegiance Airlife Heated Ventilator Breathing Circuits would draw upon its original test data. This is prospective testing related to the manufacturing and verification of the modified device before market entry. Country of origin for testing is implied to be the US (Minneapolis, Minnesota for Pulmonetic Systems, Inc.).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is largely not applicable in the context of this 510(k) modification. "Ground truth" established by external experts (like radiologists for imaging) is relevant for diagnostic devices or AI algorithms where clinical accuracy is being assessed. For a ventilator modification, the "ground truth" for performance is established by engineering specifications, international standards (e.g., ISO for ventilators), and existing predicate device performance. Device validation would be performed by qualified engineers and technicians, not typically by external clinical "experts" establishing a "ground truth" for a test set in the way this question implies. Clinical experts would inform requirements and user needs, but they wouldn't perform ground truth adjudication on device performance data in this manner.
Adjudication method for the test set:
- Not Applicable in the sense of clinical adjudication. Device performance testing against specifications typically involves defined measurement protocols, acceptance criteria, and verification by qualified test personnel. Discrepancies would be resolved through standard engineering and quality assurance processes, not a multi-reader, multi-case adjudication method.
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 a ventilator device, not an AI-assisted diagnostic or imaging system. Therefore, MRMC studies and "human readers improve with AI" metrics are irrelevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware modification for a ventilator, not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is based on engineering specifications, compliance with recognized national and international standards for medical devices (specifically ventilators and breathing circuits), and the established safety and performance profile of the predicate devices. This includes physical and functional performance measurements, material biocompatibility, electrical safety, and electromagnetic compatibility.
The sample size for the training set:
- Not Applicable. This is for a hardware modification, not a machine learning or AI algorithm development that requires a training set. The "training" for such a device would be the design and development process adhering to a quality management system.
How the ground truth for the training set was established:
- Not Applicable. See point 7.

Summary

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JUN - 3 2004

K040790

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:

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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 Ventilatorwith breathingcircuits.	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
Allegiance AirlifeHeated VentilatorBreathing Circuits	K000697	Allegiance HealthcareCorporation

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

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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.

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SUBSTANTIAL EQUIVALENCE SUMMARY TABLE

LTV 1000 with Modification	LTV 1000(Predicate Device)(K981371)	Allegiance Airlife Heated WireBreathing Circuit Limb(s)(K000697) Predicate Device	Discussion of Differences andSimilarities
Model 15090-001 Heated CircuitAssy., 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 InspiratoryLimb replaces PSI Adult InspiratoryLimb.
Model 15090-002 Heated CircuitAssy., 6', SPU, Adult PEEPless	Model 10822 Circuit Assy., 6', SPU,Adult PEEPless	RT600-850 Adult Inspiratory Limb,Heated, 6'.	Airlife Adult Heated Wire InspiratoryLimb replaces PSI Adult InspiratoryLimb.
Model 15090-003 Heated CircuitAssy., 6', SPU, Pediatric w/PEEP	Model 10821 Circuit Assy., 6', SPU.Pediatric w/PEEP	RT609-856 Pediatric Inspiratory Limb,Heated, 6'.	Airlife Pediatric Heated WireInspiratory Limb replaces PSI PediatricInspiratory Limb.
Model 15090-004 Heated CircuitAssy., 6' SPU, Pediatric PEEPless	Model 10823 Circuit Assy., 6', SPU,Pediatric PEEPless	RT609-856 Pediatric Inspiratory Limb,Heated, 6'.	Airlife Pediatric Heated WireInspiratory Limb replaces PSI PediatricInspiratory Limb.
Model 15091-001 Heated CircuitAssy., 5', SPU, Adult w/ PEEP	Model 10820 Circuit Assy., 6', SPU,Adult w/PEEP	RT500-853 AdultInspiratoty/Expiratory Limbs, Heated,5'.	Airlife Adult Heated WireInspiratory/Expiratory Limb replacesPSI Adult Inspiratory/Expiratory Limb.Length reduced from 6' to 5'.
			Airlife Adult Heated WireInspiratory/Expiratory Limb replacesPSI Adult Inspiratory/Expiratory Limb.Length reduced from 6' to 5'.
			Airlife Pediatric Heated WireInspiratory/Expiratory Limb replacesPSI Pediatric Inspiratory/ExpiratoryLimb. Length reduced from 6' to 5'.
Model 15091-004 Heated CircuitAssy., 5', SPU, Pediatric PEEPless	Model 10823 Circuit Assy., 6', SPU,Pediatric PEEPless	RT509-852 PediatricInspiratoty/Expiratory Limbs, Heated,5'.	Airlife Pediatric Heated WireInspiratory/Expiratory Limb replacesPSI Pediatric Inspiratory/ExpiratoryLimb. Length reduced from 6' to 5'.
Model 15092-001 Assy. HeatedInspiratory Limb Assy., 6', SPU,Pediatric	Model 10823 Circuit Assy., 6', SPU,Pediatric PEEPless	RT609-856 Pediatric Inspiratory Limb,Heated, 6'.	Airlife Pediatric Heated WireInspiratory Limb replaces PSI PediatricInspiratory Limb.
Model 15092- 002 Assy. HeatedInspiratory 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 InspiratoryLimb replaces PSI Adult InspiratoryLimb.

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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

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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

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Indications for Use

510(k) Number (if known):

Device Name: Ventilator, Continuous (Respirator)

Indications For Use:

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 ____________________________________________________________________________________________________________________________________________________________________

4-1

Regulation Number and Section

§ 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).