Ventilation - The RTX Respirator is indicated for external ventilation of the lungs resulting in gas exchange. 2) Secretion Clearance - Also for use in assisting patients with secretion clearance management as indicated by standard medical convention. The RTX Respirator is for use in adult and pediatric patient populations. The RTX is not for use in out-of-hospital transport. For prescription use only.

Device Description

The RTX Respirator is an external high and low frequency respirator, which controls both phases of respiration. It consists of a lightweight flexible cuirass, tubing with a keypad and display screen. The Cuirass is available in eleven (11) sizes for various patient populations and sizes. The Cuirass contains a disposable seal and is attached to the patient via Velcro and nylon straps. The RTX Respirator ventilates by decreasing and then increasing the pressure within the cuirass. The negative pressure creates expansion of the chest bringing about inspiration. The positive phase creates positive pressure on the chest and therefore creates expiration.

AI/ML Overview

Here's an analysis of the provided 510(k) summary for the RTX Respirator, focusing on acceptance criteria and the supporting study:

The provided document, a 510(k) summary for the RTX Respirator, focuses on demonstrating substantial equivalence to predicate devices, not on proving that the device meets specific performance acceptance criteria through a standalone study with detailed metrics. The summary describes an equivalence study rather than a study defining and meeting acceptance criteria for a novel device.

Therefore, many of the requested data points (like sample size for test sets, number of experts, adjudication methods, MRMC studies, specific ground truth types, training set details) are not applicable or not provided in this type of submission which primarily addresses substantial equivalence for a medical device.

However, I can extract the information that is present and indicate where requested information is absent.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)

The submission doesn't define explicit performance acceptance criteria in numerical terms that the RTX Respirator must meet. Instead, the "acceptance criteria" can be inferred as demonstrating substantial equivalence to a predicate device, meaning it performs similarly and is as safe and effective.

Acceptance Criteria (Inferred from Substantial Equivalence Goal)	Reported Device Performance (Summary of Clinical Evaluation)
Device is safe and effective for indicated uses.	"The RTX Respirator was shown... to exhibit a similar pattern of clinical results."
Performance is comparable to the predicate device (Hayek Oscillator K924341).	"A comparative clinical study was performed and the RTX Respirator was shown ... to exhibit a similar pattern of clinical results."
No substantial differences in technological characteristics raise new issues of safety or effectiveness compared to predicates.	"There are no known substantial differences between the RTX Respirator defined in this 510(k) submission and the predicate devices. They have the same or similar intended indications for use and any differences in technological characteristics do not raise issues of safety and effectiveness."
Compliant with relevant electrical safety and EMC standards.	"The RTX Respirator was tested and found to be compliant to IEC 60601-1-2, IEC 61000-3-2/3, IEC 61000-4-2/3/4/5/6/8/11, and IEC 60601-1."

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The summary refers to "A comparative clinical study was performed" but does not give patient numbers.
- Data Provenance: Not specified (e.g., country of origin). The study involved a "comparative clinical study" and a "review of recent publications on the RTX Respirator," implying a mix of directly collected data and published literature. It doesn't state if it was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable/Not Provided. The clinical evaluation focuses on comparative outcomes to a predicate device. "Ground truth" in the context of device performance metrics (like accuracy for a diagnostic device) is not the focus here. The clinical results observed in the comparative study essentially served as the "truth" for demonstrating similar performance to the predicate.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable/Not Provided. This method is typically used in image interpretation or diagnostic studies where expert consensus resolves discrepancies. The described clinical study is a comparative performance study of a therapeutic device.
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:
- No. This is a therapeutic device (ventilator), not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and "human readers improving with AI assistance" are not relevant to this submission.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable/Not Provided. The RTX Respirator is a medical device, not an algorithm. Its performance is inherent to the device's function, not a computational output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Clinical Outcomes/Performance Data: The study relied on "clinical results" to demonstrate a "similar pattern" between the RTX Respirator and the predicate Hayek Oscillator. This would involve physiological measurements and patient well-being outcomes, but specific metrics are not detailed.
The sample size for the training set:
- Not Applicable/Not Provided. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established:
- Not Applicable/Not Provided. As it's not an AI/ML device, there is no training set.

Summary

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Ko 8 a657

510(k) Summary

(per 21 CFR 807.92(c))

1. Applicant

Medivent Limited. Maryland House 10 The Downage London NW4 1AA UK

Contact Person: Shahar Hayek, Managing Director Tel: 44 870 300 5527 Fax: 44 870 300 5528 Email; shahar@mediventintl.com Date Prepared: August 25, 2008

2. Device Name

Trade Name: RTX Respirator Common/Usual Name: Non-Invasive Cuirass Respirator Classification Name: External negative pressure ventilator Regulation Number: 868.5935 Product Codes: BYT Classification: II Classification Panel: Anesthesiology

3. Predicate Devices

The RTX Respirator is substantially equivalent to the following devices:

510(k) Number	Device	Manufacturer
K924341	Hayek Oscillator	Respironics
K841529	Servo Ventilator 900C	Siemens
K884098	Thairapy TM Bronchial DrainageSystem, Model 101 now known as TheVest Airway Clearance System	Originally manufactured byAmerican Biosystems butnow manufactured by Hill-Rom

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4. Intended Use

1. Ventilation -
  The RTX Respirator is indicated for external ventilation of the lungs resulting in gas exchange.
1. Secretion Clearance -
  Also for use in assisting patients with secretion clearance management as indicated by standard medical convention

The RTX Respirator is for use in adult and pediatric patient populations. The RTX is not for use in out-of-hospital transport. For prescription use only.

5. Description of the Device

The RTX Respirator is an external high and low frequency respirator, which controls The ICTA respirator is an oneoncele. It consists of a lightweight flexible cuirass, tubing both phases or its with a keypad and display screen. The Cuirass is available is eleven (II) and a power various patient populations and sizes. The Cuirass contains a disposable seal and is attached to the patient via Velcro and nylon straps.

The RTX Respirator ventilates by decreasing and then increasing the pressure within the The NTA Respirator vennator vontrolled, triggered or synchronized inspiration and expiration. The negative pressure creates expansion of the chest bringing about inspiration. The nogative phase creates positive pressure on the chest and therefore creates expiration.

6. Summary of the Technical Characteristics

Electrical Testing 6.1
The RTX Respirator was tested and found to be compliant to IEC 60601-1-2, The RTA Respirator was tested anno-3-2/3, IEC 61000-4-2/3/4/5/6/8/11, and IEC 60601-1.
Clinical Evaluation 6.2
A comparative clinical study was performed and the RTX Respirator was shown A comparative onlined brady mas to the predicate Hayek Oscillator (K924341) to eximbly a simmal patter results. Also, a review of recent publications on the RTX Respirator showed it to be a safe and effective device.

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7. Safety & Effectiveness

There are no known substantial differences between the RTX Respirator defined in this 510(k) submission and the predicate devices. They have the same or similar intended indications for use and any differences in technological characteristics do not raise issues of safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the eagle. The logo is black and white and appears to be a simple, vectorized design. The eagle is facing to the right.

Public Health Service

OCT 0 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medivent Limited C/O Mr. Jay Y. Kogoma Responsible Third Party Official Intertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

Re: K082657

Trade/Device Name: RTX Respirator Regulation Number: 21 CFR 868.5935 Regulation Name: External Negative Pressure Ventilator Regulatory Class: II Product Code: BYT Dated: September 29, 2008 Received: September 30, 2008

Dear Mr. Kogoma:

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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Th. Manuelo Sendong foch

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: RTX Respirator

Indications for Use:

1. Ventilation -
  The RTX Respirator is indicated for external ventilation of the lungs resulting in gas exchange.
1. Secretion Clearance -
  Also for use in assisting patients with secretion clearance management as indicated by standard medical convention

The RTX Respirator is for use in adult and pediatric patient populations. The RTX is not for use in out-of-hospital transport. For prescription use only.

L.A. Ariend

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K082657 510(k) Number:

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)

Regulation Number and Section

§ 868.5935 External negative pressure ventilator.

(a)
Identification. An external negative pressure ventilator (e.g., iron lung, cuirass) is a device chamber that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient.(b)
Classification. Class II (performance standards).