RTX RESPIRATOR

K082657 · Medivent Limited · BYT · Oct 8, 2008 · Anesthesiology

Device Facts

• Record ID: K082657
• Device Name: RTX RESPIRATOR
• Applicant: Medivent Limited
• Product Code: BYT · Anesthesiology
• Decision Date: Oct 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5935
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Indications for Use

1. 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 Story

RTX Respirator is external high/low frequency negative pressure ventilator; provides ventilation and secretion clearance. System comprises lightweight flexible cuirass, tubing, and control unit with keypad/display. Cuirass attaches to patient via Velcro/nylon straps with disposable seal. Device operates by cycling pressure within cuirass; negative pressure phase expands chest to trigger inspiration; positive pressure phase compresses chest to assist expiration. Used in clinical settings; operated by healthcare professionals. Provides non-invasive respiratory support; benefits patients by facilitating gas exchange and airway clearance.

Clinical Evidence

Comparative clinical study performed against Hayek Oscillator (K924341) demonstrated similar patient results. Safety and effectiveness also supported by review of published literature.

Technological Characteristics

External negative pressure ventilator. Components: flexible cuirass (various sizes), tubing, control unit with keypad/display. Electrical safety compliance: IEC 60601-1, IEC 60601-1-2, IEC 61000-4-2/3/4/5/6/8/11. Operates via controlled pressure cycling (negative/positive phases).

Indications for Use

Indicated for adult and pediatric patients requiring external lung ventilation for gas exchange or assistance with secretion clearance. Not for out-of-hospital transport. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• Hayek Oscillator (K924341)
• Servo Ventilator 900C (K841529)
• Thairapy TM Bronchial Drainage System, Model 101 (K884098)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] Email; [e-mail] 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 Drainage<br>System, Model 101 now known as The<br>Vest Airway Clearance System | Originally manufactured by<br>American Biosystems but<br>now manufactured by Hill-<br>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.

- 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.

#### 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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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 [phone]. 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 [phone] or [phone] 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.

- 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.

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)