REMSTAR SE

K122769 · Respironics, Inc. · BZD · Oct 9, 2012 · Anesthesiology

Device Facts

• Record ID: K122769
• Device Name: REMSTAR SE
• Applicant: Respironics, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Oct 9, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The REMstar SE delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg (66 lbs). It is for use in the home or hospital/institutional environment.

Device Story

Microprocessor-controlled CPAP system; delivers continuous positive airway pressure to treat Obstructive Sleep Apnea. Inputs: patient breathing signals (flow detection). Outputs: regulated positive airway pressure. Features: ramp, adjustable pressure relief (FLEX technologies), and integrated heated humidification with heated tubing options. Used in home or hospital by patients under physician prescription. Healthcare providers use device output to manage therapy; patient benefits from improved airway patency during sleep. Modifications from predicate include updated platform design, flow detection, and humidity control.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated via non-clinical bench testing, including design verification, pressure stability, and humidifier performance testing.

Technological Characteristics

Microprocessor-controlled blower-based positive pressure system. Includes heated humidifier and patient tubing (15mm, 22mm, or heated). Standards: ISO 14971, ISO 10993-1, IEC 60601-1, IEC 62304, ISO 5356-1. Software-controlled therapy delivery.

Indications for Use

Indicated for treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing >30kg (66 lbs). Use in home or hospital/institutional settings.

Regulatory Classification

Identification

A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

Predicate Devices

• Respironics REMstar Auto A-Flex HT (K113068)
• Respironics SleepEasy CPAP System (K091112)
• Respironics REMstar Plus CPAP System (K010263)

Submission Summary (Full Text)

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# Tectiveness

Official Contact

Date Prepared

Trade Name

Common Name

Classification Name

Predicate Device(s)

#### Reason for Submission

Frank Kadi Senior Regulatory Affairs Engineer Respironics, Inc. 1740 Golden Mile Highway Monroeville, PA 15146

30 January 2012

REMstar SE

CPAP System

ventilator, non-continuous (respirator) (21 CFR 868.5905, Product Code BZD)

Respironics REMstar Auto A-Flex HT (K113068) Respironics SleepEasy CPAP System (K091112) Respironics REMstar Plus CPAP System (K010263)

The REMstar SE is the result of modifications made to the REMstar Auto A-Flex HT (K113068). The goal of these modifications is to combine the updated platform design of the REMstar Auto A-Flex HT (K113068) with both the feature set and performance aspects of the SleepEasy CPAP System (K091112) and the REMstar Plus CPAP System (K010263). In addition, modifications have been made in regards to flow detection, and humidity control. The necessary modifications have been accomplished via a combination of software, electrical and mechanical design changes.

קען ק

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The modified device has the following similarities to the previously cleared predicate devices:

- . Same Intended Use
- . Same operating principle
- . Same technology
- Same manufacturing process

Design verification tests were performed on the REMstar SE as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria. Respironics has determined that the modifications have no impact on the safety and effectiveness of the device. In summary, the device described in this submission is substantially equivalent to the predicate devices.

The modified device complies with the requirements of the following FDA Guidance Documents:

- FDA Reviewers Guidance for Premarket Notification Submissions (November 1993) ●
- FDA Reviewers Guidance for the Content of Premarket Submissions for Software Contained in . Medical Devices (May 11, 2005)

# Intended Use

The REMstar SE delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg (66 lbs). It is for use in the home or hospital/institutional environment.

The REMstar SE is a microprocessor controlled blower based positive pressure system which is comprised of the therapy device, a heated humidifier and patient tubing (15mm, 22mm, or heated tubing).

The REMstar SE includes a CPAP mode only. While in CPAP mode, the device delivers a continuous positive airway pressure throughout the entire therapy session.

In addition to the CPAP therapy mode, the REMstar SE incorporates several optional features to aid with patient comfort. These features include ramp, adjustable pressure relief (FLEX technologies), and humidification. Humidification options include both a heated humidifier and heated tubing. The heated humidifier adjusts the level of humidification by varying the temperature of a heated plate used to heat up a chamber of water. Optional heated tubing can then be used to maintain that air at a desired temperature until it reaches the patient's mask.

The REMstar SE is intended for use with a patient circuit that connects the device to a patient interface device (mask). A typical patient circuit consists of patient tubing (15mm, or heated tubing) and

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an exhalation device (if one is not present in the mask). When a heated humidifier is attached to the therapy device, the patient circuit connects to the air outlet port of the heated humidifier.

Verification activities performed to verify that the device modifications did not affect the safety and effectiveness of the subject device included the following:

### Flex Performance

Flex performance has been verified to meet product specifications for each level of control.

### Pressure Stability

Pressure stability performance for the REMstar SE has been verified across all environmental conditions including altitude, temperature, and humidity.

### Humidifier Performance

Humidifier performance has been verified to meet product specifications for humidity output.

### Standards Evaluation

The REMstar SE has been designed to meet the requirements of the following FDA Recognized Consensus Standards:

- ISO 14971 Medical devices Application of risk management to medical devices .
- ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within . a risk management process
- . IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements of Safety
- IEC 62304 Medical device software Software life cycle processes .
- ISO 5356-1 Anaesthetic and respiratory equipment Conical connectors: Part 1L Cones and . sockets

Clinical tests were not required to demonstrate the safety and effectiveness of the REMstar SE. Product functionality has been adequately assessed by non-clinical tests.

# clusions

The REMstar SE has passed all of the aforementioned non-clinical tests and required no clinical tests in order to demonstrate safety or effectiveness. It is therefore concluded that the REMstar SE is substantially equivalent to the predicate device in terms of safety and effectiveness.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT

2012

Respironics, Incorporated

Mr. Frank Kadi

Senior Regulatory Affairs Engineer

1740 Golden Mile Highway

Monroeville, Pennsylvania 15146

Re: K122769 Trade/Device Name: REMstar SE Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: September 7, 2012 Received: September 11, 2012

Dear Mr. Kadi:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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Page 2- Mr. Kadi

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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510(k) Number (if known):

# KIZZ 769

Device Name:

### REMstar SE

Indications for Use:

The REMstar SE delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg (66 lbs). It is for use in the home or hospital/institutional environment.

> Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schuler

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

K12276 510(k) Number:

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