(127 days)
Not Found
No
The description focuses on standard CPAP technology with comfort features like ramp and pressure relief, and explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes.
The device delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea, indicating a therapeutic purpose.
No
Explanation: The device provides therapy (positive airway pressure) for an existing condition (Obstructive Sleep Apnea) and does not mention any function for diagnosing or detecting a disease or condition.
No
The device description clearly outlines hardware components such as a microprocessor controlled blower, heated humidifier, patient tubing, and a heated plate. It is a physical device delivering positive airway pressure therapy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea. This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The description details a system for delivering air pressure, including a blower, humidifier, and tubing. It does not describe any components or processes for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition based on sample analysis.
The device is clearly described as a therapeutic device for treating a condition, not a diagnostic device for identifying or characterizing a condition through in vitro analysis.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
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, 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 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 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.
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
Not Found
Intended User / Care Setting
home or hospital/institutional environment.
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)
Non-Clinical Tests:
Material Evaluation: New materials used in the air flow path were verified through biocompatibility tests (ISO 10993-1): Implantation (ISO 10993-6), Genotoxicity (ISO 10993-3), Irritation (ISO 10993-10), Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10).
Cleaning and Disinfection Validation: Methods identified in product labeling were validated for single-patient reuse and multi-patient use. Performance testing demonstrated ability to withstand maximum recommended cleaning and disinfection cycles. Disinfection efficacy testing was performed.
Volatile Organic Compounds (VOC) testing: Demonstrated ability of modified device to meet established guidelines for VOCs, carbon dioxide, and carbon monoxide output.
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.
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.
Not Found
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
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
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.(b)
Classification. Class II (performance standards).
0
.
K130077
Premarket Notification – Special 510(k)
MAY 2 1 2013
| Official Contact | Frank Kadi
Senior Regulatory Affairs Engineer
Respironics, Inc.
1740 Golden Mile Highway
Monroeville, PA 15146 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | 11 January 2013 |
| Trade Name | REMstar SE |
| Common Name | CPAP System |
| Classification Name | ventilator, non-continuous (respirator) (21 CFR 868.5905,
Product Code BZD) |
| Predicate Device | Respironics REMstar SE (K122769) |
| Reason for Submission | The modified device is the result of a material modifications
made to the REMstar SE (K122769). |
・
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Substantial Equivalence
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 material modification has no impact on the safety and effectiveness of the device. In summary, the device described in this submission is substantially equivalent to the predicate device.
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.
| Comments of the controlled of the consideration of the consideration of the more of the more of the more of the more of the more of the more of the more of the more of the ma | ||||
|---|---|---|---|---|
| Device Description | ||||
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, 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 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
2
REMstar SE
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.
Non-Clinical Tests
Verification activities performed to verify that the device modification did not affect the safety and effectiveness of the subject device included the following:
Material Evaluation
New materials used in the air flow path of the device have been verified to be acceptable for use through the following biocompatibility tests, in accordance with ISO 10993-1:
- Implantation (per ISO 10993-6) .
- . Genotoxicity (per ISO 10993-3)
- . Irritation (per ISO 10993-10)
- Cytotoxicity (per ISO 10993-5) .
- Sensitization (per ISO 10993-10) ●
The cleaning and disinfection methods identified in the product labeling were validated in order to demonstrate that the device is safe and effective for single-patient reuse and multi-patient use. Performance testing was completed to demonstrate the ability of the device to withstand the maximum number of recommended cleaning and disinfection cycles, and disinfection efficacy testing was performed to demonstrate the ability of the disinfection methods to disinfect the device met the acceptance criteria for the performance tests after the maximum recommended cycles of cleaning and disinfection, and the disinfection methods were found to be effective.
Volatile Organic Compounds (VOC) testing was performed and demonstrated ability of modified device to meet established guidelines for the output of Volatile Organic Compounds (VOCs), carbon dioxide and carbon monoxide.
| привается приверсии со приведение со преднество в селение по предната на подарение на подарение по подательно по полнения с составника с составника с составника с сединание к | |
|---|---|
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.
Conclusion
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.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 21, 2013
Mr. Frank Kadi Senior Regulatory Affairs Engineer Respironics, Incorporated 1740 Golden Mile Highway MONROEVILLE PA 15146
Re: K130077
Trade/Device Name: REMstar SE Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: BZD Dated: April 24, 2013 Received: April 25, 2013
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.
4
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 devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kwame O. Ulmer for
-S FDA
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and
Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
5
510(k) Number (if known):
30077
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 J V (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)
Paul H. Shin
2013.05.16 1:48:30 -04'00'
(Division Sign-Off) (Olvision of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K130677