(99 days)
Not Found
No
The description focuses on standard microprocessor control and sensor-based pressure adjustments, with no mention of AI, ML, or related concepts.
Yes
The device is intended to provide positive airway pressure for the treatment of obstructive sleep apnea (OSA), which is a medical condition.
No
The device is described as providing positive airway pressure for the treatment of obstructive sleep apnea and monitoring breathing to adjust pressure. While it monitors breathing, the primary purpose is therapeutic, not diagnostic. The clinical evaluation assesses its non-inferiority to another device in treatment, not diagnosis.
No
The device description clearly states it is a "microprocessor-controlled, blower-based system" that generates positive airway pressure, indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, the Transcend Auto is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Transcend Auto is a therapeutic device. Its purpose is to provide positive airway pressure to treat obstructive sleep apnea by supporting the patient's breathing. It interacts directly with the patient's airway, not with a specimen taken from the patient.
- The device description clearly outlines its function as a blower-based system that generates pressure and monitors breathing. This is consistent with a therapeutic device for respiratory support.
Therefore, the Transcend Auto falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Transcend Auto provides positive airway pressure for treatment of obstructive sleep apnea (OSA) in adults weighing over 66 pounds (30 kg). The device is intended for home and hospital/institutional use.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The Transcend Auto is a microprocessor-controlled, blower-based system that generates positive airway pressure to support treatment of obstructive sleep apnea. It utilizes a differential pressure sensor connected to an internal pneumotach positioned in the airstream to determine flow levels. This flow signal, coupled with pressure sensing, is used to monitor breathing and adjust pressure. When interfaced with a mask, the system provides pressure from 4 to 20 cmHzO above the ambient atmospheric pressure to a patient's oral/nasal airway.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral/nasal airway
Indicated Patient Age Range
adults
Intended User / Care Setting
home and hospital/institutional use.
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
A 2 x 2 crossover clinical evaluation was conducted that enrolled 41 adult patients with obstructive sleep apnea to assess the non-inferiority of the Transcend Auto to the REMstar Auto in the treatment of obstructive sleep apnea, as measured by apnea hypopnea index (AHI) during treatment. No unanticipated adverse device effects were reported during the study. One adverse event was reported by a patient who had a low-level headache following treatment with the Transcend Auto. The adverse event resolved without intervention and the investigator reported that the it was possibly related to the device. The study met its primary efficacy endpoint of non-inferiority in AHI (p
§ 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
5 510(k) Summary
OCT 1 7 2013
[As required by 21 CFR 807.92]
510(k) Number: K132127
Date Prepared: October 17, 2013
| Submitter/Manufacturer | Somnetics International, Inc.
33 5th Ave NW, Suite 500
New Brighton, MN 55112 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| | Establishment Registration # 3008770104 |
| Contact Person | Melinda Swanson
Regulatory Consultant
Telephone: 651-621-1800
Email: mswanson@somnetics.com |
| Trade Name | Transcend Auto |
| Common/Usual Name | Non-continuous ventilator |
| Classification | Ventilator, Non-continuous (Respirator)
21 CFR 868.5905, Class II |
| Product Code | BZD |
| Predicate Devices | Somnetics International, Inc., Model 300157 CPAP System
(K100121)
Respironics REMstar Auto CPAP with C-Flex (K041010) |
Device Description
The Transcend Auto is a microprocessor-controlled, blower-based system that generates positive airway pressure to support treatment of obstructive sleep apnea. It utilizes a differential pressure sensor connected to an internal pneumotach positioned in the airstream to determine flow levels. This flow signal, coupled with pressure sensing, is used to monitor breathing and adjust pressure. When interfaced with a mask, the system provides pressure from 4 to 20 cmHzO above the ambient atmospheric pressure to a patient's oral/nasal airway.
Indications for Use
The Transcend Auto provides positive airway pressure for treatment of obstructive sleep apnea (OSA) in adults weighing over 66 pounds (30 kg). The device is intended for home and hospital/institutional use.
1
Substantial Equivalence and Summary of Studies
The Transcend Auto complies with the following standards:
| Document
| Number | Title |
|---|---|
| IEC 60601-1 | Medical Electrical Equipment, Part 1: General Requirements for Safety |
| IEC 60601-1-2 | Medical Electrical Equipment – Collateral Standard: Electromagnetic |
| compatibility – Requirements and tests | |
| IEC 60601-1-6 | Medical Electrical Equipment - Part 1-6: General requirements for basic |
| safety and essential performance - Collateral Standard: Usability | |
| IEC 60601-11 | Medical Electrical Equipment – Collateral Standard: Requirements for home |
| health care environment | |
| ISO 10993-1 | Biological evaluation of medical devices |
| ISO 14971 | Medical devices -- Application of risk management to medical devices |
| BS EN 17510-1 | Sleep apnoea breathing therapy, Part 1: Sleep apnoea breathing therapy |
| equipment |
The Transcend Auto is substantial equivalent to the predicate devices based on comparison of indications for use and technological characteristics.
| | | Model 300157,
(Transcend) CPAP
System | REMstar Auto
CPAP System with
C-Flex | Comparison: |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| | Transcend Auto | | | |
| 510(k) Number | Under review | K100121 | K041010 | NA |
| Product Code | BZD | BZD | BZD | Identical |
| Regulation Number | 868.5905 | 868.5905 | 868.5905 | Identical |
| Regulation Name | Ventilator, non-
continuous
(respirator) | Ventilator, non-
continuous
(respirator) | Ventilator, non-
continuous
(respirator) | Identical |
| Indications for Use | The Transcend Auto
provides positive
airway pressure for
treatment of
obstructive sleep
apnea (OSA) in adults
weighing over 66
pounds (30 kg). The | The Model 300157
CPAP System is a
single patient reusable
device. The Model
300157 CPAP System
provides continuous
positive airway
pressure (CPAP) to | The REMstar Auto
with C-Flex CPAP
System is a CPAP
(Continuous
Positive Airway
Pressure) device
designed for the
treatment of adult | Identical |
| Substantial Equivalence Comparison | | | . . | , ' |
| | I Transcend Auto | · Model 300157 | REMstar Auto | Comparison |
| | | (Transcend) CPAP | CPAP System with | |
| - - -
:" | | System | C-Flex | |
| | device is intended for | support treatment of | Obstructive Sleep | |
| | home and | adults (over 30 kg) | Apnea (OSA) only. | |
| | hospital/institutional | with Obstructive Sleep | The device is for | |
| | use. | Apnea. | use in the home or | |
| | | | hospital/institution | |
| | | | al environment. | |
| Intended | Adult | Adult | Adult | Identical |
| Population of Use | | | | |
| Accessories | For use with | For use with | For use with | ldentical |
| | Transcend CPAP | Transcend CPAP | REMstar | |
| | accessories | accessories | accessories | |
| Therapy Pressure | 4-20 cm H2O | 4-20 cm H2O | 4-20 cm H2O | ldentical |
| Pressure Regulation | ±1 cm H2O or 10%, | ±1 cm H2O or 10%, |