(254 days)
Not Found
Not Found
No
The description of the "auto mode" indicates an adjustment based on respiration, which is a common feature in non-AI/ML CPAP devices and doesn't explicitly mention or imply the use of AI/ML algorithms for this adjustment. There are no mentions of AI, ML, DNN, training sets, or test sets.
Yes
The device is intended to manage obstructive sleep apnea, which is a medical condition, by delivering air pressure for therapeutic effect.
No
The device is a therapeutic device (CPAP) for managing obstructive sleep apnea, not for diagnosing it. While it performs respiratory sensing, this is for adjusting therapy, not for producing a diagnostic output for a clinician.
No
The device description clearly outlines hardware components including a control unit, air tube, and patient mask, indicating it is not a software-only device.
Based on the provided information, the Morphee Plus Alpha is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "manage obstructive sleep apnea by delivering air pressure through a tube and mask." This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a system that delivers air pressure and senses respiration. This aligns with a respiratory support device, not a device used to examine 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 samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
The Morphee Plus Alpha is clearly described as a device for managing a medical condition through physical means (air pressure delivery).
N/A
Intended Use / Indications for Use
Morphee Plus Alpha is intended to manage obstructive sleep apnea a predetermined program of positive air pressure through administered through a tube and mask.
The Morphee Plus Alpha is intended to manage obstructive sleep apnea by delivering air pressure through a tube and mask. It is intended for use in either the hospital or home environment.
Product codes
73FLS, 73BZD
Device Description
The Morphee Plus Alpha System consists of a line powered control unit, an air tube and a patient mask. The mask is attached to the patient covering the nose and secured with straps. The air tube attaches to the mask and the control unit allowing airflow from the control unit to the mask as well as respitory sensing by the control unit.
The control unit offers both continous (CPAP) and automatice modes. In the continuous mode, the unit functions as a standard CPAP product. The auto mode allows the control unit to adjust the airway pressure based on the patient's respiration.
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
hospital or home 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
The Morphee Plus Alpha System was tested to national and international product safety standards for electrical safety and electromagnetic compatibility. The product was also tested for mechanical, environmental and biocompatibility.
The product met all requirements and is suitable for the intended use.
Key Metrics
Not Found
Predicate Device(s)
Companion 31g Nasal CPAP System - Nellcor Purtitan Bennett, DPAP Interactive Airway Management System - SleepNet Corporation
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUN 18 1997
510(k) Summary
General Information
Nellcor Puritan Bennett 10200 Valley View Road Eden Prairie, MN 55344
| Submitter's Name: | Chris Hadland |
|---|---|
| Phone: | (612) 941-3006 |
| Fax Number: | (612) 829-5423 |
Proprietary Name of the Device
Morphee Plus Alpha
Common Name of the Device
Obstructive Sleep Apnea Management System
Device Classification
Obstructive sleep apnea management systems have been classified as class II by the Anesthesiology and Respiratory Devices Panel. Devices of this type have a classification code of 73FLS, Apnea Detector (21CFR 868.2375) and 73BZD, Non-continuous Ventilator (868.5905).
Intended Use
Morphee Plus Alpha is intended to manage obstructive sleep apnea a predetermined program of positive air pressure through administered through a tube and mask.
Predicate Device Equivalence
Companion 31g Nasal CPAP System - Nellcor Purtitan Bennett DPAP Interactive Airway Management System - SleepNet Corporation
Device Description
The Morphee Plus Alpha System consists of a line powered control unit, an air tube and a patient mask. The mask is attached to the patient covering the nose and secured with straps. The air tube attaches to the mask and the control unit allowing airflow from the control unit to the mask as well as respitory sensing by the control unit.
1
The control unit offers both continous (CPAP) and automatice modes. In the continuous mode, the unit functions as a standard CPAP product. The auto mode allows the control unit to adjust the airway pressure based on the patient's respiration.
Summary of Performance Testing
The Morphee Plus Alpha System was tested to national and international product safety standards for electrical safety and electromagnetic compatibility. The product was also tested for mechanical, environmental and biocompatibility.
The product met all requirements and is suitable for the intended use.
Conclusions
We conclude that the Morphee Plus Alpha System meets its stated performance specifications and meets international safety standards. The clinical indications for use are substantially equivalent to the predicate products as well as the theory of operation and basic product design.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird-like figure, composed of three curved lines that suggest the shape of a bird's head and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chris Hadland Nellcor Puritan Bennett Inc. 10200 Valley View Road ………………………… Eden Prairie, Minnesota 55344
Re: K964019 *,Morphee Plus Alpha Regulatory Class: II (two) Product Code: 73 BZD Dated: March 17, 1997 Received: March 20, 1997
Dear Mr. Hadland:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, listinq of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
JUN 18 1997
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Chris Hadland
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Intended Use
Device Name:
Morphee Plus Alpha
Intended Use:
The Morphee Plus Alpha is intended to manage obstructive sleep apnea by delivering air pressure through a tube and mask. It is intended for use in either the hospital or home environment.
Concurence of CDRH, Office of Device Evaluation
510(k) number: _长剑丝 019
\ Prescription Use
Over the Counter
Mr. Pungl--
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_