(187 days)
Not Found
No
The description focuses on the physical components and function of a CPAP mask, with no mention of AI or ML capabilities.
Yes
The device is intended to be used with positive airway pressure devices for the treatment of adult obstructive sleep apnea, which constitutes a therapeutic use.
No
The device description clearly states it is a mask intended for use with positive airway pressure devices (CPAP, Bi-Level devices) to deliver therapy. It provides an interface for the delivery of air, not for diagnosing a condition.
No
The device description clearly details physical components like a mask, headgear, cushion, and breathing tube, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The Invacare Model Twilight Nasal CPAP Mask is a device that provides positive airway pressure directly to the patient's respiratory system. It is an interface used in vivo (within the body) to deliver therapy.
- Lack of Diagnostic Testing: The description clearly states its purpose is to deliver therapy for obstructive sleep apnea, not to perform any diagnostic tests on biological samples.
The device is a therapeutic device used in the treatment of a medical condition, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Invacare Model Twilight Nasal CPAP Mask is intended to be used with positive airway pressure devices such as CPAP, to provide 3-20 cmHzO for the treatment of adult obstructive sleep apnea. The mask is to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single patient use.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The Twilight nasal mask is a prescription device intended for use with Continuous Positive Airway Pressure (CPAP), and Bi-Level devices. It is intended to provide a single patient use interface for the delivery of CPAP or Bi-Level therapy to adult patients (>30Kg). It is designed for use with CPAP and Bi-Level delivery systems having pressure ranges from 3-20 cmH2O.
The Twilight nasal mask consists of a mask that fits over the nose of the patient and a headgear to hold the mask in place. The mask has a removable molded silicone cushion that seals around the patient's nose. A standard and a large cushion are designed for use with the same mask. This also allows for replacement of a worn or damaged cushion without the need to replace the entire mask. The cushion mounts into a rigid polycarbonate shell by means of a flanged area that fits snugly between the wall of the mask shell and an inner retaining ring that is permanently mounted into the shell.
The mask includes an opening that accepts a standard, flexible, 22cm OD breathing tube. The breathing tube is connected to the output of the CPAP/Bi-Level delivery device, and to the input of the Invacare Twilight Nasal Mask. The mask is then placed over the users' nose and mouth. The flexible tube provides a transition between the more rigid output tube of the delivery device, and the mask, thus allowing freedom of movement while maintaining patient circuit integrity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose
Indicated Patient Age Range
Adult patients (>30 kg)
Intended User / Care Setting
Not Found
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)
A number tests were conducted on the Invacare Model Twilight Nasal Mask. In all cases the mask performed as designed and intended.
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
FEB 1 1 2003
KC22642
510(k) SUMMARY (Revised December 16, 2002)
Invacare Corporation's Model Twilight Nasal Mask
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558
Contact Person:
Rae Ann Farrow Manager, Regulatory Compliance
Date Prepared: August 7, 2002
Name of Device and Name/Address of Sponsor
Invacare Model Twilight Nasal Mask
Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558
Common or Usual Name CPAP Mask
Classification Name Ventilator, Non-continuous
Predicate Devices
Resmed Corporation Mirage Nasal Mask (K982530), and the Sleepnet Corporation Model IQ™ Nasal Mask (K993269).
Intended Use
The Invacare Model Twilight Nasal CPAP Mask is intended to be used with positive airway pressure devices such as CPAP, to provide 3-20 cmHzO for the treatment of adult obstructive sleep apnea. The mask is to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single patient use.
1
Technological Characteristics and Substantial Equivalence
A. Device Description
The Twilight nasal mask is a prescription device intended for use with Continuous Positive Airway Pressure (CPAP), and Bi-Level devices. It is intended to provide a single patient use interface for the delivery of CPAP or Bi-Level therapy to adult patients (>30Kg). It is designed for use with CPAP and Bi-Level delivery systems having pressure ranges from 3-20 cmH2O.
The Twilight nasal mask consists of a mask that fits over the nose of the patient and a headgear to hold the mask in place. The mask has a removable molded silicone cushion that seals around the patient's nose. A standard and a large cushion are designed for use with the same mask. This also allows for replacement of a worn or damaged cushion without the need to replace the entire mask. The cushion mounts into a rigid polycarbonate shell by means of a flanged area that fits snugly between the wall of the mask shell and an inner retaining ring that is permanently mounted into the shell.
The mask includes an opening that accepts a standard, flexible, 22cm OD breathing tube. The breathing tube is connected to the output of the CPAP/Bi-Level delivery device, and to the input of the Invacare Twilight Nasal Mask. The mask is then placed over the users' nose and mouth. The flexible tube provides a transition between the more rigid output tube of the delivery device, and the mask, thus allowing freedom of movement while maintaining patient circuit integrity.
B. Substantial Equivalence
The Invacare Model Twilight Nasal Mask covered by this submission is substantially equivalent to the other devices currently being marketed in the United States that have been granted marketing clearance by FDA. Specifically, the Twilight Mask is substantially equivalent to the Resmed Corporation Mirage Nasal Mask (K982530), and the Sleepnet Corporation Model IQ™ Nasal Mask (K993269).
Performance Data
A number tests were conducted on the Invacare Model Twilight Nasal Mask. In all cases the mask performed as designed and intended.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
FEB 1 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Rae Ann Farrow Manager, Regulatory Compliance Invacare Corporation One Invacare Way Elyria, Ohio 44036
Re: K022642
Trade/Device Name: Invacare's Model ISP9600 Twilight Nasal Mask Regulation Number: 868.5905 Regulation Name: Non-continuous Ventilator Regulatory Class: II Product Code: BZD Dated: November 12, 2002 Received: November 14, 2002
Dear Ms. Farrow:
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.
3
Page 2 - Ms. Farrow
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 (OS) 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 Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Susan Runrer
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
10(k) Number (if known): K022642
Device Name: Invacare's Model ISP9600 Twilight Nasal Mask
Indications For Use:
The Invacare Model Twilight Nasal CPAP Mask is intended to be used with positive airway pressure devices such as CPAP, to provide 3-20 cmH2O for the treatment of adult obstructive sleep The mask is to be used on adult patients (>30 kg) for whom positive airway pressure apnea. therapy has been prescribed. The mask is intended for single patient use.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | V |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-The-Counter Use
sion Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devi-
510(k) Number ..
(Optional Format 1-2-96)