(64 days)
No
The description focuses on the mechanical components and intended use of a nasal mask for CPAP therapy, with no mention of AI or ML technologies.
Yes
The device is described as being used with positive airway pressure devices for the "treatment of adult obstructive sleep apnea," indicating a therapeutic purpose.
No
Explanation: The device is a nasal mask intended for use with positive airway pressure devices for the treatment of obstructive sleep apnea. Its function is to deliver therapy, not to diagnose a condition.
No
The device description clearly outlines physical components like a mask, headgear, cushion, and shell, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Invacare Model Twilight II Nasal Mask is a medical device used to deliver positive airway pressure to a patient's respiratory system. It is a physical interface between a CPAP machine and the patient's nose.
- Lack of Biological Sample Analysis: The description clearly states the mask's function is to provide a seal and deliver air. There is no mention of analyzing biological samples or performing any diagnostic tests on bodily fluids or tissues.
The device is a therapeutic device used in the treatment of obstructive sleep apnea, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Invacare Model Twilight II Nasal Mask is intended to be used with positive airway pressure devices such as CPAP, for the treatment of adult obstructive sleep apnea. There is a port on the mask swivel to allow for pressure measurement. 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 or multiple patient re-use.
Product codes
BZD
Device Description
The Invacare Twilight II Nasal Mask is a prescription device intended for use with positive airway pressure devices. It is intended to provide single or multiple patient use/reuse for the delivery of respiratory therapy to adult patients (>30 Kg) with obstructive sleep apnea in a sleep lab or home care setting. It is designed for use with positive airway pressure devices having pressure ranges from 3-20 cmH2O.
The Invacare Twilight II Nasal mask consists of a mask that fits over the nose of the patient and headgear to hold the mask in place. The mask has a removable molded silicone cushion that seals around the patient's nose. A small, 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, 22mm (outside diameter) breathing tube. The breathing tube is connected to the output of the positive airway pressure device and to the input of the Invacare Twilight II Nasal Mask. The mask is then placed over the user's nose. The flexible tube provides a transition between the more rigid output tube of the delivery device and the mask, thus allowing fr3eedom of movement while maintaining patient circuit integrity.
The Invacare Twilight II Nasal Mask can be reused on multiple patients by disinfecting the mask according to provided instructions. Following cleaning with Enzol® enzymatic cleaning detergent, the mask is disinfected u sing a Cidex OPA solution or STERRAD Disinfection System. Testing has shown the mask can be disinfected 30 times without loss of effectiveness.
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
Sleep lab or home care setting
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)
Performance Testing: This mask has been tested to meet the requirements of AAMI TIR12 for highlevel disinfection. Other performance standards used are the same as those used in the submission for the Twilight Nasal Mask, K022642.
Performance Data: This device is similar to the predicate devices and incorporates features from both. The only difference as compared to both predicate devices is the disinfection process, which will allow multiple users. The performance data shows the Invacare Twilight II Nasal Mask performs in a manner that is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the Invacare logo. The logo is white text on a black oval background. The word "Invacare" is written in all capital letters.
5 2006
510(K) SUMMARY FOR INVACARE CORPORATION'S TWILIGHT II NASAL MASK
This summary of 510(k) safety and effectiveness information is being supplied in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92
The assigned 510(k) number is K061874.
Date: August 31, 2006
Submitted by: Invacare Corporation One Invacare Way Elyria, Ohio 44035-4190
Telephone: 440-329-6595 Fax: 440-326-3607
Contact Person: Janice Brownlee, Director, Regulatory Affairs and Quality Systems
Trade Name: Twilight II Nasal Mask (Note: to distinguish this modification from the original mask in the marketplace, it will be marketed as the Twilight II, though the test reports may have referred to it as the Twilight Mask)
Common Name: CPAP Mask
Classification Name: Non-continuous ventilator (IPPB) accessory 21CFR 868.5905
Legally Marketed Predicate Device(s): ISP9600 Twilight Nasal Mask: K022642, February 11, 2003 ResMed Mirage Activa Nasal Mask; K030798, April 9, 2003
Device Description:
The Invacare Twilight II Nasal Mask is a prescription device intended for use with positive airway pressure devices. It is intended to provide single or multiple patient use/reuse for the delivery of respiratory therapy to adult patients (>30 Kg) with obstructive sleep apnea in a sleep lab or home care setting. It is designed for use with positive airway pressure devices having pressure ranges from 3-20 cmH2O.
The Invacare Twilight II Nasal mask consists of a mask that fits over the nose of the patient and headgear to hold the mask in place. The mask has a removable molded silicone cushion that seals around the patient's nose. A small, 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
INVACARE CORPORATION One Invacare Way P.O. Box 4028 Elyria, Ohio 44036-2125 USA 440-329-6000 Fax: 440-366-1803 www.invacare.com
1
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, 22mm (outside diameter) breathing tube. The breathing tube is connected to the output of the positive airway pressure device and to the input of the Invacare Twilight II Nasal Mask. The mask is then placed over the user's nose. The flexible tube provides a transition between the more rigid output tube of the delivery device and the mask, thus allowing fr3eedom of movement while maintaining patient circuit integrity.
The Invacare Twilight II Nasal Mask can be reused on multiple patients by disinfecting the mask according to provided instructions. Following cleaning with Enzol® enzymatic cleaning detergent, the mask is disinfected u sing a Cidex OPA solution or STERRAD Disinfection System. Testing has shown the mask can be disinfected 30 times without loss of effectiveness.
Intended Use: The Invacare Model Twilight II Nasal Mask is intended to be used with positive airway pressure devices such as CPAP, for the treatment of adult obstructive sleep apnea. There is a port on the mask swivel to allow for pressure measurement. 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 or multiple patient re-use.
Substantial Equivalence: The Invacare Twilight II Nasal Mask is similar in design, intended use, safety and performance specifications as the Invacare Twilight Nasal Mask, cleared under 510(k) accession number K022642 on February 11, 2003 and the ResMed Mirage Activa Nask, cleared under 510(k) accession number K030798 on April 9, 2003.
Performance Testing: This mask has been tested to meet the requirements of AAMI TIR12 for highlevel disinfection. Other performance standards used are the same as those used in the submission for the Twilight Nasal Mask, K022642.
Performance Data: This device is similar to the predicate devices and incorporates features from both. The only difference as compared to both predicate devices is the disinfection process, which will allow multiple users. The performance data shows the Invacare Twilight II Nasal Mask performs in a manner that is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized image of an eagle with three human figures in silhouette within its body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle image.
SEP - 5 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Janice Brownlee Director, Regulatory Affairs and Quality Systems Invacare Corporation One Invacare Way Elyria, Ohio 44035-4190
Re: K061874
Trade/Device Name: Invacare Twilight II Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontiuous Ventilator Regulatory Class: II Product Code: BZD Dated: August 24, 2006 Received: August 25, 2006
Dear Ms. Brownlee:
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. Brownlee
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 (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.
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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chris Li, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K061874
Device Name: Invacare Twilight II Nasal Mask
Indications for Use: The Invacare Model Twilight II Nasal Mask is intended to be used with positive Indications for Use. The miacale Model 1 Willight in Heatherive sleep appea. There is a port airway pressure devices such as CI AT , 101 the reasurement. The mask is to be used on adult patients (>30 kg) on the mask Swiver to anow for pressure therapy has been prescribed. The mask is intended for single or multiple patient re-use.
Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Anne Sullivan
്ഥി of Anesthesiology, General Hospital, Cuon Control, Dental Devices () Number:
Page 1 of
Response to Questions For 510k 061874 Page 32