(64 days)
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.
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.
Analysis of Invacare Twilight II Nasal Mask 510(k) Summary
This document describes the acceptance criteria and the study that proves the Invacare Twilight II Nasal Mask meets the acceptance criteria, based on the provided 510(k) summary.
Key Finding: The 510(k) summary primarily addresses the disinfection process allowing for multiple patient reuse as the main difference from predicate devices. The performance data focuses on demonstrating substantial equivalence, particularly regarding the disinfection process, rather than establishing direct clinical efficacy of the mask itself through a comparative effectiveness study.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided 510(k) summary does not explicitly list numerical acceptance criteria for a "device performance" in terms of clinical outcomes or specific engineering metrics (e.g., seal pressure, leak rate, comfort scores) directly comparable in a table with reported performance. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices and meeting disinfection standards.
Therefore, the table below reflects what can be inferred from the document regarding "acceptance" and "performance."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| A. Substantial Equivalence for Intended Use: | "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." |
| Intended Use: Treatment of adult obstructive sleep apnea (OSA) with positive airway pressure (PAP) devices. | Confirmed as: "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." |
| Patient Population: Adult patients (>30 kg) | Confirmed as: "The mask is to be used on adult patients (>30 kg)..." |
| Device Compatibility: PAP devices 3-20 cmH2O | Confirmed as: "It is designed for use with positive airway pressure devices having pressure ranges from 3-20 cmH2O." |
| B. Disinfection Efficacy & Durability: | |
| High-level disinfection capability for multiple patient reuse. | "This mask has been tested to meet the requirements of AAMI TIR12 for high-level disinfection." |
| Durability to withstand repeated disinfection cycles. | "Testing has shown the mask can be disinfected 30 times without loss of effectiveness." |
| Compatibility with specified disinfection agents. | "Following cleaning with Enzol® enzymatic cleaning detergent, the mask is disinfected using a Cidex OPA solution or STERRAD Disinfection System." |
| C. General Performance (Implied by Predicate Devices): | |
| Maintain patient circuit integrity. | Implicitly met by design (flexible tube, standard 22mm connector, seal around nose). |
| Allow for pressure measurement. | Confirmed: "There is a port on the mask swivel to allow for pressure measurement." |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify a "test set" in the context of clinical performance data in human subjects for the Twilight II Nasal Mask. The primary performance data relates to disinfection efficacy and durability.
- Test Set for Disinfection: The summary states, "Testing has shown the mask can be disinfected 30 times without loss of effectiveness." This implies a sample size of at least one mask, or a representative number, was subjected to 30 disinfection cycles. The exact number of masks tested is not provided.
- Data Provenance: The nature of disinfection testing would be laboratory-based (in vitro) and likely conducted by the manufacturer or an independent testing lab. The country of origin for the data is not specified but is presumably within the regulatory framework of the US submission (Invacare Corporation is based in Ohio). This type of testing is generally prospective as it evaluates a specific protocol applied to the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the context of this 510(k) summary. The "ground truth" for disinfection efficacy is established through standardized laboratory testing (AAMI TIR12 requirements), not expert consensus on human performance or diagnosis.
4. Adjudication Method for the Test Set
Not applicable. The disinfection testing would involve objective measurements (e.g., microbial counts, material degradation assessment) rather than subjective expert adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is a medical accessory, not an AI-powered diagnostic or assistive tool. No MRMC study was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a passive accessory and does not involve an algorithm.
7. The Type of Ground Truth Used
- For Disinfection Efficacy: The ground truth is laboratory-defined standards for high-level disinfection (AAMI TIR12) and the absence of material degradation or loss of effectiveness after repeated cycles. This is based on objective scientific measurements in a controlled environment.
- For Substantial Equivalence: The ground truth is the performance and safety profiles of the identified predicate devices (Invacare Twilight Nasal Mask K022642 and ResMed Mirage Activa Nasal Mask K030798), which were previously cleared by the FDA. The performance data demonstrates the Twilight II Nasal Mask "performs in a manner that is substantially equivalent to the predicate devices."
8. The Sample Size for the Training Set
Not applicable. There is no training set in the context of this device. The device itself is not an algorithm that learns from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
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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
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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.
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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.
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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
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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
§ 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).