(148 days)
No
The device description and performance studies focus on the physical characteristics and performance of a mask for use with a valved holding chamber, with no mention of AI or ML.
No
The device is a mask intended to help administer aerosolized medication, rather than directly providing a therapeutic effect itself. It's an accessory to a medication delivery system.
No
The device is a mask intended to help administer aerosolized medication, not to diagnose a condition or disease.
No
The device description clearly states it is a physical mask component for use with a valved holding chamber, and the performance studies involve physical tests like fine particle dose comparison and leak tests. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to help administer aerosolized medication from metered dose inhalers. This is a therapeutic or drug delivery function, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a mask used with a valved holding chamber for medication delivery. There is no mention of analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on drug delivery characteristics (fine particle dose) and mask sealing (leak test). These are relevant to the function of a drug delivery device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic results.
Therefore, the LiteTouch medium mask for ages 1-5 is a medical device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LiteTouch medium mask for ages 1-5 is to be used with OptiChamber Advantage Valved Holding Chambers. The mask is intended to be used to help administer aerosolized medication from most pressurized metered dose inhalers used with valved holding chambers as prescribed by a physician or health care professional. The intended environments for use include homes, hospitals, and clinics.
Product codes
CAF
Device Description
The LiteTouch mask is a Class II device. It is a mask for use with Respironics' OptiChamber Valved Holding Chamber (K962822).
The LiteTouch mask is a mask that utilizes the same operating principles as the AeroChamber Max Valved Holding Chamber Small and Medium Mask (K032972). The difference between the LiteTouch mask and the AeroChamber Max Valved Holding Chamber Small and Medium Mask is that, the LiteTouch mask does not come assembled to the chamber and the exhalation valve is located in different positions and is not of the same shape. (See picture below).
The LiteTouch mask comprises of a Flap Valve and a Cushion plate.
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
1-5
Intended User / Care Setting
Physician or health care professional. The intended environments for use include homes, hospitals, and clinics.
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)
Non-Clinical Tests:
The LiteTouch medium mask was tested while attached to the OptiChamber Valved Holding Chamber in comparison with the OptiChamber Valved Holding Chamber (K962822) for Fine particle Dose.
Fine Particle Dose Comparison (0.4-4.7µg):
- OptiChamber with LiteTouch: Ventolin 21.1, Flovent 18.5, Atrovent 3.7
- OptiChamber without LiteTouch: Ventolin 29.5, Flovent 27.1, Atrovent 5.4
Fine Particle Dose Percentage (Drug mass recovered) OCA with LiteTouch vs OCA without LiteTouch (%): - Ventolin 71.5, Flovent 68.3, Atrovent 68.5
The LiteTouch medium mask was also tested during inhalation in comparison with other facemasks to determine leaks.
Clinical Tests Performed: Not Applicable
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
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
JUN 2 9 2010
Section 5
510(K) SUMMARY
Prepared: October 15, 2009
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
The assigned 510(k) number is: K100285
1. Submitter's Identification:
Respironics New Jersey, Inc. 5 Wood Hollow Road Parsippany, New Jersey 07054 Phone: 973-581-6008 Fax: 973-599-5650 Contact Name: Lauren Ziegler e-mail: lauren.ziegler@respironics.com
Establishment Registration Number : 2243193
Official Correspondent:
Lauren Ziegler Director, QA, RA, and Clinical Affairs 5 Wood Hollow Road Parsippany, New Jersey 07054 Phone: 973-581-6008 Fax: 973-599-5650 e-mail: Lauren.ziegler@respironics.com
- Name of the Device:
LiteTouch mask Common Name or Classification Name (21 CFR Part 807.87) of Device: Mask, 21 CFR Part 868.5630. Device Classification: CAF
1
Predicate Device Information: 3.
Identification of legally marketed device which we claim substantial equivalence to: AeroChamber Max Valved Holding Chamber Small and Medium Mask K032972 AeroChamber Plus Valved Holding Chamber (K992917) Trudell Medical International. 725 Third Street London, Ontario Canada, N5V 5G4
Device Description: 4.
The LiteTouch mask is a Class II device. It is a mask for use with Respironics' OptiChamber Valved Holding Chamber (K962822).
The LiteTouch mask is a mask that utilizes the same operating principles as the AeroChamber Max Valved Holding Chamber Small and Medium Mask (K032972). The difference between the LiteTouch mask and the AeroChamber Max Valved Holding Chamber Small and Medium Mask is that, the LiteTouch mask does not come assembled to the chamber and the exhalation valve is located in different positions and is not of the same shape. (See picture below).
Image /page/1/Figure/5 description: The image is a diagram of a face mask with two labeled parts. The first labeled part, "Face Plate Cushion Assembly", is labeled with the number 1. The second labeled part, "Flap Valve", is labeled with the number 2.
2
The objective in using a mask is to have patients who are unable to use a spacer mouthpiece or have difficulty with hand-breath coordination get their medication through normal breathing pattern.
To use the LiteTouch mask, the user needs to unpack the mask and attach it to the mouthpiece end of the spacer. The MDI (including the actuator) is inserted into the opening in the MDI adaptor at the distal end of the spacer. The MDI and the spacer combination should be shaken vigorously just prior to inhalation. The patient should exhale normally through the mask. The valve from the mask prevents room air from entering the mask as the patient inhales. The valve's opening and closing movement also indicates that there is an effective mask/face seal; that the patient is breathing and how fast the patient is breathing.
The LiteTouch mask comprises of a Flap Valve and a Cushion plate.
5. Intended Use:
The LiteTouch medium mask for ages 1-5 is to be used with OptiChamber Advantage Valved Holding Chambers. The mask is intended to be used to help administer aerosolized medication from most pressurized metered dose inhalers used with valved holding chambers as prescribed by a physician or health care professional. The intended environments for use include homes, hospitals, and clinics.
6. Comparison to Predicate Devices:
The subject LiteTouch mask and the predicate device (AeroChamber Max Valved Holding Chamber Small and Medium Mask (K032972) are indicated for the same intended use. The difference between the LiteTouch mask and the AeroChamber Max Valved Holding Chamber Small and Medium Mask is that, the LiteTouch mask does not come assembled to the chamber and the exhalation valve is located in different locations and is not of the same shape.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
The LiteTouch medium mask was tested while attached to the OptiChamber Valved Holding Chamber in comparison with the OptiChamber Valved Holding Chamber (K962822) for Fine particle Dose (Reference table 1 below).
3
FINE PARTICLE DOSE COMPARISON (0.4-4.7µg)
| Devices | Drugs | ||
|---|---|---|---|
| Ventolin | Flovent | Atrovent | |
| OptiChamber with LiteTouch | 21.1 | 18.5 | 3.7 |
| OptiChamber without LiteTouch | 29.5 | 27.1 | 5.4 |
FINE PARTICLE DOSE PERCENTAGE (Drug mass recovered) OCA with LiteTouch vs OCA without LiteTouch (%)
| Devices | Drugs | ||
|---|---|---|---|
| (OptiChamber with LiteTouch | |||
| $\div$ | |||
| Optichamber without LiteTouch) | |||
| *100 | Ventolin | Flovent | Atrovent |
| 71.5 | 68.3 | 68.5 |
Table 1
The LiteTouch medium mask was also tested during inhalation in comparison with other facemasks to determine leaks (Reference table 2 below).
4
| DCAICCS | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| rce | Litetouch (softSeal | mask | AeroChamber Plus masl | )ptiChamber mask | (Pediatric | eroChamber | Max | mas | PocketChamber mask | ||||||||||||||||
| - డిం | -10° | 00 | 50 | 100 | |||||||||||||||||||||
| 1 0 | -50 | -10° | no | ಕೊ | 100 | -ಕಿಂ | -100 | 00 | |||||||||||||||||
| C | ട്രം | 100 | -50 | -10° | |||||||||||||||||||||
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 00 | నం | 100 | -50 | -10° | 00 | ਦੇ ਹ | 100 | |||||||||||||||||
| 1 0 | |||||||||||||||||||||||||
| 10 | ----------------------------- | ||||||||||||||||||||||||
| 13.8 | 79.6 | 0 77 | |||||||||||||||||||||||
| 6.1 W | 23 | 81.4 | 75 7 | ||||||||||||||||||||||
| i | 79 | 74.2 | 89.5 | 076 | 65.2 | 14.2 | |||||||||||||||||||
| t | ર 8 | 78.1 | 96.3 | રતું ર | 77 7 | ||||||||||||||||||||
| 4.4 | 73.6 | 93.3 | C |
- | 98.8 | C
97 | 08 | 99.4 | 1 00 |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 612
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02 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
00 |
LEAK TEST RESULTS WITH TILT ANGLES AND APPLIED FORG
Devices
Table 2
Force:
.
- , 41b are forces applied to the facemasks while on the face to create a sea
-
gele (0° is the baseline)
" is the angle of the chine is the baseline creating a gap between the mask and the nose bridge.
" is the angle of the chin tilting 10° upward from . . . . . . -
the angle of the chin tilting 5° downward from the baseline creating a gap between the mask and the ch
5
8. Discussion of Clinical Tests Performed:
Not Applicable
9. Conclusions:
We have demonstrated that the LiteTouch Mask is as safe and effective as a predicate device, the AeroChamber Max Valved Holding Chamber Small and Medium mask, presently on the market, based on substantially equivalent of effectiveness of the seal to the face, Dead space volume, and resistance to inhalation testing. The performance of the LiteTouch before and after washing is also substantially equivalent. The two devices are also substantially equivalent in terms of their operating principle and indications for use.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Respironics New Jersey, Incorporated C/O Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062
JUN 2 9 2010
Re: K100285
Trade/Device Name: LiteTouch Mask Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: June 10, 2010 Received: June 14, 2010
Dear Mr. Devine:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
7
Page 2- Mr. Devine
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): K100285
Device Name: LiteTouch mask
Indications for Use:
The LiteTouch medium mask for ages 1-5 is to be used with OptiChamber Advantage Valved Holding Chambers. The mask is intended to be used to help administer aerosolized medication from most pressurized metered dose inhalers used with valved holding chambers as prescribed by a physician or health care professional. The intended environments for use include homes, hospitals, and clinics.
Prescription Use X (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)
$\qquad$ Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off) Jivision of Anesthesiology, General Hospital infection Control, Dental Devices
510(k) Number: K100285 4-2
i