The GoLife Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital/institutional environment. This mask is to be used on patients greater than 66 lbs /30 kg.

Device Description

The GoLife Nasal Mask is intended to be used with positive airway pressure devices such as CPAP or bilevel systems. It provides a seal such that positive pressure from the positive pressure source is directed into the patient's nose. It is held in place with an adjustable headgear. It may be cleaned by the patient in the home using warm water and a mild liquid dish washing detergent (single patient use) or cleaned by the professional in the hospital/institutional environment through thermal or chemical high-level disinfection processes (multi-patient use). The design consists of a silicone nasal pillows cushion designed to fit in the patients' nostrils. The cushion is designed in such a way that it minimizes leaks and is comfortable for the patient. The cushion is connected to a nasal cushion support (frame) that rests along the patient's cheeks and supports the cushion. Areas of the frame that contact the patient's cheeks are covered in a fabric material for comfort purposes. A polycarbonate elbow is connected at the frame. The elbow is capable of rotating freely through 360 degrees. The fabric headgear is connected to the mask through slots in the frame. The nasal pillows cushion and elbow are designed in such a way that it can be easily removed, from the frame for cleaning or replacement purposes. The elbow is attached to 15mm EVA tubing that is fitted at the end with a 22mm polycarbonate swivel connector. This fitting is used to connect conventional air delivery hose between the mask and the positive airway pressure source. The 22mm swivel connector is designed in such a way that it can rotate freely through 360 degrees. The built-in vent openings are molded into the front side of the vent openings are used to flush exhaled CO2 out of the circuit and may be visually inspected for obstruction prior to use.

AI/ML Overview

The provided text describes a 510(k) summary for the GoLife Nasal Mask. However, it does not include a table of acceptance criteria with reported device performance or information about a study proving the device meets specific performance criteria in terms of clinical accuracy or diagnostic efficacy. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and functionality testing, and biocompatibility assessment.

Here's a breakdown of the requested information based on the provided text, with "N/A" where the information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly from testing)	Reported Device Performance
Performance & Functionality	Intentional Leak (pre/post cleaning)	Met performance specifications
	Unintentional Leak (pre/post cleaning)	Met performance specifications
	Pressure Drop (pre/post cleaning)	Met performance specifications
Cleaning & Disinfection Efficacy	Minimum 6 log reduction (high-level disinfection)	Achieved minimum 6 log reduction per AAMI/ASTM standards
Biocompatibility	Irritation (ISO 10993-10)	Complied with ISO 10993-1, no issues reported
	Sensitization (ISO 10993-10)	Complied with ISO 10993-1, no issues reported
	Cytotoxicity (ISO 10993-5)	Complied with ISO 10993-1, no issues reported

Study Description:

The study that proves the device meets the above (implied) acceptance criteria is a series of non-clinical bench tests. These tests were conducted to demonstrate that the performance and functionality of the GoLife Nasal Mask (modified version) were unaffected by changes in manufacturing processes (specifically, the inclusion of chemical and thermal disinfection for multi-patient use), and that it remained substantially equivalent to its predicate device. The tests included:

Performance Testing: Intentional leak, unintentional leak, and pressure drop testing. These were performed both before and after cleaning and disinfection treatments to ensure consistent performance.
Cleaning and Disinfection Efficacy Testing: This was performed to ensure the mask could achieve high-level disinfection, specifically to assure a minimum of 6 log reductions, tested in accordance with AAMI TIR No. 12-2004, AAMI TIR 30-2003, ASTM E1837-96 (2007), and relevant FDA guidance documents.
Biocompatibility Assessment: An assessment in accordance with ISO 10993-1 was completed for all skin-contacting and air path-contacting materials. This included irritation and sensitization (ISO 10993-10) and cytotoxicity (ISO 10993-5) biocompatibility tests.

The results of these tests concluded that the GoLife Nasal Mask "meets its performance specifications, raises no new issues of safety or effectiveness, and is substantially equivalent to the identified device predicate."

2. Sample Size for Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated in the document. The text mentions "performance testing" and "efficacy testing" was completed, implying multiple units were tested, but the exact number is not provided.
Data Provenance: The tests are explicitly described as "non-clinical test" and "bench testing," meaning they were conducted in a laboratory or controlled environment, not on human patients. Therefore, there is no "country of origin of the data" in the clinical sense, and the data is not retrospective or prospective from patient studies.

3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications

N/A. Since this was non-clinical bench testing for a physical device (mask), the "ground truth" was established by objective measurements and standardized test protocols (e.g., AAMI, ASTM, ISO standards) rather than expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

N/A. As described above, the testing involved objective measurements against established technical specifications and standards, not subjective assessments requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "Use of nasal masks with CPAP or bi-level therapy is proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy of the GoLife Nasal Mask, as was the case with the predicate device." This indicates that no MRMC or human reader study was deemed necessary as the device is not an AI or diagnostic tool affecting human interpretation.

6. Standalone Performance Study (Algorithm Only)

N/A. This is a physical medical device (nasal mask), not an algorithm or AI system.

7. Type of Ground Truth Used

The ground truth for the non-clinical testing was based on objective technical specifications and standardized test methods (e.g., AAMI, ASTM, ISO standards) for parameters like leak rates, pressure drop, disinfection efficacy (log reduction), and biocompatibility.

8. Sample Size for Training Set

N/A. This is a physical device, not an AI model that requires a training set.

9. How Ground Truth for Training Set Was Established

N/A. Not applicable as there is no training set for a physical device.

Summary

{0}------------------------------------------------

TAB 3

FEB 17 2011

510(K) SUMMARY

Date of Submission	30 December 2010
510(k) Owner	Respironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668
	(724) 387-4146(724) 387-3999 (fax)
Official Contact	Michelle BrinkerRegulatory Affairs Manager, Patient Interface
Proprietary Name	GoLife Nasal Mask
Common/Usual Name	Nasal Mask
Classification Name /Product Code	BZD - Ventilator, non-continuous (respirator)
Predicate Device(s)	Respironics GoLife Nasal Mask (K102502)

Device Description

The design consists of a silicone nasal pillows cushion designed to fit in the patients' nostrils. The cushion is designed in such a way that it minimizes leaks and is comfortable for the patient. The cushion is connected to a nasal cushion support (frame) that rests along the patient's cheeks and supports the cushion. Areas of the frame that contact the patient's cheeks are covered in a fabric material for comfort purposes. A polycarbonate elbow is connected at the frame. The elbow is capable of rotating freely through 360 degrees. The fabric headgear is connected to the mask through slots in the frame. The nasal

{1}------------------------------------------------

pillows cushion and elbow are designed in such a way that it can be easily removed, from the frame for cleaning or replacement purposes.

The elbow is attached to 15mm EVA tubing that is fitted at the end with a 22mm polycarbonate swivel connector. This fitting is used to connect conventional air delivery hose between the mask and the positive airway pressure source. The 22mm swivel connector is designed in such a way that it can rotate freely through 360 degrees.

The built-in vent openings are molded into the front side of the vent openings are used to flush exhaled CO2 out of the circuit and may be visually inspected for obstruction prior to use.

Intended Use

Summary of Technological Characteristics of Device Compared to the Predicate Device

The GoLife Nasal Mask has the following similarities in the technological characteristics to the previously cleared device (GoLife, K102502):

. Same intended use
. Same operating principle
Same technology l
Same material used l
Similar device design and physical properties "
Same scientific concepts that form the basis for the device 트

The GoLife Nasal Mask has the following differences in the technological characteristics to the previously cleared device (GoLife, K102502):

The hospital/institutional cleaning and disinfection treatment options for the modified mask . includes both chemical and thermal disinfection processes, whereas the predicate may be disinfected through thermal methods.

{2}------------------------------------------------

Summary of the Non-Clinical Test Submitted, Referenced or Relied on in the 510(k)

には、この後、「この時、」、「このこと、「ここで、」、「ここで、「ここで、」、「ここで、」、「このことになる」、「このことになるので、」」、「

To demonstrate performance and functionality was unaffected as a result of these changes, performance testing, including intentional leak, unintentional leak, and pressure drop testing was completed. Testing was performed pre and post cleaning and disinfection treatments. Additionally, cleaning and disinfection efficacy testing was performed to ensure that the mask could be high level disinfected to assure a minimum of 6 log reductions for this mask as tested in accordance with AAMI TIR No. 12-2004, AAMI TIR 30-2003, ASTM E1837-96 (2007), and the "Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants" -- FDA CDRH, January 3, 2000.A biocompatibility assessment in accordance with ISO 10993-1 was completed for all skin-contacting and air path-contacting materials. As required by the standard, the test suite included irritation and sensitization (ISO 10993-10) and cytotoxicity (ISO 10993-5) biocompatibility tests.

Results from this testing concluded that the verification testing performed verified that the GoLife Nasal Mask meets its performance specifications, raises no new issues of safety or effectiveness, and is substantially equivalent to the identified device predicate.

Clinical Data

Use of nasal masks with CPAP or bi-level therapy is proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy of the GoLife Nasal Mask, as was the case with the predicate device.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle, there is a stylized symbol featuring three abstract, curved shapes that resemble human figures or flowing lines. The logo is black and white and has a simple, clean design.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Michelle Brinker Regulatory Affairs Manager, Patience Interface Respironics, Incorporated 1001 Murry Ridge Lane Murrysville, Philadelphia 15668

FEB 17 2011

Re: K110008

Trade/Device Name: GoLife Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: January 31, 2011 Received: February 2, 2011

Dear Ms. Brinker :

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.

{4}------------------------------------------------

Page 2- Ms. Brinker

Enclosure

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 (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.

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Anthony Vino

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

{5}------------------------------------------------

Page __ 1_ of_ 1

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ____GoLife Nasal Mask ___________________________________________________________________________________________________________________________________________

Indications for Use: The GoLife Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital/institutional environment. This mask is to be used on patients greater than 66 lbs /30 kg.

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)
--------------------------------------------------------

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number:	K110008
----------------	---------

Regulation Number and Section

§ 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).