The BestFit™ and BestFit™2 Nasal Masks are intended for multiple use on adult patients (body weight >30kg) prescribed with using continuous positive airway pressure (CPAP) or bilevel ventilator system in hospital, clinic and/or home environment.

Device Description

The BestFit™ Nasal Masks are patient interface devices used on adult patients prescribed with CPAP and Bi-Level Positive Airway Pressure therapy. The BestFit product family consists of two models, BestFit and and BestFit 2. Both models have same function and performance, except for a slight difference in the forehead design. Both devices are vented and can be used multiple times in a hospital, clinical and/or home environment. The nasal mask style covers and seals around the patient's nose and delivers positive pressure from the therapy device to the patient via the patient air circuit of the CPAP device. The BestFit Nasal Masks include the following accessories: headgear and Instructions for Use (IFU). The model BestFit Nasal mask is available in 4 different sizes: Small (S), Medium (M), Large (L), and Medium Wide (MW). The model BestFlt 2 Nasal mask is available in 3 different sizes: Small (S), Medium (M), and Large (L).

AI/ML Overview

The provided K130663 submission describes the BestFit™ Nasal Masks and their substantial equivalence to a predicate device, Resmed Ultra Mirage II (K050359). The submission outlines various tests performed to demonstrate compliance with product specifications and relevant standards.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly present a discrete "acceptance criteria" table for the BestFit Nasal Mask models. Instead, it provides a comparative table where the predicate device's performance is the de facto acceptance criterion for several parameters. The "Comparison" column in the table implicitly indicates whether the BestFit models meet or are comparable to the predicate.

Here's a summarized table derived from the "Comparison" section, highlighting parameters where specific performance values are listed:

Parameter	Acceptance Criteria (Predicate: Resmed Ultra Mirage II (K050359))	Reported Device Performance (BestFit / BestFit 2)	Comparison / Outcome
Therapy Pressure	4 - 20 cmH20	4 - 20 cmH20	Same (Meets)
Pressure-Flow Curve	Flow: 18-54 lpm (at 4-20 cmH2O)	BestFit: 17.87-52.12 lpm (at 4-20 cmH2O)BestFit 2: 16.59-49.28 lpm (at 4-20 cmH2O)	Less flow with constant pressure - compliant with internal spec and ISO 17510-2 test procedure (Meets)
Dead Space	135 mL	BestFit: <160 mLBestFit 2: <165 mL	Larger - no clinical effect (Meets)
Sound Level	28 dbA (at 10 cmH2O & 1 Meter)	BestFit: <29 dbABestFit 2: <30 dbA	Louder, compliant with ISO 17510-2 Annex G (Meets)
Resistance to Flow	At 50 lpm, 0.1 cmH20At 100 lpm, 0.3 cmH20	50 lpm, 0.1 cmH20100 lpm, 0.5 cmH20	Same at 50 lpm, more at 100 lpm, Compliant with ISO 17510-2 Annex C (Meets)
Temperature (operating)	3 - 35 °C	3 - 35 °C	Same (Meets)
Mode operation compatibility	CPAP & BiLevel	CPAP & BiLevel	Same (Meets)
Head Gear & Clip	2 at forehead, 2 at lower half, Adjustable	2 at forehead, 2 at lower half, Adjustable	Same (Meets)
Cushion	4 sizes	BestFit - 4 sizesBestFit 2 - 3 sizes	Similar - support various sizes (Meets)
Patient circuit Interface	22 mm conical	22 mm conical	Same (Meets)
Swivel Patient circuit interface	Yes	Yes	Same (Meets)
Support Daily Cleaning	Yes	Yes	Same (Meets)
Support Disinfection	Yes	Yes	Same (Meets)
Indications For Use	Multi-patient re-use for adult patients prescribed CPAP or bilevel therapy in hospitals, clinic and home environment	Multiple use on adult patients (body weight >30kg) prescribed with CPAP or bi-level ventilator system in hospital, clinic and/or home environment	Essentially identical (Meets)

Other tests, like Sound Test, Packaging Testing, System Test Protocol, Cleaning and Disinfection, and Biocompatibility, are stated to have been conducted in accordance with relevant standards (e.g., ISO 17510-2, ISO 10993 series) and confirmed that "the products met the pre-defined acceptance criteria." However, specific numerical acceptance criteria and reported performances for these tests are not detailed in the provided text. The "acceptance criteria" here implicitly refer to compliance with the standards mentioned.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide specific sample sizes for any of the performance tests mentioned (e.g., Pressure-Flow, Dead Space, Sound Level, Resistance to Flow, etc.). The provenance of the data (e.g., country of origin, retrospective or prospective) is also not explicitly stated. It can be inferred that the testing was conducted by the manufacturer, Curative Medical Inc., but the location of the testing laboratories is not given.

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

This information is not provided in the submission. The submission relies on objective engineering and performance testing against industry standards and a predicate device, rather than subjective expert assessment to establish ground truth.

4. Adjudication Method for the Test Set

Since the ground truth was established through engineering and performance testing against standards and a predicate device, an adjudication method typically used for subjective assessment (e.g., 2+1, 3+1) is not applicable and not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of images or other data. The BestFit Nasal Mask is a patient interface device, and its performance is evaluated through engineering and physical tests.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, standalone testing was performed. The performance data presented (e.g., pressure-flow curves, dead space, sound level, resistance to flow) are all results of the device's inherent physical properties and design, tested independently without human interaction influencing the core function being measured. The "System Test Protocol and Report" and "Predicate Comparison Testing" are examples of standalone performance evaluations.

7. The Type of Ground Truth Used

The ground truth used for evaluating the BestFit Nasal Masks is based on:

Compliance with established international and national standards: ISO 17510-2, ISO 10993 series, ISO 5356-1, and ISTA - 2A - 2008.
Performance of a legally marketed predicate device: The Resmed Ultra Mirage II (K050359) serves as the benchmark for several key performance parameters.
Internal specifications and risk analysis: As stated, "All tests confirmed the products met the pre-defined acceptance criteria."

8. The Sample Size for the Training Set

This information is not applicable and not provided. The BestFit Nasal Mask is a physical medical device, not an algorithm or AI model that requires a training set in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As explained in point 8, there is no "training set" for this type of device.

Summary

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K130663

Section 5. 510(k) Summary

510(k) SUMMARY

A 510(k) summary in accordance with the requirements of 21 CFR 807.92.

Submitter:	Curative Medical Inc.3227 Kifer RoadSanta Clara, CA 95051Establishment Number: 3008361782
Company Contact Person:	Cuong Tran, R/D DirectorPhone: (408) 414-2188Fax: (408) 413-3000Email: ctran@curativemedical.com
Submission Correspondent:	Amy McKinney, Regulatory Affairs ConsultantAddress: 6518 Tamarind Sky Ln., Fulshear, TX 77441Phone: (979) 236-1622Email: amckinney29@att.net
Device Name:	BestFitTM Nasal MaskModels:BestFit2 nasal mask, S (30120032) BestFit2 nasal mask, M (30120022) BestFit2 nasal mask, L (30120012) BestFit nasal mask, S (30100030) BestFit nasal mask, M (30100020) BestFit nasal mask, L (30100010) BestFit nasal mask, MW (30100040)
Device Classification Name:	Non-continuous ventilator (BZD)21 CFR 868.5905
Predicate Devices:	Resmed Ultra Mirage II (K050359)
Preparation Date:	August 23, 2013

Device Description:

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The nasal mask style covers and seals around the patient's nose and delivers positive pressure from the therapy device to the patient via the patient air circuit of the CPAP device. The BestFit Nasal Masks include the following accessories: headgear and Instructions for Use (IFU).

The model BestFit Nasal mask is available in 4 different sizes: Small (S), Medium (M), Large (L), and Medium Wide (MW). The model BestFlt 2 Nasal mask is available in 3 different sizes: Small (S), Medium (M), and Large (L).

The BestFit Nasal Masks have the following similarities to the previous cleared predicate device:

. Same intended use
. Same operating principle
. Similar technologies

"Parameter	Resmed ultraMirage II (K050359) *		· BestFit(both models)		Comparison
TherapyPressure	4 - 20 cmH20			4 - 20 cmH20	Same
Pressure-FlowCurve	Pressure(cm H2O)48121620	Flow(Ipm)18ਨ ਰੇ3846ਟੇਤੇ	BESTFIT:Pressurecm H2O48121620BESTFIT 2:Pressurecm H2O48121620	Flow(lpm)17.8728.9437.8845.2552.12Flow(Ipm)16.5926.9235.1842.6049.28	Less flow withconstantpressure -compliant withinternal specand ISO 17510-2 test procedure
Dead spaceInformation	135 mL			BestFit: <160 mLBestFit 2: < 165 mL	Larger - noclinical effect
Sound level(10 cmH20 & 1Meter)	28 dbA			BestFit: <29 dbABestFit 2: <30 dbA	Louder,compliant withISO 17510-2Annex G

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Parameter	Resmed ultra-Mirage II (K050359)	BestFit(both models)	Comparison
Resistance toFlow	At 50 lpm, 0.1 cmH20At 100 lpm, 0.3 cmh20	50 lpm, 0.1 cmH20100 lpm, 0.5 cmH20	Same at 50 lpm,more at 100 lpm,Compliant withISO 17510-2Annex C
Dimension( HxWxD mm)	163 x 91 x 87	155 x 98 x 95 (BestFit)145 x 98 x 97 (BestFit2)	Similar, noclinical effect
Temperature(operating - °C)	3 - 35	3 - 35	Same
Mode operationcompatibility	CPAP & BiLevel	CPAP & BiLevel	Same
Head Gear & Clip	• 2 at forehead• 2 at lower half• Adjustable	• 2 at forehead• 2 at lower half• Adjustable	Same
Cushion	4 sizes	BestFit - 4 sizesBestFit 2 - 3 sizes	Similar - supportvarious sizes
Patient circuitInterface	22 mm conical	22 mm conical	Same
Swivel Patientcircuit interface	Yes	Yes	Same
Support DailyCleaning	Yes	Yes	Same
SupportDisinfection	Yes	Yes	Same
Indications ForUse	Intended formultipatient re-usefor adult patientsprescribedcontinuous positiveairway pressure(CPAP) or bileveltherapy in hospitals,clinic and homeenvironment	intended for multipleuse on adult patients(body weight >30kg)prescribed with usingcontinuous positiveairway pressure (CPAP)or bi-level ventilatorsystem in hospital, clinicand/or homeenvironment	Essentiallyidentical

Intended Use:

The BestFit™ Nasal Masks are intended for multiple use on adult patients (body weight >30kg) prescribed with using continuous positive airway pressure (CPAP) or bi-level ventilator system in hospital, clinic and/or home environment.

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Summary of Performance Data and Substantial Equivalence:

The BestFit™ Nasal Masks were designed and verified in accordance with the risk analysis and product requirements. All tests confirmed the products met the pre-defined acceptance criteria. Curative Medical Inc. has determined that the BestFit Nasal Masks are substantially equivalent to the predicate when used with CPAP and Bi-Level pressure therapy devices. The BestFit Nasal Masks have been tested and shown to be compliant with the following standards documents:

. ISO 17510-2: 2007- Sleep Apnoea Breathing Therapy - Part 2 Masks and application accessories
ISO 10993-1:2009 Biological Evaluation of Medical Devices Part 1: Evaluation and . testing within a risk management process
ISO 10993-3:2003 Biological Evaluation of Medical Devices Part 3: Genotoxicity, . Carcinogenicity and Reproductive Toxicity
. ISO 10993-5: 2009 - Biological evaluation of medical devices Part 5: Tests for in vitro cvtotoxicity
ISO 10993-6:2007 Biological Evaluation of Medical Devices Part 6: Test for local . effect after implantation
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation . and skin sensitization
ISO 10993-10:2002/Amend 1:2006 Biological Evaluation of medical devices Part 10: . Tests for irritation and skin sensitivity
ISO 5356-1:2004 Anaesthetic and Respiratory equipment conical connectors part 1: : Cones and sockets

This 510(k) submission presents the results of the following testing and detailed descriptions to demonstrate that BestFit Nasal Mask is substantially equivalent to the Resmed Ultra Mirage II Nasal Mask (K050359):

Sound Test - Tested sound requirements in accordance with ISO 17510-2: 2007 standard
. Predicate Comparison Testing - Comparative testing of BestFit Nasal Masks to predicate device, Resmed Mirage II
. Packaging Testing - Tested packaging integrity in accordance with ISTA - 2A - 2008
System Test Protocol and Report Tested to ensure compliance with product . specifications and product risk analysis
. Cleaning and Disinfection - Test to ensure compliance and survived daily cleaning and disinfection procedures
. Biocompatibility - Tested to ensure materials are biocompatible in compliance with ISO 10993-1

Testing was conducted to demonstrate the performance of BestFit™ Nasal Masks are substantially equivalent to the predicate device in their intended environment.

Conclusion:

The information and data provided in this 510(k) Notification establishes that the BestFit Nasal masks are substantially equivalent to their legally marketed predicate devices.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the eagle.

Public Health Service

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

September 27, 2013

Curative Medical, Incorporated C/O Ms. Amy E. McKinney, MS, RAC Regulatory Affairs Consultant 6518 Tamarind Sky Lane FULSHEAR TX 77441

Re: K130663

Trade/Device Name: BestFit™ Nasal Mask and BestFit2TM Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Non-continuous ventilator Regulatory Class: Il Product Code: BZD Dated: August 26, 2013 Received: August 27, 2013

Dear Ms. McKinney:

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 10 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. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs 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.

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

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Page 2 - Ms. McKinney

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. 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/ReportalProblem/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/Industrv/default.htm.

Sincerely yours,

Image /page/5/Picture/8 description: The image shows a black and white drawing of a signature. The signature is illegible, but it appears to be written in a cursive style. The signature is complex and ornate, with many flourishes and loops. The signature is likely from a historical document or manuscript.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID

FOR

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4. Indications for Use Statement

510(k) Number (if known): K130663

Device Name: BestFit Nasal Mask and BestFit2 Nasal Mask

Indications For Use:

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Anya C. Harry
--	---------------

	Digitally signed by Anya C. Harry - 5
	U.S. Government transfer to the 1995
	website, confirms Anya C. Harry - S.
	142.234.200.100.1.1-0011315590
	Date 2013.09.27 11:43:52 -04'00'

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K130663

Traditional 510(k) -BestFit Nasal Masks

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).