Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical design and function of a nasal mask for CPAP/Bi-Level therapy and does not mention any software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

No.
The device is a patient interface (nasal mask) used in conjunction with a CPAP or bilevel ventilator system, which are the therapeutic devices. The mask itself does not provide therapy but delivers the therapy from an external device.

Diagnostic

No

The device is a nasal mask, a patient interface device used with CPAP or bilevel ventilator systems, which delivers positive airflow for therapy, not for diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "patient interface device" and describes physical components like the mask, forehead design, and headgear, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for delivering positive airway pressure (CPAP or bilevel ventilation) to patients. This is a therapeutic function, not a diagnostic one.
Device Description: The description details a patient interface device (a mask) used to deliver air pressure. It does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.), which is the core of IVD devices.
No mention of biological samples or analysis: The entire document focuses on the physical interface and its use in delivering therapy. There is no mention of collecting, processing, or analyzing any biological materials.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

BZD

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).

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

adult patients (body weight >30kg)

Intended User / Care Setting

hospital, clinic and/or home environment.

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)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Resmed Ultra Mirage II (K050359)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

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 Road
Santa Clara, CA 95051
Establishment Number: 3008361782 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact Person: | Cuong Tran, R/D Director
Phone: (408) 414-2188
Fax: (408) 413-3000
Email: ctran@curativemedical.com |
| Submission Correspondent: | Amy McKinney, Regulatory Affairs Consultant
Address: 6518 Tamarind Sky Ln., Fulshear, TX 77441
Phone: (979) 236-1622
Email: amckinney29@att.net |
| Device Name: | BestFitTM Nasal Mask
Models:
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:

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.

1

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 ultra
Mirage II (K050359) * | | · BestFit
(both models) | | Comparison |
|----------------------------------------|--------------------------------------------------|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Therapy
Pressure | 4 - 20 cmH20 | | | 4 - 20 cmH20 | Same |
| Pressure-Flow
Curve | Pressure
(cm H2O)
4
8
12
16
20 | Flow
(Ipm)
18
ਨ ਰੇ
38
46
ਟੇਤੇ | BESTFIT:
Pressure
cm H2O
4
8
12
16
20
BESTFIT 2:
Pressure
cm H2O
4
8
12
16
20 | Flow
(lpm)
17.87
28.94
37.88
45.25
52.12
Flow
(Ipm)
16.59
26.92
35.18
42.60
49.28 | Less flow with
constant
pressure -
compliant with
internal spec
and ISO 17510-
2 test procedure |
| Dead space
Information | 135 mL | | | BestFit: 30kg)
prescribed with using
continuous positive
airway pressure (CPAP)
or bi-level ventilator
system in hospital, clinic
and/or home
environment | Essentially
identical |

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.

3

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.

4

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

5

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

6

Section 4. Indications for Use Statement

510(k) Number (if known): K130663

Device Name: BestFit Nasal Mask and BestFit2 Nasal Mask

Indications For Use:

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.

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
--	---------------

S

	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