BESTFIT2 NASAL MASK

K130663 · Curative Medical, Inc. · BZD · Sep 27, 2013 · Anesthesiology

Device Facts

• Record ID: K130663
• Device Name: BESTFIT2 NASAL MASK
• Applicant: Curative Medical, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Sep 27, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

BestFit and BestFit 2 are patient interface nasal masks for adult patients receiving CPAP or Bi-Level positive airway pressure therapy. Masks seal around the nose to deliver pressurized air from a therapy device via a 22mm conical connector. Used in hospitals, clinics, or home environments; operated by patients or healthcare providers. Devices include headgear and are designed for multiple-patient reuse. Masks feature vented designs to facilitate therapy delivery. Healthcare providers use the mask to interface the patient with the ventilator system; effective seal and therapy delivery support patient respiratory treatment. Performance is verified through pressure-flow, dead space, and sound level testing.

Clinical Evidence

Bench testing only. Performance verified via ISO 17510-2 (sleep apnea breathing therapy masks), ISO 10993 (biocompatibility, cytotoxicity, irritation, sensitization), and ISO 5356-1 (conical connectors). Comparative testing against Resmed Ultra Mirage II included pressure-flow curves, dead space, sound levels, and resistance to flow. Packaging integrity tested per ISTA-2A. Cleaning and disinfection protocols validated for multiple-use.

Technological Characteristics

Nasal mask with headgear; 22mm conical connector; vented design. Materials evaluated per ISO 10993. Operating pressure 4-20 cmH2O. Compliant with ISO 17510-2, ISO 10993-1/3/5/6/10, and ISO 5356-1. Multiple sizes available. No software or electronic components.

Indications for Use

Indicated for adult patients (body weight >30kg) prescribed CPAP or bi-level ventilator therapy in hospital, clinic, or home settings.

Regulatory Classification

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.

Predicate Devices

• Resmed Ultra Mirage II (K050359)

Submission Summary (Full Text)

{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.<br>3227 Kifer Road<br>Santa Clara, CA 95051<br>Establishment Number: 3008361782 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact Person: | Cuong Tran, R/D Director<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Submission Correspondent: | Amy McKinney, Regulatory Affairs Consultant<br>Address: 6518 Tamarind Sky Ln., Fulshear, TX 77441<br>Phone: [phone]<br>Email: [e-mail] |
| Device Name: | BestFitTM Nasal Mask<br>Models:<br>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)<br>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<br>Mirage II (K050359) * | | · BestFit<br>(both models) | | Comparison |
|----------------------------------------|--------------------------------------------------|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Therapy<br>Pressure | 4 - 20 cmH20 | | | 4 - 20 cmH20 | Same |
| Pressure-Flow<br>Curve | Pressure<br>(cm H2O)<br>4<br>8<br>12<br>16<br>20 | Flow<br>(Ipm)<br>18<br>ਨ ਰੇ<br>38<br>46<br>ਟੇਤੇ | BESTFIT:<br>Pressure<br>cm H2O<br>4<br>8<br>12<br>16<br>20<br>BESTFIT 2:<br>Pressure<br>cm H2O<br>4<br>8<br>12<br>16<br>20 | Flow<br>(lpm)<br>17.87<br>28.94<br>37.88<br>45.25<br>52.12<br>Flow<br>(Ipm)<br>16.59<br>26.92<br>35.18<br>42.60<br>49.28 | Less flow with<br>constant<br>pressure -<br>compliant with<br>internal spec<br>and ISO 17510-<br>2 test procedure |
| Dead space<br>Information | 135 mL | | | BestFit: <160 mL<br>BestFit 2: < 165 mL | Larger - no<br>clinical effect |
| Sound level<br>(10 cmH20 & 1<br>Meter) | 28 dbA | | | BestFit: <29 dbA<br>BestFit 2: <30 dbA | Louder,<br>compliant with<br>ISO 17510-2<br>Annex G |

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

| Parameter | Resmed ultra-<br>Mirage II (K050359) | BestFit<br>(both models) | Comparison |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Resistance to<br>Flow | At 50 lpm, 0.1 cmH20<br>At 100 lpm, 0.3 cmh20 | 50 lpm, 0.1 cmH20<br>100 lpm, 0.5 cmH20 | Same at 50 lpm,<br>more at 100 lpm,<br>Compliant with<br>ISO 17510-2<br>Annex C |
| Dimension<br>( HxWxD mm) | 163 x 91 x 87 | 155 x 98 x 95 (BestFit)<br>145 x 98 x 97 (BestFit2) | Similar, no<br>clinical effect |
| Temperature<br>(operating - °C) | 3 - 35 | 3 - 35 | Same |
| Mode operation<br>compatibility | CPAP & BiLevel | CPAP & BiLevel | Same |
| Head Gear & Clip | • 2 at forehead<br>• 2 at lower half<br>• Adjustable | • 2 at forehead<br>• 2 at lower half<br>• Adjustable | Same |
| Cushion | 4 sizes | BestFit - 4 sizes<br>BestFit 2 - 3 sizes | Similar - support<br>various sizes |
| Patient circuit<br>Interface | 22 mm conical | 22 mm conical | Same |
| Swivel Patient<br>circuit interface | Yes | Yes | Same |
| Support Daily<br>Cleaning | Yes | Yes | Same |
| Support<br>Disinfection | Yes | Yes | Same |
| Indications For<br>Use | Intended for<br>multipatient re-use<br>for adult patients<br>prescribed<br>continuous positive<br>airway pressure<br>(CPAP) or bilevel<br>therapy in hospitals,<br>clinic and home<br>environment | intended for multiple<br>use on adult patients<br>(body weight >30kg)<br>prescribed with using<br>continuous positive<br>airway pressure (CPAP)<br>or bi-level ventilator<br>system in hospital, clinic<br>and/or home<br>environment | Essentially<br>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 [phone] or [phone] 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 [phone] or [phone] 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