The Curasa AUTO CPAP (Continuous Positive Airway Pressure) with heated humidifier system is intended for the treatment of Obstructive Sleep Apnea only in spontaneously breathing patients weighing >30 kg. It is for use in the home or hospital /institutional environment.

Device Description

The Curasa AUTO CPAP System with heated humidifier is used on adult patients for treatment of obstructive sleep apnea (OSA). The Auto CPAP system provides a stable continuous positive airway pressure (CPAP). The Auto mode detects breathing phenomena (e.g. snore, hypopnea) and automatically adjusts the delivered pressure. The humidifier provides warm, humidified air for comfort to the patient, reducing nose and airway dryness. The Curasa AUTO CPAP system includes the following accessories: a power supply, a Patient Air Circuit, and a U-tube connection between CPAP and humidifier. All of the accessories provided with the Curasa AUTO CPAP are identical to those provided with the predicate Curasa CPAP SD (K123897).

The Auto CPAP system has been modified based Curasa CPAP SD (K123897) hardware and software. The design of the humidifier and humidifier interface is identical to the referenced predicate device (Curasa CPAP SD, K123897). The basic function and performance characteristics of Curasa AUTO CPAP are similar to the referenced predicate device (Curasa CPAP SD K123897). The Auto mode of operation is similar to the referenced predicate, Respironics Remstar Auto CPAP (K012554).

AI/ML Overview

The Curasa AUTO CPAP with Heated Humidifier System is intended for the treatment of Obstructive Sleep Apnea (OSA). The studies performed for this device included compliance with a number of electrical safety, biocompatibility, and performance standards, as well as a clinical study.

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria	Reported Device Performance
General Safety	IEC 60601-1-1: Medical Electrical equipment Part 1: General requirement for Safety	Pass
EMC	IEC 60601-1-2: Medical Electrical equipment Part 1-2: General requirement for Safety - Collateral Standard: Electromagnetic compatibility - Requirements and tests	Pass (ESD / EMC / EMI Testing)
Respiratory Humidifier	EN ISO 8185: Respiratory Tract humidifiers for medical use Particular requirements for respiratory humidifier systems	Pass (Humidity ISO 8185 Test - leveraged from predicate)
Sleep Apnoea Therapy Equipment	EN ISO 17510: Sleep Apnoea Breathing therapy Part 1: Sleep apnoea breathing therapy equipment specifically related to: - Pressure Range: 4-20 cm H2O - Pressure Stability: 4-20 cm H2O, +/- 2.0 cm H20 - Maximum Flow: 35 LPM	Pass (ISO 17510 compliant: - Pressure Range: 4-20 cm H2O - Pressure Stability: 4-20 cm H20 +/- 2.0 cm H20 - Maximum Flow: 35 LPM)
Biocompatibility	ISO 10993-3: Genotoxicity, Carcinogenicity and Reproductive Toxicity ISO 10993-5: Tests for in vitro cytotoxicity ISO 10993-6: Test for local effect after implantation ISO 10993-10: Tests for irritation and skin sensitization ISO 10993-12: Sample Preparation and reference materials	Pass (Biocompatibility Tests - leveraged from predicate)
Software	IEC 62304: Medical Device Software Software Life Cycle Process	Pass (Software Verification Testing)
Environmental	IEC 60068-2-6: Environmental Testing -- Test FC: Vibration (sinusoidal) IEC 60068-2-34: Environmental Testing Test FC: Vibration (Random) IEC 60068-2-27: Basic Environmental Testing Procedure: Test Ea and guidance: Shock	Pass (Shock and Vibration Testing)
Sound	Not explicitly defined, but generally related to acceptable noise levels for medical devices.	Pass (Sound Testing)
Air Quality	Not explicitly defined, but related to user safety regarding airborne particles and volatile organic compounds.	Pass (VOC and PM2.5 Testing)
Predicate Comparison (Functional Equivalence)	No statistical difference in AHI and SpO2 compared to predicate Respironics Auto CPAP.	Results showed that the Curasa AUTO CPAP is effective and that there is no statistical difference between the Curasa AUTO CPAP and the predicate Respironics Auto CPAP device based on AHI (Apnea/Hypopnea Index), minimum SpO2, and average SpO2.
System and User Interface	Not explicitly defined, but generally refers to the device's operational functionality and ease of use.	Pass (System and User Interface Testing)
IFU Validation	Not explicitly defined, but generally refers to ensuring the Instructions for Use are clear, complete, and accurate.	Pass (IFU Validation Testing)
Safety (IPX1 / ESD)	IPX1 (Drip Proof Equipment) and Class II Electrical shock protection.	Pass (IPX1 / ESD)
Reliability	Not explicitly defined, but generally refers to the consistent performance over time.	Pass (Reliability Test - leveraged from predicate)
Packaging	Not explicitly defined, but generally refers to the ability of the packaging to protect the device during transport and storage.	Pass (Packaging Test - leveraged from predicate)

2. Sample Size for the Test Set and Data Provenance

Sample Size: 60 adult patients diagnosed with Obstructive Sleep Apnea (OSA).
Data Provenance: Clinical study conducted at two (2) hospitals in China.
Retrospective or Prospective: Prospective, as patients were enrolled and underwent a 3-night study protocol specifically for this evaluation.

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

The document does not specify the number or qualifications of experts used to establish the "ground truth" for the test set in the clinical study. However, the study involved Polysomnography (PSG) for diagnosing OSA and recording AHI and SpO2, which implies interpretation by trained sleep specialists or technicians.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the test set. It mentions that AHI, minimum SpO2, and average SpO2 were recorded by PSG, and p-values were calculated for before and after treatment groups, and for trial and control groups. This implies direct measurement and statistical comparison rather than a human reader adjudication process for the primary endpoints.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A MRMC comparative effectiveness study involving human readers and AI assistance was not performed. The clinical study compared the Curasa AUTO CPAP system's performance to a predicate device (Respironics Auto CPAP) in treating OSA patients, not the performance of human readers with or without AI assistance.

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

The device itself is an automated CPAP system, implying it operates "standalone" in its function of automatically adjusting pressure based on detected breathing phenomena. The clinical study evaluated the effectiveness of this automated function. However, the term "standalone performance" often refers to an algorithm's performance against a ground truth in an AI/imaging context, which is not directly applicable here. The clinical study assessed the overall device (hardware + embedded algorithms) performance in vivo.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established using objective physiological measurements from Polysomnography (PSG). Specifically, AHI (Apnea/Hypopnea Index), minimum SpO2 (Pulse Oximeter Oxygen Saturation), and average SpO2 were recorded by PSG. These are standard, objective metrics for assessing the severity and treatment effectiveness of Obstructive Sleep Apnea.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" sample size. The clinical study enrolled 60 patients to evaluate the device's performance, implying this dataset was for verification/validation rather than training a machine learning model from scratch. Given the device's "Auto mode" functionality is described as "similar to the referenced predicate, Respironics Remstar Auto CPAP (K012554)," it's likely the auto-adjusting algorithm was developed and refined using prior knowledge and potentially internal datasets, but this information is not provided for the Curasa device.

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

As no "training set" is explicitly mentioned for the Curasa AUTO CPAP's auto-adjustment algorithm within this document, the method for establishing its ground truth for training is not provided. If the auto-mode algorithm was adapted from the predicate, then its initial ground truth would have been established during the predicate's development.

Summary

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JAN 1 3 2014

Section 5. 510(k) Summary

510(k) SUMMARY `

A 510(k) summary has been prepared 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:	Curasa AUTO CPAP with Heated Humidifier System
Device Classification Name:	Non-continuous ventilator (BZD)21 CFR 868.5905
Predicate Devices:	Respironics Remstar Auto CPAP (K012554)Curasa CPAP SD (K123897)
Preparation Date:	March 25, 2013Revised December 20, 2013Revised December 29, 2013

Device Description:

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Curative Medical Inc.

CPAP SD K123897). The Auto mode of operation is similar to the referenced predicate, Respironics Remstar Auto CPAP (K012554).

The Curasa AUTO CPAP with heated humidifier system has the following similarities to the previous cleared predicate devices:

Same intended use .
. Same operating principle
Similar technologies .
Same patient contacting materials .

Parameter	RespironicsRemstar Pro AutoCPAP system(K012554)	Curative Medical Inc.Curasa CPAP SD(K123897)	Curative Medical Inc.Curasa AUTO CPAP(Proposed Device)
CPAP Device:
Device Size (cm)	24 x 17 x 12	17 x 11.8 x 9.7	17 x 11.8 x 9.7
Weight (kg)	<1.8	1.4	1.4
Mode of Operation	CPAP and Auto	CPAP	CPAP and Auto
Indication for Use	The RespironicsREMstar AutoSystem is a CPAP(continuousPositive AirwayPressure) devicedesigned for thetreatment of adultObstructive SleepApnea (OSA) only.	The Curasa CPAP SDis designed for thetreatment ofObstructive SleepApnea only inspontaneouslybreathing patientsweighing >30 kg.It is intended to beused in the home orhospital/institutionalenvironment.	The Curasa AUTOCPAP with HeatedHumidifier System isdesigned for thetreatment ofObstructive SleepApnea only inspontaneouslybreathing patientsweighing >30 kg.It is intended to be usedin the home orhospital/institutionalenvironment.
Product Use,Transport, Storage
Operation (°C)	5 to 35	5 to 35	5 to 35
Transport & Storage(°C)	-20 to 60	-20 to 60	-20 to 60
Atmosphere Pressure(Operation)	83 to 102 kPa	70 to 106 kPa	70 to 106 kPa
Mode of Operation	Continuous	Continuous	Continuous
Type of ProtectionAgainst Electric Shock	Class II Equipment	Class II Equipment	Class II Equipment
Degree of ProtectionAgainst Electric Shock	Type BF AppliedPart	Type B Applied Part	Type BF Applied Part

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Curative Medical Inc.

Parameter	RespironicsRemstar Pro AutoCPAP system(K012554)	Curative Medical Inc.Curasa CPAP SD(K123897)	Curative Medical Inc.Curasa AUTO CPAP(Proposed Device)
Degree of ProtectionAgainst Ingress ofWater	IPX1	IPX1	IPX1
Pressure Range (cmH2O)	4 - 20	4 - 20	4 - 20
Pressure Stability(cm H2O), asmeasured by ISO17510-1	4-20 cm H2O, +/-1.0 cm H2O	4-20 cm H20 +/- 2.0cm H20ISO17510 compliant	4-20 cm H20 +/- 2.0 cmH20ISO17510 compliant
Maximum Flow (LPM),as measured by ISO17510-1	35	35	35
Humidifier
Water reservoir	415 ml	240 ml	240 ml
Weight	2.2 lbs	< 0.9 lbs	< 0.9 lbs
Power Consumption
Electrical shockprotection:	Class II	Class II	Class II
Drip Proof Equipment	IPX1	IPX1	IPX1
Heater Setting	1 - 5	continuous	continuous

Intended Use:

Contraindications:

. Bullous Lung Disease
Pathologically Low Blood Pressure .
Bypassed Upper Airway .
. Pneumothorax
Pneumocephalus has been reported in a patient using nasal Continuous Positive Airway . Pressure. Caution should be used when prescribing CPAP for susceptible patients such as those with: cerebral spinal fluid (CSF) leaks, abnormalities of the cribriform plate, prior history of head trauma, and/or pneumocephalus.
The use of positive airway pressure therapy may be temporarily contraindicated if you . exhibit signs of sinus or middle ear infection. Not for use with patients whose upper airways are by-passed.

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Summary of Performance Data and Substantial Equivalence:

The Curasa AUTO CPAP with heated humidifier system was 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 Curasa AUTO CPAP is substantially equivalent to the predicate Respironics Remstar Auto CPAP for treatment of OSA in adults. The Curasa AUTO CPAP with heated humidifier system has been tested and shown to be compliant with the following standards documents:

1. IEC 60601-1-1:1988 + A1:1991 + A2:1995 Medical Electrical equipment Part 1: General requirement for Safety
1. IEC 60601-1-2:2007 Medical Electrical equipment Part 1-2: General requirement for Safety - Collateral Standard: Electromagnetic compatibility - Requirements and tests
1. EN ISO 8185:2007 Respiratory Tract humidifiers for medical use Particular requirements for respiratory humidifier systems
1. EN ISO 17510:2007 Sleep Apnoea Breathing therapy Part 1: Sleep apnoea breathing therapy equipment
1. ISO 10993-3:2003 Biological Evaluation of Medical Devices Part 3. Genotoxicity, Carcinogenicity and Reproductive Toxicity
1. ISO 10993-5: 2009 Biological evaluation of medical devices Part 5: Tests for in vitro cvtotoxicity
1. ISO 10993-6:2007 Biological Evaluation of Medical Devices Part 6: Test for local effect after implantation
1. ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
1. ISO 10993-12:2007 Biological Evaluation of medical devices Part 12: Sample Preparation and reference materials
1. IEC 62304:2006 Medical Device Software Software Life Cycle Process
1. IEC 60068-2-6:2007 Environmental Testing -- Test FC: Vibration (sinusoidal)
1. IEC 60068-2-34:1973 Environmental Testing Test FC: Vibration (Random)
1. IEC 60068-2-27:2008 Basic Environmental Testing Procedure: Test Ea and guidance: Shock

The following testing was conducted to demonstrate the performance of Curasa AUTO CPAP, is substantially equivalent to its predicate devices in its intended environment:

Design Verification Test	Result
Sound Testing	Pass
VOC and PM2.5 Testing	Pass
Shock and Vibration Testing	Pass
Predicate Comparison Testing	Pass
System and User Interface Testing	Pass
IFU Validation Testing	Pass
ESD / EMC / EMI	Pass
Safety Testing (IPX1 / ESD)	Pass
Software Verification Testing	Pass

Test data leveraged from the predicate device, Curasa CPAP SD (K123897) includes the following:

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Reliability Test .
Packaging Test .
Humidity ISO 8185 Test .
Biocompatibility Tests .

This 510(k) submission presents the results of the testing and detailed descriptions to demonstrate that Curasa AUTO CPAP with heated humidifier system is substantially equivalent to the Respironics Remstar Auto CPAP System (K012554) and Cursasa CPAP SD (K123897).

Clinical Data:

Curative Medical conducted a clinical study at two (2) hospitals in China enrolling sixty (60) adult patients diagnosed with Obstructive Sleep Apnea (OSA) to evaluate the Curasa AUTO CPAP system compared to the predicate Respironics Auto CPAP. Selected OSA patients all underwent 3 nights of study with the PSG (polysomngram); the 1st night of PSG diagnosing; then randomly entered either the trial group or the 2nd night; following the 3rd night to complete the alternate group study. Each patient was evaluated by AHI (Apnealhypopnea Index); minimum SpO2 (Pulse Oximeter Oxygen Saturation) and average SpO2 recorded by PSG throughout the 3-night study. P-values were calculated using the t-test for before and after treatment groups and for trial and control groups. Results showed that the Curasa AUTO CPAP is effective and that there is no statistical difference between the Curasa AUTO CPAP and the predicate Respironics Auto CPAP device.

Conclusion:

The minor differences between the Curasa AUTO CPAP and its predicate devices outlined in the tables above do not raise new questions of safety and effectiveness. The information and data provided in this 510(k) notification establishes that the Curasa AUTO CPAP with heated humidifier system is substantially equivalent to the legally marketed predicate devices.

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

January 13, 2014

Curative Medical, Inc. c/o Ms. Amy E. McKinney Regulatory Affairs Consultant 6518 Tamarind Sky Ln Fulshear, TX 77441

Re: K130828

Trade/Device Name: Curasa AUTO CPAP with Heated Humidifier System Regulation Number: 21 CFR 868.5905 Regulation Name: Non-continuous ventilator Regulatory Class: II Product Code: BZD Dated: December 20, 2013 Received: December 23, 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 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.

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Page 2 - Ms. Amy McKinney

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 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/Industry/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/McdicalDevices/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/Industry/default.htm.

Sincerely yours,

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Erin Keith 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K130828

Device Name

Curasa AUTO CPAP with Heated Humidifier System

Indications for Use (Describe)

The Curasa AUTO CPAP (Continuous Positive Airway Pressure) with heated humidifier system is intended for the treatment of Obstructive Sleep Apnea only in spontaneously breathing >30 kg. It is for use in the home or hospital /institutional environment.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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2014.01.10
12:38:55 -05'00'

FORM FDA 3881 (9/13)

ﮧ ﮧﮧ

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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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).