The K Series CPAP System, is designed for the treatment of Obstructive Sleep Apnea only in spontaneously breathing patients weighing >30 kg. It is intended to be used in the home or hospital/institutional environment.

Device Description

The K Series CPAP systems are used on adult patients for treatment of obstructive sleep apnea (OSA). The K Series CPAP Systems has 3 commercially available models, Curasa CPAP (K120285), Floton CPAP (K120285), and Curasa CPAP SD (K123897). This 510(k) application adds the Curasa CPAP EUT model to the currently commercially available selection of models. as well as the AutoManager PC Software accessory. The K series CPAP system provides a stable continuous positive airway pressure (CPAP). The humidifier, which works with all the K Series CPAP Systems, provides warm, humidified air for comfort to the patient, reducing nose and airway dryness. Each K Series CPAP system also includes the following accessories: a power supply, a Patient Air Circuit, and a U-tube connection between CPAP and humidifier. The Curasa CPAP EUT has the same electronic design and similar software as the Curasa CPAP SD, except for the addition of EUT (expiratory unload trigger) feature. The EUT feature detects patient exhalation phase and reduces output pressure. EUT feature has 3 levels of pressure reduction. The CPAP EUT also works with a special accessory PC software tool, AutoManager™ AutoManager™ is used by the service provider to analyze the patient's CPAP compliant data and, if needed, update the CPAP pressure setting via the CPAP's SD card. The AutoManager™ software collects/updates CPAP device data via an SD card. The AutoManager™ PC software is an independent accessory to the CPAP device and runs on a stand-alone PC and not on the CPAP device itself.

AI/ML Overview

This document describes the Curasa CPAP EUT with AutoManager PC Software accessory, a device intended for the treatment of Obstructive Sleep Apnea. The information provided focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results for a novel device. As such, many of the requested elements (like sample size for test set, number of experts, adjudication methods, MRMC studies, specific ground truth types for training, effect size with AI) are not directly applicable or available in the provided text, as this is a 510(k) submission primarily focused on demonstrating equivalence through standard compliance and comparative design.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of specific acceptance criteria with quantitative thresholds for performance metrics. Instead, it lists compliance with various standards and successful completion of design verification tests, all reporting "Pass." The "acceptance criteria" here are implicitly linked to meeting the requirements of these standards and completing the specified tests without failure, thus demonstrating substantial equivalence rather than a novel performance claim.

Design Verification Test	Results (Acceptance Criteria)
System and User Interface Testing	Pass
ESD / EMC / EMI	Pass
IFU Validation Testing (patients)	Pass
Provider IFU Validation Testing	Pass
Software Verification Testing	Pass
AutoManager Software Verification Testing	Pass
AutoManager Software IFU & User Interface testing	Pass

2. Sample size used for the test set and the data provenance:

Sample Size: The document mentions "IFU Validation Testing (patients)", indicating that some patient data was used. However, the specific sample size for this test or any other test set is not provided.
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The study described focuses on technical compliance and equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided.

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:

MRMC Study: No MRMC comparative effectiveness study was done or mentioned. This submission does not involve AI for diagnostic purposes or human reader assistance.
Effect Size of AI Improvement: Not applicable, as this device does not incorporate AI for diagnostic assistance.

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

Standalone Performance: The "Software Verification Testing" and "AutoManager Software Verification Testing" represent standalone testing of the software components. However, this is for functional verification of the CPAP device and its accessory software, not for an algorithm-only diagnostic or AI performance evaluation. The device itself is "algorithm only" in its automated pressure adjustment, but its primary function is therapeutic, not diagnostic.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The document does not explicitly state the type of ground truth used for performance evaluation, as it primarily relies on established engineering and safety standards. For the "IFU Validation Testing (patients)", the ground truth would likely be related to patient comprehension and ability to use the device as intended, potentially assessed through observation or questionnaires, but this is not detailed. For software testing, the ground truth would be the expected functional behavior based on design specifications.

8. The sample size for the training set:

Not applicable, as this device does not involve machine learning or AI models with a distinct "training set" in the context of this submission. The development process would involve iterative testing and refinement, but this is not a traditional AI training set.

9. How the ground truth for the training set was established:

Not applicable, for the same reasons as point 8.

Summary

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Section 5. 510(k) Summary

510(k) SUMMARY

A 510(k) Summary in accordance with the requirements of 21 CFR 807.92 is provided below.

Submitter:	Curative Medical Inc.3227 Kifer RoadSanta Clara, CA 95051Establishment Number: 3008361782
Company ContactPerson:	Cuong Tran, Director Research and DevelopmentPhone: (408) 414-2188Fax: (408) 413-3000Email: ctran@curativemedical.com
SubmissionCorrespondent:	Amy McKinney, Regulatory Affairs ConsultantAddress: 6518 Tamarind Sky Ln, Fulshear, TX 77441Phone: (979) 236-1622Email: amckinney29@att.net
Device Name:	K Series CPAP System - Curasa CPAP EUTAutoManager PC Software accessory
Device ClassificationName:	Non-continuous ventilator (BZD)21 CFR 868.5905
Predicate Devices:	K Series CPAP SD System (K123897)
Preparation Date:	December 1, 2013Revised December 6, 2013

Device Description:

The Curasa CPAP EUT has the same electronic design and similar software as the Curasa CPAP SD, except for the addition of EUT (expiratory unload trigger) feature. The EUT feature detects patient exhalation phase and reduces output pressure. EUT feature has 3 levels of pressure reduction.

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The CPAP EUT also works with a special accessory PC software tool, AutoManager™ AutoManager™ is used by the service provider to analyze the patient's CPAP compliant data and, if needed, update the CPAP pressure setting via the CPAP's SD card. The AutoManager™ software collects/updates CPAP device data via an SD card. The AutoManager™ PC software is an independent accessory to the CPAP device and runs on a stand-alone PC and not on the CPAP device itself.

The K Series CPAP system, model Curasa CPAP EUT, has the following similarities to the previous cleared predicate device:

Same intended use .
Same operating principle .
. Same technology
Same manufacturing process .

Intended Use:

The K Series CPAP (Continuous Positive Airway Pressure) systems are intended for the treatment of Obstructive Sleep Apnea only in spontaneously breathing patients weighing >30 kg. It is intended to be used in the home or hospital/institutional environment.

Summary of Performance Data and Substantial Equivalence:

The K Series CPAP system, model Curasa CPAP EUT, was designed and verified in accordance with the risk analysis and product requirements. All tests were conducted on the new model to establish substantial equivalence to the predicate. The K Series CPAP system, model Curasa CPAP EUT, was tested and shown to be compliant with the following standards:

1. EN 60601-1-1:1995 + A1:1993 + A2:1995 Medical Electrical equipment Part 1: General requirement for Safety
1. EN 60601-1-2:2001 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 cytotoxicity
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

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Testing was conducted to demonstrate the performance of K series CPAP system, model Curasa CPAP EUT, is substantially equivalent to its predicate device in its intended environment. This 510(k) submission presents the results of the testing and a detailed description to demonstrate that K series CPAP system, model Curasa CPAP EUT, is substantially equivalent to the K Series CPAP SD with heated humidifier systems (K123897), model Curasa CPAP SD.

The following testing was conducted to demonstrate that the performance of Curasa EUT CPAP with the AutoManager™ software accessory is substantially equivalent to its predicate device in its intended environment:

Design Verification Test	Result
System and User Interface Testing	Pass
ESD / EMC / EMI	Pass
IFU Validation Testing (patients)	Pass
Provider IFU Validation Testing	Pass
Software Verification Testing	Pass
AutoManager Software Verification Testing	Pass
AutoManager Software IFU & UserInterface testing	Pass

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

Reliability Test .
. Sound Testing
VOC and PM2.5 Testing .
Shock and Vibration Testing .
. Packaging Test
Humidity ISO 8185 Test .
. Biocompatibility Tests

The table below provides a design comparison of the Curasa CPAP EUT to the predicate Curasa CPAP SD with heated humidifier.

Physical Features	Predicate Device -K Series Curasa CPAP SD(K123897)	K Series Curasa CPAP EUTProposed Device
CPAP Device:-
Device Size (cm)	17 x 11.8 x 9.7	Same
Weight (kg)	Curasa: 1.4	Same
Humidifier	Yes	Same
Memory Card	Yes	Yes
CPAP Technology	Stable, continuous positiveairway pressure	Same
Physical Features	Predicate Device -K Series Curasa CPAP SD(K123897)	K Series Curasa CPAP EUT -Proposed Device
Indications	The K Series CPAP System, is designed for the treatment of Obstructive Sleep Apnea only in spontaneously breathing patients weighing >30 kg. It is intended to be used in the home or hospital/institutional environment.	Same
Product Use, Transport,Storage
Operation(degree Celsius.)	5 to 35	Same
Transport & Storage(degree Celsius.)	-20 to 60	Same
Atmosphere Pressure(Operation)	70 to 106 kPa	Same
Standards Compliance
IEC-60601-1	Yes	Same
IEC-60601-2	Yes	Same
ISO 17510-1	Yes	Same
Mode of Operation	Continuous	Same
AC Power Consumption	90 to 264 VAC, 50-60 Hz,2A@115VAC and1A@230VAC	Same
DC Power Consumption	24 VDC, 2.5 A	Same
Type of Protection AgainstElectric Shock	Class II Equipment	Same
Degree of Protection AgainstElectric Shock	Type B Applied Part	Type BF - Better, New powersupply compliant to IEC-60601-1 3rd edition
Degree of Protection AgainstIngress of Water	IPX1	Same
Pressure Range (cm H2O)	4-20	Same
Pressure Stability(cm H2O), as measured byISO 17510-1	4-20 cm H20 +/- 2.0 cm H20ISO17510 compliant	Same
Maximum Flow (LPM), asmeasured by ISO 17510-1	35	Same
Power Consumption	24VDC derived from A/Cpower supply	Same
Electrical shock protection	Class II	Same
Drip Proof Equipment	IPX1	Same
Heater Setting	continuous	Same

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The table below provides a comparison of the features of the Curasa CPAP EUT to the
predicate Curasa CPAP SD with heated humidifier.

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Functional Features	Same/Different
Software	Same with the addition of EUT function andSD card Therapy Pressure setting update
Hardware Components	Same, except for new power supplycompliant with IEC-60601-1 3rd edition
Humidifier	Same
User Interface	Same
Packaging	Same
Accessory	The PC AutoManager™ softwarecollects/updates CPAP device data via anSD card. It is used on a stand-alone PC withnot interaction with the CPAP device.AutoManager™ is used by the serviceprovider

Conclusion:

The differences outlined in the tables above do not raise new questions of safety and effectiveness from the predicate device. The information and data provided in this 510(k) Notification establishes that the Curasa CPAP EUT with the accessory AutoManager™ PC software, is substantially equivalent to the legally marketed predicate device (K123897).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.

Public Health Service

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

December 6, 2013

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

Re: K131702

Trade/Device Name: K Series CPAP System - Curasa CPAP EUT AutoManager PC Software accessory Regulation Number: 21 CFR 868.5905 Regulation Name: Non-continuous ventilator Regulatory Class: II Product Code: BZD Dated: November 5, 2013 Received: November 6, 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.

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

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Page 2 - Ms. McKinney

... .. .. .

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/Resourcesfor You/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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/6/Picture/7 description: The image contains a signature and some text. The text reads "Tejashri Purghit-Sheth, M.D. Clinical Deputy Din FOR". The signature is illegible but appears to be a stylized version of a name.

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) K131702

Device Name

K Series CPAP System - Curasa CPAP EUT and AutoManager PC Software Accessory

Indications for Use (Describe)

The K Series CPAP System, is designed for the treatment of Obstructive Sleep Apnea only in spontaneously breathing patients weighing >30 kg.

It is intended to be used 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.

FOR FDA USE ONLY

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

Digitally signed by Anya C. Harry -S
DN: ceUS, o=U.S. Government, ou=HHHS, rrv ou=FDA, ou=Poople, cn=Anya C. Harry -0.9.2342.19200300.100.1.1=0011315590
Date: 2013.12.05 15:58:27 -05100'

FORM FDA 3881 (9/13)

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

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).