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 2 commercially available models, Curasa CPAP and Floton CPAP (K120285). This special 510(k) adds the Curasa CPAP SD model to the currently commercially available selection of models. 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 SD has similar electronic design and software as the Curasa CPAP, except for the addition of a SD card interface and associated software driver. The Curasa CPAP SD can store/read CPAP patient compliance data onto a SD card where it can be viewed by an external PC.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Curasa CPAP SD device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present specific quantitative acceptance criteria with corresponding performance metrics for the new SD card functionality. Instead, it relies on demonstrating that the new model (Curasa CPAP SD) is substantially equivalent to the predicate device (Curasa CPAP) and passes various design verification tests. The acceptance is implied by these tests passing.

Acceptance Criteria (Measured against Predicate)	Reported Device Performance (Curasa CPAP SD)
Functional Equivalence
Same intended use	Same
Same operating principle	Same
Same technology	Same
Same manufacturing process	Same
Software (with SD card driver addition)	Same (with SD card driver addition)
Hardware Components (with SD card board addition)	Same (with SD card board addition)
Humidifier	Same
User Interface	Same
Labeling (with SD card handling addition)	Same (with SD card handling addition)
Packaging	Same
Physical Equivalence
Device Size (cm)	Similar (17 x 11.8 x 9.7 vs. 17 x 11.7 x 9.3)
Weight (kg)	Same (1.4 kg)
Performance Standards Compliance
EN 60601-1-1:1995 + A1:1993 + A2:1995	Compliant
EN 60601-1-2:2001	Compliant
EN ISO 8185:2007	Compliant
EN ISO 17510:2007	Compliant
IEC-60601-1	Same
IEC-60601-2	Same
ISO 17510-1	Same
Pressure Range (cm H2O)	Same (4-20)
Pressure Stability (cm H2O)	Same (4-20 cm H2O +/- 2.0 cm H2O)
Maximum Flow (LPM)	Same (35 LPM)
Design Verification Tests
Pressure Testing	Pass
System and User Interface Testing	Pass
IFU Verification Testing	Pass
ESD / EMC / EMI	Pass
Safety Testing (IPX1 / ESD)	Pass
Software Verification Testing	Pass

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

The document does not specify a distinct "test set" in the context of clinical data for the new device. The testing focuses on compliance with standards and design verification for the modifications. There's no mention of a patient-based test set or its provenance (country of origin, retrospective/prospective). The tests referenced are primarily engineering and performance verification tests.

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

Not applicable. The study is not a clinical study involving experts establishing ground truth for patient outcomes or diagnoses. The "ground truth" for the engineering tests would be the established specifications and standards.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described as this is not a study requiring expert consensus on subjective interpretations.

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

Not applicable. This device is a CPAP machine with an added SD card for data storage, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. The device's primary function is to deliver CPAP therapy, and the SD card functionality is for data storage, not a standalone algorithm performing diagnostic or predictive tasks.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the engineering and performance tests, the ground truth would be defined by the established technical specifications, recognized industry standards (e.g., EN ISO 17510), and the performance of the predicate device. For example, "Pressure Stability" is compared against "4-20 cm H2O +/- 2.0 cm H20 ISO17510 compliant," indicating the ISO standard sets the ground truth.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-driven device that requires a training set. The changes are hardware and software modifications.

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

Not applicable, as no training set was used.

Summary

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Curative Medical Inc.

MAR 1 3 2013

Section 5. Special 510(k) Summary

Special 510(k) SUMMARY

A summary of Special 510(k) safety and effectiveness information 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 ContactPerson:	Cuong Tran, Director Research and Development
Phone:	(408) 414-2188
Fax:	(408) 413-3000
Email:	ctran@curativemedical.com
SubmissionCorrespondent:	Amy McKinney, Regulatory Affairs Consultant
Address:	6518 Tamarind Sky Ln, Fulshear, TX 77441
Phone:	(979) 236-1622
Email:	amckinney29@att.net
Device Name:	K Series CPAP System - Curasa CPAP SD
Device ClassificationName:	Non-continuous ventilator (BZD)21 CFR 868.5905
Predicate Devices:	K Series CPAP System (K120285)
Date of Preparation:	February 6, 2013

Device Description:

The Curasa CPAP SD has similar electronic design and software as the Curasa CPAP, except for the addition of a SD card interface and associated software driver. The Curasa CPAP SD can store/read CPAP patient compliance data onto a SD card where it can be viewed by an external PC.

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K123897-S01

Curative Medical Inc.

The K Series CPAP system, model Curasa CPAP SD, 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.

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.

Summary of Performance Data and Substantial Equivalence:

The K Series CPAP system, model Curasa CPAP SD, 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 SD, 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

The following testing was conducted to demonstrate the performance of K series CPAP system. model Curasa CPAP SD, is as safe and effective as its predicate device in its intended environment:

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Design Verification Test	Result
Pressure Testing	Pass
System and User Interface Testing	Pass
IFU Verification Testing	Pass
ESD / EMC / EMI	Pass
Safety Testing (IPX1 / ESD)	Pass
Software Verification Testing	Pass

Test data leveraged from the predicate device includes the following:

Sound Test .
Reliability Test .
Packaging Test �
. Humidity ISO 8185 Test
VOC and PM2.5 Test .
. Biocompatibility Tests

This Special 510(k) submission presents the results of the testing and detailed description to demonstrate that K series CPAP system, model Curasa CPAP SD, is substantially equivalent to the K Series CPAP with heated humidifier systems (K120285), models Curasa CPAP and Floton CPAP.

The table below provides a design comparison of the Curasa CPAP SD to the predicate K Series CPAP with heated humidifier, Curasa model.

Physical Features	Predicate Device -K Series Curasa CPAP(K120285)	K Series Curasa CPAP SD
CPAP Device:
Device Size (cm)	Curasa: 17 x 11.7 x 9.3	Similar,.17 x 11.8 x 9.7
Weight (kg)	Curasa: 1.4	Same
Humidifier	Yes	Same
Memory Card	No	Yes
Technology	Stable, continuous positiveairway pressure	Same
Indications	The K Series CPAP System, isdesigned for the treatment ofObstructive Sleep Apnea onlyin spontaneously breathingpatients weighing >30 kg.It is intended to be used in thehome or hospital/institutionalenvironment.	Same
Product Use, Transport,Storage:
Operation(degree Celsius.)	5 to 35	Same

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Curative Medical Inc.

. .. .	. .
. .	-----

Physical Features	Predicate Device K Series Curasa CPAP (K120285)	K Series Curasa CPAP SD
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 and 1A@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	Same
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
Compliance
	IEC-60601-1ISO 8185:2007	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

The table below provides a comparison of the features of the Curasa CPAP SD to the predicate K Series CPAP with heated humidifier, Curasa model.

Functional Features	Same/Different
Software	Same with the addition of SD cardreader driver to Curasa CPAP SD
Hardware Components	Same with the addition of SD cardreader circuit board to Curasa CPAP SD
Humidifier	Same
User Interface	Same
Labelling	Same with the addition of handling theSD card to Curasa CPAP SD and newproduct name
Packaging	Same

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K123897-S01

Curative Medical Inc.

Conclusion:

Concilision:
The information and data provided in this Special 510(k) Notification establishes that the K i he information and data provided in this Openal of o(t) , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , substantially equivalent to the legally marketed predicate device (K120285).

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

Public Health Service

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

March 13, 2013

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

Re: K123897

Trade/Device Name: K Series CPAP System - Curasa CPAP SD Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: February 8, 2013 Received: February 11, 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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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 devicerelated 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 shows the text "Kwame O. Ulmer for". The text is in a simple, sans-serif font. The words "Kwame" and "Ulmer" are in bold, while the "O." and "for" are not. The letters "O" and "U" are stylized with a pattern of concentric lines.

Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use Statement

1123897 510(k) Number (if known): 长什2XXXXX

Device Name: K Series CPAP System - Curasa CPAP SD Indications For Use:

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.

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)

c=US, o=U.S. Government,
ou=HHS, ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=130
0059331, cn=Albert E. Moyal -5
2013.03.13:13:35:19-04'00'

Albert

Moyal-S for LS

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

510(k) Number:

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).