(178 days)
No
The description focuses on standard CPAP functionality, pressure reduction based on detected exhalation, and data management software. There is no mention of AI, ML, or related concepts.
Yes
The device is designed for the treatment of Obstructive Sleep Apnea, which is a medical condition, making it a therapeutic device.
No
The device is designed for treatment (therapy) of Obstructive Sleep Apnea by providing continuous positive airway pressure, not for diagnosing the condition. While it collects compliance data, this is for treatment management, not diagnosis.
No
The device description clearly outlines a physical CPAP system with hardware components (CPAP device, humidifier, power supply, air circuit, U-tube connection). While it includes an accessory PC software (AutoManager™), the primary medical device is a hardware system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of Obstructive Sleep Apnea by providing continuous positive airway pressure. This is a therapeutic device, not a diagnostic one.
- Device Description: The description focuses on the mechanical and software aspects of delivering air pressure and managing patient data related to that therapy. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) which is the core function of an IVD.
- Lack of IVD-related terms: The text does not contain any terms typically associated with IVD devices, such as "assay," "reagent," "sample," "analyte," "diagnosis," or "in vitro."
The device is clearly designed to treat a condition by providing a physical intervention (air pressure), not to diagnose a condition by analyzing biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BZD
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.
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 weighing >30 kg.
Intended User / Care Setting
Home or hospital/institutional 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 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:
-
- EN 60601-1-1:1995 + A1:1993 + A2:1995 Medical Electrical equipment Part 1: General requirement for Safety
-
- EN 60601-1-2:2001 Medical Electrical equipment Part 1-2: General requirement for Safety - Collateral Standard: Electromagnetic compatibility - Requirements and tests
-
- EN ISO 8185:2007 Respiratory Tract humidifiers for medical use Particular requirements for respiratory humidifier systems
-
- EN ISO 17510:2007 Sleep Apnoea Breathing therapy Part 1: Sleep apnoea breathing therapy equipment
-
- 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 cytotoxicity
-
- 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 10993-12:2007 Biological Evaluation of medical devices Part 12: Sample Preparation and reference materials
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:
- 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
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
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.
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
§ 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).
0
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 Road
Santa Clara, CA 95051
Establishment Number: 3008361782 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact
Person: | Cuong Tran, Director Research and Development
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: | K Series CPAP System - Curasa CPAP EUT
AutoManager PC Software accessory |
| Device Classification
Name: | Non-continuous ventilator (BZD)
21 CFR 868.5905 |
| Predicate Devices: | K Series CPAP SD System (K123897) |
| Preparation Date: | December 1, 2013
Revised December 6, 2013 |
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.
1
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:
-
- EN 60601-1-1:1995 + A1:1993 + A2:1995 Medical Electrical equipment Part 1: General requirement for Safety
-
- EN 60601-1-2:2001 Medical Electrical equipment Part 1-2: General requirement for Safety - Collateral Standard: Electromagnetic compatibility - Requirements and tests
-
- EN ISO 8185:2007 Respiratory Tract humidifiers for medical use Particular requirements for respiratory humidifier systems
-
- EN ISO 17510:2007 Sleep Apnoea Breathing therapy Part 1: Sleep apnoea breathing therapy equipment
-
- 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 cytotoxicity
-
- 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 10993-12:2007 Biological Evaluation of medical devices Part 12: Sample Preparation and reference materials
2
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 & User | |
| Interface 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 EUT
Proposed 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 positive
airway 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 and
1A@230VAC | Same |
| DC Power Consumption | 24 VDC, 2.5 A | Same |
| Type of Protection Against
Electric Shock | Class II Equipment | Same |
| Degree of Protection Against
Electric Shock | Type B Applied Part | Type BF - Better, New power
supply compliant to IEC-60601-
1 3rd edition |
| Degree of Protection Against
Ingress of Water | IPX1 | Same |
| Pressure Range (cm H2O) | 4-20 | Same |
| Pressure Stability
(cm H2O), as measured by
ISO 17510-1 | 4-20 cm H20 +/- 2.0 cm H20
ISO17510 compliant | Same |
| Maximum Flow (LPM), as
measured by ISO 17510-1 | 35 | Same |
| Power Consumption | 24VDC derived from A/C
power supply | Same |
| Electrical shock protection | Class II | Same |
| Drip Proof Equipment | IPX1 | Same |
| Heater Setting | continuous | Same |
3
The table below provides a comparison of the features of the Curasa CPAP EUT to the
predicate Curasa CPAP SD with heated humidifier.
·
4
| Functional Features | Same/Different |
|---|---|
| Software | Same with the addition of EUT function and |
| SD card Therapy Pressure setting update | |
| Hardware Components | Same, except for new power supply |
| compliant with IEC-60601-1 3rd edition | |
| Humidifier | Same |
| User Interface | Same |
| Packaging | Same |
| Accessory | The PC AutoManager™ software |
| collects/updates CPAP device data via an | |
| SD card. It is used on a stand-alone PC with | |
| not interaction with the CPAP device. | |
| AutoManager™ is used by the service | |
| provider |
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).
5
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
6
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
7
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
いたいない。 出張・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ .
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.