(85 days)
Not Found
No
The summary describes a standard CPAP device with data storage capabilities, and there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is designed for the treatment of Obstructive Sleep Apnea (OSA), which is a medical condition, making it a therapeutic device.
No.
The device is a CPAP system designed for the treatment of Obstructive Sleep Apnea by providing positive airway pressure, not for diagnosing the condition. While it can store patient compliance data, this is for monitoring treatment adherence, not for diagnosis.
No
The device description clearly outlines hardware components such as the CPAP system itself, a humidifier, power supply, patient air circuit, and a U-tube connection. While it mentions software, it is integrated into a physical device.
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 electronic aspects of delivering air pressure and humidification. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) which is the core function of an IVD.
- Lack of IVD-related information: The document does not contain any information typically associated with IVDs, such as:
- Analysis of biological samples.
- Detection or measurement of substances in the body.
- Diagnostic claims.
- Performance metrics like sensitivity, specificity, etc., in a diagnostic context.
The device is clearly described as a therapeutic system for treating a respiratory condition.
N/A
Intended Use / Indications for 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.
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
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 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.
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 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:
- 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
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:
Design Verification Test: Pressure Testing - Pass
Design Verification Test: System and User Interface Testing - Pass
Design Verification Test: IFU Verification Testing - Pass
Design Verification Test: ESD / EMC / EMI - Pass
Design Verification Test: Safety Testing (IPX1 / ESD) - Pass
Design Verification Test: 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
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.
K Series CPAP System (K120285)
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
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 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 SD |
| Device Classification | |
| Name: | Non-continuous ventilator (BZD) |
| 21 CFR 868.5905 | |
| Predicate Devices: | K Series CPAP System (K120285) |
| Date of Preparation: | February 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 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.
1
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:
-
- EN 60601-1-1:1995 + A1:1993 + A2:1995
Medical Electrical equipment - Part 1: General requirement for Safety
- EN 60601-1-1:1995 + A1:1993 + A2:1995
-
- 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
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:
2
| 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 positive
airway pressure | Same |
| 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 |
3
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 Against | ||
| Electric Shock | Class II Equipment | Same |
| Degree of Protection Against | ||
| Electric Shock | Type B Applied Part | Same |
| 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 |
| Compliance | ||
| IEC-60601-1 | ||
| ISO 8185:2007 | 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 |
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 card |
| reader driver to Curasa CPAP SD | |
| Hardware Components | Same with the addition of SD card |
| reader circuit board to Curasa CPAP SD | |
| Humidifier | Same |
| User Interface | Same |
| Labelling | Same with the addition of handling the |
| SD card to Curasa CPAP SD and new | |
| product name | |
| Packaging | Same |
4
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).
5
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.
6
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
7
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: