(153 days)
Not Found
No
The document describes a standard CPAP device and its humidifier, focusing on pressure delivery and humidification. There is no mention of AI, ML, or any features that would suggest the use of such technologies for analysis, prediction, or adaptive control beyond basic pressure regulation. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended for the treatment of Obstructive Sleep Apnea, which is a medical condition.
No
This device is a therapeutic device (CPAP system) designed for the treatment of Obstructive Sleep Apnea, not for diagnosing it.
No
The device description clearly states it is a "CPAP System with heated humidifier" and includes physical components like a power supply, patient air circuit, and U-tube connection, indicating it is a hardware device with potentially embedded software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is designed for the treatment of Obstructive Sleep Apnea by providing continuous positive airway pressure. This is a therapeutic intervention, not a diagnostic test performed on biological samples.
- Device Description: The description focuses on delivering air pressure and humidification to the patient's airway. It does not mention analyzing biological samples (like blood, urine, tissue, etc.) to diagnose a condition.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or prognosis based on laboratory testing.
In summary, the K Series CPAP with Heated Humidifier System is a medical device used for treatment, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
The K Series CPAP (Continuous Positive Airway Pressure) with heated humidifier systems are 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.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The K Series CPAP Systems with heated humidifier are used on adult patients for treatment of obstructive sleep apnea (OSA). The K Series CPAP Systems are available in two models: Curasa model and Floton model. The CPAP system provides a stable continuous positive airway pressure (CPAP). The humidifier works only with the K Series CPAP Systems and provides warm, humidified air for comfort to the patient, reducing nose and airway dryness. The K Series systems also include the following accessories: a power supply, a Patient Air Circuit, and a U-tube connection between CPAP and humidifier.
The K Series CPAP with heated humidifier system has the following similarities to the previous cleared predicate device:
- Same intended use .
- Same operating principle .
- Similar technologies .
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
30 kg (implicitly adult patients)
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 with heated humidifier systems were designed and verified in accordance with the risk analysis and product requirements. All tests confirmed the products met the predefined acceptance criteria. Curative Medical Inc. has determined that the K Series is safe and effective for CPAP treatment of OSA in adults. The K Series CPAP with heated humidifier systems have been tested and shown to be compliant with the following standards documents:
-
- 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 8185:1997 Respiratory Tract humidifiers for medical use - Particular requirements for respiratory humidifier systems
-
- EN ISO 17510:2002 Sleep Apnoea Breathing therapy - Part 1: Sleep apnoea breathing therapy equipment
Testing was conducted to demonstrate the performance of K series CPAP with heated humidifier system is as safe and effective as its predicate device in its intended environment.
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
510(k) SUMMARY K / 202 85
A summary of 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) 605 9917 |
| Fax: | (408) 413-3000 |
| Email: | ctran@curativemedical.com |
| Submission
Correspondent: | Amy McKinney, Regulatory Affairs Consultant |
| Address: | 63 Chicory Ct., Lake Jackson, TX 77566 |
| Phone: | (979) 236-1622 |
| Email: | amckinne@comcast.net |
| Device Name: | K Series CPAP Systems
Curasa Model (Product # 31011321)
Floton Model (Product # 31015121) |
| Device Classification
Name: | Non-continuous ventilator (BZD)
21 CFR 868.5905 |
| Predicate Devices: | Respironics Remstar Pro M Series with heated humidifier
(K072996) |
| Date of Preparation: | May 28, 2012 |
Device Description:
The K Series CPAP Systems with heated humidifier are used on adult patients for treatment of obstructive sleep apnea (OSA). The K Series CPAP Systems are available in two models: Curasa model and Floton model. The CPAP system provides a stable continuous positive airway pressure (CPAP). The humidifier works only with the K Series CPAP Systems and provides warm, humidified air for comfort to the patient, reducing nose and airway dryness. The K Series systems also include the following accessories: a power supply, a Patient Air Circuit, and a U-tube connection between CPAP and humidifier.
The K Series CPAP with heated humidifier system has the following similarities to the previous cleared predicate device:
- Same intended use .
- Same operating principle .
- Similar technologies .
The following table provides a comparison to the predicate device:
1
| Comparison Parameter | Respironics Remstar Pro M Series (K072996) | Curative Medical Inc. K Series CPAP |
|---|---|---|
| Device Size (cm) | 19x12.7x7.9 | Curasa: 17x11.7x9.3 |
| Floton: 18x21x10.5 | ||
| Weight (kg) | 1.0 | Curasa: 1.4 |
| Floton: 1.6 | ||
| Product Use, Transport, | ||
| Storage | 5 to 35 | 5 to 35 |
| Operation | ||
| (degreeCelsius.) | 5 to 35 | 5 to 35 |
| Transport & Storage | ||
| (degree Celsius.) | -20 to 60 | -20 to 60 |
| Atmosphere Pressure | ||
| (Operation) | 77 to 101 kPa | 70 to 106 kPa |
| Mode of Operation | Continuous | Continuous |
| Type of Protection Against | ||
| Electric Shock | Class II Equipment | Class II Equipment |
| Degree of Protection | ||
| Against Electric Shock | Type BF Applied Part | Type B Applied Part |
| Degree of Protection | ||
| Against Ingress of Water | IPX1 | IPX1 |
| Pressure Range (cm H2O) | 4-20 | 4-20 |
| Pressure Stability | ||
| (cm H2O) | 4-20 cm H2O, +/- 1.0 cm H2O | 4-20 cm H20 +/- 2.0 cm H20 |
| Maximum Flow (LPM) | 35 | 35 |
| Humidifier | ||
| Water reservoir | 1 2/3 cup | 240 ml |
| Dimensions: | 8.25" x 8.75" x 4" | 6.5" x 3.3" x 4" |
| Weight | 2.2 lbs | 30 kg. It is for use in the home or hospital /institutional environment. |
2
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 with heated humidifier systems were designed and verified in accordance with the risk analysis and product requirements. All tests confirmed the products met the predefined acceptance criteria. Curative Medical Inc. has determined that the K Series is safe and effective for CPAP treatment of OSA in adults. The K Series CPAP with heated humidifier systems have been tested and shown to be compliant with the following standards documents:
-
- 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 8185:1997 Respiratory Tract humidifiers for medical use - Particular requirements for respiratory humidifier systems
-
- EN ISO 17510:2002 Sleep Apnoea Breathing therapy - Part 1: Sleep apnoea breathing therapy equipment
This 510(k) submission presents the results of the testing and detailed descriptions to demonstrate that K series CPAP with heated humidifier system is substantially equivalent to the Respironics Remstar Pro M Series (K072996).
Testing was conducted to demonstrate the performance of K series CPAP with heated humidifier system is as safe and effective as its predicate device in its intended environment.
Conclusion:
The information and data provided in this 510(k) Notification establishes that the K Series CPAP with heated humidifier systems are substantially equivalent to the legally marketed predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Curative Medical, Incorporated C/O Ms. Amy Mckinney, MS, RAC Regulatory Affairs Consultant 63 Chicory Court Lake Jackson, Texas 77566
2 2012 JUL
Re: K120285
Trade/Device Name: K Series CPAP Systems Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: June 1, 2012 Received: June 4, 2012
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.
4
Page 2- Ms. 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 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.goy/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.
Nh fa
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 4. Indications for Use Statement
510(k) Number (if known):
Device Name: K Series CPAP Systems
Indications For Use:
The K Series CPAP with Heated Humidifier 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)
L. Shults
(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices
0285 510(k) Number:
Traditional 510(k) - K Series CPAP with Heated Humidifier