K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER

K120285 · Curative Medical, Inc. · BZD · Jul 2, 2012 · Anesthesiology

Device Facts

• Record ID: K120285
• Device Name: K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER
• Applicant: Curative Medical, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Jul 2, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

K Series CPAP (Curasa and Floton models) provides continuous positive airway pressure to treat obstructive sleep apnea in adult patients (>30 kg). System includes CPAP unit, heated humidifier, power supply, patient air circuit, and U-tube connection. Used in home or hospital settings by patients under physician prescription. Device delivers warm, humidified air to reduce airway dryness. Operation is continuous; pressure range 4-20 cm H2O. Healthcare providers use device to maintain airway patency during sleep, potentially improving patient outcomes by preventing apnea events. Device is operated by the patient.

Clinical Evidence

No clinical data. Performance established via bench testing and verification against predefined acceptance criteria. Compliance with IEC 60601-1, IEC 60601-2, ISO 17510-1, and ISO 8185 standards confirmed.

Technological Characteristics

Class II non-continuous ventilator (BZD). Pressure range 4-20 cm H2O; flow 35 LPM. Heated humidifier with 240 ml reservoir. Electrical: Class II, Type B applied part, IPX1 ingress protection. Standards: IEC 60601-1, IEC 60601-2, ISO 17510-1, ISO 8185.

Indications for Use

Indicated for treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing >30 kg. Contraindicated for patients with bullous lung disease, pathologically low blood pressure, bypassed upper airway, pneumothorax, or pneumocephalus. Use caution in patients with CSF leaks, cribriform plate abnormalities, prior head trauma, or active sinus/middle ear infections.

Regulatory Classification

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.

Predicate Devices

• Respironics Remstar Pro M Series with heated humidifier (K072996)

Submission Summary (Full Text)

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## 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.<br>3227 Kifer Road<br>Santa Clara, CA 95051<br>Establishment Number: 3008361782 |
|--------------------------------|-------------------------------------------------------------------------------------------------------|
| Company Contact<br>Person: | Cuong Tran, Director Research and Development |
| Phone: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |
| Submission<br>Correspondent: | Amy McKinney, Regulatory Affairs Consultant |
| Address: | 63 Chicory Ct., Lake Jackson, TX 77566 |
| Phone: | [phone] |
| Email: | [e-mail] |
| Device Name: | K Series CPAP Systems<br>Curasa Model (Product # 31011321)<br>Floton Model (Product # 31015121) |
| Device Classification<br>Name: | Non-continuous ventilator (BZD)<br>21 CFR 868.5905 |
| Predicate Devices: | Respironics Remstar Pro M Series with heated humidifier<br>(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:

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| Comparison Parameter | Respironics Remstar Pro M Series (K072996) | Curative Medical Inc. K Series CPAP |
|--------------------------------------------------|--------------------------------------------|-------------------------------------------|
| Device Size (cm) | 19x12.7x7.9 | Curasa: 17x11.7x9.3<br>Floton: 18x21x10.5 |
| Weight (kg) | 1.0 | Curasa: 1.4<br>Floton: 1.6 |
| Product Use, Transport,<br>Storage | 5 to 35 | 5 to 35 |
| Operation<br>(degreeCelsius.) | 5 to 35 | 5 to 35 |
| Transport & Storage<br>(degree Celsius.) | -20 to 60 | -20 to 60 |
| Atmosphere Pressure<br>(Operation) | 77 to 101 kPa | 70 to 106 kPa |
| Mode of Operation | Continuous | Continuous |
| Type of Protection Against<br>Electric Shock | Class II Equipment | Class II Equipment |
| Degree of Protection<br>Against Electric Shock | Type BF Applied Part | Type B Applied Part |
| Degree of Protection<br>Against Ingress of Water | IPX1 | IPX1 |
| Pressure Range (cm H2O) | 4-20 | 4-20 |
| Pressure Stability<br>(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 | < 0.9 lbs |
| Power Consumption | | |
| Electrical shock protection: | Class II | Class II |
| Drip Proof Equipment | IPX1 | IPX1 |
| Heater Setting | 1 - 5 | continuous |
| Standards Compliance | | |
| IEC-60601-1 | Yes | Yes |
| IEC-60601-2 | Yes | Yes |
| ISO 17510-1 | Yes | Yes |
| ISO 8185 | Yes | Yes |

## Intended 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.

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#### 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:

- 1. EN 60601-1-1:1995 + A1:1993 + A2:1995 Medical Electrical equipment - Part 1: General requirement for Safety
- 2. EN 60601-1-2:2001 Medical Electrical equipment - Part 1-2: General requirement for Safety - Collateral Standard: Electromagnetic compatibility - Requirements and tests
- 3. EN ISO 8185:1997 Respiratory Tract humidifiers for medical use - Particular requirements for respiratory humidifier systems
- 4. 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.

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## 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.

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#### 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 [phone] or [phone] 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

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# 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