(13 days)
The Evo Heated Humidifier is intended to warm and add moisture to the breathing gases for administration to a patient. It is used for patients requiring Continuous Positive Airway Pressure (CPAP) therapy for the treatment of Obstructive Sleep Apnea. The addition of heated humidification to this therapy relieves the drying and irritating effects on the patient airways, which may arise from the use of a CPAP system. Use only with RemRest 900 series CPAP devices. It is portable and is intended to be used in the home, hospital, and institutional settings.
The RemRest Heated Humidifier is a simple heated humidifier to be used with a CPAP device to provide heated and humidified air to the patient. It operates by a conductive heating surface warming a water reservoir and air passes over the water. The device has the following basic specifications: Size 13.1" L x 8.4" W x 4.7" H, Weight 2.5 lbs. dry, Water capacity 400 ml (1 2/3 cups), Power 100-240 VAC 50/60Hz or 1.0 A max., Heater setting 1-5 (85°F to 149°F / 29.4°C to 65°C), Humidity Range 30 mg H2O/l @ 25 lpm, Pressure drop 0.5 cm H2O @ 40 lpm.
The provided text is a summary of safety and effectiveness for the RemRest heated humidifier and does not describe acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against specific acceptance criteria.
Therefore, I cannot extract the requested information from the provided text.
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Summary of Safety and Effectiveness 3.1
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 March 2, 2005
| Medical Industries America, Inc.dba Evo Medical Solutions | |
|---|---|
| 2636 – 289th Place | Tel: (515) 993-5001 |
| Adel, IA 50003-8021 | Fax: (515) 993-4172 |
| Official Contact: | Keith Theisen, Director of Engineering |
| Proprietary or Trade Name: | RemRest heated humidifier |
| Common/Usual Name: | Heated humidifier |
| Classification Name: | Humidifier, Respiratory Gas (Direct Patient Interface) |
| Predicate Devices: | Respironics - RemStar - K010263 |
Device Description:
The RemRest Heated Humidifier is a simple heated humidifier to be used with a CPAP device to provide heated and humidified air to the patient. It operates by a conductive heating surface warming a water reservoir and air passes over the water. The device has the following basic specifications:
Fisher & Paykel - HC 150 - K003973
| Size | 13.1" L x 8.4" W x 4.7" H |
|---|---|
| Weight | 2.5 lbs. dry |
| Water capacity | 400 ml (1 2/3 cups) |
| Power | 100-240 VAC 50/60Hz or 1.0 A max. |
| Heater setting | 1-5 (85°F to 149°F / 29.4°C to 65°C) |
| Humidity Range | 30 mg H2O/l @ 25 lpm |
| Pressure drop | 0.5 cm H2O @ 40 lpm |
Indications:
| Indications for Use -- | The evo Heated Humidifier is intended to warm and addmoisture to the breathing gases for administration to a patient. Itis used for patients requiring Continuous Positive AirwayPressure (CPAP) therapy for the treatment of Obstructive SleepApnea. The addition of heated humidification to this therapyrelieves the drying and irritating effects on the patient airways,which may arise from the use of a CPAP system. Use only withRemRest 900 series CPAP devices. |
|---|---|
| Patient Population -- | Patients utilizing CPAP devices for OSA and desire to haveheated humidification |
| Environment of Use -- | Home, Hospital, and Institutional settings |
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Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 March 2, 2005
Comparison to Predicate Devices:
| RemRest | Predicates | |
|---|---|---|
| Heated Humidifier | ||
| Attributes | ||
| Indications for use | To warm and add moisture to the breathinggases for administration to a patient. It is usedfor patients requiring Continuous PositiveAirway Pressure (CPAP) therapy for thetreatment of Obstructive Sleep Apnea. Theaddition of heated humidification to thistherapy relieves the drying and irritating effectson the patient airways, which may arise fromthe use of a CPAP system. | F&P - HC 150 - K003973Respironics - RemStar withhumidifier - K010263Same |
| Environments of use | Home, Hospital, Institutional | Same |
| Patient Population | Patients utilizing CPAP devices for OSA anddesire to have heated humidification | Same |
| Contraindications | None | Same |
| Technology | ||
| Method of heating | Heated plate | Yes |
| Temperaturecontrolled | Yes | Yes |
| Connects betweenCPAP and patient | Yes | Yes |
| Thermal cutoff | Yes | Yes |
Differences Between Other Legally Marketed Predicate Devices
There are no significant differences between the proposed device, RemRest Heated Humidifier, and the identified predicates.
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Third Party Review Quality Assessment
| Section 1 – Submission Information | |
|---|---|
| 510(k) No.: | K050990 |
| Third Party Organization: | Intertek / Artek |
| Third Party's Primary Reviewer(s): | Mel Devine |
| ODE/OIVD Division: | DAEID |
| Branch/Team: | ARDB |
| Section 2 – 510(k) Decision | |
|---|---|
| Third party recommendation: | SE x NSE ______ Other (specify): ______ |
| ODE/OIVD final decision: | SE x NSE ______ Other (specify): ______ |
| Section 3 – Assessment of Third Party Review | |||
|---|---|---|---|
| Review Element | Rating (check one) | ||
| Adequate | Minor Issue(s) | Major Issue(s) | |
| a. Determination of device eligibility for third party review | x | ||
| b. Extent of pre-submission consultation with ODE/OIVD division | x | ||
| c. Organization and format of review documentation | x | ||
| d. Determination of 510(k) administrative completeness (screening review) | x | ||
| e. Summary of device characteristics, intended use, and performance (including accessories, if applicable) and reason for 510(k) submission | x | ||
| f. Comparison to legally marketed devices—identification and analysis of key similarities and differences | x | ||
| g. Rationale for conclusions and recommendation | x | ||
| h. Use of guidance documents and standards | x | ||
| i. Resolution of 510(k) deficiencies and FDA requests for additional information | n/a | ||
| j. Scope of reviewer expertise and use of consulting reviewers | x | ||
| k. Other (specify): |
Comments (explanation of ratings/issues): ___________________________________________________________________________________________________________________________________
Section 4 – ODE/OIVD Assessor Information
Assessed by: Oalom Date: 4/26/05 Tel. No.: 827 4479
Routing: Division--Clip completed assessment (this page only) to inside front cover of 510(k).
DMC--Forward this page only to Eric Rechen, POS/ODE, Rm. 120J, Corp. Blvd. (HFZ-402).
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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 caduceus symbol, which features a staff with a snake winding around it, and three horizontal lines above it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medical Industries America, Incorporated C/O Mr. Ned E. Devine Responsible Third Party Official Intertek Testing Services NA, Incorporated 70 Codman Hill Road, Boxborough, Massachusetts 01719 ·
Re: K050990
Trade/Device Name: RemRest Heated Humidifier Regulation Number: 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: April 18, 2005 Received: April 19, 2005
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed yoursed the device is substantially equivalent (for the icierciccu above and have acteriminosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate conments of provises that have been reclassified in accordance with the provisions of Amendinents, or to de rouses 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 approval uppreation (The Act. The general controls provisions of the Act include controls provisions of the gistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (500 additional controls. Existing major regulations affecting (PMA), it may oc subject to sach adam f Federal Regulations, Title 21, Parts 800 to 898. In your device can oc round in the announcements concerning your device in the Federal Register.
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Page 2 - Mr. Devine
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 moan mat I DA mas made statutes and regulations administered by other Federal agencies. of the Act of ally I oderal business requirements, including, but not limited to: registration 1 od indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Pat 001), labelity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quadistion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anon you be objection.
premarket notification. The FDA finding of substantial equivalence of your device to a premarket notification. - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific ach of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Synette Michie Davis
Chiu Lin, Ph.D. 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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Indications for Use 3.3
Page 1 of 1
| 510(k) Number: | K050990 (To be assigned) |
|---|---|
| Device Name: | RemRest Heated Humidifier |
| Indications for Use: | The Evo Heated Humidifier is intended to warm and add moisture to the breathing gases for administration to a patient. It is used for patients requiring Continuous Positive Airway Pressure (CPAP) therapy for the treatment of Obstructive Sleep Apnea. The addition of heated humidification to this therapy relieves the drying and irritating effects on the patient airways, which may arise from the use of a CPAP system. Use only with RemRest 900 series CPAP devices. It is portable and is intended to be used in the home, hospital, and institutional settings. |
Prescription Use XX (Per CFR 801.109)
:
or
Over-the-counter use
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ulus
(Division Sign
Division of ----------Infection Control. Duntal De Cests
510(k) Number...
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).