HOFFRICHTER TREND 110 CPAP DEVICE WITH AQUATREND III CPAP HUMIDIFIER ACCESSORY FOR TREND

K041035 · Hoffrichter GmbH · BZD · Jun 9, 2004 · Anesthesiology

Device Facts

• Record ID: K041035
• Device Name: HOFFRICHTER TREND 110 CPAP DEVICE WITH AQUATREND III CPAP HUMIDIFIER ACCESSORY FOR TREND
• Applicant: Hoffrichter GmbH
• Product Code: BZD · Anesthesiology
• Decision Date: Jun 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TREND 110 device is for treatment of obstructive sleep apnea (OSA) in adult patients weighing at least 30 kg. These devices are not intended for use with ventilator-dependent patients. The TREND 110 device provides continuous positive airway pressure. The AquaTREND Humidifier accessory provides humidification of the air delivered to the patient. Caution: Federal law restricts this device to sale by or on the order of a physician.

Device Story

TREND 110 is a mono-level CPAP device for obstructive sleep apnea treatment; provides constant positive airway pressure (4-18 cmH2O) to prevent upper airway collapse. Input: ambient air; output: pressurized air delivered via mask. Features: LCD display, user-selectable ramp function (0-30 mins), and optional AquaTREND III heated humidifier. Used in home/bedside settings; operated by patient under physician prescription. Pressure measured at mask via integrated measurement tube for accuracy. Healthcare providers use device to manage OSA; patient benefits from improved sleep and reduced airway obstruction. Device is non-life-supporting.

Clinical Evidence

No clinical data. Bench testing only. Static and dynamic pressure testing, humidification testing, and electrical/environmental safety testing performed in comparison with predicate devices. Software verified and validated via parameter and event testing.

Technological Characteristics

Computer-controlled blower system; mono-level CPAP; 4-18 cmH2O pressure range. Heated humidifier uses hotplate design. Pressure sensing via integrated measurement tube in therapy hose. Connectivity: standalone. Power: 115-230 VAC. Biocompatible materials used for patient-contacting components.

Indications for Use

Indicated for treatment of obstructive sleep apnea (OSA) in adult patients weighing at least 30 kg. Not for ventilator-dependent patients.

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

• SCALAR/VECTOR CPAP with Humidifier "Plus" option (K014074)
• Fischer and Paykel HC200 CPAP with Heated Humidifier (K973161)
• Invacare Poseidon Passover Humidifier (K003561)

Submission Summary (Full Text)

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K041035

JUN - 9 2004

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510(k) Summary of Safety and Effectiveness in accordance with 21 CFR 807.92

| a) | (1) | Submitted by: | HOFFRICHTER GmbH<br>Mettenheimer Strasse 12/14<br>D-19061 Schwerin<br>Germany<br>Tel .: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
|----|-----|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Contact Person: | Norbert Küchemann |
| | | Position/Title: | Sales Manager |
| | | Date of Preparation: | April 10, 2004 |
| | (2) | Trade Name: | TREND 110 CPAP device with<br>Aqua TREND III Humidifier Accessory |
| | | Common/Classification Name: VENTILATOR, CONTINUOUS, | NON-LIFE-SUPPORTING;<br>HUMIDIFIER, RESPIRATORY GAS<br>(Humidification on Plus Models only) |
| | | Product Code(s): | BZD, 21 CFR §868.5905<br>BTT, 21 CFR §868.5450 |
| | | Class: | Class II |
| | (3) | Predicate Device(s): | · SCALAR/VECTOR CPAP with<br>Humidifier "Plus" option (K014074)<br>· Fischer and Paykel HC200 CPAP<br>with Heated Humidifier (K973161)<br>· Invacare Poseidon Passover<br>Humidifier (K003561) |
| | | Reason for Submission: | New Device |

### Description of Device: (4)

Hoffrichter TREND 110 devices provide mono-level CPAP treatment levels over the clinician settable range of 4 to 18 cmH₂O.

The TREND 110 CPAP device is provided in a compact lightweight enclosure for easy bedside use. A 2 x 16 character LCD display with keys on the operator panel provides the user with displayed information about

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the treatment level as well as access to menus for soft-start ramp, clinical prescription (set by doctor, PIN code protected) and hours of operation. TREND 110's power supply automatically supply adapts to regional mains voltage (115 to 230 VAC).

Heated humidification is available by installing the AquaTREND /// heated humidifier accessory. A key with LED indicator permits the user to select the humidification level. Moisture contacting materials in the humidifier and therapy tube meet biocompatibility requirements.

Treatment pressure is measured as close as possible to the patient mask Freathern of a measuring tube integrated into the therapy tubing. This maximizes accuracy and control of pressure and minimizes losses due to the therapy delivery circuit.

TREND 110 has a user selectable ramp function, which starts with a reduced pressure and gradually increases to the treatment pressure to make it more comfortable to fall asleep. The user can adjust the ramp time in 10 minute increments to 0 (no ramp), 10, 20, or 30 minutes.

Standard accessories include treatment tubing with integrated measurement tube and headgear. Commercially available masks and swivels are specified.

Hoffrichter CPAP devices are prescription use devices, and are not intended for life supporting or life sustaining applications.

#### (5) Intended use:

Obstructive sleep apnea (OSA) is a condition caused by closing of the upper airway during sleep. The uvula and soft pallet collapse on the back wall of the upper airway, and when the tongue moves back, the airway is temporarily sealed, causing disruptions in normal respiration and sleep.

Continuous Positive Airway Pressure (CPAP) is an effective treatment for OSA. CPAP devices treat the condition by supplying a constant positive pressure to the airway, most commonly via the nasal passages, in order to prevent the collapse of the soft tissue of the uvula and soft palate during sleep.

## Indications for Use:

The TREND 110 device is for treatment of obstructive sleep apnea (OSA) in adult patients weighing at least 30 kg. These devices are not intended for use with ventilator-dependent patients.

The TREND 110 device provides continuous positive airway pressure.

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The AquaTREND Humidifier accessory provides humidification of the air delivered to the patient.

### Technological Characteristics: (6)

The TREND 110 CPAP device employs the same technological characteristics as the predicate devices. The devices employ a computer controlled blower system which is attached via tubing to a swivel and nasal mask to deliver a prescribed mono-level CPAP treatment to a patient. Devices with humidification employ a hotplate type design to heat a water reservoir to add humidification or a passive (unheated) humidifier.

Hoffrichter CPAP devices employ pressure measurement at the mask via a measurement hose integrated into the breathing hose. This enables improved pressure control and accuracy by the Hoffrichter CPAP devices.

#### Non-Clinical Tests Submitted: (1) (b)

The TREND 110 and AquaTREND III devices were tested in accordance applicable standards for medical device Electrical Safety, with with with with a Electromagnetic Compatibility, Shock and Vibration, and Environmental Temperature and Humidity. The CPAP devices passed all of the tests.

Static and dynamic pressure testing and humidification testing was performed in comparison with predicate devices. The Hoffrichter TREND 110 and AquaTREND III devices met specified requirements and were comparable to the applicable specifications of the predicate devices.

Software across all platforms was verified to requirements and validated to meet intended use by parameter and event testing.

#### Clinical Tests Submitted: (None) (2)

#### Conclusions from Tests: (3)

As described in (b)(1) above, all of the testing demonstrated that the Hoffrichter TREND 110 and AquaTREND III CPAP devices are as safe and effective as and perform in a manner equivalent to the predicate devices, the Hoffrichter SCALAR/VECTOR Plus, Fisher and Paykel HC200, and Invacare Poseidon.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized representation of a human figure embracing a globe, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 9 2004

Hoffrichter GmbH C/O Mr. Stephen H. Gorski Consultant Imagenix, Incorporated S65 W 35739 Piper Road Eagle, WI 53119

Re: K041035

Ko+1055
Trade/Device Name: Hoffrichter Trend 110 CPAP with AquaTrend III Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator Regulatory Class: II Product Code: BZD Dated: April 10, 2004 Received: April 21, 2004

Dear Mr. Gorski:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your contermined the device is substantially equivalent (for the releiced above and nave actively to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Annehuments, or to do roos and Cosmetic Act (Act) that do not require approval of a premarket the roderal I ou, Drag, and Country, therefore, market the device, subject to the general approval uppreation (1 the Act. The general controls provisions of the Act include controls providions of an annual registration, 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Nr.), it may be bacyson to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be fourther announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not Fleast be advisod that I DTP of issualles on that your device complies with other requirements Incall that I DX mas made weeks and regulations administered by other Federal agencies. UI the Act of ally I oderal statues and equirements, including, but not limited to: registration r out must comply with and the Pieveling (21 CFR Part 801); good manufacturing practice and ilsung (21 CFR Part 807), labsiting (QS) regulation (21 CFR Part 820); and if requirences as set form in the quality sion 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 anow you to objacting of substantial equivalence of your device to a premarket notification. The PDF Pinners in a classification for your device and thus, permits 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 at 100 to pliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Carls

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

510(k) Number (if known): K041035

Hoffrichter TREND 110: CPAP with AquaTREND Humidifier Accessory Device Name:

Indications for use:

The TREND 110 device is for treatment of obstructive sleep apnea (OSA) in adult patients The TREND 110 device 15 for treatment or obstituent of one with ventilator-dependent patients.

The TREND 110 device provides continuous positive airway pressure.

The AquaTREND Humidifier accessory provides humidification of the air delivered to the patient.

Caution: Federal law restricts this device to sale by or on the order of a physician.

× Prescription Use _ (Part 21 CFR 801 Subpart D) AND / OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Auytweron

(Division Sign Off) Division of Anesthesiology, General Hospital, Infection Control, Dental D

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510(k) Number: K041534