(20 days)
Not Found
No
The description focuses on hardware modifications and basic data logging/display features, with no mention of AI or ML algorithms for treatment adjustment or analysis.
Yes
The device is intended for the treatment of obstructive sleep apnea (OSA) by providing continuous positive airway pressure (CPAP), which is a therapeutic intervention.
No
The device is described as a CPAP device for the treatment of obstructive sleep apnea (OSA). Its primary function is to provide continuous positive airway pressure, which is a therapeutic intervention, not a diagnostic one. While it records patient compliance data (times of device use), this is for monitoring treatment adherence, not for diagnosing a condition.
No
The device description clearly outlines a hardware device (TREND 200 CPAP device) that provides continuous positive airway pressure. While it includes accompanying software (TRENDset PC Software), the primary medical device is the physical CPAP machine.
Based on the provided information, the TREND 200 device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of obstructive sleep apnea (OSA) in adult patients. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device provides continuous positive airway pressure (CPAP) to treat OSA. It measures pressure within the therapy tubing to ensure accurate delivery of the treatment.
- Lack of Diagnostic Function: The device's primary function is to deliver air pressure to the patient's airway. While it records patient compliance data (times of device use), this data is used to monitor the effectiveness of the treatment, not to diagnose a condition or analyze biological samples.
- No Mention of Biological Samples: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue). There is no mention of the TREND 200 interacting with or analyzing any biological samples.
The TRENDset PC Software is used to read compliance data from the device, which is related to the treatment delivery, not a diagnostic test.
Therefore, the TREND 200 is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TREND 200 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 200 device provides continuous positive airway pressure.
The TRENDset PC Software is a program for reading the TREND CPAP device patient compliance data.
Product codes (comma separated list FDA assigned to the subject device)
BZD, 21 CFR §868.5905
Device Description
The Hoffrichter TREND 200 device provides mono-level CPAP treatment levels over the clinician settable range of 4 to 18 cmH2O.
The TREND 200 CPAP device is modification of the TREND 110 CPAP device which adds the following features:
- Real time clock with wake-alarm support. .
- Audible tone generator with audible alert functions. .
- EEPROM capacity increased to store times of device use (patient compliance . data).
- Serial port which can transmit the stored times of device use. .
- TRENDset PC software which may be used by the clinician to communicate . TRENDSETT O sollware which may be and print the patient compliance data (times of use).
- DC power inlet for alternate power source option. .
The TREND 200 CPAP device is provided in a compact lightweight THE TREND 200 OF .. See and utilizes the same form factor and enclosure for Casy bodolae acce, and 16 character LCD display with keys accessones as the 7 (END 170 the user with displayed information about on the operator panel provides the access to menus for soft-start ramp, clinical the treathern (set by doctor, PIN code protected), day/date/wake-alarm, prescription (SCL by doctor) nower supply automatically supply adapts to regional mains voltage (115 to 230 VAC).
Standard accessories include treatment tubing with integrated Standard - aoceoonoo - including - including available masks and swivels are specified.
As in the TREND 110, TREND 200 treatment pressure is measured as As in the 7AEND 110, 178, 1782AB by means of a measuring tube integrated into the therapy tubing. This maximizes accuracy and control of megrated into the therapy tabing.
pressure and accounts for losses due to the therapy delivery circuit.
Hoffrichter CPAP devices are prescription use devices, and are not intended for life supporting or life sustaining applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Not Found
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)
Not Found
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
JAN 4 2006
K053486
Page 1 of 3
510(k) Summary of Safety and Effectiveness in accordance with 21 CFR 807.92
| (a) (1) Submitted by: | | HOFFRICHTER GmbH
Mettenheimer Strasse 12/14
D-19061 Schwerin
Germany
Tel.: +49-385-39925-0
Fax: +49-385-39925-25
E-mail: info@hoffrichter.de |
|-----------------------------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | | Norbert Küchemann |
| Position/Title: | | Sales Manager |
| Date of Preparation: | | December 12, 2005 |
| (2) Trade Name: | | TREND 200 CPAP device with
TRENDset PC Software |
| Common/Classification Name: | | VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING; |
| Product Code(s): | | BZD, 21 CFR §868.5905 |
| Class: | | Class II |
| (3) Predicate Device(s): | | • TREND 110 CPAP Device (K041035) |
| Reason for Submission: | | Device modification to TREND 110 |
Description of Device: (4)
The Hoffrichter TREND 200 device provides mono-level CPAP treatment levels over the clinician settable range of 4 to 18 cmH2O.
The TREND 200 CPAP device is modification of the TREND 110 CPAP device which adds the following features:
- Real time clock with wake-alarm support. .
- Audible tone generator with audible alert functions. .
- EEPROM capacity increased to store times of device use (patient compliance . data).
- Serial port which can transmit the stored times of device use. .
- TRENDset PC software which may be used by the clinician to communicate . TRENDSETT O sollware which may be and print the patient compliance data (times of use).
- DC power inlet for alternate power source option. .
1
The TREND 200 CPAP device is provided in a compact lightweight THE TREND 200 OF .. See and utilizes the same form factor and enclosure for Casy bodolae acce, and 16 character LCD display with keys accessones as the 7 (END 170 the user with displayed information about on the operator panel provides the access to menus for soft-start ramp, clinical the treathern (set by doctor, PIN code protected), day/date/wake-alarm, prescription (SCL by doctor) nower supply automatically supply adapts to regional mains voltage (115 to 230 VAC).
Standard accessories include treatment tubing with integrated Standard - aoceoonoo - including - including available masks and swivels are specified.
As in the TREND 110, TREND 200 treatment pressure is measured as As in the 7AEND 110, 178, 1782AB by means of a measuring tube integrated into the therapy tubing. This maximizes accuracy and control of megrated into the therapy tabing.
pressure and accounts for losses due to the therapy delivery circuit.
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 Obstructive sleep aprica (OSA) 16 a contract collapse on the back wall of the upper airway, and when the tongue moves back, the airway is wall of the upper ullway, and sruptions in normal respiration and sleep.
Continuous Positive Airway Pressure (CPAP) is an effective treatment for Continuous I Usitive Allway Fressultion by supplying a constant positive OSA. OF Ar devices trout the commonly via the nasal passages, in order to pressure to the alrway, most of the uvula and soft palate during sleep.
Indications for Use:
The TREND 200 device is for treatment of obstructive sleep apnea (OSA) The TREND 200 device to the signing at least 30 kg. These devices are not intended for use with ventilator-dependent patients.
The TREND 200 device provides continuous positive airway pressure.
The TRENDset PC Software is a program for reading the TREND CPAP device patient compliance data.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Public Health Service
2006 JAN 4
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hoffrichter GmbH C/O Mr. Stephen H. Gorski Submission Correspondent/USA Agent S65 IMAGENIX, Incorporated S65 W35739 Piper Road Eagle, Wisconsin 53119
Re: K053486
Trade/Device Name: Hoffrichter TREND 200 CPAP Device Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: December 12, 2005 Received: December 15, 2005
Dear Mr. Gorski:
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 muroutions for are barror to May 28, 1976, the enactment date of the Medical Device Intersule comments, or to devices that have been reclassified in accordance with the provisions of Amendinene, or to activelic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include econorements for 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 11 your do ree is clabbitional controls. Existing major regulations affecting (1 Writ), it hay of our in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or routish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Gorski
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 mean that ITDA has made a deceminations administered by other Federal agencies. of the Act of ally I ederal statutes and reguirements, including, but not limited to: registration
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice i and listing (21 CFR Pat 607), laboling (21 CFR Parts (QS) regulation (21 CFR Part 820); and if requirements as Sectionic me quality brovisions (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 begal finding of substantial equivalence of your device to a premiation. The PDF internet on 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), II you desire specific aurroo for your de at (240) 276-0120. Also, please note the regulation i please contact the Other of Compilan promarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general mionnal.com of Consumer Assistance at its toll-free Drumber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clive Lis, Ph.D.
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
4
Indications for Use
510(k) Number (if known):
Hoffrichter TREND 200 CPAP Device Device Name:
Indications for use:
The TREND 200 device is for treatment of obstructive sleep apnea (OSA) in adult mc TreNo 200 devices to These devices are not intended for use with ventilatordependent patients.
The TREND 200 device provides continuous positive airway pressure.
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)
The worn raturing General Hugh ... of, Lennal Dovices
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