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.

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.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, specifically addressing the device's acceptance criteria and the study proving it meets them.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It usually doesn't include detailed clinical study results with specific acceptance criteria, sample sizes, or ground truth methodologies in the same way a PMA (Pre-Market Approval) application or a clinical trial report would. Instead, 510(k)s often rely on bench testing, comparison to predicate performance, and adherence to recognized standards.

Therefore, many of the requested fields below will indicate "Not explicitly stated" or "Not applicable" based on the nature of a 510(k) summary for a CPAP device modification.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric/Feature	Acceptance Criteria (Implicit/Explicit)	Reported Device Performance
CPAP Treatment Levels	Clinician settable range: 4 to 18 cmH2O	Provides mono-level CPAP treatment levels over the clinician settable range of 4 to 18 cmH2O.
Pressure Accuracy	Maximized accuracy and control of pressure, accounting for therapy delivery circuit losses. (Implicit: Must be at least equivalent to predicate TREND 110)	Pressure measured "by means of a measuring tube integrated into the therapy tubing. This maximizes accuracy and control of pressure and accounts for losses due to the therapy delivery circuit." (Same as TREND 110)
New Features Functionality	All new features (real-time clock, audible tone, increased EEPROM, serial port, PC software, DC power inlet) must function as intended.	All new features are listed as added and described; no specific quantified performance metrics are given in this summary beyond their existence and intended purpose.
Electrical Safety & EMC	Adherence to relevant safety and EMC standards. (Implicit for all medical devices)	Not explicitly detailed in the 510(k) summary; typically addressed through compliance with IEC 60601-1 and related EMC standards (e.g., IEC 60601-1-2) in a separate section of the full submission.
Biocompatibility	All patient-contacting materials are biocompatible. (Implicit)	Not explicitly detailed in the 510(k) summary; typically addressed through ISO 10993 series in a separate section of the full submission.
Software Validation	TRENDset PC Software must be validated to read/communicate/print patient compliance data accurately.	TRENDset PC software "may be used by the clinician to communicate and print the patient compliance data (times of use)."
Performance Equivalence to Predicate	Substantially equivalent to the TREND 110 CPAP Device (K041035).	The TREND 200 is a "modification of the TREND 110 CPAP device." The summary identifies no new safety or effectiveness concerns compared to the predicate.

Study Details Proving Device Meets Acceptance Criteria:

The provided document is a 510(k) submission summary for a device modification. For such submissions, the primary "study" is often a comparison to a predicate device alongside bench testing and adherence to recognized standards, rather than a large-scale clinical trial with formal acceptance criteria in the sense of accuracy, sensitivity, or specificity.

Nature of the Study: The "study" described in the 510(k) summary is a demonstration of substantial equivalence to the predicate device, the HOFFRICHTER TREND 110 CPAP Device (K041035). This involves:
- Description of Modifications: Detailing the added features (real-time clock, audible tone, increased EEPROM, serial port, TRENDset PC software, DC power inlet).
- Functional Comparison: Showing that the core therapeutic function (CPAP delivery at 4-18 cmH2O, pressure measurement via integrated tubing) remains identical to the predicate.
- Intended Use and Indications: Demonstrating that the intended use and indications for use are the same as the predicate (treatment of obstructive sleep apnea in adults >30kg, not for ventilator-dependent patients).
- Performance Data: While not explicitly detailed as a formal 'study' in this summary, the implicit data includes:
  - Bench Testing: To verify the functionality of the new features and ensure the existing core functions (like pressure delivery) are not adversely affected and meet the 4-18 cmH2O range.
  - Software Validation: For the TRENDset PC Software to ensure it correctly reads, communicates, and prints compliance data. (No details provided on this specific validation).
  - Electrical Safety and EMC Testing: (Not detailed in the summary but required for a medical device).
  - Biocompatibility Assessment: (Not detailed in the summary but required for patient-contacting parts).

2. Sample Size Used for the Test Set and the Data Provenance

Test Set Sample Size: Not explicitly stated. For device modifications and 510(k)s, this typically refers to the number of devices tested on the bench for functionality and safety, rather than a patient cohort.
Data Provenance: Not explicitly stated. Likely internal company testing (Hoffrichter GmbH) in Germany. Retrospective/Prospective is not applicable as it's not a clinical study on patient outcomes.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable. For this type of device modification, "ground truth" typically refers to engineering specifications, national/international standards, and the performance characteristics of the predicate device.
Qualifications of Experts: Not applicable in the context of clinical ground truth. For technical evaluations, internal Hoffrichter engineers and potentially third-party testing labs would be involved.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Since this is not a clinical study with subjective assessments (like image interpretation), there's no need for an adjudication method for a test set in that sense. Acceptance is based on meeting technical specifications and demonstrating equivalence.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically used for AI-powered diagnostic devices where human reader performance is being evaluated with and without AI assistance on a set of clinical cases. This 510(k) is for a therapeutic CPAP device with added features, not a diagnostic tool where reader performance is a key metric.
Effect Size of AI Improvement: Not applicable, as no MRMC study was conducted.

6. If a Standalone Study (Algorithm Only Without Human-In-The-Loop Performance) Was Done

Standalone Study: Yes, in an indirect sense. The "algorithm" here refers to the device's operational software and the new TRENDset PC software. The device's ability to deliver CPAP, and the software's ability to read/store/transmit data, would have been tested in a "standalone" (device-only, benchtop) manner to ensure they meet specifications. There is no "human-in-the-loop" component for the standalone performance of a CPAP delivery algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: For a CPAP device, the "ground truth" for performance relates to:
- Engineering Specifications: The device's ability to accurately deliver and measure specified pressure levels (4-18 cmH2O).
- Predicate Device Performance: Performance of the TREND 110 (K041035) serves as a benchmark for equivalence.
- Regulatory Standards: Adherence to recognized standards for safety, electromagnetic compatibility, and biocompatibility.
- Functional Verification: For new features, the "ground truth" is whether they perform their intended function (e.g., real-time clock keeps accurate time, software accurately displays usage data).

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. CPAP devices are not (typically) machine learning/AI diagnostic devices that require a "training set" of clinical data in the conventional sense. The device's internal algorithms are based on established control theory and engineering principles for pressure delivery. The software functionality (TRENDset PC) is developed and validated through traditional software engineering methods, not machine learning training.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there isn't a "training set" in the context of machine learning. The "ground truth" for the device's operational parameters is established through engineering design, physiological principles of respiration, desired therapeutic outcomes for OSA, and performance of the established predicate device.

Summary

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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 GmbHMettenheimer Strasse 12/14D-19061 SchwerinGermanyTel.: +49-385-39925-0Fax: +49-385-39925-25E-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 withTRENDset 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}------------------------------------------------

Standard accessories include treatment tubing with integrated Standard - aoceoonoo - including - including 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 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.

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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.

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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

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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

Page 1 of 1_

Regulation Number and Section

§ 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).