(20 days)
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.
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.
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.
§ 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).