(86 days)
The Summit IP is intended for use in private practices or hospital environments for the detection of human respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. Signals from patient worn thoracic and abdominal sensors are demodulated, amplified and summed to provide electrical signals suitable for connection to the inputs of physiological recording equipment.
The Summit IP unit is only to be used under the direction and supervision of a physician.
The Summit IP unit is not intended for use as life support equipment such as vital signs monitoring in intensive care units.
The Summit IP unit is not intended for use on infant or pediatric patients.
The Compumedics Summit IP consists of a small plastic enclosure with two input sockets for connection to Compumedics respiratory effort bands (Thoracic and Abdominal), and output sockets for the Thoracic, Abdominal and Sum channels. The Sum channel is a weighted surn of the Thoracic and Abdominal signals. The output channels may be connected to the inputs of standard physiological equipment for the purpose of recording or monitoring respiratory effort.
The Summit IP is powered by a user-replaceable 1.5 volt battery and automatically switches on when any or both sensors are connected.
The provided document, a 510(k) summary for the Compumedics Summit IP, does not contain detailed information about a study proving the device meets specific acceptance criteria in the manner requested.
Instead, it focuses on demonstrating substantial equivalence to a predicate device, primarily through a comparison of technical characteristics and general safety/performance testing. There is no mention of a clinical study, specific performance metrics with acceptance criteria, or an AI component.
However, based on the information provided, here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with corresponding performance results in the context of specific quantitative clinical metrics. The performance claims are primarily based on:
- Substantial Equivalence: The device is deemed substantially equivalent to the Pro-Tech Synchrony™ Summing Amplifier and the respiratory effort sensors of the Compumedics Somté System.
- Compliance with Standards: Successful completion of safety tests to IEC60601-1, electromagnetic emission tests to IEC60601-1-2, and electromagnetic immunity tests to IEC60601-1-2.
- Hardware and Firmware Testing: Compliance tested to hardware and firmware test specifications to ensure conformance to all design requirements.
| Acceptance Criteria Category (Derived from document) | Reported Device Performance |
|---|---|
| Safety | Met: "Safety tests to IEC60601-1 (1988 +A1:1999+ A2:1995), Medical Electrical Equipment, Safety tests... to ensure there are no detrimental effects on patients, operators or the surrounding environment. Safety tests to U.S. and Canadian deviations from IEC60601-1. Cables and leads confirm to CDRH Guidance Document on the "Performance Standard for Lead Wires and Patient Cables" March 9 1998." |
| Electromagnetic Compatibility (EMC) - Emission | Met: "Electromagnetic emission tests to IEC60601-1-2 (2001) Medical Electrical Equipment, Electromagnetic emission tests...to ensure no intolerable electromagnetic disturbances are introduced to the environment." |
| Electromagnetic Compatibility (EMC) - Immunity | Met: "Electromagnetic immunity tests to IEC60601-1-2 to ensure safe and effective operation in the presence of electromagnetic interference." |
| Hardware and Firmware Conformance | Met: "Compliance tested to hardware and firmware test specifications to ensure conformance to all design requirements." |
| Functional Equivalence | Met (to predicate devices): "The Summit IP is intended for use during sleep disorder studies to acquire respiratory effort suitable for recording using a physiological recorder for diagnostic purposes." (Same as predicate). "Number of inputs: 2" (Same as predicate). "Sensor location: Around thorax and abdomen" (Same as predicate). "Sensor type: Linear response to stretch" (Same as predicate). "Output channels: 3 (thoracic, abdominal, sum)" (Same as predicate). "Output connectors: 1.5mm touch-proof safety connectors" (Same as predicate). "Function of sum channel: To more easily identify thoracic and abdominal effort signals that are out of phase (paradoxical)" (Same as predicate). "Calibration initiation: Automatic after connection of both sensors" (Predicate: Press red "cal" button). "Purpose of calibration: Measure amplitudes of Thoracic and Abdominal signals to set mix of these signals used by Sum channel" (Same as predicate). "Operating indication: Slow flashing Green LED" (Predicate: none). "Maximum calibration time: 10 minutes" (Predicate: 3 minutes). Note: Some functional differences exist (e.g., auto-calibration vs. manual, battery type, indicator LEDs), but are presented as not impacting substantial equivalence or safety/effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: The document discusses engineering and compliance testing, not a clinical test set with a sample size of patients/data. There is no mention of "test sets" in the context of patient data in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided: This information is relevant to clinical studies involving expert interpretation, which is not described in this 510(k) summary. The ground truth for engineering tests would be derived from physical measurements and adherence to technical specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: This is not applicable to the type of testing described (safety, EMC, hardware/firmware conformance). Adjudication methods are typically used in clinical trials involving human readers.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable / Not Provided: This document describes a medical device for measuring respiratory effort, not an AI-assisted diagnostic tool. No MRMC study or AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided: As noted above, this device does not involve an algorithm for diagnostic interpretation. It is a signal acquisition and processing device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the safety and EMC testing, the "ground truth" would be the objective measurements taken during testing and their comparison against the specified limits and requirements of the referenced IEC standards.
- For hardware and firmware testing, the "ground truth" would be the established design requirements and technical specifications of the device.
8. The sample size for the training set
- Not Applicable / Not Provided: This device does not use machine learning or AI, and therefore does not have a "training set" in that context.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: As there is no AI/ML component or training set, this information is not relevant.
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APR 2 3 2004
SECTION 4. 510(k) SUMMARY
In accordance with 21 CFR 807.92, the following information constitutes the Compurnedics Limited summary for the Compumedics Summit IP.
SUBMITTER'S NAME: Compumedics Limited
ADDRESS:
7850 Paseo del Norte El Paso, TX 79912 USA
Elvira Garcia
915-225-0303
915-845-2965
January 22, 2004
CONTACT PERSON: TELEPHONE NUMBER: FAX NUMBER: DATE OF SUBMISSION:
1. Identification of device
| Proprietary name: | Compumedics Summit IP |
|---|---|
| Common name: | respiratory effort module |
| Classification name: | Ventilatory Effort Recorder |
| Class: | Class II per regulations 868.2375 |
| Product Code: | MNR |
2. Predicate devices
Compumedics Limited believes the Compumedics Summit IP is substantially equivalent to:
| Device name: | Synchrony™ summing amplifier |
|---|---|
| Supplier: | Pro-Tech Services, Inc. |
| 510(k) number: | K013905 |
The sensors used by the Summit IP are identical to those used by the respiratory effort part of the Compumedics Somté System.
Device name: Compumedics Somté System Supplier: Compumedics Limited 510(k) number: K021176
3. Description of the Device
The Compumedics Summit IP consists of a small plastic enclosure with two input sockets for connection to Compumedics respiratory effort bands (Thoracic and Abdominal), and output sockets for the Thoracic, Abdominal and Sum channels. The Sum channel is a weighted surn of the Thoracic and Abdominal signals. The output channels may be connected to the inputs of standard physiological equipment for the purpose of recording or monitoring respiratory effort.
The Summit IP is powered by a user-replaceable 1.5 volt battery and automatically switches on when any or both sensors are connected.
4. Intended Use
The Summit IP is intended for use in private practices or hospital environments for the detection of human respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. Signals from patient worn thoracic and abdominal sensors are demodulated, amplified and summed to provide electrical signals suitable for connection to the inputs of physiological recording equipment.
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The Summit IP unit is only to be used under the direction and supervision of a physician.
The Summit IP unit is not intended for use as life support equipment such as vital signs monitoring in intensive care units.
The Summit IP unit is not intended for use on infant or pediatric patients.
·
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Technical characteristics, comparison to predicate device ട.
| Characteristic | Compumedics Summit IP | Pro-Tech Synchrony™ Summing Amplifier |
|---|---|---|
| Intended Use | Intended for use during sleepdisorder studies to acquirerespiratory effort suitable forrecording using a physiologicalrecorder for diagnosticpurposes. | same |
| Number of inputs | 2 | same |
| Sensor location | Around thorax and abdomen | same |
| Sensor type | Linear response to stretch | same |
| Output channels | 3 (thoracic, abdominal, sum) | same(Qsum is name of sum channel) |
| Output connectors | 1.5mm touch-proof safetyconnectors | same |
| Output Signal size, typical | 1mVpp for all channels | 0.6mVpp for thoracic andabdominal, 1.2mVpp for Qsum |
| Equipment outputs to beconnected to | Physiological recorder | same |
| Physiological recorder highpass frequency | <0.3Hz | same |
| Physiological recorder lowpass frequency | 5Hz to 20 Hz | 5Hz to 15Hz |
| Function of sum channel | To more easily identify thoracicand abdominal effort signalsthat are out of phase(paradoxical) | same |
| Power | Internal 1.5V alkaline battery,user replaceable | Internal 3.6V lithium battery, notuser replaceable |
| Controls | None | One, cal switch |
| Indicators | 3 (red, amber, green) LEDs | 1 bicolor(red/green) LED |
| Indicator functions | Calibration, battery condition,operating status | Calibration, battery condition |
| Method of reducing batteryconsumption when not in use | Disconnection of sensors | same |
| Calibration initiation | Automatic after connection ofboth sensors | Press red "cal" button |
| Maximum calibration time | 10 minutes | 3 minutes |
| Calibrating indication | Fast Flashing Green LED | Green LED |
| Failed calibrating indication | Flashing Amber LED | Red LED |
| Purpose of calibration | Measure amplitudes ofThoracic and Abdominalsignals to set mix of thesesignals used by Sum channel | Same |
| Operating indication | Slow flashing Green LED | none |
| Size, mm | 59 L x 41 W x 21 H | 70 L x 51 W x 20 H |
COMPARATIVE TABLE
NOTE
There is no comparative table for the respiratory effort sensors used in the Compumedics Somté System, K021176, as the sensors used by Summit IP are identical.
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Discussion of performance testing 6.
An extensive collection of tests has been conducted and successfully completed, includina:
Safety tests to IEC60601-1 (1988 +A1:1999+ A2:1995), Medical Electrical Equipment, Safety tests to iEO000 >> (role to ensure there are no detrimental effects on patients, operators or the surrounding environment.
Electromagnetic emission tests to JEC60601-1-2 (2001) Medical Electrical Equipment, Electromagnetic emission tests to fE06001 + + 2 = 0 = Flectromagnetic compatibility – General Nequirements for Salety, on intolerable electromagnetic disturbances are introduced to the environment.
Electromagnetic immunity tests to IEC60601-1-2 to ensure safe and effective operation in the presence of electromagnetic interference.
Safety tests to U.S. and Canadian deviations from IEC60601-1.
Cables and leads confirm to CDRH Guidance Document on the "Performance Standard for Lead Wires and Patient Cables" March 9 1998.
Compliance tested to hardware and firmware test specifications to ensure conformance to all design requirements.
Conclusion 7.
Based on extensive performance testing and comparison to the predicate device, it is Based on extensive performance tooting that the Compumedics Summit IP is the conclusion of Ocumpanouse = already on the market (cleared by the 510(k) substantially equivalient to do noon concerns about safety and effectiveness.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.
Public Health Service
APR 2 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elvira Garcia Compumedics USA, LTD. 7850 Paseo Del Norte El Paso, Texas 79912
K040194 Rc:
Trade Name: Compumedics Summit IP Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: March 31, 2004 Received: April 1, 2004
Dear Ms. Garcia:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your secures is see is substantially equivalent (for the referenced above and have determined the ta heally marketed predicate devices marketed in indications for use stated in all 28, 1976, the enactment date of the Medical Device interstate connitetee pror to that have been reclassified in accordance with the provisions of Amendments, of to devices that have been rockers to not require approval of a premarket the Federal Food, Drug, and Cosment Tre (res) ................................................................................................................................ approval appreation (1 Mr.). I The general controls provisions of the Act include confors provisions of the Fiel. "The given of devices, good manufacturing practice, requirements prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Spccial Controls) or class III If your device is classified (see ao) into seating major regulations affecting (PMA), it may be subject to suen additions, Title 21, Parts 800 to 898. In your device can be found in the Seas nouncements concerning your device in the Federal Register.
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Page 2 - Ms. Garcia
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s issualled of a bases and its with other requirements mean that FDA has made a decembination administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other started to registratio of the Act of ally rederal statutes and regulations, but not limited to: registration You must comply with an the Fee brequire of the Part 801); good manufacturing practice and ifsung (21 CFR Pat 607), laoolity systems (QS) regulation (21 CFR Part 820); and if requirements as sectionin the quality bystems (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 whi anow you to begin mationing your device of your device to a premarket notification. The PDF Imaling or celessification 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 advice to: your de records of the splease note the regulation in please contact the Other or Comphanes are (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miorination on Journational and Consumer Assistance at its toll-free Division of Di638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Chiu Lin, 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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SECTION 3. STATEMENT OF INDICATION FOR USE
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Device Name: Compumedics Summit IP
Indications for use:
The Summit IP is intended for use in private practices or hospital environments for the The Summit IP is intended for use in private practiced is of sleep disorders of sleep disorders of sleep detection of numan respiratory offert to assist in worn thoracic and abdominal sensors
related respiratory disorders. Signals from patient worn is note with work with he for related respiratory disorders. Bignals from partical signals suitable for are demodulated, anputs of physiological recording equipment.
The Summit IP is only to be used under the direction and supervision of a physician.
The Summit IP unit is not intended for use as life support equipment such as vital signs monitoring in intensive care units.
The Summit IP unit is not intended for use on infant or pediatric patients
(Please do not write bclow this line – continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
OR
Over the Counter Use__________________________________________________________________________________________________________________________________________________________
Cinh
510(k) Number: K040194
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).