(86 days)
Not Found
No
The device description focuses on signal processing (demodulation, amplification, summing) and hardware components. There is no mention of AI, ML, or any learning algorithms. The performance studies are focused on safety and electromagnetic compatibility, not algorithmic performance.
No.
The device is for detection and diagnosis of sleep disorders, not for therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is intended "to assist in the diagnosis of sleep disorders or sleep related respiratory disorders."
No
The device description explicitly states it consists of a "small plastic enclosure with two input sockets" and "output sockets," indicating it is a physical hardware device, not software only. The performance studies also focus on hardware-related testing (safety, electromagnetic compatibility).
Based on the provided information, the Summit IP is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Summit IP Function: The Summit IP detects and processes physiological signals from patient-worn sensors (thoracic and abdominal bands) to measure respiratory effort. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for "detection of human respiratory effort" and provides "electrical signals suitable for connection to the inputs of physiological recording equipment." This aligns with a physiological monitoring device, not an IVD.
Therefore, the Summit IP falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
MNR
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Around thorax and abdomen
Indicated Patient Age Range
The Summit IP unit is not intended for use on infant or pediatric patients.
Intended User / Care Setting
private practices or hospital environments
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)
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.
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
§ 868.2375 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).
0
Image /page/0/Picture/0 description: The image shows the text "K040194" in a handwritten style. The text is slightly tilted, with the characters appearing somewhat uneven and bold. The overall impression is that the text was written quickly or with a thick marker.
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.
1
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.
·
2
Technical characteristics, comparison to predicate device ട.
| Characteristic | Compumedics Summit IP | Pro-Tech Synchrony™ Summing Amplifier |
|---|---|---|
| Intended Use | Intended for use during sleep | |
| disorder studies to acquire | ||
| respiratory effort suitable for | ||
| recording using a physiological | ||
| recorder for diagnostic | ||
| purposes. | 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 safety | |
| connectors | same | |
| Output Signal size, typical | 1mVpp for all channels | 0.6mVpp for thoracic and |
| abdominal, 1.2mVpp for Qsum | ||
| Equipment outputs to be | ||
| connected to | Physiological recorder | same |
| Physiological recorder high | ||
| pass frequency | > (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.
4
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.
5
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
6
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