Solar Compact (G4-1)
Device Facts
| Record ID | K240007 |
|---|---|
| Device Name | Solar Compact (G4-1) |
| Applicant | Laborie Medical Technologies, Corp. |
| Product Code | FFX · Gastroenterology, Urology |
| Decision Date | May 6, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1725 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The Solar Compact is intended to record, store, view, and analyze pressure, impedance, and EMG data, gathered from anywhere in the gastrointestinal tract (pharynx, esophagus, stomach, and anorectal area, including rectum and pelvic floor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders. Designated catheters and accessories are required for measurement in each specific area of the gastrointestinal tract. An optional perfusion pump can also be used for automated balloon filling (for anorectal manometry studies). The filling lumen of the catheter can be connected to the perfusion pump. The Solar Compact is indicated for use in adult to infants with common gastrointestinal conditions, for the monitoring and diagnosis of motility disorders of the GI tract.
Device Story
Solar Compact is an electromechanical system for gastrointestinal motility monitoring. It accepts pressure, impedance, and EMG signals via external catheters and surface electrodes. The device includes an integrated air compressor for automated rectal balloon inflation/deflation. Hardware connects via Bluetooth to a PC running Laborie software. Software provides a patient database and analysis module, displaying data as time-tracing plots, Clouse Contour Plots (High Resolution Manometry), and 3D plots. Clinicians use the software to place markers and perform calculations to aid in diagnosing GI and swallowing disorders. The device does not provide independent diagnoses. It is intended for clinical use by healthcare professionals.
Clinical Evidence
No clinical data. Substantial equivalence was demonstrated through bench testing, including functional, electrical, and lifetime verification, calibration, volume measurement, and software verification. Safety testing complied with IEC 60601-1 and 60601-1-2. Package integrity testing followed ISTA 3A standards.
Technological Characteristics
Electromechanical system with external housing, pneumatics, and electronics. Compatible with air-charged and solid-state pressure catheters and surface electrodes. Connectivity via Bluetooth to PC. Energy source: electrical. Software: Laborie PC software (v10.1). Safety standards: IEC 60601-1, IEC 60601-1-2. Packaging standard: ISTA 3A.
Indications for Use
Indicated for adult to infant patients with gastrointestinal conditions requiring monitoring and diagnosis of GI tract motility disorders.
Regulatory Classification
Identification
A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.
Predicate Devices
Submission Summary (Full Text)
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May 6, 2024
Laborie Medical Technologies Corp. Ingrid Dirtzu Regulatory Affairs Specialist II 180 International Drive Portsmouth, New Hampshire 03801
Re: K240007
Trade/Device Name: Solar Compact (G4-1) Regulation Number: 21 CFR 876.1725 Regulation Name: Gastrointestinal Motility Monitoring System Regulatory Class: Class II Product Code: FFX Dated: April 5, 2024 Received: April 5, 2024
Dear Ingrid Dirtzu:
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 interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
# Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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### Indications for Use
Submission Number (if known)
#### K240007
Device Name
Solar Compact (G4-1)
### Indications for Use (Describe)
The Solar Compact is intended to record, store, view, and analyze pressure, impedance, and EMG data, gathered from anywhere in the gastrointestinal tract (pharynx, esophagus, stomach, and anorectal area, including rectum and pelvic floor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders. Designated catheters and accessories are required for measurement in each specific area of the gastrointestinal tract.
An optional perfusion pump can also be used for automated balloon filling (for anorectal manometry studies). The filling lumen of the catheter can be connected to the perfusion pump.
The Solar Compact is indicated for use in adult to infants with common gastrointestinal conditions, for the monitoring and diagnosis of motility disorders of the GI tract.
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) #: | K240007 | | K240007 Page 1 of 2 Prepared on: 2024-04-18 |
|-----------|---------|--|---------------------------------------------|
|-----------|---------|--|---------------------------------------------|
510(k) Summary
Contact Details
| | 21 CFR 807.92(a)(1) |
|-----------------------------|-----------------------------------------------------------|
| Applicant Name | Laborie Medical Technologies Corp. |
| Applicant Address | 180 International Drive Portsmouth NH 03801 United States |
| Applicant Contact Telephone | 952-564-3948 |
| Applicant Contact | Ms. Ingrid Dirtzu |
| Applicant Contact Email | idirtzu@laborie.com |
Device Name
| | 21 CFR 807.92(a)(2) |
|---------------------|------------------------------------------------|
| Device Trade Name | Solar Compact (G4-1) |
| Common Name | Gastrointestinal motility monitoring system |
| Classification Name | System, Gastrointestinal Motility (Electrical) |
| Regulation Number | 876.1725 |
| Product Code | FFX |
Legally Marketed Predicate Devices
| | 21 CFR 807.92(a)(3) |
|--|---------------------|
|--|---------------------|
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|-------------|----------------------------------------------------------|--------------|
| K052338 | Solar Gl with CIM-AUX | FFX |
| K121014 | MPP Plus | FFX |
Device Description Summary
| | 21 CFR 807.92(a)(4) |
|--|---------------------|
|--|---------------------|
The Solar Compact is a medical device for measuring gastrointestinal motility characteristics. The system consists of an electromechanical hardware device which connects to pressure catheters (air-charged or solid-state), and a PC software. Catheters provide measurements of pressure and impedance to the device from various sites along the gastrointestinal tract, which are then displayed and analyzed by the Laborie PC software. This provides the clinician with data that may aid in the diagnosis or management of various gastrointestinal disorders. Additionally, the system connects to provide EMG measurements of the muscles along the pelvic floor. Devices such as pressure catheters and surface electrodes are required to complete a gastrointestinal motility investigation, but they are not considered part of the Solar Compact device and not included standard with the system.
The device hardware consists of an external housing, pneumatics to inflate and deflate rectal balloons, and electronics to readout data from the pressure catheters and to control all other functions of the system. The device connects to a PC via Bluetooth to display measurements `within the Laborie software. The Laborie software contains a patient database module, and an analysis module. The software displays measurements from the system as time-tracing based plots, Clouse Countour Plots (High Resolution Manometry), and as 3D plots. Clinicians can analyze the data provided by placing markers and using calculations within the software. The device does not provide an independent diagnosis.
The Solar Compact device is compatible with a number of of catheters for these aforementioned parameter measurements. For a full list of these compatible catheters please consult the instructions for use.
### Intended Use/Indications for Use
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The Solar Compact is intended to record, store, view, and analyze pressure, impedance, and EMG data, gathered from anywhere in the gastrointestinal tract (pharynx, esophagus, and anorectal area, including rectum and pelvic floor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders. Designated catheters and accessories are required for measurement in each specific area of the gastrointestinal tract.
An optional perfusion pump can also be used for automated balloon filling (for anorectal manometry studies). The filling lumen of the catheter can be connected to the perfusion pump.
The Solar Compact is indicated for use in adult to infants with conditions, for the monitoring and diagnosis of motility disorders of the GI tract.
## Indications for Use Comparison
The indications for use of the proposed Solar Compact are similar to that of the primary predicate device, Solar Gl with ClM-AUX (K052338). While the number of sites for investigation by way of example has been limited, the Solar Compact device retains the statement that it can be used to analyze data anywhere in the gastrointestinal tract, and in this regard the devices are similar.
The signals analyzed by the proposed Solar Compact are limited relative to the Solar Gl with CIM-AUX and do not specify swallow or respiration. The proposed Solar Compedance data within the indications as a form of auxiliary device input data which the system analyzes. However, the predicate device, Solar Gl with CM-AUX, has incorporated impedance measurement since the Solar GI with CIM-AUX (K052338) clearance.
The MPP Plus (K121014) is an accessory to a system whose primary intended use is as an accessory to a complete gastrointestinal motility system, whereas the proposed is a complete gastrointestinal motility system. The proposed Solar Compact incorporates the same functionality of automated balloon filling that specified for the predicate MPP Plus (K121014), in order to achieve the system's intended use of gastrointestinal motility investigations.
## Technological Comparison
The principles of operation, energy source, measuring range, and materials used in the proposed Solar Compact are similar to those used in the predicate devices.
The proposed Solar Compact features a smaller device form factor relative to primary predicate Solar Gl with CM-AUX (K052338). Additionally, Bluetooth functionality is incorporated drectly within the main housing of the than as a accessory module.
For the proposed Solar Compact, the pump is incorporated within the body of the than as an accessory item as on the MPP Plus predicate (K121014). The pump system in the proposed Solar Compact is an air compressor and does not perfuse water, whereas the pump in the MPP Plus pressurizes a water-perfusion system for compatibility with water-perfused catheters.
The proposed Solar Compact is compatible with solid-state and air-charged catheters, which is identical to the primary predicate, Solar GI with CIM-AUX (K052338). The Solar Gl with MPP Plus (K121014) is compatible with water catheters only; the Solar Gl with MPP Plus is a secondary predicate and is considered not applicable in this regard.
The pump in the proposed Solar Compact is able to control both inflation and deflation, whereas the pump in the predicate MPP Plus (K121014) controls inflation only and does not have a controlled deflation.
#### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
System verifications were conducted, including functional, electrical, lifetime verification testing, calibration and volume measurement, to ensure that the Solar Compact demonstrates by meeting requirements defined for the device. Additionally, software verfitcations were conducted to verify system requirements during device development and an additional software verification was performed to confirm the Solar Compact software into the Laborie software 10.1 release. Package integrity testing was performed to the ISTA 3A standard and electrical/mechanical safety testing was performed to demonstrate compliance with IEC 60601-1 and 60601-1-2.
Clinical testing was not conducted and is not applicable for demonstrating substantial equivalence.
The Solar Compact device passed all verification testing, confirming the device performance and demonstrating that the device is as safe, as effective, and perform as as well or better than the legally marketed device predicates.
21 CFR 807.92(a)(5)
### 21 CFR 807.92(a)(6)
