(90 days)
The Esophageal Manometry System is intended to record, store, view and analyze data on line in the gastrointestinal tract to assist in the diagnoses of gastrointestinal disorders.
The system is a stationary manometry system for use in evaluating the function of the gastrointestinal tract. The system measures pressure and other parameters online using sensors on and in the patient. The parameters are presented during the capture and are also recorded for later display, analysis and reporting.
The provided 510(k) summary for the Medtronic Esophageal Manometry System (K992713) does not describe specific acceptance criteria or a detailed study proving the device meets said criteria in the way typically expected for an AI/ML or new complex device submission. Instead, it relies on a comparison to a predicate device and verification results.
Here's a breakdown of the information based on the provided text, addressing your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define acceptance criteria as a set of quantified performance metrics like sensitivity, specificity, or accuracy. Instead, the "acceptance criteria" appear to be implicit in the claim of "equivalence" to the predicate device and the successful verification of enhanced technical features.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-
| Functional Equivalence to Predicate Device | "Verifications results shows that the enhanced system performs as its predicate system." The device is intended to record, store, view, and analyze data online in the GI tract to assist in the diagnoses of GI disorders, which is the "Same" as the predicate. |
| Increased Performance (Technical Features) | The new device offers enhanced performance in: |
| * Number of Channels | Up to 16 (Predicate: Up to 16) - Self-contradictory in table, previous predicate showed "up to 16", modified device showed "4-16 channels" and explanation states "Enhanced performance". This implies the modified device consistently handles 4-16 channels well. |
| * Sampling rate | 105-1674 Hz (Predicate: 1/128 to 128 Hz) |
| * Power supply | 24 V DC (Predicate: 9-12 V DC) - accommodates 110-230 V Power Supply in one. |
| * Measuring range | -2.5 Vpm, 5 % to 2.5 Vpm 5% (Predicate: 0-9 pH) |
| * Insulation | HCPL-0710. NMV 2405S, and safety power supply: class I (Predicate: Burr Brown722 dual isolated DC/DC converter); with isolation within each module of 4 channels. |
| * Current consumption | Max 0.8 A (Predicate: 260 mA nom standard (8bit)) |
| * Communication | USB (Universal Serial Bus) (Predicate: Optical serial RS 232); "Enhanced performance (band width)" |
| * Resolution | 22 bit (Predicate: 8 bit) |
| * Operating system | Windows 98 (Predicate: Windows 3.11, 95) |
| Safety | "doesn't raise any new safety or performance issues." The device complies with EN 60601-1, UL 2601-1, and CAN/CSA C22.2 No.610.1-M90. |
Study Proving Acceptance Criteria:
The document explicitly states: "Clinical trials are not performed."
The justification for equivalence and performance relies on non-clinical performance data verification. The "Verifications results shows that the enhanced system performs as its predicate system." This implies internal testing and validation of the hardware and software components to ensure they meet their design specifications and function comparably or with enhancements to the predicate. No further details on the specifics of this verification study (e.g., test protocols, results metrics, sample sizes for verification) are provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test set sample size: Not specified. The document states "Clinical trials are not performed" and relies on "Verifications results" (non-clinical data). This means there wasn't a "test set" in the context of patient data in a clinical study.
- Data provenance: Not applicable, as clinical trials were not performed. The data underpinning the "verifications results" would be engineering and performance test data generated internally by the manufacturer, Medtronic Functional Diagnostics A/S in Denmark.
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. Since clinical trials were not performed and there was no patient-specific "test set" to establish a ground truth for diagnostic accuracy, no experts were used for this purpose in the context of this submission. The "ground truth" for the non-clinical verification would be the expected performance based on engineering specifications and comparison to the predicate device's known characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring expert adjudication was used.
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
No MRMC comparative effectiveness study was done. The device described appears to be a data acquisition and analysis system, not an AI-assisted diagnostic tool that directly impacts human reader interpretation in a measurable way (like an AI algorithm for image analysis). The "analysis" provided by the system is based on calculated parameters from physiological signals, not interpretation of complex images or data that typically requires an MRMC study for AI evaluations.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a standalone performance evaluation of a diagnostic algorithm. The Esophageal Manometry System is a measurement and analysis system for physiological signals, not a standalone diagnostic algorithm in the sense of AI/ML. The "analysis" it performs (e.g., LES location, resting pressure, amplitude, duration, velocity) are calculations based on the acquired signals. The performance of these calculations would have been "verified" as part of the non-clinical performance data, ensuring their accuracy and consistency. However, no specific standalone algorithm performance study, as understood for AI, is described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Verifications results" (non-clinical performance data), the "ground truth" would be engineering specifications, expected physical measurements, and the known performance/output of the predicate device. For example, testing the sampling rate would involve inputting known frequency signals and verifying the system's output. For calculated parameters, the ground truth would be established by mathematical correctness and consistency with the predicate device's calculations.
8. The sample size for the training set
Not applicable. This device is not an AI/ML system that utilizes a training set in the conventional sense.
9. How the ground truth for the training set was established
Not applicable, as there was no training set for an AI/ML algorithm.
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510(k) SUMMARY
as required per 807.92(c)
1. Submitters Name, Address:
Medtronic Functional Diagnostics A/S Tonsbakken 16-18 DK-2740 SKOVLUNDE Tel: (+ 45 ) 44 57 90 00 Fax: (+ 45 ) 44 57 90 10 Contact person for this submission: Ann-Christine Jönsson Date submission was prepared: 6d August, 1999
2. Trade Name, Common Name and Classification Name:
A. Trade Name: Esophageal Manometry System
B. Common Name, Classification Name, Class and Regulation Number:
| Common Name | ClassificationNumber | Class | Regulation Number |
|---|---|---|---|
| Polygraf ID | 78 FFX | II | 21 CFR 876.1725 |
| Polygram 98, Esophageal ManometryApplication | 78 KLA,FFX | II | 21 CFR 876.1725 |
3. Predicate Device Identification:
The functionality and intended use of the Esophageal Manometry System is equivalent to Medtronic Synectics Polygraf HR (K872712) with Polygram for Windows, Base Module (K946322) and Esophageal Manometry Analysis Module (K961070).
4. Device Description:
The system is a stationary manometry system for use in evaluating the function of the gastrointestinal tract. The system measures pressure and other parameters online using sensors on and in the patient. The parameters are presented during the capture and are also recorded for later display, analysis and reporting.
In its daily use, a trained technician and/or a physician are the main users of the system.
1 (4) COMPANY CONFIDENTIAL
Medtronic Functional Diagnostics A/S
Tonsbakken 16-18 DK-2740 SKOVLUNDE
Tel: + 45 44 57 90 00 Fax: + 45 44 57 90 10
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The main tasks when performing a manometry procedure with a stationary manometry system are:
- . Prepare equipment including calibration
- . Enter patient/study demographic information
- Perform procedure and obtain relevant data .
- Review, analysis and post procedure activities .
- . Create and print a report
The Polygram 98 Esophageal Manometry Application software runs on Microsoft Windows® 98
5. Intended Use:
The Esophageal Manometry System is intended to record, store, view and analyze data on line in the gastrointestinal tract to assist in the diagnoses of gastrointestinal disorders.
6. Table of Device Similarities and differences to predicate device
| Manufacturer | Medtronic Synectics AB | Medtronic FunctionalDiagnostics A/S | - |
|---|---|---|---|
| 510(k) number | Predicate devices• Polygraf HR- K 872712• Polygram software,base module- K 946322• EsophagealManometry AnalysisModule- K 961070 | Modified DeviceEsophageal Manometry System,(EM System) i.e- Polygraf ID &- Polygram 98,Esophageal ManometryApplicationK number to be decided | - |
| General: | Predicate devics:- all | Modified Device- EM System | Explanation of the differencescompared |
| to the Predicate devices | |||
| Intended Use /Indication of Use | Record, store, view andanalyze data on line in thegastrointestinal tract toassist in the diagnoses ofgastrointestinal disorders.. | Same | -- |
| Intended Populations | Infant, Pediatric to Adults | Same | -- |
| Sterilization | Accessories are notsupplied sterile,manufacturer label theaccessories with cleaninginstructions. | Same | -- |
| Biocompatibility | The Sensors are the onlypart that comes intocontact with the patients. | Same | -- |
COMPANY CONFIDENTIAL
Medtronic Functional Diagnostics A/S
Tonsbakken 16-18 DK-2740 SKOVLUNDE
Tel: + 45 44 57 90 00 Fax: + 45 44 57 90 10
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| Technical Features: | Predicate devices- Polygraf HR | Modified Device- Polygraf ID | Explanation of the differencescomparedto the Predicate devices |
|---|---|---|---|
| Number of Channels | Up to 16 | 4-16 channels | Enhanced performance |
| Sampling rate | 1/128 to 128 Hz | 105-1674 Hz | Enhanced performance |
| Power supply | 9-12 V DC | 24 V DC | 110-230 V Power Supply in one |
| Measuring range | 0-9 pH | -2.5 Vpm, 5 % to 2.5 Vpm 5% | Enhanced performance |
| Insulation | Burr Brown722 dualisolated DC/DC converter | HCPL-0710. NMV 2405S, andsafety power supply: class I | Enhanced performance, isolationprovided also within each module of 4channels (4, 8, 12, 16.) |
| Current consumption | 260 mA nom standard(8bit) | Max 0.8 A | Enhanced performance requires morepower |
| Communication | Optical serial RS 232 | USB (Universal Serial Bus) | Enhanced performance (band width) |
| Resolution | 8 bit | 22 bit | Enhanced performance |
| Dimension | 11.2" x 2" x 6 " | 14" x 8.8" x 2.8" | More channels require more space |
| Weight | 1 050 g | < 3 000 g | Larger box weight more |
| On-line monitoring | Via PC Screen | Same | --- |
| Features: | Predicate devices- Base module&- pH Analysis Module,EsopHogram pH RefluxAnalysis | Modified Device- Polygram '98, EM Extension | Explanation of the differencescomparedto the Predicate devices |
| Signals to analyze | Ph, pressure, flow, volume,respiration, oxygensaturation, pulse rate, bodyposition, snoring | Pressure, respiration andswallow | Not all are implemented in this firstversion. |
| User commands | Menu selections, keyboardcombinations, screen"buttons" | Same | -- |
| Esophageal Analysis | - LES analysis- Esophageal motilityanalysis- UES analysis | - LES analysis- Esophageal motility analysis | - UES analysis, will be introduced incoming versions of the SW. |
| Calculatedparameters | LES locationLES resting pressureLES relaxationLES residual pressureEsophageal motility:amplitudedurationvelocityUES locationUES resting pressureUES residual pressureQuick calculations | LES locationLES resting pressureLES relaxationLES residual pressureEsophageal motility:amplitudedurationvelocity | The following parameters will beintroduced in coming versions of theSW:UES locationUES resting pressureUES residual pressureQuick calculations |
| Reports | Signal tracings and reports.Optionally selections only. | Same | -- |
| Patient database | Relational database withlogical patient- recordingrelations | Same | -- |
| Additional data | User definable additionalpatient/recordingparameters | Same | -- |
| User help system | Online help system withdescriptions of procedures | Same | -- |
| Signal review method | Time - tracing based | Same | -- |
| Recording control | Real time monitoring ofsignals | Same | -- |
| Calibration | Adjustable and fixed gainmethod. Monitoring ofcalibration result for rangeand resolution requirement. | Same | -- |
| Recordingconfiguration | A template is used for eachtype of recording. Userdefinable. Once used, notpossible to change,ensuring recordingintegrity | Same ('templates' are nowcalled 'protocols') | -- |
| Programminglanguage | 'C' | C++, Visual Basic | -- |
| Operating system | Windows 3.11, 95 | Windows 98 | Enhanced performance |
3 (4)
COMPANY CONFIDENTIAL
Medtronic Functional Diagnostics A/S
Tonsbakken 16-18 DK-2740 SKOVLUNDE
{3}------------------------------------------------
7. Assessment of non-clinical performance data for equivalence:
Verifications results shows that the enhanced system performs as its predicate system.
8. Assessment of clinical performance data for equivalence:
Clinical trials are not performed. This new system doesn't raise any new safety or performance issues.
9. Biocompatability:
Not applicable .
10. Sterilization:
Not applicable
11. Standards and Guidances:
The Esophageal Manometry System complies to the following standards:
-
EN 60601-1:1990 and Amendments A1, A11, A12 and A13
-
UL 2601-1, Second Edition, 1997
-
CAN/CSA C22.2 No.610.1-M90
4 (4)
COMPANY CONFIDENTIAL
Medtronic Functional Diagnostics A/S
Tonsbakken 16-18 DK-2740 SKOVLUNDE
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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 1999
Ms. Ann-Christine Jönsson Regulatory Affairs Medtronic Functional Diagnostics A/S Tonsbakken 16-18 Skovlunde DK-2740 DENMARK
Re: K992713 Esophageal Manometry Testing Application (Polygraf ID, Polygram '98) Dated: August 6, 1999 Received: August 12, 1999 Regulatory Class: II 21 CFR 876.1725/Procode: 78 FFX
Dear Ms. Jönsson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use Statement
Page 1 of 1 --
510(k) Number (if known): K992713
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Esophageal Manometry System is intended to record, store, view and analyze data on line in the gastrointestinal tract to assist in the diagnoses of gastrointestinal disorders.
MRI Compatibility Statement:
The Esophageal Manometry System is not compatible for use in a MRI magnetic field.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ V (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K992713 |
|---|---|
| --------------- | --------- |
COMPANY CONFIDENTIAL
Medtronic Functional Diagnostics A/S
Tonsbakken 16-18 DK-2740 SKOVLUNDE
§ 876.1725 Gastrointestinal motility monitoring system.
(a)
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.(b)
Classification. Class II (performance standards).