(262 days)
The pH System is intended to record, store, view and analyze esophageal and gastric pH data to diagnose reflux disorders. The pH System can also be used to locate the position of the proximal Lower Esophageal Sphincter (LES) manometrically, to assist in the accurate placement of the pH catheter.
The pH Testing System consists of a general purpose PC running the pH Application software namned EsopHogram '98, a recording device namned Digitrapper Delta and catheters appropriate for the study to be performed. The illustration below shows the various components.
The provided text describes a 510(k) Notification for a pH Testing System, focusing on its equivalence to a predicate device. However, it does not include detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the manner typically found for AI/ML medical devices. The document is primarily a comparison to a predicate device to demonstrate substantial equivalence, rather than a performance study with defined criteria.
Based on the provided text, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define acceptance criteria as pass/fail thresholds for specific performance metrics (e.g., accuracy, sensitivity, specificity) for the new device. Instead, it relies on demonstrating that the enhanced system performs "as its predicate system."
| Performance Metric/Feature | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| General Functionality | Perform "as its predicate system" (functional equivalence) | "Verifications results shows that the enhanced system performs as its predicate system." |
| Sampling Rate | Capable of recording current and future demands | Programmable through 1/16Hz up to 8 Hz (new range captures old range + flexibility for future higher sampling rates) |
| Memory Size | Sufficient for current and future enhancements | 4Mb Flash Data RAM (larger memory size to incorporate possible future enhancements) |
| Resolution | Equal to or better than predicate device (0.04 pH) | Better than 0.01 pH (new one has 12bit resolution and adjustable gain, vs. 8 bit converter and fixed gain for predicate) |
| Calculated Parameters | Must include all parameters of predicate (except specific exclusions) | Same as predicate, with specific exclusions (Symptom Association Probability, Boix-Ochoa (pediatric), Infant normals percentile graph) in the first version. |
| LES Identification | Equivalent or enhanced to predicate (Bar Graph) | Displays an actual manometric tracing on screen (enhanced user interface) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states, "Field tests are on going." This indicates that any clinical performance data was not yet complete or available at the time of submission for this 510(k). Therefore, there is no disclosed sample size or data provenance for a test set. The submission focuses on non-clinical (engineering and functional) equivalence.
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. No test set involving human expert adjudication for ground truth establishing is described. The assessment is based on technical verification against the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set involving human expert adjudication for ground truth establishing is described.
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. This device is a pH testing system primarily for data acquisition and analysis, not an AI/ML diagnostic tool that would typically involve human readers using AI assistance. The study described is a non-clinical verification of equivalence.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document reports on "Verifications results shows that the enhanced system performs as its predicate system." This implies that standalone functional tests and comparisons were performed to ensure the new Digitrapper Delta and Polygram '98 software performed equivalently to the older system. The resolution improvement from 0.04 pH to "better than 0.01 pH" is a standalone performance metric. However, explicit details of these tests (e.g., number of test cases, methodology) are not provided beyond the general statement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance assessment, the "ground truth" was the performance of the predicate system. The new device's performance was measured against the established performance and technical specifications of the Medtronic Synectics Digitrapper MK III and its associated software.
8. The sample size for the training set
Not applicable. This document describes a traditional medical device (pH testing system) and does not refer to AI/ML components that would require a training set in the conventional sense.
9. How the ground truth for the training set was established
Not applicable, as no training set for an AI/ML component is mentioned.
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510(k) Notification pH Testing System
4 1998 FEB
510(k) SUMMARY
as required per 807.92(c)
1. Submitters Name, Address:
Medtronic Synectics AB Renstiernas gata 12 S-116 28 STOCKHOLM Tel: (45 ) 44 57 90 00 Fax: (45 ) 44 57 90 10 Contact person for this submission: Ann-Christine Jönsson Date submission was prepared: 18th May, 1998
2. Trade Name, Common Name and Classification Name:
A. Trade Name: pH Testing System
B. Common Name, Classification Name, Class and Regulation Number:
| Common Name | ClassificationNumber | Class | Regulation Number |
|---|---|---|---|
| Digitrapper Delta | 78 FFX | II | 21 CFR 876.1725 |
| Polygram '98, pH Testing Application | 78 FFX | II | 21 CFR 876.1725 |
| pH catheters | 78 FFT | I | 21 CFR 876.1400 |
3. Predicate Device Identification:
The functionality and intended use of the pH Testing System is equivalent to Medtronic Synectics Digitrapper MK III (K913387) with Polygram for Windows, Base Module (K946322) and EsopHogram reflux Analysis (K961346).
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4. Device Description:
The pH Testing System consists of a general purpose PC running the pH Application software namned EsopHogram '98, a recording device namned Digitrapper Delta and catheters appropriate for the study to be performed. The illustration below shows the various components.
Image /page/1/Figure/3 description: The image shows a pH system with several components. A host PC with platform and pH extension software is connected via an IrDA 1.1 connection to a Delta Device with embedded software. Two catheters are connected to the Delta Device. The image provides a schematic representation of the pH system setup.
The general process for use of the system occurs in two parts. In the first part, physiological data is collected by the Delta. This is done by a technician intubating a patient with the appropriate catheter(s), connect the catheter(s) to a Digitrapper Delta, turning on the recording, and allowing the patient to proceed with their normal life. At the prescribed time, the patient returns to the technician who removes the equipment from the patient.
Following that, the technician transfers the recorded data in the Digitrapper Delta to the PC where the pH Extension software is used to analyze it. This analysis includes marking refluxes in the data traces and calculating a variety a measurements such as DeMeester score and the Boix-Ochoa scoring method. Hardcopies can be printed of the raw data as well as tailored reports.
Results of the analysis are then used by a doctor to help make a diagnosis
5. Intended Use:
The pH System is intended to record, store, view and analyze esophageal and gastric pH data to diagnose reflux disorders. The pH System can also be used to locate the position of the proximal Lower EsopHageal Sphincter (LES) manometrically, to assist in the accurate placement of the pH catheter.
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6. Table of Device Similarities and differences to predicate device
| Manufacturer | Medtronic Synectics AB | Medtronic Synectics AB | |
|---|---|---|---|
| 510(k) number | Predicate devicesMK III- K 913387Polygram software, basemodule- K 946322pH Analysis Module- K 961346 | Modified DevicePolyram 98' pH TestingSystem, i.eDigitrapper Delta &Polygram '98,pH Testing Application- K 981733 | - |
| General: | Predicate devics:- all | Modified Device- pH System | Explanation of the differencescomparedto the Predicate devices |
| Intended Use /Indication of Use | Esophageal and gastric pH dataacquisition and analysis to diagnosereflux disorders. | Same | -- |
| IntendedPopulations | Pediatric to Adults | Same | -- |
| Sterilization | Accessories are not supplied sterile,manufacturer label the accessorieswith cleaning instructions. | Same | -- |
| Biocompatibility | Catheters are the only part thatcomes into contact with thepatients. | Same | -- |
| TechnicalFeatures: | Predicate devices- MK III | Modified Device- Digitrapper Delta | Explanation of the differencescomparedto the Predicate devices |
| Number ofChannels | 4 pH, 1 p | Same | -- |
| Sampling rate | 1/4, 1/8, 1/16 Hz | Programmable through 1/16Hzup to 8 Hz | This new range captures all theold range while also allowing thepossibility to be flexible enoughto cope with possible futuredemands for higher samplingrates. |
| Memory Size | 96 kB | 4Mb Flash Data RAM | Larger memory size toincorporate possible futureenhancements. |
| Event markers | 4 | 3 | Customer requirement |
| Built in memoryback up | 14 days | Now has Flash ram (no backuprequired). Clock has 14 daysbackup. | Flash RAM is non-volatiletherefor requires no 'backup'.However the clock will keep thetime for convenience sake. (youdon't have to reset the time). |
| Power supply | 9 V alkaline battery | 2 x 1.5 AA alkaline | More available batteries |
| Measuring range | 0-9 pH | Same | -- |
| Recording time | 24, 48 & 96 hours | 24 Hours | Customer requirement with only24 hours. |
| Currentconsumption | 4 mA | 20mA | The new device runs at 3V so thecurrent increases to meet thepower demands. |
| Communication | 8 bit parallel Synectics Liberty orCombi Interface, Serial interface tocomputer or printer | IrDA Communication(Infra Red) | This is a standard device that ispresent on all Notebooks. The IRDongle can also be plugged into |
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510(k) Notification pH Testing System
:
| Resolution | 0.04 pH | Better than 0.01pH | not require a removal of the computer cover to install.The MKIII has an 8 bit converter and fixed gain. The new one has 12bit resolution and adjustable gain. | ||||
|---|---|---|---|---|---|---|---|
| Display | 32 character LCD LES identification display | 119 by 73 pixel graphic display. | Enhances user interface | ||||
| Clock | Built-in real time clock | Same | -- | ||||
| Dimension | 4.8 x 2.6 x 1.0 in | 115 x 140 x 50 | -- | ||||
| Weight | 10.6 oz (300g) | Approx. the same | -- | ||||
| On-line monitoring | Via own Screen | Same | -- | ||||
| Features: | Predicate devices- Polygram software, base module &- pH Analysis Module, EsopHogram pH Reflux Analysis | Modified Device- Polygram '98, pH Testing Application | Explanation of the differences compared to the Predicate devices | ||||
| Signals to analyze | pH | Same | -- | ||||
| User commands | Menu selections, keyboard combinations, screen "buttons" | Same | -- | ||||
| Calculated parameters | 1. Maximum, Minimum2. Duration of period3. Number of acid refluxes4. Number of long acid refluxes5. Longest acid reflux6. Total time pH below 47. Fraction time pH below 48. Symptom index9. Symptom Association Probability10. Number of alkaline shifts11. Number of long alkaline shifts12. Longest alkaline shift13. Total tome pH above 814. Fraction time pH above 8 | SameNot AvailableNot Available | --Excluded in the first versionExcluded in the first version | ||||
| Scoring, Normals | 1. DeMeester & Johnson (adult)2. Boix-Ochoa (pediatric)3. Infant normals percentile graph (ESPGAN normals) | SameNot AvailableNot Available | --Excluded in the first versionExcluded in the first version | ||||
| LES identification | Bar Graph | Displays an actual manometric tracing on screen. | Enhanced LES identification. | ||||
| Reports | Signal tracings and reports. Optionally selections only. | Same | -- | ||||
| Patient database | Relational database with logical patient- recording relations | Same | -- | ||||
| Additional data | User definable additional patient/recording parameters | Same | -- | ||||
| User help system | Online help system with descriptions of procedures | Same | -- | ||||
| Signal review method | Time - tracing based | Same | -- | ||||
| Recording control | Real time monitoring of signals | Same | -- | ||||
| Recording configuration | Recordingconfiguration | A template is used for each type of recording. User definable. Once used, not possible to change, | A template is used for each type ofrecording. User definable. Onceused, not possible to change,ensuring recording integrity | Same | Same | -- | -- |
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-
- Assessment of non-clinical performance data for equivalence:
Verifications results shows that the enhanced system performs as its predicate system.
- Assessment of non-clinical performance data for equivalence:
8. Assessment of clinical performance data for equivalence: Fields tests are on going.
-
- Biocompatability: Not applicable .
- Sterilization: Not applicable
11. Standards and Guidances:
The pH System complies to the following standard:
- IEC 60601-1, Second edition, 1988 with Amendment 1, 1991 and Amendment 2, 1995. (EN 60601-1:1990 and Amendments A1, A11, A12 and A13)
- UL 2601-1, 1994
- CAN/CSA-22.2 No 601.1-M90
- JIST 1001
- AS/NZS 3200-1-0
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 1999 FEB
Ann-Christine Jönsson Regulatory Affairs Medtronic Functional Diagnostics AB 16-18 Tonsbakken DK-2740 Skovlunde DENMARK
Re: K981733
Digitrapper Delta, Model 9043G0201 and Polygram '98 pH Extension Dated: November 4, 1998 Received: November 9, 1998 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 pror 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 requlation (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 requlatory 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,
M. Daniel C. Stahl, M.D.
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radioloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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:
510(k) Notification pH System
Indication for Use Statement
Page 1 of 1 _
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The pH System is intended to record, store, view and analyze esophageal and gastric pH data to diagnose reflux disorders. The pH System can also be used to locate the position of the proximal Lower Esophageal Sphincter (LES) manometrically, to assist in the accurate placement of the pH catheter.
MRI Compatibility Statement:
The pH 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 (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 | K981733/500 |
|---|---|
| --------------- | ------------- |
§ 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).