The Polygram 98 pH Testing System is intended to record, store, view and analyze esophageal and gastric refluxate data to diagnose reflux disorders. The Polygram 98 pH Testing 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.

Device Description

The system is an ambulatory system for use in evaluating reflux disorders in the gastrointestinal tract. The system measures bile online using sensors in the patient. The data is captured and recorded. The data is uploaded from the Bilitec 2000 by use of the Polygram 98 pH Testing Application software for later display, analysis and reporting. In its daily use, a trained technician and/or physician are the main user of the system.

AI/ML Overview

The provided document is a 510(k) submission for the Polygram 98 pH Testing System (incl. bile). It describes a device that measures pH and bile reflux in the gastrointestinal tract. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical performance data with acceptance criteria in the way a novel AI/ML device might.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance from a clinical trial or a standalone algorithm assessment. Instead, it focuses on demonstrating equivalence to a predicate device. The modifications primarily involve the addition of bile measurement capabilities and software updates.

The document lists "Calculated parameters" for both pH and Bile analysis, which are effectively the output of the system. These include various measurements like:

Maximum, Minimum
Duration of period
Number of (acid/bile) refluxes
Number of long (acid/bile) refluxes
Longest (acid/bile) reflux
Total time (pH below 4 / bile above 0.14)
Fraction time (pH below 4 / bile above 0.14)
Symptom index
Symptom Association Probability

For pH, it also lists "Scoring Normals" like DeMeester & Johnson, Bolx-Ochoa, and Infant normals. For Bile analysis, it explicitly states "No scoring system exists for Bile analysis." This indicates that while the system measures bile, there aren't established clinical thresholds or scoring systems for it, unlike pH.

The primary "acceptance criterion" implicit in a 510(k) submission is substantial equivalence to the predicate device. The document states:

"Verifications results show that the enhanced system performs as its predicate system." (referring to non-clinical performance data)
"This new system does not raise any new safety or performance issues."

Therefore, a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy) is not provided because the submission's focus is on demonstrating that the new features (bile measurement and software) do not negatively impact the safety or effectiveness of the previously cleared pH system and that the bile measurement functionality is appropriately described and safe.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "Clinical trials have not been performed." This means there is no test set in the sense of patient data used to evaluate the clinical performance of the device or its new features. The evaluation relies on non-clinical verification and a comparison of technical features to the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Since no clinical trials were performed and no specific test set was evaluated for clinical performance, there were no experts used to establish ground truth in this context.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This device is a measurement system, not an AI-assisted diagnostic tool for human readers, and no MRMC study was performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

The device is a "system" (Bilitec 2000 hardware + Polygram 98 software) that measures physiological parameters. It does not contain an "algorithm" in the AI/ML sense that would have a standalone performance evaluated for accuracy, sensitivity, specificity, etc. The software analyzes and displays the data collected by the hardware. The documentation states "Verifications results show that the enhanced system performs as its predicate system," referring to non-clinical technical verifications.

7. The Type of Ground Truth Used

Given that clinical trials were not performed, there's no ground truth established from pathology, expert consensus, or outcomes data for the new components of the device. The "ground truth" for the predicate device's pH measurements would have been established historically but is not detailed here. For the added bile measurement, the system reports absorbance units, and the document notes that "No scoring system exists for Bile analysis," implying that clinical "ground truth" thresholds or diagnostic criteria for bile reflux were not established or leveraged at the time of this submission.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML system that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Summary regarding this specific document:

This 510(k) submission is for a device that is primarily an updated version of an existing physiological measurement system, adding the capability to measure bile reflux. The regulatory pathway chosen (510(k)) primarily requires demonstrating substantial equivalence to a predicate device, and for this submission, no clinical trials were conducted to assess the performance of the new features against specific clinical acceptance criteria or ground truth. The assessment relies on non-clinical verification that the "enhanced system performs as its predicate system" and that it "does not raise any new safety or performance issues." The lack of specific performance metrics, clinical test sets, or expert evaluations is typical for 510(k) submissions of this nature, especially when the changes are characterized as modifications to an existing device rather than a fundamentally new technology requiring de novo clinical validation.

Summary

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8 2002 NOV

K011471 Page 1 of 5

510(k) Notification 43S11 Polygram 98 pH Testing System (incl. bile)

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 95 02 Fax: + 45 44 57 90 10 Contact person for this submission: Tove Kjaer Date submission was prepared: May 10, 2001

2. Trade Name, Common Name and Classification Name:

A. Trade Name: Polygram 98 pH Testing System (incl. bile)

B. Common Name, Classification Name, Class and Regulation Number:

Common Name	ClassificationNumber	Class	RegulationNumber
Bilitec 2000	78 FFX	II	21 CFR 876.1725
Optical Fiber Probe	78 FFX	II	21 CFR 876.1725
Polygram 98 pH Testing Application	78 FFX	II	21 CFR 876.1725

3. Predicate Device Identification:

The functionality and intended use of the Polygram 98 pH Testing System (incl. bile) is equivalent to Medtronic Functional Diagnostics A/S's Polygram 98 pH Testing System (K 981733).

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4. Device Description:

The Main tasks when performing a reflux festing procedure:

. Prepare equipment including calibration
. Enter patient demographic information
perform procedure and obtain relevant data .
Review, analysis and post procedure activities
. Create and print a report

5. Intended Use:

6. Table of Device Similarities and differences to predicate device

Manufacturer	Medtronic Synectics AB	Medtronic FunctionalDiagnostics A/S
510(k) number	Predicate DevicePolygram 98° pHTesting System, i.e• Digitrapper pH• Polygram '98,pH TestingApplication• K 981733	Modified DevicePolygram 98 pH Testing Systemv2.2 (incl. Bile), i.e• Bilitec 2000• Polygram 98,pH Testing Application v2.2(including Bile)	Polygram 98 software has beenupdated in order to facilitateupload and analysis of datarecorded by the Bilitec 2000device
General:	Predicate devics:- all	Modified Device- pH System	Explanation of the differencescomparedto the Predicate devices
Intended Use /Indication ofUse	The pH System isintended to record,store, view and analyzeesophageal and gastricpH data to diagnosereflux disorders. The pHSystem can also beused to locate theposition of the proximalLower EsophagealSphincter (LES)manometrically, toassist in the accuratepositioning of the pHcatheter	The pH System is intended torecord, store, view and analyzeesophageal and gastric refluxateto diagnose rellux disorders.The pH System can also beused to locate the position of theproximal Lower EsophagealSphincter (LES) manometrically,to assist in the accuratepositioning of the pH catheter	Same
IntendedPopulations	Pediatric to Adults	Same
Sterilization	Accessories are notsupplied sterile,manufacturer label theaccessories withcleaning instructions.	Same
Biocompatibility	Catheters are the onlypart that come intocontact with thepatients.	Same
TechnicalFeatures:	Predicate devices- Digitrapper pH	Modified Device- Bilitec 2000	Explanation of the differencescomparedTo the Predicate devices
Number ofChannels	4 channels pH, 1pressure	2 channels Bile
Sampling rate	¼ Hz	1 Hz with 4, 8 or 16secaveraging time
Memory Size	2Mb Flash Data RAM	128 Kbytes flash memory
Event markers	3	1 event marker
Built in memoryback up	Now has Flash ram (nobackup required). Clockhas 14 days backup.	Has Flash ram.	Flash RAM is non-volatile thereforrequires no 'backup'. The Bilitechas no clock and no back-up ofdate/time information is thenrequired
Power supply	2 x 1.5V AA alkaline	4 x 1,5V AA size alkalinebatteries
Measuringrange	0-9 pH	Absorbance from 0 to 1 unit	The spectrophotometricmeasurement of the absorbanceof Bile (bilirubin) is measured inthe range of 0 to 1 (0-100%)
Recording time	24 Hours	24 Hours
Currentconsumption	20mA	30 mA in normal mode and 16mA on average in Sampling/idlemode	The set-up mode and thespectrophotometric measurementrequires different levels of currentconsumption
Communication	IrDA Communication(Infra Red)	Serial communication 9600baud	This is a standard serial port as onall PC's.
Resolution	Better than 0.01pH	<= 0,004 absorbance unit
Display	119 by 73 pixel graphicdisplay.	LCD consists of 4 rows with 16characters
Dimension	115 x 140 x 50 mm	200mm x 100mm x 35mm
Weight	300 gr.	450 gr.
On-linemonitoring	Via own Screen	Same
Signals toanalyze	pH	PH and Bile
Usercommands	Menu selections,keyboard combinations,screen "buttons"	Same
Calculated,parameters	1. Maximum,Minimum2. Duration of period3. Number of acidrefluxes4. Number of longacid refluxes5. Longest acid reflux6. Total time pHbelow 47. Fraction time pHbelow 48. Symptom index9. Symptom AssociationProbability10. Number of alkalineshifts11. Number of longalkaline shifts12. Longest alkalineshift13. Total tome pHabove 814. Fraction time pHabove 8	Same for pH, plus for Bileanalysis:1. Maximum, Minimum2. Duration of period3. Number of bile refluxes4. Number of long bilerefluxes5. Longest bile reflux6. Total time bile above 0,147. Fraction time bile above0,148. Symptom index9. Symptom AssociationProbability	Calculated parameters for bile aresimilar to the pH analysis
Scoring,Normals	15. DeMeester &Johnson (adult)16. Bolx-Ochoa(pediatric)17. Infant normalspercentile graph(ESPGAN normals)	Same for pH.NA for the Bile analysis	No scoring system exists for Bileanalysis
Reports	Signal tracings andreports. Optionalselections only.	Same
Patientdatabase	Relational database withlogical patient- recordingrelations	Same
Additional data	User definable additionalpatient/recordingparameters	Same
User helpsystem	Online help system withdescriptions ofprocedures	Same
Signal reviewmethod	Time - tracing based	Same
Recordingcontrol	Real time monitoring ofsignals	Same
Recordingconfiguration	A template is used foreach type of recording.	Same

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K011471

510(k) Notification 43S11 Polygram 98 pH Testing System (incl. bile)

Page 3 of 5

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510(k) Notification 43$11 Polygram 98 pH Testing System (incl. bile)

Page 4 of 5

Features:

Predicate Device

Polygram '98, pH
Testing Application

Modified Device - Polygram '98, pH Testing Application v2.2 (including Bile) Explanation of the differences compared to the Predicate devices

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Page 5 of 5

1. Assessment of non-clinical performance data for equivalence:
  Verifications results show that the enhanced system performs as its predicate system.

8. Assessment of clinical performance data for equivalence:

Clinical trials have not been performed. This new system does not raise any new safety or performance issues.

9. Biocompatability: The Optical Fiber probe has been tested for biocompatibility.

10. Sterilization:

Not applicable

11. Standards and Guidances:

The Polygram 98 pH testing System (incl bile) conforms to the following voluntary and mandatory standards:

. EN 60601-1, Medical equipment
The following guidances were followed:
DRAERD Premarket Notification 510(k) Screening checklist, RRG Rev. 3/14/95
ODE Guidance for the Content of Premarket Submission for Medical Device Containing Software Draft Document

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

Public Health Service

8 2002 NOV

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Toni Kennet Jørgensen Regulatory Affairs Specialist Medtronic Functional Diagnostics A/S Tonsbakken 16-18 DK-2740 Skovlunde DENMARK

Re: K011471

Trade/Device Name: Polygram '98 pH Testing System (incl Bile), Bilitec™ 2000 and Optical Fiber Probe Regulation Number: 21 CFR 8876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: 78 FFX Dated: August 9, 2002 Received: August 12, 2002

Dear Mr. Jørgensen:

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 (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. 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 cither 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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

. 8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html.

Sincerely yours,

Nancy Chrizdon.

Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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Indication for Use Statement

Page 1 of 1

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Polygram 98 pH Testing System (incl. bile)

Indications for Use:

MRI Compatibility Statement:

The Ambulatory 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)
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Prescription Use	/	OR	Over-The-Counter Use ______
(Per 21 CFR 801.109)			(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal,and Radiological Devices
510(k) Number

Regulation Number and Section

§ 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).