POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102

K014269 · Medtronic Functional Diagnostics A/S · MYE · Nov 21, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K014269
• Device Name: POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102
• Applicant: Medtronic Functional Diagnostics A/S
• Product Code: MYE · Gastroenterology, Urology
• Decision Date: Nov 21, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1735
• Device Class: Class 2

Intended Use

The PolygrafID with POLYGRAM NET™ ElectroGastroGraphy Application is intended to record, store, process and view gastric myoelectrical activity as an aid in the diagnosis of gastrointestinal motility disorders.

Device Story

Stationary electrogastrography (EGG) system; measures myoelectrical activity of gastrum via skin-surface sensors. System captures, stores, and displays data on computer screen; allows review, analysis, and reporting. Operated by trained technician, nurse, or physician in clinical setting. Replaces external strip chart recorder and external amplifier of predicate; uses software-based protocol settings for measurement setup. Software high-pass filter eliminates need for 5-minute settling period. Provides 1 to 4 channels for analysis. Output used by healthcare provider to assist in diagnosing gastrointestinal motility disorders.

Clinical Evidence

No clinical data. Bench testing only; verification results demonstrate performance equivalent to predicate system.

Technological Characteristics

PC-based stationary system; 1-4 channels; disposable electrodes. Software-based high-pass filtering for DC offset removal. Connectivity: external data acquisition device. Standards: EN 60601-1, EN 60601-1-1, EN 60601-1-2, CAN/CSA 22.2 No. 601.1-M90. Digital resolution: 1.12 µV (Gain 1), 0.112 µV (Gain 10), 0.0112 µV (Gain 100).

Indications for Use

Indicated for adults with symptoms consistent with gastrointestinal motility disorders to record, store, process, and view gastric myoelectrical activity as an aid in diagnosis.

Regulatory Classification

Identification

An electrogastrography system (EGG) is a device used to measure gastric myoelectrical activity as an aid in the diagnosis of gastric motility disorders. The device system includes the external recorder, amplifier, skin electrodes, strip chart, cables, analytical software, and other accessories.

Special Controls

*Classification.* Class II (Special Controls). The special controls are as follows:(1) The sale, distribution and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter. (2) The labeling must include specific instructions: (i) To describe proper patient set-up prior to the start of the test, including the proper placement of electrodes; (ii) To describe how background data should be gathered and used to eliminate artifact in the data signal; (iii) To describe the test protocol (including the measurement of baseline data) that may be followed to obtain the EGG signal; and (iv) To explain how data results may be interpreted. (3) The device design should ensure that the EGG signal is distinguishable from background noise that may interfere with the true gastric myoelectric signal. (4) Data should be collected to demonstrate that the device has adequate precision and the EGG signal is reproducible and is interpretable.

Predicate Devices

• 3CPM EGG Machine (K984637)

Submission Summary (Full Text)

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# KO14269 OF 4

## 510(k) Notification Electrogastrography (EGG) System

NOV 2 1 2002

## 510(k) SUMMARY

as required per 807.92(c)

#### 1. Submitters Name, Address:

Medtronic 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: Liselotte Sander Date submission was prepared: August 20, 2002.

#### 2. Trade Name, Common Name and Classification Name:

A. Trade Name: Electrogastrography (EGG) System

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

| Common Name | Classificati<br>on Number | Class | Regulation<br>Number |
|--------------|---------------------------|-------|----------------------|
| Polygraf ID | MYE | II | 21 CFR 876.1735 |
| Polygram NET | MYE | II | 21 CFR 876.1735 |

#### 3. Predicate Device Identification:

The scientific technology and the functionality and intended use of the Polygram NET and the Polygraf ID are equivalent to 3CPM Company's 3CPM EGG Machine (K 984637)

#### 4. Device Description:

The system is a stationary electrogastrography system for use in the evaluation of gastrointestinal motility disorders. The system measures the myoelectrical activity of the gastrum using sensors situated on the skin. The parameters measured are presented on a computer screen during the capture and are also stored for later display, review, analysis and reporting.

In the daily use, a trained technician, nurse and/or a physician are the main users of the system.

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## 510(k) Notification Electrogastrography (EGG) System

The main tasks when performing an electrogastrography procedure with a stationary EGG system are:

- Prepare equipment including verification of correct levels for skin/electrode . impedance levels.
- Enter patient/study demographic information ●
- Perform procedure and obtain relevant data ●
- Review, analysis and post procedure activities ●
- Create and print a report ●

The Polygram NET application software runs on the Microsoft Windows® 2000 operating system.

#### 5. Intended Use:

The Polygaf ID with Electrogastrography (EGG) System is intended to record, store view and process gastric myoelectrical activity as an aid in the diagnosis of gastrointestinal motility disorders.

| | 6. Table of Device Similarities and differences to predicate device | | | |
|--|---------------------------------------------------------------------|--|--|--|
| | | | | |

| Manufacturer | 3CPM CO., Inc. | Medtronic Functional Diagnostics |
|---------------|----------------------|------------------------------------------------------------|
| 510(k) nummer | Predicate device | New device |
| | • 3CPM EGG Machine – | K011468 |
| | K984637 | Polygram NET Electrogastro-graphy |
| | | (EGG) Application: |
| | | • Polygraf ID |
| | | • Polygram NET Electrogastrography<br>Application Software |

| General: | Predicate device<br>3CPM | Modified device<br>Polygram NET<br>Electrogastrography<br>(EGG) Application | Explanation of the<br>differences compared to<br>the predicate device |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| PC. Based | Yes | Yes | same |
| External data acquisition<br>device | Yes | Yes | same |
| External amplifier | Yes | No | Better |
| Use of a external Strip<br>Chart Recorder | Yes | No1 | Better<br>Makes the system simpler. |
| Measurement setup | On HW devices | By use of protocol | Better |
| | | settings in SW. | Ensures initially same setting<br>every time |
| Visualize signals in time<br>domain. | Yes | Yes | same |
| Running Spectrum<br>Analysis | Yes | Yes | same |
| Gain | 100 | 1, 10, 1002 | same |
| High-Freq. | 0.25 Hz | 0.25Hz | same |
| Low Freq. | 0.016 Hz | DC,<br>0.0083Hz;<br>0.016Hz;<br>0.030Hz | Better |
| Offset | 0 | High Pass filter3 | Same result |
| SW high pass filter | NO | Yes | Better.<br>No need for 5 minutes period<br>to "settle down". The recor-<br>ding can begin immediately |
| Number of channels | 1 | 1 to 4 | Better.<br>Gives the ability to analyze<br>the channel with the most<br>significant data |
| Motion sensor | Yes | Yes | Same |
| Indications for use | To be used to record<br>electrogastro-grams,<br>as a component of a<br>comprehensive clini-<br>cal evaluation in pa-<br>tients with symptoms<br>consistent with ga-<br>strointestinal motility<br>disorders | Record, store view and<br>analyze gastric myoe-<br>lectrical activity as an<br>aid in the diagnosis of<br>gastrointestinal motility<br>disorders | Same |
| Intended populations | Infants, pediatrics to<br>adults | Adults | Less |
| Sterilization | Accessories are not<br>supplied sterile,<br>manufacturer labels<br>the accessories with<br>cleaning instructions | Electrodes are dispo-<br>sable. Cables are not<br>supplied sterile, manu-<br>facturer labels the ac-<br>cessories with cleaning<br>instructions | Same |
| Biocompatibility | The sensors are the<br>only part that comes<br>into contact with the<br>patients | Same | Same |

I The raw data is presented on the screen formatted as a strip chart. The hole recording or part's of it can be printed or included in the report.

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## 510(k) Notification Electrogastrography (EGG) System

י

#### 7. Assessment of non-clinical performance data for equivalence:

Verifications results show that the enhanced system performs as its predicate system.

² The Digital resolution is as following: Gain 1 -> 1.12 µV ; Gain 10 -> 0.112 µV; Gain 100 -> 0.0112µV

³ The Polygraf ID handles signals in the range of f +- 2.5 V. The DC offset is removed by use of a software high pass filter.

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KC14269
PAGE 4 OF 4

## 510(k) Notification Electrogastrography (EGG) System

#### 8. Assessment of clinical performance data for equivalence: Clinical trials are not performed. This new system does not raise any new safety or performance issues.

#### 9. Biocompatability:

Not applicable

#### 10. Sterilization:

Not applicable

#### 11. Standards and Guidances:

The Polygraf ID conforms to the following voluntary and mandatory standards:

- EN 60601-1, Medical equipment .
- EN 60601-1-1, Electrical Safety ●
- EN 60601-1-2, Electro magnetic Compatibility ●
- CAN/CSA 22.2 No. 601.1 - M90

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20:350

NOV 21 2002

Re: K014269

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

Trade/Device Name: Polygraf ID with POLYGRAM NET™ ElectroGastroGraphy (ECG) Application Software Regulation Number: 21 CFR 8876.1735 Regulation Name: Electrogastrography system Regulatory Class: II Product Code: 78 MYE Dated: August 20, 2002 Received: August 23, 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 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.

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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C Brogdon

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

Enclosure

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510(k) Number (if known): K014269

Device Name: ElectroGastroGraphy (EGG) Application Software

Indications For Use:

The PolygrafID with POLYGRAM NET™ ElectroGastroGraphy Application is intended to record, store, process and view gastric myoelectrical activity as an aid in the diagnosis of gastrointestinal motility disorders.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGIE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David C. Ingram

(Optional Format 3-10-98)

Prescription Use