POLYGRAM NET BIOFEEDBACK APPLICATION

K041244 · Medtronic Vascular · HCC · Aug 12, 2004 · Neurology

Device Facts

• Record ID: K041244
• Device Name: POLYGRAM NET BIOFEEDBACK APPLICATION
• Applicant: Medtronic Vascular
• Product Code: HCC · Neurology
• Decision Date: Aug 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5050
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The POLYGRAM NET™ Biofeedback Application is intended for the assessment and treatment of pelvic floor dysfunction through biofeedback in patients 4 years of age or older.

Device Story

The POLYGRAM NET™ Biofeedback Application is a software-based system for pelvic floor muscle reeducation. It processes physiological signals (manometry and EMG) acquired via catheters and sensors placed in the anorectal canal. These sensors connect to the Medtronic Polygraf ID, which transmits data to the application. The software transforms muscle activity signals into a real-time graphical interface, displaying a lane that the patient navigates by squeezing and relaxing pelvic floor muscles. The patient attempts to keep a signal level indicator within the lane boundaries. Used in clinical settings, the device provides visual feedback to patients to facilitate muscle control, aiding in the treatment of pelvic floor dysfunction.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Software application for biofeedback; utilizes manometry catheters and EMG sensors for signal acquisition; connects to Medtronic Polygraf ID hardware; graphical user interface for real-time patient feedback.

Indications for Use

Indicated for assessment and treatment of pelvic floor dysfunction via biofeedback in patients 4 years of age or older.

Regulatory Classification

Identification

A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.

Predicate Devices

• POLYGRAM Anorectal Functional Testing Application (K000386)
• Regain Desktop (K003127)
• Orion Platinum (K003367)

Reference Devices

• Medtronic Polygraf ID (K992713)

Submission Summary (Full Text)

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| 8.0 510(K) SUMMARY | AUG 1 2 2004 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Medtronic Gastroenterology and Urology<br>4000 Lexington Ave N<br>Shoreview, MN 55126 |
| Contact: | Julie Goode<br>Senior Regulatory Affairs Specialist<br>Medtronic Gastroenterology and Urology<br>4000 Lexington Ave N<br>Shoreview, MN 55126<br>[phone]<br>[phone] |
| Trade Name: | POLYGRAM NETTM Biofeedback Application |
| Common Name: | Biofeedback software application |
| Classification Name: | Gastrointestinal motility monitoring system |
| Name of Predicate Device | POLYGRAM Anorectal Functional Testing Application, K000386<br>Regain Desktop, K003127<br>Orion Platinum, K003367 |

# Device Description

The POLYGRAM NET™ Biofeedback Application is used to assess and treat pelvic floor dysfunction. Data is collected in the anorectal canal, using sensors, and is displayed to the patient in a simple graphical format. The patient can modulate the activity of the anorectal muscles, thereby reeducating the pelvic floor muscles.

During a biofeedback study, a manometry catheter and/or EMG sensors are placed in the patient's anorectal canal at the sphincter. EMG sensors are then inserted anally and applied to the side of the anus. These EMG sensors, which are the same as used with the POLYGRAM Anorectal Function Testing Software (K000386), sense the patient's pelvic floor muscle activity during sequences of squeezing and relaxing maneuvers. These sensors and catheters are connected to the Medtronic Polygraf ID (K992713), which acquires the data to be displayed by the POLYGRAM NET™ Biofeedback Application.

The POLYGRAM NET™ Biofeedback Application displays a lane, that the patient navigates using their pelvic floor muscles. By squeezing and relaxing the pelvic floor muscles, the patient moves the signal level indicator up and down, trying to keep the signal level within the limits of the lane.

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# Performance Standards

K041244
Page 2 of 2

No applicable mandatory performance standards or special controls exist for this device.

# Statement of Intended Use

The POLYGRAM NET™ Biofeedback Application is intended for the assessment and The I OLA GRANA NET - Blorection through biofeedback in patients 4 years of age or older.

### Substantial Equivalence

This premarket notification is being submitted for the Medtronic POLYGRAM NET™ This promance includes . Other Gastrointestinal motility monitoring systems, previously cleared by FDA, and currently marketed include:

- Medtronic POLYGRAM NET™ Anorectal Functional Testing Application (K000386) .
- SRS Medical Systems Orion Platinum (K003367) .
- SRS Medical Systems Regain Desktop (K003127) .

#### Summary of Testing

In-vitro testing was performed to support substantial equivalence to the predicate devices. In vitte testing was points indicate that the Medtronic POLYGRAM NET™ Biofeedback Application meets all of the design and performance requirements.

### Conclusion

Through the data and information presented, as well as similarities to a legally marketed I mough are aans , Inc. considers the Medtronic POLYGRAM NET™ Biofeedback device, incutrome, the substantially equivalent to the previously discussed legally marketed predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 12 2004

Ms. Julie Goode Semor Regulatory Affairs Specialist Medtronic Gastroenterology and Urology 4000 Lexington Avenue North SHOREVIEW MN 55126-2983

Re: K041244

Trade/Device Name: POLYGRAM NET™ Biofeedback Application Regulation Number: 21 CFR §882.5050 Regulation Name: Biofeedback device Product Code: 84 HCC Regulation Number: 21 CFR §876.1725 Regulation Name: Gastrointestinal motility monitoring system Product Code: 78 FFX Regulatory Class: II Dated: May 7, 2004 Received: May 11, 2004

Dear Ms. Goode:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your boctor 9 re(s) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enviosars) to regary at ment date of the Medical Device Amendments, or to conninered prior to May 20, 1976, the encounce with the provisions of the Federal Food, Drug, devices that have been recurse in avere approval of a premarket approval application (PMA). and Costinetto Act (Rel) that do not require subject to the general controls provisions of the Act. The r ou may, dicience, market the act include requirements for annual registration, listing of general controls provisions of the fies 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 your device is classified (500 above) in existing major regulations affecting your device can be It may of Subject to additional collience in the 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 r trass oc advised that + Dr. 3185aanted or our device complies with other requirements of the Act that I 127 has made a deceminations administered by other Federal agencies. You must of any Pederal Statues and regulations as manifical to: registration and listing comply with an the Act stequirements, menting. .
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 807), labemig (21 CFR Part 820), and if applicable, the electronic fordly in the quanty by stems (20) = (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 Section 510(k) This lefter will allow you to begin marketing your active of your device of your dever to a legally premarket notification. The FDA momg of bassification 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 Cirk Part 801), please
s the same of the same of the same of the same of the regulation it you desire specific advice for your don'ts be following numbers, based on the regulation in number at the top of the 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 Additionally, Tor questions on the promotion and more the regulation entitled, "Misbranding
Office of Compliance at [phone]. Also, please now Othice of Compliance at [phone]. Part 807.97) you may obtain. Other general by reterence to premarked nomication (210) For Friday of Stan the Division of Strating of Stration of Stration information on your responsionnes and consumer Assistance at its toll-friend democrain burgh Manufacturers, International and Collaumer - Secondants - Second Colors of Section of September 1991.
[phone] or at its Internet address http://www.fda.gov/cdrl/dsmama

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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#### INDICATIONS FOR USE 3.0

44 510(k) Number:

Device Name; POLYGRAM NET™ Biofeedback Application

Indications for use:

The POLYGRAM NET™ Biofeedback Application is intended for the assessment and treatment of pelvic floor dysfunction through biofeedback in patients 4 years of age or older.

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use

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

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Broydon

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devi 510(k) Number

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