INSIGHT GENESIS

K011983 · Fasstech · HCC · Aug 30, 2001 · Neurology

Device Facts

• Record ID: K011983
• Device Name: INSIGHT GENESIS
• Applicant: Fasstech
• Product Code: HCC · Neurology
• Decision Date: Aug 30, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5050
• Device Class: Class 2

Intended Use

To measure bilateral differences in surface EMG along the spine To measure surface EMG along the spine during functional tasks To chart patient progress during the course of treatment

Device Story

Insight Genesis is a non-invasive, single-modality physiologic monitoring device used in clinical settings. It utilizes two surface EMG sensors to capture muscle activity signals along the spine. The hardware includes an instrument console and sensors, connecting to an IBM-compatible PC via an isolated serial port. The software processes raw analog EMG signals, displays real-time data, and generates reports for clinicians. By measuring bilateral EMG differences and activity during functional tasks, the device assists clinicians in monitoring patient progress throughout treatment. The system employs opto-isolation and medical-grade power supplies to ensure patient safety during data acquisition.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Non-invasive surface EMG monitor. Materials: Impact-resistant, flame-retardant ABS case. Sensing: 2 smart sensors with integral preamplifiers; 20-500 Hz bandwidth; 150 dB CMRR; >1,000,000 Megaohms input impedance. Energy: 12V, 500 mA via UL-2601 listed wall-mounted power supply. Connectivity: Opto-isolated RS232 serial link to PC. Data Acquisition: 12-bit, 8-channel A/D converter. Software: Real-time display and reporting.

Indications for Use

Indicated for patients requiring surface EMG measurement along the spine to assess bilateral differences, monitor muscle activity during functional tasks, and track treatment progress.

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

• Insight Millennium (K990778)

Submission Summary (Full Text)

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AUG 3 0 2001

K011983

# Insight Genesis

510(k) Summary

Submitted by:

Company Name: Company Address #1: Company Address #2: Contact Person: Phone Number: Fax Number:

Submitted on:

Fasstech 155 Middlesex Turnpike Burlington, MA 01803 Lee Brody 781.229.1500 781.229.9035

June 25, 2001

510(k) Summary
Fasstech
*Insight Genesis*

NE/Y
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3 GO / MOD

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#### Device Name Section 1:

Biofeedback Device Common or Usual Name: Insight Genesis Proprietary Model Name:

#### Indications for Use Section 2:

- To measure bilateral differences in surface EMG along the spine I
- To measure surface EMG along the spine during functional tasks 無
- To chart patient progress during the course of treatment 제 -

### Device Description Section 3:

The Insight Genesis is a non-invasive, single-modality physiologic monitoring device. The The misight Genesis contains two surface EMG sensors used to measure muscle activity.

## Hardware

The Insight Genesis hardware consists of an instrument console and two surface EMG sensors, The Insight Genesis nardware consists of the Insight Instrument Console. The Insight Genesis Williall pug directly into the from pair. 02601 listed wall mounted power supply. The Instrument Instrument Console is powered that a many ter (IBM compatible) via an isolated serial port connection.

## Software

The Insight Genesis software displays real-time surface EMG, allowing the user to ensure that The Insight Ochesis software anplays Fon. The Insight Genesis software allows the user to: (1) readings are stable prior to data concential and and one of ace EMG, and (4) print out reports.

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#### Predicate Device Section 4:

This section documents the substantial equivalence of the Insight Genesis to legally marketed I no been of the Insight Genesis is a subset of the Insight Millennium (K990778). The Insight devices: The Insight Geneers is a subse containing four surface EMG sensors, an infrared thermal scanner and an inclinometer. The Insight Genesis is a simplified version of the Insight Millennium and only contains two surface EMG sensors.

(K990778) Fasstech Insight Millennium

| Feature | Insight Genesis | Insight Millennium |
|-----------------------------------------------------------|-------------------|--------------------|
| Two Channels of surface EMG for Static EMG | Yes | Yes |
| Two Channels of surface EMG for Dynamic EMG | Yes | Yes |
| Additional two channels of surface EMG for Dynamic EMG | No | Yes |
| Skin Temperature measurement via infrared thermal scanner | No | Yes |
| Range of Motion Sensor | No | Yes |
| UL-2601 listed wall-mounted power supply | Yes | Yes |
| Opto-isolated RS232 output | Yes | Yes |
| A/D Converter | 12 bit, 8 channel | 12 bit, 8 channel |

#### Performance Specification Section 5:

## EMG

2 ea. Smart Sensors with low-noise Electrodes: preamplifiers integral to electrode assemblies 0.1 - 999 uV Calibrated Range: Less than 2.0 Picoamperes Input Bias Current: Differential Input Impedance: Greater than 1,000,000 Megaohms 150 dB Common Mode Rejection: 20-500 Hz (50/60 Hz notch) Bandwidth: Less than 0.1 uV (inputs shorted) Noise: Log power detector, 250 mS averaging filter. Detector: None Controls:

Instrument Console Inputs: Output: A/D converter: Controls: Power:

2 each EMG electrodes Opto-isolated RS232 (9 pin sub-D jack) 12 bit, 8 channel None 12V, 500 mA UL-2601 listed wall-mounted power supply.

510(k) Summary Fasstech Insight Genesis

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Physical:

Case Material: Impact resistant, flame retardant ABS. 3.5"H x 8.375"W x 9"D. Weight 3 lbs. 11 oz.

#### Patient Safety Section 6:

The Insight Genesis patient safety is assured by the following design architecture:

There are three primary components to the patient Patient Isolation Circuitry: isolation circuitry: (a) an external plug-in medical-grade wall transformer. This device is a Isolation circuit y. (a) an enterner plag nouput of 12VDC and 500 mA max. There is also a 1A OL2001 itstod wall transformer input,(b) an industry standard DC-to-DC converter that Slow-blow luse at the wall transformer informer of the UL2601 standard for meets the "dicience withistand" and "feating Jours and (c) the opto-isolation couplers described in Data Acquisition below.

Processed signals are converted from analog voltages to Data Acquisition / RS232 Data Link: 12 bit digital values by the analog-to-digital converter (ADC). The digital data is sent to and 12 bit the serial port of the PC across the isolation barrier via opto-coupler devices. The ADC and a portion of the RSR232 data link are on the patient side of the isolation barrier. The proper use a portion of the RDR252 data provides the dielectric withstand and low leakage current of migh voltage opto-couplers pro rises an on-isolated sides of the opto-couplers are then routed to RS232 drivers and receivers which are, in turn, routed to a DB9 connector at the rear panel of the Instrument Console. A standard RS232 serial cable connects the Instrument Console to the PC serial port.

#### Conclusion Section 7:

The Insight Genesis is substantially equivalent to the predicate device. Furthermore, the device is safe and effective for its intended use.

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AUG 3 0 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Lee Brody Chief Operating Officer Fasstech 155 Middlesex Turnpike Burlington, Massachusetts 01803

Re: K011983

Trade/Device Name: Insight Genesis Regulation Number: 882.5050 Regulatory Class: II Product Code: HCC Dated: June 25, 2001 Received: June 26, 2001

Dear Mr. Brody:

We have reviewed your Section 510(k) notification of intent to market the device referenced we nave hove have determined the device is substantially equivalent (for the indications for use above and we nave actering marketed predicate devices marketed in interstate commerce Stated in the encrosure) to logally manote of the Medical Device Amendments, or to devices that provisions of the rollance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Costicity for the Act. The general controls provisions of the Act include requirements for annual provisions of the Frea - Frees, 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 (1 charket rippto tal), it the '60 on Joe of Federal Regulations, Title 21, Parts 800 to 895. alleouning Jour as novalent determination assumes compliance with the Current Good A substantially equirements, 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 mspootions, the GMP regulation may result in regulatory action. In addition, FDA may publish comply with the Crice of Crice 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.

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## Page 2 - Mr. Lee Brody

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 [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" (21CFR 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Lisa Walker, MD

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of of

<============================================================================================================================================================================= 510(k) Number (if known):

Insight Genesis Device Name: _

Indications for Use:

To measure bilateral differences in surface EMG along the spine To measure surface EMG along the spine during functional tasks To chart patient progress during the course of treatment

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_R011983