INSIGHT MILLENNIUM PLUS

K011964 · Fasstech · HCC · Sep 20, 2001 · Neurology

Device Facts

• Record ID: K011964
• Device Name: INSIGHT MILLENNIUM PLUS
• Applicant: Fasstech
• Product Code: HCC · Neurology
• Decision Date: Sep 20, 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 measure bilateral differences in skin temperature along the spine To measure Range of Motion of the three spinal regions. To measure patient self-reported pressure sensitivity in joints and muscles To chart patient progress during the course of treatment

Device Story

Insight Millennium Plus is a non-invasive, multi-modality physiologic monitoring device used in clinical settings by healthcare providers. It collects data via four sensor types: surface EMG electrodes (muscle activity), infrared thermal sensors (skin temperature), inclinometers (spinal range of motion), and an algometer (pressure sensitivity). Sensors connect to an instrument console, which transmits digitized data via an isolated RS232 serial connection to a PC. Software displays real-time readings, allowing clinicians to verify signal stability, record measurements, graph data, and generate reports. The device assists clinicians in quantifying spinal physiological parameters and monitoring patient progress over the course of treatment.

Clinical Evidence

Bench testing only. Performance specifications provided for EMG (0.1-999 uV range, 20-500 Hz bandwidth), Range of Motion (+/- 1 degree accuracy), Temperature (+/- 0.2F accuracy), and Algometer (+/- 3% accuracy). Patient safety verified via UL2601-compliant isolation circuitry.

Technological Characteristics

Multi-modality monitor with four sensor types. Materials: Impact-resistant ABS plastic, machined aluminum. Sensing: EMG (low-noise preamplifiers), infrared thermopile, inclinometer, pressure transducer. Connectivity: Isolated RS232 serial port to PC. Power: 12V DC UL2601-listed supply. Data acquisition: 12-bit, 8-channel A/D converter. Software: Real-time display, recording, and reporting.

Indications for Use

Indicated for patients requiring spinal physiological monitoring, including surface EMG, skin temperature, range of motion, and pressure sensitivity assessment for tracking 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)
• JTECH Commander™ Algometer (K971407)

Submission Summary (Full Text)

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SEP 2 0 2001

K011964

# Insight Millennium Plus

# 510(k) Summary

Submitted by:

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

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

Submitted on:

June 22, 2001

510(k) Summary Fasstech Insight Millennium Plus

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#### Device Name Section 1:

Biofeedback Device Common or Usual Name: Insight Millennium Plus Proprietary Model Name:

## Indications for Use Section 2:

- To measure bilateral differences in surface EMG along the spine 트
- To measure surface EMG along the spine during functional tasks 트
- To measure bilateral differences in skin temperature along the spine 트
- To measure Range of Motion of the three spinal regions 트
- To measure patient self-reported pressure sensitivity in joints and muscles 트
- To chart patient progress during the course of treatment 트

#### Device Description Section 3:

The Insight Millennium Plus is a non-invasive, multi-modality physiologic monitoring device. The Insight Millennium Plus contains the following four sensor types: (1) surface EMG used to measure muscle activity, (2) infrared temperature sensor used to measure skin temperature, (3) inclinometer used to measure end-point range of motion, and (4) algometer used to measure patient self-reported pressure sensitivity.

#### Hardware

The Insight Millennium Plus hardware consists of an instrument console and four different sensor types. All four sensor types plug directly into the front panel of the Insight Instrument Console. The Insight Millennium Plus Instrument Console is powered via a UL2601 listed wall mounted power supply. The Instrument Console is connected to a personal computer (IBM compatible) via an isolated serial port connection.

#### Software

The Insight Millennium Plus software displays real-time surface EMG, spinal Range of Motion, skin temperature and pressure readings, allowing the user to ensure that readings are stable prior to data collection. The Insight Millennium software allows the user to: (1) enter patient information, (2) record surface EMG, spinal Range of Motion, skin temperature and pressure readings, (3) graph surface EMG, spinal Range of Motion, skin temperature and pressure readings, and (4) print out reports.

510(k) Summary Fasstech Insight Millennium Plus

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#### Predicate Device Section 4:

This section documents the substantial equivalence of the Insight Millennium Plus to legally marketed devices. The Insight Millennium Plus is a modest expansion of the Insight Millennium. The Insight Millennium Plus expansion is limited to the addition of a fourth sensor type. The fourth sensor type is the Insight Algometer. The algometer is a calibrated pressure stimulus device. It measures pressure applied by examiner to elicit a response for pain tolerance, pain threshold, and trigger point tenderness. The Algometer utilized in the Insight Millennium Plus is substantially equivalent to the JTECH Commander™ Algometer (510(k): K971407):

| Fasstech Insight Millennium | (K990778) |
|-----------------------------|-----------|
| JTECH Commander™ Algometer | (K971407) |

| Feature | Insight<br>Millennium Plus | Insight<br>Millennium | Commander<br>Algometer |
|-----------------------------------------------------------------------|----------------------------|-----------------------|-----------------------------|
| Four Channels of<br>surface EMG | Yes | Yes | N/A |
| Skin<br>Temperature<br>measurement via<br>infrared thermal<br>scanner | Yes | Yes | N/A |
| Range of Motion<br>Sensor | Yes | Yes | N/A |
| Algometer | Yes | No | Yes |
| UL-2601 listed<br>wall-mounted<br>power supply | Yes | Yes | N/A |
| Opto-isolated<br>RS232 output | Yes | Yes | N/A |
| A/D Converter | 12 bit, 8 channel | 12 bit, 8 channel | N/A |
| Algometer Skin<br>Contact Area | $1.0 cm^2$ | N/A | $0.5 cm^2$ or<br>$1.0 cm^2$ |
| Instrument Body<br>Material | Machined<br>Aluminum | N/A | Machined<br>Aluminum |
| Instrument Body<br>Coating | Powder Coated | N/A | Powder Coated |
| Downloadable to<br>PC | Yes | N/A | Yes |
| Range | 0-100 lbs | N/A | 0-100 lbs |
| Accuracy | +/- 3% | N/A | Not Published |
| Skin Contact<br>Material | ABS Plastic | N/A | Not Published |
| Stand-alone | No | N/A | Yes |

510(k) Summary Fasstech Insight Millennium Plus

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#### Section 5: Performance Specification

### EMG

Electrodes:

| Calibrated Range: | |
|-------------------------------|--|
| Input Bias Current: | |
| Differential Input Impedance: | |
| Common Mode Rejection: | |
| Bandwidth: | |
| Noise: | |
| Detector: | |
| Controls: | |

### Range of Motion

Range: Accuracy: Controls: Physical:

Temperature

Calibrated Range: Accuracy: Sensors:

Controls: Physical:

Size:

Algometer

Calibrated Range: Accuracy: Contact Area: Sensor: Controls: Physical:

Size:

Instrument Console Inputs:

4 ea. Smart Sensors with low-noise preamplifiers integral to electrode assemblies 0.1 - 999 uV Less than 2.0 Picoamperes Greater than 1,000,000 Megaohms 150 AB 20-500 Hz (50/60 Hz notch) Less than 0.1 uV (inputs shorted) Log power detector, 250 mS averaging filter. None

360 degrees +/- 1 degree nominal Enter and Skip Buttons Case Material: Impact resistant, flame retardant ABS. 3.4"H x 3.5"W x 1.25"D. Weight 6.5 oz.

55°F - 120°F +0.2ºF nominal Two thermopile, fixed 2.5" apart (center-tocenter) Enter button Case Material: Impact-resistant, Aluminum with 0.5" ABS Plastic Outer Ring. 5.5"L x 3.5"W x 2.5"H. Weight 15 oz.

0-100 lbs. +3% nominal 1.0 cm2 One pressure transducer attached to a stiff rod. Enter button Case Material: Impact-resistant, Aluminum with 3.0" ABS Plastic Stiff Rod. 5.5"L x 1.75"W x 2.5"H. Weight 9 oz.

4 each EMG electrodes 1 each inclinometer

510(k) Summary Fasstech Insight Millennium Plus

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| | 1 each temperature sensor |
|----------------|----------------------------------------------------------|
| | 1 each algometer sensor |
| Output: | Opto-isolated RS232 (9 pin sub-D jack) |
| A/D converter: | 12 bit, 8 channel |
| Controls: | None |
| Power: | 12V, 500 mA UL-2601 listed wall-mounted<br>power supply. |
| Physical: | Case Material: Impact resistant, flame retardant<br>ABS. |
| | 3.5"H x 8.375"W x 9"D. Weight 3 lbs. 11 oz. |

#### Patient Safety Section 6:

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

Patient Isolation Circuitry: There are three primary components to the patient isolation circuitry: (a) an external plug-in medical-grade wall transformer. This device is a UL2601 listed wall transformer with an output of 12VDC and 500 mA max. There is also a 1A slow-blow fuse at the wall transformer input,(b) an industry standard DC-to-DC converter that meets the "dielectric withstand" and "leakage current" requirements of the UL2601 standard for Patient Care Equipment with isolated patient leads, 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 from 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 of high voltage opto-couplers provides the dielectric withstand and low leakage current characteristics specified in UL2601. The non-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.

#### Section 7: Conclusion

The Insight Millennium Plus is substantially equivalent to the two predicate devices. Furthermore, the device is safe and effective for its intended use.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a bird or a stylized human figure, composed of three curved lines.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP 2 0 2001

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

Re: K011964

Trade/Device Name: Insight Millenium Plus Regulation Number: 882.5050 Regulation Name: Biofeedback device Regulatory Class: II Product Code: HCC, HRW Dated: June 22, 2001 Received: June 25, 2001

Dear Mr. Brody:

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 for assured in the encreases in 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 general controls proficturing 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 If your de roo is exassined (too at 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 r reaso oe actived 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 or car) i 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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# Page 2 - Mr. Lee Brody

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 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.

Susan Welker, us

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

510(k) Number (if known): K Oll 964

Insight Millennium Plus 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 measure bilateral differences in skin temperature along the spine To measure Range of Motion of the three spinal regions. To measure patient self-reported pressure sensitivity in joints and muscles 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)

Prescription Denes

SL

(Division Sign- 9) Division of General, Restorative and Neurologic Devices

510(k) Number: k011964