INSIGHT DISCOVERY

{0}------------------------------------------------ # Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx # ATTACHMENT 4 AUG 16 2007 # Insight Discovery 510(k) Summary Submitted by: Company Name: Company Address #1: Company Address #2: Contact Person: Phone Number: Fax Number: Fasstech 76 Treble Cove Road, #2 North Billerica, MA 01862 Lee Brody 978.663.2800 978.663.0999 Submitted on: April 13, 2007 Insight Discovery 510(k) Summary {1}------------------------------------------------ #### Section 1: Device Name Proprietary Model Name: Common or Usual Name: Regulatory Name: Regulation Number: Product Code: Regulatory Class: Insight Discovery Diagnostic Electromyograph Diagnostic Electromyograph 21 CFR 890.1375 IKN II ### Section 2: Indications for Use - I 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 - I To measure Range of Motion of the three spinal regions - l To measure patient self-reported pressure sensitivity in joints and muscles - . To measure Heart Rate - 미 To chart patient progress during the course of treatment #### Section 3: Device Description The Insight Discovery is a non-invasive, multi-modality physiologic monitoring device. The Insight Discovery contains the following six sensor types: (1) surface EMG used to measure muscle activity, (2) infrared temperature sensor used to measure skin temperature, (3) algometer used to measure patient self-reported pressure sensitivity, and (4) heart rate sensor to measure heart rate, (5) an inclinometer used to measure end-point range of motion, and (6) a wireless version of the inclinometer. ## Hardware The Insight Discovery hardware consists of an instrument console and six different sensor types. The sensor types plug directly into the front panel of the Insight Instrument Console, with the exception of the wireless inclinometer. The Insight Discovery Instrument Console is powered via a UL2601 listed power supply. The Instrument Console is connected to a personal computer (IBM compatible) via an isolated USB port connection. ## Software The Insight Discovery software displays real-time surface EMG, spinal Range of Motion, skin temperature, pressure, and heart rate readings, allowing the user to ensure that readings are stable prior to data collection. The Insight Discovery software allows the user to: (1) enter patient information, (2) record surface EMG, spinal Range of Motion, skin temperature, pressure and heart rate readings, (3) graph surface EMG, spinal Range of Motion, skin temperature, pressure and heart rate readings, and (4) print out reports, including an integrated report containing the results of all five recording types. {2}------------------------------------------------ ## Section 4: Predicate Device This section documents the substantial equivalence of the Insight Discovery to a legally marketed device. Specifically, this section documents the substantial equivalence of Insight Discovery to the following product: | Manufacturer | Predicate Device Name | 510(k) Number | |------------------------|-----------------------|---------------| | Insight Millennium III | Fasstech | K023209 | The Insight Discovery is equivalent to this legally marketed device in the following ways: - The physical characteristics and electrical characteristics (performance characteristics) of the . Insight Discovery are identical as to the Insight Millennium III, as cleared by FDA. The only difference is the addition of an optional wireless dual inclinometer in the place of the standard wired inclinometer. The Insight Discovery differs from the legally marketed device in the following ways: - l The addition of an optional wireless dual inclinometer - . The extension of the Insight software to interface with the new inclinometer | Feature | Insight Discovery | Insight Millennium III | |-----------------------------------------------------------|-------------------|------------------------| | Four Channels of surface EMG | Yes | Yes | | Skin Temperature measurement via infrared thermal scanner | Yes | Yes | | Range of Motion Sensor | Yes | Yes | | Algometer | Yes | Yes | | UL-2601 listed power supply | Yes | Yes | | Heart-rate measure using IR Phethsmograph | Yes | Yes | | Wireless version of the inclinometer | Yes | N/A | ## Predicate Device Comparison Chart ## Section 5: Performance Specification Insight Discovery 510(k) Summary {3}------------------------------------------------ The Insight Discovery specifications are summarized below and are identical to Insight Millennium III (except for the addition of the Dual Inclinometer): EMG Electrodes: Calibrated Range: Input Bias Current: Differential Input Impedance: Common Mode Rejection: Bandwidth: Noise: Detector: Controls: Temperature Calibrated Range: Accuracy: Sensors: Controls: Physical: Size: Algometer Calibrated Range: Accuracy: Contact Area: Sensor: Controls: Physical: Size: Heart Rate Sensor Sensor Type > Output Voltage: Output Impedance: Weight: Sensor Size: Single Inclinometer Range: Accuracy: Axes: Controls: 4 ea. Smart Sensors with low-noise preamplifiers integral to clectrode assemblies 0.1 - 999 uV Less than 2.0 Picoamperes Greater than 1,000,000 Megaohms 150 dB 20-500 Hz (50/60 Hz notch) Less than 0.1 uV (inputs shorted) Log power detector, 250 mS averaging filter. None 55°F - 120°F +0.2°F 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 cm4 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. IR Plethsmograph (attached to finger with Velcro) 5 - 50 mV, typical at rest 1 kΩ2, nominal 28 grams 15 x 15 x6.3 mm 360 degrees +/- 1 degree nominal One Enter and Skip Buttons Insight Discovery 510(k) Summary {4}------------------------------------------------ | | Physical: | Case Material: Impact resistant, flame retardant ABS. | |--|--------------------|----------------------------------------------------------------------------------------------------------------------------------| | | | 3.4"H x 3.5"W x 1.25"D. Weight 6.5 oz. | | | Dual Inclinometer | | | | Range: | 360 degrees | | | Accuracy: | +/- 1 degree nominal | | | Axes: | Three | | | Controls: | None | | | Bluetooth Type: | Class 1 / +7dBm 5 mW | | | Physical: | Case Material: Impact resistant, flame retardant ABS. | | | | (1) 3.9"L x 2.0"W x 0.8"D. Weight 2.9 oz. | | | | (2) 1.4"L x 1.4"W x 0.6"D. Weight 1.8 oz. | | | Instrument Console | | | | Inputs: | 4 each EMG electrodes<br>1 each inclinometer<br>1 each temperature sensor<br>1 each algometer sensor<br>1 each Heart Rate sensor | | | Output: | Isolated USB | | | A/D converter: | 16 bit, 16 channel | | | Controls: | None | | | Power: | 12V, 500 mA UL-2601 listed power supply. | | | Physical: | Case Material: Impact resistant, flame retardant ABS. | | | | 3.5"H x 8.375"W x 9"D. Weight 3 lbs. 11 oz. | #### Section 6: Patient Safety The Insight Discovery patient isolation is assured by the following two electrical isolation barriers: - 1 . Medical-Grade Universal Power Supply: This device is a UL2601 compliant AC line to 12 VDC, 28 W converter. This internal power supply is partitioned from all other circuitry via an earthed steel chassis. The power supply accepts 85-264 VAC, and 47-63 Hz via a IEC 60320 fused input module. This supply provides low-level isolated power to the Non-Patient Side of the Insight Discovery circuitry, as well as power to the DC-to-DC isolation converter that powers to the Patient Side (see #2 below). - 2. DC-to-DC Patient Isolation Converter: This converter is a UL2601 compliant DC-to-DC converter, and meets the dielectric withstand and leakage current requirements of the UL2601 standard for Patient Care Equipment with isolated patient leads. This converter supplies all power to patient-applied parts and related circuitry. Each of the direct patient-applied parts have individual current limiters for fault condition. {5}------------------------------------------------ In addition, the Patient Side of the Insight Discovery is isolated from the host PC as follows: - Signals are converted from analog voltages to 16 bit 3. Optically Isolated Data Link: digital values by the analog-to-digital converter (ADC). The digital data is sent to and from the USB of the PC across an optically isolated data link. This optical link is UL2601 compliant, providing the dielectric withstand and low leakage current characteristics specified in UL2601. ## Section 7: Conclusion The Insight Discovery is substantially equivalent to the predicate device. Furthermore, the device is safe and effective for its intended use. {6}------------------------------------------------ Image /page/6/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Fasstech % Intertek Testing Services NA, Inc. 2307 East Aurora Road Unit B7 Twinsburg, Ohio 44087 ATTN: Daniel W. Lehtonen DEPARTMENT OF HEALTH & HUMAN SERVICES AUG 1 6 2007 Re: K063447 Trade/Device Name: Insight Discovery Diagnostic Electromyograph Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic Electromyograph Regulatory Class: Class II Product Code: IKN, HCC Dated: August 2, 2007 Received: August 3, 2007 Dear Mr. Lehtonen: 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 such 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 {7}------------------------------------------------ Page 2 -- Mr. Daniel W. Lehtonen 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. 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark A. Millham Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: Insight Discovery 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 measure Heart Rate To chart patient progress during the course of treatment Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Mudk N. Willians (Division Sign-Off) Division of General, Restorative, and Neurological Devices **510(k) Number** K06344 Page of