(65 days)
Not Found
No
The summary describes standard EMG measurement and data display/analysis software without mentioning any AI/ML techniques.
No
The device is described as a "physiologic monitoring device" used to measure and analyze surface EMG, chart patient progress, and collect and store data. It does not provide any therapeutic intervention.
Yes
The device measures bilateral differences in surface EMG and surface EMG during functional tasks to chart patient progress during the course of treatment. This process of measuring physiological data to monitor and analyze a patient's condition falls under the definition of a diagnostic device, which is used for the diagnosis, prevention, or monitoring of diseases or conditions.
No
The device description explicitly states that the Insight Genesis includes hardware components: an instrument console and two surface EMG sensors. The software is described as interacting with and displaying data from this hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Insight Genesis measures surface EMG (electromyography), which is a non-invasive technique that measures the electrical activity of muscles. This is done by placing sensors on the skin, not by analyzing samples taken from the body.
- Intended Use: The intended uses described (measuring bilateral differences, measuring during functional tasks, charting progress) are all related to assessing muscle function directly on the patient, not through laboratory analysis of biological samples.
Therefore, the Insight Genesis falls under the category of a physiologic monitoring device rather than an in vitro diagnostic device.
N/A
Intended Use / 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
Product codes
HCC
Device Description
The Insight Genesis is a non-invasive, single-modality physiologic monitoring device. The Insight 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 will plug directly into the UL2601 listed wall mounted power supply. The Instrument Console is powered from a computer (IBM compatible) via an isolated serial port connection.
Software: The Insight Genesis software displays real-time surface EMG, allowing the user to ensure that readings are stable prior to data collection. The Insight Genesis software allows the user to: (1) view real-time surface EMG, (2) collect surface EMG, (3) review surface EMG, and (4) print out reports.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5050 Biofeedback device.
(a)
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.(b)
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.
0
AUG 3 0 2001
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
Page 1/4
3 GO / MOD
5K2
**1**
#### 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.
**2**
#### 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](https://510k.innolitics.com/search/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](https://510k.innolitics.com/search/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
Page 3/4
**3**
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.
Page 4/4
**4**
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles suggesting community and support. The text is arranged in a circular pattern around the symbol.
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](https://510k.innolitics.com/search/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.
**5**
## 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
**6**
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