(379 days)
No
The summary describes a multi-modality physiological monitoring device with various sensors. There is no mention of AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms. The device appears to be a data acquisition and charting tool.
No
The device is described as a "physiologic monitoring device" used to measure various bodily functions and chart patient progress. Its intended uses are focused on measurement and monitoring rather than providing treatment or therapy.
No
The device is a physiologic monitoring device used to measure and chart patient progress, but not to diagnose conditions.
No
The device description explicitly lists five different sensor types (surface EMG, infrared temperature sensor, inclinometer, algometer, and heart rate sensor) which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The Insight Millennium III measures physiological parameters directly from the patient's body (surface EMG, skin temperature, range of motion, pressure sensitivity, heart rate). It does not analyze specimens in vitro.
- Intended Use: The intended uses listed are all related to monitoring physiological responses and patient progress, not analyzing biological samples.
Therefore, the Insight Millennium III falls under the category of a non-invasive physiological monitoring device, not an IVD.
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 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
Product codes
IKN, HCC
Device Description
The Insight Millennium III is a non-invasive, multi-modality physiologic monitoring device. The Insight Millennium III contains the following five 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, (4) algometer used to measure patient self-reported pressure sensitivity, and (5) heart rate sensor to measure heart rate.
Hardware: The Insight Millennium III hardware consists of an instrument console and five different sensor types. All five sensor types plug directly into the front panel of the Insight Instrument Console. The Insight Millennium III 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 Millennium III 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 Millennium software allows the user to: (1) enter patient information, (2) record surface EMG, spinal Range of Motion, skin temperature, pressure and heart readings, (3) graph surface EMG, spinal Range of Motion, skin temperature, pressure and heart rate readings, 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, Joints and muscles
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
§ 890.1375 Diagnostic electromyograph.
(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).
0
OCT 1 0 2003
Insight Millennium III
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
(023209
116
ubinasovva
Submitted on:
September 25, 2002
1
K023209 2/6
.
ﺍﻟﺘﻨﺎﻭﻳﺔ
Section 1: Device Name
Common or Usual Name: Electromyograph, Diagnostic Proprietary Model Name: Insight Millennium III
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 ■
- 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 ■
- 트 To measure Heart Rate
- 1 To chart patient progress during the course of treatment
Device Description Section 3:
The Insight Millennium III is a non-invasive, multi-modality physiologic monitoring device. The Insight Millennium III contains the following five 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, (4) algometer used to measure patient self-reported pressure sensitivity, and (5) heart rate sensor to measure heart rate.
Hardware
The Insight Millennium III hardware consists of an instrument console and five different sensor types. All five sensor types plug directly into the front panel of the Insight Instrument Console. The Insight Millennium III 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 Millennium III 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 Millennium software allows the user to: (1) enter patient information, (2) record surface EMG, spinal Range of Motion, skin temperature, pressure and heart readings, (3) graph surface EMG, spinal Range of Motion, skin temperature, pressure and heart rate readings, and (4) print out reports.
2
Section 4: Predicate Device
This section documents the substantial equivalence of the Insight Millennium III to legally marketed devices. Specifically, this section documents the substantial equivalence of Insight Millennium III to the following three products:
| Manufacturer | Predicate Device Name | 510(k) Number |
|---|---|---|
| Insight Millennium Plus | Fasstech | K011964 |
| Medac System/3 | Davicon | K914925 |
The Insight Millennium III is equivalent to these legally marketed devices in the following ways:
- l The physical characteristics and electrical characteristics (performance characteristics) of the Insight Millennium III are equivalent to the Insight Millennium Plus. The only difference is the addition of a fifth sensor type, the Insight Heart Rate Sensor.
- . The physical characteristics and electrical characteristics (performance characteristics) of the Insight Millennium Heart Rate Sensor is equivalent to the Medac System/3 heart rate sensor
The Insight Millennium III differs from these legally marketed devices in the following ways:
-
. The device types listed above have been combined for reasons of user convenience,
This section documents the substantial equivalence of the Insight Millennium III to legally marketed devices. The Insight Millennium III is a modest expansion of the Insight Millennium Plus, a device that we have previously registered with FDA. The Insight Millennium III differs from the Insight Millennium Plus in the following manner: -
- Hardware: Addition of a new sensor, The Insight Heart Rate Sensor. The Insight Millennium III Instrument Console is identical to that of the Insight Millennium Plus Console, including patient isolation and PC connection.
-
- Software: The Insight Millennium III software is extended to include the Insight Heart Rate Sensor.
| Feature | Insight
Millennium III | Insight
Millennium Plus | Medac System/3 |
|---------------------------------------------------------------|---------------------------|----------------------------|----------------|
| Four Channels of
surface EMG | Yes | Yes | N/A |
| Skin | Yes | Yes | N/A |
| Temperature
measurement via
infrared thermal
scanner | | | |
| Range of Motion | Yes | Yes | N/A |
Predicate Device Comparison Chart
3
K023209 4 6
| Sensor | |||
|---|---|---|---|
| Algometer | Yes | Yes | N/A |
| UL-2601 listed | |||
| power supply | Yes | Yes | N/A |
| Heart-rate | |||
| measure using IR | |||
| Phethsmograph | Yes | N/A | Yes |
Section 5: Performance Specification
The Insight Millennium III specifications are summarized below:
EMG
| EMG | Electrodes: | 4 ea. Smart Sensors with low-noise
preamplifiers integral to electrode assemblies |
|-----------------|-------------------------------|--------------------------------------------------------------------------------------|
| | Calibrated Range: | 0.1 - 999 uV |
| | Input Bias Current: | Less than 2.0 Picoamperes |
| | Differential Input Impedance: | Greater than 1,000,000 Megaohms |
| | Common Mode Rejection: | 150 dB |
| | Bandwidth: | 20-500 Hz (50/60 Hz notch) |
| | Noise: | Less than 0.1 uV (inputs shorted) |
| | Detector: | Log power detector, 250 mS averaging filter. |
| | Controls: | None |
| Range of Motion | | |
| | Range: | 360 degrees |
| | Accuracy: | +/- 1 degree nominal |
| | Controls: | Enter and Skip Buttons |
| | Physical: | Case Material: Impact resistant, flame retardant
ABS. |
| | | 3.4"H x 3.5"W x 1.25"D. Weight 6.5 oz. |
| Temperature | | |
| | Calibrated Range: | 55°F - 120°F |
| | Accuracy: | +0.2°F nominal |
| | Sensors: | Two thermopile, fixed 2.5" apart (center-to-
center) |
| | Controls: | Enter button |
| | Physical: | Case Material: Impact-resistant, Aluminum with |
| | | 0.5" ABS Plastic Outer Ring. |
| | Size: | 5.5"L x 3.5"W x 2.5"H. Weight 15 oz. |
| Algometer | | |
| | Calibrated Range: | 0-100 lbs. |
| | Accuracy: | +3% nominal |
510(k) Summary Fasstech Insight Millennium III
4
K023209 5/6
| | Contact Area:
Sensor:
Controls:
Physical:
Size: | 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. |
|--------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Heart Rate Sensor | | |
| | Sensor Type | IR Plethsmograph (attached to finger with
Velcro) |
| | Output Voltage: | 5 - 50 mV, typical at rest |
| | Output Impedance: | 1 kΩ, nominal |
| | Weight: | 28 grams |
| | Sensor Size: | 15 x 15 x6.3 mm |
| Instrument Console | | |
| | Inputs:
Output:
A/D converter:
Controls:
Power:
Physical: | 4 each EMG electrodes
1 each inclinometer
1 each temperature sensor
1 each algometer sensor
1 each Heart Rate sensor
Isolated USB
16 bit, 16 channel
None
12V, 500 mA UL-2601 listed power supply.
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 Millennium III patient isolation is assured by the following two electrical isolation barriers:
-
Medical-Grade Universal Power Supply: This device is a UL2601 compliant AC line to 1. 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 IEC 60320 fused input module.
This supply provides low-level isolated power to the Non-Patient Side of the Insight Millennium III circuitry, as well as power to the DC-to-DC isolation converter that powers to the Patient Side (see #2 below). -
DC-to-DC Patient Isolation Converter is a UL2601 compliant DC-to-DC 2. converter, and meets the dielectric withstand and leakage current requirements of the UL2601 standard for Patient Care Equipment with isolated patient leads.
5
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.
In addition, the Patient Side of the Insight Millennium III is isolated from the host PC as follows:
- Signals are converted from analog voltages to 16 bit Optically Isolated Data Link: 3. 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 Millennium III is substantially equivalent to the predicate devices. Furthermore, the device is safe and effective for its intended use.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 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 image of an eagle with its wings spread.
OCT 1 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Lee Brody Chief Operating Officer Fasstech 76 Treble Cove Road, Bldg. #2 North Billerica, Massachusetts 01862
Re: K023209
Trade/Device Name: Insight Millennium III Regulation Number: 21 CFR 890.1375, 882.5050 Regulation Name: Diagnostic electromyography, Biofeedback device Regulatory Class: II Product Code: IKN, HCC Dated: September 5, 2003 Received: September 9, 2003
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 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 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.
7
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), please contact the Office of Compliance at (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
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
8
Page
510(k) Number (if known):
Device Name: ____Insight Millennium III
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 nange 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
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number