(379 days)
- 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
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.
The provided text describes the Insight Millennium III, a non-invasive, multi-modality physiologic monitoring device. However, it does not include information about specific acceptance criteria for its performance (beyond general accuracy specifications) or the studies conducted to prove the device meets these criteria in the context of clinical efficacy or diagnostic accuracy.
The document is a 510(k) Summary, which focuses on establishing substantial equivalence to predicate devices rather than proving new clinical efficacy or diagnostic performance through specific studies with acceptance criteria.
Therefore, the following information is not present in the provided document:
- A table of acceptance criteria and reported device performance related to a clinical study (only general performance specifications are given).
- Sample size used for a test set or data provenance in a study for performance validation.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- Standalone performance study.
- Type of ground truth used (beyond implying the device measures physiological parameters).
- Sample size for training set.
- How ground truth for the training set was established.
What is available in the document regarding "performance" are the device's technical specifications:
1. Table of Acceptance Criteria (Technical Specifications) and Reported Device Performance
| Parameter | Acceptance Criteria (Specification) | Reported Device Performance (Implied by specification) |
|---|---|---|
| EMG | ||
| Calibrated Range | 0.1 - 999 uV | Meets 0.1 - 999 uV |
| Input Bias Current | Less than 2.0 Picoamperes | Meets < 2.0 Picoamperes |
| Differential Input Impedance | Greater than 1,000,000 Megaohms | Meets > 1,000,000 Megaohms |
| Common Mode Rejection | 150 dB | Meets 150 dB |
| Bandwidth | 20-500 Hz (50/60 Hz notch) | Meets 20-500 Hz (50/60 Hz notch) |
| Noise | Less than 0.1 uV (inputs shorted) | Meets < 0.1 uV |
| Detector | Log power detector, 250 mS averaging filter. | Meets log power detector, 250 mS avg. filter. |
| Range of Motion | ||
| Range | 360 degrees | Meets 360 degrees |
| Accuracy | +/- 1 degree nominal | Meets +/- 1 degree nominal |
| Temperature | ||
| Calibrated Range | 55°F - 120°F | Meets 55°F - 120°F |
| Accuracy | +/- 0.2°F nominal | Meets +/- 0.2°F nominal |
| Algometer | ||
| Calibrated Range | 0-100 lbs. | Meets 0-100 lbs. |
| Accuracy | +/- 3% nominal | Meets +/- 3% nominal |
| Heart Rate Sensor | ||
| Output Voltage | 5 - 50 mV, typical at rest | Meets 5 - 50 mV, typical at rest |
| Output Impedance | 1 kΩ, nominal | Meets 1 kΩ, nominal |
The study that proves the device meets the acceptance criteria:
The document is a 510(k) submission, which primarily establishes substantial equivalence to a previously legally marketed device (the Insight Millennium Plus and Medac System/3) rather than demonstrating de novo clinical effectiveness or diagnostic accuracy through new performance studies against specific acceptance criteria.
The "study" cited for regulatory clearance is the comparison of technical specifications and features of the Insight Millennium III to its predicate devices. The submission asserts that the physical and electrical characteristics (performance characteristics) of the Insight Millennium III are equivalent to the Insight Millennium Plus, with the key difference being the addition of a heart rate sensor whose characteristics are equivalent to the Medac System/3 heart rate sensor.
The closest thing to "proving it meets acceptance criteria" for the new heart rate sensor is the assertion that its physical and electrical characteristics are equivalent to the already cleared Medac System/3 heart rate sensor. This implies that the performance parameters of the Medac System/3 heart rate sensor serve as the "acceptance criteria" for the Insight Millennium III's heart rate sensor. However, the document does not elaborate on specific performance studies for this equivalence beyond the comparison of specifications.
In summary, the provided text describes a 510(k) submission focused on substantial equivalence rather than a clinical trial demonstrating performance against predefined acceptance criteria for diagnostic accuracy or clinical efficacy.
{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 | InsightMillennium III | InsightMillennium Plus | Medac System/3 |
|---|---|---|---|
| Four Channels ofsurface EMG | Yes | Yes | N/A |
| Skin | Yes | Yes | N/A |
| Temperaturemeasurement viainfrared thermalscanner | |||
| Range of Motion | Yes | Yes | N/A |
Predicate Device Comparison Chart
{3}------------------------------------------------
K023209 4 6
| Sensor | |||
|---|---|---|---|
| Algometer | Yes | Yes | N/A |
| UL-2601 listedpower supply | Yes | Yes | N/A |
| Heart-ratemeasure using IRPhethsmograph | 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-noisepreamplifiers 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 retardantABS. | |
| 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 cm²One pressure transducer attached to a stiff rod.Enter buttonCase Material: Impact-resistant, Aluminum with3.0" 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 withVelcro) | |
| 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 electrodes1 each inclinometer1 each temperature sensor1 each algometer sensor1 each Heart Rate sensorIsolated USB16 bit, 16 channelNone12V, 500 mA UL-2601 listed power supply.Case Material: Impact resistant, flame retardantABS.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
§ 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).