(219 days)
Not Found
No
The description focuses on electromechanical amplification based on detected EMG signals, with no mention of AI or ML algorithms for signal processing or control.
Yes.
The device facilitates stroke rehabilitation by muscle re-education and maintaining or increasing range of motion as part of prescribed physical therapy.
No
The Myomo e100 is described as an electromechanically powered device to facilitate movement and increase range of motion for stroke patients, and it uses detected EMG as an indication of residual muscle strength to amplify movement. It is used as part of physical therapy, and progress is monitored through other conventional evaluation techniques like goniometers or Fugl-Meyer testing. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly states it is an "electromechanically powered device" and lists hardware components such as a brace, EMG sensors, and a control user interface with a motor mechanism.
Based on the provided information, the Myomo e100 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Myomo e100 Function: The Myomo e100 is an electromechanically powered device that assists with physical movement and range of motion for stroke patients during rehabilitation. It uses EMG signals from the patient's muscles to amplify their strength and facilitate exercise.
- No Specimen Analysis: The device does not analyze any biological specimens taken from the patient. It interacts directly with the patient's body to provide physical assistance.
Therefore, the Myomo e100 falls under the category of a physical therapy or rehabilitation device, not an IVD.
N/A
Intended Use / Indications for Use
The Myomo e100 is indicated for use by stroke patients undergoing rehabilitation to facilitate the following:
- Stroke rehabilitation by muscle re-education
- Maintaining or increasing range of motion
Product codes
OAL, BXB, IOY
Device Description
The Myomo e100 is an electromechanically powered device intended to facilitate movement and increase range of motion for stroke patients. This device would be included as part of prescribed physical therapy to enable stroke patients to exercise that would otherwise be unable to independently do so. The Myomo e100 is an automatic strength amplifier using the detected electromyograph (EMG) as an indication of residual muscle strength. In the case of a patient who is unable to move his/her arm, the addition of strength amplification allows him/her to perform standard physical therapy exercises.
The Myomo e100 is available in left and right arm configurations. Foam pad inserts of various shapes are provided for fitting the brace for individual patients. Placement of the EMG sensors is configured for the individual patient allowing placement on either the tricep or bicep depending on the prescribed exercise. Optional adjustments for bicep and tricep gain are set and stored as part of the customization.
Adjustable straps are used to attach the brace to the arm. Once the brace is properly fitted to the arm the Myomo e100 is turned on using the "Control User Interface". The EMG signals are calibrated in the resting position and then the brace is ready for operation. The battery pack attaches to the "Control User Interface" and is not in contact with the patient.
The Myomo e100 consists of three main elements:
- Brace: provides support for the forearm during lift.
- EMG Sensors: B & L Electrodes
- Control User Interface: provides the signal processing function and the motor mechanism and controls for operation of the Myomo e100.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arm (forearm, tricep, bicep)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescribing health care provider
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)
Neither bench, animal nor clinical testing were assessed.
Design verification and design validation, e.g., bench testing was performed according to FDA's Design Control Requirements, Title 21 Code of Federal Regulations, Part 820.30.
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
Premarket Notification 510(k) Summary
- 1 Submitter Information
- Company Name and Address: 1.3
APR 1 2 2007
Myomo Incorporated 529 Main Street, Suite 205 Charlestown, MA 02129
-
1.4 Contact Name:
Kate Zebrose , Vice President, Product Development Phone: 617-996-9058 Fax: 617-886-0333 -
1 .5 Date Prepared: April 11, 2007
-
2 Name of Device
Trade Name: Myomo e100
Common Name: Active Elbow Brace
Classification Name:
890.1375, EMG-triggered powered exercise equipment OAL 890.5380, Powered Exercise Equipment, applicable product code BXB 890.3475, Limb Orthosis, applicable product code IOY
-
3 Substantial Equivalence Claimed to Predicate Devices
Kinetec 6080 CPM for Elbow, Class I Biomove 3000, Class II - K042650, cleared January 27, 2005 Boston Digital Arm System, Class I -
4 Device Description
The Myomo e100 is an electromechanically powered device intended to facilitate movement and increase range of motion for stroke patients. This device would be included as part of prescribed physical therapy to enable stroke patients to exercise that would otherwise be unable to independently do so. The Myomo e100 is an automatic strength amplifier using the detected electromyograph (EMG) as an indication of residual muscle strength. In the case of a patient who is unable to move his/her arm, the addition of strength amplification allows him/her to perform standard physical therapy exercises.
Premarket Notification 510(k) Summary
1
The Myomo e100 is available in left and right arm configurations. Foam pad inserts of various shapes are provided for fitting the brace for individual patients. Placement of the EMG sensors is configured for the individual patient allowing placement on either the tricep or bicep depending on the prescribed exercise. Optional adjustments for bicep and tricep gain are set and stored as part of the customization.
As pictured in Figure 1, adjustable straps are used to attach the brace to the arm. Once the brace is properly fitted to the arm the Myomo e100 is turned on using the "Control User Interface". The EMG signals are calibrated in the resting position and then the brace is ready for operation. The battery pack attaches to the "Control User Interface" and is not in contact with the patient.
The prescribing health care provider incorporates use of the Myomo e100 as part of a patient's physical therapy regimen. Progress can be monitored through the prescribed therapy using a goniometer, Fugl-Meyer testing, or other conventional evaluation techniques.
The Myomo e100 consists of three main elements:
- Brace: provides support for the forearm during lift. 4.1
- 4.2 EMG Sensors: B & L Electrodes
- Control User Interface: provides the signal processing function and the motor 4.3 mechanism and controls for operation of the Myomo e100.
5 Intended Use
The Myomo e100 is indicated for use by stroke patients undergoing rehabilitation to facilitate the following:
- . Stroke rehabilitation by muscle re-education
- Maintaining or increasing range of motion .
Predicate Device Comparison of Indications for Use / Intended Use and Technical б Characteristics
The comparison of the Myomo e100 was based on a review of the Design Control documentation for the device, relevant aspects of which are included in the company's 510(k) Premarket Notification, and information concerning the predicate devices that was available to the company via the FDA web site or those of the respective companies. The comparison considered technical characteristics and the indications for use / intended use. Neither bench, animal nor clinical testing were assessed.
2
7 Performance Data
-
7.1 Performance Standards (Section 514 Compliance): No performance standards applicable to this device under the following product codes have been adopted under Section 514 of the Food Drug and Cosmetic Act: 890.5380, Powered Exercise Equipment, and 890.3475, Limb Orthosis.
Title 21 CFR Part 898 Performance Standard for Electrode Lead is applicable to this device under the product code: 890.1375, Diagnostic Electromyography and is demonstrated by conformity to IEC 60601-1-1 as indicated below. -
7.2 FDA Recognized Standards: The Myomo e100 conforms to the following.
- Thermal, Electrical and Mechanical Safety: IEC 60601-1-1, Medical 7.2.1 Electrical Equipment - Part 1: General Requirements for Safety 1: Collateral Standard: Safety Requirements for Medical Electrical Systems
- 7.2.2 Electromagnetic Compatibility: IEC 60601-1-2, Medical Electrical Equipment - Part 1: General Requirements for Safety 2: Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- 7.2.3 Software
FDA's "Reviewer Guidance for the Content of Premarket Submission for Software Contained in Medical Devices", May 11, 2005
FDA's "Guidance for Off-The-Shelf Software Use in Medical Devices"
- 7.2.4 Risk Analysis: ISO 14971:2000, Application of risk management to medical devices
- Biocompatibility: ISO 10993-1:2003, Biological evaluation of 7.2.5 medical devices
- Performance Testing: Design verification and design validation, e.g., bench 7.3 testing was performed according to FDA's Design Control Requirements, Title 21 Code of Federal Regulations, Part 820.30.
- 8 Conclusion:
The information and data provided in this 510(k) Premarket Notification establish
3
that the Myomo e100 is substantially equivalent to the afore-mentioned predicate devices with respect to indications for use/intended use, and technical characteristics.
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:
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. . . .
Premarket Notification 510(k) Summary
.
.
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract emblem that resembles an eagle or other bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Myomo, Inc. % Ms. Kate Zebrose Vice President, Product Development The Schrafft Center 529 Main Street, Suite 205 Boston, MA 02129
APR 1 2 2007
Re: K062631
Trade Name: Myomo e 100 Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic electromyograph Regulatory Class: II Product Code: OAL Dated: January 11, 2007 Received: January 12, 2007
Dear Ms. Zebrose:
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.
5
Page 2 - Ms. Kate Zebrose
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,
for
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
6
ODE Indications Statement
510(k) Number (if known): K062631
Device Name: Myomo e100
Indications for Use:
The Myomo e100 is indicated for use by stroke patients u ng rehabilitation to facilitate the following: (Division Sign-Off)
- Stroke rehabilitation by muscle re-education Division of General, Restorative, .
- Maintaining or increasing range of motion 포
Prescription Use: _ X ________________________________________________________________________________________________________________________________________________________
AND/OR
(Part 21 CFR 801 Subpart D)
To C26561 510(k) Number (21 CFR 807 Subpart C).
and Neurological Devices
Over-the-Counter Use: