(169 days)
K951770, N/A
Not Found
No
The description focuses on electromechanical components, visual feedback, and data collection for therapist review, with no mention of AI or ML algorithms for analysis, decision-making, or adaptive therapy.
Yes.
The device is used for rehabilitative exercise therapy to measure, evaluate, exercise, re-educate, and strengthen muscles, increase joint range of motion, and provide muscle relaxation through vibration, which aligns with the definition of a therapeutic device.
Yes
The device measures, evaluates, and tests a patient's active range-of-motion and strength, providing data to determine baseline status and monitor changes in rehabilitation. These functions directly correspond to diagnostic activities.
No
The device description explicitly states it is an "electromechanical physical therapy device" that combines "3 motion assemblies," "5 therapeutic vibrators," and a "visual feedback unit," all contained in one device. This indicates the presence of significant hardware components beyond just software.
Based on the provided information, the AMES Therapy Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- AMES Therapy Device Function: The AMES Therapy Device is a physical therapy device that interacts directly with the patient's body (limbs) for rehabilitation purposes. It measures physical parameters like range of motion and strength through mechanical interaction, not by analyzing biological samples.
- Intended Use: The intended use clearly describes a rehabilitative exercise therapy device, not a diagnostic test performed on biological specimens.
- Device Description: The description details electromechanical components, motion assemblies, vibrators, and visual feedback, all related to physical therapy and measurement of physical performance. There is no mention of handling or analyzing biological samples.
Therefore, the AMES Therapy Device falls under the category of a physical therapy or rehabilitation device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AMES Therapy Device is a rehabilitative exercise therapy device that uses assisted movement to measure, evaluate, exercise, re-educate and strengthen muscles, and to increase joint range of motion. It also uses muscle vibration for muscle relaxation.
Product codes (comma separated list FDA assigned to the subject device)
IKK, IRO
Device Description
The AMES Therapy Device is an electromechanical physical therapy device that combines 3 motion assemblies (one for the ankle, one for the wrist, and one for the thumb-and-fingers), 5 therapeutic vibrators, and a visual feedback unit, all contained in one device. The patient is seated in a separate conventional chair or wheelchair so that the appropriate limb can be attached to the AMES Therapy Device for therapy.
The AMES Therapy Device includes assisted movement to the limb being treated and applies simultaneous vibration to the antagonist muscle. The device provides visual feedback to the patient to indicate whether he/she is producing the requisite force (torque) in assisting the device's motion and encourages the patient to keep working the agonist muscle. The feedback also includes a force (torque) "target," set to a level by the the patient can achieve repeatedly during therapy without becoming too fatigued, but that is also moderately challenging. The torque produced by the patient is indicated on the video touch screen.
Testing and reporting on the patient's therapy and functional status can be performed at each therapy session prior to or following administration of therapy. Data for each session include therapy delivery (date, duration, performance) and test results. Two tests are carried out during the treatment session to measure: 1) active range-of-motion, and 2) strength. These test scores permit the therapist: (i) to determine each patient's baseline status at the time that the patient first receives the AMES therapy, and (ii) to monitor changes in rehabilitation status during the course of the patient's therapy. This testing enables therapists to modify the treatment regimen in response to observed improvements and to determine when is no longer benefiting from the therapy.
The AMES Therapy Device is non-invasive and there is no electrical stimulation involved in the device, nor any recording of bioelectric potentials. No heat is applied by the AMES Therapy Device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, wrist, thumb-and-fingers (limbs)
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)
Non-clinical testing showed that the AMES device performs as designed. Based on the information presented in this submission, we believe that the AMES Therapy Device is substantially equivalent to the predicate devices in intended use, indications for use, and device function and features.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K951770, N/A
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.1925 Isokinetic testing and evaluation system.
(a)
Identification. An isokinetic testing and evaluation system is a rehabilitative exercise device intended for medical purposes, such as to measure, evaluate, and increase the strength of muscles and the range of motion of joints.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
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AMES Therapy Device, K123746/S001 Response to Request for Additional Information
510(k) SUMMARY
1. Contact Information
| Submitter's name: | AMES Technology, Inc.
657 SW Regency Place
Portland, OR 97225 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Contact name and address: | Sheila Ramerman, RAC
SJR Associates
927 Throne Dr.
Eugene, OR 97402
PH/FAX: 541.683.3017
Email: sramerman@aol.com |
| Date summary prepared: | May 17, 2013 |
2. Device names:
·
| Proprietary name | Common name | Classification names |
|---|---|---|
| AMES Therapy Device | Electromechanical physical therapy | |
| device | Isokinetic Testing & | |
| Evaluation Device | ||
| Therapeutic Vibrator |
Device Classification:
| Classification Name | Product Code | 21 CFR citation | Class | Panel |
|---|---|---|---|---|
| Isokinetic Testing & | ||||
| Evaluation | ||||
| Device | IKK | 890.1925 | II | Physical Medicine |
| Therapeutic Vibrator | IRO | 890.5975 | I | Physical Medicine |
3. Predicate Devices:
The AMES Therapy Device is a combination of the intended use, functions, and features of the following currently marketed physical therapy devices:
| 510(k) Number | Product Code,
Class | Trade Name | Manufacturer |
|--------------------------------|------------------------|-------------|-----------------------------------------------------------|
| K951770
(now 510(k)-exempt) | IKK
Class II | System 4 | Biodex Medical Systems, Inc. |
| N/A
(510(k)-exempt) | IRO
Class I | Vibracussor | Innovative Machinery
Packaging and Converting,
Inc. |
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4. Device Description:
The AMES Therapy Device is an electromechanical physical therapy device that combines 3 motion assemblies (one for the ankle, one for the wrist, and one for the thumb-and-fingers), 5 therapeutic vibrators, and a visual feedback unit, all contained in one device. The patient is seated in a separate conventional chair or wheelchair so that the appropriate limb can be attached to the AMES Therapy Device for therapy.
The AMES Therapy Device includes assisted movement to the limb being treated and applies simultaneous vibration to the antagonist muscle. The device provides visual feedback to the patient to indicate whether he/she is producing the requisite force (torque) in assisting the device's motion and encourages the patient to keep working the agonist muscle. The feedback also includes a force (torque) "target," set to a level by the the patient can achieve repeatedly during therapy without becoming too fatigued, but that is also moderately challenging. The torque produced by the patient is indicated on the video touch screen.
Testing and reporting on the patient's therapy and functional status can be performed at each therapy session prior to or following administration of therapy. Data for each session include therapy delivery (date, duration, performance) and test results. Two tests are carried out during the treatment session to measure: 1) active range-of-motion, and 2) strength. These test scores permit the therapist: (i) to determine each patient's baseline status at the time that the patient first receives the AMES therapy, and (ii) to monitor changes in rehabilitation status during the course of the patient's therapy. This testing enables therapists to modify the treatment regimen in response to observed improvements and to determine when is no longer benefitting from the therapy.
The AMES Therapy Device is non-invasive and there is no electrical stimulation involved in the device, nor any recording of bioelectric potentials. No heat is applied by the AMES Therapy Device.
5. Intended Use/Indications for Use:
The AMES Therapy Device is a rehabilitative exercise therapy device that uses assisted movement to measure, evaluate, exercise, re-educate and strengthen muscles, and to increase joint range of motion. It also uses muscle vibration for muscle relaxation.
6. Comparison with the Predicate Devices:
Because the AMES Therapy Device combines the functions and characteristics of different physical therapy devices, multiple predicate devices are presented. Like the System 4 device, the AMES Device is intended to exercise, measure, evaluate and increase the strength of muscles and increase the Range of Motion (ROM) of joints. Like the Vibracussor device, the AMES Device is intended to relax muscles using vibration. The AMES Therapy Device uses isokinetic principles like the System 4 device to deliver therapy, and uses vibration like the Vibracussor device to deliver therapy to relax muscles. Based on these comparisons, the AMES Therapy Device is substantially equivalent to the predicate devices in intended use, indications for use, and device function and features.
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2
7. Non-Clinical Testing:
Testing has been conducted to UL 60601-1 Standard for Safety for Medical Electrical Equipment, Part 1: General Requirements for Safety and IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements for Safety: Electromagnetic Compatibility - Requirements and Tests.
Biocompatibility testing for patient-contacting materials is included that demonstrates that the patient-contacting materials are not irritating, sensitizing, or cytotoxic.
Design verification testing was performed on fully functional AMES Therapy Devices to demonstrate that the AMES device performed as designed and met its specifications.
8. Clinical Testing:
Safety data from clinical evaluations of the AMES Therapy Device were used to evaluate the safety of the device with respect to skin integrity.
9. Conclusions:
Non-clinical testing showed that the AMES device performs as designed. Based on the information presented in this submission, we believe that the AMES Therapy Device is substantially equivalent to the predicate devices in intended use, indications for use, and device function and features.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Public Health Service
May 24,2013
AMES Technology, Inc. C/O Ms. Sheila Ramerman. RAC SJR Associates 927 Thorne Drive Eugene, Oregon 97402
Re: K123746
Trade Name: AMES Therapy Device Regulation Number: 21 CFR 890.1925 Regulation Name: Isokinetic Testing and Evaluation Device Regulatory Class: Class II Product Code: IKK, IRO Dated: April 25, 2013 Received: April 26, 2013
Dear Ms. Ramerman:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Sheila Ramerman
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to: http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to:
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address: http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
https://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _ K123746
Device Name:
Indications For Use:
The AMES Therapy Device is a rehabilitative exercise therapy device that uses assisted movement to measure, evaluate, exercise, re-educate and strengthen muscles, and to increase joint range of motion. It also uses muscle vibration for muscle relaxation.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joyce M. Whang
(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number __ K123746
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