(12 days)
Exempt
Not Found
No
The description focuses on PC-based parameter adjustment and monitoring, not AI/ML algorithms for control or analysis.
No
The device is described as an "adult external electric upper extremity system" that allows a CPO to adjust parameters of an external powered upper extremity prosthesis. Its function is to facilitate the adjustment and monitoring of a prosthesis, not to directly treat a disease or condition in a therapeutic manner.
No
The device is an external electric upper extremity system used by a CPO to adjust parameters and monitor performance of a prosthesis, not to diagnose a medical condition.
Yes
The device is described as a "PC Software program" that allows for monitoring and adjustment of parameters for an external powered upper extremity prosthesis. While it interacts with a prosthesis (hardware), the device itself is the software running on a PC, and the description focuses on the software's functionality for parameter adjustment and monitoring.
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 used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The described device is an "Adult External Electric Upper Extremity System" used by a CPO to adjust the control parameters of an external powered upper extremity prosthesis. It interacts with the prosthesis and a PC, not with biological specimens.
- Intended Use: The intended use is to facilitate the fitting and adjustment of a prosthetic limb, not to diagnose or monitor a medical condition through analysis of bodily samples.
Therefore, the function and intended use of this device clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The MyoSystem with Customizing is intended for adult(s) who require an external electric upper extremity system.
Product codes (comma separated list FDA assigned to the subject device)
GXY, IQZ
Device Description
The MyoSystem with Customizing is an adult external electric upper extremity system which allows the CPO to adjust all relevant parameters of the control of an external powered upper extremity prosthesis by a Personal Computer (PC).
The system allows the connection of the control of a prosthesis with a PC by serial communication. A PC Software program allows the monitoring of how the patient performs with the prosthesis and enables the practitioner to change the control parameters according to the patient's needs.
In addition, the practitioner can do the same program changes between control programs of a component as he/she can do by changing a colored coding plug. As it is a much faster process to change a program by the click of a button rather than to dismantle the prosthesis to gain access to the coding plug of a component, there is less disruption in the fitting process. This makes it less tiring for the patient and practitioner.
As this system allows only additional adjustments to the existing adjustment possibilities by dials, there is no program change in the components, The same components which are used by the current conventional adjustment process are used with the adjustment process by CUSTOMIZING.
The MyoSystem with Customizing is composed of the following parts:
MyoBoy (757M10)
MyoBoy, Test adapter, Infrared cable (757P23)
MyoBock System
EnergyPack (757B20)
Li-lon battery charger (757L20)
System Electric Greifer DMC plus (8E33=8X047108)
Electric wrist rotator (10S17)
Ergo arm electronic plus (12K50=50-1)
SensorHand (8E38=5-L7¾)
Transcarpal Hand Digital Twin (8E44=7-L7¾)
Four channel processor II (13E195)
Adjustment cap (13E196)
2 x Myobock-Elektrode 228 (Electrode 60Hz) (13E125=60)
2 x Myobock-Elektrode 392 (Electrode 60Hz) (13E68=60)
Distributor (13E68190)
Battery connection cable (13E188=200)
Coaxial plug (9E169)
3 x Electrode cable for 13E68 (3E48=G800)
Electrode cable for 13E125 (3E129=G1000)
Lamination ring (10S1=50)
Coding Plug set (13E182)
Coupling piece (none)
Battery mounting set (757Z184=1)
MyoCom (757T11)
MyoCom hardware (757T9)
Myo simulator (757T10)
Light wave cable (519K27=430)
Serial port converter (519K28)
PC adaptor (none)
Connection cable MyoCom-MyoBoy (757P37)
Connection cable MyoCom-battery mounting set (757P38)
Battery mounting set for EnergyPack (757B20)
Battery mounting set for EnergyPack (757P21)
Software / Instructions / Manuals / Customizing
Product Component (Revision): Myo Soft (Rev. 1222H, Update Rev. 12222K), Myosoft Customizing (Rev. 1.0, Rev. 2.X), Customizing (Rev. D1 (Beta-review), Rev. 2.0.3, Rev.2.1.1)
Training Instructions Customizing (Powerpoint presentation)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper extremity
Indicated Patient Age Range
Adult(s)
Intended User / Care Setting
CPO (Certified Prosthetist Orthotist), Practitioner
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): 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.
Exempt
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
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).
0
Otto Bock
HEALTH CARE
510(k) SUMMARY of SAFETY and EFFECTIVENESS
A. General Information
| 1. Submitter's Name: | Otto Bock Health Care, LP |
|---|---|
| 2. Address: | Two Carlson Parkway, Suite 100 |
| Minneapolis, MN 55447-4467 | |
| 3. Telephone: | 763-553-9464 |
| 4. Contact Person: | Bert Harman |
- June 25, 2003 5. Date Prepared:
-
- Registration Number: 2182293
B. Device
-
Trude Name:
-
Common Name:
-
Product Code:
-
Class:
-
Classification Name:
-
Regulation Number:
| 1. Name: | MyoSystem with Customizing |
|---|---|
| ---------- | ---------------------------- |
-
MyoSystem with Customizing
MyoSystem -
MyoSystem with Customizing
External Limb Prosthetic Component
C. Identification of Legally Marketed Devices
-
- Name:
-
- K Number: Exempt
-
- Date Cleared: Exempt
QUALITY FOR LIFE
North American Headquarters Two Carlson Parkway N., Suite 1 Minneapolis, MN 55447 Phone 1.800.328.4058 Fax 1.800.655.4963
14630 28ª Avenue North Minneapolis, MN 55447 nc 1.800.328.4058
Avenue North, Suite anolis MN 55447 1.800.795.8841
00 3 200 254 50
Ohio Area Fabrication Center
84 Westpark Road
Centerville, OH 45459
Phone 1.937.432.0082
Fax 1.937.432.0087
- 11 8411
Minnesota Design &
Manufacturing Center
820 Sundial Drive
Waite Park, MN 56387
Phone 1.800.688.4832
Fax 1.320.251.0110
ner Satisfaction Hotli 7.08SOIVF
ttobockus.com
1
363
1
D. Description of the Device
The MyoSystem with Customizing is an adult external electric upper extremity system which allows the CPO to adjust all relevant parameters of the control of an external powered upper extremity prosthesis by a Personal Computer (PC).
The system allows the connection of the control of a prosthesis with a PC by serial communication. A PC Software program allows the monitoring of how the patient performs with the prosthesis and enables the practitioner to change the control parameters according to the patient's needs.
In addition, the practitioner can do the same program changes between control programs of a component as he/she can do by changing a colored coding plug. As it is a much faster process to change a program by the click of a button rather than to dismantle the prosthesis to gain access to the coding plug of a component, there is less disruption in the fitting process. This makes it less tiring for the patient and practitioner.
As this system allows only additional adjustments to the existing adjustment possibilities by dials, there is no program change in the components, The same components which are used by the current conventional adjustment process are used with the adjustment process by CUSTOMIZING.
| The MyoSystem with Customizing is composed of the following parts: | |
|---|---|
| MyoBoy | 757M10 |
| MyoBoy, Test adapter, Infrared cable | 757P23 |
| MyoBock System | |
| EnergyPack | 757B20 |
| Li-lon battery charger | 757L20 |
| System Electric Greifer DMC plus | 8E33=8X047108 |
| Electric wrist rotator | 10S17 |
| Ergo arm electronic plus | 12K50=50-1 |
| SensorHand | 8E38=5-L7¾ |
| Transcarpal Hand Digital Twin | 8E44=7-L7¾ |
| Four channel processor II | 13E195 |
| Adjustment cap | 13E196 |
| 2 x Myobock-Elektrode 228 (Electrode 60Hz) | 13E125=60 |
| 2 x Myobock-Elektrode 392 (Electrode 60Hz) | 13E68=60 |
| Distributor | 13E68190 |
| Battery connection cable | 13E188=200 |
| Coaxial plug | 9E169 |
2
2
| 3 x Electrode cable for 13E68 | 3E48=G800 |
|---|---|
| Electrode cable for 13E125 | 3E129=G1000 |
| Lamination ring | 10S1=50 |
| Coding Plug set | 13E182 |
| Coupling piece | none |
| Battery mounting set | 757Z184=1 |
| MyoCom | 757T11 |
| MyoCom hardware | 757T9 |
| Myo simulator | 757T10 |
| Light wave cable | 519K27=430 |
| Serial port converter | 519K28 |
| PC adaptor | none |
| Connection cable MyoCom-MyoBoy | 757P37 |
| Connection cable MyoCom-battery mounting set | 757P38 |
| Battery mounting set for EnergyPack | 757B20 |
| Battery mounting set for EnergyPack | 757P21 |
| Software / Instructions / Manuals / Customizing | |
| Product Component | Revision |
| Myo Soft | Rev. 1222H, Update |
| Rev. 12222K | |
| Myosoft Customizing | Rev. 1.0, Rev. 2.X |
| Customizing | Rev. D1 (Beta-review) |
| Rev. 2.0.3, Rev.2.1.1 | |
| Training Instructions Customizing |
(Powerpoint presentation)
E. Intended Use Statement
The MyoSystem with Customizing is intended for adult(s) who require an external electric upper extremity system.
F. Technological Characteristics Summary
The MyoSystem with Customizing is substantially equivalent to Otto Bock's MyoSystem, a Class I Exempt Device according to 21 CFR Price 890.3420.
Differences that exist between these devices, relating to technical specifications, physical appearance and design, do not affect the relative safety and effectiveness of the MyoSystem with Customizing.
કુદર્ડ
3
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings outstretched, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN -3 2010
Otto Block Health Care, LP % Mr. Bert Herman 2 Carlson Pkwy. Suite 100 Minneapolis, Minnesota 55447
Re: K032833
Trade/Device Name: Myosystem with Customizing Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY, IQZ Dated: June 25, 2003 Received: September 11, 2003
Dear Mr. Herman:
This letter corrects our substantially equivalent letter of September 23, 2003.
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 (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 additional controls. Existing major regulations affecting your device (1 n 1 e 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 aft 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 liating (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 - Mr. Bert Herman
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.
Sincerely yours.
Sincerely yours,
Barbace Buehnd
Mark N. Me Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
5
K032833 510(k) Number:
Device Name: MyoSystem with Customizing
Indications for Use:
- Adult External Electric Upper Extremity System ●
PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
OR
OVER-THE-COUNTER USE (optional Form 1-2-96)
Division Sign-Off
(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K032833