MYOSYSTEM WITH CUSTOMIZING

K032833 · Otto Bock Healthcare LP · GXY · Sep 23, 2003 · Neurology

Device Facts

• Record ID: K032833
• Device Name: MYOSYSTEM WITH CUSTOMIZING
• Applicant: Otto Bock Healthcare LP
• Product Code: GXY · Neurology
• Decision Date: Sep 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The MyoSystem with Customizing is intended for adult(s) who require an external electric upper extremity system.

Device Story

MyoSystem with Customizing is an adult external electric upper extremity prosthetic system. It allows a Certified Prosthetist Orthotist (CPO) to adjust control parameters of an externally powered prosthesis via a Personal Computer (PC) connected through serial communication. The system monitors patient performance and enables practitioners to modify control programs without physically dismantling the prosthesis to access coding plugs. It utilizes existing components (e.g., electrodes, processors, electric hands/rotators) and provides an alternative to manual dial-based adjustments. The practitioner uses the PC software to optimize prosthesis control based on patient needs, reducing fitting process disruption and fatigue for both patient and practitioner.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

External electric upper extremity prosthetic system. Components include electrodes, processors, electric hands, and wrist rotators. Connectivity via serial communication to a PC for parameter adjustment. Software-based customization replaces manual coding plug changes. System operates on electric power (EnergyPack/Li-Ion battery).

Indications for Use

Indicated for adults requiring an external electric upper extremity prosthetic system.

Regulatory Classification

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.

Predicate Devices

• Otto Bock MyoSystem (Exempt)

Submission Summary (Full Text)

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Otto Bock
HEALTH CARE

K032833

### 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<br>Minneapolis, MN 55447-4467 |
| 3. Telephone: | 763-553-9464 |
| 4. Contact Person: | Bert Harman |

- June 25, 2003 5. Date Prepared:
- 6. Registration Number: 2182293

#### B. Device

2. Trude Name:

3. Common Name:

5. Product Code:

6. Class:

4. Classification Name:

7. Regulation Number:

| 1. Name: | MyoSystem with Customizing |
|----------|----------------------------|
|----------|----------------------------|

- MyoSystem with Customizing
MyoSystem

- MyoSystem with Customizing
### External Limb Prosthetic Component

# C. Identification of Legally Marketed Devices

- 1. Name:
- 2. K Number: Exempt
- 3. Date Cleared: Exempt

#### QUALITY FOR LIFE

North American Headquarters Two Carlson Parkway N., Suite 1 Minneapolis, MN 55447 Phone [phone] Fax [phone]

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 [phone]
Fax [phone]

+ 11 8411

Minnesota Design &
Manufacturing Center
820 Sundial Drive
Waite Park, MN 56387
Phone [phone]
Fax [phone]

ner Satisfaction Hotli 7.08SOIVF

ttobockus.com

1

363

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#### 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

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| 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

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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

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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 [phone] or [phone] 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

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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