PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-3)

K991090 · Dynamic Systems, Inc. · ITI · Sep 24, 1999 · Physical Medicine

Device Facts

• Record ID: K991090
• Device Name: PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-3)
• Applicant: Dynamic Systems, Inc.
• Product Code: ITI · Physical Medicine
• Decision Date: Sep 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2

Indications for Use

The Peachtree Proportional Head Control model PHC-3 is intended to offer persons restricted to a seated position the ability to operate a powered wheelchair by three different methods. The first is a non-contact, fully proportional head movement commanded driving control. The next is controlled by a series of blowing and inhaling into a straw. This allows for four way directional control of the wheelchair. The last driving method uses a combination of the two previous drive controls. The user would tilt their had laterally to move the wheelchair left or right and blow or inhale into the straw to control forward/reverse direction/speed. At current the PHC-3 has only been made to be compatible with Invacare's MKIV series of electronics and Dynamic Controls DX series of electronics.

Device Story

PHC-3 is a proportional head control unit for powered wheelchairs; enables mobility for users restricted to seated positions. Inputs: head movement (non-contact) and/or sip-and-puff (blowing/inhaling into straw). Operation: translates physical head tilts or pneumatic pressure changes into directional/speed commands for wheelchair electronics. Output: electrical signals compatible with Invacare MKIV or Dynamic Controls DX series electronics. Used by patients in clinical or home settings. Benefits: provides independent mobility for individuals with limited motor function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Proportional head control unit; non-contact movement sensing and pneumatic sip-and-puff interface. Compatible with Invacare MKIV and Dynamic Controls DX electronic systems. Standalone control module.

Indications for Use

Indicated for persons restricted to a seated position requiring powered wheelchair mobility assistance via head movement or sip-and-puff control.

Regulatory Classification

Identification

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Predicate Devices

• Peachtree Head Control PHC-2 (K972147)
• ASL Model #104 (K914737)
• Invacare model MCC-MKIV Micro (Sip & Puff and R.I.M.) (K940972)
• Invacare Model #1555 Remote Joystick (K880364)

Submission Summary (Full Text)

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SEP 2 4 1999

K991070

#### 510(k) SUMMARY

Dynamic Systems, Inc.'s PHC-3

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Dynamic Systems, Inc. 5002 North Royal Atlanta Drive, Suite P Tucker, GA 30084 Phone: [phone] Facsimile: 770 939-7722

Contact Person: David R. Court

Date Prepared: September 15, 1998

## Name of Device and Name/Address of Sponsor

Dynamic Systems, Inc. 5002 North Royal Atlanta Drive, Suite P Tucker, GA 30084 Phone: [phone] Facsimile: 770 939-7722

## Common or Usual Name

Peachtree Proportional Head Control Unit (PHC-3)

### Classification

Power Wheelchair Control Unit

#### Predicate Devices

The PHC-3 is substantially equivalent to other legally marketed driver control systems for powered wheelchairs such as Dynamic Systems Inc.'s Peachtree Head Control PHC-2 (K972147), Adaptive Switch Lab's ASL Model #104 (K914737); Invacare's model MCC-MKIV Micro (Sip & Puff and R.I.M.) (K940972); and Invacare's Model #1555 Remote Joystick (K880364).

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 1999

Mr. David R. Court President and CEO Dynamic Systems, Inc. 5002 North Royal Atlanta Drive, Suite P Tucker, Georgia 30084

Re: K991090 Trade Name: Peachtree Head Control (PHC-3) Regulatory Class: II Product Code: ITI Dated: July 6, 1999 Received: July 6, 1999

Dear Mr. Court:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Mr. David R. Court

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | K991090 |
|---------------------------|--------------------------------|
| Device Name: | Peachtree Head Control (PHC-3) |

Indications For Use:

:: ::

Indications for Use: The Peachtree Proportional Head Control model PHC-3 is intended to offer persons restricted to a seated position the ability to operate a powered wheelchair by three different methods. The first is a non-contact, fully proportional head movement commanded driving control. The next is controlled by a series of blowing and inhaling into a straw. This allows for four way directional control of the wheelchair. The last driving method uses a combination of the two previous drive controls. The user would tilt their had laterally to move the wheelchair left or right and blow or inhale into the straw to control forward/reverse direction/speed.

At current the PHC-3 has only been made to be compatible with Invacare's MKIV series of electronics and Dynamic Controls DX series of electronics.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K991090 |

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use X

(Optional Format 1-2-96)

Na Olieo eeel-80-932