(176 days)
Not Found
No
The summary describes a device controlled by head movement and sip-and-puff, with no mention of AI or ML technologies.
No.
The device is described as a head control system for operating a powered wheelchair, which is an assistive mobility device, not a therapeutic device intended for treatment or diagnosis of a medical condition.
No
The device is described as a control system for operating a powered wheelchair, not for diagnosing a medical condition.
No
The device description explicitly mentions "three different methods" of operating a powered wheelchair, including "non-contact, fully proportional head movement commanded driving control" and "blowing and inhaling into a straw." These methods inherently involve hardware components (sensors for head movement, a straw/pressure sensor) that interact with the user and the wheelchair electronics. The summary also mentions compatibility with specific hardware electronics (Invacare's MKIV and Dynamic Controls DX series). Therefore, this is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide control of a powered wheelchair for individuals restricted to a seated position. This is a functional assistive device, not a diagnostic tool.
- Device Description: While the description is "Not Found," the intended use clearly describes a device for controlling movement, not for analyzing biological samples or providing diagnostic information.
- No mention of biological samples: There is no indication that this device interacts with or analyzes any biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVDs.
- No mention of diagnostic purpose: The purpose is to enable mobility, not to diagnose a disease or condition.
Therefore, the Peachtree Proportional Head Control model PHC-3 falls under the category of a medical device (specifically, an assistive technology device) but not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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.
K972147, K914737, K940972, K880364
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
§ 890.3860 Powered wheelchair.
(a)
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.(b)
Classification. Class II (performance standards).
0
SEP 2 4 1999
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: 770 939-1122 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: 770 939-1122 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).
1
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.
2
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597, 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
3
| 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