(77 days)
Not Found
Not Found
No
The description focuses on a non-contact head position sensing device using an electrical field, with no mention of AI or ML algorithms for interpreting head movements or controlling the wheelchair.
No
The device provides mobility control for operating a power-drive wheelchair, which is an assistive function rather than a therapeutic treatment for a medical condition.
No
The device is described as a control unit for operating a power-drive wheelchair through head movements, not for diagnosing any medical condition.
No
The device description explicitly states that the PHC-2 consists of a "headrest pad containing a control unit" and describes it as a "remote, electronic, two dimensional head position sensing device," indicating the presence of physical hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The PHC-2 is a mobility control device for power wheelchairs. It uses head movements to control the wheelchair's functions.
- Lack of Biological Samples: The device does not interact with or analyze any biological samples from the user. It relies on sensing the user's head position.
- Intended Use: The intended use is to provide mobility control, not to diagnose or monitor a medical condition through the analysis of biological samples.
Therefore, the PHC-2 falls under the category of a medical device, specifically a mobility aid, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PHC-2 is intended to provide mobility control to persons restricted to a seated position while operating a power-drive wheelchair.
The Peachtree Proportional Head Control Unit is non-contact, fully proportional, head movement commanded driving control intended to provide mobility control to persons restricted to a seated position while operating a variety of available power-drive wheelchairs.
Product codes (comma separated list FDA assigned to the subject device)
ITI
Device Description
The PHC-2 consists of a headrest pad containing a control unit which provides invisible contact between the user and the wheelchair. The control unit is a remote, electronic, two dimensional head position sensing device that utilizes a low level, high frequency electrical field to provide contact between the user and the wheelchair.
The PHC-2 control unit does not require physical attachments to the user. The user simply tilts his or her head to provide control commands to the wheelchair. The PHC-2 has two operational modes: control and drive, the user enters the various modes and functions by gently tapping the head rest a designated number of times. On power up, the unit is always in control mode which includes the following functions: stop, recline, ECU, and drive. The stop function results in no activity, recline allows the user to recline the back of the wheelchair with head motions, and the ECU function controls an environmental control unit, if available. The second level is drive mode which includes: stop, reverse, forward low, and forward high. Within the drive modes the user can accelerate, brake, spin, and turn by utilizing non-contact head movements.
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.
Adaptive Switch Laboratories. Inc.'s ASL Head Array, Invacare's Sip & Puff Head Array, Invacare's Remote Joystick, and Invacares R.I.M. controles L
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
510(k) SUMMARY
Dynamic Systems, Inc.'s PHC-2
C
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Dynamic Systems, Inc. 5002 North Royal Atlanta Drive, Suite P Tucker, GA 30084-3050 Phone: (770) 939-1122 Facsimile: (770) 850-9875
David Court Contact Person:
June 3, 1997 Date Prepared:
Name of Device and Name/Address of Sponsor
Dynamic Systems, Inc. 5002 North Royal Atlanta Drive, Suite P Tucker, GA 30084-3050 Phone: (770) 939-1122 Facsimile: (770) 850-9875
Common or Usual Name
Peachtree Proportional Head Control Unit (PHC-2)
Classification Name
Power Wheelchair Control Unit
Predicate Devices
The PHC-2 ("PHC-2 ") is substantially equivalent to Adaptive Switch Laboratories. Inc.'s ASL Head Array, Invacare's Sip & Puff Head Array, Invacare's Remote Joystick, and Invacares R.I.M. controles L
1
Intended Use
The PHC-2 is intended to provide mobility control to persons restricted to a seated position while operating a power-drive wheelchair.
Technological Characteristics and Substantial Equivalence
A. Device Description
The PHC-2 consists of a headrest pad containing a control unit which provides invisible contact between the user and the wheelchair. The control unit is a remote, electronic, two dimensional head position sensing device that utilizes a low level, high frequency electrical field to provide contact between the user and the wheelchair.
The PHC-2 control unit does not require physical attachments to the user. The user simply tilts his or her head to provide control commands to the wheelchair. The PHC-2 has two operational modes: control and drive, the user enters the various modes and functions by gently tapping the head rest a designated number of times. On power up, the unit is always in control mode which includes the following functions: stop, recline, ECU, and drive. The stop function results in no activity, recline allows the user to recline the back of the wheelchair with head motions, and the ECU function controls an environmental control unit, if available. The second level is drive mode which includes: stop, reverse, forward low, and forward high. Within the drive modes the user can accelerate, brake, spin, and turn by utilizing non-contact head movements.
B. Substantial Equivalence
The PHC-2 has the same intended use, similar principles of operation, and similar technological characteristics as the previously cleared predicate devices. Although there are minor differences in the characteristics of the PHC-2 and its predicate devices, those differences do not raise new questions of safety or efficacy.
Although there are some differences between the PHC-2 and its predicates, these differences are minor and raise no new questions of safety and effectiveness. The only significant differences between the named predicate devices and the PHC-2 are in the method employed to acquire user control input. The PHC-2 utilizes a remote, electronic, fully proportional, two dimensional head position sensing device to generate wheelchair control commands whereas the predicate devices either use
2
a joystick requiring physical contact or a nonproportional switch control mechanism to generate the commands.
3
Substantial Equivalence Table Comparing Dynamic Systems, Inc.'s PHC-2 with Predicate Devices
| | PHC-2 | ASL Head
Array | SIP &
PUFF | FLIGHT
LINK
JOYSTICK | R.I.M. |
|----------------------------|-------------------------------------------------------------------------------------------------------|-----------------------|-------------------------------------|----------------------------|---------------------------|
| Intended Use | Movement
Commande
d Driving
Control for
Operating a
Variety of
Power
Wheelchairs | Same | Same | Same | Same |
| Operating
Principle | Capacitance
Sensing | Fiberoptic
Sensing | Air Pressure
Sensing | Mechanical | Mechanical |
| Non-contact
control | Yes | Yes | No | No | No |
| Device
interface | Wheelchair
Joystick Input
Port | Same | Same | Same | Same |
| Proportional
control | Yes | No | No | Yes | Yes |
| Movement
control | Head | Head | Head | Hand | Head |
| Functions | Stop -
Forward-
Reverse -
Turn -
Spin - | Same | Same | Same | Same |
| Physical
Characteristic | Headrest | Headrest | Headrest
with Sip &
Puff Pipe | Joystick | Headrest
with Joystick |
4
Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that appears to be three faces in profile, one behind the other, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David R. Court ·Dynamic Systems, Inc. 5002 North Royal Atlanta Drive Suite P Tucker, Georgia 30084
AUG 2 5 1997
K972147 Re: Peachtree Proportional Head Control Unit (PHC-2) Regulatory Class: II Product Code: ITI Dated: June 3, 1997 Received: June 9, 1997
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to 895. ಡ 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 In addition, FDA may publish further announcements action. 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.
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Page 2 - Mr. David R. Court
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.
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 (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
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INDICATIONS FOR USE STATEMENT
510(K) Number: K972147
Device Name: Peachtree Proportional Head Control
(UNIT PHC-2)
Indications for Use: The Peachtree Proportional Head Control Unit is non-contact, fully proportional, head movement commanded driving control intended to provide mobility control to persons restricted to a seated position while operating a variety of available power-drive wheelchairs.
PLEASE DO NOT WRITE BELOW THIS LINE (CONTINUE ON ANOTHER PAGE IF NEEDED)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
| OR | Over-the-Counter Use |
|---|---|
| (Optional Format 1-2-96) | |
| (Division Sign-Off) |
Division of General Restorative Devices 510(k) Number .