(83 days)
No
The device description clearly states it is a "manually operated, self propelled mechanical wheelchair" and there are no mentions of AI, ML, or related technologies in the summary.
No.
The device description and intended use focus on providing mobility and transport, rather than treating or curing a medical condition.
No.
Explanation: The device description states its intended use is to provide mobility. There is no mention of diagnosing conditions, analyzing data to detect diseases, or any diagnostic capabilities.
No
The device description clearly states it is a "manually operated, self propelled mechanical wheelchair," indicating it is a physical hardware 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 mobility to persons limited to a seated position. This is a mechanical function related to physical support and movement, not the diagnosis of disease or other conditions through the examination of specimens derived from the human body.
- Device Description: The device is described as a "manually operated, self propelled mechanical wheelchair." This further reinforces its function as a mobility aid.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or any other activity typically associated with in vitro diagnostics.
Therefore, the PDG Model Luna wheelchair is a medical device, but it falls under a different category than IVDs.
N/A
Intended Use / Indications for Use
To provide mobility to persons limited to a sitting position
To provide mobility to persons limited to a seated position.
Product codes
IOR
Device Description
The PDG Model Luna wheelchair is manually operated, self propelled mechanical wheelchair. Its intended function and use is to provide mobility to persons that may be limited to a seated position. It may also be used as attendant propelled transport device in a health care environment such as a hospital, nursing home or extended care facility.
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
The Luna manual wheelchair is designed to meet the applicable requirements of ISO 7176 - Standard for Manual, Mechanical Wheelchairs.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).
0
510(k) SUMMARY PDG Product Design Group Luna Manual Wheelchair
DEC 2 3 2010
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
PDG Product Design Group, Inc. Unit 102-366 E. Kent Avenue South Vancouver, British Columbia Canada V5X 4N6 Contact Person:
Edward A. Kroll President, Spectre Solutions, Inc and Representative Consultant for PDG Product Design Group 5905 Fawn Lane Cleveland, Ohio 44141
Date Prepared: September 4, 2010
Name of Device and Name/Address of Sponsor
PDG Product Design Group, Inc. Unit 102-366 E. Kent Avenue South Vancouver, British Columbia Canada V5X 4N6 Contact Person:
Common or Usual Name
Wheelchair
Classification Name
Wheelchair, Mechanical
Predicate Device
Invacare Model 9000 Bariatric Wheelchair (K002317)
Intended Use
To provide mobility to persons limited to a sitting position
1
Technological Characteristics and Substantial Equivalence
A. Device Description
The PDG Model Luna wheelchair is manually operated, self propelled mechanical wheelchair. Its intended function and use is to provide mobility to persons that may be limited to a seated position. It may also be used as attendant propelled transport device in a health care environment such as a hospital, nursing home or extended care facility.
B. Substantial Equivalence
The Luna is substantially equivalent to Invacare Corporation Model 9000 Bariatric Wheelchair (Invacare 9000). The Invacare 9000 was granted marketing clearance by FDA on August 25, 2000 under 510(k) Accession Number K002317.
Performance Data
The Luna manual wheelchair is designed to meet the applicable requirements of ISO 7176 - Standard for Manual, Mechanical Wheelchairs.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol. The logo is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
PDG Product Design Group, Inc. % Spectre Solutions, Inc. Mr. Edward A. Kroll President 5905 Fawn Lane Cleveland, Ohio 44141
DEC 2 3 2010
Re: K102910
Trade/Device Name: Luna Mechanical Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: September 4, 2010 Received: October 1, 2010
Dear Mr. Kroll:
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 thè 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 Foond, Or to and Cosmetic Act (Act) that do not require approval of a premarket approval application (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 can be 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 of 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 listing (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
3
Page 2 - Mr. Edward A. Kroll
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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Al. B. n.h
p.
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): Kl 029 / D
DEC 2 3 2010
Device Name: Luna Mechanical Wheelchair
Indications for Use:
To provide mobility to persons limited to a seated position.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K102910