(83 days)
To provide mobility to persons limited to a sitting position
To provide mobility to persons limited to a seated position.
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.
The provided document describes a 510(k) submission for the PDG Product Design Group Luna Manual Wheelchair, which is a mechanical device, not an AI or software-based device. Therefore, many of the requested categories related to AI performance studies (sample sizes for test and training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance, etc.) are not applicable in this context.
However, I can extract the information relevant to mechanical device testing and conformance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Applicability to ISO 7176 - Standard for Manual, Mechanical Wheelchairs | The Luna manual wheelchair is designed to meet the applicable requirements of ISO 7176. |
2. Sample size used for the test set and the data provenance
The document does not specify a specific sample size for a test set or data provenance for the performance data. It broadly states the device is "designed to meet" ISO 7176, implying conformance through manufacturing and design processes, rather than a specific clinical or performance test on a defined sample that would be typical for AI/software.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a mechanical device, not one requiring expert interpretation of output.
4. Adjudication method for the test set
Not applicable. This is a mechanical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a mechanical device, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the AI sense. For mechanical devices, "ground truth" typically refers to engineering specifications, performance standards (like ISO 7176), and material properties, which are verified through engineering tests and quality control, not medical ground truth as in diagnostics.
8. The sample size for the training set
Not applicable. This is a mechanical device.
9. How the ground truth for the training set was established
Not applicable. This is a mechanical device.
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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
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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.
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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
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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
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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
§ 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).