(14 days)
The intended use of the Golden Spyder is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
The intended use of the Golden Spyder is to provide mobility for those persons limited to a seated position that are capable of operating a simple hand control.
The Golden Spyder is a six wheeled battery powered wheelchair. It has a Dynamics Shark controller which is used to operate the Golden Spyder. The main frame of the wheelchair is made of welded steel construction. The main frame also consists of a battery box. The center drive wheels are mounted on the drive shafts of separate motor/gear assemblies, one on the left side of the wheelchair, the other on the right side. It would frame via a four-post mounting system. The seat connected, to the drive and near the center wheels to aid in traction. All seating Concentrates the ascrowing to the Golden Spyder comes standard with two easily removable 12-volt batteries and an on or off board charger. It has an operating range of 15-20 miles on a full charge. The weight capacity is 300-lbs and it has a maximum speed of 5-mph.
The provided text describes a 510(k) premarket notification for a powered wheelchair, the Golden Spyder. The primary purpose of this notification is to demonstrate substantial equivalence to a predicate device, not to present a study proving the device meets specific acceptance criteria based on clinical performance metrics typically associated with AI/software devices.
Therefore, many of the requested sections regarding AI device performance studies, ground truth establishment, sample sizes for training/test sets, expert adjudication, and MRMC studies are not applicable or cannot be extracted from this document, as this is a traditional medical device (a wheelchair) and not an AI-powered device being evaluated.
Here's an analysis of the information that is available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
For a traditional medical device like a wheelchair, acceptance criteria are generally based on compliance with recognized consensus standards for safety and performance rather than clinical performance metrics (like sensitivity, specificity, etc.) typically found in AI/software evaluations.
| Acceptance Criteria (Standard / Test) | Reported Device Performance / Evaluation |
|---|---|
| ANSI/RESNA WC/01 1990 Determination of Static Stability Testing | Non-clinical testing performed, device found substantially equivalent. |
| ANSI/RESNA WC/02 1991 Determination of Dynamic Stability Testing | Non-clinical testing performed, device found substantially equivalent. |
| ANSI/RESNA WC/03 1990 Determination of the Effectiveness of brakes | Non-clinical testing performed, device found substantially equivalent. |
| ANSI/RESNA WC/05 1990 Determination of overall Dimensions, Mass, and Turning Space | Non-clinical testing performed, device found substantially equivalent. |
| ANSI/RESNA WC/10 1990 Determination of Obstacle Climbing Ability | Non-clinical testing performed, device found substantially equivalent. |
| ANSI/RESNA WC/Vol. 2-1998 Requirements and Test Methods for Electromagnetic Compatibility of Electric Powered Wheelchairs and Scooters. | Non-clinical testing performed, device found substantially equivalent. |
| Overall Acceptance Criterion: Substantial Equivalence to Predicate Device (Alante, K011153) | Demonstrated through similar intended use, technological characteristics, and non-clinical testing. Differences do not raise new questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This refers to a physical device evaluated against standards, not a data-driven model.
- Data Provenance: Not applicable. The evaluation is of the physical wheelchair.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth as typically understood for AI models is not relevant here. The "ground truth" for a wheelchair's performance is its direct measurement against engineering and safety standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable.
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, as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this is not an AI/algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this device, the "ground truth" is adherence to established engineering and safety standards (e.g., stability, braking effectiveness, EMC). There's no clinical "ground truth" in the sense of a diagnosis or outcome that an AI would predict.
8. The sample size for the training set
- Not applicable. This is not an AI device trained on data.
9. How the ground truth for the training set was established
- Not applicable.
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JUN 0 3 2004
Page 1 of 2
510 (K) Summary Golden Technologies, Inc. 510 (K) Premarket Notification Golden Spyder
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:
Golden Technologies, Inc. 401 Bridge Street Old Forge, Pa. 18518 Phone: (800) 624-6374 Facsimile: (570) 451-7494 Contact Person: Gene Kulon Official Correspondent Date Prepared: May 18, 2004
Name of Device and Name / Address of Sponsor:
Golden Spyder
Golden Technologies, Inc. 401 Bridge Street Old Forge, Pa. 18518 Phone: (800) 624-6374 Facsimile: (570) 451-7494
Common or Usual Name: Power Wheelchair
Classification Name: Wheelchair, Powered
Comparison to Predicate Devices:
The product, which is substantially equivalent to the Golden Spyder, is the Alante, (K011153). They are both controlled by the use of a joystick controller with onboard batteries and battery charger. All safety features are equivalent.
Device Description:
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Page 2 of 2
The Golden Spyder is a six wheeled battery powered wheelchair. It has a Dynamics The Golden Opyder 18 a on which is used to operate the Golden Spyder. The one-Shark of the wheelchair is made of welded steel construction. The main frame plece base of the whoclehall is made a center drive wheels are mounted on the drive also consists of a battory noor passemblies, one on the left side of the wheelchair, the sharts of separate motorigoar assemment with a removable fold down seat, which is other on the nght date it would frame via a four-post mounting system. The seat connected, to the unve and neer the center wheels to aid in traction. All seating Concentrates the ascrowing to the Golden Spyder comes standard with two easily removable 12-volt batteries and an on or off board charger. It has an operating range of 15-20 miles on a full charge. The weight capacity is 300-lbs and it has a maximum speed of 5-mph.
Intended Use:
The intended use of the Golden Spyder is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
Discussion of non-clinical tests performed for determinations of substantial equivalence are as follows:
ANSI/RESNA WC/01 1990 Determination of Static Stability Testing ANSI/RESNA WC/02 1991 Determination of Dynamic Stability Testing ANSI/RESNA WC/03 1990 Determination of the Effectiveness of brakes ANSI/RESNA WC/05 1990 Determination of overall Dimensions, Mass, and Turning Space ANSI/RESNA WC/10 1990 Determination of Obstacle Climbing Ability ANSI/RESNA WC/Vol. 2-1998 Requirements and Test Methods for Electromagnetic Compatibility of Electric Powered Wheelchairs and Scooters.
Discussion of Clinical Tests Performed:
N/A
Conclusions:
The Golden Spyder has the same intended use and similar technological characteristics as the Alante. Moreover, the non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Golden Spyder device is substantially equivalent to the predicate device.
Discussion of Clinical Tests Performed:
N/A
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 0 3 2004
Gene R. Kulon Golden Technologies, Inc. 401 Bridge Street Old Forge, Pennsylvania 18518
Re: K041341
Trade/Device Name: Golden Spyder, Wheelchair, Powered Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: May 18, 2004 Received: May 20, 2004
Dear Mr. Kulon:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your become 310(x) premaince is substantially equivalent (for the indications felerenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the encreate) to legans intentional date of the Medical Device Amendments, or to commerce prior to May 20, 1770, the exceence with the provisions of the Federal Food. Drug. devices that have been reclassified in accessfired in a premarket approval application (PMA). and Cosment Act (Act) that do not require approvise to the general controls provisions of the Act. The Act. The r ou may, mercetore, market the device, boojes requirements for annual registration, listing of general controls provisions of the fiel 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 such additional controls. Existing major regulations affecting your device can may be subject to suell additional controllations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Out occurents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease of advised that I Dri- Sissaanse or our device complies with other requirements of the Act that I DX has made a actoring administered by other Federal agencies. You must or any I edelar statutes and regulations anchuding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set a CI K r at 807), laboling (21 OF X Part 820), and if applicable, the electronic forul in the quality of control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ocgin makemig your avine equivalence of your device to a legally premarket notification. The PDA midnig of substance equive 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), please If you desire specific advice for your ac 1100 %. Also, please note the regulation entitled, the more obtain Contact the Office of Comphanes at (301) 57 160 - 1007.97). You may obtain " Misorallumg by Icierchec to premantel international in the Act from the Division of Small other general information on your responsibility of the mumber (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-ifremation brought (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. P Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Golden Spyder, Wheelchair, Powered Device Name:
Indications for Use:
The intended use of the Golden Spyder is to provide mobility for those persons limited The intended ass of the Select capable of operating a simple hand control.
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use V (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K041341
§ 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).