(52 days)
Wheelchair mobility, either self-propelled or propelled by an attendant, for the physically impaired.
The wheelchair is a standard lightweight manual folding chair that provides mobility based on an individual user's needs and capabilities. Since it has the same intended use as typical wheelchairs, its features are also comparable. A sling seat and backrest are affixed to a sturdy frame that is supported by two large rear wheels and two forward swivel caster wheels. The two side frames are connected by a horizontal cross brace, rather than a vertical cross brace, that can assume a folded configuration. The wheelchair accommodates removable armrests, detachable footrests, rear anti-tippers, push handles, and wheel locks.
The ActivX Wheelchair is a standard lightweight manual folding chair. The manufacturer, Adorno/Rogers Technology, Inc. (A/RT), claims that its device is substantially equivalent to the Quickie2 (K890050) wheelchair. The primary difference is the ActivX's horizontal cross brace, which allows for a different folding mechanism.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Mechanical Durability (related to folding mechanism) | Performed acceptably in the ANSI/RESNA two-drum test. |
| User Safety/Functionality | Subject evaluations supported substantial equivalence. |
| Dimensions, Construction Materials, Standard Features/Options | Substantially equivalent to the predicate device. |
| Intended Use | Identical to the predicate device (wheelchair mobility for the physically impaired). |
| Propulsion/Maneuvering | Identical to the predicate device in how the user propels and maneuvers the chair. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly mentions "subject evaluations" but does not specify the sample size of these subjects. It also doesn't indicate the country of origin for this data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide details on the number or qualifications of experts used for the "subject evaluations."
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the subject evaluations.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The study focused on the ActivX's performance against a standard, not on comparing human readers' improvement with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone study was performed. The "Design Validation/Verification" included the ANSI/RESNA two-drum test and subject evaluations, which assessed the device's performance independently.
7. Type of Ground Truth Used
The ground truth appears to be a combination of:
- Performance Standards: The ANSI/RESNA two-drum test provides an objective, standardized measure of mechanical durability.
- User Feedback/Subjective Evaluation: "Subject evaluations" indicate that users tested the device and their feedback was part of the assessment.
8. Sample Size for the Training Set
The document does not mention any training set or related sample size. This is a medical device, not an AI/ML product, so a training set in the typical AI sense would not apply.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a training set, the establishment of ground truth for such a set is not applicable.
{0}------------------------------------------------
JAN 28
JAN 28 8 1999
510(K) - APRT - ActivX Wheelchair
1984367
VI. 510(K) SUMMARY
| Submitter: | Adorno/Rogers Technology, Inc.PO Box 160337Austin, TX 78716512-474-7267Fax: 512-476-6460 |
|---|---|
| Contact Person: | Paul Gibb |
| Date of Preparation: | December 3, 1998 |
| Common Name:Proprietary Name:Predicate Device: | Mechanical Folding Wheelchair (per 21 CFR section 890.3850)ActivXQuickie2 (K890050) |
| Intended Use: | Wheelchair mobility, either self-propelled or propelled by anattendant, for the physically impaired. |
| Device Description: | The wheelchair is a standard lightweight manual folding chair thatprovides mobility based on an individual user's needs and capabilities.Since it has the same intended use as typical wheelchairs, its featuresare also comparable. A sling seat and backrest are affixed to a sturdyframe that is supported by two large rear wheels and two forwardswivel caster wheels. The two side frames are connected by ahorizontal cross brace, rather than a vertical cross brace, that canassume a folded configuration. The wheelchair accommodatesremovable armrests, detachable footrests, rear anti-tippers, pushhandles, and wheel locks. |
| Comparison WithPredicate Device: | The ActivX wheelchair and the predicate device have an identicalintended use and are identical with respect to the way the userpropels and maneuvers the chair. The dimensions, constructionmaterials, and standard features/options of the two chairs aresubstantially equivalent. The only difference between the A/RTchair and the predicate device is in the way the chairs are opened andfolded. The A/RT chair has a horizontal cross brace, rather than thetypical vertical cross brace of most folding wheelchairs. This newfeature has been tested for Design Validation/Verification and hasperformed acceptably. The results of the ANSI/RESNA two-drumtest and subject evaluations support a determination of "substantiallyequivalent" for the ActivX wheelchair. |
{1}------------------------------------------------
Public Health Service
Image /page/1/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
JAN 28 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Paul Gibb Vice President and Chief Operating Officer Adorno/Rogers Technology, Inc. P.O. Box 160337 Austin, Texas 78716
K984367 Re: Trade Name: ActivX Regulatory Class: I Product Code: IOR December 3, 1998 Dated: Received: December 7, 1998
Dear Mr. Gibb:
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 reguirements 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ 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.
{2}------------------------------------------------
Page 2 - Mr. Paul Gibb
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
{3}------------------------------------------------
510(k) NUMBER (IF KNOWN): K984367 Mechanical Folding Wheelchair - ActivX DEVICE NAME:
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
INDICATIONS FOR USE:
Intended Use:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
... — - .
Wheelchair mobility, either self-propelled or propelled by an attendant, for the physically impaired.
(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 K984367
§ 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).