(415 days)
Not Found
No
The device description focuses on mechanical and electrical components for tilting and positioning a wheelchair, with no mention of AI or ML technologies for control, analysis, or decision-making.
No
The device is described as a platform that securely holds wheelchairs and reclines to position patients for treatment, primarily for accessibility and clinician ergonomics, not for directly treating a medical condition itself.
No
The device is a platform designed to position patients in wheelchairs for easier treatment by clinicians. It does not perform any diagnostic functions like detecting, characterizing, or monitoring diseases or conditions.
No
The device description clearly outlines a physical piece of equipment made of steel fabrication with electrical and mechanical components (linear drive, battery, power supply, backrest support, headrest, switches, remote control, pressure sensitive mat, guarding). This is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to provide a safe and adjustable platform for treating patients in wheelchairs, particularly for procedures like dentistry, podiatry, ENT, and maxio-facial work. This involves physically positioning the patient for treatment.
- Device Description: The device is a mechanical and electrical system designed to accommodate and tilt wheelchairs, with features for patient support (backrest, headrest).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratories or point-of-care settings for analyzing biological samples.
The device described is a piece of medical equipment designed to facilitate patient positioning and access for clinical procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Patients in wheelchairs present problems to clinicians who need to treat them and the patients themselves can be seriously disadvantaged by their situation. This is particularly true of dental treatment. To be treated the dentist would need to bend around the patient in the wheelchair, that cusses back pain and sometimes injury. An alternate approach is to transfer the patient to a conventional chair by slings and hoists or other approaches, all of which hold significant health and safety risks.
The wheelchair platform offers a safe environment for both clinician and patient. The wheelchair is moved onto the platform up against a back wall support and the wheelchair and patient are then supported by a backrest and a head support. The platform is reclined, and possibly raised and lowered, to present the patient in the best position for treatment.
Product codes
INO
Device Description
The device accommodates wheelchairs in a secure way, to enable them to be tilted backwards. Patient support is by an adjustable backrest with head support using an adjustable head cushion. The primary use is with patients who cannot be easily transferred from their chairs for such procedures as dentistry, Podiatry, Ear, nose and throat, maxio-facial work
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
Clinicians (dental and medical applications)
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)
Performance testing is carried out under the requirements as set out in BSEN1570:1999. This specifies the allowable stresses as 60% of yield stress at the design load and states that:
- . Full dynamic test at rated load recording operation times
- . 10 min delay under load to determine sink
- Load increase by 10% and full dynamic test .
Static test to 25% increase load
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.
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
§ 890.3110 Electric positioning chair.
(a)
Identification. An electric positioning chair is a device with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. The device is used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions.(b)
Classification. Class II. The electric positioning chair is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9 and the following conditions for exemption:(1) Appropriate analysis and non-clinical testing must demonstrate that the safety controls are adequate to ensure safe use of the device and prevent user falls from the device in the event of a device failure;
(2) Appropriate analysis and non-clinical testing must demonstrate the ability of the device to withstand the rated user weight load with an appropriate factor of safety;
(3) Appropriate analysis and non-clinical testing must demonstrate the longevity of the device to withstand external forces applied to the device and provide the user with an expected service life of the device;
(4) Appropriate analysis and non-clinical testing must demonstrate proper environments of use and storage of the device to maximize the longevity of the device;
(5) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ES60601-1, “Medical Electrical Equipment—Part 1: General Requirements for Basic Safety and Essential Performance,” and ANSI/AAMI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Electromagnetic Disturbances—Requirements and Tests”) must validate electromagnetic compatibility and electrical safety;
(6) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of ANSI/AAMI/ISO 10993-1, “Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process,” ANSI/AAMI/ISO 10993-5, “Biological Evaluation of Medical Devices—Part 5: Tests for In Vitro Cytotoxicity,” and ANSI/AAMI/ISO 10993-10, “Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Skin Sensitization”) must validate that the skin-contacting components of the device are biocompatible;
(7) Appropriate analysis and non-clinical testing (such as that outlined in the currently FDA-recognized editions of IEC 62304, “Medical Device Software—Software Life Cycle Processes”) must validate the software life cycle and that all processes, activities, and tasks are implemented and documented;
(8) Appropriate analysis and non-clinical testing must validate that the device components are found to be non-flammable;
(9) Appropriate analysis and non-clinical testing must validate that the battery in the device (if applicable) performs as intended over the anticipated service life of the device; and
(10) Adequate patient labeling is provided to the user to document proper use and maintenance of the device to ensure safe use of the device by the patient in the intended use environment.
0
design & specific
Executive Summary 510(k) Submission
Wheelchair Platform
Description
The device accommodates wheelchairs in a secure way, to enable them to be tilted backwards. Patient support is by an adjustable backrest with head support using an adjustable head cushion. The primary use is with patients who cannot be easily transferred from their chairs for such procedures as dentistry, Podiatry, Ear, nose and throat, maxio-facial work
Performance testing
$\nabla$
Testing is carried out under the requirements as set out in BSEN1570:1999. This specifies the allowable stresses as 60% of yield stress at the design load and states that:
- . Full dynamic test at rated load recording operation times
- . 10 min delay under load to determine sink
- Load increase by 10% and full dynamic test .
Static test to 25% increase load
R. Fletcher 18.10.07
1
design → specific
Substantial Equivalence Discussion 510(k) Submission
Wheelchair Platform
Predicate Devices
Convertible I-series Positioning and Transfer Chair Barton Medical Corp. 5725 Hway 290 West #103 Austin TX 78735 8701 510(k) No. K071793
Electronic Positioning Chair Medline Industries Inc One Medline Place 11 60060 510(k) No. K001937
Dental Tilting Ramp TRICO Metal Products Wyandotte Rd. Willow Grove Pennsylvania 19060 Manufacturers claim distribution prior to 1976
Rehabilitation Hospital Philadelphia Introduction 1968, several sold. Currently in use manufacturer unknown
Substantial equivalence is sought within the category 'Electronic Positioning Chair' (INO)
The Barton and Medline equipment under the heading is intended for use by patients who are NOT in wheelchairs. The Trico product is designed for the specific treatment of wheelchair patients. Equivalence is therefore sought, not on the grounds of visual appearance only, but on functionality. Patients in wheelchairs must be considered as being integral with their chairs, for it is not safe or beneficial for them to be removed
The Philadelphia Rehabilitation Hospital unit clearly predates the May 28th 1976 date and is the earliest version of equipment found so far. It has all the features and functions of a modern wheelchair recliner but uses the technology available at the period. At least two of these units are in current use and they were made available for sale.
2
The table, attached, shows that the Design Specific Standard Wheelchair Platform is equivalent in both function and technology to both the Medline and Barton positioning chairs. It shows that the Trico Wheelchair Tilting Ramp is similar in form and designed for exactly the same medical procedures. The Philadelphia Recliner has the same function and intended purpose as the Design Specific model, but takes a different design solution. The technology is appropriate to the period of the design.
Flowchart Analysis
| Is the device new to the market? | Yes |
|---|---|
| Is new device to be compared to an existing device | Yes |
| Does new device have same indicated use statement? | Yes |
| Does the new device have the same technological characteristics | |
| (See table above) | Yes |
| Are descriptive characteristics enough to ensure equivalence | Yes |
| Substantial Equivalence been shown. |
R. Fletcher 19.3.08
·
3
| Characteristic | Medline Ind. Inc. | Barton Medical Corps | Trico Metal Ind. | Rehab. Hospital Philadelphia 1968 | Design Specific Wheelchair Platform |
|---|---|---|---|---|---|
| Basic Platform shape | Steel fabrication | Steel fabrication | Steel with cast iron base | Steel assembly | Steel fabrication |
| Drive mechanism | Electrical Linear Drive | Electrical Linear Drive | Electrical Linear Drive | Hydraulic | Electrical Linear Drive |
| Power source | Battery 12v | Battery 12v | 110v supply ac | Manual | Battery 24v and Power supply delivering 24v |
| Backrest support | Normal chair back | Normal chair back | Uses wheelchair back with wheelchair locked in place | Uses wheelchair back with wheelchair locked in place | Pivots in and out adjustable by worm and wheel |
| Headrest | No separate headrest | Vertically adjustable headrest | Fixed headrest | Headrest attached to the wheelchair | Adjustable using a slotted arm with an adjustable headrest cushion for neck and head support. |
| Motions command input | Tilt only | ||||
| Fixed switches | Tilt and rise and fall | ||||
| Hand held controller | Tilt and rise | ||||
| Fixed stalk with switch box | Tilt and rise | Tilt only | |||
| Fixed switches and radio remote control. | |||||
| Foot crush protection | None | None | None | None | Pressure sensitive mat and guarding |
| Max. angle of tilt | Horizontal | Horizontal | Approx 25deg. | 35deg. approx | 45deg |
| Rated capacity | 850lb | 1000lb | Not known | Not known | 594lb (BSEN1570:1999) |
| Proposed uses | "...medical purposes." | "...used to allow postural position." | Wheelchair dentistry | Wheelchair Dentistry | Dental and medical applications |
| Static or mobile | Mobile on wheels | Mobile on wheels | Mobile on air cushion base | Static fixed base | Mobile on air cushion pads or ball castors |
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4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Design Specific Ltd % Ms. Dawn Edwards 1310 Templar Boulevard Norfolk, Virginia 23518
Re: K073565
Trade Name: Standard Wheelchair Platform Regulation Number: 21 CFR 890.3110 Regulation Names: Electric positioning chair Regulatory Class: II Product Code: INO Dated: October 21, 2008 Received: October 31, 2008
FEB - 6 2009
Dear Ms. Edwards:
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 the 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 Food. Drug, 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 such 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); good manufacturing practice requirements as set 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.
5
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely vours,
Mark M. Mullerian
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for use
510(k) Number (if known): K073565
Device Name: standard Wheelchair Platform
Indications For Use:
Patients in wheelchairs present problems to clinicians who need to treat them and the patients themselves can be seriously disadvantaged by their situation. This is particularly true of dental treatment. To be treated the dentist would need to bend around the patient in the wheelchair, that cusses back pain and sometimes injury. An alternate approach is to transfer the patient to a conventional chair by slings and hoists or other approaches, all of which hold significant health and safety risks.
The wheelchair platform offers a safe environment for both clinician and patient. The wheelchair is moved onto the platform up against a back wall support and the wheelchair and patient are then supported by a backrest and a head support. The platform is reclined, and possibly raised and lowered, to present the patient in the best position for treatment.
Prescription Use 7 (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (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)
Division S
Division of General, Restorative. and Neurological Devices