(68 days)
The intended use of the TACAMO Manual Wheelchair is to provide mobility to persons limited to a sitting position.
The DALTON INSTRUMENT CORPORATION Model TACAMO is a manually operated, self propelled, manual, mechanical wheelchair. The primary design function and use is to provide mobility to persons who may be restricted to a sitting position. This product may also be used as an attendant propelled patient transport device in a health care environment such as a hospital, nursing home or long term care facilities. The product has standard manual wheelchair features. It consists of the frame, 24" rear wheels with hand rims for propelling the chair, and 8'' front casters for steering and turning. The wheelchair frame is constructed from both 1.25" and 1" outside diameter(OD) round, mechanical, steel tubing. The side frames are of welded construction and are secured to the remaining frame members using screws and bolts. This device is a rigid, "non folding" type wheel chair that incorporates a solid seating surface. TACAMO also comes with wheelchair cushion and seating system. TACAMO also includes a "Tilt in Space" feature which allows the seat and back of the wheelchair to be tilted. This feature is used for those patients who require a tilt feature for stability, comfort or head control. It also serves as an attendant aid in those situations where a patient need to be tilted to be fed, or attended to in some situations. The "Tilt in Space" feature is manually operated and is activated by two release levers located at the rear of the wheelchair. Adjusting the tilt is achieved by squeezing the two release lever handles inward simultaneously. When the levers are squeezed, flexible cables attached to each release lever disengage gear rack segments from independent actuator rods which are notched to match the teeth of the gear segments. Once the desired tilt angle has been obtained, the handles are released and the chair will remain at the angle chosen. The chair has a tilt angle range of 30 degrees and 30 degrees of reclining angle.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| RESNA ANSI/RESNA WC/Vol.1-1998 "Requirements and Test Methods for Wheelchairs (including Scooters)" | The DALTON INSTRUMENT CORPORATION wheelchair TACAMO meets the applicable performance requirements specified in this standard. |
| DIS ISO 7176 (1992) Part 8: "Requirements and Test Methods for Static, Impact and Fatigue Strengths" | The DALTON INSTRUMENT CORPORATION wheelchair TACAMO meets the applicable performance requirements specified in this standard. |
2. Sample Size and Data Provenance:
The document does not specify a separate "test set" in the context of typical AI algorithm evaluation with a specific sample size, country of origin, or retrospective/prospective nature. Instead, the performance is demonstrated through adherence to established wheelchair international standards. This implies that the device was physically tested against the specified parameters of these standards. The data provenance would be the results of these physical tests, likely conducted at the manufacturer's facility or a certified testing lab.
3. Number and Qualifications of Experts for Ground Truth:
Not applicable in the context of this type of device submission. Ground truth is established by the specifications and methodologies within the RESNA and ISO standards, not by expert consensus on particular data points. The "experts" would be the engineers and technicians who conducted the tests according to the standard protocols and interpreted the results against the standard's criteria.
4. Adjudication Method:
Not applicable. Device performance is determined by meeting objective industrial standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a physical medical device (manual wheelchair), not a diagnostic or AI-driven imaging device that would typically undergo MRMC studies.
6. Standalone Performance Study:
Yes, a standalone performance was done in the sense that the device was tested independently against the published international standards (RESNA ANSI/RESNA WC/Vol.1-1998 and DIS ISO 7176 (1992) Part 8). The stated compliance confirms its standalone performance against these benchmarks.
7. Type of Ground Truth Used:
The ground truth used is based on established, internationally recognized engineering and safety standards for wheelchairs. This includes quantitative measurements and test procedures for static, impact, and fatigue strengths, as well as general requirements for wheelchairs.
8. Sample Size for the Training Set:
Not applicable. This is a physical device, not an AI algorithm that requires a "training set" of data. The design and manufacturing processes are informed by engineering principles and safety standards, rather than machine learning from data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in the context of this device. The design specifications and manufacturing processes are guided by recognized engineering practices and the requirements outlined in the RESNA and ISO standards.
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May 13, 2010
- TH DMC
Image /page/0/Picture/2 description: The image shows the logo for Dalt Instruments. The logo features the letters 'DI' in a stylized font, with an oval shape surrounding the 'I'. Above the logo, the text 'K101719' is written in a handwritten style. The overall image appears to be a scan or photocopy, with some imperfections and variations in contrast.
JUN. 1.8 2010
Received
510(k) SUMMARY DALTON INSTRUMENT CORPORATION'S Model TACAMO Manual Wheelchair
AUG 2 5 2010
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
Dalton Instrument Corp. 3788 Arapaho Road Addison, TX 75001 Tel: 469-522-1200 Fax: 469-522-1202
Contact Person: President, Mei Lein Date Prepared: May 13, 2010
Name of Device and Name/Address of Sponsor
Model TACAMO Manual Wheelchair
Dalton Instrument Corp. 3788 Arapaho Road Addison, TX 75001 Tel: 469-522-1200 Fax: 469-522-1202
Common or Usual Name: Manual Wheelchair
Classification Name: Wheelchair, Mechanical 89IOR
Predicate Devices
The Dalton Instrument Corp. Model TACAMO substantially equivalent to the Invacare Manual Wheelchair Model Action AT II (K984447, 1/8/1999) and Sunrise Medical/Quickie Design Model "Quickie TSR" Manual Wheelchair (K952641, 6/9/1995)
Intended Use: the intended use of the Model TACAMO Manual Wheelchair is to provide mobility to persons limited to a sitting position.
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Technological Characteristics and Substantial Equivalence
A. Device Description
The DALTON INSTRUMENT CORPORATION Model TACAMO is a manually operated, self propelled, manual, mechanical wheelchair. The primary design function and use is to provide mobility to persons who may be restricted to a sitting position. This product may also be used as an attendant propelled patient transport device in a health care environment such as a hospital, nursing home or long term care facilities.
The product has standard manual wheelchair features. It consists of the frame, 24" rear wheels with hand rims for propelling the chair, and 8'' front casters for steering and turning.
The wheelchair frame is constructed from both 1.25" and 1" outside diameter(OD) round, mechanical, steel tubing. The side frames are of welded construction and are secured to the remaining frame members using screws and bolts. This device is a rigid, "non folding" type wheel chair that incorporates a solid seating surface. TACAMO also comes with wheelchair cushion and seating system.
TACAMO also includes a "Tilt in Space" feature which allows the seat and back of the wheelchair to be tilted. This feature is used for those patients who require a tilt feature for stability, comfort or head control. It also serves as an attendant aid in those situations where a patient need to be tilted to be fed, or attended to in some situations.
The "Tilt in Space" feature is manually operated and is activated by two release levers located at the rear of the wheelchair. Adjusting the tilt is achieved by squeezing the two release lever handles inward simultaneously. When the levers are squeezed, flexible cables attached to each release lever disengage gear rack segments from independent actuator rods which are notched to match the teeth of the gear segments. Once the desired tilt angle has been obtained, the handles are released and the chair will remain at the angle chosen. The chair has a tilt angle range of 30 degrees and 30 degrees of reclining angle.
B. Substantial Equivalence
The DALTON INSTRUMENT CORPORATION Model TACAMO substantially equivalent to numerous manual, mechanical wheelchairs currently in market place,
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for which FDA has granted marketing clearance through the 510(k) premarket notification process. More specifically the DALTON INSTRUMENT CORPORATION Model TACAMO is substantially equivalent to the Sunrise Medical/Quickie Design Model "Quickie TSR" Manual Wheelchair(K952641 6/9/95) and the Invacare Model AT II Manual Wheelchair(K984447 1/8/1999)
Each of the products is a manual operated, attendant or user propelled, manual mechanical wheelchair with the same intended function and use which is to provide mobility to persons that may be limited to a seated position. All products consist basically of a mechanical frame to support the wheelchair, 24" rear wheels for propelling the wheelchair, and 8" casters for turning and steering. Additionally, each of these wheelchairs incorporates a manually operated "tilt in space" feature for patient comfort and positioning.
Performance Data
The DALTON INSTRUMENT CORPORATION wheelchair TACAMO meets the applicable performance requirements specified in:
- . Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/Vol.1-1998 "Requirements and Test Methods for Wheelchairs(including Scooters)"
- DIS ISO 7176 (1992) Part 8: Requirements and Test Methods for Static, ● Impact and Fatigue Strengths
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Dalton Instrument Corporation % Mei Lein President 3788 Arapaho Road Addison, Texas 75001
AUG 2 5 2010
Re: K101719
Trade/Device Name: TACAMO Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: August 9, 2010 Received: August 16, 2010
Dear Mei Lein:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
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Page 2 - Mei Lein
device-related adverse events) (21 CFR 803); 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.
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,
Marki McMullerson
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): K101719
Device Name: TACAMO Manual Wheelchair
Indications for Use: The intended use of the TACAMO Manual Wheelchair is to provide mobility to persons limited to a sitting position.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _X (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)
.
Page 1 of
: Sim-Off sion of Surgical. Orthopedic, i Kestorative Devices
510(k) Number K101719
§ 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).