(105 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical safety standards for a wheelchair and examination table, with no mention of AI or ML technologies.
No
The device is a mechanical wheelchair indicated for providing mobility and transferring patients, not for treating a disease or condition.
No.
The Martin Chair Model C4S1 is a mechanical wheelchair indicated for providing mobility and facilitating patient transfer. It does not perform diagnostic examinations or collect diagnostic information. The Martin Examination Table, which is an accessory to the chair, is indicated for use during diagnostic examinations, but the question specifically asks about the device described, which is the Martin Chair Model C4S1.
No
The device description clearly states it is a "mechanical wheelchair" made from "composites of steel, plastics and fabrics," indicating it is a physical hardware device.
Based on the provided text, the Martin Chair Model C4S1 and the Martin Examination Table are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The descriptions clearly state the function of both devices:
- Martin Chair Model C4S1: Provides mobility and facilitates patient transfer.
- Martin Examination Table: Supports and positions a patient during examinations or procedures.
- No Specimen Analysis: Neither device is described as analyzing or testing any biological specimens. Their function is purely mechanical and related to patient support and movement.
- Intended Use: The intended uses are focused on mobility, transfer, and patient positioning, not on diagnostic testing of samples.
Therefore, these devices fall under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Martin Chair Model C4S1 is indicated for providing mobility to persons limited to a sitting position. It is also specifically indicated to transfer a patient to and from the Martin Examination Table.
The Martin Examination Table is indicated for use during diagnostic examinations or surgical procedures to support and position a patient.
Product codes (comma separated list FDA assigned to the subject device)
IOR, LGX
Device Description
The Martin Chair Model C4S1 mechanical wheelchair is an indoor/outdoor wheelchair that has a base with two larger rear wheels and two smaller front wheels and a seat. The wheelchair is intended to be manually propelled by a person seated in the wheelchair or by an attendant or clinician. The device is made from composites of steel, plastics and fabrics. The wheelchair is for use by adult persons.
The wheelchair can be secured to a compatible, electrically elevated examination table which allows for the seat of the wheelchair to become part of the examination table. This removes the need for the patient to be lifted during transfer from the wheelchair to the examination table. The wheelchair is latched to the examination table and the side frame and wheels are removed for the examination. The sides and wheels are replaced prior to lowering the examination table allowing the wheelchair to be used according to its intended use.
The Martin Examination Table is a 510(k) exempt device, 21 CFR 878.4960, product code LGX. It is an accessory to the Martin Chair. It is a device intended as a powered examination table to provide positioning and support to patients during general examinations and procedures. It is intended for medical purposes as an electrically operated table with movable components that can be adjusted to various positions, the same intended use as other currently marketed powered tables. The Martin Examination Table is a standard powered examination table that includes standard components and features of other currently marketed powered examination tables including side rails for additional safety. The Martin Examination Table includes latches under the seat cushion that are compatible with the fixed metal receivers of the Martin Chair Model C4S1,
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
adult persons
Intended User / Care Setting
Not Found
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)
The Martin Chair Model C4S1 mechanical wheelchair meets the applicable FDA recognized ANSI/RESNA consensus standards tested by Human Engineering Research Laboratories (HERL) for mechanical wheelchairs and has successfully passed testing. Data within the 510(k) demonstrates successful performance against flame retardant standards.
The Martin Examination Table has been tested to in accordance with standards: UL 60601-1, UL 60601-1-2, and CSA 22.2 No 601-1.
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.
K012167, K894134, K874448, K964246
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
§ 890.3850 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).
0
Koso506
510(k) Summary
JUN - 9 2008
A. GENERAL INFORMATION
| 1. Submitter's Name: | Martin Manufacturing Co., LLC |
|---|---|
| 2. Address: | 621-101 Hutton St. |
| Raleigh, NC 27606 | |
| 3. Contact Person: | Michael Zapata III |
| 4. Date prepared: | 25 February 2008 |
| 5. Registration Number: | Not currently registered |
| 6. Telephone Number: | (919) 741-4401 |
| 7. Fax Number: | (919) 829-8045 |
B. DEVICE
| 1. Proprietary or Trade Name: | Martin Chair C4S1 |
|---|---|
| 2. Common Name: | Mechanical Wheelchair |
| 3. Classification Name: | Wheelchair, Mechanical |
| 4. Classification Panel(s): | General Hospital, Physical medicine |
| 5. Product Code(s): | IOR, LGX, FRZ |
| 6. Class for New Device: | Class I |
| 7. Regulation Number: | 890.3850 |
C. INDICATIONS FOR USE
Martin Chair Model C4S1 is intended for use for providing mobility to persons limited to a sitting position. It is specifically indicated to transfer a patient to and from a wheelchair. :
.
.
.
1
D. DESCRIPTION OF THE DEVICE
The Martin Chair Model C4S1 mechanical wheelchair is an indoor/outdoor wheelchair that has a base with two larger rear wheels and two smaller front wheels and a seat. The wheelchair is intended to be manually propelled by a person seated in the wheelchair or by an attendant or clinician. The device is made from composites of steel, plastics and fabrics. The wheelchair is for use by adult persons.
The wheelchair can be secured to a compatible, electrically elevated examination table which allows for the seat of the wheelchair to become part of the examination table. This removes the need for the patient to be lifted during transfer from the wheelchair to the examination table. The wheelchair is latched to the examination table and the side frame and wheels are removed for the examination. The sides and wheels are replaced prior to lowering the examination table allowing the wheelchair to be used according to its intended use.
The Martin Examination Table is a 510(k) exempt device, 21 CFR 878.4960, product code LGX. It is an accessory to the Martin Chair. It is a device intended as a powered examination table to provide positioning and support to patients during general examinations and procedures. It is intended for medical purposes as an electrically operated table with movable components that can be adjusted to various positions, the same intended use as other currently marketed powered tables. The Martin Examination Table is a standard powered examination table that includes standard components and features of other currently marketed powered examination tables including side rails for additional safety. The Martin Examination Table includes latches under the seat cushion that are compatible with the fixed metal receivers of the Martin Chair Model C4S1,
ui PERFORMANCE TESTING
The Martin Chair Model C4S1 mechanical wheelchair meets the applicable FDA recognized ANSI/RESNA consensus standards tested by Human Engineering Research Laboratories (HERL) for mechanical wheelchairs and has successfully passed testing. Data within the 510(k) demonstrates successful performance against flame retardant standards.
The Martin Examination Table has been tested to in accordance with standards: UL 60601-1, UL 60601-1-2, and CSA 22.2 No 601-1.
2
ட் LEGALLY MARKETED DEVICE FOR SUBSTANTIAL EQUIVALENCE COMPARISON
| | Mechanical
Wheelchair Predicate | Table
Predicate | Patient Transfer
Predicate |
|-----------------------|------------------------------------|------------------------|------------------------------------------|
| Manufacturer: | Invacare
Corporation | Midmark
Corporation | Nova
Technologies, Inc. |
| Model: | Terminator | 411 | Novabed Patient
Transfer System |
| Cleared Under: | K012167 | K894134 | K874448, K964246 |
| Date Cleared: | August 1, 2001 | 08/28/1989 | December 17,
1987
January 22, 1997 |
| Class: | I | I | II |
| Regulation
Number: | 890.3850 | 878.4960 | 890.3860
880.5100 |
| Product Code(s): | IOR, FRZ, LGX | LGX | FRZ, FNL, IOR |
G. SUMMARY OF SUBSTANTIAL EQUIVALENCE COMPARISON
The new device and the predicate devices have the same intended use which is to provide mobility to persons limited to a sitting position and to transfer patients to and from a wheelchair.
The wheelchair is manually powered and has similar weight bearing capacity. The overall dimensions and materials are similar. The ability to remove the side rails and/or wheels via a contained, quick release axle is also similar compared to Invacare Terminator, K012167. The Invacare Terminator uses an enclosed camber to hold the rear quick release axle. Similarly, the Martin Chair has an enclosed quick release axle and an enclosed positioning pin that secure the side frame of the wheelchair. Like the predicates, the Martin Chair has been tested to and found to meet the applicable FDA recognized ANSI/RESNA consensus standards tested by HERL for mechanical wheelchairs.
The one technological difference between the new device and the predicates is the ability to latch to the Martin Examination Table thus facilitating patient transfer. As described within the 510(k), processes for transferring patients in and out of wheelchairs have previously been established by both the predicate wheelchairs and the Novabed Patient Transfer System. While patient transfer currently takes place routinely using the predicated wheelchair, the technological features between the Martin Chair and the Novabed Patient Transfer System are similar in that both devices provide a means for securing the patient during
3
transfer and placing the patient directly onto the examination table. The method of patient transfer is well established and does not present new issues of safety and effectiveness.
Thus the Martin Chair is substantially equivalent to the predicate devices.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine and health. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Martin Manufacturing Co., LLC % Mr. Michael Zapata, III President 621-101 Hutton Street Raleigh, North Carolina 27606
Re: K080506
Trade/Device Name: Martin Chair Wheelchair Model C4S1, Martin Examination Table Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR, LGX Dated: May 23, 2008 Received: May 23, 2008
JUN - 9 2008
Dear Mr. Zapata:
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 for assuration to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reviassified 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 that i Dri has made a actor regulations administered by other Federal agencies. You must or any I cataled and 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 Of It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in and quality by overns (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2 - Mr. Michael Zapata, III
This letter will allow you to begin marketing your device as described in your Scction 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 the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N Mulkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K080506
Device Name:
Martin Chair Wheelchair Model C4S1
Martin Examination Table
Indications For Use:
The Martin Chair Model C4S1 is indicated for providing mobility to persons limited to a sitting position. It is also specifically indicated to transfer a patient to and from the Martin Examination Table.
The Martin Examination Table is indicated for use during diagnostic examinations or surgical procedures to support and position a patient.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
DRH, Office of Device Evaluation (ODE)
Yeil R.P. Oglan for AKM
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K080506