(87 days)
K/DEN: Not Found
Not Found
No
The device description focuses on mechanical and electrical features of a treatment chair, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is a medical treatment chair designed to position patients for medical procedures, not to provide therapy itself.
No
The device description clearly states it is a "Medical Treatment Chair" used for positioning patients and aiding medical procedures like dialysis, blood collection, and chemotherapy. It does not mention any function for diagnosing conditions.
No
The device description clearly outlines a physical, electric-powered chair with various mechanical and electrical components, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the chair's function as supporting patients during medical procedures like dialysis, blood collection, and chemotherapy, and positioning patients for healthcare professionals. It does not mention any use in examining specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the physical features and functionalities of a medical chair, such as power-operated adjustments, side arms, headrests, and castors. These are all related to patient positioning and comfort, not to the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of reagents, calibrators, controls, analytical methods, or any other components or processes typically associated with in vitro diagnostic devices.
The device is a medical chair used to support patients during procedures, which falls under the category of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Medical Treatment Chair, T688 series is intended for use in medical procedures such as the administration of renal dialysis to, and collecting blood from, patients in hospital the administration of femal the supervision of trained medical staff. The Medical department Chair is also intended for use in day surgery and nursing homes. T688 chair is Treathent Onali is also intendou for ammodated in a seated position with the hips moved designed so that the occupant's back is against the back rest and the legs outstretched and supported by the seat and leg rests.
T688 series chair is also used to position patients for easy access by healthcare rood sches than 16 also acouned so that the occupant is accommodated in a seated professionals: The Shall "The occupant's back is against the back is against the back rest and the legs outstretched and supported by the seat and leg rests.
Product codes
INO, FKS
Device Description
T688 series chair is used to aid medical procedures such as renal dialysis, blood collection and chemotherapy and is called as Medical Treatment Chair.
T688 series is electric-powered treatment chair with the following features:
- Power-operated seat and leg rest and back rest reclines, with options offering one-. touch memorized positions
- Swing Out Side/Arms .
- Adjustable head/neck rest .
- Adjustable height .
- CPR support posts, gas spring assisted back rest and accessories. .
- . Fold-down trays
- Four individually locking castors .
- Heavy duty washable vinyl .
- Removable upholstery .
- The chair will recline to Trendelenburg position .
- Suitable for side transfer of patients .
- No timber included in the frame .
- Battery back-up-24V rechargeable .
- 2 Actuators & 1 Column .
- Compact Design .
- Lighter weight .
- Reduced components ●
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
trained medical staff. The Medical Treatment Chair is also intended for use in day surgery and nursing homes.
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
Fresenius Medical Care South Asia Pacific Pty Ltd has chosen to test the Fresenius Medical Treatment Chair T688 series against self imposed load and repeatability test requirements. Representative samples for the device underwent load and repeatability testing to verify functional and performance characteristics.
Key Metrics
Not Found
Predicate Device(s)
Fresenius Medical Treatment Chair - T600 Series
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Fresenius Medical Care
K112944 PAGE 1 OF 6
Fresentus Medical Care South Asia Pacific Ply Ltd
DEC 3 0 2011
Fresenius Medical Care South Asia Pacific Pty Ltd ACN 128 754 218 Level 17, 61 Lavender Street Milsons Point. NSW 2061 Australia Tel: +61 (02) 9466 8000 Fax: +61 (02) 9929 5595
510(k) Summary
Submitter Information:
Fresenius Medical Care South Asia Pacific Pty Ltd Level 17, 61 Lavender Street Milsons Point NSW 2061 AUSTRALIA 1
Contact Person:
Mr Ram Kamath Mil Kam Ramath
Quality, Regulatory Affairs & Management Systems Manager - South Asia Pacific Fresenius Medical Care South Asia Pacific Pty Ltd T: +61 2 9466-8023 F: +61 2 9466-8073 . e: ram.kamath@fmc-asia.com
Manufacturer:
Fresenius Medical Care South Asia Pacific Pty Ltd Level 17, 61 Lavender Street Milsons Point NSW 2061 AUSTRALIA
Device Information:
| Trade/Proprietary Name: | Fresenius Medical Treatment Chair T688 Series |
|---|---|
| Common/Usual Name: | Medical Treatment Chair |
| Classification Name: | Chair, Electric, Positioning |
| Chair, Dialysis, Powered Without Scales |
Legally Marketed Predicate Device:
Fresenius Medical Treatment Chair - T600 Series
013
1
Device Description:
T688 series chair is used to aid medical procedures such as renal dialysis, blood collection and chemotherapy and is called as Medical Treatment Chair.
T688 series is electric-powered treatment chair with the following features:
- Power-operated seat and leg rest and back rest reclines, with options offering one-. touch memorized positions
- Swing Out Side/Arms .
- Adjustable head/neck rest .
- Adjustable height .
- CPR support posts, gas spring assisted back rest and accessories. .
- . Fold-down trays
- Four individually locking castors .
- Heavy duty washable vinyl .
- Removable upholstery .
- The chair will recline to Trendelenburg position .
- Suitable for side transfer of patients .
- No timber included in the frame .
- Battery back-up-24V rechargeable .
- 2 Actuators & 1 Column .
- Compact Design .
- Lighter weight .
- Reduced components ●
The device is classified as:
- Class II (FKS, INO) electric-powered version. .
Specific ancillary devices and accessories are not listed here due to the wide variety of procedures in which the chair is used.
2
Image /page/2/Picture/0 description: The image shows a technical drawing of a piece of medical equipment, possibly a specialized chair or stretcher. The drawing includes multiple views and dimensions, providing a detailed representation of the equipment's structure and components. The drawing includes wheels, a frame, and a handle.
The following engineering drawing shows the final assembly for the T688 frame:
The configuration of the chair is shown in the photograph below:
Image /page/2/Picture/3 description: The image shows a black T688 Series recliner chair. The chair has a high back, padded armrests, and a footrest. The chair is on wheels, which makes it easy to move around. There is a small table attached to the left side of the chair.
PAGE 3 OF 6
3
| MODEL | Length
Upright
(mm) | Length
Tren/CPR
(mm) | Overall
Width
(mm) | Seat
Width
(mm) | Weight
Capacity
(kgs) | Seat
Height
to Floor
(mm) | Seat
Height to
Footstool
(mm) | Backrest
Length
(mm) |
|----------------|---------------------------|----------------------------|--------------------------|-----------------------|-----------------------------|------------------------------------|----------------------------------------|----------------------------|
| T688
Series | 930 | 1800 | 730 | 510 | 200 | 590 | n/a | 800 |
Intended Use:
The Medical Treatment Chair, T688 series is intended for use in medical procedures such as the administration of renal dialysis to, and collecting blood from, patients in hospital the administration of femal the supervision of trained medical staff. The Medical department Chair is also intended for use in day surgery and nursing homes. T688 chair is Treathent Onali is also intendou for ammodated in a seated position with the hips moved designed so that the occupant's back is against the back rest and the legs outstretched and supported by the seat and leg rests.
T688 series chair is also used to position patients for easy access by healthcare rood sches than 16 also acouned so that the occupant is accommodated in a seated professionals: The Shall "The occupant's back is against the back is against the back rest and the legs outstretched and supported by the seat and leg rests.
This chair is intended to be used by patients with a weight not exceeding:
- 200kg (T688 series) .
Substantial Equivalence:
The Fresenius Medical Treatment Chair, T688 series and the predicate device (Fresenius Medical Treatment Chair, T600) are substantially equivalent and are similar in characteristics such as:
- Intended Use .
- Basic construction .
- Principles of operation �
- Electrical and mechanical characteristics ●
- General safety and EMC compliance .
However, the T688 series chair is an improved design with advance features when compared to Thower, the 1000 conce thankeight, compact design with central column lift, reduced number of 1000 Senos: 1000 is nghter in weightenance, removable upholstery for easy cleaning, swing out side arms for patient side transfer and adjustable height. Compared to T600, the main difference is side anns for patient side dumn lift, which is a substantial variation to the design resulting in smaller foot print.
4
Performance Standards:
Although no performance standards or special controls have been developed under Section 514 of the FDC Act for Medical Treatment Chairs, Fresenius Medical Care South Asia Pacific Pty Ltd has chosen to test the Fresenius Medical Treatment Chair T688 series against self imposed load and repeatability test requirements. Representative samples for the device underwent load and repeatability testing to verify functional and performance characteristics.
Biocompatibility:
. Materials used on the Fresenius Medical Treatment Chair T688 that may come into contact with patients are biocompatible. The material was evaluated in accordance with guidelines of ISO 10993: Biological Evaluation of Medical Devices, Part 1: Evaluation and testing within a risk management process.
Electromagnetic Compatibility and Electrical Safety:
The Fresenius Medical Treatment Chair T688 series meets the applicable requirements of IEC 60601-1 General Safety and IEC 60601-1-2 EMC.
5
Cited Standards:
| CRITICAL AREA | STANDARD |
|---|---|
| Quality System | |
| standards | ISO 13485:2003 (Medical devices -- Quality management systems -- |
| Requirements for regulatory purposes) | |
| Risk Analysis | |
| standards | ISO 14971:2009 (Medical devices -- Application of risk management to medical |
| devices) | |
| Design Control | |
| Flame | |
| retardant | California 117 sD p2 (Requirements, Test Procedure and Apparatus for |
| Testing the Flame Retardance of Resilient Filling Materials Used in | |
| Upholstered Furniture) | |
| AS/NZS4088.1:1996 (Specification for burning behaviour of upholstered | |
| furniture - Upholstery materials for domestic furniture - Smouldering ignitability) | |
| AS 1530.3-1999 (Methods for fire tests on building materials, components and | |
| structures - Simultaneous determination of ignitability, flame propagation, heat | |
| release and smoke release) | |
| Frame loading | AS 4688.2:2000 (Furniture - Fixed height chairs. Part 3: Determination of |
| stability - Upright chairs, s8, s7.1) | |
| Electrical | Whole Chair: |
| • IEC60601-1 | |
| • IEC60601-1-2 | |
| Biocompatibility | ISO 10993 -1:2008 (Safety Machinery. Evaluation of the emission of airborne |
| hazardous substances. Selection of test methods.) | |
| Castors and brakes | EN 12526 - 12533 Castors and wheels. Hospital bed castors. |
| Labelling | BS EN 1041:2008 Information supplied by the manufacturer of medical devices |
| BS EN 980:2008 Symbols for use in the labelling of medical devices | |
| Clinical | AS ISO 14155-1: 2004 Clinical investigation of medical devices for human |
| subjects - General requirements | |
| AS ISO 14155-2: 2004 Clinical investigation of medical devices for human | |
| subjects - Clinical investigation plans |
:
6
Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings spread and head facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Fresenius Medical Care South Asia Pacific Pty Ltd. % Mr. Ram Kamath Level 17, 61 Lavender Street Milsons Point NSW 2061 Australia
DEC 30 2011
Re: K112944
Trade/Device Name: Medical Treatment Chairs - T688 Series Regulation Number: 21 CFP. 890.3110 Regulation Name: Electric positioning chair Regulatory Class: Class II Product Code: INO, FKS Dated: September 26, 2011 Received: October 4, 2011
Dear Mr. Kamath:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
7
Page 2 - Mr. Ram Kamath
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/ReportaProblem/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 vours.
Sincerely yours,
Mark McMillen
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use Form
Indications for Use
510(k) Number (if known): _ K1129444
Device Name: Medical Treatment Chairs - T688 Series
Indications for Use:
The Medical Treatment Chair, T688 Series is intended for use in medical procedures such The Medical Preatinent Chalysis to, and collecting blood from, patients in hospital departments or home use, under the supervision of trained medical staff. The Medical Treatment Chair is also intended for use in day surgery and nursing homes. T688 chair is I readined so that the occupant is accommodated in a seated position with the hips moved designed so that the occupant is against the back rest and the legs outstretched and supported by the seat and leg rests.
T688 chair is also used to position patients for easy access by healthcare professionals. The I voo enair is designed so that the occupant is accommodated in a seated position with the hips enair is decired or that the occupant's back is against the back rest and the legs outstretched and supported by the seat and leg rests.
This chair is intended to be used by patients with a weight not exceeding:
- 200kg (T688 series) .
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature Sign Off
(Diy'sion Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number _
012