(87 days)
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) .
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.
The Fresenius Medical Treatment Chair T688 Series is a medical treatment chair designed for use in medical procedures such as renal dialysis, blood collection, and chemotherapy, under the supervision of trained medical staff. It is also intended for use in day surgery and nursing homes.
Here's an analysis of the acceptance criteria and the study proving the device meets these criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Weight Capacity | 200 kg (T688 series) |
| Biocompatibility | Materials used that may come into contact with patients are biocompatible, conforming to ISO 10993: Biological Evaluation of Medical Devices, Part 1. |
| Electrical Safety | Meets applicable requirements of IEC 60601-1 General Safety. |
| Electromagnetic Compatibility (EMC) | Meets applicable requirements of IEC 60601-1-2 EMC. |
| Frame Loading | Tested against AS 4688.2:2000 (Furniture - Fixed height chairs. Part 3: Determination of stability - Upright chairs, s8, s7.1) |
| Flame Retardancy | Tested against California 117 sD p2, AS/NZS4088.1:1996, and AS 1530.3-1999 for various aspects of flame retardance. |
| Quality System Compliance | ISO 13485:2003 (Medical devices -- Quality management systems -- Requirements for regulatory purposes) |
| Risk Analysis Compliance | ISO 14971:2009 (Medical devices -- Application of risk management to medical devices) |
| Castors and Brakes | Conforms to EN 12526 - 12533 Castors and wheels. Hospital bed castors. |
| Labeling | Conforms to BS EN 1041:2008 and BS EN 980:2008. |
| Dimensional Specifications | - Length Upright: 930 mm |
- Length Tren/CPR: 1800 mm
- Overall Width: 730 mm
- Seat Width: 510 mm
- Seat Height to Floor: 590 mm
- Backrest Length: 800 mm |
2. Sample Size Used for the Test Set and the Data Provenance
The document states that "Representative samples for the device underwent load and repeatability testing to verify functional and performance characteristics." It does not specify the exact sample size for these tests. There is no information provided regarding data provenance (e.g., country of origin of the data, retrospective or prospective) for any of the testing mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device is a medical treatment chair, and its performance is evaluated against engineering standards and functional requirements, not against ground truth established by experts in a diagnostic context.
4. Adjudication Method for the Test Set
Not applicable, as the testing involves engineering and performance standards rather than subjective assessments requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or data, which is not the case for a medical treatment chair.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. The device is a physical medical chair and does not involve an algorithm for standalone performance. Its performance is assessed through physical and electrical testing against established standards.
7. The Type of Ground Truth Used
The ground truth for this device is based on engineering standards, functional specifications, and safety requirements. This includes:
- Specified weight capacity (200 kg).
- Compliance with various ISO, IEC, AS/NZS, BS EN standards for biocompatibility, electrical safety, EMC, flame retardancy, quality management, risk analysis, and component specifications (e.g., castors).
- Internal "self-imposed load and repeatability test requirements" to verify functional and performance characteristics.
8. The Sample Size for the Training Set
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
§ 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.