MEDICAL TREATMENT CHAIR, T400, T500,T600

K091727 · Fresenius Medical Care South Asia Pacific Pty , Ltd. · INO · Jul 6, 2009 · Physical Medicine

Device Facts

• Record ID: K091727
• Device Name: MEDICAL TREATMENT CHAIR, T400, T500,T600
• Applicant: Fresenius Medical Care South Asia Pacific Pty , Ltd.
• Product Code: INO · Physical Medicine
• Decision Date: Jul 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3110
• Device Class: Class 2

Indications for Use

The Medical Treatment Chairs are intended for use in medical procedures such as the administration of renal dialysis to, and taking bloods from, patients in hospital departments or home use, under the supervision of trained medical staff. The Medical Treatment Chairs are also intended for use in day surgery and nursing homes. The chairs are designed so that the occupant is accommodated in a seated position with the hips moved back so that the occupant's back is against the back rest and the legs outstretched and supported by the seat and leg rests. The chairs are also used to position patients for easy access by healthcare professionals. The chairs are designed so that the occupant is accommodated in a seated position with the hips moved back so that the occupant's back is against the back rest and the legs outstretched and supported by the seat and leg rests. All models are intended to be used by patients with a weight not exceeding: 130kg (T100 and T200 series) 130kg (T300 and T400 series) 200kg (T500, T550, T600 and T650 series) 300kg (T500B, T600B)

Device Story

Medical Treatment Chairs (T-series) provide patient support and positioning for renal dialysis, blood collection, and chemotherapy. Manually operated models (T100-T300) feature gas-spring assisted backrests, locking castors, and adjustable head/neck rests. Electric-powered models (T400-T650) utilize 2-3 actuators for motorized seat, leg, and backrest adjustment, with some models offering one-touch memory positions and 24V battery backup. Used in hospitals, clinics, and home settings; operated by trained medical staff. Healthcare professionals adjust chair position to optimize patient access during procedures. Benefits include improved patient comfort and ergonomic access for clinicians. Device construction includes reinforced frames for higher weight capacity models.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified via load and repeatability testing. Biocompatibility evaluated per ISO 10993-1. Electrical safety and EMC verified per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

Electric-powered positioning chairs using 24V DC actuators (Linak/Dewert). Materials evaluated per ISO 10993. Compliance with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC). Flame retardant upholstery per California 117 and AS/NZS 4088.1. Features include locking castors, battery backup, and motorized recline/lift.

Indications for Use

Indicated for patients requiring positioning for medical procedures including renal dialysis, blood collection, and chemotherapy in hospital, day surgery, nursing home, or home settings under medical supervision. Weight limits: 130kg (T100-T400 series), 200kg (T500-T650 series), 300kg (T500B, T600B).

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

• Convertible I-Series Positioning and Transfer Chair

Submission Summary (Full Text)

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Fresenius Medical Care

Fresentus Medical Care South Asia: Planfic Pty Ltd

14.9

JUL - 6 2009

Fresenius Medical Care South Asia Pacific Pty Ltd ACN 128 754 218 Level 17. 61 Lavender Street Milsons Point, NSW 2061 Australia Tel: [phone] Fax: [phone]

1691727

# 510(k) Summary

### Submitter Information:

Fresenius Medical Care South Asia Pacific Pty Ltd Artistic Healthcare Seating Division Pty Ltd Level 17, 61 Lavender Street Milsons Point NSW 2061 AUSTRALIA

#### Contact Person:

Mr Ram Kamath Quality, Regulatory Affairs & Management Systems Manager - South Asia Pacific Fresenius Medical Care South Asia Pacific Pty Ltd T: [phone] F: [phone] e: [e-mail]

#### Manufacturer:

Artistic Healthcare Seating Pty Ltd, (Subsidiary of Fresenius Medical Care South Asia Pacific Pty Ltd) 13-15 Century Drive Braeside VIC 3195 Australia

### Device Information:

Fresenius Medical Treatment Chair T-series Trade/Proprietary Name: Medical Treatment Chair Common/Usual Name: Chair, Electric, Positioning Classification Name: Chair, Dialysis, Powered Without Scales

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# Legally Marketed Predicate Device:

Convertible I-Series Positioning and Transfer Chair

# Device Description:

The range of chairs, used to aid medical procedures such as renal dialysis, blood collection and chemotherapy, are called Medical Treatment Chairs and are made up of models T-100, 200, 300, 400, 550, 500B, 550, 600, 600B, 650:

The manually-operated range of treatment chairs (T100, 200, 300) typically have the following features:

- Manually-operated recliner ●
- Adjustable head/neck rest .
- Upholstered arms .
- Four locking braked castors .
- Vinyl-covered .
- The T100, T200 and T300 models offer optional CPR support . posts, gas spring assisted back rest and accessories, whilst other models come standard with these features
- Fold-down trays ●
- Fold-out arms .

The electric-powered range of treatment chairs (T400 through to T600 series) offer the above features in addition to:

- . power-operated seat and leg rest and back rest reclines, with some models offering one-touch memorized positions
- battery back-up 24V rechargeable .
- height-adjustable swing-out arm rests (except the T400) .

The electric-powered chairs, depending on the model, may have different numbers of actuators, i.e:

- . T400 2 actuators
- T500 2 actuators
- T500B 2 actuators, reinforced frame .
- T550 3 actuators ●
- T600 3 actuators
- T600B 3 actuators, 2 motors, reinforced frame, extra lift levers .
- T650 3 actuators

The device is classified as:

- Class I (FMR) .
- 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.

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Image /page/2/Picture/0 description: The image is a technical drawing of a piece of medical equipment, possibly a patient transport or seating device. The drawing shows a three-dimensional view of the equipment, highlighting its various components such as the frame, wheels, adjustable sections, and support structures. The drawing includes some text labels and annotations, providing details about the design and specifications of the equipment.

The following engineering drawing shows the final assembly for the T600 frame:

The configurations of the different models of chairs are shown in the photographs below:

# T100 series

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Image /page/2/Picture/4 description: The image shows a recliner chair. The chair is upholstered and has a high back. The armrests are padded. The chair is in a reclined position. The recliner appears to be old and worn.

T400 series

Image /page/2/Picture/6 description: The image shows a black medical chair with a footrest and armrests. The chair has a high back and appears to be padded for comfort. It is positioned on a wheeled base, suggesting it is designed for easy movement within a medical facility. The chair's design indicates it may be used for patient examinations or treatments.

Image /page/2/Picture/7 description: The image shows a chair with the text "T200 series" at the top. The chair has a boxy design with armrests and a high back. The image is in black and white and has a grainy texture.

T500 series

Image /page/2/Picture/8 description: The image shows the text 'T300 series' in bold, black font. The text is underlined with a thin, black line. The text appears to be a title or heading, possibly indicating a product line or model number.

Image /page/2/Picture/9 description: The image shows a black chair with a footrest. The chair appears to be made of a dark material, possibly leather or vinyl. The footrest is extended, providing a place to rest one's feet. The chair is positioned on a surface that appears to be textured or patterned.

#### T600 series

Image /page/2/Picture/11 description: The image shows a medical recliner chair. The chair is dark in color and has armrests. It has wheels on the bottom for easy movement. There is a small oxygen tank attached to the side of the chair.

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| MODEL | Length<br>Upright<br>(mm) | Length<br>Tren/CPR<br>(mm) | Overall<br>Width<br>(mm) | Seat<br>Width<br>(mm) | Weight<br>Capacity<br>(kgs) | Seat<br>Height<br>to Floor<br>(mm) | Seat<br>Height to<br>Footstool<br>(mm) | Backrest<br>Length<br>(mm) |
|----------------|---------------------------|----------------------------|--------------------------|-----------------------|-----------------------------|------------------------------------|----------------------------------------|----------------------------|
| T100<br>series | 900 | 1800 | 860 | 550 | 130 | 470 | n/a | 700 |
| T200<br>series | 900 | 1800 | 860 | 550 | 130 | 470 | n/a | 700 |
| T300<br>series | 900 | 1800 | 860* | 550 | 150 | 610 | 430 | 700 |
| T400<br>series | 900 | 1800 | 860* | 550 | 150 | 610 | 430 | 700 |
| T500<br>series | 1030 | 1800 | 900 | 600 | 200 | 550 | n/a | 800 |
| T550<br>series | 1300 | 1800 | 900 | 600 | 200 | 550 | n/a | 800 |
| T600<br>series | 1300 | 1800 | 900 | 600 | 200 | 540-840 | n/a | 800 |

### Intended Use:

The Medical Treatment Chairs are intended for use in medical procedures such as the administration of renal dialysis to, and taking bloods from, patients in hospital departments or home use, under the supervision of trained medical staff. The Medical Treatment Chairs are also intended for use in day surgery and nursing homes. The chairs are designed so that the occupant is accommodated in a seated position with the hips moved back so that the occupant's back is against the back rest and the legs outstretched and supported by the seat and leg rests.

The chairs are also used to position patients for easy access by healthcare professionals. The chairs are designed so that the occupant is accommodated in a seated position with the hips moved back so that the occupant's back is against the back rest and the legs outstretched and supported by the seat and leg rests.

All models are intended to be used by patients with a weight not exceeding:

- 130kg (T100 and T200 series) �
- 130kg (T300 and T400 series) .

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- 200kg (T500, T550, T600 and T650 series)
- 300kg (T500B, T600B)

#### Substantial Equivalence:

The Fresenius Medical Treatment Chair T-600 and the predicate devices have similar, and in many cases the same:

- Intended Use ●
- Basic construction .
- Principles of operation .
- Electrical and mechanical characteristics .
- General safety and EMC compliance .

# 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 (Artistic Seating Healthcare Division) has chosen to test the Fresenius Medical Treatment Chair T-600 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 T-600 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. The model chosen for testing was representative of other chairs in the series.

### Electromagnetic Compatibility and Electrical Safety:

The Fresenius Medical Treatment Chair T-600 meets the applicable requirements of IEC 60601-1 General Safety and IEC 60601-1-2 EMC.

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# Cited Standards:

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| CRITICAL AREA | STANDARD |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Quality System<br>standards | ISO 13485:2003 (Medical devices -- Quality management systems --<br>Requirements for regulatory purposes) |
| Risk Analysis<br>standards | ISO 14971:2000 (Medical devices -- Application of risk management to medical<br>devices) |
| Design Control | |
| Flame<br>retardant | California 117 sD p2 (Requirements, Test Procedure and Apparatus for<br>Testing the Flame Retardance of Resilient Filling Materials Used in<br>Upholstered Furniture) |
| | AS/NZS4088.1:1996 (Specification for burning behaviour of upholstered<br>furniture - Upholstery materials for domestic furniture - Smouldering ignitability) |
| | AS 1530.3-1989 (Methods for fire tests on building materials, components and<br>structures - Simultaneous determination of ignitability, flame propagation, heat<br>release and smoke release) |
| Frame loading | AS 4688.2:2000 (Furniture - Fixed height chairs. Part 3: Determination of<br>stability - Upright chairs, s8, s7.1) |
| Electrical | Whole Chair:<br>• IEC60601-1. |
| | Linak actuators:<br>• EN 60601-1-2:2002 EMC test specification for CB open Bus system |
| | • EMC parts of EN 1970:200, EN 60601-2-38:1997 and EN 60601-2-<br>52:2007 |
| | • IEC 60601-1:1988+A1:91+A2:95 |
| | Dewert actuators: |
| | • EN 60601-1/A2:1995 |
| | • EN 60601-2-38:1996 |
| | • EN 60335-1/A2:2006 |
| | • EN 60601-1-2:2001 |
| | • EN 1970:2000 |
| | • EN 60529/A2:2000 |
| Biocompatibility | ISO 10993-1:2003 (Evaluation and testing) |
| 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 980:2003 Graphical 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 |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with stylized lines representing its wings and body.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Fresenius Medical Care South Asia Pacific Pty Ltd. % Mr. Ram Kamath Quality, Regulatory Affairs & Management Systems Manager - South Asia Pacific Level 17, 61 Lavender Street Milsons Point, NSW Australia 2061

JUL - 6 2009

Re: K091727

Trade/Device Name: Medical Treatment Chairs Regulation Number: 21 CFR 890.3110 Regulation Name: Electric positioning chair Regulatory Class: II Product Code: INO Dated: May 8, 2009 Received: June 11, 2009

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 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 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.

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Page 2- Mr. Ram Kamath

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 [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Malkerson

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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310(K) Ruport list Modical Treatment Chairs Freenhus Medical Card - Indications for Use Form

#### Indications for Use

510(k) Number (if known): K091727

Medical Treatment Chairs

Indications for Use:

Device name:

The Medical Treatment Chairs are intended for use in medical procedures such as the The Medical Tradition of renal dialysis to, and taking blood from, patients on home use, under the supervision of trained medical staff. The Medical Treatment on that the on use, unter the supervision of hambe modified home. The chairs are designed so that the occupant intended for use in Gay July one nervity the hips moved back so that the occupant's back is Is accommodated in a ocutou positions and supported by the seat and leg rests.

The chairs are also used to position patients for easy access by healthcare professionals. The The Chairs are designed so that the occupant is accommodated in a seated position with the hips Chairs are designed so that the occupant is accent the back rest and the legs outstretched and supported by the seat and leg rests.

All models are intended to be used by patients with a weight not exceeding:

- 130kg (T100 and T200 series)
- 130kg (T300 and T400 series)
- 200kg (T500, T550, T600 and T650 series)
- 300kg (T500B, T600B)

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 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)

Yuriy L. Slaff

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091727

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