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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

The document doesn't explicitly list "acceptance criteria" in a typical quantitative format (e.g., "Accuracy > 90%"). Instead, it describes compliance with various standards and self-imposed test requirements for functional and performance characteristics. The "reported device performance" is primarily stated as meeting these standards and requirements.

Table of Acceptance Criteria and Reported Device Performance

Critical Area/Acceptance Criteria (Implied)	Standard Met/Reported Device Performance
Quality System	ISO 13485:2003
Risk Analysis	ISO 14971:2000
Design Control	(Not specified, but generally implied by QS)
Flame Retardancy	California 117 sD p2, AS/NZS4088.1:1996, AS 1530.3-1989
Frame Loading	AS 4688.2:2000 (Specifically for stability)
Electrical Safety (Whole Chair)	IEC 60601-1
Electrical Safety (Linak actuators)	EN 60601-1-2:2002 (EMC), EMC parts of EN 1970:200, EN 60601-2-38:1997, EN 60601-2-52:2007, IEC 60601-1:1988+A1:91+A2:95
Electrical Safety (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
Labeling	BS EN 1041:2008, BS EN 980:2003
Clinical Investigation	AS ISO 14155-1:2004, AS ISO 14155-2:2004
Self-imposed Load and Repeatability	"Representative samples for the device underwent load and repeatability testing to verify functional and performance characteristics." (Implied successful Verification)
Weight Capacity	- T100, T200, T300, T400 series: 130kg
	- T500, T550, T600, T650 series: 200kg
	- T500B, T600B: 300kg
Substantial Equivalence	Found substantially equivalent to the Convertible I-Series Positioning and Transfer Chair in intended use, basic construction, principles of operation, electrical and mechanical characteristics, and general safety and EMC compliance.

Study Details

The document describes pre-market testing and adherence to various recognized standards rather than a typical "study" in the sense of an AI/software device performance evaluation. The "device" in question is a medical treatment chair, primarily a mechanical and electrical device, not an AI or diagnostic tool.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: "Representative samples for the device" were used for load and repeatability testing. A specific number is not provided.
Data Provenance: Not explicitly stated, but the company (Fresenius Medical Care South Asia Pacific Pty Ltd) has its primary contact in Australia, and several cited standards are Australian (AS/NZS, AS). Testing would likely have been conducted in a relevant facility that adheres to these international and local standards, potentially in Australia or a subcontracted testing lab. The testing for substantial equivalence is implied to be prospective verification against defined standards.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the device is a medical chair, not a diagnostic or AI device requiring expert ground truth for output evaluation. Performance is assessed against engineering and safety standards.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Performance is determined by meeting specified technical requirements of the cited standards, not by human consensus or adjudication of results.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (a chair).

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance is against established engineering, electrical, mechanical, safety, flame retardancy, and biocompatibility standards (e.g., ISO, IEC, AS, EN, California standards). These standards define acceptable performance metrics and test methods. The weight capacities are also a form of "ground truth" against which the chairs were tested.

7. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

8. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

Summary

{0}------------------------------------------------

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: +61 (02) 9466 8000 Fax: +61 (02) 9929 5595

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: +61 2 9466-8023 F: +61 2 9466-8073 e: sr.kamath@fmc-asia.com

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

{1}------------------------------------------------

Legally Marketed Predicate Device:

Convertible I-Series Positioning and Transfer Chair

Device Description:

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.

{2}------------------------------------------------

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

ي تركيب في القرب الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع ال :

1 - -

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.

{3}------------------------------------------------

MODEL	LengthUpright(mm)	LengthTren/CPR(mm)	OverallWidth(mm)	SeatWidth(mm)	WeightCapacity(kgs)	SeatHeightto Floor(mm)	SeatHeight toFootstool(mm)	BackrestLength(mm)
T100series	900	1800	860	550	130	470	n/a	700
T200series	900	1800	860	550	130	470	n/a	700
T300series	900	1800	860*	550	150	610	430	700
T400series	900	1800	860*	550	150	610	430	700
T500series	1030	1800	900	600	200	550	n/a	800
T550series	1300	1800	900	600	200	550	n/a	800
T600series	1300	1800	900	600	200	540-840	n/a	800

Intended Use:

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

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

{4}------------------------------------------------

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.

{5}------------------------------------------------

Cited Standards:

、

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.............................................................................................................................................................................. :

:

CRITICAL AREA	STANDARD
Quality Systemstandards	ISO 13485:2003 (Medical devices -- Quality management systems --Requirements for regulatory purposes)
Risk Analysisstandards	ISO 14971:2000 (Medical devices -- Application of risk management to medicaldevices)
Design Control
Flameretardant	California 117 sD p2 (Requirements, Test Procedure and Apparatus forTesting the Flame Retardance of Resilient Filling Materials Used inUpholstered Furniture)
	AS/NZS4088.1:1996 (Specification for burning behaviour of upholsteredfurniture - Upholstery materials for domestic furniture - Smouldering ignitability)
	AS 1530.3-1989 (Methods for fire tests on building materials, components andstructures - Simultaneous determination of ignitability, flame propagation, heatrelease and smoke release)
Frame loading	AS 4688.2:2000 (Furniture - Fixed height chairs. Part 3: Determination ofstability - Upright chairs, s8, s7.1)
Electrical	Whole Chair:• IEC60601-1.
	Linak actuators:• 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 60601-2-52:2007
	• 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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{6}------------------------------------------------

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{7}------------------------------------------------

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.

{8}------------------------------------------------

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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

{9}------------------------------------------------

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

Page 1 of

Fax2/5

Regulation Number and Section

§ 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.