CONVERTIBLE I-SERIES POSITIONING AND TRANSFER CHAIR

K071793 · Barton Medical Corp. · INO · Aug 3, 2007 · Physical Medicine

Device Facts

• Record ID: K071793
• Device Name: CONVERTIBLE I-SERIES POSITIONING AND TRANSFER CHAIR
• Applicant: Barton Medical Corp.
• Product Code: INO · Physical Medicine
• Decision Date: Aug 3, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3110
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The Convertible® I-1000 Positioning & Transfer Chair is an electric positioning chair with motorized positioning control that can be adjusted to various positions. The device is used to alter postural positions and to provide a means of transferring a patient horizontally from a height adjustable bed or trolley, to the chair and vice versa. The chair can then be transformed from a supine position into the sitting position without ever lifting the patient. This device may be used on a wide range of patients, including adults and children up to 1000 pounds.

Device Story

Electric positioning and transfer chair; steel tubular construction with foam-filled upholstery. Operates via hand-held push-button controller; two DC linear actuators enable transition between horizontal supine and sitting positions, plus independent tilt-in-space inclination. Powered by 24-volt rechargeable battery system. Used in clinical or home settings to facilitate horizontal patient transfer from height-adjustable beds or trolleys without patient suspension or manual lifting. Benefits include reduced physical strain on caregivers and improved patient safety during transfers. Healthcare providers operate the device to position patients for mobility or care.

Clinical Evidence

No clinical data. Bench testing only. Device underwent load and repeatability testing to verify functional performance. Biocompatibility testing for skin irritation/sensitization performed per ISO 10993-10; results categorized as negligible. Electrical safety and EMC verified per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

Steel tubular frame; foam-filled upholstery. Dual DC linear actuators; 24V rechargeable battery power. Dimensions/form factor: positioning chair. Connectivity: none. Sterilization: N/A. Standards: IEC 60601-1, IEC 60601-1-2, ISO 10993-10, JIS T9201, EN 12531-12, JIS Z0237.

Indications for Use

Indicated for adults and children up to 1000 lbs requiring postural adjustment or horizontal transfer between a height-adjustable bed/trolley and the chair without manual lifting.

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

• Altimate Medical EasyStand Evolv (K062402)
• Invacare Model LC Series Lift-Out Chair (K002171)

Submission Summary (Full Text)

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K071793

AUG - 3 2007

Image /page/0/Picture/1 description: The image shows the logo for BARTON MEDICAL CORPORATION. The logo is in black and white and features the company name in a bold, sans-serif font. The word "BARTON" is on the top line, and "MEDICAL CORPORATION" is on the bottom line in a smaller font. The logo has a slightly distressed or textured appearance.

www.bartonmedical.com

5725 Hwy 290 West, Suite 103 Austin, TX 78735 Tel: [phone] Fax: [phone]

## 510(k) Summary

Submitter Information:

Barton Medical Corporation 5725 Hwy 290 West Suite #103 Austin, TX 78735 512-176-7199 Phone [phone] Fax

Contact Person:

Lawrence W. Swol Chief Quality Officer 512-476-7199 Phone [phone] Fax Larry. [e-mail] July 19, 2007

Manufacture:

Takano Co., Ltd. 137 Miyada-Mura, Kamuna-Gun Nagano 399-4301 Japan

Device Information:

Trade/Proprietary Name: I-1000 Convertible® I-Series Positioning and Common/Usual Name: Transfer Chair Chair, Electric, Positioning Classification Name:

Legally Marketed Predicate Device:

Altimate Medical EasyStand Evolv; K062402, Sept. 21, 2006 Invacare Model LC Series Lift-Out Chair, K002171, Aug. 10, 2000

Device Description:

The Convertible® Positioning and Transfer Chair construction is made of steel tubular components, on to which is fitted foam filled upholstery. The mechanism allows the Convertible® Positioning and Transfor Chair to transform from the horizontal supine position into a chair, which can then be tilted. This is accomplished through the

510 (k) Summary

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hand-held controller, which in turn operates two DC linear actuators. The first DC actuator allows the Chair and patient profile to change from a sitting position to a horizontal or supine position suitable for transferring. The second DC linear actuator allows the I-1000 to be independently inclined to the rear (Tilt-in-Space). A hand-held push button controller is used to engage actuator motion and vary the I-1000's position. The electric system is composed of a 24-volt rechargeable battery, an external battery charger, and a control unit. Recharging of the battery is accomplished via the external battery charger.

The Convertible® Positioning & Transfer Chair is ideal for moving those patients who are unable to move themselves. The Convertible® Positioning and Transfer Chair have been specifically designed to provide a means of transferring a patient horizontally from a height adjustable bed or trolley, to the chair and vice versa. The patient will always be supported either on the bed and/or the chair and is never suspended. To achieve this, The Barton® Positioning and Transfer System (PTS®) must be used.

#### Intended Use:

The Convertible® I-1000 Positioning & Transfer Chair is an electric positioning chair with motorized positioning control that can be adjusted to various positions. The device is used to alter postural positions and to provide a means of transferring a patient horizontally from a height adjustable bed or trolley, to the chair and vice versa. The chair can then be transformed from a supine position into the sitting position without ever lifting the patient. This device may be used on a wide range of patients, including adults and children up to 1000 pounds.

#### Substantial Equivalence:

The Convertible® I-1000 Positioning and Transfer Chair and the predicate devices have similar, and in many cases, the same:

- Intended use,
- Basic construction,
- Principals of operation,
- Electrical and mechanical characteristics, and
- General safety and EMC compliance.

#### 510 (k) Summary

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## Performance Standards

Although no performance standards or special controls have been developed under Section 514 of the FDC Act for electric positioning chairs, Barton Medical Corporation has chosen to test the Convertible® I-1000 Positioning and Transfer Chair against self imposed load and repeatability test requirements. Representative sample for the device underwent load and repeatability testing to verify functional and performance characteristics.

#### Biocompatibility

Materials that may contact patients used on the Convertible® I-1000 Positioning and Transfer Chair are biocompatible. The material was evaluated for primary skin irritation in accordance with in the guidelines of the requirements of ISO 10993: Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Sensitization. Under the conditions of the study, no erythema and no edema were observed. The response of the test article was categorized as negligible.

### Electromagnetic Compatibility and Electrical Safety

The Convertible® I-1000 I-Series Positioning and Transfer Chair meet the applicable requirements of IEC 60601-1 General Safety and IEC 60601-1-2 EMC.

#### Cited Standards

The Convertible® I-1000 Positioning and Transfer Chair conform to relevant portions of applicable guidance and standards that include the following:

- IEC 60601-1:1998 General Requirements for Safety
- IEC 60601-1-2:2001 Medical Electrical Equipment, -Electromagnetic Compatibility
- JIS T9201:1998 Manually Propelled Wheelchairs -
- ISO 10993-10:2003 Biological Evaluation of Medical Devices -– Part 10: Tests for Irritation and Sensitization
- EN 12531-12:1999 Castors and wheels. Hospital bed castors. ー Test condition 12: Test of castors for hospital beds

JIS Z0237:2000 Adhesive Strength Measurement Conditions 】 510(k) Summary చ్-4

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Barton Medical Corporation % Intertek Testing Services NA, Inc. 2307 East Aurora Road Unit B7 Twinsburg, Ohio 44087 ATTN: Daniel W. Lehtonen

AUG - 3 2007

Re: K071793

Trade/Device Name: Convertible® I-Series (I-1000) Positioning and Transfer Chair Regulation Number: 21 CFR 890.3110 Regulation Name: Electric Positioning Chair Regulatory Class: Class II Product Code: INO. FMR Dated: July 24, 2007 Received: July 25, 2007

Dear Mr. Lehtonen:

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. Iisting 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 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); good manufacturing practice requirements as set

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Page 2 -- Mr. Daniel W. Lehtonen

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.

This letter will allow you to begin marketing your device as described in your Section 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

For

ark N. Melkerson

Mark N. Mel Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

## 510(k) Number (if known): K071793

Device Name:

Convertible® I-Series Positioning and Transfer Chair, Model I-1000

Indications for Use:

The Convertible® I-1000 I-Series Positioning and Transfer Chair is an electric positioning chair with motorized positioning control that can be adjusted to various positions. The device is used to alter postural positions and to provide a means of transferring a patient horizontally from a height adjustable bed or trolley, to the chair and vice versa. The chair can then be transformed from a supine position into the sitting position without ever lifting the patient.

This device may be used on a wide range of patients, including adults and children up to 1000 pounds.

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)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| (Division Sign-Off) | |
| Division of General, Restorative | |
| and Neurological Devices | Page |
| 510(k) Number | K071793 |

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