BANTAM

K091242 · Altimate Medical, Inc. · INO · Jul 6, 2009 · Physical Medicine

Device Facts

• Record ID: K091242
• Device Name: BANTAM
• Applicant: Altimate Medical, Inc.
• Product Code: INO · Physical Medicine
• Decision Date: Jul 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3110
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

To assist persons who have difficulty rising from a seated position to a standing position and is indicated for persons weighing between 50 - 100 lbs., including pediatrics.

Device Story

EasyStand Bantam is a standing frame/electric positioning chair for individuals with physical disabilities. Device supports user from sitting to standing position; functions as desk/workstation in seated or standing positions. Available in two models accommodating heights 28"-40" (up to 50 lbs) and 28"-54" (up to 100 lbs). Operation involves manual or electric seat elevation; electric lift activated by hand pendant; gas cylinder allows caregiver-actuated elevation. Includes optional supine position for users unable to tolerate upright posture. Used in clinical or home settings to provide weight-bearing position and exercise body. Benefits include assistance with rising, improved positioning, and workstation utility.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electric positioning chair; manual or electric lift mechanism; gas cylinder for seat elevation; hand pendant control; optional supine positioning. Dimensions vary by model (height ranges 28"-40" or 28"-54").

Indications for Use

Indicated for pediatric and other patients weighing 50-100 lbs. who have difficulty transitioning from a seated to a standing position.

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)

Submission Summary (Full Text)

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Easy Stand Bantam 510(k) Page 36

# JUL - 6 2009

## 510(K) SUMMARY FOR ALTIMATE MEDICAL'S EASYSTAND BANTAM

This summary of 510(k) safety and effectiveness information is being supplied in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92

\$\qquad K091242\qquad.\$

The assigned 510(k) number is ________________________________________________________________________________________________________________________________________________

Date: April 23, 2009

Submitted by: Invacare Corporation Registration No. 1525712 One Invacare Way Elyria, Ohio 44035-4190

Manufacturer: Altimate Medical Registration No. 2183634 262 West First St. Morton, MN 56270

Telephone: [phone] Fax: [phone]

Contact Person: Mr. Carroll Martin

Trade Name: EasyStand Bantam

Common Name: Electric lift chair

Classification Name: Chair, positioning, electric per 21 CFR 890.3110

Legally Marketed Predicate Device(s): Altimate Medical EasyStand Evolv; K062402 September 21, 2006

Device Description: The EasyStand Bantam is a standing frame for indov use that allows users with Device Description. The Easy Dailers is a standing, weight-bearing position. The various degrees of pirysical disability to ob supported in a suitioning. The optional Shadow Tray device is a sit-io stands standing and can be used as a desk/workstation in the seated and/or
supports the user from sitting to standing and can be used as a desk/workstation supports the user from shtting to standing and can over on raise the seat, manually and standing position. The device comes in two il (accommodating individuals ranging in electrically. The device contes in two models, exto Silbs (23kg) and small (accommodating individuals
height from 28" – 40" (71cm – 102 cm) and so books (23kg) neight from 26" - 10 - 10 - 10 - 10 - 137 cm - 137 cm) and up to 100lbs (23kg).

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Intended Use: To assist persons who have difficulty rising from a seated position to a standing position and is indicated for persons weighing between 50 - 100 lbs., including pediatrics.

Substantial Equivalence: Products that are substantially equivalent to the Altimate Medical EasyStand Substantial Equivate Medical EasyStand Evolvo, K062402, September 21, 2006

The EasyStand Bantam is comparable to the EasyStand Evolv in its intended use, construction and I IIE EasyStally Danam-IS comparable to the Basy Start a person in a standing position, providing a tunctionally. The meet ass of provised to a fully standing position and offering a method of means for a person to fise from a between the two devices. The power lift feature is the same in exercising the oody remains the saile other manually by a user operated hydraulic oil both devices in that crevation is accomplished that is activated by a hand pendant. The main differences between the two devices are as follows:

- The user population. The EasyStand Evolv is intended for larger persons (2001) 1277-X I he user population. The Lasyound ENOTA Internet 188 cm) and up to 280lbs (127kg) and the Individuals ranging in neight from 9-18-1-1-1-11-2011 (aling pediatrics) (accommodates Lasyotalio Danian is meinted von 28" – 40" (71cm – 102 cm) and up to 50bs (23kg) and individuals ranging in height from 20 – 10 – (1 cm – 137 cm) and up to 100lbs (23kg). ranging from addition of the power lift feature.
- from adultion of the power int feature.
The EasyStand Bantam comes standard with a gas cylinder to allow for seat elevation that can be actuated only by the caregiver.
- actuation only by the carogr.
The EasyStand Bantam has a supine position option for those users who don't have the neck or -The DasyDuline Bullow them to tolerate an upright position for long periods.

Performance Standards: Although no performance standards or special controls have been developed to test Performance Stailuaus. Anthogir no portoniano vianing chairs, Altimate Medical has chosen to test the EasyStand Bantam against the standards as referenced in this submission.

#### NVACARE CORPORATION

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with stylized lines forming the body and wings.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Altimate Medical, Incorporated % Mr. Carroll L. Martin Regulatory Affairs Manager Invacare Corporation One Invacare Way Elyria, Ohio 44035-4190

JUL - 6 2009

Re: K091242

Trade/Device Name: EasyStand Bantam Regulation Number: 21 CFR 890.3110 Regulation Name: Electric Positioning Chair Regulatory Class: II Product Code: INO Dated: May 15, 2009 Received: May 19, 2009

Dear Mr. Martin:

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.

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

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Page 2- Mr. Carroll L. Martin

(reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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,

for
Mark N. Molkerson
Des

Mark N. Melkerson Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

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

## Device Name: EasyStand Bantam

Indications for Use: The Altimate Medical EasyStand Bantam is intended to assist persons who have difficulty for Use. The Fridate nestion to a standing position and is indicated for persons weighing between 50 - 100 lbs., including pediatrics.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kauran M. Fany

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

510(k) Number K091242

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