(108 days)
The Balder Finesse and Balder Junior stand-up powered wheelchairs by Etac are indoor/outdoor battery operated multifunctional wheelchairs. The intended use of these powered wheelchairs is to provide mobility to persons that have the capability of operating a powered wheelchair.
The Balder Finesse and Balder Junior powered wheelchairs are front-wheel driven power wheelchairs that have been designed and developed to be used in both indoor and outdoor environments. and to transport one (1) person at a time. The wheelchairs are outfitted with a seat lift, so that its user can reach objects on high shelves as well as slide their legs under the table when seated. The Balder Finesse and Balder Junior powered wheelchairs can also be purchased with a stand-up function option that allows the user to be placed in a stand-up position, thus allowing them to operate the wheelchair while standing. The Balder Finesse and Balder Junior powered wheelchairs operate using an electric, front-wheel drive motor that is driven by two (2) 12 Volt, 52 Amp dry cell batteries, and contains a D.C. permanent magnet type motor that uses graphite-copper brushes with integrated brakes (12/24V). The wheelchair frame is of welded steel construction and includes the rear castor wheels, front driving wheels with drive motor (i.e., motor, gear, brakes) and batteries. The motor controller, with joystick, can be mounted on either the left or right armrest depending on the user's needs. The motor controller, with joystick and software that is found in each wheelchair is manufactured by Dynamic Controls, a division of Invacare Corporation, and was previously cleared by the FDA on May 12, 1997 (see K970094).
The provided submission K072475 for the Balder Finesse and Balder Junior Powered Wheelchairs is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical performance metrics through a study.
Therefore, many of the requested items related to a clinical performance study (like sample size for test set, number of experts, adjudication methods, MRMC studies, specific ground truth types, and training set details) are not applicable or not provided in this type of submission.
The "acceptance criteria" here relate to compliance with recognized standards and substantial equivalence to a predicate device.
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Safety and Effectiveness Equivalence | The Balder Finesse and Balder Junior stand-up powered wheelchairs are designed to be as safe and effective as the predicate device (LEVO Comfort II K051387) and do not raise different questions regarding safety and effectiveness. |
| Compliance with Applicable ISO and EN Standards | The Balder Finesse and Balder Junior stand-up powered wheelchairs have been designed, manufactured, and tested for conformance to applicable ISO and EN standards. (Specific standards are not listed in this summary but referenced in the full submission). |
| Compliance with FDA Guidance Document | The Balder Finesse and Balder Junior stand-up powered wheelchairs passed all required consensus standards testing for conformance to the FDA's Guidance Document For the Preparation of Premarket Notification [510(K)] Applications For Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles. |
Study Details (Generally Not Applicable for 510(k) Substantial Equivalence for this type of device)
- Sample size used for the test set and the data provenance: Not applicable. This submission relies on engineering testing against consensus standards and a comparison to a predicate device, not a performance study with a clinical test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/diagnostic devices is not relevant here. Compliance with standards and substantial equivalence are the "ground truth."
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 or assistive technology in that context.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this submission is established through compliance with recognized consensus standards (ISO, EN, FDA Guidance) and the demonstrated equivalence to a legally marketed predicate device.
- The sample size for the training set: Not applicable. This is not a machine learning/AI device that requires a training set in that sense.
- How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
K072475
SECTION 5 – 510(k) SUMMARY
| Submission Correspondent: | Emergo Group, Inc. |
|---|---|
| Address: | 1705 S. Capital of Texas HwySuite 500Austin, TX 78746 |
| Phone: | (512) 327-9997 |
| Fax: | (512) 327-9998 |
| Contact: | Mr. Ian Gordon |
| Submission Sponsor: | Etac Sverige ABSE-16541 Kista, SwedenTel: +46.8.633 47 00Fax: +46.8.653 18 70www.etac.com |
| Date Prepared: | August 17, 2007 |
| Trade Name(s): | (1) Balder Finesse Powered Wheelchair(2) Balder Junior Powered Wheelchair |
| Common/Usual Name: | Powered Standup Wheelchair |
| Classification Name: | Wheelchair, Stand-up |
| Classification Number: | 890.3900 |
| Classification Panel: | Physical Medicine Devices |
| CDRH Product Code: | IPL |
| Regulatory Class: | II |
| Description: | The Balder Finesse and Balder Junior poweredwheelchairs are front-wheel driven powerwheelchairs that have been designed and developedto be used in both indoor and outdoor environments.and to transport one (1) person at a time. The |
| wheelchairs are outfitted with a seat lift, so that itsuser can reach objects on high shelves as well asslide their legs under the table when seated. TheBalder Finesse and Balder Junior poweredwheelchairs can also be purchased with a stand-upfunction option that allows the user to be placed in astand-up position, thus allowing them to operate thewheelchair while standing. | |
| The Balder Finesse and Balder Junior poweredwheelchairs operate using an electric, front-wheeldrive motor that is driven by two (2) 12 Volt, 52Amp dry cell batteries, and contains a D.C.permanent magnet type motor that uses graphite-copper brushes with integrated brakes (12/24V). | |
| The wheelchair frame is of welded steelconstruction and includes the rear castor wheels,front driving wheels with drive motor (i.e., motor,gear, brakes) and batteries. The motor controller,with joystick, can be mounted on either the left orright armrest depending on the user's needs. | |
| The motor controller, with joystick and softwarethat is found in each wheelchair is manufactured byDynamic Controls, a division of InvacareCorporation, and was previously cleared by theFDA on May 12, 1997 (see K970094). | |
| Intended Use: | The Balder Finesse and Balder Junior stand-uppowered wheelchairs by Etac are indoor/outdoorbattery operated multifunctional wheelchairs. Theintended use of these powered wheelchairs is toprovide mobility to persons that have the capabilityof operating a powered wheelchair. |
| Predicate Devices: | 1. LEVO Comfort II (K051387); Wheelchair (IPL)2. DX Micro Computer Control for PowerWheelchairs (K970094); Controller (ITI) |
| Safety and Effectiveness: | By definition, a device is substantially equivalent toa predicate device when the device has the sameintended use and the same technologicalcharacteristics as the previously cleared predicatedevice, or has the same intended use and differenttechnological characteristics. But, it can be |
{1}------------------------------------------------
:
{2}------------------------------------------------
| Performance Data: | demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device. |
|---|---|
| As such, it has been shown in this 510(k) submission, that the differences between the Balder Finesse and Balder Junior stand-up powered wheelchairs by Etac and the predicate device, the LEVO Comfort II (K051387), do not raise any questions regarding their safety and effectiveness. | |
| The Balder Finesse and Balder Junior stand-up powered wheelchairs by Etac as designed are as safe and effective as the predicate device and therefore are determined to be substantially equivalent to the referenced predicate device. | |
| The Balder Finesse and Balder Junior stand-up powered wheelchairs by Etac have been designed, manufactured and tested for conformance to the applicable ISO and EN standards as referenced in this submission. In addition, the Balder Finesse and Balder Junior stand-up powered wheelchairs passed all required consensus standards testing for conformance to the FDA's Guidance Document For the Preparation of Premarket Notification [510(K)] Applications For Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles. |
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
DEC 2 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Etac Sverige AB % Emergo Group, Inc. Mr. Ian Gordon Senior Vice President 1705 Capital of Texas Highway, Suite 500 Austin, Texas 78746
Re: K072475
Trade/Device Name: Balder Finesse and Balder Junior Regulation Number: 21 CFR 890.3900 Regulation Name: Standup Wheelchair Regulatory Class: Class II Product Code: 89IPL Dated: November 29, 2007 Received: December 03, 2007
Dear Mr. Gordon:
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 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 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.
{4}------------------------------------------------
Page 2 - Mr. Ian Gordon
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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.
Mark N Mullens
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Balder Finesse and Balder Junior
Indications for Use:
The Balder Finesse and Balder Junior stand-up powered wheelchairs by Etac are indoor/outdoor battery operated multifunctional wheelchairs. The intended use of these powered wheelchairs is to provide mobility to persons that have the capability of operating a powered wheelchair.
Prescription Use _ X (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)
/`
(Division Sig-Off)
Division of General, Restorative, and Neurological I
510(k) Number
§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).