The BRAVOracer is a lightweight, rigid, high strength aluminum wheelchair for everyday use. This wheelchair provides mobility to physically challenged children. This wheelchair can be moved by the user propelling the hand rims, which are attached to the rear (drive) wheels. This wheelchair can also be pushed by an assistant grasping the pushbar attached to the back rest.
Children who are unable to walk or who have a walking impediment.

Device Description

The BRAVOracer is a lightweight, adaptive, and multifunctional wheelchair. It was designed for children who are unable to walk or who have a walking impediment. This wheelchair can be moved either by the patient him/herself or by another person. The BRAVOracer is a rigid frame of aluminum.Seat height is front and rear adjustable, with various widths and heights. It has a width of 47-66 cm. The seat material is nylon upholstery. All backs are adjustable and all armrests are removable. It has a swing-away footrest with a weight capacity of 60 kg or approximately 132 pounds.

AI/ML Overview

The BRAVOracer is a manual wheelchair that was determined to be substantially equivalent to the predicate device, Start Junior (K073512), based on performance testing to recognized international standards.

Here's a breakdown of the acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Mechanical Safety & Performance Standards	The BRAVOracer was tested and found to meet the requirements of the following standards:
EN 12182	Met
EN 12183	Met
EN/ISO 10993-5	Met
ISO 7176-1	Met
ISO 7176-3	Met
ISO 7176-5	Met
ISO 7176-7	Met
ISO 7176-8	Met
ISO 7176-16	Met
ANSI/RESNA 7176-19	Met
Weight Capacity	60 kg (approximately 132 pounds)
Intended Use	Provides mobility to physically challenged children who are unable to walk or have a walking impediment.
Material	Rigid aluminum frame and nylon upholstery seat (matches predicate's material characteristics)

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not explicitly state the number of BRAVOracer units tested. However, compliance with a suite of international standards (EN, ISO, ANSI/RESNA series) generally implies testing on a representative sample of devices to ensure robustness and consistency.
Data Provenance: The standards testing was conducted by Berlin Cert. While the country isn't explicitly stated for "Berlin Cert", it generally refers to a certification body based in Berlin, Germany. The testing conducted to these standards is typically prospective, meaning the tests are designed and performed specifically to assess the device's adherence to the standard criteria.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This type of information (expert consensus, qualifications) is not applicable to the testing performed for the BRAVOracer. The "ground truth" in this context is defined by objective engineering and safety standards (e.g., strength, stability, durability, biocompatibility), not by expert interpretation of images or clinical outcomes. The testing involves standardized procedures and measurements as defined by the listed EN, ISO, and ANSI/RESNA standards.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation is based on objective measurements and adherence to specified performance limits within the engineering standards, rather than subjective expert review needing adjudication.

5. 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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human interpretation plays a role. The BRAVOracer is a mechanical wheelchair and its evaluation focuses on engineering performance and safety.

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

Not Applicable. The BRAVOracer is a mechanical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used was objective engineering and safety standards. These standards define the acceptable performance parameters and test methods for manual wheelchairs. Compliance with these established standards serves as the "ground truth" for ensuring the device's safety and effectiveness.

8. The Sample Size for the Training Set

Not Applicable. The BRAVOracer is a mechanical device, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no training set, this question is not relevant.

Summary

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Ko82314

OCT 2 8 2008

510(k) SUMMARY of SAFETY and EFFECTIVENESS

A. General Information

Classification Name:
Regulation Number:
Product Code:
Class:

1.	Submitter's Name:	OTTO BOCK Health Care, LP
2.	Address:	Two Carlson Parkway North, Suite 100Minneapolis, Minnesota USA 55447-4467
3.	Telephone:	651-773-0002
4.	Contact Person:	William (Bill) Jackson
5.	Date Prepared:	June 28, 2008
6.	Registration Number:	2182293
B. Device
1.	Name:	BRAVOracer
2.	Trade Name:	BRAVOracer
3.	Common Name:	Manual Wheelchair

IOR

890.3850

Manual Wheelchair

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C. Identification of Legally Marketed Devices

1. Name:	Start Junior
2. K Number:	K073512
3. Date Cleared:	January 14, 2008

D. Description of the Device

The BRAVOracer is a lightweight, adaptive, and multifunctional wheelchair.

It was designed for children who are unable to walk or who have a walking impediment. This wheelchair can be moved either by the patient him/herself or by another person.

The BRAVOracer is a rigid frame of aluminum.Seat height is front and rear adjustable, with various widths and heights. It has a width of 47-66 cm. The seat material is nylon upholstery. All backs are adjustable and all armrests are removable. It has a swing-away footrest with a weight capacity of 60 kg or approximately 132 pounds.

Each wheelchair has the following accessories:

Anti-Tipper .
Transport Wheels ♥
Crutch Holder ●
Clothing Protector or Side Panels .
Drum Brakes ●
Wheel Lock .
. Tray
Lap Bclt .
Aluminum Footrest .
Elevating Footrest .
. Folding Back
Spoke Protectors .
20-24" Rear Wheels #

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E. Intended Use Statement

F. Technological Characteristics Summary

The BRAVOracer is substantially equivalent to the Start Junior, cleared on January 14, 2008 as K073512.

The wheelchair is an aluminum frame, rigid, manual, folding wheelchair for everyday usc with an adjustable seat, removable armrests, and adjustable back heights for users of approximately 60kg or 132 lbs.

The Start Junior was tested by Berlin Cert to the following standards:

. EN 12182
EN 12183 .
EN/ISO 10993-5 .
ISO 7176-1 .
. ISO 7176-3
. ISO 7176-5
� ISO 7176-7
. ISO 7176-8
ISO 7176-16 .
. ANSI/RESNA 7176-19

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 8 2008

Otto Bock Health Care, LP % Mr. William Jackson 2247 Jennifor Lanc Saint Paul, Minnesota 55109

Re: K082314

Trade/Device Name: BRAVOracer Pediatric Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair. Regulatory Class: Class I Product Code: IOR Dated: June 28, 2008 Received: August 28, 2008

Dear Mr. Jackson:

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 cnclosure) 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 (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. 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

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Page 2 - Mr. William Jackson

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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mulkerson

Mark N. Melkerson 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): To be determined

Device Name: BRAVOracer Pediatric Manual Wheelchair

Indications for Use:

. Children who are unable to walk or who have a walking impediment.
Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (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)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number.

Page 1 of 1

Regulation Number and Section

§ 890.3850 Mechanical wheelchair.

(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).