K Number

Device Name

CENTRO FAMILY OF MANUAL WHEELCHAIRS

Manufacturer

OTTO BOCK HEALTHCARE, LP

Date Cleared

2011-07-15

(91 days)

Product Code

IOR

Regulation Number

890.3850

Intended Use

The Centro wheelchairs are designed solely for individual use by persons who are unable to walk or who have a walking impediment, and can be operated either by the patient or by another person. Centro wheelchairs are suitable for patients with walking impediments/inability due to, but not limited to: - . Palsies/Paralyses - . Defective and/or deformed limbs - Loss of limb (leg amputation) . - . Joint contractures/defects - Diseases such as cardiac or circulatory insufficiency, balance disorders . or cachexia, as well as geriatric patients who still have usable residual strength in the upper limbs.

Device Description

The Centro Wheelchairs are an uncomplicated line of wheelchair (S1 and A3 models) and are appropriate for short-term use. The Centro wheelchairs are very robust, which ensures that they will have a long service life. The product has a functional knee lever lock. The stable cross brace ensures that it folds easily. Thus, the Gentro can be folded to a very small size easily, and it is convenient to transport or space-saving for storage. The Centro with 124 rear wheels offers the possibility to use it as a functional transit wheelchair. Due to the nylon covering of seat and back upholstery, the chairs are easy to clean or disinfect and thus always quickly ready for use.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K052681

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical features, durability, and compliance with standards for manual wheelchairs. There is no mention of AI or ML.

Therapeutic

No.
The Centro Wheelchair is a mobility aid designed for individuals with walking impediments, but it does not provide any therapeutic intervention or treatment for these conditions.

Diagnostic

The device is a wheelchair designed for individuals with walking impediments. Its function is to provide mobility and aid, not to diagnose medical conditions or provide medical insights.

SaMD (Software as a Medical Device)

The device description clearly outlines a physical wheelchair with various hardware components and features. There is no mention of any software component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the Centro wheelchairs are designed for individuals with walking impediments or inability to walk. This is a physical aid for mobility.
Device Description: The description details the physical components and features of a wheelchair, such as the frame, footrests, wheels, and braking system. These are all related to providing mobility support.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information about a physiological or pathological state, or to monitor therapeutic measures. This is the core definition of an IVD.
Performance Studies: The performance studies listed are related to the physical and mechanical properties of the wheelchair (stability, braking, dimensions, strength), not diagnostic accuracy or performance related to analyzing biological samples.
Predicate Device: The predicate device listed (Start – Mobile Positioning System) is also a mobility aid, not an IVD.

In summary, the Centro wheelchair is a medical device designed to assist with mobility, not a device used for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

. Palsies/Paralyses
. Defective and/or deformed limbs
Loss of limb (leg amputation) .
. Joint contractures/defects
Diseases such as cardiac or circulatory insufficiency, balance disorders . or cachexia, as well as geriatric patients who still have usable residual strength in the upper limbs.

Product codes (comma separated list FDA assigned to the subject device)

IOR

Device Description

The Centro with 124 rear wheels offers the possibility to use it as a functional transit wheelchair. Due to the nylon covering of seat and back upholstery, the chairs are easy to clean or disinfect and thus always quickly ready for use.
Features

. Silver-colored frame made of aluminum or steel
Footrests with swinq in/swing out function, removable .
Side panels adjustable, can be swung away to the rear .
Small folded size .
Single stable steel cross-brace .
. 8 Variants available from stock
. 6" caster of solid rubber
Variant with drum brakes available ●
. Tip-Assist included
. Knee lever lock standard
Options
. Anti-tipper
. Desk Side Panels
Fold-down Footrests
Lap belt .
Transfer Version with 12" Drive Wheel .
Heel Band ●
Seat Cushion Sizes .
Crutch holder .

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

TÜV – test for medical devices (requirements according to the European Directive for Medical Products 93/42/EEC, DIN EN 12183:1999, DIN EN 12182:1999, and tests specified for wheelchairs (DIN EN 1888). The product is certified for CE conformity and its suitability for daily use was verified in a field test.

Additional product testing to the following ISO standards was conducted by Berlin Cert, Institute for Testing and Certification of Medical Devices: (http://www.berlincert.de/de/frameset.php?lang=en&page=home )

DIN EN 12182:1999 Technical aids for disabled persons
DIN EN 12183:1999 manually propelled wheelchairs requirements & test methods
ISO 7176-1:1999 -- Wheelchairs -- Part 3: Determination of static stability
ISO 7176-3:2003 Wheelchairs Part 3: Determination of efficiency of brake
ISO 7176-5:1986 Wheelchairs Part 5: Determination of dimensions, turning space
ISO 7176-7:1998 Wheelchairs part 7: Measurement of seating & wheel dimensions
ISO 7176-8:1998 Wheelchairs Part 8: Requirements, static impact/fatigue strengths
ISO 7176-15:1996 Wheelchairs Part 15: Requirement for labeling

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K052681

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

OTTO BOCK®

QUALITY FOR LIFE

K111045
JUL 15 2011

510(k) SUMMARY of SAFETY and EFFECTIVENESS

A. General Information

1. Submitter's Name.:	OTTO BOCK Health Care, LP
2. Address:	Two Carlson Parkway North, Suite 100
Minneapolis, Minnesota USA 55447-4467
3. Telephone:	763-253-5610
4. Contact Person:	William Kabitz, Quality Assurance Manager
5. Date Prepared:	March 29th, 2011
6. Registration Number:	2182293

B. Device

1. Name:	Centro Family of Wheelchairs
2. Trade Name:	Centro S1 and Centro A3
3.Common Name:	Manual Wheelchair
4. Classification Name:	Wheelchair, Manual
5. Product Code:	IOR
6. Class:	I
7. Regulation Number:	890.3850

C. Identification of Legally Marketed Predicate Device

1. Name:	Start – Mobile Positioning System
2. Manufacture:	Otto Bock HealthCare, Mobility Solutions
3. K Number:	K052681
4. Date Cleared:	October 06, 2005

D. Description of the Device

్లో ప్ర

Otto Bock®

QUALITY FOR LIFE

Features

. Silver-colored frame made of aluminum or steel
Footrests with swinq in/swing out function, removable .
Side panels adjustable, can be swung away to the rear .
Small folded size .
Single stable steel cross-brace .
. 8 Variants available from stock
. 6" caster of solid rubber
Variant with drum brakes available ●
. Tip-Assist included
. Knee lever lock standard

Options

. Anti-tipper
. Desk Side Panels
Fold-down Footrests
Lap belt .
Transfer Version with 12" Drive Wheel .
Heel Band ●
Seat Cushion Sizes .
Crutch holder .

E. Indicated Use Statement

The Centro wheelchairs are designed solely for individual use by persons who are unable to walk or who have a walking impediment, and can be operated either by the patient or by another person.

F. Field of Application

The Centro S1 and A3 standard wheelchairs are suitable for patients with walking impediments/inability due to, but not limited to:

. Palsies/Paralyses
Defective and/or deformed limbs .
Loss of limb (leg amputation) .
. Joint contractures/defects
. Diseases such as cardiac or circulatory insufficiency, balance disorders or cachexia, as well as geriatric patients who still have usable residual strength in the upper limbs.

Otto Bock®

UALITY FOR LIF

G. Technological Characteristics Summary

DIN EN 12182:1999 Technical aids for disabled persons
DIN EN 12183:1999 manually propelled wheelchairs requirements & test methods
ISO 7176-1:1999 -- Wheelchairs -- Part 3: Determination of static stability
ISO 7176-3:2003 Wheelchairs Part 3: Determination of efficiency of brake
ISO 7176-5:1986 Wheelchairs Part 5: Determination of dimensions, turning space
ISO 7176-7:1998 Wheelchairs part 7: Measurement of seating & wheel dimensions
ISO 7176-8:1998 Wheelchairs Part 8: Requirements, static impact/fatigue strengths
ISO 7176-15:1996 Wheelchairs Part 15: Requirement for labeling

Signatures:

Quality Assurance Manager
mf Kabitz

President & CEO US Healthcare

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 stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OTTO Bock Health, Care, LP % Mr. William Kabitz Quality Assurance Manager Two Carlson Parkway North, Suite 100 Minneapolis, Minnesota 55447

JUL 1 5 2011

Re: K111045

Trade/Device Name: Centro Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: April 1, 2011 Received: April 18, 2011

Dear Mr. Kabitz:

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 note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

Page 2 - Mr. William Kabitz

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

El Keith

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

Enclosure

Otto Bock®

QUALITY FOR LIFE

APPENDIX F

Indications For Use Form

510(k) Number (if known): To be determined

Device Name: Centro Manual Wheelchair

Indications for Use:

. Palsies/Paralyses
. Defective and/or deformed limbs
Loss of limb (leg amputation) .
. Joint contractures/defects
Diseases such as cardiac or circulatory insufficiency, balance disorders . or cachexia, as well as geriatric patients who still have usable residual strength in the upper limbs.

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

KIII Q45 510(k) Number .

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)