(215 days)
Not Found
Not Found
No
The description mentions a "microprocessor-controlled" system that reads sensor data and makes decisions based on pre-programmed logic related to gait phases. There is no mention of learning, training data, or adaptive algorithms characteristic of AI/ML.
Yes
The device is intended to provide a safer and more physiologically correct gait for patients with knee instability, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The provided text describes a medical device called the SensorWalk, which is a microprocessor-controlled Knee Ankle Foot Orthosis (KAFO) designed to assist patients with gait instability. Its purpose is to lock and unlock the knee joint during walking, providing support and improving mobility. There is no information in the text to suggest that this device is used for diagnosing a condition.
No
The device description explicitly lists multiple hardware components including a microprocessor, clutch spring knee joint, foot pressure sensors, knee angle sensor, battery, and battery charger. It is a physical orthosis with integrated electronics and sensors.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- SensorWalk Function: The SensorWalk is a mechanical and electronic device designed to assist with walking by controlling knee joint movement. It interacts with the patient's body externally and uses sensors to detect physical parameters (foot pressure, knee angle) to control the orthosis's function.
- Lack of Biological Sample Analysis: The description does not mention the analysis of any biological samples from the patient.
The SensorWalk is clearly described as a medical device, specifically a Knee Ankle Foot Orthosis (KAFO), used for rehabilitation and mobility assistance. Its function is entirely external and mechanical/electronic, not diagnostic based on biological samples.
N/A
Intended Use / Indications for Use
The Sensor Walk is intended solely for the orthotic fitting of the lower limbs and is intended for use by patients who are community ambulators The Sensor Walk is intended for forward walking on level surfaces. when the power is turned on, only, it is non intended for sports or aggressive use.
The Sensor Walk is indicated for patients who exhibit knee instability in the sagittal plane while bearing weight during the stance phase of their gait cycle.
The SensorWalk is intended to lock the knee joint during the stance phase and to unlock the knee joint during the swing phase when walking forward on level surfaces. It is intended solely for the orthotic fitting of the lower limbs of patients who are community ambulators and who:
- Exhibit knee instability in the sagittal plane while bearing weight during the . stance phase of their gait cycle;
- Have hip extensor strength of at least grade 3 (against gravity); .
- Have the muscle strength in their torso or pelvis required to swing the . SensorWalk forward while they are walking;
- Have a gait in which the step length on level ground exceeds the length of the ● opposing foot;
- Weigh 300 pounds or less; and ●
- Are able to understand and carry out the instructions. .
Product codes (comma separated list FDA assigned to the subject device)
IQI, IOI
Device Description
The Sensor Walk is a microprocessor-controlled Knee Ankle Foot Orthosis (KAFO) designed to help wearers achieve a safer, more physiologically correct gait. It does this by unlocking the knee joint when the wearer is ready for swing phase and locking it again for stability during stance phase.
The Sensor Walk system includes an onboard microprocessor, a clutch spring knee joint, foot pressure sensors, a knee angle sensor, a battery, and a battery charger. When the sound limb has been loaded during walking and the affected side is about to enter swing phase (with the toe still on the ground) the microprocessor reads signal information from the foot and knee sensors and allows the knee to go into flexion. When the orthosis begins to extend again, the knee will enter a stable phase, preventing any flexion while allowing full extension for stance phase. The Sensor Walk will support the wearer if they load it at any point while it is extending, offering them exceptional stability. Wearers can disengage the knee joint, such as for sitting, simply by pressing the manual release switch.
The Sensor Walk offers 12 hours of continuous use before it needs to be recharged, and contains an audible warning to alert the use if the battery is running low.
When the Sensor Walk is turned off, it offers the stability of a traditional locked KAFO throughout the gait cycle.
The Sensor Walk has Manual Release Function. A control collar at the knee joint can be manually pushed back to temporarily override the locking mechanism and put the joint into free swing mode. As soon as the collar is reling meetialism und be able to lock.
To override the Sensor Walk's locking mechanism for a longer period, a Manual Release Rocker Switch can be pressed to lock the control collar in the free swing mode. When the Manual Release Rocker Switch is pressed and the joint is in free-swing mode, the switch will show an amber dot to indicate that caution should be used. In normal operating mode, the switch will show a green dot indicating that the locking feature will function normally.
The Sensor Walk™ is comprised of the following parts: a traditional, doubleupright KAFO with a free-articulating medial knee joint; a lateral mechanical clutch, 6 spring knee joint, microprocessor-controlled electronics, foot sensors, a battery, and a battery charger.
The foot sensor plate includes 4 sensors arranged in a straight line on the bottom of the foot plate. They are numbered from 1 to 4, beginning with the most posterior. The sensors overlap by 3/8 inch (10mm), and are wired to a sensor selection switch located in the electronics of the Sensor Walk. The Sensor Walk comes delivered with sensors 1 and 2 activated, but, if necessary, other sensors can be selected to optimize patient fitting.
The Sensor Walk is delivered with the following components:
- . Fabricated KAFO with Sensor Walk (17B500) knee joint and foot sensor (520E500)
- . Battery (517B20) and Charger (517L20)
- . Sensor Walk Instructions for Use
The Sensor Walk comes in either a right or left, laminated or thermoplastic. The Order Numbers are as follows:
- 17B500 == R-L300 == Laminated Right .
- 17B500 = L-L300 Laminated Left
- 17B59() = R-T300 Thermoplastic Right .
- 178500 -- L-T300 -- Thermoplastic Left ゃ
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limbs
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)
Not Found
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.
Not Found
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
§ 890.3475 Limb orthosis.
(a)
Identification. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.
0
Otto Bock®
s 27
QUALITY FOR LIFE
MAY 3 2006
510(k) SUMMARY of SAFETY and EFFECTIVENESS
A. General Information
B.
| 1. | Submitter's Name: | OTTO BOCK HealthCare LP |
|---|---|---|
| 2. | Address: | Two Carlson Parkway N., Suite 100 |
| Minneapolis, MN 55447-4467 | ||
| 3. | Telephone: | 763-489-5142 |
| 4. | Contact Person: | Bill Clover |
| 5. | Date Prepared: | February 8, 2006 |
| 6. | Registration Number: | 2182293 |
| Device | ||
| 1. | Name: | Sensor Walk™ |
| 2. | Trade Name: | Sensor Walk™ |
| 3. | Common Name: | Electronic Stance Control KAFO |
| 4. | Classification Name: | Orthosis, Limb Brace |
| 5. | Product Code: | IQI |
| 6. | Class: | I |
| 7. | Regulation Number: | 890.3475 |
page 1 of 4
Customer Service, Technical Support, and General: 800.328.4058 · Fox 800.962.2549 Fabrication Orders: 877.FAB.OTTO (877.322.6886) • • Fox 800.810.7994 Customer Satisfaction Hotline: 877.627.6583 ww.ottobockus.com
1
Otto Bock®
长652771
C. Identification of Legally Marketed Devices
| 1. Name: | OTTO BOCK FreeWalk |
|---|---|
| 2. K Number: | Not Applicable |
| 3. Date Cleared: | Not Applicable |
D. Description of the Device
The Sensor Walk is a microprocessor-controlled Knee Ankle Foot Orthosis (KAFO) designed to help wearers achieve a safer, more physiologically correct gait. It does this by unlocking the knee joint when the wearer is ready for swing phase and locking it again for stability during stance phase.
The Sensor Walk system includes an onboard microprocessor, a clutch spring knee joint, foot pressure sensors, a knee angle sensor, a battery, and a battery charger. When the sound limb has been loaded during walking and the affected side is about to enter swing phase (with the toe still on the ground) the microprocessor reads signal information from the foot and knee sensors and allows the knee to go into flexion. When the orthosis begins to extend again, the knee will enter a stable phase, preventing any flexion while allowing full extension for stance phase. The Sensor Walk will support the wearer if they load it at any point while it is extending, offering them exceptional stability. Wearers can disengage the knee joint, such as for sitting, simply by pressing the manual release switch.
The Sensor Walk offers 12 hours of continuous use before it needs to be recharged, and contains an audible warning to alert the use if the battery is running low.
When the Sensor Walk is turned off, it offers the stability of a traditional locked KAFO throughout the gait cycle.
The Sensor Walk has Manual Release Function. A control collar at the knee joint can be manually pushed back to temporarily override the locking mechanism and put the joint into free swing mode. As soon as the collar is reling meetialism und be able to lock.
To override the Sensor Walk's locking mechanism for a longer period, a Manual Release Rocker Switch can be pressed to lock the control collar in the free swing
page 2 of 4
Customer Service, Technical Support, and General: 800.328.4058 • Fax 800.962.2549
Fabrication Orders: 877.FAB.OTTO (877.322.6886) • Fax 800.810.7994
Customer Satisfaction Hotline: 877.627.6583
www.ottobockus.com
2
Otto Bock®
UALITY FOR LIF
mode. When the Manual Release Rocker Switch is pressed and the joint is in free-swing mode, the switch will show an amber dot to indicate that caution should be used. In normal operating mode, the switch will show a green dot indicating that the locking feature will function normally.
The Sensor Walk™ is comprised of the following parts: a traditional, doubleupright KAFO with a free-articulating medial knee joint; a lateral mechanical clutch, 6 spring knee joint, microprocessor-controlled electronics, foot sensors, a battery, and a battery charger.
The foot sensor plate includes 4 sensors arranged in a straight line on the bottom of the foot plate. They are numbered from 1 to 4, beginning with the most posterior. The sensors overlap by 3/8 inch (10mm), and are wired to a sensor selection switch located in the electronics of the Sensor Walk. The Sensor Walk comes delivered with sensors 1 and 2 activated, but, if necessary, other sensors can be selected to optimize patient fitting.
The Sensor Walk is delivered with the following components:
- . Fabricated KAFO with Sensor Walk (17B500) knee joint and foot sensor (520E500)
- . Battery (517B20) and Charger (517L20)
- . Sensor Walk Instructions for Use
The Sensor Walk comes in either a right or left, laminated or thermoplastic. The Order Numbers are as follows:
- 17B500 == R-L300 == Laminated Right .
- 17B500 = L-L300 Laminated Left �
- 17B59() = R-T300 Thermoplastic Right .
- 178500 -- L-T300 -- Thermoplastic Left ゃ
E. Intended Use Statement
The Sensor Walk is intended solely for the orthotic fitting of the lower limbs and is intended for use by patients who are community ambulators The Sensor Walk is intended for forward walking on level surfaces. when the power is turned on, only, it is non intended for sports or aggressive use.
The Sensor Walk is indicated for patients who exhibit knee instability in the sagittal plane while bearing weight during the stance phase of their gait cycle.
page 3 of 4
Customer Service, Technical Support, and General: 800.328.4058 • Fax 800.962.2549
Fabrication Orders: 877.FAB.OTTO (877.322.6886) • Fax 800.810.7994
Customer Satisfaction Hotline: 877.827.6583
3
Otto Bock®
sz71
QUALITY FOR LIFE
Patients must:
- Have hip extensor strength of at least grade 3 (against gravity), .
- . Have the muscle strength in their torso or pelvis required to swing the Sensor Walk forward while walking,
- . Have a gait in which the step length on level ground exceeds the length of the opposing foot,
- . Weigh 300 pounds or less,
- . Be able to understand and carry out the instructions.
F. Technological Characteristics Summary
The Sensor Walk is substantially equivalent to the OTTO BOCK FreeWalk which is a Class I. Exempt device according to 21CFR Part 890.3475.
Similarities between both KAFOs are the following:
- KAFO .
- Steel Uprights .
- . Fabricated
- . Indications
- . Materials
- Weight Limit
Differences are the Sensor Walk allows the knee joint to unlock in late stance phase, but not before weight is transferred to the leading limb. The FreeWalk has automatic lock initiated by knee extension.
The Sensor Walk is microprocessor controlled by sensors in the footplate. The FreeWalk is not controlled by sensors but by a mechanical locking mechanism. The Sensor Walk is battery operated that powers the knee joint for 12 hours.
None of the differences raise any new questions of safety or effectiveness that have not been addressed by the developers (OTTO BOCK and Mayo Clinic).
page 4 of 4
Customer Service, Technical Support, and General: 800.328.4058 • Fax 800.962.2549
Fabrication Orders: 877.FAB.OTTO (877.322.6886) • Fax 800.810.7994
Customer Satisfaction Hotline: 877.627.6583
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is written around the top of the circle.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Otto Bock HealthCare LP % Mr. Bill Clover Vice President Research and Development Two Carlson Parkway N., Suite 100 Minneapolis, Minnesota 55447-4467
Re: K052771
Trade/Device Name: Sensor Walk Regulation Number: 21 CFR 890.3475 Regulation Name: Limb orthosis Regulatory Class: Class I Product Code: IOI Dated: February 8, 2006 Received: February 28, 2006
Dear Mr. Clover:
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.
MAY - 3 2006
5
Page 2 - Mr. Bill Clover
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Hubert Lermerrio
fix
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number : K052771
Device Name: Sensor Walk
Indications for Use:
The SensorWalk is intended to lock the knee joint during the stance phase and to unlock the knee joint during the swing phase when walking forward on level surfaces. It is intended solely for the orthotic fitting of the lower limbs of patients who are community ambulators and who:
- Exhibit knee instability in the sagittal plane while bearing weight during the . stance phase of their gait cycle;
- Have hip extensor strength of at least grade 3 (against gravity); .
- Have the muscle strength in their torso or pelvis required to swing the . SensorWalk forward while they are walking;
- Have a gait in which the step length on level ground exceeds the length of the ● opposing foot;
- Weigh 300 pounds or less; and ●
- Are able to understand and carry out the instructions. .
Hubl Limer
Division of General, Restorative, and Neurological Devices
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
510(k) Number K052771
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)