(103 days)
Not Found
No
The summary describes a prosthetic knee with sensors and a hydraulic damper, but there is no mention of AI, ML, or any related concepts like training data or performance metrics typically associated with AI/ML devices.
No
The device is a prosthetic knee, which replaces a missing limb. While it assists with functional movement, its primary role is replacement and support, not active therapy or treatment of a disease.
No
Explanation: A diagnostic device is used to identify a disease, condition, or injury. This device, REL-k, is a prosthetic knee intended to replace a missing or deformed limb, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly lists multiple hardware components including sensors, a hydraulic damper, battery, electronics compartment, and a carbon fiber shell.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the REL-k is a prosthetic knee used to replace a missing or deformed limb and assist with walking. This is a therapeutic or rehabilitative function, not a diagnostic one.
- Device Description: The components listed (Pyramidal Head, Angular Sensor, Force sensor, Servo assisted Hydraulic Damper, etc.) are all related to the mechanical and functional aspects of a prosthetic limb. None of them are involved in testing samples from the human body to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The REL-k does not fit this description.
N/A
Intended Use / Indications for Use
REL-k is a prosthetic knee, important element of a lower limb prosthesis, a medical device that is used to replace a missing or deformed limb in both static and dynamic deambulation functions
Product codes
89 ISY
Device Description
The Rel-k is an artificial limb prosthesis indicated for individuals that have undergone a trans-femoral amputation. The Rel-k is intended to replace a missing or deformed limb and functions in both normal/standing (static) and dynamic walking.
The Rel-k consists of:
- . Pyramidal Head
- Angular Sensor .
- . Force sensor
- . Servo assisted Hydraulic Damper (MPC damper)
- Removable Battery and electronics compartment .
- Carbon Fiber Shell (outer casing)
- . Attachment for a standard 30mm diameter tube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limb
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3420 External limb prosthetic component.
(a)
Identification. An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.(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
510(k) Summary of Safety and Effectiveness
OCT 1 3 2010
A. General Information
| 1. | Submitter's Name: | Rizzoli Ortopedia, S.p.A. |
|---|---|---|
| 2. | Submitter's Address: | Via C. Battisti 44 - 40054 BUDRIO (BO) - ITALIA |
| 3. | Submitter's Telephone: | +390516930735 |
| 4. | Contact Person: | Diane C. Tiernan, MS RAC |
| Consultant | ||
| McCormick LifeScience Consultants | ||
| 58A Bates Road | ||
| Watertown, MA 02472 | ||
| 5. | Date Prepared: | July 1, 2010 |
| 6. | Registration Number: | not yet assigned |
| B. Device | ||
| 1. | Name: | Rel-k |
| 2. | Trade Name: | Rel-k |
| 3. | Common Name: | External Limb Prosthetic Component (Knee) |
| 4. | Classification Name: | External Limb Prosthetic Component (Knee) |
| 5. | Product Code: | 89 ISY |
| 6. | Class: | I, Exempt |
C. Identification of Legally Marketed Devices
| 1. Name: | C-Leg (3C100) |
|---|---|
| 2. 510(k) Number: | K991590 |
-
- Date Cleared: July 8, 1999
1
D. Description of the Device
The Rel-k is an artificial limb prosthesis indicated for individuals that have undergone a trans-femoral amputation. The Rel-k is intended to replace a missing or deformed limb and functions in both normal/standing (static) and dynamic walking.
The Rel-k consists of:
- . Pyramidal Head
- Angular Sensor .
- . Force sensor
- . Servo assisted Hydraulic Damper (MPC damper)
- Removable Battery and electronics compartment .
- Carbon Fiber Shell (outer casing) �
- . Attachment for a standard 30mm diameter tube.
E. Intended Use Statement
The Rel-k is prosthetic knee, important element of a lower limb prosthesis, a medical device that is used to replace a missing or deformed limb in both static and dynamic deambulation functions.
F. Technological Characteristics Summary
The Rel-k is substantially equivalent to the Otto Bock C-Leg (C100), a Class I Exempt Device per 21CFR Part 890.3420.
Differences that exist between the Rel-k and the C-Leg (C100) devices related to the technical specifications, physical appearance and design does not raise new questions of safety and effectiveness; and demonstrates that the Rel-k device is at least as safe and effective as the legally marketed Otto Bock C-Leg (C100) device.
2
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 features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The bird is oriented towards the upper right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Rizzoli Ortopedica S.P.A. % McCormick LifeScience Consultants Ms. Diane C. Tiernan, MS RAC Consultant 58A Bates Road Watertown, Massachusetts 02472
OCT 1 3 2010
Re: K101859
Trade/Device Name: Rel-k Artificial Limb Prosthesis Regulation Number: 21 CFR 890.3420 Regulation Name: External limb prosthetic component Regulatory Class: Class I Product Code: ISY Dated: September 29, 2010 Received: September 30, 2010
Dear Ms. Tiernan:
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. Ilsting 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
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Page 2 - Ms. Diane C. Tiernan, MS RAC
device-related adverse events) (21 CFR 803); 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.
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/CDRH/CDRHOffices/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/ReportaProblem/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,
For Ditta Desdir
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known):
K101859 OCT 1 3 2010
Device Name: Rel-k Artificial Limb Prosthesis
Indications For Use:
REL-k is a prosthetic knee, important element of a lower limb prosthesis, a medical device that is used to replace a missing or deformed limb in both static and dynamic deambulation functions
Prescription Use X ___________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Page 1 of
Yung D. Nguyen
Divis (Division Sign-city), Orthopedic, and Restorative Devices
510(k) Number K101859