(94 days)
No
The summary describes disposable surgical instruments for knee replacement and does not mention any AI or ML capabilities.
No.
The device is an accessory instrument used for preparing bone and positioning components during total knee replacement, not for direct therapeutic treatment.
No
The documents state that the instruments are used to "further prepare the bone and assist in the positioning of total knee replacement components intraoperatively." They are accessory devices for implantation, not for diagnosis.
No
The device description explicitly states it is comprised of "Disposable Instruments" and discusses "mechanical performance," indicating it is a physical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "further prepare the bone and assist in the positioning of total knee replacement components intraoperatively." This is a surgical instrument used directly on the patient's body during a procedure.
- Device Description: The device is described as "accessory devices" and "instruments which assist in the implantation of Class II Smith & Nephew Total Knee Systems." This reinforces its role as a surgical tool.
- 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 for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples. This device is used inside the body during surgery.
N/A
Intended Use / Indications for Use
Smith & Nephew's VISIONAIRE™ Disposable Instruments are intended to be used to further prepare the bone and assist in the positioning of total knee replacement components intraoperatively. Smith & Nephew VISIONAIRE™ Disposable Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Genesis II and Legion knee systems and their cleared Indications for Use.
The contraindications, potential adverse events, precautions, and warnings for the knee systems can be found in the Smith & Nephew Knee System package insert. The VISIONAIRE™ Patient Matched Cutting Blocks and Disposable instruments are intended for single use only. Do not reuse due to risks of breakage, failure or patient infection.
Product codes
JWH, MBH
Device Description
Per U.S. Food and Drug Administration (FDA) regulation, device-specific instruments are accessory devices and take on the classification of the device(s) with which they are used. Although these instruments are similar in design to 510(k)-exempt orthopaedic manual instruments classified under 21 CFR 888.4540, instruments which assist in the implantation of Class II Smith & Nephew Total Knee Systems and are classified as Class II devices are subject to pre-market notifications and regulations.
The Smith & Nephew Disposable Instruments include line additions to the Smith & Nephew Disposable Knee Instruments that were cleared in K123159. The subject devices are intended prepare the bone for Total Knee Arthroplasty.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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)
Biocompatibility testing for the new colorants and materials was conducted per the recommendations of ISO 10993-1. A review of the results indicates that the Disposable Instruments are equivalent to existing, leqally marketed predicate instrumentation with reqards to mechanical performance and that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
LEGION PRIMARY SYSTEM K093746, GENESIS II TOTAL KNEE SYSTEM K951987, GENESIS II P/S HIGH FLEXION KNEE INSERT K032295, GENESIS II DEEP FLEXION C/R ARTICULAR INSERT K041825, TOTAL KNEE SYSTEM INSTRUMENTATION K121393, Disposable Knee Instruments K123159, Smith & Nephew Disposable Fin Punch K141585
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/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 three faces in profile, stacked one behind the other, representing people. The faces are rendered in a simple, abstract style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2015
Smith & Nephew Incorporated Ms. Shereen Bienz Senior Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K143226
Trade/Device Name: VISIONAIRE™ Disposable Instruments Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBH Dated: November 26, 2014 Received: November 28, 2014
Dear Ms. Bienz:
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
1
Page 2 - Ms. Shereen Bienz
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Premarket Notification Indications for Use Statement
510(k) Number (if known): K143226___
Device Name: VISIONAIRE™ Disposable Instruments
Indications for Use:
Smith & Nephew's VISIONAIRE™ Disposable Instruments are intended to be used to further prepare the bone and assist in the positioning of total knee replacement components intraoperatively. Smith & Nephew VISIONAIRE™ Disposable Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Genesis II and Legion knee systems and their cleared Indications for Use.
The contraindications, potential adverse events, precautions, and warnings for the knee systems can be found in the Smith & Nephew Knee System package insert. The VISIONAIRE™ Patient Matched Cutting Blocks and Disposable instruments are intended for single use only. Do not reuse due to risks of breakage, failure or patient infection.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR Over-the-Counter Use (21 CFR 807 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 Orthopedic Devices 510(k) Number: K143226
3
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | January 2, 2015 |
| Contact Person and Address: | Shereen Bienz
Senior Regulatory Affairs Specialist
T 901.399.6325
F 901.566.7075 |
| Name of Device: | Smith & Nephew, Inc. Disposable Instruments |
| Common Name: | Orthopaedic Surgical Instrumentation |
| Device Classification Name and
Reference: | 21 CFR 888.3560 Knee joint patellofemorotibial
polymer/metal/ polymer semi-constrained cemented
prosthesis
21 CFR 888.3565 Knee joint patellofemorotibial
metal/polymer porous-coated uncemented prosthesis |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
Device Description
Per U.S. Food and Drug Administration (FDA) regulation, device-specific instruments are accessory devices and take on the classification of the device(s) with which they are used. Although these instruments are similar in design to 510(k)-exempt orthopaedic manual instruments classified under 21 CFR 888.4540, instruments which assist in the implantation of Class II Smith & Nephew Total Knee Systems and are classified as Class II devices are subject to pre-market notifications and regulations.
The Smith & Nephew Disposable Instruments include line additions to the Smith & Nephew Disposable Knee Instruments that were cleared in K123159. The subject devices are intended prepare the bone for Total Knee Arthroplasty.
Intended Use
Smith & Nephew's VISIONAIRE™ Disposable Instruments are intended to be used to further prepare the bone and assist in the positioning of total knee replacement components intraoperatively. Smith & Nephew VISIONAIRE™ Disposable Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Genesis II and Legion knee systems and their cleared Indications for Use.
The contraindications, potential adverse events, precautions, and warnings for the knee systems can be found in the Smith & Nephew Knee System package insert. The VISIONAIRE™ Patient Matched Cutting Blocks and Disposable instruments are intended for single use only. Do not reuse due to risks of breakage, failure or patient infection.
Table 5.1 includes the Smith & Nephew Total Knee Systems to be used in conjunction with the subject device.
4
| Description | 510(k) | Clearance Date |
|---|---|---|
| LEGION PRIMARY SYSTEM | K093746 | 04/14/2010 |
| GENESIS II TOTAL KNEE SYSTEM | K951987 | 08/22/1995 |
| GENESIS II P/S HIGH FLEXION KNEE INSERT | K032295 | 08/21/2003 |
| GENESIS II DEEP FLEXION C/R ARTICULAR | ||
| INSERT | K041825 | 03/11/2005 |
| TOTAL KNEE SYSTEM INSTRUMENTATION | K121393 | 08/07/2012 |
| Disposable Knee Instruments | K123159 | 05/03/2013 |
| Smith & Nephew Disposable Fin Punch | K141585 | 08/21/2014 |
Table 5.1 Smith & Nephew Inc. Compatible Total Knee Systems
Technological Characteristics
Biocompatibility testing for the new colorants and materials was conducted per the recommendations of ISO 10993-1. A review of the results indicates that the Disposable Instruments are equivalent to existing, leqally marketed predicate instrumentation with reqards to mechanical performance and that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.
Substantial Equivalence Information
The Smith & Nephew Disposable Instruments are line additions to the Smith & Nephew Disposable Knee Instruments that were cleared in K123159. Smith & Nephew Disposable Knee Instruments cleared in K123159 are comprised of the following instrument types with their respective purposes described in the following table. In addition, the material composition of the subject devices is identical to the instruments cleared via premarket notification K123159.
| Manufacturer | Description | Submission
Number | Clearance Date |
|-----------------------|--------------------------------------|----------------------|----------------|
| Smith and Nephew Inc. | Disposable A-P Cut Block | K123159 | 05/03/2013 |
| Smith and Nephew Inc. | Disposable Ream through
Trial | K123159 | 05/03/2013 |
| Smith and Nephew Inc. | Disposable Tibia Base Plate
Trial | K123159 | 05/03/2013 |
| Smith and Nephew Inc. | Disposable Cam Module | K123159 | 05/03/2013 |
| Smith and Nephew Inc. | Disposable Insert Trials | K123159 | 05/03/2013 |
Table 5.2 Substantially Equivalent Predicates to the Disposable Instruments
Conclusion
As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the Smith and Nephew Disposable Instruments. Based on the similarities to the predicate devices and a review of the testing performed, the devices are substantially equivalent to above predicate Total Knee Instrumentation.