(271 days)
Not Found
No
The summary describes software modifications for designing and manufacturing patient-matched cutting blocks based on imaging data, but there is no mention of AI or ML algorithms being used in this process. The focus is on patient-specific instrumentation and image processing for design, not on learning or predictive capabilities.
No.
The device is described as patient-specific surgical instrumentation used to assist in the positioning of total knee replacement components intra-operatively, not to treat a disease or condition.
No
Explanation: The device is described as "patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting." Its purpose is to guide surgical procedures, not to diagnose a medical condition.
No
The device description explicitly states that the subject of the notification are modifications to the software components used to design and manufacture "Patient Matched Cutting Blocks," which are described as "patient-specific surgical instrumentation." This indicates the device includes physical hardware (the cutting blocks) in addition to the software used in their creation.
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 device is "patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting". This describes a surgical tool used during a procedure, not a device used to examine specimens in vitro (outside the body) to provide diagnostic information.
- Device Description: The description focuses on the design and manufacturing of physical cutting blocks based on patient imaging data. It doesn't mention any components or processes related to analyzing biological samples or providing diagnostic results.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Providing diagnostic, prognostic, or screening information
- Use in a laboratory setting
The device is a surgical instrument designed to aid in a specific surgical procedure based on pre-operative imaging. This falls under the category of medical devices used for surgical intervention, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Smith & Nephew's Patient Matched Cutting Blocks are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Patient Matched Cutting Blocks are intended for use with the following existing Smith & Nephew, Inc. knee systems and their cleared indications for use:
- Genesis 2 Knee System .
- Legion Knee System o
- O Journey BCS Knee System
- . Journey II Knee System
The Patient Matched Cutting Blocks are intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
OOG, JWH, MBH
Device Description
The Patient Matched Cutting Blocks were previously cleared for market via premarket notification K082358. Subject of this premarket notification are modifications to the software components used to design and manufacture the Patient Matched Cutting Blocks. The Patient Matched Cutting Blocks are designed and manufactured from patient imaging data (MRJ, X-Ray).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRJ, X-Ray
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)
Smith & Nephew conducted a cadaveric assessment of the subject devices. The results of this study show that the patient matched cutting blocks designed using the case processing applications perform equivalent to conventional instrumentation or within clinically acceptable parameters with respect to resection depth, coronal alignment (varus/valgus), rotation and tibial posterior slope.
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.
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
§ 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
> We are smith&nephew
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | January 10, 2014 |
| Contact Person and Address: | Bradley Heil
Regulatory Affairs Specialist
T (901) 399-6339
F (901) 566-7831 |
| Name of Device: | Smith & Nephew, Inc. Patient Matched Cutting Block |
| Common Name: | Knee Prosthesis |
| Device Classification Name and
Reference: | 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 |
| Product Code: | OOG, JWH, MBH |
Device Description
The Patient Matched Cutting Blocks were previously cleared for market via premarket notification K082358. Subject of this premarket notification are modifications to the software components used to design and manufacture the Patient Matched Cutting Blocks. The Patient Matched Cutting Blocks are designed and manufactured from patient imaging data (MRJ, X-Ray).
Technological Characteristics
Software verification and validation testing was completed in line with FDA's guidance document entitled, "General Principles of Software Validation; Final Guidance for Industry and FDA Staff," dated January 11, 2002. A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject device and the software will perform as intended. Clinical data was not needed to support the safety and effectiveness of the subject devices.
Intended Use
Smith & Nephew's Patient Matched Cutting Blocks are intended to be used as patientspecific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Patient Matched Cutting Blocks are intended for use with the following existing Smith & Nephew, Inc. knee systems and their cleared indications for use:
1
- Genesis 2 Knee System .
- Legion Knee System o
- O Journey BCS Knee System
- . Journey II Knee System
The Patient Matched Cutting Blocks are intended for single use only.
Performance Data
Smith & Nephew conducted a cadaveric assessment of the subject devices. The results of this study show that the patient matched cutting blocks designed using the case processing applications perform equivalent to conventional instrumentation or within clinically acceptable parameters with respect to resection depth, coronal alignment (varus/valgus), rotation and tibial posterior slope.
Substantial Equivalence Information
The subject devices are identical in function, intended use, indications for use, and material composition, and very similar in overall design to the Patient Matched Cutting Blocks cleared via premarket notification K082358.
Table 1: Substantially equivalent predicates to the modified Patient Matched Cutting Blocks
| Manufacturer | Description | Submission
Number | Clearance Date |
|-------------------------|--------------------------------|----------------------|----------------|
| Smith & Nephew,
Inc. | Patient Matched Cutting Blocks | K082358 | 11/25/2008 |
Conclusion
As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the modified Patient Matched Cutting Blocks. Based on the similarities to the predicate components, a cadaveric assessment, and a review of the software validation testing performed, the devices are substantially equivalent to above predicate Patient Matched Cutting Blocks.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, with three overlapping profiles facing to the right. The profiles are rendered in black and appear to be abstract representations of human faces. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2104
Smith & Nephew, Inc. Mr. Bradley Heil Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116
Re: K130708
Trade/Device Name: Smith & Nephew Patient Matched Cutting Blocks 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, OOG Dated: October 29, 2013 Received: October 30, 2013
Dear Mr. Heil:
This letter corrects our substantially equivalent letter of December 11, 2013.
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
3
Page 2 - Mr. Bradley Heil
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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Vincent J. Devlin -S
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K130708
Device Name: Smith & Nephew, Inc. Patient Matched Cutting Blocks
Indications for Use:
Smith & Nephew's Patient Matched Cutting Blocks are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Patient Matched Cutting Blocks are intended for use with the following existing Smith & Nephew, Inc. knee systems and their cleared indications for use:
- · Genesis II Knee System
- · Legion Knee System
- · Journey BCS Knee System
- · Journey II Knee System
The Patient Matched Cutting Blocks are intended for single use only.
Prescription Use X (Part 21 CFR 801 Subpart AND/OR D)
Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
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