(99 days)
Not Found
No
The summary describes patient-matched cutting blocks manufactured from imaging data, but there is no mention of AI, ML, or any related technologies being used in the design or manufacturing process. The process appears to be based on direct interpretation of imaging data to create the custom blocks.
No
The device is described as "patient-specific surgical instrumentation" to assist in positioning total knee replacement components and guiding bone marking, rather than directly treating a disease or condition.
No
The device is described as "patient-specific surgical instrumentation" used to assist in the "positioning of total knee replacement components intra-operatively" and "guiding the marking of bone before cutting," not for diagnosing medical conditions.
No
The device description explicitly states the device is "designed and manufactured from patient imaging data" and refers to "cutting blocks," which are physical instruments used in surgery, indicating it is a hardware device.
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 "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 instrument used during a procedure on a patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such tests on biological samples.
- Device Description: The description confirms it's a physical cutting block designed from patient imaging data, not a diagnostic test kit or instrument.
The device is a surgical tool used in conjunction with existing knee systems, not a diagnostic test.
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. The Patient Matched Cutting Blocks are intended for use with existing Smith & Nephew, Inc. knee systems and their cleared indications for use. 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
Subject of this premarket notification are Smith & Nephew's Patient Matched Cutting Blocks. The Patient Matched Cutting Blocks are designed and manufactured from patient imaging data (MRI, CT, X-Ray).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI, CT, 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)
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.
K951987, K962137, K962557, K030612, K032683, K073325, K042515
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
NOV 2 5 2008
510(k) Summary Smith & Nephew, Inc. Patient Matched Cutting Blocks
| Submitter's Name: | Smith & Nephew, Inc., Orthopaedic Division |
|---|---|
| Submitter's Address: | 1450 Brooks Road, Memphis, TN 38116 |
| Submitter's Telephone Number: | 901-399-5340 |
| Contact Person: | Megan Bevill |
| Date Summary Prepared: | November 17, 2008 |
| Trade or Proprietary Device Name: | Patient Matched Cutting Blocks |
| Common or Usual Name: | Knee Prosthesis |
| Classification Name: | 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/JWH, MBH |
Device Description
Subject of this premarket notification are Smith & Nephew's Patient Matched Cutting Blocks. The Patient Matched Cutting Blocks are designed and manufactured from patient imaging data (MRI, CT, X-Ray).
Intended Use and Indications
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.
The Patient Matched Cutting Blocks are intended for use with existing Smith & Nephew, Inc. knee systems and their cleared indications for use.
The Patient Matched Cutting Blocks are intended for single use only.
Substantial Equivalence
The design and intended use of the Patient Matched Cutting Blocks are substantially equivalent to Smith & Nephew, Inc.'s distal femoral and proximal tibial cutting blocks which are used in conjunction with the Smith & Nephew, Inc. implant systems identified in the table below.
| System | 510(k) | Clearance Date |
|---|---|---|
| Genesis II Knee System | K951987 | 8/22/1995 |
| K962137 | 8/2/1996 | |
| K962557 | 12/5/1996 | |
| K030612 | 5/27/2003 | |
| K032683 | 8/28/2003 | |
| Legion Knee System | K073325 | 12/20/2007 |
| Journey BCS Knee System | K042515 | 3/14/2005 |
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew, Inc. % Ms. Megan Bevill 1450 East Brooks Road Memphis, Tennessee 38116
APR 1 5 2011
Re: K082358
Trade/Device Name: 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: OOG, JWH, MBH Dated: November 14, 2008 Received: November 18, 2008
Dear Ms. Bevill:
This letter corrects our substantially equivalent letter of November 25, 2008.
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 (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 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.
2
Page 2 - Ms. Megan Bevill
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 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 vou 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
A. B.
for
Dr h
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K082358
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 palient-specific surgical instrumentation to assist in the positioning of total knee replacement components intraoperatively and in guiding the marking of bone before cutting.
The Patient Matched Cutting Blocks are intended for use with existing Smith & Nephew, Inc. knee systems and their cleared indications for use.
The Patient Matched Cutting Blocks are intended for single use only.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
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)
Mark A. Melkerson
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K082358