(186 days)
Not Found
No
The summary describes patient-specific instruments designed from CT data, but there is no mention of AI, ML, or related terms, nor any description of training or test sets typically associated with AI/ML development.
No
The device is described as "patient-specific surgical instrumentation" used to assist in the positioning of a joint replacement component and guiding bone marking, making it a surgical tool rather than a device that directly treats or prevents a disease/condition.
No
The device is described as "patient-specific surgical instrumentation" used to assist in the positioning of a joint replacement component and in guiding the marking of bone before cutting. Its purpose is interventional (surgical guidance), not diagnostic (determining a medical condition).
No
The device description explicitly states that the TruMatch™ Patient Specific Instruments are "designed and manufactured from patient imaging data" and are physical instruments used intra-operatively. The performance studies also include tests like "TruMatch™ Dimensional Stability Test" and "Cadaver Accuracy Study," which are indicative of a physical device, not software alone.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the TruMatch™ Patient Specific Instruments are used intra-operatively to assist in the positioning of a joint replacement component and guiding bone marking during surgery. This is a surgical aid, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description reinforces that these are instruments designed and manufactured from patient imaging data for use with other implants.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The TruMatch™ instruments are surgical tools used on the patient during a procedure.
N/A
Intended Use / Indications for Use
The TruMatch™ Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting.
The anatomical landmarks necessary for the creation of the TruMatch™ Patient Specific Instruments must be present and identifiable on CT.
The TruMatch™ Patient Specific Instruments are intended for use with Sigma® Total Knee Implants and Attune™ Total Knee Implants and their cleared indications for use.
The TruMatch™ Patient Specific Instruments are intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH, OOG
Device Description
Subject of this premarket notification are TruMatch™ Patient Specific Instruments which are designed and manufactured from patient imaging data and used with other DePuy Orthopaedics implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
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)
Non-Clinical Testing:
The following testing was performed to demonstrate the substantial equivalence of the TruMatch™ Patient Specific Instruments to the predicate devices.
- TruMatch™ Dimensional Stability Test .
- . Cadaver Accuracy Study
- Design Process and Design Software Repeatability Study .
- Software Validation and Verification Summary
The tests results demonstrate that all acceptance criteria were met.
Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between the TruMatch™ Patient Specific Instruments and the predicate devices.
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.
Smith & Nephew's Patient Matched Cutting Blocks
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.
K882234, K884796, K943462, K950010, K944538, K961685, K961685, K971189, K971189, K082500, K101433
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
510(k) Summary
AUG 16 2011
| Applicant / Sponsor: | DePuy Orthopaedics Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
Establishment Registration No.: 1818910 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Nancy S. Friddle
Project Manager, Regulatory Affairs
Tel: (574) 371-4923
Fax: (574) 371-4987 |
| Proprietary Name: | TruMatch™ Personalized Solutions |
| Common Name: | Total Knee Prosthesis |
| Classification Name: | 21 CFR 888.3560: Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained cemented prosthesis.
Class II |
| Product Code: | JWH |
| Subsequent Product Code: | OOG |
Device Description:
Subject of this premarket notification are TruMatch™ Patient Specific Instruments which are designed and manufactured from patient imaging data and used with other DePuy Orthopaedics implants.
Indications and Intended Use:
The TruMatch™ Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting.
The anatomical landmarks necessary for the creation of the TruMatch™ Patient Specific Instruments must be present and identifiable on CT.
The TruMatch™ Patient Specific Instruments are intended for use with Sigma® Total Knee Implants and Attune™ Total Knee Implants and their cleared indications for use.
The TruMatch™ Patient Specific Instruments are intended for single use only.
:
.
1
Summary of Technologies/Substantial Equivalence:
The TruMatch™ Patient Specific Instruments have the same indications, intended use, similar design and are substantially equivalent to the Smith & Nephew's Patient Matched Cutting Blocks and also to the traditional instruments that are associated with the Sigma® and Attune™ cleared knee implant systems. The TruMatch™ Patient Specific Instruments are used in conjunction with the DePuy Orthopaedics, Inc Sigma and Attune implant systems identified in the table below.
| System | 510k | Clearance Date |
|---|---|---|
| Sigma Total Knee System | K882234 | 10/20/1988 |
| Sigma Total Knee System | K884796 | 3/29/1989 |
| Sigma Total Knee System | K943462 | 12/21/1994 |
| Sigma Total Knee System | K950010 | 5/15/1995 |
| Sigma Total Knee System | K944538 | 9/26/1995 |
| Sigma Total Knee System | K961685 | 7/10/1996 |
| Sigma Total Knee System | K961685 | 7/10/1996 |
| Sigma Total Knee System | K971189 | 7/17/1997 |
| Sigma Total Knee System | K971189 | 7/17/1997 |
| Sigma Total Knee System | K082500 | 11/18/2008 |
| Attune Total Knee System | K101433 | 12/10/2010 |
Non-Clinical Testing:
The following testing was performed to demonstrate the substantial equivalence of the TruMatch™ Patient Specific Instruments to the predicate devices.
- TruMatch™ Dimensional Stability Test .
- . Cadaver Accuracy Study
- Design Process and Design Software Repeatability Study .
- Software Validation and Verification Summary �
The tests results demonstrate that all acceptance criteria were met.
Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between the TruMatch™ Patient Specific Instruments and the predicate devices.
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 consists of a stylized depiction of a bird-like symbol with three curved lines, positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DePuy Orthopaedics, Inc. % Ms. Nancy S. Friddle Project Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw. Indiana 46581-0988
AUG 1 6 2011
Re: K110397
Trade/Device Name: DePuy TruMatch™ Patient Specific 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, OOG Dated: June 15, 2011 Received: June 16, 2011
Dear Ms. Friddle:
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. Iisting 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.
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
3
Page 2 - Ms. Nancy S. Friddle
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.fdgg.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/wcm115809.html 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/ReportalProblem/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
Mark N. Melkerson
Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K110397
2. INDICATIONS FOR USE
510(k) Number (if known):
Device Name: DePuy TruMatch™ Patient Specific Instruments
Indications for Use:
The TruMatch™ Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting.
The anatomical landmarks necessary for the creation of the TruMatch™ Patient Specific Instruments must be present and identifiable on CT.
The TruMatch™ Patient Specific Instruments are intended for use with Sigma® Total Knee Implants and Attune™ Total Knee Implants and their cleared indications for use.
The TruMatch™ Patient Specific Instruments are intended for single use only.
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Melleuson
(Division Sign Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110397