(179 days)
P830055/S217
No
The summary describes software used for surgical planning and instrument design based on CT images and surgical techniques, but there is no mention of AI or ML being used in this process. The focus is on patient-specific instruments and planning based on anatomical landmarks and surgical techniques.
No.
The device is described as "intent-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting," and "intended to be used as patient-specific surgical instrumentation in total knee arthroplasty," which indicates it is a surgical tool, not a therapeutic device.
No
The device description clearly states "The TruMatch Patient Specific Instruments are intent-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting." It also mentions "The TRUMATCH Personalized Solutions System is comprised of patient-specific instruments and the software utilized to design the patient-specific surgical plans and instruments." These functions are for surgical guidance and planning, not for diagnosing a condition.
No
The device description explicitly states the system is comprised of "patient-specific instruments" and the software used to design them. The instruments are physical components manufactured based on the software plan.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The TruMatch Patient Specific Instruments are surgical instruments used during a surgical procedure (total knee replacement) to assist in positioning and guiding bone cuts. They are not used to analyze samples taken from the body.
- Intended Use: The intended use clearly states the instruments are for "assisting in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting." This is a surgical function, not a diagnostic one.
- Device Description: The description focuses on the instruments themselves and the software used to design them for surgical planning.
- Input: The input is CT images, which are used for surgical planning, not for analyzing biological samples.
Therefore, the TruMatch Patient Specific Instruments fall under the category of surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The TruMatch Patient Specific Instruments are intent-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 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
JWH, OOG
Device Description
The TRUMATCH Personalized Solutions System is comprised of patient-specific instruments and the software utilized to design the patient-specific surgical plans and instruments. The predicate TRUMATCH System creates a surgical plan based on a mechanical axis surgical technique. Changes to the Planning software component allow the surgeon to select a mechanical axis surgical technique or a patient-specific alignment surgical technique. Upon approval of the surgical plan, the TRUMATCH Guides are manufactured according to the plan.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT Images
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
Model creation process verification for Patient Specific Alignment Guides Cadaver lab with simulated surgery for assessment of guide fit, implant alignment and size, and bone resection accuracy analysis Software verification testing
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
P830055/S217
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
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June 16, 2020
DePuy Orthopaedics, Inc. Melissa Cook Regulatory Affairs Specialist III 700 Orthopaedic Dr. Warsaw, Indiana 46582
Re: K193540
Trade/Device Name: TRUMATCH Personalized Solutions Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, OOG Dated: May 15, 2020 Received: May 18, 2020
Dear Melissa Cook:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Ting Song, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K193540
Device Name
TRUMATCH Personalized Solutions
Indications for Use (Describe)
The TruMatch Patient Specific Instruments are intent-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 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
(As required by 21 CFR 807.92)
| Submitter Information | |
|---|---|
| Name | DePuy Orthopaedics, Inc. |
| Address | 700 Orthopaedic Dr. |
| Warsaw, IN 46582 | |
| Phone number | 574-371-4906 |
| Establishment Registration | |
| Number | 1818910 |
| Name of contact person | Melissa Cook |
| Date prepared | June 16, 2020 |
| Name of device | |
| Trade or proprietary name | DePuy TRUMATCH Personalized Solutions |
| Common or usual name | Total knee prosthesis instrumentation |
| Classification name | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, |
| Polymer/Metal/Polymer | |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | 21 CFR 888.3560 |
| Product Code(s) | JWH, OOG |
| Legally marketed device(s) to | |
| which equivalence is claimed | TRUMATCH Personalized Solutions, K110397 |
| Reference device: TRUMATCH Personalized Solutions, bundled | |
| P830055/S217 | |
| Reason for 510(k) submission | Device modification - This submission seeks clearance for changes to the |
| software that enable the TRUMATCH surgical plan and Guides to be | |
| designed for a patient specific alignment surgical technique. | |
| Device description | The TRUMATCH Personalized Solutions System is comprised of patient- |
| specific instruments and the software utilized to design the patient-specific | |
| surgical plans and instruments. The predicate TRUMATCH System creates | |
| a surgical plan based on a mechanical axis surgical technique. Changes to the | |
| Planning software component allow the surgeon to select a mechanical axis | |
| surgical technique or a patient-specific alignment surgical technique. Upon | |
| approval of the surgical plan, the TRUMATCH Guides are manufactured | |
| according to the plan. | |
| Intended use of the device | Intended for patients with osteoarthritis who: |
| Meet the criteria for primary total knee replacement performed with a measured resection technique. Have mild bone deformities and/or angular deformities less than 15 degrees of fixed varus/valgus, or flexion. Have some previous implants, such as hip implants, ankle implants, and soft tissue anchors. Contralateral knee replacement is acceptable as long as the contralateral knee is flexed away (not within the same medial/lateral axis) from the knee of interest during the CT scan. | |
| 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. |
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| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE | ||
|---|---|---|
| COMPARED TO THE PREDICATE DEVICE |
| Characteristics | Subject Device:
TRUMATCH Personalized Solutions | Predicate Device: TRUMATCH
Personalized Solutions
(K110397) |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Intended Use | Intended for patients with osteoarthritis who:
Meet the criteria for primary total knee replacement performed with a measured resection technique. Have mild bone deformities and/or angular deformities less than 15 degrees of fixed varus/valgus, or flexion. Have some previous implants, such as hip implants, ankle implants, and soft tissue anchors. Contralateral knee replacement is acceptable as long as the contralateral knee is flexed away (not within the same medial/lateral axis) from the knee of interest during the CT scan. | Same |
| Material | Accura and Stainless Steel | Same |
| Image Inputs | CT Images | Same |
| Software
Packages | TRUMATCH 3.0 System software | TRUMATCH 2.5 System software |
| Size | Patient-specific | Same |
| Implant
Compatibility | Used with the implantation of the
ATTUNE and SIGMA Total Knee
Implants | Same |
| Packaging, Sterilization and Shelf Life | | |
| Sterile Method | Gamma | Same |
| Packaging | Polyurethane bag within a single blister
tray, sealed with Tyvek lid, placed in unit
carton | Same |
| Shelf Life | 185 Days | 120 days |
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The subject TRUMATCH Personalized Solutions is the same as the predicate TRUMATCH Personalized Solutions (K110397) in intended use, design, and materials. The subject and predicate devices are intended to be used as patient-specific surgical instrumentation in total knee arthroplasty. The subject device utilizes the same software system components as the reference device TRUMATCH Personalized Solutions (bundled P830055/S217). The subject device is modified to enable either a mechanical axis alignment or patient specific alignment surgical technique.
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The following tests were performed to demonstrate substantial equivalence of safety and efficacy with the predicate device:
- Model creation process verification for Patient Specific Alignment Guides ●
- Cadaver lab with simulated surgery for assessment of guide fit, implant alignment and size, and bone resection accuracy analysis
- Software verification testing ●
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
No clinical tests were conducted to demonstrate substantial equivalence.
CONCLUSION DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The subject device TRUMATCH Personalized Solutions System is substantially equivalent to the predicate TRUMATCH Personalized Solutions System.