(25 days)
No
The summary describes patient-specific design based on imaging and software, but does not mention AI or ML. The software testing focuses on verification and validation, not performance metrics typical of AI/ML models.
Yes
This device is a total knee replacement system intended to alleviate pain and disability in patients with knee joint issues, which constitutes a therapeutic purpose.
No
The device is a knee replacement system intended for treatment, not diagnosis. It uses imaging data to design a patient-specific implant, but this is part of the treatment planning, not for diagnosing a medical condition.
No
The device description clearly states that the iTotal CR Knee Replacement System is a physical implant consisting of femoral, tibial, and patellar components made of CoCrMo alloy and UHMWPE. While software is used in the design process, the device itself is a hardware implant.
Based on the provided text, 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 Description: The iTotal CR Knee Replacement System is a surgical implant designed to replace a damaged knee joint. It is a physical device implanted into the patient's body.
- Intended Use: The intended use is to treat knee joint pain and disability by replacing the joint, not by analyzing biological samples.
- Input: While it uses imaging (CT or MR scans) to design the implant, these are imaging modalities of the body itself, not analysis of biological samples.
The device is a surgical implant and associated instrumentation, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The iTotal® CR Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patello-femoral or bi-compartmental prosthesis.
The indications for use include :
- Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee.
- Post traumatic loss of joint function.
- Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
- Failed osteotomies, hemiarthoplasties, and unicondylar, patello-femoral or bi-compartmental implants.
The iTotal CR KRS is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH, OOG
Device Description
The iTotal CR Knee Replacement System (hereafter referred to as the "iTotal CR KRS") is a patient specific tricompartmental faceted posterior cruciate ligament (PCL) retaining knee replacement system. The iTotal CR KRS is a semi-constrained cemented knee implant which consists of a femoral, tibial and patellar component. The product design incorporates a bone preserving approach with minimal bone resection of the tibia and femur for the treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma.
Using patient imaging (either CT or MR scans) and a combination of proprietary and off the shelf software a patient-specific implant and related instrumentation are designed, that best meet the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum ("CoCrMo") alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and either one or two polyethylene inserts manufactured from UHMWPE of identical configuration. The patellar component is manufactured from UHMWPE.
For user convenience, and similar to the predicate iTotal CR KRS, accessory orthopedic manual surgical instruments designed for use with the modified iTotal CR KRS are provided to assist with implantation. The ancillary instruments are provided sterile and for single-use only. These patient specific instruments are provided to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting. The function and general design features of the patient specific ancillary instruments remain similar to those described in the predicate 510k i.e. K094050, K103117 and K112780.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR scans
Anatomical Site
Knee joint
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)
Nonclinical Testing: The determination of substantial equivalence for this device was based on a detailed device description. The following non-clinical laboratory testing was performed demonstrating that the device is safe and can be considered substantially equivalent to the predicate device for the intended use:
- Detailed software description and software verification and validation testing of proprietary software
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
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...
FEB - 3 2012
.
5.0 510(K) SUMMARY
| Submitter's Name and Address | ConforMIS Inc.
11 North Ave.
Burlington, MA 01803 |
|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number | 3004153240 |
| Date of Summary | January 4, 2012 |
| Contact Person | Amita S. Shah, Vice President, Quality Assurance and Regulatory Affairs |
| Telephone Number | (781) 345-9164 |
| Fax Number | (781) 345-0104 |
| Name of the Device | ConforMIS iTotal® CR Knee Replacement System (KRS) |
| Common or Usual Name | Cruciate Retaining Total Knee Replacement System |
| Classification Name | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis |
| Indications for Use | The iTotal® CR Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patello-femoral or bi-compartmental prosthesis.
The indications for use include :
Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee.Post traumatic loss of joint function.Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.Failed osteotomies, hemiarthoplasties, and unicondylar, patello-femoral or bi-compartmental implants. The iTotal CR KRS is intended for cemented use only. |
| Identification of the Legally Marketed Device (Predicate Device) | ConforMIS iTotal CR Knee Replacement System (KRS)
Device Class: II
Product Code: JWH, OOG
Regulation Number: 21 CFR 888.3560
510(k) number: K094050, K103117 and K112780 |
1
510(k) Summary continued
| Device Description | The iTotal CR Knee Replacement System (hereafter referred to as
the "iTotal CR KRS") is a patient specific tricompartmental faceted
posterior cruciate ligament (PCL) retaining knee replacement
system. The iTotal CR KRS is a semi-constrained cemented knee
implant which consists of a femoral, tibial and patellar component.
The product design incorporates a bone preserving approach with
minimal bone resection of the tibia and femur for the treatment of
severe pain and/or disability of a knee damaged by osteoarthritis or
trauma. |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Using patient imaging (either CT or MR scans) and a combination
of proprietary and off the shelf software a patient-specific implant
and related instrumentation are designed, that best meet the
geometric and anatomic requirements of the specific patient. The
femoral component is manufactured from cobalt chromium
molybdenum ("CoCrMo") alloy. The tibial component includes a
metal tray manufactured from CoCrMo alloy and either one or two
polyethylene inserts manufactured from UHMWPE of identical
configuration. The patellar component is manufactured from
UHMWPE. |
| | For user convenience, and similar to the predicate iTotal CR KRS,
accessory orthopedic manual surgical instruments designed for
use with the modified iTotal CR KRS are provided to assist with
implantation. The ancillary instruments are provided sterile and for
single-use only. These patient specific instruments are provided
to assist in the positioning of total knee replacement components
intra-operatively and in guiding the marking of bone before cutting.
The function and general design features of the patient specific
ancillary instruments remain similar to those described in the
predicate 510k i.e. K094050, K103117 and K112780. |
| Substantial
Equivalence: | The product subject of this premarket notification is substantially
equivalent to the iTotal Cruciate Retaining Knee Replacement
System (K094050 cleared September 16, 2010, K103117 cleared
January 7, 2011, K112780 cleared December 15, 2011). The
following testing was performed to establish substantial
equivalence:
Software verification and validation testing of proprietary
software |
2
K1200681314
510(k) Summary continued
Device Comparison
| | Predicate
iTotal CR Knee Replacement
System
(K112780) | Modified Device
iTotal CR Knee Replacement
System
(This submission) |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Components | • Femoral Component
• Tibial Implant
• Metal Backed Tibial
Component
• Patellar component | • Femoral Component
• Tibial Implant
• Metal Backed
Tibial Component
• Patellar component |
| Materials | • Femoral Implant: CoCrMo
• Metal Backed Tibial
Components:
o Tibial tray: CoCrMo
o Tibial Inserts:
UHMWPE
• All Polymer Patellar
Component: UHMWPE | • Femoral Implant: CoCrMo
• Metal Backed Tibial
Components:
o Tibial tray: CoCrMo
o Tibial Inserts:
UHMWPE
• All Polymer Patellar
Component: UHMWPE |
| Design | Knee joint patellofemorotibial
semi-constrained cemented
prosthesis | Knee joint patellofemorotibial
semi-constrained cemented
prosthesis |
| Principle of Operation | Cemented Use fixed Bearing
Design | Cemented Use fixed Bearing
Design |
| Patient Matched | Yes | Yes |
| Patellar Design/
Dimensions | Symmetrical, offered in various
sizes | Symmetrical, offered in various
sizes |
| Minimum Thickness
Tibial Insert
(UHMWPE) | 6 mm | 6 mm |
| Posterior Cruciate
Ligament (PCL)
Sparing | Yes | Yes |
| Instrumentation | Patient specific Nylon jigs | Patient specific Nylon jigs |
| Proprietary Software
for femoral iJig
instrumentation | N/A -manual process | iTotal FemJigs version 1.0 |
3
510(k) Summary continued
| Description and
Conclusion of
Testing | Nonclinical Testing: The determination of substantial equivalence
for this device was based on a detailed device description. The
following non-clinical laboratory testing was performed
demonstrating that the device is safe and can be considered
substantially equivalent to the predicate device for the intended
use:
• Detailed software description and software verification and
validation testing of proprietary software |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and
Performance | The determination of substantial equivalence for this device was
based on a detailed device description. Non-clinical laboratory
testing was performed demonstrating that the device is safe and
can be considered substantially equivalent to the predicate device
for the intended use. Clinical data is not necessary to demonstrate
substantial equivalence. |
| Conclusion: | Based on the testing conducted it is concluded that the iTotal
Cruciate Retaining Knee Replacement System with the use of the
iTotal FemJigs manufacturing software is substantially equivalent
to the iTotal Cruciate Retaining Knee Replacement System
(K094050 cleared September 16, 2010, K103117 cleared January
7, 2011 and K112780 cleared Dec 15, 2011. |
:
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and features an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ConforMIS. Incorporated % Ms. Amita S. Shah Vice President, Quality Assurance and Regulatory Affairs 11 North Avenue Burlington, Massachusetts 01803
FEB - 3 2012
Re: K120068
Trade/Device Name: iTotal CR Knee Replacement System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prothesis Regulatory Class: Class II Product Code: JWH, OOG Dated: January 4, 2012 Received: January 9, 2012
Dear Ms. Shah:
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.
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
5
Page 2 - Ms. Amita Shah
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.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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Erich Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K120068
Device Name: iTotal CR Knee Replacement System
Indications for Use:
The iTotal® CR Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee ioint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patello-femoral or bi-compartmental prosthesis. The indications for use include:
- Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or . osteonecrosis of the knee.
- Post traumatic loss of joint function. .
- Moderate varus, valgus or flexion deformity in which the ligamentous structures can be . returned to adequate function and stability.
- Failed osteotomies, hemiarthoplasties, and unicondylar, patello-femoral or bi-. compartmental implants.
The iTotal CR KRS is intended for cemented use only.
Over-The-Counter Use Prescription Use × AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) .
(Division Sign Off)
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
CR Knee Replacement System - iTotal FemJigs