(63 days)
Not Found
Unknown
The summary mentions proprietary software used with patient imaging to design a patient-specific implant, but it does not explicitly state whether this software utilizes AI or ML algorithms. The focus is on patient-specific design based on imaging, which could be achieved through various computational methods, not necessarily AI/ML.
Yes
The device is a total knee replacement system intended to treat knee joint pain and disability due to various conditions like osteoarthritis, trauma, and rheumatoid arthritis, which are therapeutic indications.
No
The device is a knee replacement system intended for surgical implantation, not for diagnosing conditions. It uses imaging for patient-specific implant design, but its primary function is therapeutic.
No
The device description clearly states that the system includes physical components such as a femoral component made of CoCrMo alloy, a tibial component with a metal tray and polyethylene insert, and a patellar component made of UHMWPE or iPoly XE™. While software is used for design, the final device is a physical implant.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The iTotal PS KRS is a knee replacement system, which is an implantable medical device used to surgically replace a damaged knee joint.
- Intended Use: The intended use is to treat knee joint pain and disability by replacing the joint with a prosthetic device. This is a surgical intervention, not a diagnostic test performed on a specimen.
- No Mention of Specimens: The description focuses on the implant components, surgical instruments, and the process of designing a patient-specific implant based on imaging. There is no mention of analyzing biological specimens.
While the device uses patient imaging (CT scans) and software for design, this is part of the surgical planning and device manufacturing process, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The iTotal® Posterior Stabilized (PS) 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, patellofemoral or bicompartmental prosthesis.
The Indications for Use include:
Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, polyarthritis or osteonecrosis of the knee. Post traumatic loss of joint function. Moderate varus, valgus or flexion deformity. Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants. Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans
This implant is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH, OOG, OIY
Device Description
The iTotal Posterior Stabilized Retaining Knee Replacement System (hereafter referred to as the "iTotal PS KRS") is a patient specific tricompartmental faceted, cruciate sacrificing knee replacement system. The iTotal PS KRS is a semi-constrained, fixed bearing, cemented knee implant which consists of a femoral, tibial and patellar component.
Using patient imaging (CT scan) and a combination of proprietary and off the shelf software, a patient specific implant is designed, that best meets 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 a polyethylene insert that is manufactured from ultra-high molecular weight polyethylene (UHMWPE). The patellar component is manufactured from either UHMWPE or from a highly cross-linked Vitamin E infused polyethylene (iPoly XE™).
For user convenience, and similar to the predicate iTotal PS KRS, patient specific accessory orthopedic manual surgical instruments designed for use with the modified iTotal PS KRS are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. These instruments are single use only and may be provided sterile. In addition, reusable orthopedic manual surgical instruments are provided separately.
The function and general design features of the patient specific implants and ancillary instruments remain similar to those described in the predicate 510(k)s K152704, K142404 and K142161.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan
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)
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 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 iTotal PS iView v1.0.
Substantial Equivalence: The product subject of this premarket notification is substantially equivalent to the iTotal PS KRS (K152704, cleared October 21, 2015, K142404, cleared December 11, 2014 and K142161, cleared November 14, 2014). The following testing was performed to establish substantial equivalence:
- Software verification and validation testing of proprietary software iTotal PS iView v1.0.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three overlapping faces suggesting community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the department's role and national scope. The logo is simple, using a single color, and is designed to be easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 7, 2016
ConforMIS, Incorporated Ms. Amita Shah Senior Vice President, Regulatory and Quality Affairs 28 Crosby Drive Bedford, Massachusetts 01730
Re: K153217
Trade/Device Name: ConforMIS iTotal® Posterior Stabilized Knee Replacement System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibal polymer/metal/polymer semi-contrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, OOG, OIY Dated: November 3, 2015 Received: November 5, 2015
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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സ്വലംബം
ອຢາ 107 ຂະໜາດ | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
les PRA Statement below. |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| 500(k) Number (if known
7733317 | |
| Device Name
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| ອນ ໃນ ຂອງປະຈາບອາຣາ 10 ຊຶ່ງເປັນຮູບິດ ລ້າງການປະກວດນາງການປະກວດນາງ ເປັນປີ 10 ປີ 2000 ປີ ອານີ ອາຂອງປີ ນາມປູ່ ເມີນເຮົາ ຈ
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The Indications for Use include:
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Indications for Use (Describe) | |
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3
6.0 510(K) SUMMARY (PAGE 1 OF 5)
| Submitter's Name and
Address: | ConforMIS, Inc.
28 Crosby Drive
Bedford, MA 01730 |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration
Number: | 3009844603 and 3004153240 |
| Date of Summary: | November 3, 2015 |
| Contact Person:
Telephone Number:
Fax Number: | Amita S. Shah, Sr. Vice President, Regulatory and Quality Affairs
(781) 345-9164
(781) 345-0147 |
| Name of the Device: | ConforMIS iTotal® Posterior Stabilized Knee Replacement System
(iTotal PS KRS) |
| Common Name: | Total Posterior Stabilized Knee Replacement System |
| Regulatory Status and
Regulation Number: | Class II
21 CFR 888.3560 |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained
cemented prosthesis |
| Device Classification: | Product Code:
JWH: Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis.
OOG: Knee Arthroplasty Implantation System.
Intended to be used to assist in the implantation of a specific knee
arthroplasty device or a set of specific knee arthroplasty devices.
Indicated to include guiding alignment, making or establishing cuts,
selecting, sizing, attaching, positioning or orienting implant
components.
OIY: prosthesis, knee, patellofemorotibial, semi-constrained, cemented,
polymer + additive/metal/polymer + additive.
This generic type of device includes prosthesis that have a femoral
component made of alloys, such as cobalt-chromium-molybdenum, and
a tibial component(s) and/or a retropatellar resurfacing component
made of ultra-high molecular weight polyethylene plus an additive, such
as a-tocopherol. |
| Indications for Use: | The iTotal® Posterior Stabilized (PS) 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, patellofemoral or bicompartmental prosthesis.
The Indications for Use include:
Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, polyarthritis or osteonecrosis of the knee. Post traumatic loss of joint function. Moderate varus, valgus or flexion deformity. Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants. Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans |
| This implant is intended for cemented use only. | |
| Identification of the Legally
Marketed Device (Predicate
Device): | ConforMIS iTotal PS Knee Replacement System (ITOTAL PS KRS)
Device Class: II
Product Code: JWH, OOG, OIY
Regulation Number: 21 CFR 888.3560
510(k) Number: K152704, K142404, K142161 |
4
510(K) SUMMARY (PAGE 2 OF 5)
5
510(K) SUMMARY (PAGE 3 OF 5)
The iTotal Posterior Stabilized Retaining Knee Replacement System Device Description: (hereafter referred to as the "iTotal PS KRS") is a patient specific tricompartmental faceted, cruciate sacrificing knee replacement system. The iTotal PS KRS is a semi-constrained, fixed bearing, cemented knee implant which consists of a femoral, tibial and patellar component.
Using patient imaging (CT scan) and a combination of proprietary and off the shelf software, a patient specific implant is designed, that best meets 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 a polyethylene insert that is manufactured from ultra-high molecular weight polyethylene (UHMWPE). The patellar component is manufactured from either UHMWPE or from a highly cross-linked Vitamin E infused polyethylene (iPoly XE™).
For user convenience, and similar to the predicate iTotal PS KRS, patient specific accessory orthopedic manual surgical instruments designed for use with the modified iTotal PS KRS are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. These instruments are single use only and may be provided sterile. In addition, reusable orthopedic manual surgical instruments are provided separately.
The function and general design features of the patient specific implants and ancillary instruments remain similar to those described in the predicate 510(k)s K152704, K142404 and K142161.
6
510(K) SUMMARY (PAGE 4 OF 5)
Comparison Summary of Technological Characteristics and Modifications Proposed:
The modified iTotal PS KRS and predicate iTotal PS KRS have the same technological characteristics. There have been no changes to the modified iTotal PS KRS device with respect to design, materials and methods of manufacture, packaging, or sterilization. The designs of the device remains similar to that cleared in K152704, K142404 and K142161.
Modifications which represent improving manufacturing efficiencies are primarily focused on adding the option of automating the generation of the iTotal PS iView using the proprietary software module iTotal PS iView v1.0.
Table 6.0-1: Comparison between the Modified and Predicate Device
| Characteristic | Predicate
iTotal PS KRS
(K152704, K142404
and K142161) | Modified iTotal PS
KRS
(This submission) |
|------------------------|-----------------------------------------------------------------|------------------------------------------------|
| Generation of
iView | Manual process | iTotal PS iView v1.0
or Manual process |
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 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 iTotal PS iView v1.0.
Substantial Equivalence: The product subject of this premarket notification is substantially equivalent to the iTotal PS KRS (K152704, cleared October 21, 2015, K142404, cleared December 11, 2014 and K142161, cleared November 14, 2014). The following testing was performed to establish substantial equivalence: -
. Software verification and validation testing of proprietary software iTotal PS iView v1.0.
7
510(K) SUMMARY (PAGE 5 OF 5)
Conclusion: 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 can be considered substantially equivalent to the predicate device for the intended use. Clinical data is not necessary to demonstrate substantial equivalence.
Based on the testing conducted, it is concluded that the modified iTotal PS KRS is substantially equivalent to the predicate iTotal PS KRS (K152704, cleared October 21, 2015, K142404, cleared December 11, 2014 and K142161, cleared November 14, 2014).