(85 days)
No
The summary describes a patient-specific implant designed from MR scans, but there is no mention of AI or ML being used in the design process or any other aspect of the device's function. The performance studies are based on cadaveric testing, not algorithmic performance.
Yes
The device, a Knee Interpositional Mini-Repair System, is intended for use in osteoarthritic knees to treat degenerated articular cartilage and provides an intra-articular support for the knee joint, which falls under the definition of a therapeutic device designed to treat a medical condition.
No.
The device is an implantable orthopedic device intended to treat osteoarthritis in the knee, not to diagnose a condition.
No
The device description explicitly states it is a "metallic device" manufactured from "cobalt chromium molybdenum alloy" and is "implanted into the joint space." This indicates a physical hardware component, not a software-only device.
Based on the provided information, the Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System (KIMRS) is not an In Vitro Diagnostic (IVD) device.
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.
- KIMRS Function: The KIMRS is an implantable medical device designed to be surgically placed within the knee joint to treat osteoarthritis. It is a physical device that interacts directly with the patient's anatomy.
- Intended Use: The intended use clearly states it's for "use in the osteoarthritic knee" and is "implanted in the knee as a non-fixated, intra-articular support." This describes a therapeutic intervention, not a diagnostic test performed on a specimen outside the body.
- Device Description: The description details a metallic implant designed from patient MR scans and placed within the joint space. This is consistent with an implantable device.
- Performance Studies: The performance studies involve testing the implant's movement within a cadaveric knee, which is relevant to the mechanical function of an implant, not the analytical performance of a diagnostic test.
In summary, the KIMRS is a therapeutic implantable device, not a device used for testing specimens outside the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System (KIMRS) is intended for use in the osteoarthritic knee, where substantial amounts of articular cartilage have degenerated as a result of the disease, and in patients who are candidates for total and/or uni-compartmental arthroplasty procedures. The implant is indicated for the un-cemented treatment of the medial and/or lateral tibial articulating surfaces of the following:
Moderate degeneration of the medial or lateral compartment of the knee (grade II-IV chondromalacia) and minimal degeneration (grade I-II chondromalacia, no loss of joint space) in the patellofemoral compartments.
The Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System is intended to be implanted in the knee as a non-fixated, intra-articular support with minimal to no movement of the device after implantation.
Product codes
HSH
Device Description
Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System is a minimally invasive, bone preserving, approach for the treatment of the osteoarthritic knee. Developed from patient Magnetic Resonance (MR) scans a patient specific implant is designed.
The treatment allows for the placement of an un-cemented metallic device designed from the patient's natural cartilage and meniscal geometry that is implanted into the joint space either in the medial or lateral compartment above the affected tibial plateau. The femur then articulates against the smooth implant surface. The implant is manufactured from cobalt chromium molybdenum alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR) scans
Anatomical Site
Knee, medial and/or lateral tibial articulating surfaces
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
To compare the properties of the ImaTx Knee Interpositional Mini-Repair System with that of the Centerpulse Unispacer, both implants were inserted into the same cadaveric knee and examined under fluoroscopy. The test was performed on two knee specimens.
In the lateral view, anterior and posterior landmarks were chosen on the tibial plateau. The maximum motion of the anterior edge of the implant with respect to the anterior landmark and of the posterior edge of the implant with respect to the posterior landmark was recorded over the range from 0° (full extension) to 150° of flexion. Similarly, the maximum mediolateral excursion of both implants was measured in the AP views.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The ImaTx Knee Interpositional Mini-Repair System performed comparably to the Unispacer implant. On the lateral view, the values for anteroposterior translation are similar for both implants. Of note, the anterior and the posterior values should be similar or the same if the implant exhibits only translational movement. Remarkably, there is a significant difference in anterior and posterior maxima seen with the Unispacer in knee #1. This appears to be the result of implant rotation in addition to translation. Thus, the data in knee #1 indicate that the Unispacer rotates in addition to anteroposterior translation.
On the AP view, the ImaTx Knee Interpositional Mini-Repair System demonstrated no significant translation medially. The Unispacer, demonstrated considerably more movement medially.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3590 Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis.
(a)
Identification. A knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This prosthesis is made of alloys, such as cobalt-chromium-molybdenum, and is intended to resurface one tibial condyle. The generic type of device is limited to those prostheses intended for use without bone cement (§ 888.3027).(b)
Classification. Class II.
0
Page 1 of 4
510(k) Summary
Imaging Therapeutics, Inc.
Knee Interpositional Mini-Repair System
510(k) Notification KO33242
GENERAL INFORMATION
Manufacturer:
Imaging Therapeutics, Inc. 1720 Amphlett Blvd Suite 240 San Matco, CA 94402 Phone 650-286-4166 FAX 650-286-4160
Contact Person:
Lyndall Erb, PhD Director, Regulatory/Clinical Affairs & Quality Assurance
Date Prepared:
October 3, 2003
DEVICE INFORMATION
Trade/Proprietary Name
Knee Interpositional Mini-Repair System (KIMRS) / TBD
Common/Classification Name
Hemi-knee prosthesis
21 CFR 888.3590 -- Knee joint Unicondular Interpositional (hemi-knee) metallic resurfacting un-comented prosthesis
Class II
Device Product Code: HSH
1
PREDICATE DEVICES
·
033042
page 2 of 4
The Imaging Therapcutics, Inc. Knee Interpositional Mini-Repair System is substantially equivalent to FDA-approved predicate devices with regard to indications for use and technological characteristics. These predicate devices are:
| Indications for Use | Technological Characteristics |
|---|---|
| • Hayes Medical, Patient Specific Implant | |
| (PSI)-Femoral Component (K964395) | |
| • Biomet, Patient Matched Implants, | |
| Femoral Implants (K911802) | |
| • Techmedica, CAD/CAM Custom Hip | |
| (K911058) | • Sulzer Orthopedics, Inc., (Centerpulse), |
| Unicondylar Interpositional Spacer | |
| (K003269) | |
| • OTI Unicondular Interpositional Spacer | |
| System (K022779) | |
| • McKeever Hemiarthroplasty Prosthesis | |
| (Preamendment device) |
INTENDED USE
The Imaging Therapeutics, Inc. Knec Interpositional Mini-Repair System (KIMRS) is intended for use in the osteoarthritic knee, where substantial amounts of articular cartilage have degenerated as a result of the disease, and in patients who are candidates for total and/or uni-compartmental arthroplasty procedures. The implant is indicated for the un-cemented treatment of the medial and/or lateral tibial articulating surfaces of the following:
Moderate degeneration of the medial or lateral compartment of the knee (grade II-IV chondromalacia) and minimal degeneration (grade I-II chondromalacia, no loss of joint space) in the patellofemoral compartments.
The Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System is intended to be implanted in the knee as a non-fixated, intra-articular support with minimal to no movement of the device after implantation.
PRODUCT DESCRIPTION
Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System is a minimally invasive, bone preserving, approach for the treatment of the osteoarthritic knee. Developed from patient Magnetic Resonance (MR) scans a patient specific implant is designed.
The treatment allows for the placement of an un-cemented metallic device designed from the patient's natural cartilage and meniscal geometry that is implanted into the joint space either in the medial or lateral compartment above the affected tibial plateau. The femur then articulates against the smooth implant surface. The implant is manufactured from cobalt chromium molybdenum alloy.
2
SUBSTANTIAL EQUIVALENCE
033242
page 3 of 4
Technological Characteristics
The technological characteristics of the Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System are identical to those of the cited predicate orthopedic devices. This device is equivalent in terms of design process, materials, production process, and equipment.
Indications for Use
Substantial equivalence is also supported for the Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System by the predicate devices previously cited and cleared in the treatment of osteoarthritic knees where total knee replacement is not warranted.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
To compare the properties of the ImaTx Knee Interpositional Mini-Repair System with that of the Centerpulse Unispacer, both implants were inserted into the same cadaveric knee and examined under fluoroscopy. The test was performed on two knec specimens.
In the lateral view, anterior and posterior landmarks were chosen on the tibial plateau. The maximum motion of the anterior edge of the implant with respect to the anterior landmark and of the posterior edge of the implant with respect to the posterior landmark was recorded over the range from 0° (full extension) to 150° of flexion. Similarly, the maximum mediolateral excursion of both implants was measured in the AP views. The results are listed in the table below.
3
033242
page 4 of 4
| Cadaver Knee 1 | ImaTx KIMRS (in mm) | Unispacer (in mm) |
|---|---|---|
| Implant Length | 42 | 46 |
| Implant Width | 25 | 29 |
| Anterior Excursion (Lateral | ||
| view) | 4.5 | 3.1 |
| Posterior Excursion (Lateral | ||
| view) | 4.8 | 6.0 |
| Medial-Lateral Excursion | ||
| (Anterior-Posterior View) | 1.2 | 2.8 |
| Cadaver Knee 2 | ||
| Implant Length | 42 | 50 |
| Implant Width | 25 | 31 |
| Anterior Excursion (Lateral | ||
| view) | 3.6 | 4.0 |
| Posterior Excursion (Lateral | ||
| view) | 2.9 | 4.5 |
| Medial-Lateral Excursion | ||
| (Anterior-Posterior View) | 0.3 | 1.9 |
Table 1. Maximum excursion of KIMRS compared to Unispacer
The ImaTx Knee Interpositional Mini-Repair System performed comparably to the Unispacer implant. On the lateral view, the values for anteroposterior translation are similar for both implants. Of note, the anterior and the posterior values should be similar or the same if the implant exhibits only translational movement. Remarkably, there is a significant difference in anterior and posterior maxima seen with the Unispacer in knee #1. This appears to be the result of implant rotation in addition to translation. Thus, the data in knee #1 indicate that the Unispacer rotates in addition to anteroposterior translation.
On the AP view, the ImaTx Knee Interpositional Mini-Repair System demonstrated no significant translation medially. The Unispacer, demonstrated considerably more movement medially.
SUMMARY
Based on the similarities in design, matcrials, function, and intended use, the Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. In addition, the Imaging Therapcutics, Inc. Knee Interpositional Mini-Renair System raises no new safety on effectiveness issues.
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or bird in flight, composed of three curved lines. The emblem is positioned to the right of the text.
DEC 3 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lyndall Erb, Ph.D. Director Regulatory/Clinical Affairs & Quality Assurance Imaging Therapeutics, Inc. 1720 South Amphlett Boulevard, Suite 240 San Mateo, California 94402
Re: K033242
Trade/Device Name:s Knee Interpositional Mini-Repair System (KIMRS) Regulation Numbers: 21 CFR 888.3590 Regulation Names: Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis Regulatory Class: II Product Codes: HSH Dated: October 3, 2003 Received: October 7, 2003
Dear Dr. Erb:
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 such 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); good manufacturing practice requirements as sct 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.
5
Page 2 - Dr. Lyndall Erb
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
( Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known): K033342
Imaging Therapeutics, Inc.
Knee Interpositional Mini-Repair System
510(k) Premarket Notification
STATEMENT OF INDICATIONS FOR USE
The Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System (KIMRS) is intended for use in the osteoarthritic knee, where substantial amounts of articular cartilage have degenerated as a result of the disease, and in patients who are candidates for total and/or unicompartmental arthroplasty procedures. The implant is indicated for the un-cement of the medial and/or lateral tibial articulating surfaces of the following:
Moderate degeneration of the medial or lateral compartment of the knee (grade II-IV chondromalacia) and minimal degeneration (grade I-II chondromalacia, no loss of joint space) in the patellofemoral compartments.
The Imaging Therapeutics, Inc. Knee Interpositional Mini-Repair System is intended to be implanted in the knee as a non-fixated, intra-articular support with minimal to no movement of the device after implantation.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K033242