(89 days)
No
The 510(k) summary describes a mechanical surgical instrument (a cut guide) used with a surgical system. There is no mention of AI, ML, image processing, or any data-driven algorithms in the device description or performance studies. The focus is on the mechanical function and usability of the cut guide.
No.
The device is a surgical instrument used to guide a saw during total knee arthroplasty, which is an operative tool rather than a therapeutic device that directly treats or prevents a disease or condition.
No
Explanation: The device is a surgical instrument used to guide a saw during total knee arthroplasty, not to diagnose a condition or disease.
No
The device description explicitly states it is a "set of surgical instrument components" and describes its function as guiding a surgical saw, indicating it is a physical hardware device.
No, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the RI.KNEE Adjustable Tibia Cut Guide is a set of surgical instrument components used during total knee arthroplasty to guide a surgical saw. It is a physical tool used in a surgical procedure.
- Intended Use: The intended use is to be used in conjunction with a surgical system during a surgical procedure (total knee arthroplasty). It does not involve testing samples from the body.
The device is a surgical instrument, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The RI.KNEE Adjustable Tibia Cut Guide is intended to be used in conjunction with the CORI surgical system during total knee arthroplasty.
Product codes
OLO
Device Description
The subject RI.KNEE Adjustable Tibia Cut Guide is a set of surgical instrument components used during total knee arthroplasty (TKA) to make the resections to the tibia by guiding a surgical saw through the saw slot. The cut guide is used with the Smith and Nephew (Blue Belt Technologies) CORI surgical system. The subject Tibia Cut Guide offers an alternative to the tibia cut guides currently available in the CORI system and provides direct attachment of the tibia tracker to reduce surgical steps for tibia tracker fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, Tibia
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
The RI.KNEE Adjustable Tibia Cut Guide has been tested in the following test modes:
- Summative Usability Evaluation
- Function and Robustness Testing
In addition to the bench testing, the instrument biocompatibility and the instrument cleaning and sterilization processes have been evaluated. The results of this non-clinical testing and evaluations show that the performance of the RI.KNEE Adjustable Cut Guide is sufficient for its function and intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
June 27, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Enztec Limited % Nathan Wright Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Dr. Colorado Springs, Colorado 80918
Re: K230876
Trade/Device Name: RI.KNEE Adjustable Tibia Cut Guide Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 30, 2023 Received: March 30, 2023
Dear Nathan Wright:
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.
1
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 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 (QS) 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 medical devices and radiation-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.
Tejen D. Soni -S 2023.06.27 16:39:00 -04'00'
For
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230876
Device Name RI.KNEE Adjustable Tibia Cut Guide
Indications for Use (Describe)
The RI.KNEE Adjustable Tibia Cut Guide is intended to be used in conjunction with the CORI surgical system during total knee arthroplasty.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Remediation Use (Part 21 CFR 201 Subpart D) | ☐ Over-The-Counter Use (21 CFR 201 Subpart G) |
|---|---|
| ------------------------------------------------------------------------------------ | ----------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
| Submitter's Name: | Enztec Limited |
|---|---|
| Submitter's Address: | 3/17 Print Place |
| Middleton, Christchurch 8024 | |
| Submitter's Telephone: | +64 27 829 2440 |
| Contact Person: | Nathan Wright MS |
| Empirical Technologies | |
| 1-719-351-0248 | |
| nwright@empiricaltech.com | |
| Date Summary was Prepared: | March 30, 2023 |
| Trade or Proprietary Name: | RI.KNEE Adjustable Tibia Cut Guide |
| Device Classification Name: | Orthopedic Stereotaxic Instrument |
| Classification & Regulation #: | Class II per 21 CFR §882.4560 |
| Product Code: | OLO |
| Classification Panel: | Stereotaxic, Trauma and Restorative Devices (DHT6C) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The subject RI.KNEE Adjustable Tibia Cut Guide is a set of surgical instrument components used during total knee arthroplasty (TKA) to make the resections to the tibia by guiding a surgical saw through the saw slot. The cut guide is used with the Smith and Nephew (Blue Belt Technologies) CORI surgical system. The subject Tibia Cut Guide offers an alternative to the tibia cut guides currently available in the CORI system and provides direct attachment of the tibia tracker to reduce surgical steps for tibia tracker fixation.
INDICATIONS FOR USE
The RI.KNEE Adjustable Tibia Cut Guide is intended to be used in conjunction with the CORI surgical system during total knee arthroplasty.
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have similar technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are comparable between the subject and predicates:
- Indications for Use
- Materials of manufacture ●
- CORI Surgical System Application
- Function - Knee Resection
Predicate Devices
| 510k Number | Trade or Proprietary or
Model Name | Manufacturer | Product
Code | Predicate
Type |
|-------------|---------------------------------------|------------------------------|-----------------|-------------------|
| K221224 | Real Intelligence Cori (Cori) | Blue Belt Technologies, Inc. | OLO | Primary |
PERFORMANCE DATA
The RI.KNEE Adjustable Tibia Cut Guide has been tested in the following test modes:
- Summative Usability Evaluation
- Function and Robustness Testing ●
4
In addition to the bench testing, the instrument biocompatibility and the instrument cleaning and sterilization processes have been evaluated. The results of this non-clinical testing and evaluations show that the performance of the RI.KNEE Adjustable Cut Guide is sufficient for its function and intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the RI.KNEE Adjustable Cut Guide is substantially equivalent to the predicate device.