(58 days)
The CORUS™ Navigation Access System for use with the CORUS™ Spinal System is intended to be used during spinal surgery to assist the surgeon in locating and preparing facet joints in either open, or minimally invasive procedures. The CORUSTM Navigation Access System is specifically designed for use with the Medtronic StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
The CORUS™ Navigation Access System is a manually operated disposable instrument set to be used with the Medtronic StealthStation™ System to assist the surgeon in precise site preparation during open or minimally invasive spinal surgery. The CORUS™ Navigation Access System includes the Navigated Access Chisel, Guide Tube, and Trephine Decorticator. The instruments are manufactured from stainless steel.
The provided text is a 510(k) summary for the CORUS™ Navigation Access System. It describes the device, its intended use, and its technological characteristics. However, it does not contain specific acceptance criteria, performance metrics, or detailed study results that would typically be presented in a clinical validation or performance study.
Instead, the performance data section states:
"The CORUS™ Navigation Access System has been evaluated though an engineering analysis and geometric comparison to the predicate device. A validation was also conducted to demonstrate navigation compatibility with the Medtronic StealthStation™ System. The results show that the subject device is substantially equivalent to the cleared predicates."
This indicates that the manufacturer performed:
- Engineering analysis: Likely involved design reviews, material compatibility, and structural integrity assessments.
- Geometric comparison: Compared the dimensions and design of the CORUS™ system to existing, cleared predicate devices.
- Navigation compatibility validation: This would have assessed if the CORUS™ Navigation Access System correctly interfaces and functions with the Medtronic StealthStation™ System as intended.
Therefore, based only on the provided text, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions 2 through 9, as this information is not present. The document focuses on demonstrating substantial equivalence through engineering analysis and compatibility rather than a clinical performance study with defined criteria and metrics.
If this were a typical clinical performance study, the requested information would be available. Since it is not, the response must reflect the absence of such data in the provided document.
Summary of missing information based on the provided text:
- 1. A table of acceptance criteria and the reported device performance: Not provided. The document states "evaluated though an engineering analysis and geometric comparison" and "A validation was also conducted to demonstrate navigation compatibility," but no specific criteria or results are listed.
- 2. Sample sized used for the test set and the data provenance: Not mentioned.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- 4. Adjudication method: Not mentioned.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not mentioned. No human reader interaction is implied or detailed.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a "manually operated disposable instrument set" that "assists the surgeon." It is not an "algorithm only" device. The validation focused on navigation compatibility.
- 7. The type of ground truth used: Not applicable in the context of the described engineering and compatibility validations.
- 8. The sample size for the training set: Not applicable; this is not an AI/ML device requiring a training set.
- 9. How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 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, and then the word "ADMINISTRATION" in a smaller font size below.
May 3, 2024
Providence Medical Technology, Inc. % Hannah Taggart, MS Regulatory Associate Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K240625
Trade/Device Name: CORUSTM Navigation Access System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 5, 2024 Received: March 6, 2024
Dear Ms. Taggart:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Shumaya Ali -S
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K240625
Device Name CORUSTM Navigation Access System
Indications for Use (Describe)
The CORUS™ Navigation Access System for use with the CORUS™ Spinal System is intended to be used during spinal surgery to assist the surgeon in locating and preparing facet joints in either open, or minimally invasive procedures. The CORUSTM Navigation Access System is specifically designed for use with the Medtronic StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
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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Image /page/3/Picture/0 description: The image shows the logo for Providence Medical Technology. The logo consists of an orange symbol on the left and the words "PROVIDENCE" and "MEDICAL TECHNOLOGY" on the right. The word "PROVIDENCE" is in gray, and the words "MEDICAL TECHNOLOGY" are in orange. There is a trademark symbol after the word "PROVIDENCE".
| 510(k) Owner: | Providence Medical Technology, Inc.4234 Hacienda Dr. Suite 150, Pleasanton, California 94588T: 415-923-9376; F: 415-923-9377 |
|---|---|
| Company Contact Person: | Edward Liou, Providence Medical Technology, Inc.415-754-8593; ed@providencemt.com |
| Submission Correspondent: | Hannah Taggart, MS, Empirical Technologies719-457-1152; htaggart@empiricaltech.com |
| Date Summary Prepared: | April 23, 2024 |
| Trade Name: | CORUST™ Navigation Access System |
| Common Name: | Stereotaxic Instruments |
| Device Classification Name: | Orthopedic Stereotaxic Instruments |
| Classification & Regulation: | Class II per 21 CFR §882.4560 |
| Product Code: | OLO |
| Panel: | Orthopedic - Stereotaxic, Trauma, and Restorative Devices (DHT6C) |
PREMARKET NOTIFICATION 510(K) SUMMARY
DEVICE DESCRIPTION:
The CORUS™ Navigation Access System is a manually operated disposable instrument set to be used with the Medtronic StealthStation™ System to assist the surgeon in precise site preparation during open or minimally invasive spinal surgery. The CORUS™ Navigation Access System includes the Navigated Access Chisel, Guide Tube, and Trephine Decorticator. The instruments are manufactured from stainless steel.
INDICATIONS FOR USE
The CORUS™ Navigation Access System for use with the CORUS™ Spinal System is intended to be used during spinal surgery to assist the surgeon in locating and preparing facet joints in either open, or minimally invasive procedures. The CORUSTM Navigation Access System is specifically designed for use with the Medtronic StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
TECHNOLOGICAL CHARACTERISTICS
The subject has similar indications for use, materials, sterilization method, technological characteristics, geometry, and compatibilities with Medtronic StealthStation™ System as the predicates devices and the minor differences do not raise any new issues of safety and effectiveness.
| Predicate Devices | |
|---|---|
| ------------------- | -- |
| 510k # | Trade Name | Manufacturer | ProductCode | PredicateType |
|---|---|---|---|---|
| K211441 | Navigated Anterolateral Disc Prep Instruments | Medtronic Sofamor Danek USA, Inc. | OLO | Primary |
| K212636 | CORUS™ Spinal System-X | Providence Medical Technology | HRX | Additional |
| K150231 | Navigated Disc Preparation Instruments | Medtronic Sofamor Danek, USA Inc. | OLO | Additional |
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Image /page/4/Picture/0 description: The image shows the logo for Providence Medical Technology. The logo consists of an orange symbol on the left and the words "PROVIDENCE" in gray and "MEDICAL TECHNOLOGY" in orange on the right. The symbol is a stylized letter "P" made up of three curved lines.
PERFORMANCE DATA
The CORUS™ Navigation Access System has been evaluated though an engineering analysis and geometric comparison to the predicate device. A validation was also conducted to demonstrate navigation compatibility with the Medtronic StealthStation™ System. The results show that the subject device is substantially equivalent to the cleared predicates.
CONCLUSION
The overall technological characteristics, engineering analysis, geometric comparison, and navigation compatibility validation lead to the conclusion that the CORUS™ Navigation Access System is substantially equivalent to the predicate device.
§ 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).