(114 days)
Camber Spine Navigation System instruments are intended to be used in the preparation and placement of ORTHROS Posterior Stabilization System and ORTHROS MIS Posterior Stabilization System screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic® 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 vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.
Camber Spine Navigation System contains reusable instruments, provided non-sterile, including inserters, taps, probes, awls, and awl taps. These instruments are intended to be used with the Medtronic StealthStation® Navigation System and its associated NavLock arrays, to assist surgeons in precisely locating anatomical structures for preparation and placement of ORTHROS Posterior Stabilization System and ORTHROS MIS Posterior Stabilization System screws during spinal surgery. The instrumentation is designed for use with the Medtronic StealthStation® Navigation System hardware and software. These instruments are made of medical grade stainless steel according to the ASTM F899 and many include a titanium nitride coating per SAE AMS 2444A.
This document does not contain information about acceptance criteria and a study proving the device meets the acceptance criteria. It is a 510(k) summary and FDA clearance letter for the Camber Spine Navigation System.
The document primarily focuses on:
- FDA Clearance: Announcing the 510(k) clearance for the Camber Spine Navigation System.
- Device Description: Describing the components and intended use of the Camber Spine Navigation System.
- Indications for Use: Specifying the medical conditions and procedures for which the device is intended.
- Substantial Equivalence: Explaining how the device is similar to legally marketed predicate devices.
- Performance Testing (General Statement): Briefly mentioning that performance testing was conducted to verify functionality, accuracy, and compatibility, and to demonstrate substantial equivalence, but does not provide details of the acceptance criteria, the specific study design, or the results of this testing.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for the test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study or effect size.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document indicates that performance testing was done ("Performance testing demonstrates that the Camber Spine Navigation System instruments are substantially equivalent to the predicate devices."), but it does not provide the details of this testing that would allow me to answer your specific questions about acceptance criteria, study methodology, or results.
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April 29, 2022
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Camber Spine Technologies % Christine Scifert Partner MRC Global, LLC 9085 E. Mineral Cir., Suite 110 Centennial. Colorado 80112
Re: K220038
Trade/Device Name: Camber Spine Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 28, 2022 Received: March 30, 2022
Dear Christine Scifert:
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.
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
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es. You must comply with all the Act's
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,
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
Enclosure
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Indications for Use
510(k) Number (if known) K220038
Device Name Camber Spine Navigation System
Indications for Use (Describe)
Camber Spine Navigation System instruments are intended to be used in the preparation and placement of ORTHROS Posterior Stabilization System and ORTHROS MIS Posterior Stabilization System screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtron® 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 vertebra, can be identified relative to a CT or MRI 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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510(k) Summary Camber Spine Navigation System 28 April 2022
| Company: | Camber Spine Technologies501 Allendale RdKing of Prussia, PA 19406 |
|---|---|
| Company Contact: | Noel HetrickDirector, Quality Assurance/Regulatory Affairs(484) 427-7060nhetrick@cambermedtech.com |
| Official Correspondent: | Christine Scifert – MRC Global, LLCChristine.scifert@askmrcglobal.com901-831-8053 |
| Trade Name: | Camber Spine Navigation System |
| Common Name: | Orthopedic Stereotaxic Instrument |
| Classification: | Class II |
| Regulation Number: | 21 CFR 882.4560 (Stereotaxic Instrument) |
| Panel: | Orthopedic |
| Product Code: | OLO |
Device Description:
Camber Spine Navigation System contains reusable instruments, provided non-sterile, including inserters, taps, probes, awls, and awl taps. These instruments are intended to be used with the Medtronic StealthStation® Navigation System and its associated NavLock arrays, to assist surgeons in precisely locating anatomical structures for preparation and placement of ORTHROS Posterior Stabilization System and ORTHROS MIS Posterior Stabilization System screws during spinal surgery. The instrumentation is designed for use with the Medtronic StealthStation® Navigation System hardware and software. These instruments are made of medical grade stainless steel according to the ASTM F899 and many include a titanium nitride coating per SAE AMS 2444A.
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Indications for Use:
Camber Spine Navigation System instruments are intended to be used in the preparation and placement of ORTHROS Posterior Stabilization System and ORTHROS MIS Posterior Stabilization System screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are 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 vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.
Substantial Equivalence:
The subject Camber Spine Navigation System is substantially equivalent to the following predicate devices:
Primary Predicate:
- . Medtronic Sofamor Danek – Medtronic Navigated Instruments (K153442)
Secondary Predicates:
- . Medtronic Sofamor Danek – Medtronic Navigated Instruments (K124004)
- . Camber Spine – Orthros™ Posterior Stabilization System and Orthros™ MIS Posterior Stabilization (K180980)
Similar to the predicate navigated instruments, Camber Spine Navigation System instruments are intended to be used with the Medtronic's StealthStation® System to assist the surgeon in locating anatomical structures. Additionally, the Camber Spine Navigation System instruments and their predicate devices have similar technological characteristics, including design, dimensions, materials and technology, and they function in the same manner. Performance testing demonstrates that the Camber Spine Navigation System instruments are substantially equivalent to the predicate devices. Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness.
Performance Testing:
The performance evaluation included a one-to-one dimensional comparison to demonstrate substantially equivalent geometry that is critical to navigation accuracy. Testing, including anatomical and navigated simulated use and accuracy and reliability testing, has been conducted to verify that the Camber Spine Navigation System instruments are appropriate for their intended use, to ensure functionality, accuracy and compatibility with the Medtronic StealthStation® System using the NavLock Tracker, and to demonstrate substantial equivalence to the predicate instruments.
Conclusion:
Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.
§ 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).