(29 days)
Medtronic Navigated Reusable Instruments for use with StealthStation™ and IPC™ POWEREASE™ Systems
Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the 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 skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Reusable Instruments are also compatible with the IPC™ POWEREASE™ System.
Medtronic Surgical Instruments for use with MAZOR X Stealth™ Edition
Medtronic Surgical Instruments are intended to be used during the preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the MAZOR X Stealth™ Edition, 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 skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Surgical Instruments can be navigated or non-navigated manual instruments that may or may not be guided through the MAZOR X Stealth™ Edition Arm Guide. Medtronic surgical drills shall only be used through the MAZOR X Stealth™ Edition arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPC™ POWEREASE™ System or AO* style quick connect drilling motors. An instrument may incorporate a measuring function which has uses as described on the label and the instrument.
The subject CD Horizon™ Spinal System drivers are non-sterile instruments that may be used during placement of various Medtronic screws during spinal surgery. The Medtronic instruments are made from materials commonly used in orthopedic and neurological procedures which meet available national or international standards specifications. The subject CD Horizon™ Spinal System drivers are compatible with POWEREASE, Medtronic NavLock trackers and Medtronic single-use sterile spheres to allow a Medtronic computer-assisted surgery system to track the instruments in the surgical field.
The provided text is a 510(k) Summary for the Medtronic CD Horizon™ Spinal System Instruments. This document is a regulatory submission for a medical device and describes its intended use, comparison to predicate devices, and testing performed to demonstrate substantial equivalence. It does not contain information about the performance of an AI/ML device in detail as it pertains to acceptance criteria and performance metrics typically expected for such technologies.
The device in question is "CD Horizon™ Spinal System Instruments", which are non-sterile instruments for use during spinal surgery with navigation systems (StealthStation, MAZOR X Stealth™ Edition) and power tools (IPC™ POWEREASE™ System, AO* style quick connect drilling motors). These are physical surgical instruments, not an AI/ML software device.
Therefore, many of the requested categories regarding AI/ML device performance, such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, and training set information are not applicable to this submission, as it is for physical surgical instruments.
However, I can extract the relevant information regarding the performance testing for these instruments as described in the document.
Acceptance Criteria and Device Performance for Medtronic CD Horizon™ Spinal System Instruments
The document describes the performance testing undertaken to ensure the functionality and compatibility of the instruments. While specific numerical acceptance criteria (e.g., accuracy thresholds) are not explicitly stated in this summary, the tests confirmed the instruments meet their functional requirements.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Description | Stated Outcome |
|---|---|---|
| Navigation Accuracy Testing | Confirmed navigated instrument accuracy. | Test results show that the subject device and the predicate device are equivalent. |
| CAD Model Verification | Confirm the driver's CAD models are accurately reflected in the application software. | Test results show that the subject device and the predicate device are equivalent. |
| Tools Package Functional Verification Testing | Provides confirmation that the Spine tools package has met the required interface needs of the spine application software. | Test results show that the subject device and the predicate device are equivalent. |
| Navigated Simulated Use | Validate that the design outputs meet the requirements associated with customer needs. | Test results show that the subject device and the predicate device are equivalent. |
| Anatomical Simulated Use Testing | User needs are satisfied by performing simulated testing per the instructions outlined in the surgical techniques. | Test results show that the subject device and the predicate device are equivalent. |
2. Sample size used for the test set and the data provenance: Not applicable. This submission concerns physical instruments, not data-driven AI/ML models. Testing would have involved the instruments themselves, likely in a lab setting or simulated surgical environment. No specific sample sizes for data or data provenance (country, retrospective/prospective) are mentioned as it's not a data-based study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For physical instruments, "ground truth" typically refers to engineering specifications and functional performance. Clinical experts might be involved in defining "customer needs" for simulated use testing, but specific numbers and qualifications are not mentioned.
4. Adjudication method for the test set: Not applicable. This type of regulatory submission for physical instruments does not typically involve adjudication methods like those used for expert consensus in AI/ML model ground truth generation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. This is not applicable to physical surgical instruments.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a set of physical surgical instruments, which are used by humans and with other integrated navigation systems. There is no "standalone algorithm" performance to assess for these instruments.
7. The type of ground truth used: For these physical instruments, the "ground truth" would be established through engineering specifications, design requirements, and possibly functional performance benchmarks against predicate devices or industry standards. The document states that testing was "completed to ensure the functionality and compatibility with the identified Medtronic products" and that the "test results show that the subject device and the predicate device are equivalent." This implies a comparison to established performance of predicate devices and adherence to design specifications.
8. The sample size for the training set: Not applicable. This device is not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established: Not applicable. This device is not an AI/ML model.
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December 8, 2020
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Medtronic Sofamor Danek USA, INC. Erikka Edwardsen Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K203291
Trade/Device Name: CD Horizon Spinal System Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 6, 2020 Received: November 9, 2020
Dear Erikka Edwardsen:
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 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
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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 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,
For: 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)
K203291
Device Name CD Horizon™ Spinal System Instruments
Indications for Use (Describe)
Indications for Use Medtronic Navigated Reusable Instruments for use with StealthStation™ and IPC™ POWEREASE™ Systems
Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the 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 skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Reusable Instruments are also compatible with the IPC™ POWEREASE™ System.
Medtronic Surgical Instruments for use with MAZOR X Stealth™ Edition
Medtronic Surgical Instruments are intended to be used during the preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the MAZOR X Stealth™ Edition, 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 skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Surgical Instruments can be navigated or non-navigated manual instruments that may or may not be guided through the MAZOR X Stealth™ Edition Arm Guide. Medtronic surgical drills shall only be used through the MAZOR X Stealth™ Edition arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Mectronic Surgical Instruments are also compatible with the IPC™ POWEREASE™ System or AO* style quick connect drilling motors. An instrument may incorporate a measuring function which has uses as described on the label and the instrument.
Type of Use (Select one or both, as applicable)
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
November 6, 2020
| I. Submitter: | Medtronic Sofamor Danek, USA Inc.1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901)396-3133 |
|---|---|
| --------------- | ----------------------------------------------------------------------------------------------------------------- |
| Contact: | Erikka EdwardsenSr Regulatory Affairs SpecialistTelephone Number: (901) 399-2485Email: rikka.r.edwardsen@medtronic.com |
|---|---|
| ---------- | ------------------------------------------------------------------------------------------------------------------------------------ |
II. Device:
| Proprietary Trade Name: | CD Horizon™ Spinal System |
|---|---|
| Common Name: | Stereotaxic Instrument, Navigated Instruments |
| Classification Name: | Stereotaxic Instrument |
| Regulation Numbers: | Class II (21 CFR 882.4560) |
| Classification: | Class II |
| Product Code: | OLO |
III. Predicates:
Predicate:
- Primary Predicate: CD Horizon™ SOLERA Instruments (K140454, S.E. . 05/22/2014)
- Additional Predicate: CD Horizon™ Spinal System Instruments (K182121, S.E. . 11/02/2018)
The predicate devices have not been subject to a design-related recall.
IV. Product Description:
The subject CD Horizon™ Spinal System drivers are non-sterile instruments that may be used during placement of various Medtronic screws during spinal surgery. The Medtronic
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instruments are made from materials commonly used in orthopedic and neurological procedures which meet available national or international standards specifications. The subject CD Horizon™ Spinal System drivers are compatible with POWEREASE, Medtronic NavLock trackers and Medtronic single-use sterile spheres to allow a Medtronic computer-assisted surgery system to track the instruments in the surgical field.
V. Indications for Use
Medtronic Navigated Reusable Instruments for use with StealthStation™ and IPC™ POWEREASE™ Systems
Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the 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 skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Reusable Instruments are also compatible with the IPC™ POWEREASE™ System.
Medtronic Surgical Instruments for use with MAZOR X StealthTM Edition
Medtronic Surgical Instruments are intended to be used during the preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the MAZOR X Stealth™ Edition, 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 skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Surgical Instruments can be navigated or non-navigated manual instruments that may or may not be guided through the MAZOR X Stealth™ Edition Arm Guide. Medtronic surgical drills
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shall only be used through the MAZOR X Stealth™ Edition arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPC™ POWEREASE™ System or AO* style quick connect drilling motors. An instrument may incorporate a measuring function which has uses as described on the label and the instrument.
VI. Comparison of Technological Characteristics:
The subject CD Horizon™ instruments are intended to be used during the placement of Medtronic screws during spinal surgery. The subject devices have similar designs, principle of operation, fundamental scientific technology, material, intended use, as the predicate devices and incorporate the same design features to enable navigation and compatibility and use with IPC™ POWEREASE™ System when desired.
The only change to the subject CD Horizon™ Spinal System drivers (K182121, S.E. 11/02/2018) is the expanded indications. Expanding the indications will provide surgeons additional driver options during procedures currently enabled on the StealthStation™ system. The subject drivers will have the same indications for use as the CD Horizon Solera™ drivers (K140454, S.E. 05/22/2014). The devices continue to be compatible with the Mazor X Stealth Edition, NavLock Trackers, the IPC POWEREASE System (K111520, S.E. 10/26/2011) quick connect manual handles and CD Horizon Spinal System bone screws
VII. Discussion of the Performance Testing:
Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. The test results show that the subject device and the predicate device are equivalent.
| Test | Description |
|---|---|
| Navigation AccuracyTesting | Confirmed navigated instrument accuracy |
| CAD Model Verification | Confirm the driver's CAD models are accurately reflectedin the application software. |
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| Tools PackageFunctional VerificationTesting | Provides confirmation that the Spine tools package has metthe required interface needs of the spine applicationsoftware. |
|---|---|
| Navigated Simulated Use | Validate that the design outputs meet the requirementsassociated with customer needs. |
| Anatomical SimulatedUse Testing | User needs are satisfied by performing simulated testing perthe instructions outlined in the surgical techniques |
VIII. Conclusion:
Based on the supporting information provided in this pre-market notification, the subject CD Horizon™ Spinal System Drivers are substantially equivalent to CD HORIZON SOLERA Instruments (K140454, S.E. 05/22/2014)
§ 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).