StealthStation Spinous Process Clamps

K211442 · Medtronic Navigation · OLO · Jul 8, 2021 · Neurology

Device Facts

• Record ID: K211442
• Device Name: StealthStation Spinous Process Clamps
• Applicant: Medtronic Navigation
• Product Code: OLO · Neurology
• Decision Date: Jul 8, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The navigated 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. When used with a Medtronic StealthStation™ Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery.

Device Story

StealthStation Spinous Process Clamps are reusable orthopedic stereotaxic instruments designed for use with the Medtronic StealthStation Navigation System. The device provides rigid attachment between a patient and a patient reference frame during surgery. It functions by clamping onto the spinous process of a vertebra, allowing the navigation system to track the patient's anatomy relative to pre-operative or intra-operative imaging (CT, MR, or fluoroscopy). The clamps are operated by surgeons in an OR setting. By maintaining a stable reference frame, the device enables the navigation system to provide real-time guidance, potentially increasing surgical accuracy and reducing risks associated with spinal procedures. The device is constructed from titanium and stainless steel and is steam-sterilizable.

Clinical Evidence

Bench testing only. Evidence includes functional verification, useful life testing, navigation accuracy testing, and packaging verification (ASTM D4169, ISTA 2A). Biological safety testing conducted per ISO 10993-1:2018 confirms the device is non-cytotoxic, non-sensitizing, non-irritating, non-toxic, and non-pyrogenic.

Technological Characteristics

Materials: Titanium, 17-4 Stainless Steel, 300 Series Stainless Steel. Principle: Mechanical clamping for rigid fixation of navigation reference frames. Form factor: Reusable clamps with varying jaw shapes (concave/non-concave) and sizes (Short, Medium, Tall). Sterilization: Steam sterilization. Connectivity: Passive component used with StealthStation navigation system.

Indications for Use

Indicated for patients requiring stereotactic surgery where rigid anatomical structures (skull, long bone, vertebra) can be referenced against CT/MR models, fluoroscopy, or digitized landmarks. Used for rigid attachment of patient reference frames during surgery.

Regulatory Classification

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.

Predicate Devices

• Navigated CAPSTONE® Trials, CLYDESDALE® Trials, and CAPSTONE® & CLYDESDALE® Inserter (K131425)

Submission Summary (Full Text)

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July 8, 2021

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Medtronic Navigation Victoria Baldock Associate Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027

## Re: K211442

Trade/Device Name: StealthStation Spinous Process Clamps Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 7, 2021 Received: May 10, 2021

## Dear Victoria Baldock:

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 ([e-mail]) or phone [phone] 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) K211442

Device Name StealthStation™ Spinous Process Clamps

### Indications for Use (Describe)

The navigated 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.

When used with a Medtronic StealthStation™ Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------------|
| Prescription Use (Ref 21 CFR 201 Subpart D) | <span style="text-decoration: overline;">X</span> |
| Over-The-Counter Use (21 CFR 201 Subpart C) | <span style="text-decoration: overline;"> </span> |

> Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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K211442

Page 1 of 4

## 510(k) Summary

## May 07, 2021

### l. Company: Medtronic Navigation 826 Coal Creek Circle Louisville, CO 80027 Telephone Number: [phone]

Contact: Victoria Baldock Associate Regulatory Affairs Specialist Telephone Number: [phone] Email: [e-mail]

> Rishi Sinha (Alternate) Regulatory Affairs Director Telephone Number: [phone] Email: [e-mail]

- Proprietary Trade Name: StealthStation™ Spinous Process Clamps II.
- lll. Common Name: Orthopedic Stereotaxic Instrument
- IV. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
- V. Classification: Class II
- VI. Product Code: OLO (Stereotaxic Instrument)

### VII. Predicate Devices:

The legally marketed predicate devices are identified below:

| Predicate | 510(k) Clearance |
|--------------------------------------------------------------------------------------|------------------|
| Navigated CAPSTONE® Trials, CLYDESDALE® Trials, and CAPSTONE® & CLYDESDALE® Inserter | K131425 |

#### VIII. Product Description:

The Spinous Process Clamps are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery. The subject devices are designed for use with the StealthStation™ System and are intended to be reusable.

### IX. Indications for Use:

The navigated 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.

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When used with a Medtronic StealthStation™ Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery.

### X. Comparison of the Technological Characteristics:

The subject Spinous Process Clamps (Generation 4) utilize the same fundamental scientific technology and have the same mode of operation and functionality as the predicate Spinous Process Clamps (Generation 2) (K131425). The subject devices have equivalent materials and sterilization/reprocessing methods as the predicate (K131425). The changes in design features between the subject and the predate do not raise any new risks or any concerns about the safety and effectiveness. The subject devices also meet the established navigational accuracy requirements.

| Feature | Subject Devices<br>StealthStation™ Spinous<br>Process Clamps | Predicate Devices<br>Navigated CAPSTONE®<br>Trials, CLYDESDALE®<br>Trials, and CAPSTONE®<br>& CLYDESDALE®<br>Inserter (K131425) |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | When used with a<br>Medtronic StealthStation™<br>Navigation System, the<br>Spine Referencing fixation<br>devices are intended to<br>provide rigid attachment<br>between patient and patient<br>reference frame for the<br>duration of the surgery. The<br>devices are intended to be<br>reusable. | When used with a<br>Medtronic StealthStation™<br>Navigation System, the<br>Spine Referencing fixation<br>devices are intended to<br>provide rigid attachment<br>between patient and<br>patient reference frame for<br>the duration of the surgery.<br>The devices are intended<br>to be reusable. |
| Indications for Use | The navigated instruments<br>are specifically designed for<br>use with the<br>StealthStation™ System,<br>which is indicated for any<br>medical condition in which<br>the use of stereotactic<br>surgery may be<br>appropriate, and where<br>reference to a rigid<br>anatomical structure such<br>as a skull, a long bone, or<br>vertebra can be identified<br>relative to a CT or MR<br>based model, fluoroscopy<br>images, or digitized<br>landmarks of the anatomy. | The navigated instruments<br>are specifically designed<br>for use with the<br>StealthStation™ System,<br>which is indicated for any<br>medical condition in which<br>the use of stereotactic<br>surgery may be<br>appropriate, and where<br>reference to a rigid<br>anatomical structure such<br>as a skull, a long bone, or<br>vertebra can be identified<br>relative to a CT or MR<br>based model, fluoroscopy<br>images, or digitized<br>landmarks of the anatomy. |

## Table 1. Comparison of Technological Characteristics

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| Sterilization Method | Non-sterile, Steam sterilization, Reusable | Non-sterile, Steam sterilization, Reusable |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Material | Titanium, 17-4 Stainless Steel, 300 Series Stainless Steel | Titanium, 17-4 Stainless Steel, 300 Series Stainless Steel |
| Thread Relief | Screw engaged threads with clamping mechanism at all time, due to full threaded screw design. Removal of two washer components due to screw changes. | Unengaged screw when clamps are open, due to thread relief in screw design. |
| Jaw Shape | Single Clamps: Concave shape of jaws to align to the spinous process bulbous top<br>Double Clamps: Non-concave | Single Clamps: Non-concave<br>Double Clamps: Non-concave |
| Teeth | Single Clamps: Small teeth on the upper (concave) part of jaws, same size teeth as predicate on lower part of jaws<br>Double Clamps: Teeth all same size | Single Clamps: Teeth all same size<br>Double Clamps: Teeth all same size |
| Distal End Shape | Single Clamps: Pointed jaw at distal end<br>Double Clamps: Blunt jaw at distal end | Single Clamps: Blunt jaw at distal end<br>Double Clamps: Blunt jaw at distal end |
| Clamping Range | Single Clamps: 11 mm<br>Double Clamps: 9 mm | Single Clamps: 9 mm<br>Double Clamps: 9 mm |
| Size Offerings | Short, Medium, and Tall | Short and Tall |

### XI. Discussion of the Performance Testing:

Testing conducted to demonstrate equivalency of the subject device to the predicate is summarized as follows:

| Performance Testing<br>Activity | Description |
|---------------------------------|------------------------------------------------------------------------------------------------|
| Functional Verification | Confirms that the Spinous Process Clamp design<br>satisfies functional requirements. |
| Useful Life Testing | Confirms that the Spinous Process Clamps can<br>operate normally throughout their useful life. |

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| Navigation Accuracy Testing | Verifies the robustness and navigational accuracy of<br>the Spinous Process Clamps. |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Packaging Verification | Confirms that the Spinous Process Clamps when<br>packaged in their packaging can withstand ship<br>testing per ASTM D4169 and ISTA 2A. |

Additionally, biological endpoint testing, conducted per recommendations from ISO 10993-1:2018, indicates that the subject devices are non-cytotoxic, non-sensitizing, nonirritating, non-toxic, and non-pyrogenic and pose a negligible risk of adverse biological effects to patients when used as intended.

### XII. Conclusion:

The subject devices have shown through comparison to be substantially equivalent to the identified predicate.