Erisma LP Navigated Instruments

K202956 · Clariance, Sas · OLO · Feb 26, 2021 · Neurology

Device Facts

• Record ID: K202956
• Device Name: Erisma LP Navigated Instruments
• Applicant: Clariance, Sas
• Product Code: OLO · Neurology
• Decision Date: Feb 26, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

Erisma®-LP Navigated Instruments are intended to be used in the preparation and placement of Erisma® 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Device Story

Manual, reusable surgical instruments (drivers, taps, bone awls, probes) used in spinal surgery; designed for integration with Medtronic StealthStation® Navigation System. Instruments feature tracking markers compatible with Medtronic hardware; allow surgeon to track instrument position relative to patient anatomy (CT/MR/fluoroscopy) during pedicle screw placement. Used in OR by surgeons; provides real-time visual guidance on navigation system display. Enhances surgical precision in locating anatomical structures; facilitates minimally invasive or open procedures; reduces potential for malpositioning of spinal implants.

Clinical Evidence

Bench testing only. Mechanical testing demonstrated compatibility with Medtronic StealthStation® System, including registration capability and simulated pedicle insertion performance. No clinical data provided.

Technological Characteristics

Manual, reusable surgical instruments. Materials: medical-grade stainless steel (ASTM F899) and titanium alloy (ASTM F136). System includes drivers, taps, bone awls, and probes. Connectivity: passive tracking via integration with Medtronic StealthStation® Navigation System hardware. Sterilization: reusable (method not specified).

Indications for Use

Indicated for use in spinal surgery to assist surgeons in locating anatomical structures during the preparation and placement of Erisma® screws in open or minimally invasive procedures. Designed for use with the Medtronic StealthStation® System for patients requiring stereotactic surgery where rigid anatomical structures (e.g., vertebrae) can be referenced against CT, MR, fluoroscopy, or digitized landmarks.

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 CD Horizon Solera Screwdriver/Taps (K140454)

Reference Devices

• Erisma-Lp Spinal Fixation System (K153326)
• Erisma®-Lp Mis (K162367)

Submission Summary (Full Text)

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February 26, 2021

Image /page/0/Picture/1 description: The image shows 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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Clariance, SAS % Jennifer Daudelin Senior Project Manager M Squared Associates, INC 127 West 30th Street. Floor 9 New York, New York 10001

Re: K202956

Trade/Device Name: Erisma LP Navigated Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: January 22, 2021 Received: January 25, 2021

Dear Jennifer Daudelin:

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

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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 (OS) 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, MPH 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) K202956

#### Device Name

Erisma®-LP Navigated Instruments

### Indications for Use (Describe)

Erisma®-LP Navigated Instruments are intended to be used in the preparation and placement of Erisma® 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 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)

| <div> <b> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </b> </div> |
|----------------------------------------------------------------------------------------|
| <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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Class

II

II

II

NKB

# 510(k) Summary

Clariance SAS

The following information is provided as required by 21 CFR § 807.87 for the Clariance SAS 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

The safety and effectiveness of the Clariance SAS is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate device(s).

| Sponsor: | CLARIANCE, SAS<br>18 rue Robespierre<br>F-62217 Beaurains, France | | |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|-------------|
| Contact: | Jennifer A. Daudelin, M.S.J.<br>M Squared Associates, Inc.<br>127 West 30th Street, Floor 9<br>Ph: 347-954-0395<br>Fax: [phone]<br>Email: [e-mail] | | |
| Date Prepared: | September 25, 2020 | | |
| Proposed Class: | II | | |
| Proprietary Name: | ERISMA® LP_NAVIGATED INSTRUMENTS | | |
| Common Name: | Stereotaxic Instrument | | |
| Classification Name: | Stereotaxic Instrument | | |
| Regulation Number: | 21 CFR 882.4560 | | |
| Product Codes: | OLO | | |
| Predicate Device(s): | | | |
| | Device Name | 510(k) Number | Procode |
| Primary Predicate: | | | |
| Medtronic Sofamor<br>Danek USA | Navigated CD Horizon<br>Solera Screwdriver/Taps | K140454 | OLO,<br>HBE |
| Reference Devices: | | | |
| Clariance SAS | Erisma-Lp Spinal<br>Fixation System | K153326 | NKB |

K162367

Erisma®-Lp Mis

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## Indications for Use

Erisma®-LP Navigated Instruments are intended to be used in the preparation and placement of Erisma® LP 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

## Device Description

The Erisma®-LP Navigated Instruments are manual, non-sterile, reusable surgical instruments for use with the Medtronic StealthStation™ Navigation System to assist the surgeon in locating anatomical structures in either open, minimally invasive or percutaneous procedures for preparation and placement of the Clariance Erisma®-LP, Erisma®- MIS pedicle screw implants. The Erisma®-LP Navigated Instruments include the following instruments: Drivers, Tap, Bone Awl, Probes. The instrumentation is designed for use with the Medtronic StealthStation™ Navigation System hardware and software. These instruments are made of medical quality stainless steel according to the ASTM F899 and titanium alloy according to the ASTM F136.

## Performance Data – Non-Clinical

A series of mechanical tests have been performed to support the substantial equivalence of the Erisma®-LP Navigated Instruments with the Medtronic Navigated Instruments cleared in 510(k), K140454. CLARIANCE performed tests to demonstrate the compatibility between Erisma®-LP Navigated Instruments and Medtronic Naclock Tracker, the ability of Erisma®-LP Navigated Instruments to be registered by Medtronic StealthStation™ System, and a simulation of pedicle insertion, all of which demonstrated the substantial equivalence of the system to legally marketed devices.

There have been no changes to the manufacturing methods or patient contacting materials from the predicate Erisma® instruments cleared in 510(k)s K153326 and K162367; therefore, no new testing was required to demonstrate biocompatibility of the Erisma®-LP Navigated Instruments.

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## Substantial Equivalence

The Erisma®-LP Navigated Instruments has the same indications for use and similar design features as compared with the predicate systems. The bench testing demonstrates that the performance characteristics of the Erisma®-LP Navigated Instruments are equivalent to those of the other legally marketed stereotaxic instrument devices, and therefore supports a determination of Substantial Equivalence for the proposed indications for use. Any differences between the subject and predicate devices would not render the device NSE, affect the safety or effectiveness, or raise different questions of safety and effectiveness.