(149 days)
No
The summary describes navigated surgical instruments used with a navigation system. It does not mention AI or ML in the device description, intended use, or performance studies. The navigation system itself (Medtronic StealthStation) is mentioned, but the summary focuses on the instruments' compatibility and function within that system, not on any AI/ML capabilities of the system or instruments.
No
The device is a set of surgical instruments intended to assist surgeons in precisely locating anatomical structures during spinal surgery, specifically for the preparation and placement of screws. It is an accessory to a navigation system and does not directly treat a medical condition.
No
The device is a set of navigated surgical instruments used for guidance during spinal surgery, not for diagnosing medical conditions.
No
The device description explicitly states that the Erisma®-LP Navigated Instruments are "manual, non-sterile, reusable surgical instruments" made of "medical quality stainless steel" and "titanium alloy." These are physical hardware components, not software. While they are designed for use with a navigation system that includes software, the instruments themselves are hardware.
Based on the provided information, the Erisma®-LP Navigated Instruments are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for surgical guidance during spinal surgery to assist in the preparation and placement of screws. This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description clearly states they are "manual, non-sterile, reusable surgical instruments." These are tools used directly in a surgical procedure.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health. The Erisma®-LP Navigated Instruments do not perform this function. They are used on the body during surgery.
Therefore, the Erisma®-LP Navigated Instruments fall under the category of surgical instruments used for navigation and guidance during a procedure, not as a diagnostic tool that analyzes samples.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
OLO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Anatomical Site
Spinal, vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, clinical setting (spinal surgery)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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
18 rue Robespierre
F-62217 Beaurains, France | | |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|-------------|
| Contact: | Jennifer A. Daudelin, M.S.J.
M Squared Associates, Inc.
127 West 30th Street, Floor 9
Ph: 347-954-0395
Fax: 703-562-9797
Email: jdaudelin@msquaredassociates.com | | |
| 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
Danek USA | Navigated CD Horizon
Solera Screwdriver/Taps | K140454 | OLO,
HBE |
| Reference Devices: | | | |
| Clariance SAS | Erisma-Lp Spinal
Fixation System | K153326 | NKB |
Erisma®-Lp Mis
5
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.