(283 days)
No
The summary describes navigated instruments used with a separate navigation system (Medtronic StealthStation® System). The instruments themselves are described as manual, reusable tools made of stainless steel. There is no mention of AI/ML in the description of the instruments or their function. The navigation system's capabilities are not detailed in this summary, but the focus here is on the instruments.
No.
The instruments are used in the preparation and placement of screws during spinal surgery to assist the surgeon, not to directly treat a medical condition.
No
The device description indicates that the OLYMPIC NAVIGATED INSTRUMENTS are taps and drivers used during spinal surgery for preparation and placement of screws, not for diagnosing medical conditions.
No
The device description explicitly states the device is comprised of "nonsterile, reusable instruments including taps and drivers" made from stainless steel, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The OLYMPIC NAVIGATED INSTRUMENTS are surgical instruments (taps and drivers) used during spinal surgery to assist in the placement of screws. They are used on the patient's anatomy, not on samples taken from the patient.
- Intended Use: The intended use clearly states they are for "preparation and placement of OLYMPIC PSFS screws during spinal surgery to assist the surgeon in precisely locating anatomical structures." This is a surgical procedure, not a diagnostic test performed on a sample.
- Device Description: The description confirms they are "nonsterile, reusable instruments including taps and drivers." These are physical tools used in surgery.
The device utilizes imaging modalities (CT, MR, fluoroscopy) and navigation technology, but this is for guiding the surgical procedure, not for analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The OLYMPIC NAVIGATED INSTRUMENTS are intended to be used in the preparation and placement of OLYMPIC PSFS 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 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.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The OLYMPIC NAVIGATED INSTRUMENTS are comprised of nonsterile, reusable instruments including taps and drivers that can be operated manually. These instruments are intended to be used with the Medtronic StealthStation® System (v 2.1.0) and are manufactured from stainless steel, as specified in ASTM F899.
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, skull, a long bone, or vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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)
The following analyses were conducted:
- Dimensional analysis compared to predicate
- Anatomical simulated use and navigation accuracy
The results of these evaluations indicate that the OLYMPIC NAVIGATED INSTRUMENTS are equivalent to the predicate 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.
Medtronic Instruments (K143628, K143375, K140454)
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.
OLYMPIC Posterior Spinal Fixation System (Screws), K143446
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).
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April 27, 2018
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 the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size in blue.
Astura Medical Parker Kelch Quality Manager 3186 Lionshead Avenue Suite 100 Carlsbad, California 92010
Re: K172166
Trade/Device Name: OLYMPIC Navigated Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 29, 2018 Received: March 30, 2018
Dear Parker Kelch:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172166
Device Name OLYMPIC NAVIGATED INSTRUMENTS
Indications for Use (Describe)
The OLYMPIC NAVIGATED INSTRUMENTS are intended to be used in the preparation and placement of OLYMPIC PSFS 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 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.
| 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: OLYMPIC NAVIGATED INSTRUMENTS
| Date Prepared | July 17, 2017 |
|---|---|
| Submitted By | Astura Medical |
| 3186 Lionshead Ave, Suite 100 | |
| Carlsbad, Ca 92010 | |
| Phone: 760-814-8047 | |
| Contact | Parker Kelch |
| 3186 Lionshead Ave, Suite 100 | |
| Carlsbad, Ca 92010 | |
| Phone: 760-814-8047 x413 | |
| Email: quality@asturamedical.com | |
| Trade Name | Olympic navigated instruments |
| Common Name | Navigated instruments |
| Classification Name | Stereotaxic instrument |
| Class | Class II |
| Product Code | OLO |
| Cfr Section | 21 CFR Section 882.4560 |
| Device Panel | Orthopedic |
| Primary Predicate Device | Medtronic Instruments (K143628, K143375, K140454) |
| Reference Device(s) | OLYMPIC Posterior Spinal Fixation System (Screws), K143446 |
| Device Description | The OLYMPIC NAVIGATED INSTRUMENTS are comprised of nonsterile, |
| reusable instruments including taps and drivers that can be operated | |
| manually. These instruments are intended to be used with the Medtronic | |
| StealthStation® System (v 2.1.0) and are manufactured from stainless | |
| steel, as specified in ASTM F899. | |
| Materials | Stainless Steel per ASTM F899 |
| Substantial Equivalence | |
| Claimed to Predicate | |
| Devices | The OLYMPIC NAVIGATED INSTRUMENTS are substantially equivalent to |
| the predicate devices in terms of intended use, design, materials used, | |
| mechanical safety and performances. | |
| Indications for Use | The OLYMPIC NAVIGATED INSTRUMENTS are intended to be used in the |
| preparation and placement of OLYMPIC PSFS 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 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. | |
| NON-CLINICAL TEST | |
| SUMMARY | The following analyses were conducted: |
| ● Dimensional analysis compared to predicate | |
| ● Anatomical simulated use and navigation accuracy | |
| The results of these evaluations indicate that the OLYMPIC NAVIGATED | |
| INSTRUMENTS are equivalent to the predicate devices. | |
| CONCLUSIONS: NON- | |
| CLINICAL AND CLINICAL | Astura medical considers the OLYMPIC NAVIGATED INSTRUMENTS to be |
| equivalent to the predicate devices listed above. This conclusion is based | |
| upon the devices' similarities in principles of operation, technology, | |
| materials, and indications for use. |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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