(67 days)
The BRIDALVEIL NAVIGATED INSTRUMENTS are intended to be used in the preparation and placement of BRIDALVEIL 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.
The BRIDALVEIL 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.
The provided text describes the BRIDALVEIL Navigated Instruments, but it does not contain detailed information about acceptance criteria or a study proving that the device meets specific performance metrics.
The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a performance study against predefined acceptance criteria for a novel device.
However, based on the NON-CLINICAL TEST SUMMARY, we can infer the types of evaluations conducted. Here's what we can extract and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from tests) | Reported Device Performance (Inferred from summary) |
|---|---|
| Dimensional equivalence to predicate instruments | Dimensional analysis compared to predicate devices showed equivalence. |
| Navigation accuracy in anatomical simulated use | Anatomical simulated use and navigation accuracy were evaluated. (No specific numerical performance is reported in this document beyond "equivalent to the predicate devices.") |
| Equivalence in materials | Uses Stainless Steel per ASTM F899, similar to predicate. |
| Equivalence in mechanical safety and performance | Claimed substantial equivalence in mechanical safety and performances to predicate. |
| Functionality with Medtronic StealthStation® System | Designed for use with the Medtronic StealthStation® System (v 2.1.0). |
Note: The document explicitly states: "The results of these evaluations indicate that the BRIDALVEIL NAVIGATED INSTRUMENTS are equivalent to the predicate devices." However, it does not provide specific numerical acceptance criteria (e.g., "navigation accuracy must be within X mm") or quantitative performance results.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document mentions "dimensional analysis" and "anatomical simulated use," but without detailing the number of instruments tested or the number of simulated uses/scenarios.
- Data Provenance: Not specified. The tests are non-clinical, so human data provenance (country, retrospective/prospective) is not applicable. The evaluations were likely conducted in-house by Astura Medical or a contracted test lab.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable: This was a non-clinical, device-centric evaluation (dimensional analysis, mechanical testing, simulated use) and not a study requiring expert interpretation of results to establish ground truth in a clinical context.
4. Adjudication Method for the Test Set
- Not Applicable: As this was a non-clinical engineering and functional evaluation, adjudication methods like 2+1 or 3+1 (often used for expert consensus in clinical image interpretation) are not relevant here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No: The document states, "No clinical studies were performed." Therefore, no MRMC study or AI assistance evaluation was conducted.
6. Standalone Performance Study
- Partially Addressed (Non-Clinical): While no "standalone" clinical performance in the sense of an algorithm operating without human intervention for diagnostic or therapeutic outcomes was performed, the non-clinical tests (dimensional analysis, anatomical simulated use, navigation accuracy) represent an evaluation of the device's inherent functional performance characteristics. However, these are mechanical and functional tests, not clinical outcome studies.
7. Type of Ground Truth Used
- Engineering Specifications and Predicate Performance: For dimensional analysis, the ground truth would be the design specifications and the dimensions of the predicate devices. For navigation accuracy, the ground truth would typically be established by a highly accurate measurement system (e.g., CMM, optical tracking system) comparing the navigated instrument's reported position to its actual position in a controlled setup.
8. Sample Size for the Training Set
- Not Applicable: This device is a set of physical surgical instruments, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data used for model development.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: No training set for an AI/ML algorithm was used.
In summary, the provided document is a 510(k) summary demonstrating substantial equivalence primarily through non-clinical mechanical and functional evaluations. It does not provide detailed specific performance metrics or acceptance criteria as would be found in a clinical performance study with predefined endpoints.
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January 4, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is an emblem of the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The emblem features a stylized depiction of a bird or eagle, while the text clearly identifies the organization as the FDA.
Astura Medical Parker Kelch Quality Manager 3186 Lionshead Ave. Suite 100 Carlsbad, California 92010
Re: K182982
Trade/Device Name: BridalVeil Navigated Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: December 6, 2018 Received: December 7, 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. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-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,
Shumaya Ali -S
for
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)
Device Name BRIDALVEIL NAVIGATED INSTRUMENTS
Indications for Use (Describe)
The BRIDALVEIL NAVIGATED INSTRUMENTS are intended to be used in the preparation and placement of BRIDALVEIL 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: BRIDALVEIL NAVIGATED INSTRUMENTS
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
| Date Prepared | October 26, 2018 |
|---|---|
| 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 | |
| Email: quality@asturamedical.Com | |
| Trade Name | BRIDALVEIL 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) | BRIDALVEIL Occipital Cervical Thoracic System, (Screws) (K171250) |
| OLYMPIC Navigated Instruments (K172166) | |
| Device Description | The BRIDALVEIL 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 | The BRIDALVEIL Navigated Instruments are substantially equivalent to the |
| Claimed to Predicate | predicate BRIDALVEIL devices in terms of intended use, materials used, |
| Devices | mechanical safety and performances. The changes in design on the |
| instruments are the addition of a Navlock feature, this is equivalent to the | |
| Navlock found on Medtronic Navigated instruments and intended for use | |
| with the Medtronic StealthStation® System. | |
| Indications for Use | The BRIDALVEIL NAVIGATED INSTRUMENTS are intended to be used in |
| the preparation and placement of BRIDALVEIL 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 digitizedlandmarks of the anatomy. | |
| NON-CLINICAL TEST | The following analyses were conducted: |
| SUMMARY | |
| Dimensional analysis compared to predicate• | |
| • Anatomical simulated use and navigation accuracyThe results of these evaluations indicate that the BRIDALVEIL NAVIGATEDINSTRUMENTS are equivalent to the predicate devices. | |
| CLINICAL TEST SUMMARY | No clinical studies were performed |
| CONCLUSIONS: NON-CLINICAL AND CLINICAL | Astura medical considers the BRIDALVEIL NAVIGATED INSTRUMENTS tobe equivalent to the predicate devices listed above. This conclusion isbased upon the devices' similarities in principles of operation,technology, materials, and indications for use. |
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§ 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).