(157 days)
No
The device description and intended use focus on mechanical spinal fixation components and their function, with no mention of AI or ML capabilities. The performance studies are non-clinical mechanical tests.
Yes
The device is a spinal fixation system intended to provide immobilization of spinal segments as an adjunct to fusion for multiple medical conditions, including traumatic spinal fractures, instability, deformity, and degenerative diseases, which aligns with the definition of a therapeutic device.
No
Explanation: The device is described as a spinal fixation system intended to provide immobilization and stability for spinal segments as an adjunct to fusion. It contains implants and instruments for surgical purposes to treat various spinal conditions, not to diagnose them.
No
The device description explicitly states that the system contains a wide variety of implants and instruments, which are physical hardware components made from specific materials.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The BRIDALVEIL Occipital Cervical Thoracic System is a spinal fixation system. Its intended use is to provide immobilization and stabilization of spinal segments within the body as an adjunct to fusion or to restore spinal column integrity. This is a surgical implant used inside the body.
The description clearly indicates a device used for surgical intervention and internal fixation, not for testing biological samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The BRIDALVEIL Occipital Cervical Thoracic System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (Cl to C7) and the thoracic spine from TI-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions ( e.g., pseudarthrosis ); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The BRIDALVEIL Occipital Cervical Thoracic System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the BRIDALVEIL Occipital Thoracic System may be connected to the OLYMPIC Posterior Spinal Fixation System rods and connectors. Transition rods with differing diameters may also be used to connect the BRIDALVEIL Occipital Cervical Thoracic System to the OLYMPIC Posterior Spinal Fixation System. Refer to the OLYMPIC Posterior Spinal Fixation System package insert for instructions for use and indications for use.
Product codes
NKG, KWP
Device Description
The BRIDALVEIL Occipital Cervical Thoracic System is a spinal fixation system intended to stabilize the uppermost portion of the spine during the fusion process. The system contains a wide variety of implants and instruments which allows for the transition across multiple spinal segments: Occipital Plate with Screws, Cervical Polyaxial Screws, Laminar Hooks, Cross Connectors, Rod Connectors, and Rods manufactured from Ti6Al4V ELI (ASTM F136) and cobalt chrome alloy (ASTM F1537).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
No clinical studies were performed.
Non-clinical tests conducted:
- Static Compression Bending – ASTM F1717
- Dynamic Compression Bending – ASTM F1717
- Static Torsion - ASTM F1717
- Static Compression Bending – ASTM F2706
- Dynamic Compression Bending - ASTM F2706
- Static Torsion - ASTM F2706
- Dynamic Torsion – ASTM F2706
- Static Axial Grip – ASTM F1798
- Static Torsional Grip - ASTM F1798
- Static Transverse Moment – ASTM F1798
Key results: The results of these evaluations indicate that the BRIDALVEIL Occipital Cervical Thoracic System is equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K143471, K152338, K150474, K153336, K153631, K150650, K073654
Reference Device(s)
K052201, K111076, K123906, K093319, K070573, K091689, K141897, K110353, K132332, K142741, K111719, K032394, K131833, K143278
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 2, 2017
Astura Medical Mr. Thomas Purcell Vice President 3186 Lionshead Avenue, Suite 100 Carlsbad, California 92010
Re: K171250
Trade/Device Name: BRIDALVEIL Occipital Cervical Thoracic System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: September 1, 2017 Received: September 6, 2017
Dear Mr. Purcell:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Ronald P. Jean - 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) K171250
Device Name
BRIDALVEIL Occipital Cervical Thoracic System
Indications for Use (Describe)
The BRIDALVEIL Occipital Cervical Thoracic System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (Cl to C7) and the thoracic spine from TI-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions ( e.g., pseudarthrosis ); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The BRIDALVEIL Occipital Cervical Thoracic System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the BRIDALVEIL Occipital Thoracic System may be connected to the OLYMPIC Posterior Spinal Fixation System rods and connectors. Transition rods with differing diameters may also be used to connect the BRIDALVEIL Occipital Cervical Thoracic System to the OLYMPIC Posterior Spinal Fixation System. Refer to the OLYMPIC Posterior Spinal Fixation System package insert for instructions for use and indications for use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| x 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 Occipital Cervical Thoracic System
| Date Prepared | September 1, 2017 |
|---|---|
| Submitted By | Astura Medical |
| 3186 Lionshead Ave, Suite 100 | |
| Carlsbad, CA 92010 | |
| Phone: 760-814-8047 | |
| Contact | Thomas Purcell |
| 3186 Lionshead Ave, Suite 100 | |
| Carlsbad, CA 92010 | |
| Phone: 760-814-8047 | |
| Email: thomas@asturamedical.com | |
| Trade Name | BRIDALVEIL Occipital Cervical Thoracic System |
| Common Name | Occipital Cervical Thoracic System |
| Classification Name | Othosis, Cervical Pedicle Screw Spinal Fixation |
| Spinal interlaminal fixation orthosis | |
| Class | Unclassified |
| Product Code | NKG |
| KWP | |
| CFR Section | N/A |
| Device Panel | Orthopedic |
| Primary Predicate Device | Medtronic VERTEX® Reconstruction System - K143471, K152338 |
| Secondary Predicate | |
| Devices | NuVasive® VuePoint® OCT System - K150474, K153336 |
| Zimmer Spine Virage® OCT Spinal Fixation System - K153631 | |
| Ulrich GmbH neon3™ universal OCT spinal stabilization - K150650 | |
| Blackstone Ascent POCT System - K073654 | |
| Reference Devices | Alphatec Spine Solanas™ Posterior Stabilization System - (K052201) |
| Alphatec Spine Solanas Avalon Posterior Fixation System (K111076) | |
| Medtronic VERTEX® Reconstruction System - K123906 | |
| NuVasive® VuePoint® OCT System - K093319 | |
| Synthes Spine Synapse System - K070573, K091689, K141897 | |
| DePuy Spine MOUNTAINEER® OCT Spinal System - K110353, K132332 | |
| Stryker Spine OASYS® System - K142741, K111719, K032394 | |
| Orthofix Inc. Centerion POCT System - K131833 | |
| LnK Cervical Screw System - K143278 | |
| Device Description | The BRIDALVEIL Occipital Cervical Thoracic System is a spinal fixation |
| system intended to stabilize the uppermost portion of the spine during | |
| the fusion process. The system contains a wide variety of implants and | |
| instruments which allows for the transition across multiple spinal | |
| segments: Occipital Plate with Screws, Cervical Polyaxial Screws, Laminar | |
| Hooks, Cross Connectors, Rod Connectors, and Rods manufactured from | |
| Ti6Al4V ELI (ASTM F136) and cobalt chrome alloy (ASTM F1537). | |
| Materials | Ti-6Al-4V ELI (ASTM F136) |
| CoCrMo alloy (ASTM F1537) | |
| Elgiloy CoCrNi alloy (ASTM F1058) | |
| Nitinol #1 (ASTM E2063) | |
| Substantial Equivalence | |
| Claimed to Predicate | |
| Devices | The BRIDALVEIL Occipital Cervical Thoracic System is substantially |
| equivalent to the predicate devices in terms of intended use, design, | |
| materials used, mechanical safety and performances. | |
| Indications for Use | The BRIDALVEIL Occipital Cervical Thoracic System is intended to provide |
| immobilization and stabilization of spinal segments as an adjunct to | |
| fusion for the following acute and chronic instabilities of the | |
| craniocervical junction, the cervical spine (C1 to C7) and the thoracic | |
| spine from T1-T3: traumatic spinal fractures and/or traumatic | |
| dislocations; instability or deformity; failed previous fusions (e.g., | |
| pseudarthrosis); tumors involving the cervical spine; and degenerative | |
| disease, including intractable radiculopathy and/or myelopathy, neck | |
| and/or arm pain of discogenic origin as confirmed by radiographic | |
| studies, and degenerative disease of the facets with instability. | |
| The BRIDALVEIL Occipital Cervical Thoracic System is also intended to | |
| restore the integrity of the spinal column even in the absence of fusion | |
| for a limited time period in patients with advanced stage tumors involving | |
| the cervical spine in whom life expectancy is of insufficient duration to | |
| permit achievement of fusion. | |
| In order to achieve additional levels of fixation, the BRIDALVEIL Occipital | |
| Cervical Thoracic System may be connected to the OLYMPIC Posterior | |
| Spinal Fixation System rods and connectors. Transition rods with differing | |
| diameters may also be used to connect the BRIDALVEIL Occipital Cervical | |
| Thoracic System to the OLYMPIC Posterior Spinal Fixation System. Refer | |
| to the OLYMPIC Posterior Spinal Fixation System package insert for | |
| instructions for use and indications for use. | |
| Non-clinical Test | |
| Summary | The following analyses were conducted: |
| ● Static Compression Bending – ASTM F1717 | |
| ● Dynamic Compression Bending – ASTM F1717 | |
| ● Static Torsion - ASTM F1717 | |
| ● Static Compression Bending – ASTM F2706 | |
| ● Dynamic Compression Bending - ASTM F2706 | |
| ● Static Torsion - ASTM F2706 | |
| ● Dynamic Torsion – ASTM F2706 | |
| ● Static Axial Grip – ASTM F1798 | |
| ● Static Torsional Grip - ASTM F1798 | |
| ● Static Transverse Moment – ASTM F1798 | |
| The results of these evaluations indicate that the BRIDALVEIL Occipital | |
| Cervical Thoracic System is equivalent to the predicate devices. | |
| Clinical Test Summary | No clinical studies were performed |
| Conclusions: Non-Clinical | |
| and Clinical | Astura Medical considers the BRIDALVEIL Occipital Cervical Thoracic |
| System 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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