(302 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and fixation capabilities of cranial plates and screws, with no mention of AI or ML technologies.
Yes
The device is used for the internal fixation of cranial fractures and bone flaps, which is a therapeutic intervention aimed at restoring function and structure following injury or surgery.
No
This device is a cranial plating system used for the internal fixation and reconstruction of cranial bone, not for diagnosing medical conditions.
No
The device description explicitly lists physical components such as plates, burr hole covers, mesh, and screws, which are hardware.
Based on the provided information, the Alliance Spine RAAS Cranial Plating System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for osteotomies, cranial fractures, and reconstruction of non-load bearing cranial areas. This describes a surgical device used in vivo (within the body) for structural support and fixation.
- Device Description: The description details plates, mesh, and screws – physical implants used to stabilize bone. This is consistent with a surgical implant, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro testing.
Therefore, the Alliance Spine RAAS Cranial Plating System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Alliance Spine RAAS Cranial Plating System is indicated for osteotomies, cranial fractures, and reconstruction of non-load bearing cranial areas.
Product codes (comma separated list FDA assigned to the subject device)
GWO, GXR, HBW
Device Description
The Alliance Spine RAAS Cranial Plating System consists of various sizes and geometries of malleable low profile cranial plates including straight, box, and gap plates, burr hole covers, malleable mesh as well as fasteners (screws) that provide stable internal fixation of cranial fractures and bone flaps, as well as coverage and stabilization of burr holes and other cranial defects.
The RAAS plates and burr hole covers are 0.5mm thick, while the RAAS malleable Mesh is supplied in 0.3mm and 0.6mm thickness. The fasteners (screws) are supplied in 1.5mm diameter Self-Drilling and 1.5mm diameter Self-Tapping configurations in 4mm and 5mm lengths, while the RAAS Rescue Screws are 1.7mm in diameter in 5mm and 6mm lengths. The Screws and Mesh are color anodized for identification.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing:
- Static Axial Compression: Worst case Burr Hole plates were subjected to loading as described in ASTM F382. Peak load and stiffness values were acceptable based on intended use and predicate data. Subject device expected to perform similarly to predicate.
- Insertion/Removal Torque: Worst case screws were inserted into and then removed from a test block as described in ASTM F543. Driving torque values were acceptable based on intended use and predicate data. Subject device expected to perform similarly to predicate.
- Ultimate Torque: Worst case screws were fixed below the head and subjected to loading as described in ASTM F543. Peak torque values were acceptable based on intended use and predicate data. Subject device expected to perform similarly to predicate.
- Axial Pullout: Worst case screws were inserted to a fixed depth and subjected to loading as described in ASTM F543. Peak load values were acceptable based on intended use and predicate data. Subject device expected to perform similarly to predicate.
Clinical testing: Clinical testing was not required to demonstrate substantial equivalence in this premarket notification.
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.
Not Found
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
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a stylized symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The symbol is a stylized representation of a human figure, with three profiles facing 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
February 27, 2015
Alliance Partners, LLC % Mr. Kellen Hills Quality & Regulatory Consultant Orchid Design. A Division of Orchid Orthopedic Solutions 4600 East Shelby Drive, Suite 1 Memphis. TN 38118
Re: K141123
Trade/Device Name: Alliance Spine RAAS Cranial Plating System Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO, GXR, HBW Dated: February 20, 2015 Received: February 25, 2015
Dear Mr. Kellen Hills,
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 (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 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 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 yours,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141123
Device Name RAAS Cranial Plating System
Indications for Use (Describe)
The Alliance Spine RAAS Cranial Plating System is indicated for osteotomies, cranial fractures, and reconstruction of non-load bearing cranial areas.
Type of Use (Select one or both, as applicable)
| For Activities Under CEE 301.5(c) | For Site Controls Under CEE 301.5(d) |
|---|---|
| ------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------ |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
| (a)(1) | Submitted By: | Alliance Partners, LLC
(dba Alliance Spine™)
14206 Northbrook Dr.
San Antonio, TX 78232 | |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Date: | February 20, 2015 | |
| | Contact Person: | Tim M. Lohnes
Senior Regulatory Consultant
Orchid Design | |
| | Phone:
Fax: | 203-922-0105
203-922-0130 | |
| (a)(2) | Proprietary Name: | RAAS Cranial Plating System | |
| | Common Name: | Bone Plates, Bone Fixation Fasteners | |
| | Classification Names and References: | 882.5320 - Preformed alterable
cranioplasty plate
882.5250 - Burr hole cover
882.3560 - Cranioplasty plate fastener | |
| | Product Codes: | GWO, GXR, HBW | |
| (a)(3) | Predicate Devices: | Stryker-NEURO II (K031659)
OsteoMed-Low Profile Neuro (K111176) | |
| | SUBJECT DEVICE | PREDICATE DEVICES | |
| Manufacturer | Alliance Spine | Stryker | OsteoMed |
| System Name | RAAS Cranial
Plating System | Neuro 2 Cranial Plate
System | Low Profile Neuro
Fixation System |
| 510(k) | Subject | K031659 | K111176 |
| Product Codes | GWO, GXR, HBW | JEY, HWC | GWO, GXR |
| Indications for Use | The RAAS Cranial
Plating System is
indicated for
osteotomy,
craniotomy,
cranial fractures,
and
reconstruction of
non-load bearing
cranial areas. | The Stryker Leibinger
Universal Neuro
System is a low-
profile plate and
screw system
intended for
osteotomy,
craniotomy,
stabilization and rigid
fixation of craniofacial
fractures and
reconstruction of
non-load bearing
areas. | The OsteoMed
LowProfile Neuro
Fixation System is
indicated for use in
ostemtomies,
fractures or
reconstruction of
cranial bones.
Implants and drills
are single use only. |
| Sterilization | End User (steam) | Non-sterile and sterile | Not specified |
| Shelf Life | n/a | Not specified | Not specified |
| Implant Material: | | | |
| Plates and
Burr Hole Covers - | ASTM F136 | CP Ti | ASTM F136/F67 |
| Mesh – | ASTM F67 | CP Ti | ASTM F136/F67 |
| Screws - | ASTM F136 | Ti Alloy | ASTM F136 |
| Thickness: | | | |
| Plates & Burr Hole
Covers - | 0.5mm | 0.6 and 0.5mm | 0.25 to 1.0mm |
| Mesh - | 0.3 and 0.6mm | 0.1, 0.2, 0.3 and
0.6mm | 0.25 to 1.0mm |
| Surface
Treatment:
Plates & Burr Hole
Covers | None | Type III Anodized | Not specified |
| Surface
Treatment: Mesh | Type III Anodized | Type III Anodized | Not specified |
| Screws - type | Self-tapping,
drilling, and
rescue | Self-tapping, drilling,
and rescue | "Auto Drive" and
rescue |
| Screws:
diameter/length | 1.5 x 4 & 5mm,
1.7 x 5 & 6mm | 1.5mm x 4, 5 & 6mm
1.7mm x 4mm | 1.6mm x 4, 5, 6 & 8mm, 1.9mm x 4, 5, 6 & 8mm |
| Surface
Treatment: Screws | Type III Anodized | Type III Anodized | Not specified |
Device Description: (a)(4)
The Alliance Spine RAAS Cranial Plating System consists of various sizes and geometries of malleable low profile cranial plates including straight, box, and gap plates, burr hole covers, malleable mesh as well as fasteners (screws) that provide stable internal fixation of cranial fractures and bone flaps, as well as coverage and stabilization of burr holes and other cranial defects.
The RAAS plates and burr hole covers are 0.5mm thick, while the RAAS malleable Mesh is supplied in 0.3mm and 0.6mm thickness. The fasteners (screws) are supplied in 1.5mm diameter Self-Drilling and 1.5mm diameter Self-Tapping configurations in 4mm and 5mm lengths, while the RAAS Rescue Screws are 1.7mm in diameter in 5mm and 6mm lengths. The Screws and Mesh are color anodized for identification.
4
The Alliance Spine™ RAAS Cranial Plating System is indicated for osteotomies, craniotomy, cranial fractures, and reconstruction of non-load bearing cranial areas.
- Technological Characteristics: (a)(6)
5
(b)(1) Non-clinical testing:
| Test | Test Method Summary | Results |
|---|---|---|
| Static Axial Compression | Worst case Burr Hole plates | |
| were subjected to loading as | ||
| described in ASTM F382. | Peak load and stiffness values | |
| were acceptable based on | ||
| intended use and predicate data. | ||
| Subject device expected to | ||
| perform similarly to predicate. | ||
| Insertion/Removal Torque | Worst case screws were | |
| inserted into and then | ||
| removed from a test block as | ||
| described in ASTM F543. | Driving torque values were | |
| acceptable based on intended | ||
| use and predicate data. Subject | ||
| device expected to perform | ||
| similarly to predicate. | ||
| Ultimate Torque | Worst case screws were fixed | |
| below the head and subjected | ||
| to loading as described in | ||
| ASTM F543. | Peak torque values were | |
| acceptable based on intended | ||
| use and predicate data. Subject | ||
| device expected to perform | ||
| similarly to predicate. | ||
| Axial Pullout | Worst case screws were | |
| inserted to a fixed depth and | ||
| subjected to loading as | ||
| described in ASTM F543. | Peak load values were acceptable | |
| based on intended use and | ||
| predicate data. Subject device | ||
| expected to perform similarly to | ||
| predicate. |
Clinical testing: (b)(2)
Clinical testing was not required to demonstrate substantial equivalence in this premarket notification.
(b)(3) Conclusions:
Based on the information provided in this premarket notification, we believe that the subject RAAS Cranial Plating System demonstrates substantial equivalence and has a safety and effectiveness profile that is similar to the identified predicate devices.