(189 days)
Not Found
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is an implantable plate system designed for temporary stabilization during spinal fusions, which is a structural support rather than a direct therapeutic intervention.
No
The device is described as an anterior cervical plate system intended for temporary stabilization during spinal fusions, which is a therapeutic rather than a diagnostic function. The "Intended Use / Indications for Use" section clearly states its purpose in treating existing conditions through stabilization, not diagnosing them.
No
The device description clearly states it is composed of physical components like plates and screws, and the performance studies involve mechanical testing of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Asfora Anterior Cervical Plate System is for providing temporary stabilization to the anterior spine during fusion procedures. This is a surgical implant used directly on the patient's body.
- Device Description: The description details physical components like plates and screws, which are also consistent with a surgical implant.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The information provided describes a surgical implant used for spinal fusion, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoathrosis, and failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Asfora Anterior Cervical Plate System is composed of plates of varying lengths to accommodate surgical procedures from one to four levels. The plates are designed for application to the anterior aspect of the cervical spine and have three locking tabs to reduce the potential for screws to back out of the vertebral body. The screws are provided in diameters of 4.0mm (Variable Angle Implant Screw and Fixed Angle Implant Screw) and 4.4mm (Rescue Screw) and lengths of 12mm, 14mm and 16mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine fusions (C2-T1), anterior spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Mechanical testing was conducted, in accordance with Guidance for Industry and FDA Staff: Spinal System 510(k)s and ASTM F 1717-14 to ensure the device performs according to specification, to verify that the device is able to withstand clinical loading and maintain mechanical integrity, and is suited for its intended purpose. Testing included dynamic compression bending, static compression bending, static torsion, screw insertion torque evaluation and screw retention force evaluation.
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 1, 2015
Medical Designs, LLC Ms. Kristi Vondra Vice President of Operations 6709 South Minnesota Avenue, Suite 204 Sioux Falls, South Dakota 57108
Re: K143688
Trade/Device Name: Asfora Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 3, 2015 Received: June 4, 2015
Dear Ms. Vondra:
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
1
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 vours.
Lori A. Wiggins -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page 1 of 1
510(k) Number (if known) K143688
Device Name
Asfora Anterior Cervical Plate (AACP) System
Indications for Use (Describe)
The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoathrosis, and failed previous fusion.
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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510(k) Summary
1. Submission Sponsor
Medical Designs, LLC 6709 S. Minnesota Ave., Suite 204 Sioux Falls, South Dakota 57108
2. Submission Correspondent
Kristi Vondra, Vice President of Operations Tel: (605) 275-1032 FAX: (605) 335-3734
3. Date Prepared
June 3, 2015
4. Device Identification
| Trade/Proprietary Name: | Asfora Anterior Cervical Plate System |
|---|---|
| Common/Usual Name: | Anterior Cervical Plate System |
| Classification Name: | Spinal intervertebral body fixation orthosis |
| Classification Regulation: | 21 CFR §888.3060 |
| Product Code: | KWQ |
| Device Class: | Class II |
| Classification Panel: | Orthopaedic and Rehabilitation Devices Panel |
5. Predicate Devices
| Primary: K122497 | Asfora Anterior Cervical Plate System |
|---|---|
| Additional: K030866 | Synthes Cervical Spine Locking Plate |
6. Device Description
The Asfora Anterior Cervical Plate System is composed of plates of varying lengths to accommodate surgical procedures from one to four levels. The plates are designed for application to the anterior aspect of the cervical spine and have three locking tabs to reduce the potential for screws to back out of the vertebral body. The screws are provided in diameters of 4.0mm (Variable Angle Implant Screw and Fixed Angle Implant Screw) and 4.4mm (Rescue Screw) and lengths of 12mm, 14mm and 16mm.
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7. Indication for Use
The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
8. Comparison to Predicates
No changes have been made to the intended use. Indications for Use, principle of operation or device materials of the cleared primary predicate Asfora Anterior Cervical Plate System. The subject device is identical to the primary predicate device except for the following differences. The additional plate and screw dimensions are substantially equivalent to the additional predicate.
| Characteristic | Difference in Subject Device to Primary Predicate |
|---|---|
| Plate locking | |
| mechanism | Locking tabs instead of locking rings |
| Plate dimensions | maximum plate width decreased from 19 to 17.5mm (in range of reference predicate)additional plate lengths at all 4 levels (in range of reference predicate)lateral hole to hole distance decreased (from 9 to 8.5mm) |
| Plate pre-bent angle | All plates pre-lordosed with a radius of 190mm |
| Screw Drive Feature | Square instead of hexalobe |
| Variable Angle | |
| Implant Screws | Added 4.0 x 12mm screw (in range of reference predicate); spherical head to fit plate recess |
| Variable Angle | |
| Rescue Screw | Diameter decreased (5.0 to 4.4mm) and added 4.4 x 12mm screw (in range of reference predicate) |
| Fixed Angle Screws | Added fixed angle screws (in range of reference predicate); spherical head to fit plate recess and shank to match plate exit hole |
| Temporary Fixation | |
| Screws | Removed from system; Casper Pin Style recommended for ease of use and functionality, but not provided |
| Extractor Assembly | Square interface instead of hexalobe |
| Drill Guide | Change in tip geometry to interface with spherical cavity of plate; addition of fixed angle drill guide configuration |
| Plate Bender | Simplified, off the shelf French bender |
| Retention Assembly | Nemcomed design; one-piece square driver with thermoplastic insert. |
| Sterilization Tray | Minor modification to hold redesigned cervical plates, screws and instruments |
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9. Functional and Safety Testing
Mechanical testing was conducted, in accordance with Guidance for Industry and FDA Staff: Spinal System 510(k)s and ASTM F 1717-14 to ensure the device performs according to specification, to verify that the device is able to withstand clinical loading and maintain mechanical integrity, and is suited for its intended purpose. Testing included dynamic compression bending, static compression bending, static torsion, screw insertion torque evaluation and screw retention force evaluation.
10. Conclusion
Medical Designs. LLC considers the Asfora Anterior Cervical Plate System to be equivalent to the predicate Asfora Anterior Cervical Plate System listed above. This conclusion is based upon the device similarities in intended use, Indications for Use, principle of operation, materials and performance testing.