(110 days)
Not Found
No
The summary describes a mechanical implant for spinal fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a "posterior, non-pedicle supplemental fixation device" intended for "achieving supplemental fusion" in the spine for conditions such as degenerative disc disease, spondylolisthesis, trauma, and tumor. These uses clearly indicate a medical purpose to treat or alleviate a medical condition.
No
The device is described as a "supplemental fixation device" intended for surgical use to achieve fusion, not for diagnosing conditions.
No
The device description clearly states it is a "Spinous Process Plate System," which is a physical implantable device made of hardware, not software. The performance studies also describe mechanical testing of the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fixation. It is used in vivo (within the body) to provide supplemental support for fusion in the spine.
- Device Description: The description reinforces that it is a physical implant (plate) attached to the spinous process.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are typically used to diagnose diseases or conditions outside of the body.
This device falls under the category of a surgical implant or orthopedic device.
N/A
Intended Use / Indications for Use
The Affix II Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions:
- Degenerative disc disease (DDD) defined as back pain of discogenic origin with t degeneration of the disc confirmed by history and radiographic studies.
- . Spondylolisthesis
- Trauma (i.e., fracture or dislocation) .
- Tumor
The Affix II Spinous Process Plate System is not intended for stand-alone use.
Product codes (comma separated list FDA assigned to the subject device)
PEK
Device Description
The Affix II Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion, and is not intended for stand-alone use. When the Affix II Plate is used as supplemental fixation in interbody fusion procedures, its use is limited to the treatment of degenerative disc disease (DDD) of the lumbosacral spine (L2-S1).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine (T1 - S1), lumbosacral spine (L2-S1)
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)
Nonclinical testing was performed to demonstrate that the subject Affix II Spinous Process Plate System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic axial compression .
- Static torsion .
- Static post distraction ●
The results demonstrate that the subject Affix II Spinous Process Plate System is substantially equivalent to the predicate.
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.
NuVasive Spinous Process Plate System (K073278), NuVasive Affix Spinous Process Plate System (K131238)
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
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
Image /page/0/Picture/2 description: The image shows the Nuvasive logo. The logo consists of a stylized abstract shape on the left, followed by the word "NUVASIVE" in capital letters. Below "NUVASIVE" is the tagline ": Speed of Innovation" in a smaller font. The logo appears to be in black and white.
Affix® II Spinous Process Plate System July 31, 2013
510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
Submitted by: A.
Olga Lewis Regulatory Affairs Specialist NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
Date Prepared: July 31, 2013
Device Name B.
Trade or Proprietary Name: Common or Usual Name: Classification Name:
Device Class: Classification: Product Code: Spinal interlaminal fixation orthosis Spinal interlaminal fixation orthosis
Affix® II Spinous Process Plate System
Class II 21 CFR § 888.3050 РЕК
C. Predicate Devices
The subject Affix II Spinous Process Plate System is substantially equivalent to the predicate device, NuVasive Spinous Process Plate System (K073278) and NuVasive Affix Spinous Process Plate System (K131238).
Device Description D.
The Affix II Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion, and is not intended for stand-alone use. When the Affix II Plate is used as supplemental fixation in interbody fusion procedures, its use is limited to the treatment of degenerative disc disease (DDD) of the lumbosacral spine (L2-S1).
Intended Use E.
The Affix II Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions:
- Degenerative disc disease (DDD) defined as back pain of discogenic origin with t degeneration of the disc confirmed by history and radiographic studies.
- . Spondylolisthesis
- Trauma (i.e., fracture or dislocation) .
- Tumor
The Affix II Spinous Process Plate System is not intended for stand-alone use.
CONFIDENTIAL
Page 1 of 2
1
Technological Characteristics F.
As was established in this submission, the subject Affix II Spinous Process Plate System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate device through comparison in areas including design, labeling/intended use, material composition, and function.
G. Performance Data
Nonclinical testing was performed to demonstrate that the subject Affix II Spinous Process Plate System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic axial compression .
- Static torsion .
- Static post distraction ●
The results demonstrate that the subject Affix II Spinous Process Plate System is substantially equivalent to the predicate.
H. Conclusions
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject Affix II Spinous Process Plate System has been shown to be substantially equivalent to legally marketed predicate devices.
2
Image /page/2/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping waves or abstract human figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20, 2013
NuVasive, Incorporated Ms. Olga Lewis Specialist Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121
Re: K132411
Trade/Device Name: Affix® II Spinous Process Plate System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: October 28, 2013 Received: October 29, 2013
Dear Ms. Lewis:
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Olga Lewis
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers, International and Consumer Assistance 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.
Mark Nielkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Affix® II Spinous Process Plate System
Indications For Use:
The Affix II Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions:
- Degenerative disc disease (DDD) defined as back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies.
- Spondvlolisthesis . �
- . Trauma (i.e., fracture or dislocation)
- Tumor o
The Affix II Spinous Process Plate System is not intended for stand-alone use.
AND/OR
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ronald P. Jean -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132411
Page 1 of 1