(99 days)
No
The device description and performance studies focus on mechanical properties and structural equivalence, with no mention of AI/ML or related concepts.
Yes
The device is described as a "supplemental fixation device" intended for "achieving supplemental fusion" in the lumbosacral spine for conditions like degenerative disc disease, spondylolisthesis, trauma, and tumor. These functions treat or alleviate a disease or injury.
No
This device is a fixation system intended for surgical use in the lumbosacral spine to achieve supplemental fusion. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a "Spinous Process Plate System," which is a physical implantable device made of hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The Affix IIS Spinous Process Plate System is a surgical implant intended for fixation and fusion in the spine. It is a physical device implanted in the body, not a test performed on a sample outside the body.
The description clearly indicates it's a surgical implant for spinal fixation, which falls under the category of implantable medical devices, not IVDs.
N/A
Intended Use / Indications for Use
The Affix IIS Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the lumbosacral spine (L1 - 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.
• Spondylolisthesis
• Trauma (i.e., fracture or dislocation)
• Tumor
The Affix IIS Spinous Process Plate System is not intended for stand-alone use.
Product codes
PEK
Device Description
The Affix IIS Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the lumbosacral spine (L1-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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral spine (L1-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
Nonclinical testing was performed to demonstrate that the subject Affix IIS Spinous Process Plate System is substantially equivalent to other predicate devices. The following testing was performed:
- . Static and dynamic axial compression
- Static torsion
The results demonstrate that the subject Affix IIS Spinous Process Plate System is substantially equivalent to the predicate.
Key Metrics
Not Found
Predicate Device(s)
NuVasive Affix II Spinous Process Plate (K132411), Lanx Spinous Process Fusion Plate (K121940), Axle Interspinous Fusion System (K130438)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure, with three faces merging into one another. The symbol is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 5. 2015
NuVasive, Incorporated Ms. Olga Lewis Regulatory Affairs Specialist 7475 Lusk Boulevard San Diego, California 92121
Re: K143388
Trade/Device Name: NuVasive® Affix IIS® Spinous Process Plate System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: February 4, 2015 Received: February 5, 2015
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
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" (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,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143388
Device Name
NuVasive® Affix IIS® Spinous Process Plate System
Indications for Use (Describe)
The Affix IIS Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the lumbosacral spine (L1 - 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.
· Spondylolisthesis
· Trauma (i.e., fracture or dislocation)
• Tumor
The Affix IIS Spinous Process Plate System is not intended for stand-alone use.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summarv
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: March 4, 2015
B. Device Name
| Trade or Proprietary Name: | NuVasive® Affix® IIS Spinous Process Plate System |
|---|---|
| Common or Usual Name: | Spinal interlaminal fixation orthosis |
| Classification Name: | Spinal interlaminal fixation orthosis |
| Device Class: | Class II |
|---|---|
| Classification: | 21 CFR § 888.3050 |
| Product Code: | PEK |
C. Predicate Devices
The subject Affix IIS Spinous Process Plate System is substantially equivalent to the primary predicate device, NuVasive Affix II Spinous Process Plate (K132411) and additional predicate devices Lanx Spinous Process Fusion Plate (K121940) and Axle Interspinous Fusion System (K130438).
Device Description D.
The Affix IIS Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the lumbosacral spine (L1-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.
E. Indications for Use
The Affix IIS Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the lumbosacral spine (L1 - 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.
- Spondylolisthesis
- Trauma (i.e., fracture or dislocation) .
- Tumor
The Affix IIS Spinous Process Plate System is not intended for stand-alone use.
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Technological Characteristics F.
As was established in this submission, the subject Affix IIS 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 IIS Spinous Process Plate System is substantially equivalent to other predicate devices. The following testing was performed:
- . Static and dynamic axial compression
- Static torsion
The results demonstrate that the subject Affix IIS 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 IIS Spinous Process Plate System has been shown to be substantially equivalent to legally marketed predicate devices.