(191 days)
No
The summary describes a mechanical implant for spinal fixation and does not mention any software, algorithms, or AI/ML capabilities.
No
The Z-Clamp ISP System is a surgical implant designed to provide stabilization and act as an adjunct to fusion in the lumbar spine, specifically indicated for conditions like degenerative disc disease, spondylolisthesis, trauma, and tumor. While it aids in treatment, it is a medical implant for structural support and not a device that independently delivers therapy (e.g., electrical stimulation, drug delivery, light therapy).
No
The document describes "The Zavation Z-CLAMP ISP System" as a "posterior, non-pedicle supplemental fixation device" and a "spinous process plate" used for "achieving stabilization as an adjunction in patients with degenerative disc disease...spondylolisthesis, trauma...and/or tumor." It states it’s "not intended for standalone use." This device is a surgical implant designed for support and stabilization, not for diagnosing medical conditions.
No
The device description explicitly states it is a "spinous process plate" made of "titanium alloy" and is a "multiple component system comprised of a variety of nonsterile, single use implantable components." This clearly indicates a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "posterior, non-pedicle supplemental fixation device, intended for use as an adjunct to fusion at a single level in the lumbar spine (L1-S1)." This describes a surgical implant used to stabilize the spine.
- Device Description: The description details a "spinous process plate" made of titanium alloy, consisting of plates and lock screws. This is a physical implant.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests. It is a physical device implanted in the body.
The information provided describes a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Z-Clamp ISP System is a posterior, non-pedicle supplemental fixation device, intended for use as an adjunct to fusion at a single level in the lumbar spine (L1-S1). It is intended for attachment to the spinous process for the purpose of achieving stabilization as an adjunction in patients with degenerative disc disease – 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) and/or tumor. The Z-Clamp ISP System is not intended for standalone use.
Product codes
PEK
Device Description
The Zavation Z-CLAMP ISP System is a spinous process plate which is a temporary, titanium alloy (Ti-6AL-4V ELI per ASTM F136), multiple component system comprised of a variety of nonsterile, single use implantable components. The system consist of plates and lock screw. The components are available in a variety of lengths and sizes in order to accommodate patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine (L1-S1), spinous process
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
Static torsion test, static compression bending test, dynamic compression bending test, static foam pull-off test and static plate dissociation test were performed according to a modified ASTM F1717 on a worst-case construct. The mechanical test results demonstrated the Z-CLAMP ISP System performs as well as or better than the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K141508 Spineart, Romeo 2Pad
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure, emphasizing the organization's name and national affiliation. The logo is simple, clean, and uses a monochromatic color scheme.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 20, 2016
Zavation, LLC Mr. Milton Phillips Engineer 220 Lakeland Parkway Flowood, Mississippi 39232
Re: K161016
Trade/Device Name: Z-Clamp ISP System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: September 20, 2016 Received: September 21, 2016
Dear Mr. Phillips:
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 Parts 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/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,
Mark N. Melkerson -S
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) K161016
Device Name Z-Clamp ISP System
Indications for Use (Describe)
The Z-Clamp ISP System is a posterior, non-pedicle supplemental fixation device, intended for use as an adjunct to fusion at a single level in the lumbar spine (L1-S1). It is intended for attachment to the spinous process for the purpose of achieving stabilization as an adjunction in patients with degenerative disc disease – 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) and/or tumor. The Z-Clamp ISP System is not intended for standalone use.
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) |
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510K Summary
| Date: | September 20, 2016 |
|---|---|
| Submitter: | Zavation, LLC |
| 220 Lakeland Parkway | |
| Flowood, MS 39232 | |
| Phone: 601-919-1119 | |
| Fax: 800-447-1302 | |
| Contact person: | Milton Phillips |
| Trade name: | Z-CLAMP ISP System |
| Classification: | Spinal Interlaminal Fixation Orthosis |
| 21 CFR 888.3050 | |
| Product Code: PEK | |
| Regulatory Class: II | |
| Panel Code: 87 | |
| Primary Predicate: |
K141508 Spineart, Romeo 2Pad
Device Description:
The Zavation Z-CLAMP ISP System is a spinous process plate which is a temporary, titanium alloy (Ti-6AL-4V ELI per ASTM F136), multiple component system comprised of a variety of nonsterile, single use implantable components. The system consist of plates and lock screw. The components are available in a variety of lengths and sizes in order to accommodate patient anatomy.
Indications for Use:
The Z-Clamp ISP System is a posterior, non-pedicle supplemental fixation device, intended for use as an adjunct to fusion at a single level in the lumbar spine (L1-S1). It is intended for attachment to the spinous process for the purpose of achieving stabilization as an adjunction to fusion in patients with degenerative disc disease – 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) and /or tumor. The Z-Clamp ISP System is not intended for standalone use.
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K161016 Page 2 of 2
Technological Characteristics:
The Z-CLAMP ISP System possesses the same technological characteristics, design and principles of operation as the predicates. These include: basic design, material, intended use and indications.
Performance Data:
Static torsion test, static compression bending test, dynamic compression bending test, static foam pull-off test and static plate dissociation test were performed according to a modified ASTM F1717 on a worst-case construct. The mechanical test results demonstrated the Z-CLAMP ISP System performs as well as or better than the predicate devices.
Conclusion:
The Z-CLAMP ISP System is substantially equivalent to the predicate device referenced above.