(181 days)
Not Found
No
The summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are based on Finite Element Analysis (FEA), which is a simulation technique, not an AI/ML method.
Yes
The device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for conditions like degenerative disc disease, spondylolisthesis, trauma, and/or tumor, thereby alleviating pain and improving function.
No
The device is described as a "posterior, non-pedicle supplemental fixation device" intended for "plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion." It is a surgical implant designed to provide immobilization and stabilization, not to diagnose conditions.
No
The device description clearly indicates it is a bilateral locking plate system and implants, which are physical hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion, which is a therapeutic procedure performed in vivo (within the body).
- Device Description: The description details a physical implant designed to be attached to the spinous process.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests outside of the body on biological samples. This device is a surgical implant used inside the body.
N/A
Intended Use / Indications for Use
The Aurora Spine ZIP™ MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (TI-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 (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 Aurora Spine ZIP™ MIS Interspinous Fusion System is intended for use with bone graft material and is not intended for stand-alone use.
Product codes (comma separated list FDA assigned to the subject device)
PEK
Device Description
The Aurora Spine ZIPIM MIS Interspinous Fusion System is a bilateral locking plate system which attaches to the posterior noncervical spinous processes. The implants have superior and inferior surfaces and a central chamber for receiving bone graft. The devices are available in a variety of cylinders to accommodate variations in pathology and patient anatomy. The Aurora Spine ZIP™ MIS Interspinous Fusion System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine (TI-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)
Finite Element Analysis (FEA) testing was provided to demonstrate substantial equivalence of the modified components compared to the predicate ZIP™ MIS system. FEA testing showed the additional geometries of the subject device do not offer a worst-case scenario as compared to the predicate ZIPTM MIS Interspinous Fusion System components.
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
§ 888.3050 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 is a circular seal for the U.S. Department of Health & Human Services. The seal features the department's logo, which is a stylized caduceus with three intertwined snakes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top of the circle. The logo and text are in black and the background is white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 17, 2014
Aurora Spine. Incorporated % Mr. Justin Eggleton Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street Northwest, 12th Floor Washington, District of Columbia 20005
Re: K141317
Trade/Device Name: ZIP™ MIS Interspinous Fusion System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: September 17, 2014 Received: September 18, 2014
Dear Mr. Eggleton:
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
Page 2 – Mr. Justin Eggleton
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.
Sincerelv vours.
Mark N. Melkerson -S
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
510(k) Number (if known) K141317
Device Name ZIPTM MIS Interspinous Fusion System
Indications for Use (Describe)
The Aurora Spine ZIP™ MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (TI-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 (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 Aurora Spine ZIP™ MIS Interspinous Fusion System is intended for use with bone graft material and is not intended for stand-alone 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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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
| Contact: | Justin Eggleton
Director, Spine Regulatory Affairs
Musculoskeletal Clinical Regulatory Advisers, LLC
1331 H Street NW, 12th Floor
Washington, DC 20005
202.552.5800
jeggleton@mcra.com |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | November 17, 2014 |
| Device Trade Name: | ZIP™ MIS ULTRA Interspinous Fusion System
ZIP™ MIS Interspinous Fusion System |
| Manufacturer: | Aurora Spine, Inc.
1920 Palomar Point Way
Carlsbad, CA 92008 |
| Common Name: | Interspinous Fusion Device |
| Classification: | 21 CFR §888.3050; Spinal interlaminal fixation orthosis |
| Class: | II |
| Product Code: | PEK |
Summary of Technological Characteristics:
The purpose of this Special 510(k) is to introduce a line extension (ZIP™ Flared) to the Aurora Spine ZIP™ MIS Interspinous Fusion System that accommodates spinal level between T1 and S1 with greater lordosis. There have been no changes to the intended use of the device or its fundamental scientific technology.
Indications For Use:
The Aurora Spine ZIP™ MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use 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 (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 Aurora Spine ZIP™ MIS Interspinous Fusion System is intended for use with bone graft material and is not intended for stand-alone use.
4
Device Description:
The Aurora Spine ZIPIM MIS Interspinous Fusion System is a bilateral locking plate system which attaches to the posterior noncervical spinous processes. The implants have superior and inferior surfaces and a central chamber for receiving bone graft. The devices are available in a variety of cylinders to accommodate variations in pathology and patient anatomy. The Aurora Spine ZIP™ MIS Interspinous Fusion System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine.
Predicate Device:
The modified Aurora Spine ZIP™ MIS Interspinous Fusion System is substantially equivalent to the predicate Aurora Spine ZIP™ MIS Interspinous Fusion System (K140715, K133091) with respect to indications, design, function, performance and materials.
Non-Clinical Testing:
Finite Element Analysis (FEA) testing was provided to demonstrate substantial equivalence of the modified components compared to the predicate ZIP™ MIS system. FEA testing showed the additional geometries of the subject device do not offer a worst-case scenario as compared to the predicate ZIPTM MIS Interspinous Fusion System components.
Conclusion:
The Aurora Spine ZIP™ MIS Interspinous Fusion System has been modified to include modified spinous process fusion plates with different angles and spike orientations to accommodate varying degrees of lordosis. Substantial equivalence has been demonstrates to predicate ZIP™ MIS Interspinous Fusion System 510(k)s.