(122 days)
Not Found
No
The description focuses on the mechanical design and materials of a spinal implant, with no mention of AI or ML capabilities. The performance studies are mechanical tests, not related to algorithmic performance.
No.
The device is a non-pedicle supplemental fixation system intended for use in spinal fusion, which is a structural support device rather than one that treats or cures a disease.
No.
The device description indicates that the SeaSpine Spinous Process System is a "posterior, non-pedicle supplemental fixation device" intended for implantation to achieve "supplemental fusion" in the spine. It is a physical implant used for treatment and stabilization, not for diagnosing conditions.
No
The device description clearly states it is an implantable system consisting of physical components (spacer, plates, set screws) made from Ti-6Al-4V ELI. This is a hardware device, not software.
No, 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, or tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Description: The SeaSpine Spinous Process System is an implantable device designed to be surgically placed inside the body to provide structural support and aid in spinal fusion.
- Intended Use: The intended use is for "plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion" in specific spinal conditions. This is a therapeutic and structural function, not a diagnostic test performed on a sample.
The description clearly indicates a device that is implanted within the body for mechanical support and fusion, which is the opposite of how IVDs function.
N/A
Intended Use / Indications for Use
The SeaSpine Spinous Process System is a posterior non-pedicle supplemental fixation system intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes 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)
- · Spinal tumor
The SeaSpine Spinous Process System is not intended for stand-alone use.
Product codes
PEK
Device Description
The SeaSpine Spinous Process System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). The Spinous Process System consists of an implantable spacer featuring 2 plates (male and female) with a variable barrel width, fixed wing length, and fixed plate width, and set screws that clamp bilaterally to the spinous processes. Each plate contains spikes (teeth) for fixation to the spinous process to aid in resisting rotation, flexion, and extension after implantation. Implants are available in a range of sizes to suit the individual pathology and anatomical conditions of the patient, and manufactured from Ti-6Al-4V ELI per ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine (T1-S1), spinous processes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Non-Clinical Testing: Static axial compression, static axial torsion, and dynamic axial compression bending tests were performed using methods based on ASTM F1717 and ASTM F2624. The testing demonstrated substantially equivalent mechanical performance as compared to the predicate.
Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K121924, K071877, K121316, K141317
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/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 4, 2021
SeaSpine Orthopedics Corporation Gina Flores Sr. Regulatory Affairs Specialist 5770 Armada Drive Carlsbad, California 92008
Re: K173334
Trade/Device Name: SeaSpine Spinous Process System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK
Dear Gina Flores:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 22, 2018. Specifically, FDA is updating this SE Letter to correct the trade name in the Indications for Use Page and Indications for Use section of the 510(k) Summary.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Colin O'Neill, M.B.E., OHT6: Office of Orthopedic Devices, (301) 796-6428, colin.oneill@fda.hhs.gov.
Sincerely,
Colin O'neill -S
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 22, 2018
SeaSpine Orthopedics Corporation Ms. Gina Flores Senior Regulatory Affairs Specialist 5770 Armada Drive Carlsbad, California 92008
Re: K173334
Trade/Device Name: SeaSpine Spinous Process System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: January 26, 2018 Received: January 29, 2018
Dear Ms. Flores:
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 forth in the quality systems (OS) regulation (21 CFR Part 820);
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Page 2 - Ms. Gina Flores
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ronald P. Jean
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K173334
Device Name SeaSpine Spinous Process System
Indications for Use (Describe)
The SeaSpine Spinous Process System is a posterior non-pedicle supplemental fixation system intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes 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)
- · Spinal tumor
The SeaSpine Spinous Process System is not intended for stand-alone use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -------------- |
X 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
Contact Details
| Applicant Name: | SeaSpine Orthopedics Corporation |
|---|---|
| Address: | 5770 Armada Drive, Carlsbad CA |
| Phone number: | (760) 216-5136 |
| Fax number: | (760) 683-6874 |
| Contact person: | Gina Flores, Sr. Regulatory Specialist |
| Email address: | gina.flores@seaspine.com |
| Date Prepared: | February 21, 2018 |
| Device Name | |
| Trade Name: | SeaSpine Spinous Process System |
| Common Name: | Spinous Process Plate |
| Classification Name: | Spinal Interlaminal Fixation Orthosis |
| Classification: | 21 CFR 888.3050, Spinal Interlaminal Fixation Orthosis |
| Class: | II |
| Product Code: | PEK |
Legally Marketed Predicate Device
| 510(k)
| Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| Primary Predicate | |||
| K121924 | PEK | SeaSpine Spinous Process | |
| System | SeaSpine | ||
| Orthopedics | |||
| Corporation | |||
| Additional Predicates | |||
| K071877, | |||
| K121316 | KWP, MNI | Aspen MIS Fixation System | Zimmer/Biomet |
| (formerly Lanx, Inc.) | |||
| K141317 | PEK | Aurora Spine ZIP Flared | |
| System | Aurora Spine, Inc. |
Device Description
The SeaSpine Spinous Process System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). The Spinous Process System consists of an implantable spacer featuring 2 plates (male and female) with a variable barrel width, fixed wing length, and fixed plate width, and set screws that clamp bilaterally to the spinous processes. Each plate contains spikes (teeth) for fixation to the spinous process to aid in resisting
5
rotation, flexion, and extension after implantation. Implants are available in a range of sizes to suit the individual pathology and anatomical conditions of the patient, and manufactured from Ti-6Al-4V ELI per ASTM F136.
Intended Use/Indications for Use
The SeaSpine Spinous Process System is a posterior non-pedicle supplemental fixation system intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes 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)
- · Spinal tumor
The SeaSpine Spinous Process System is intended for stand-alone use.
Summary of Technological Characteristics
The Spinous Process System and predicate device have the same operational principle; they are spacers that engage the spinous processes and provide fixation during fusion.
The SeaSpine Spinous Process System is substantially equivalent to the cited predicate devices in areas including intended use/indications for use, technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) and performance (mechanical safety).
The subject and predicate device are based on the following similar technological elements:
- · Plate lengths
- Plate widths
- · Barrel lengths and widths
- · Same implant materials, Titanium Alloy (6AL-4V ELI per ASTM F136)
- · Utilize the same set screw
Non-Clinical Testing
Static axial compression, static axial torsion, and dynamic axial compression bending tests were performed using methods based on ASTM F1717 and ASTM F2624. The testing demonstrated substantially equivalent mechanical performance as compared to the predicate.
Clinical Testing
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
Conclusions
The submitted data demonstrate that the SeaSpine Spinous Process System is as safe, as effective, and performs at least as safely and effectively as the cited legally marketed predicate devices.