(158 days)
Not Found
No
The summary describes a mechanical interbody fusion device and does not mention any AI or ML components or functionalities.
Yes.
The device is an interbody fusion device for treating degenerative disc disease, which qualifies it as a therapeutic device.
No
The device is an interbody fusion device intended for treatment of degenerative disc disease, not for diagnosing it.
No
The device description clearly indicates it is a physical implantable device (intervertebral body fusion device with screws and a plate) and not software.
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 fusion. It is used in the body to treat a physical condition (degenerative disc disease).
- Device Description: The description details a physical implantable device (spacer, plate, screws) made of radiolucent and radiopaque materials.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body. This device is a surgical implant used directly in the body.
N/A
Intended Use / Indications for Use
The SYNFIX Evolution Secured System is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the interior of the spacer component of the SYNFIX Evolution can be packed with autograft.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
Product codes
OVD
Device Description
The SYNFIX Evolution Secured Spacer System is a combination radiolucent and radiopaque intervertebral body fusion device. Four screws are inserted through the anteriorly-located plate into the adjacent vertebral bodies. The screws lock securely to the plate using a tapered-thread locking mechanism.
The SYNFIX Evolution Secured Spacer System is available as assembled components in various heights and geometries to suit individual pathology and anatomical conditions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1 (Spine)
Indicated Patient Age Range
skeletally mature
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Performance data in the form of Finite Element Analysis and mechanical testing per ASTM F2077 (compression, compression shear) was performed to provide data to support a substantial equivalence determination. The Finite Element Analysis and mechanical testing was performed to characterize the properties and functionality of the system, as well as to allow comparison with established acceptance criteria.
No clinical data was necessary to demonstrate substantial equivalence, nor safety and effectiveness of this system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes SYNFIX-LR (K072253), Synthes Zero-P (K072981), Synthes SYNCAGE Evolution (K122639), Synthes SYNFIX Lateral (K131276), Medtronic Sovereign (K121982), Centinel Spine Midline II (K141942)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three faces in profile, representing the department's focus on health and well-being. The logo is simple, clean, and easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2015
Synthes (USA) Products LLC Mr. Eugene Bang Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767
Re: K150673
Trade/Device Name: SYNFIX® Evolution Secured Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: July 31, 2015 Received: August 3, 2015
Dear Mr. Bang:
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
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Page 2 - Mr. Eugene Bang
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.
Sincerely 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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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page 1 of 1
510(k) Number (if known) K150673
B 667 B
Device Name SYNFIX® Evolution Secured Spacer System
Indications for Use (Describe)
The SYNFIX Evolution Secured System is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the interior of the spacer component of the SYNFIX Evolution can be packed with autograft.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
| 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary
| Submitter: | Synthes USA Products, LLC.
325 Paramount Drive
Raynham, MA 02767 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Eugene Bang
Regulatory Affairs Associate
Telephone: (508) 977-3966
Fax: (508) 828-3797 |
| Date Prepared: | March 13, 2015 |
| Trade Name: | SYNFIX® Evolution Secured Spacer System |
| Device Class: | Class II |
| Product Code: | OVD |
| Common Name: | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Classification Name: | Intervertebral Body Fusion Device |
| Regulation Number: | 21 CFR 888.3080 |
| Classification Panel: | Orthopaedic and Rehabilitation Devices Panel (87) |
| Primary Predicate: | Synthes SYNFIX-LR (K072253) |
| Additional Predicates: | Synthes Zero-P (K072981)
Synthes SYNCAGE Evolution (K122639)
Synthes SYNFIX Lateral (K131276)
Medtronic Sovereign (K121982)
Centinel Spine Midline II (K141942) |
| Device Description: | The SYNFIX Evolution Secured Spacer System is a combination
radiolucent and radiopaque intervertebral body fusion device. Four
screws are inserted through the anteriorly-located plate into the adjacent
vertebral bodies. The screws lock securely to the plate using a tapered-
thread locking mechanism.
The SYNFIX Evolution Secured Spacer System is available as
assembled components in various heights and geometries to suit
individual pathology and anatomical conditions. |
| Indications: | The SYNFIX Evolution Secured Spacer System is a stand-alone anterior
interbody fusion device indicated for use in patients with degenerative
disc disease (DDD) at one or two contiguous levels from L2 to S1. These
patients may also have up to Grade I spondylolisthesis at the involved
level(s). The interior of the spacer component of the SYNFIX Evolution
can be packed with autograft.
DDD is defined as back pain of discogenic origin with degeneration of
the disc confirmed by history and radiographic studies. These patients
should be skeletally mature and have had six months of non-operative
treatment. |
| Materials: | The spacer component is manufactured from medical grade PEEK
OPTIMA LT-1 (ASTM F2026) with tantalum alloy markers (ASTM F
560). The plate and screws are manufactured from Ti-6Al-7Nb (ISO
5832). |
| Comparison to
Predicate Device: | The substantial equivalence of the subject device to the predicates
identified above is based upon the equivalence of intended use, design
(fundamental scientific technology), materials, performance, sterility,
and biocompatibility. |
| Performance Data: | Performance data in the form of Finite Element Analysis and mechanical
testing per ASTM F2077 (compression, compression shear) was
performed to provide data to support a substantial equivalence
determination. The Finite Element Analysis and mechanical testing
was performed to characterize the properties and functionality of
the system, as well as to allow comparison with established acceptance
criteria. |
| Clinical Test
Summary: | No clinical data was necessary to demonstrate substantial equivalence,
nor safety and effectiveness of this system. |
| Conclusion: | Based on the predicate comparison of intended use, indications,
technological characteristics, and device performance, the SYNFIX
Evolution Secured Spacer System has demonstrated substantial
equivalence to the identified predicate device systems. |
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