(268 days)
No
The device description focuses on the material, dimensions, and mechanical properties of a spinal implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an interbody fusion cage (spacer) designed to provide structural stability and support bone graft in patients with degenerative disc disease, which is a therapeutic intervention.
No.
The device is described as an interbody fusion spacer, indicated for structural support in patients with degenerative disc disease, not for diagnosing medical conditions.
No
The device description clearly states it is a physical implant fabricated from PEEK and tantalum, designed for surgical implantation. It 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The SynCage Evolution spacer is a physical implant designed to be surgically placed in the spine to facilitate bone fusion. It is a structural device, not a test performed on a biological sample.
- Intended Use: The intended use is to treat degenerative disc disease by providing structural support and promoting fusion, not to diagnose or monitor a condition through analysis of a biological sample.
The information provided clearly describes a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SynCage Evolution spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the SynCage Evolution spacer should be packed with autogenous bone graft (i.e. 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
MAX
Device Description
The Synthes SynCage Evolution spacer is a radiolucent device for use in interbody fusion. It is to be used in conjunction with supplemental fixation to provide structural stability in skeletaly mature individuals. The Synthes SynCage Evolution spacer is fabricated from Invibio® PEEK-OPTIMA® LT-1 (ASTM F2026-10) with four anterior and one posterior tantalum (ASTM F560-08) radiopaque markers. The markers allow intra-operative radiographic assessment of the position of the implant. Implantation is through an anterior or anterolateral approach. The Synthes SynCage Evolution spacer is provided sterile.
The Synthes SynCage Evolution spacer is available in three footprints (Small: 32x25mm; Medium, 36x28mm; Large, 40x31mm), four lordotic angles (6°, 10°, 14°, 18°), and a range of heights (9-19mm) to suit individual pathology and anatomical conditions. Pyramidal teeth that assist in stabilization of the construct are located on the inferior and superior surfaces of the spacers. The open architecture of the device allows it to be packed with autogenous bone graft material (i.e., autograft).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1
Indicated Patient Age Range
skeletally mature
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)
Non-Clinical Performance and Conclusions:
Synthes conducted the following bench testing (as recommended within FDA Guidances and in accordance with ASTM F2077-11 and ASTM F2267-04): Static Axial Compression; Dynamic Axial Compression; Static Compression Shear; Expulsion; and Subsidence.
The conclusions drawn from testing and an engineering rationale demonstrate that the Synthes SynCage Evolution Spacer is substantially equivalent in performance to predicate devices.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes OPAL Spacer (K072791), LDR Spine ROI-A (K090507), Biomet Enclave (K081636), SeaSpine Redondo (K082310), DePuy Spine Cougar (K081917 & K113348)
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/2 description: The image shows the logo for SYNTHES Spine. The logo consists of the SYNTHES trademark symbol, the word "SYNTHES" in bold, and the word "Spine" in a smaller font size. There is a horizontal line below the word "Spine".
510(k) Summary : K122639 6
| 510(k) Summary -SynCage Evolution Spacer | |
|---|---|
| Name of Firm: | DePuy Synthes Spine |
| 1302 Wrights Lane East | |
| West Chester, PA 19380 | |
| 510(k) Contact: | Hemal Mehta |
| Regulatory Affairs Specialist | |
| Telephone: 610-719-5424 | |
| Facsimile: 610-719-5102 | |
| Email: mehta.hemal@synthes.com | |
| Date Prepared: | May 22, 2013 |
| Trade Name(s): | Synthes SynCage Evolution Spacer |
| Classification: | 21 CFR 888.3080 - Intervertebral Body Fusion Device |
| Class II (special controls) | |
| Orthopaedic and Rehabilitation Devices Panel (87) | |
| Product Code MAX (Intervertebral Fusion Device with Bone Graft, | |
| Lumbar) | |
| Predicates: | Synthes OPAL Spacer (K072791) |
| LDR Spine ROI-A (K090507) | |
| Biomet Enclave (K081636) | |
| SeaSpine Redondo (K082310) | |
| DePuy Spine Cougar (K081917 & K113348) | |
| The Synthes SynCage Evolution spacer is a radiolucent device for use in | |
| interbody fusion. It is to be used in conjunction with supplemental | |
| fixation to provide structural stability in skeletaly mature individuals. The | |
| Synthes SynCage Evolution spacer is fabricated from Invibio® PEEK- | |
| OPTIMA® LT-1 (ASTM F2026-10) with four anterior and one posterior | |
| tantalum (ASTM F560-08) radiopaque markers. The markers allow intra- | |
| operative radiographic assessment of the position of the implant. | |
| Implantation is through an anterior or anterolateral approach. The | |
| Synthes SynCage Evolution spacer is provided sterile. | |
| Device | |
| Description(s): | The Synthes SynCage Evolution spacer is available in three footprints |
| (Small: 32x25mm; Medium, 36x28mm; Large, 40x31mm), four lordotic | |
| angles (6°, 10°, 14°, 18°), and a range of heights (9-19mm) to suit | |
| individual pathology and anatomical conditions. Pyramidal teeth that | |
| assist in stabilization of the construct are located on the inferior and | |
| superior surfaces of the spacers. The open architecture of the device | |
| allows it to be packed with autogenous bone graft material (i.e., | |
| autograft). | |
| Intended Use/ | The SynCage Evolution spacer is indicated for use in patients with |
| Indications for | degenerative disc disease (DDD) at one or two contiguous levels from L2 |
| 510(k) Summary –SynCage Evolution Spacer | |
| Use: | to S1 whose condition requires the use of interbody fusion combined with |
| supplemental fixation. The interior of the SynCage Evolution spacer | |
| should be packed with autogenous bone graft (i.e. 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. | |
| Comparison of | |
| the device to | |
| predicate | |
| device(s): | Synthes SynCage Evolution Spacer is substantially equivalent to the |
| predicates in design, function, performance, material, and intended use. | |
| Performance | |
| Date | |
| (Non-Clinical | |
| and/or Clinical): | Non-Clinical Performance and Conclusions: |
| Synthes conducted the following bench testing (as recommended within | |
| FDA Guidances and in accordance with ASTM F2077-11 and ASTM | |
| F2267-04): Static Axial Compression; Dynamic Axial Compression; | |
| Static Compression Shear; Expulsion; and Subsidence. | |
| The conclusions drawn from testing and an engineering rationale | |
| demonstrate that the Synthes SynCage Evolution Spacer is substantially | |
| equivalent in performance to predicate devices. | |
| Clinical Performance and Conclusions: | |
| Clinical data and conclusions were not needed for this device. |
:
.
1
® SYNTHES® Spine
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure, with stylized lines representing its wings and body.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter dated: May 24, 2013
Synthes (USA) Products LLC % Mr. Hemal Mehta Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K122639
Trade/Device Name: Synthes SynCage Evolution Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 30, 2013 Received: May 1, 2013
Dear Mr. Mehta:
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
3
Page 2 – Mr. Hemal Mehta
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Mark N.Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the logo for Synthes Spine. The word "SYNTHES" is in bold, sans-serif font, with a registered trademark symbol next to it. Below the word "SYNTHES" is the word "Spine" in a smaller, sans-serif font. To the left of the word "SYNTHES" is a circular logo with a stylized image inside.
Indications for Use Statement 6
510(k) Number(s): K122639 (if known)
Device Name: Synthes SynCage Evolution Spacer
The SynCage Evolution spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the SynCage Evolution spacer should be packed with autogenous bone graft (i.e. 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.
Prescription Use X (21 CFR 801 Subpart D) AND / OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices