(80 days)
Synthes Synapse System is indicated for the following:
Hooks, Plate/Rods, Plates, Rods and Screws
When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, plates, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix, Axon, OC Fusion and Synapse Systems are indicated for the following:
• Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Spinal Stenosis
• Fracture/dislocation
• Atlantoaxial fracture with instability
• Occipitocervical dislocation
• Revision of previous cervical spine surgery
• Tumor
When used to treat these cervical and occipitocervical conditions, screws are limited to occipital fixation only.
Hooks and Rods
The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws, and Transverse Bars
The rods, clamps, screws, nuts, variable axis screws, locking screws, and transverse bars are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).
The use of these screws (3.5 mm, 4.0 mm and 4.5 mm cancellous, and 3.5 mm and 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The Synthes CerviFix, Axon, and Synapse Systems can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm parallel connectors from that system and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks, 4.2 mm screws and the 5.0 mm/6.0 mm parallel connector.
Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12), or lumbar spine.
The Synthes Synapse Transconnector is a top-loading transconnector placed on top of two mono-segmental variable axis screws to cover the exposed spinal cord following laminectomy. The Synthes Synapse Transconnector is designed to be a rigid link between longitudinal rods, and is compatible only with Synthes Synapse System.
The Synthes Synapse Transconnector is a line extension to Synthes Synapse System, and a modification to the Synthes Cervifix transconnector.
The implants are manufactured from Titanium Aluminum Niobium TAN (Ti-6Al-7Nb) ASTM F1295, the same as the predicate device.
The provided document is a 510(k) summary for a medical device called the "Synthes Synapse Transconnector," which is a component of a posterior cervical system. It describes the device, its intended use, and its comparison to predicate devices for regulatory clearance.
However, this document does not contain information about acceptance criteria, detailed study designs, or performance metrics in the way you've requested for AI/algorithm performance. The 510(k) summary primarily focuses on demonstrating substantial equivalence to pre-existing, legally marketed devices based on design, function, material, and intended use.
Here's a breakdown of why this document doesn't fit your request and what information it does provide:
Key Takeaways from the Document Regarding "Performance":
- Non-Clinical Performance and Conclusions: "Bench testing results demonstrate that the Synthes Synapse System is substantially equivalent to the predicate device." This indicates that physical/mechanical testing was performed to show the new device performs similarly to existing ones.
- Clinical Performance and Conclusions: "Clinical data and conclusions were not needed for this device." This is crucial. For this specific device and 510(k) submission (K090549), clinical studies in humans were not required by the FDA to establish substantial equivalence.
Therefore, the following information you requested cannot be found or is not applicable based on the provided text:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study and effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How the ground truth for the training set was established.
In summary, this document describes a traditional medical device (a surgical implant component) and its regulatory clearance process, not an AI or algorithm-based device. Therefore, the detailed performance study information relevant to AI/algorithm acceptance criteria is not present.
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K090549 page 1 of 2
MAY 2 1 2009
10 510(k) Summary
| Name of Firm: | Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380 |
|---|---|
| 510(k) Contact: | Stacey BonnellRegulatory Affairs SpecialistTelephone: 610-719-5895 Facsimile: 610-719-5102Email: bonnell.stacey@synthes.com |
| Date Prepared: | February 27, 2009 |
| Trade Name: | Synthes Synapse Transconnector |
| Common Name: | Posterior Cervical System |
| Classification: | 21 CFR 888.3050 Appliance, Fixation, Spinal InterlaminalClass II; Orthopaedic and Rehabilitation Devices PanelProduct Code: KWP |
| Predicate Device: | Synthes Synapse System (K072434 & K070573)Synthes Cervifix (K011969) |
| Device Description: | The Synthes Synapse Transconnector is a top-loading transconnectorplaced on top of two mono-segmental variable axis screws to cover theexposed spinal cord following laminectomy. The Synthes SynapseTransconnector is designed to be a rigid link between longitudinal rods,and is compatible only with Synthes Synapse System.The Synthes Synapse Transconnector is a line extension to SynthesSynapse System, and a modification to the Synthes Cervifixtransconnector.The implants are manufactured from Titanium Aluminum NiobiumTAN (Ti-6Al-7Nb) ASTM F1295, the same as the predicate device. |
| Intended Use /Indications for Use: | Synthes Synapse System is indicated for the following:Hooks, Plate/Rods, Plates, Rods and ScrewsWhen intended to promote fusion of the cervical spine andoccipitocervical junction (occiput-T3), the plate/rod, plates, rod, hookand screw (3.2 mm cortex) components of the Synthes Cervifix, Axon,OC Fusion and Synapse Systems are indicated for the following:• Degenerative Disc Disease (DDD) (defined as neck pain ofdiscogenic origin with degeneration of the disc as confirmed bypatient history and radiographic studies)• Spondylolisthesis• Spinal Stenosis• Fracture/dislocation• Atlantoaxial fracture with instability• Occipitocervical dislocation• Revision of previous cervical spine surgery• TumorWhen used to treat these cervical and occipitocervical conditions,screws are limited to occipital fixation only. |
| Hooks and RodsThe rod and hook components are also intended to provide stabilization | |
| to promote fusion following reduction of fracture/dislocation or traumain the cervical/upper thoracic (C1-T3) spine. | |
| Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws, and Transverse Bars | |
| The rods, clamps, screws, nuts, variable axis screws, locking screws,and transverse bars are intended to promote fusion following reductionof fracture/dislocation or trauma in the upper thoracic spine (T1-T3). | |
| The use of these screws (3.5 mm, 4.0 mm and 4.5 mm cancellous, and3.5 mm and 4.2 mm cortex) is limited to placement in T1-T3 in treatingthoracic conditions only. They are not intended to be placed in or treatconditions involving the cervical spine. | |
| The Synthes CerviFix, Axon, and Synapse Systems can also be linkedto the Synthes Universal Spinal System using the 3.5 mm/6.0 mmparallel connectors from that system and via the CerviFix tapered rodsusing lamina hooks, transverse process hooks, pedicle hooks, 4.2 mmscrews and the 5.0 mm/6.0 mm parallel connector. | |
| Warning: This device is not intended for screw attachment or fixationto the posterior elements (pedicles) of the cervical, thoracic (T4-T12),or lumbar spine. | |
| Comparison of thetechnologicalcharacteristics of thedevice to thepredicate device: | The Synthes Synapse Transconnector is a result of design modificationsto the predicate device. Synthes has established that it is substantiallyequivalent to the predicates in design, function, material, and intendeduse. |
| Performance Data(Nonclinical and/orClinical) | Non-Clinical Performance and Conclusions:Bench testing results demonstrate that the Synthes Synapse System issubstantially equivalent to the predicate device. |
| Clinical Performance and Conclusions:Clinical data and conclusions were not needed for this device. |
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Page 12 of 34
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Page 2 of 2
Special 510(k) - Synthes Synapse Transconnector
Page 13 of 34
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the symbol.
MAY 21 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Synthes Spine % Ms. Stacey Bonnell Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K090549
Trade/Device Name: Synthes Synapse System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: April 20, 2009 Received: April 21, 2009
Dear Ms. Bonnell:
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 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 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.
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Page 2 - Ms. Stacey Bonnell
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Howard W. Epps
fx
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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page 1 of 2
Indications for Use Statement 9
к 090549
510(k) Number: (if known)
Device Name: Synthes Synapse
Hooks, Plate/Rods, Plates, Rods and Screws
When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, plates, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix, Axon, OC Fusion and Synapse Systems are indicated for the following:
- · Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- · Spondylolisthesis
- · Spinal Stenosis
- · Fracture/dislocation
- · Atlantoaxial fracture with instability
- · Occipitocervical dislocation
- · Revision of pervious cervical spine surgery
- · Tumor
When used to treat these cervical and occipitocervical conditions, screws are limited to occipital fixation only.
Hooks and Rods
The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws, & Transverse Bars
The rods, clamps, screws, nuts, variable axis screws, locking screws, and transverse bars are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).
The use of these screws (3.5 mm, 4.0 mm and 4.5 mm cancellous, and 3.5 mm and 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The Synthes CerviFix, Axon, and Synapse Systems can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm parallel connectors from that system and via the CerviFix tapered rods using lamina hooks, transverse
Special 510(k) - Synthes Synapse Transconnector
Page 10 of 34
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process hooks, pedicle hooks, 4.2 mm screws and the 5.0 mm/6.0 mm parallel connector.
Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12), or lumbar spine.
X Prescription Use (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)
Gmin Heis
for (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices .
K090549 510(k) Number.
Special 510(k) - Synthes Synapse Transconnector
Page 11 of 34
§ 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.