(89 days)
When used as an intervertebral body fusion device, the SeaSpine Spacer System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and supplemental fixation.
When used as a vertebral body replacement device (VBR), the SeaSpine Spacer System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The SeaSpine Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period. Additionally, the device is intended for use with bone graft.
The SeaSpine Spacer System is an implantable device made from polyetheretherketone (PEEK) with markers for radiographic visualization. The device has a central canal for receiving bone graft and is offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy.
The SeaSpine Spacer System is an implantable device made from PEEK with markers for radiographic visualization. It is intended for spinal fusion procedures (L2-S1) as an intervertebral body fusion device and for vertebral body replacement (T1 to L5) in cases of tumor, trauma/fracture.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Appropriate properties for intended use | Mechanical testing results indicated that the SeaSpine Spacer System possessed appropriate properties for its intended use. |
| Substantially equivalent to predicate devices | Mechanical testing results indicated that the SeaSpine Spacer System is substantially equivalent to the predicate devices. Comparison in areas including use, design, materials, and function also showed substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail a "test set" in the context of clinical or algorithmic performance. The study described is mechanical testing. Therefore, the concept of sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable here as clinical data was explicitly not required.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the study involved mechanical testing, not a clinical study requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable as the study involved mechanical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document states, "Clinical data was not required for this device."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable since the device is a physical medical implant and not a software algorithm.
7. The Type of Ground Truth Used
The ground truth used was based on mechanical testing results and comparison to predicate devices in terms of use, design, materials, and function to establish substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable as the study did not involve a training set for an algorithm or a clinical trial in the traditional sense. It was mechanical testing and comparison to predicate devices.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. The "ground truth" for demonstrating the device's suitability was established through mechanical testing and direct comparison to legally marketed predicate devices based on their established performance and characteristics. The FDA determined "substantial equivalence" based on these comparisons.
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K082310 Page 1 of 2
NOV 1 0 2008
510(k) Summary
| Company Name: | SeaSpine, Inc.2302 La Mirada DriveVista, CA 92081 | ||
|---|---|---|---|
| Contact Person: | Jeff BrittanSenior Project EngineerE-mail: jbrittan@seaspine.comPhone: (760) 727-8399 x213, Fax: (760) 727-8809 | ||
| Date Prepared: | August 11, 2008 | ||
| Trade Name: | SeaSpine Spacer System - Hollywood™, Pacifica™, Redondo™, Ventura™ | ||
| Common Name: | Vertebral Body Replacement DeviceInterbody Fusion Device | ||
| Classification Name: | Spinal Intervertebral Body Fixation OrthosisIntervertebral Body Fusion Device | ||
| Classification Number (s)/Product Codes(s): | 21 CFR 888.3060, Product Code MQP, Class IIOrthopedic Review Committee21 CFR 888.3080, Product Code MAX, Class IIOrthopedic Review Committee | ||
| Device Description: | The SeaSpine Spacer System is an implantable device made frompolyetheretherketone (PEEK) with markers for radiographic visualization.The device has a central canal for receiving bone graft and is offered in avariety of sizes and geometries to accommodate variations in pathologyand patient anatomy. | ||
| Intended Use: | When used as an intervertebral body fusion device, the SeaSpine SpacerSystem is intended for spinal fusion procedures at one or two contiguouslevels (L2-S1) in skeletally mature patients with degenerative disc disease(DDD). DDD is defined as back pain of discogenic origin with degenerationof the disc confirmed by history and radiographic studies. DDD patientsmay also have up to Grade 1 spondylolisthesis or retrolisthesis at theinvolved level(s). These patients may have had a previous non-fusion spinalsurgery at the involved spinal level(s). These patients should have had sixmonths of non-operative treatment. The device is intended to be usedwith autogenous bone graft and supplemental fixation. | ||
| When used as a vertebral body replacement device (VBR), the SeaSpineSpacer System is intended for use in the thoracolumbar spine (T1 to L5) toreplace a collapsed, diseased, damaged or unstable complete or partial |
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device.
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| vertebral body due to tumor or trauma/fracture, to achieve anteriordecompression of the spinal cord and neural tissues, and to restore theheight of a collapsed vertebral body. The SeaSpine Spacer System isdesigned to restore the biomechanical integrity of the anterior, middle, andposterior spinal column, even in the absence of fusion for a prolongedperiod. Additionally, the device is intended for use with bone graft. | |
|---|---|
| SubstantialEquivalence: | The SeaSpine Spacer System was shown to be substantially equivalent tothe predicate devices through comparison in areas including use, design,materials, and function. |
| Performance Data: | Mechanical testing results indicated that the SeaSpine Spacer Systempossessed appropriate properties for its intended use and is substantiallyequivalent to the predicate devices. Clinical data was not required for this |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with healthcare, alongside the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the emblem. The caduceus is depicted with a staff entwined by two snakes and topped with wings, a common representation of medicine and healing. The overall design is simple and monochromatic, emphasizing the official nature of the seal.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SeaSpine, Inc. % Mr. Jeffrey Brittan Senior Project Engineer 2302 La Mirada Drive Vista, California 92081-7862
NOV 1 0 2008
Re: K082310
Trade/Device Name: SeaSpine Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX, MQP Dated: August 11, 2008 Received: August 13. 2008
Dear Mr. Brittan:
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, l'isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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 - Mr. Jeffrey Brittan
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, periods your levice to proceed to the market.
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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmanlet Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M Wilkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
1082310 510(k) Number (if known): _
Device Name: SeaSpine Spacer System
Indications for Use:
When used as an intervertebral body fusion device, the SeaSpine Spacer System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and supplemental fixation.
When used as a vertebral body replacement device (VBR), the SeaSpine Spacer System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The SeaSpine Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period. Additionally, the device is intended for use with bone graft.
Prescription Use א (Part 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 OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
§ 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.