(217 days)
The Spinal USA Interbody Fusion Device ACIF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Spinal USA Interbody Fusion Device ACIF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device. The device should be used with supplemental fixation.
The Spinal USA Interbody Fusion Device ACIF System consists of implants with various heights to accommodate individual patient anatomy and graft material size. It is implanted from the anterior approach. It is to be packed with autogenous bone graft to facilitate fusion. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved. All components are manufactured from medical grade polyetheretherketone (Peek Optima, LT)). The products are supplied clean and "NON-STERILE".
The provided text is a 510(k) summary for a medical device (Spinal USA Anterior Cervical Interbody Fusion Device). This type of document focuses on demonstrating substantial equivalence to a predicate device through pre-clinical performance testing. It does not contain information about clinical studies with human subjects, AI performance, or the specific criteria requested about acceptance criteria, sample sizes, ground truth establishment, or expert evaluation related to those types of studies.
Therefore, I cannot provide the requested information from the given input. The "PERFORMANCE TESTING" section only states:
"The pre-clinical testing performed indicated that the Spinal USA Interbody Fusion Device ACIF System is substantially equivalent to the predicate devices and is adequate for the intended use."
This indicates that engineering and bench testing were conducted to show the device's mechanical and material properties are comparable to existing, legally marketed devices. It does not refer to clinical performance in patients or algorithmic performance.
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510(k) Summary of Safety and Effectiveness
083118
MAY 27 2009
| Date Summary Prepared: | October 20, 2008 |
|---|---|
| Submitter Information: | Spinal USA2050 Executive DrivePearl, MS 39208 |
| Contact Name: | Jeffrey Johnson |
| Phone: | 601-420-4244 |
| Fax: | 601-420-5501 |
| E-mail: | jeff@spinalusa.com |
| Device Trade Name: | Spinal USA Anterior Cervical Interbody Fusion Device |
| Common Name: | Intervertebral Body Fusion Device |
| Regulatory Number: | 888.3080 |
| Classification: | Class II |
| Product Code: | ODP |
INTENDED USE:
The Spinal USA Interbody Fusion Device ACIF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Spinal USA Interbody Fusion Device ACIF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device. The device should be used with supplemental fixation.
DEVICE DESCRIPTION:
The Spinal USA Interbody Fusion Device ACIF System consists of implants with various heights to accommodate individual patient anatomy and graft material size. It is implanted from the anterior approach. It is to be packed with autogenous bone graft to facilitate fusion. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved. All components are manufactured from medical grade polyetheretherketone (Peek Optima, LT)). The products are supplied clean and "NON-STERILE".
PREDICATE DEVICE(S):
The predicate devices previously cleared by FDA are the Novel Cervical Spinal Spacer, Alphatec Spine (K081730), Crystal, Spinal Elements (K073351)
PERFORMANCE TESTING:
The pre-clinical testing performed indicated that the Spinal USA Interbody Fusion Device ACIF System is substantially equivalent to the predicate devices and is adequate for the intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with three stylized wing segments.
Public Health Service
MAY 27 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Spinal USA % Mr. Jeffery Johnson 2050 Executive Drive Pearl, Mississippi 39208
Re: K083118
Trade/Device Name: Spinal USA Anterior Cervical Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: ODP Dated: April 20, 2009 Received: April 20, 2009
Dear Mr. Johnson:
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 The The The The The The The The The The The The The The The The The The The general controls provisions of the Act include requirements for annual registration. Iisting 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 - Mr. Jeffery Johnson
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
Barbara Buena
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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K083118
Page 1 of 1
Indication for Use
1608 3118 510(k) Number (if known):
Device Name: Spinal USA Anterior Cervical Interbody Fusion Device
Indication For Use:
The Spinal USA Interbody Fusion Device ACIF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Spinal USA Interbody Fusion Device ACIF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device. The device should be used with supplemental fixation.
Prescription Use_ × (21 CFR Part 801 Subpart D) AND/OR
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chun Htin
ivision of Surgical, Orthopedic, and Restorative Devices
510(k) Number K083118
§ 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.