(158 days)
The ShurFit CpTi-HA Coated Anterior Cervical Interbody Fusion 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. ShurFit Anterior Cervical Interbody Fusion System 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 ShurFit Anterior Cervical Interbody Fusion (ACIF) System consists of implants with various widths, heights and lengths to accommodate individual patient anatomy and graft material size. It is implanted from the anterior approach and 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 as described by ASTM F2026, specifically PEEK Optima LT1. The cages are included without a coating (already cleared K083118) or with a CpTi-HA (Commercially Pure Titanium -Hydroxyapatite) coating (this submission).
I am sorry, but the provided text is a 510(k) summary for a medical device (ShurFit CpTi-HA ACIF Interbody Fusion System). It describes the device, its indications for use, and a comparison to predicate devices, including a brief summary of non-clinical tests performed.
However, this document does not contain information about:
- Acceptance criteria
- A study that proves the device meets acceptance criteria.
- Reported device performance values against specific criteria.
- Sample sizes used for test sets.
- Data provenance (country of origin, retrospective/prospective).
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size and ground truth establishment for the training set.
The document primarily focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and mechanical testing according to established ASTM standards for interbody fusion devices and coatings. It details what tests were performed on the device and its coating (e.g., Static Axial Compression, Static Tensile Bond Strength), but not the specific quantitative results or how those results compare to pre-defined acceptance criteria for a "study that proves the device meets the acceptance criteria."
Therefore, I cannot fulfill your request for the specific details you've asked for based on the provided text. This document is a regulatory submission for device marketing clearance, not a clinical study report or a detailed performance validation study report.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 a stylized image of three human profiles facing to the right, layered on top of each other to create a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 6, 2016
Precision Spine, Inc. Michael C. Dawson, Esq. Sr. Director of Regulatory Affairs 2050 Executive Drive Pearl, Mississippi 39208
Re: K161809
Trade/Device Name: ShurFit CpTi-HA ACIF Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: November 16, 2016 Received: November 21, 2016
Dear Mr. Dawson:
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 devicerelated 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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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Vincent J. Devlin -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| Indications for Use | See PRA Statement on last page. |
| 510(k) Number (if known) | K161809 |
| Device Name | ShurFit CpTi-HA ACIF Interbody Fusion System |
| Indications for Use (Describe) | The ShurFit CpTi-HA Coated Anterior Cervical Interbody Fusion 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. ShurFit Anterior Cervical Interbody Fusion System 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. |
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: | |
| Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. " | |
| FORM FDA 3881 (12/13) Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF |
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Image /page/3/Picture/1 description: The image shows the logo for Precision Spine. The words "PRECISION SPINE" are written in blue font. There is a yellow spine graphic between the two words. There is a blue line above and below the words.
510(K) SUMMARY
| Submitter's Name: | Precision Spine, Inc. |
|---|---|
| Submitter's Address: | 2050 Executive DrivePearl, MS 39208 |
| Submitter's Telephone: | 973-455-7150 ext. 128 |
| Contact Person: | Michael C. Dawson |
| Date Summary was Prepared: | June 22, 2016 |
| Trade or Proprietary Name: | ShurFit CpTi-HA ACIF Interbody Fusion System |
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | ODP |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The ShurFit Anterior Cervical Interbody Fusion (ACIF) System consists of implants with various widths, heights and lengths to accommodate individual patient anatomy and graft material size. It is implanted from the anterior approach and 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 as described by ASTM F2026, specifically PEEK Optima LT1. The cages are included without a coating (already cleared K083118) or with a CpTi-HA (Commercially Pure Titanium -Hydroxyapatite) coating (this submission).
CHANGE FROM PREDICATE:
The purpose of this submission is to add CpTi-HA (Commercially Pure Titanium -Hydroxyapatite) coated cages to the ShurFit ACIF Interbody Fusion System cleared in K083118. This submission seeks to add a line of ShurFit ACIF devices that have a coating on their endplates. The coating consists of a commercially pure Titanium (CpTi) based layer with a Hydroxyapatite (HA) layer on top of the CpTi. Precision Spine relies of the Master File of its contract manufacturer, APS Biomaterials Inc. located at 4011 Riverside Drive, Dayton, Ohio, for the composition and other technical characteristics of the HA and the CpTi coating. The coated products will be supplied sterile in validated sterile packaging.
INDICATIONS FOR USE
The ShurFit CpTi-HA Coated Anterior Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc
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level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. ShurFit Anterior Cervical Interbody Fusion System 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.
TECHNOLOGICAL CHARACTERISTICS
The intended use and technological features of the modifications to the components of the ShurFit Anterior Cervical Interbody Fusion System do not substantially differ from the legally marketed predicate devices.
All ShurFit CpTi-HA ACIF Interbody Fusion System components are manufactured from medical grade polyetheretherketone as described by ASTM F2026, specifically PEEK Optima LT1. The coated implants are provided sterile. The subject and predicate devices have identical technological characteristics and differ only in the fact that a CpTi-HA coating has been added and the coated devices will be provided supplied sterile. Additional predicates that contain CpTi or HA are listed below.
| 510k Number | Trade or Proprietary orModel Name | Manufacturer | Primary orAdditional |
|---|---|---|---|
| K083118 | Interbody Fusion DeviceACIF System | Precision Spine(Spinal USA) | Primary |
| K142269 | Reliance HA InfusedCervical IBF | RelianceMedicalSystems | Additional |
| K142026 | Arena-C HA infusedCervical cage | Spine Frontier | Additional |
| K112036 | Calix PC Titanium coatedCervical cage | X Spine | Additional |
| K123909 | CeSpace Titanium coatedCervical cage | Aesculap | Additional |
Table 5-1 Predicate Devices
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The following is a brief summary of non-clinical tests provided to the agency for review:
Mechanical performance of the CpTi-HA coated ShurFit® ACIF System was evaluated under the standards of ASTM F2077-11, F2267-04, and the draft standard F-04.25.02.02. The following properties were tested:
- Static Axial Compression ●
- Dynamic Axial Compression ●
- Static Torsion ●
- Dynamic Torsion ●
- Static Compression Shear ●
- Dynamic Compression Shear
- Static Expulsion
- Static Subsidence
Coating properties were evaluated using the standards ASTM 1147, ASTM F1044, ASTM F1160, and ASTM F1854. The following properties were tested:
- Static Tensile Bond Strength ●
- Static Shear Strength ●
- Shear Fatigue ●
- Solubility and Dissolution ●
- Microstructural and Image Analysis of coated surface ●
Additional information on both the CpTi and the HA coatings can be found in the Master Access File of the coatings vendor, APS Materials.
CONCLUSION
The overall technology characteristics and mechanical engineering analysis lead to the conclusion that the ShurFit CpTi-HA ACIF Interbody Fusion System is substantially equivalent to the predicate devices.
§ 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.