(271 days)
There are no Reference Devices listed in the provided text.
No
The description focuses on the physical characteristics, materials, and mechanical testing of a lumbar intervertebral fusion device. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for use in patients with degenerative disc disease to provide structural stability and is used with bone graft, directly addressing a medical condition.
No
Explanation: The device is an intervertebral body fusion device designed for structural stability, not for diagnosing medical conditions.
No
The device description clearly indicates that the device is a physical implant made from PEEK polymer with titanium or tantalum markers, intended for surgical insertion. 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 medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The SUSTAIN® Spacers are implantable medical devices designed to provide structural support and facilitate fusion in the spine during surgery. They are physically inserted into the body.
- Intended Use: The intended use clearly states they are "lumbar intervertebral body fusion devices" for treating degenerative disc disease. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The provided information describes a surgical implant, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
When used as lumbar intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R and SUSTAIN®-IR) are intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). SUSTAIN® Spacers are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These devices are intended to be used with supplemental fixation.
Product codes
MAX
Device Description
SUSTAIN®-IR Spacers are lumbar intervertebral fusion devices used to provide structural stability in skeletally mature individuals following discectomy and may be inserted using a posterior or transforaminal approach. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. SUSTAIN® IR Spacers are inserted into the disc space and rotated 90° to the final position. Ridges on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. SUSTAIN®-IR Spacers have an axial hole to allow autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to be packed inside the spacer.
SUSTAIN®-IR Spacers are made from radiolucent PEEK polymer with titanium alloy or tantalum markers as specified in ASTM F136, F560, F1295, and F2026.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral spine (L2-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)
Mechanical testing (static and dynamic compression, static and dynamic compression-shear, and subsidence) was conducted in accordance with the "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, ASTM F2077, and ASTM F2267 to demonstrate substantial equivalence to the predicate devices. A cadaver implantation study was also performed to demonstrate feasibility of device insertion and assess potential endplate damage.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K130478, K102293, K123231, K120368, K100043, K143163
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 16, 2016
Globus Medical Incorporated % Dr. Kellv Baker Senior Vice President, Regulatory and Clinical Affairs Valley Forge Business Center 2560 General Armistead Avenue Audubon, Pennsylvania 19403
Re: K151665
Trade/Device Name: SUSTAIN® Additional Implants Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: February 12, 2016 Received: February 16, 2016
Dear Dr. Baker:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 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" (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 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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K151665
Device Name SUSTAIN® Additional Implants
Indications for Use (Describe)
When used as lumbar intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R and SUSTAIN®-IR) are intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). SUSTAIN® Spacers are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These devices are intended to be used with supplemental fixation.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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K151665 Page 1 of 1
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510(k) Summary: SUSTAIN® Additional Implants
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
610-930-1800 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kelly J. Baker, Ph.D.
Senior Vice President, Regulatory and Clinical Affairs |
| Date Prepared: | March 15, 2016 |
| Device Name: | SUSTAIN® Additional Implants |
| Classification: | Per 21 CFR as follows:
§888.3080 Intervertebral Body Fusion Device
Product Codes: MAX
Regulatory Class: II, Panel Code: 87 |
Primary Predicate: SUSTAIN® Spacers (K130478)
| Additional
| Predicates: | CALIBER® Spacer (K102293 & K123231) |
|---|---|
| Medtronic Capstone Control (K120368) | |
| NuVasive CoRoent (K100043) | |
| Stryker AVS PL PEEK Spacers (K143163) |
Purpose:
The purpose of this submission is to request clearance for SUSTAIN® Additional Implants (SUSTAIN®-IR Spacers) and to update indications for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft for SUSTAIN® Spacers (including SUSTAIN® R and SUSTAIN®-IR).
Device Description:
SUSTAIN®-IR Spacers are lumbar intervertebral fusion devices used to provide structural stability in skeletally mature individuals following discectomy and may be inserted using a posterior or transforaminal approach. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. SUSTAIN® IR Spacers are inserted into the disc space and rotated 90° to the final position. Ridges on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. SUSTAIN®-IR Spacers have an axial hole to allow autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to be packed inside the spacer.
SUSTAIN®-IR Spacers are made from radiolucent PEEK polymer with titanium alloy or tantalum markers as specified in ASTM F136, F560, F1295, and F2026.
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Indications for Use:
When used as lumbar intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R and SUSTAIN®-IR) are intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). SUSTAIN® Spacers are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These devices are intended to be used with supplemental fixation.
Performance Data:
Mechanical testing (static and dynamic compression, static and dynamic compression-shear, and subsidence) was conducted in accordance with the "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, ASTM F2077, and ASTM F2267 to demonstrate substantial equivalence to the predicate devices. A cadaver implantation study was also performed to demonstrate feasibility of device insertion and assess potential endplate damage.
Basis of Substantial Equivalence:
SUSTAIN® Additional Implants have been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices. SUSTAIN® Additional Implants are as safe, as effective, and perform as well as or better than the predicate devices.