(169 days)
No
The device description and performance studies focus on the mechanical properties and clinical use of physical interbody fusion spacers, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for treating various cervical spine conditions such as cervical disc disease, instability, trauma, deformity, myelopathy, spinal stenosis, and failed previous fusion, which directly address and alleviate medical conditions.
No
Explanation: The PATRIOT® COLONIAL® ACDF Spacers and SUSTAIN® Spacers are described as interbody fusion devices or cervical intervertebral body fusion devices. Their intended use is to provide structural stability and facilitate fusion in the cervical spine, rather than to diagnose medical conditions.
No
The device description clearly states that the devices are "cervical interbody fusion devices" and "spacers" which are physical implants used in surgery. The performance studies also describe mechanical testing of these physical implants.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The text clearly describes the PATRIOT® COLONIAL® ACDF Spacers and SUSTAIN® Spacers as implantable medical devices used for spinal fusion in the cervical spine. They are physical structures inserted into the body to provide stability and facilitate bone growth.
- Lack of Diagnostic Activity: There is no mention of the device analyzing biological samples or providing diagnostic information about a patient's health status.
The device is a surgical implant used for treatment, not a diagnostic tool.
N/A
Intended Use / Indications for Use
PATRIOT® COLONIAL® ACDF Spacers are interbody fusion devices indicated at one or more levels of the cervical spine C2-T1 in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. All PATRIOT® TPS coated spacers are indicated for the same use as non-coated versions. PATRIOT® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation, such as the ASSURE® or PROVIDENCE® Anterior Cervical Plate Systems.
When used as cervical intervertebral body fusion devices, SUSTAIN® Spacers including SUSTAIN® R are intended for one or more levels of the cervical spine C2-T1 in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. All SUSTAIN® TPS coated spacers are indicated for the same use as non-coated versions. SUSTAIN® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation, such as the ASSURE®, PROVIDENCE®, or XTEND® Anterior Cervical Plate Systems.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
PATRIOT® COLONIAL® ACDF Spacers are cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. PATRIOT® Spacers are inserted through an anterior cervical approach, and are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.
SUSTAIN® Spacers, including SUSTAIN® R, are devices that may be used as cervical intervertebral fusion devices. These spacers are available in different shapes and heights to accommodate various surgical approaches and anatomical needs. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine C2-T1
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 compression-shear and torsion was conducted with the additional implants in accordance with the "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, ASTM F2077 to demonstrate substantial equivalence to the predicate spacers. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST72:2011.
Published clinical data for cervical interbody fusion devices is provided in this submission to support the additional indications in the cervical spine. The clinical data demonstrates that the use of anterior cervical interbody fusion devices to treat patients with cervical disc disease, cervical spondylotic myelopathy, trauma including fractures, deformity defined as kyphosis, or scoliosis, spinal stenosis or failed previous fusion does not pose new risks to patients.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K072991, K143578, K130478, K163491, K150619, K153373
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 23, 2018
Globus Medical Inc. Kelly Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403
Re: K173722
Trade/Device Name: PATRIOT® COLONIAL® Spacer, SUSTAIN® Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: April 20, 2018 Received: April 23, 2018
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 Part 801); medical device 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);
1
Page 2 - Dr. Kelly Baker
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K173722
Device Name PATRIOT® COLONIAL® Spacer
Indications for Use (Describe)
PATRIOT® COLONIAL® ACDF Spacers are interbody fusion devices indicated at one or more levels of the cervical spine C2-T1 in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radioulopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. All PATRIOT® TPS coated spacers are indicated for the same use as non-coated versions.
PATRIOT® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation, such as the ASSURE® or PROVIDENCE® Anterior Cervical Plate Systems.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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 Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@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."
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K173722
Device Name SUSTAIN® Spacer
Indications for Use (Describe)
When used as cervical intervertebral body fusion devices, SUSTAIN® SUSTAIN® R are intended for one or more levels of the cervical spine C2-T1 in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radior myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (0) weeks of non-operative treatment. All SUSTAIN® TPS coated spacers are indicated for the same use as non-coated versions.
SUSTAIN® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation, such as the ASSURE®, PROVIDENCE®, or XTEND® Anterior Cervical Plate Systems.
Type of Use (Select one or both, as applicable)X 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 Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@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."
4
510(k) Summary: PATRIOT® COLONIAL® and SUSTAIN® Spacers
| Company: | Globus Medical Inc. |
|---|---|
| 2560 General Armistead Ave. | |
| Audubon, PA 19403 | |
| 610-930-1800 |
- Contact: Kelly Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs
- May 18, 2018 Date Prepared:
- Device Name: PATRIOT® COLONIAL® Spacer SUSTAIN® Spacer
- Common Name: Cervical Intervertebral Body Fusion Device
- Classification: Per 21 CFR as follows: §888.3080 Intervertebral Body Fusion Device Product Codes: ODP Regulatory Class: II, Panel Code: 87
Primary Predicate: PATRIOT® COLONIAL® Spacers (K072991)
Additional
| Predicates: | PATRIOT® COLONIAL® Spacers (K143578) |
|---|---|
| SUSTAIN® Spacers (K130478, K143578) | |
| NuVasive CoRoent Small Interbody (K163491) | |
| Orthofix CONSTRUX Mini PEEK Spacer (K150619) | |
| Medtronic Cornerstone® PSR (K153373) | |
| Reference Devices: | NuVasive CoRoent Small Interlock (K161442) |
| UNIFY® Dynamic Anterior Cervical Plate (K121049) |
Purpose:
The purpose of this submission is to request clearance for additional implants and indications for the PATRIOT® COLONIAL® and SUSTAIN® spacers.
Device Description:
PATRIOT® Cervical Spacers
PATRIOT® COLONIAL® ACDF Spacers are cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. PATRIOT® Spacers are inserted through an anterior cervical approach, and are available in various heights and geometric options to fit the anatomical needs of a
5
wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.
SUSTAIN® Spacers
SUSTAIN® Spacers, including SUSTAIN® R, are devices that may be used as cervical intervertebral fusion devices. These spacers are available in different shapes and heights to accommodate various surgical approaches and anatomical needs. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.
Indications for Use Statement:
PATRIOT® Cervical Spacers
PATRIOT® COLONIAL® ACDF Spacers are interbody fusion devices indicated at one or more levels of the cervical spine C2-T1 in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. All PATRIOT® TPS coated spacers are indicated for the same use as non-coated versions.
PATRIOT® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation, such as the ASSURE® or PROVIDENCE® Anterior Cervical Plate Systems.
SUSTAIN® Spacers
When used as cervical intervertebral body fusion devices. SUSTAIN® Spacers including SUSTAIN® R are intended for one or more levels of the cervical spine C2-T1 in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic mvelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. All SUSTAIN® TPS coated spacers are indicated for the same use as non-coated versions.
SUSTAIN® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. These devices
6
are intended to be used with supplemental fixation, such as the ASSURE® PROVIDENCE®, or XTEND® Anterior Cervical Plate Systems.
Performance Data:
Mechanical testing static compression-shear and torsion was conducted with the additional implants in accordance with the "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, ASTM F2077 to demonstrate substantial equivalence to the predicate spacers. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST72:2011.
Clinical Literature:
Published clinical data for cervical interbody fusion devices is provided in this submission to support the additional indications in the cervical spine. The clinical data demonstrates that the use of anterior cervical interbody fusion devices to treat patients with cervical disc disease, cervical spondylotic myelopathy, trauma including fractures, deformity defined as kyphosis, or scoliosis, spinal stenosis or failed previous fusion does not pose new risks to patients.
Technological Characteristics:
PATRIOT® Spacers and SUSTAIN® implants have the same technological characteristics as the predicate devices including design, intended use, material composition, function, and range of sizes.
Basis of Substantial Equivalence:
PATRIOT® COLONIAL® and SUSTAIN® spacers 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 of the subject spacers to the predicate devices.