(114 days)
Not Found
No
The document describes a physical implantable device (cervical intervertebral body fusion device) and its intended use, materials, and performance studies. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The focus is on the physical characteristics and clinical performance of the implant.
Yes
Explanation: The device is intended for spinal fusion procedures to treat degenerative disc disease, which clearly indicates a therapeutic purpose.
No
The device is an orthopedic implant (spinal fusion device) used to facilitate fusion, not to diagnose a condition.
No
The device description clearly states that the devices are physical implants made of PEEK, tantalum, and titanium alloy, intended for surgical implantation. It also mentions plates and screws as part of the system. This indicates a hardware medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that these are implants (cervical intervertebral body fusion devices) designed to be surgically placed within the body to facilitate spinal fusion. They are used in conjunction with bone graft material.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. Its function is structural support and facilitating bone growth.
Therefore, the device described is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Breckenridge® Small Intervertebral Body Fusion System: When used as a cervical intervertebral body fusion device, the Breckenridge implant is intended for spinal fusion procedures to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion in skeletally mature patients with degenerative disc disease ("DDD") at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The Breckenridge device is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Biomet Anterior Cervical Plate System.
C-Thru™ Anterior Spinal System: When used as a cervical intervertebral fusion device, the C-Thru™ Anterior Spinal System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. The C-Thru™ Spacers are intended for use with supplemental fixation and autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate the fusion.
Solitaire®-C Cervical Spacer System: The Solitaire®-C Cervical Spacer System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2 to T1. Cervical degenerative 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. The Solitaire®-C Cervical Spacer System is to be used with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and implanted via an anterior approach. The Solitaire-C spacer must be implanted with the Solitaire-C titanium screws that are part of the system. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
Product codes (comma separated list FDA assigned to the subject device)
OVE, ODP
Device Description
The cervical intervertebral body PEEK spacers have a hollowed cut-out central area to accommodate autogenous and/or allogeneic bone graft. Furthermore, the upper and lower surfaces have a series of transverse slots or grooves to improve stability and fixation once the device is inserted. All implants in these systems are made of PEEK-OPTIMA®, tantalum, and titanium alloy (Ti-6AI-4V ELI). The spacer body, plates and screws are available in a variety of sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Solitaire-C spacer is a stand-alone device that must be implanted with the Solitaire-C titanium screws that are part of the system.
The Solitaire®-C Cervical Spacer System and C-Thru™ Anterior Spinal System implants are offered in sterile packed versions while the Breckenridge® Small Intervertebral Body Fusion is packaged non-sterile, to be sterilized by the end user.
This Traditional 510(k) is being submitted to seek clearance for the addition of allograft (cancellous and/or corticocancellous bone graft) indications to the aforementioned cervical intervertebral body PEEK spacer systems (both stand-alone devices and devices which require supplemental fixation).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C2-C3 disc to C7-T1 disc, C2 to T1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Performance Data - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence: The changes proposed did not require non-clinical testing in order to demonstrate substantial equivalence to the predicate devices.
Performance Data - Summary of Clinical Test Conducted for Determination of Substantial Equivalence: Published retrospective clinical data for cervical interbody fusion devices similar to the subject devices was completed to support this Premarket Notification. The published clinical outcomes demonstrated that the use of allograft (cancellous and/or corticocancellous bone graft) in anterior cervical interbody fusion poses no new risks to patients. No changes were made to the existing devices; therefore, no additional testing was required or performed.
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.
K142152, K113796, K092336, K103660
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.
Not Found
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/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 words "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, stacked one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 12, 2015
Biomet Spine Ms. Alexandra Beck Regulatory Affairs Specialist 310 Interlocken Parkway, Suite 120 Broomfield, Colorado 80021
Re: K151064
Trade/Device Name: Solitaire®-C Cervical Spacer System, C-Thru™ Anterior Spinal System, and Breckenridge® Small Intervertebral Body Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE, ODP Dated: July 10, 2015 Received: July 13, 2015
Dear Ms. Beck:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Alexandra Beck
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/Resourcesfor You/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 vours.
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: January 31, 2017 See PRA Statement below.
Page 1 of 3
510(k) Number (if known) K151064
Device Name
Breckenridge® Small Intervertebral Body Fusion System
Indications for Use (Describe)
When used as a cervical intervertebral body fusion device, the Breckenridge implant is intended for spinal fusion procedures to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion in skeletally mature patients with degenerative disc disease ("DDD") at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The Breckenridge device is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Biomet Anterior Cervical Plate System.
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: January 31, 2017 See PRA Statement below.
Page 2 of 3
510(k) Number (if known) K151064
Device Name C-Thru™ Anterior Spinal System
Indications for Use (Describe)
When used as a cervical intervertebral fusion device, the C-Thru™ Anterior Spinal System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. The C-Thru™ Spacers are intended for use with supplemental fixation and autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate the fusion.
| 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
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page 3 of 3
510(k) Number (if known) K151064
Device Name Solitaire®-C Cervical Spacer System
Indications for Use (Describe)
The Solitaire®-C Cervical Spacer System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2 to T1. Cervical degenerative disc disease is defined as intractable radiculopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Solitaire®-C Cervical Spacer System is to be used with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and implanted via an anterior approach. The Solitaire-C spacer must be implanted with the Solitaire-C titanium screws that are part of the system. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
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."
5
Image /page/5/Picture/0 description: The image shows the logo for Biomet Spine. The word "BIOMET" is in large, bold, sans-serif font. Below "BIOMET" is the word "SPINE" in a smaller, lighter font. The logo is simple and modern.
510(k) Summary
This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR § 807.92.
| Preparation Date: | 07 August2015 |
|---|---|
| Applicant/Sponsor: | Biomet Spine |
| 310 Interlocken Parkway, Suite 120 | |
| Broomfield, CO 80021 | |
| Contact Person: | Alexandra Beck |
| Regulatory Affairs Specialist | |
| Phone: 303-501-8397 | |
| Fax: 303-501-8444 | |
| Trade name: | Solitaire®-C Cervical Spacer System |
| Common Name: | Cervical interbody fusion device with integrated fixation |
| Classification Name | |
| (Product Code): | Intervertebral Fusion Device with Integrated Fixation, Cervical |
| (OVE) | |
| Device Panel - Regulation | |
| No.: | Orthopedic - 21 CFR § 888.3080 |
| Trade name: | C-Thru™ Anterior Spinal System |
| Common Name: | Cervical and non-cervical spinal spacer |
| Classification Name | |
| (Product Code): | Intervertebral Fusion Device with Bone Graft, Cervical (ODP) |
| Device Panel - Regulation | |
| No.: | Orthopedic - 21 CFR § 888.3080 |
| Trade name: | Breckenridge® Small Intervertebral Body Fusion System |
| Common Name: | Biomet Intervertebral Body Fusion Device |
| Classification Name | |
| (Product Code): | Intervertebral Fusion Device with Bone Graft, Cervical (ODP) |
| Device Panel - Regulation | |
| No.: | Orthopedic - 21 CFR § 888.3080 |
| Primary Predicate: | CONSTRUX Mini PEEK Spacer System (K142152) |
| Solitaire®-C Cervical Spacer System (K113796) | |
| Other Predicates: | C-ThruTM Anterior Spinal System ( K092336) |
| Breckenridge® Small Intervertebral Body Fusion System | |
| (K103660) |
Device Description:
The cervical intervertebral body PEEK spacers have a hollowed cut-out central area to accommodate autogenous and/or allogeneic bone graft. Furthermore, the upper and lower surfaces have a series of transverse slots or grooves to improve stability and fixation once the device is inserted. All implants in these systems are made of PEEK-OPTIMA®, tantalum, and titanium alloy (Ti-6AI-4V ELI). The
6
spacer body, plates and screws are available in a variety of sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Solitaire-C spacer is a stand-alone device that must be implanted with the Solitaire-C titanium screws that are part of the system.
The Solitaire®-C Cervical Spacer System and C-Thru™ Anterior Spinal System implants are offered in sterile packed versions while the Breckenridge® Small Intervertebral Body Fusion is packaged non-sterile, to be sterilized by the end user.
This Traditional 510(k) is being submitted to seek clearance for the addition of allograft (cancellous and/or corticocancellous bone graft) indications to the aforementioned cervical intervertebral body PEEK spacer systems (both stand-alone devices and devices which require supplemental fixation).
Indications for Use:
Solitaire®-C Cervical Spacer System
The Solitaire -C Cervical Spacer System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2 to T1. Cervical degenerative 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. The Solitaire -C Cervical Spacer System is to be used with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and implanted via an anterior approach. The Solitaire-C spacer must be implanted with the Solitaire-C titanium screws that are part of the system. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
C-Thru™ Anterior Spinal System
When used as a cervical intervertebral fusion device, the C-Thru " Anterior Spinal System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. The C-Thru" Spacers are intended for use with supplemental fixation and autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate the fusion.
Breckenridge® Small Intervertebral Body Fusion system
When used as a cervical intervertebral body fusion device, the Breckenridge implant is intended for spinal fusion procedures to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion in skeletally mature patients with degenerative disc disease ("DDD") at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The Breckenridge device is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Biomet Anterior Cervical Plate System.
Summary of Technologies:
As established in this submission, the subject systems are substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject devices were shown to be substantially equivalent and have the same technological characteristics to the predicate devices through comparison in areas including design, intended use, material composition, and function. These devices do not contain software or electrical equipment.
7
Performance Data - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence
The changes proposed did not require non-clinical testing in order to demonstrate substantial equivalence to the predicate devices.
Performance Data - Summary of Clinical Test Conducted for Determination of Substantial Equivalence
Published retrospective clinical data for cervical interbody fusion devices similar to the subject devices was completed to support this Premarket Notification. The published clinical outcomes demonstrated that the use of allograft (cancellous and/or corticocancellous bone graft) in anterior cervical interbody fusion poses no new risks to patients. No changes were made to the existing devices; therefore, no additional testing was required or performed.
Substantial Equivalence:
The devices included in this submission have the same or similar intended uses, indications, technological characteristics, and principles of operation as the previously cleared CONSTRUX Mini PEEK Spacer System (K142152). Thus, the subject devices with expanded indications to include allograft (cancellous and/or corticocancellous bone graft) are substantially equivalent to the predicate devices.
Conclusion:
In summary, the expanded indications for the Solitaire®-C Cervical Spacer System, C-Thru™ Anterior Spinal System, and Breckenridge® Small Intervertebral Body Fusion System have the same or similar: intended use, indications for use, technological characteristics, principles of operation and performances as the previously cleared CONSTRUX Mini PEEK Spacer System (K142152). A retrospective evaluation of clinical literature demonstrates that expanding the indications of the above mentioned systems does not raise new questions of safety and that the subject systems are substantially equivalent to the previously cleared CONSTRUX Mini PEEK Spacer System (K142152).