(73 days)
No
The summary describes a physical implant (PEEK spacer with titanium screws) for spinal fusion and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes.
This device is designed for intervertebral body fusion to treat degenerative disc disease, which involves addressing a medical condition to restore function, thus classifying it as therapeutic.
No
The device description indicates it is a PEEK spacer with titanium bone screws designed for intervertebral body fusion, which is used for treatment rather than diagnosis.
No
The device description explicitly states it consists of a PEEK spacer with titanium bone screws, which are physical hardware components.
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.
- A-CIFT™ SoloFuse™ Function: The A-CIFT™ SoloFuse™ is a surgical implant designed to be placed within the body to facilitate the fusion of vertebrae in the spine. It is a structural device, not a testing device.
- Intended Use: The intended use clearly states it's for "intervertebral body fusion of the spine." This is a surgical procedure, not a diagnostic test.
- Device Description: The description details a PEEK spacer and titanium bone screws, which are components of a surgical implant, not diagnostic reagents or equipment.
The A-CIFT™ SoloFuse™ is a surgical implant used for spinal fusion, not a device used for testing samples outside of the body.
N/A
Intended Use / Indications for Use
A-CIFT™ SoloFuse™ is intended for stand-alone use for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The A-CIFT™ SoloFuse™ system must be used with the internal bone screws for fixation. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one level from the C2-C3 disc to the C7-T1 disc. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
Degenerative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by a history and radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to the treatment with an intervertebral spacer.
Product codes
OVE
Device Description
The A-CIFT™ SoloFuse™ consists of a PEEK spacer with titanium bone screws for intervertebral body fusion. Fixation is achieved by inserting bone screws through the openings in the spacer into the vertebral bodies of the cervical spine. System is provided non-sterile with instructions for sterilization. The lordotic and non-lordotic PEEK spacers are provided in heights of 5mm to 12mm with a width of 17mm and depths of 13.5mm and 14mm. The lag and rigid screws are offered in diameters 4.2mm and 4.5mm and lengths of 12mm to 16mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine at one level from the C2-C3 disc to the C7-T1 disc.
Indicated Patient Age Range
skeletally mature patients
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)
No performance testing is being included as part of this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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 faces in profile, stacked one behind the other. The faces are rendered in a simple, abstract style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
SpineFrontier, Incorporated % Kenneth C. Maxwell II Regulatory and Quality Specialist Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K151198
Trade/Device Name: A-CIFTTM SoloFuse™ Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: June 18, 2015 Received: June 19, 2015
Dear Mr. Maxwell:
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
July 17, 2015
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/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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page. |
|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | |
| K151198 | |
| Device Name | |
| A-CIFT™ SoloFuse™ | |
| Indications for Use (Describe) | |
A-CIFT™ SoloFuse™ is intended for stand-alone use for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The A-CIFT™ SoloFuse™ system must be used with the internal bone screws for fixation. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one level from the C2-C3 disc to the C7-T1 disc. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
Degenerative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by a history and radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to the treatment with an intervertebral spacer.
| 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) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☒ 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)
3
FORM FDA 3881 (9/13)
Page 1 of 2
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4
510(k) Summary
| Submitter's Name: | Spine Frontier, Inc. |
|---|---|
| Submitter's Address: | 500 Cummings Center, Suite 3500 |
| Beverly, MA 01915 | |
| Submitter's Telephone: | 978.232.3990 x252 |
| Company Contact Person: | Manthan Damani, MSRA |
| Associate Manager, Regulatory Affairs | |
| Contact Person: | Kenneth C Maxwell II |
| Empirical Consulting LLC | |
| 719.291.6874 | |
| Date Summary was Prepared: | 18 June 2015 |
| Trade or Proprietary Name: | A-CIFTTM SoloFuseTM |
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | OVE |
| Classification Panel: | Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION
The A-CIFT™ SoloFuse™ consists of a PEEK spacer with titanium bone screws for intervertebral body fusion. Fixation is achieved by inserting bone screws through the openings in the spacer into the vertebral bodies of the cervical spine. System is provided non-sterile with instructions for sterilization. The lordotic and non-lordotic PEEK spacers are provided in heights of 5mm to 12mm with a width of 17mm and depths of 13.5mm and 14mm. The lag and rigid screws are offered in diameters 4.2mm and 4.5mm and lengths of 12mm to 16mm.
INDICATIONS FOR USE
A-CIFT™ SoloFuse™ is intended for stand-alone use for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The A-CIFT™ SoloFuse™ system must be used with the internal bone screws for fixation. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one level from the C2-C3 disc to the C7-T1 disc. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
Degenerative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by a history and radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to the treatment with an intervertebral spacer.
TECHNICAL CHARACTERISTICS
The spacers are manufactured from PEEK-OPTIMA® LT1 (ASTM F2026) and Tantalum (ASTM F560-05) markers. The bone screws are manufactured from titanium alloy meeting requirements of ASTM F136.
5
Table 5-1 Predicate Devices
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Type |
|---|---|---|---|
| K131880 | A-CIFT™ SoloFuse™ | SpineFrontier® | Primary |
| K102547 | CoRent® Small Interlock™ System | NuVasive® | Reference |
PERFORMANCE TESTING SUMMARY
No performance testing is being included as part of this submission.
REASON FOR SUBMISSION
The purpose of this submission is to include additional surgical instruments with an optional freehand surgical technique for the SpineFrontier A-CIFT™ SoloFuse™.
CONCLUSION
The subject modified A-CIFT™ SoloFuse™ is very similar to previously cleared A-CIFT™ SoloFuse™. The subject A-CIFT™ SoloFuse™ has similar intended uses, indications, technological characteristics, and principles of operation as the predicate devices. The modifications raise no new types of safety or effectiveness questions. The overall technology characteristics lead to the conclusion that the A-CIFT™ SoloFuse™ is substantially equivalent to the predicate device.