(264 days)
Not Found
No
The summary describes a physical implant (spacer and screws) for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended for intervertebral body fusion to treat degenerative disc disease, which is a medical condition, making it a therapeutic device.
No
The device is an intervertebral body fusion device used for treatment, not for diagnosing conditions.
No
The device description clearly states that the A-CIFT™ SoloFuse™ consists of a PEEK or PEEK-OPTIMA HA Enhanced spacer with titanium bone screws, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "intervertebral body fusion of the spine." This is a surgical procedure performed on the body.
- Device Description: The device is described as a "spacer with titanium bone screws" and is implanted into the spine. This is a physical implant, not a diagnostic tool used on samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for a therapeutic purpose (fusion).
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, ODP
Device Description
The A-CIFT™ SoloFuse™ consists of a PEEK or PEEK-OPTIMA HA Enhanced 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. The A-CIFT™ SoloFuse™ PEEK-OPTIMA HA Enhanced implants are provided sterile and irradiated by gamma radiation. The A-CIFT™ SoloFuse™ PEEK implants are provided non-sterile with instructions for sterilization. The lordotic and non-lordotic PEEK or PEEK-OPTIMA HA Enhanced spacers are provided in various sizes. The lag and rigid screws are offered in various diameters and lengths.
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
No performance testing is being included as part of this submission. Failure Effects Analysis (FEA) was used in lieu of mechanical testing to show substantial equivalence to the previously cleared design.
Key Metrics
Not Found
Predicate Device(s)
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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May 8, 2018
SpineFrontier, Inc. % Meredith L May Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K172484
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, ODP Dated: April 13, 2018 Received: April 17, 2018
Dear Meredith May
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);
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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
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Indications for Use
510(k) Number (if known) K172484
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) |
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| Submitter's Name: | SpineFrontier, Inc. |
|---|---|
| Submitter's Address: | 350 Main Street, 3rd Floor |
| Malden, MA 02148 | |
| Submitter's Telephone: | 978.232.3990 x275 |
| Company Contact Person: | Director of Innovation |
| Contact Person: | Meredith L May MS, RAC |
| Empirical Consulting LLC | |
| 719-337-7579 | |
| Date Summary was Prepared: | 13 December 2017 |
| Trade or Proprietary Name: | A-CIFT™ SoloFuse™ |
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | OVE, ODP |
| Classification Panel: | Division of Orthopedic Devices |
510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The A-CIFT™ SoloFuse™ consists of a PEEK or PEEK-OPTIMA HA Enhanced 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. The A-CIFT™ SoloFuse™ PEEK-OPTIMA HA Enhanced implants are provided sterile and irradiated by gamma radiation. The A-CIFT™ SoloFuse™ PEEK implants are provided non-sterile with instructions for sterilization. The lordotic and non-lordotic PEEK or PEEK-OPTIMA HA Enhanced spacers are provided in various sizes. The lag and rigid screws are offered in various diameters and lengths.
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.
TECHNOLOGICAL CHARACTERISTICS
The spacers are manufactured from PEEK-OPTIMA HA Enhanced and PEEK-OPTIMA® LT1 (ASTM F2026) and Tantalum (ASTM F560-05) markers. The bone screws are manufactured from titanium alloy meeting requirements of ASTM F136.
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| 510k
Number | Trade or Proprietary or Model Name | Manufacturer | Predicate
Type |
|----------------|------------------------------------|---------------|-------------------|
| K151198 | A-CIFTTM SoloFuseTM | SpineFrontier | Primary |
| K142026 | Arena-C® HA PEEK Cervical IBFD | SpineFrontier | Additional |
Table 5-1: Predicate Devices
PERFORMANCE TESTING SUMMARY
No performance testing is being included as part of this submission. Failure Effects Analysis (FEA) was used in lieu of mechanical testing to show substantial equivalence to the previously cleared design.
REASON FOR SUBMISSION
The purpose of this submission is to manufacture the SpineFrontier, Inc. A-CIFT™ SoloFuse™ from PEEK-OPTIMA HA Enhanced.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the SpineFrontier, Inc. A-CIFT™ SoloFuse™ is safe and effective and substantially equivalent to the previously cleared product.