(63 days)
No
The summary describes a physical implant device 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 used to facilitate fusion in patients with degenerative disc disease, which is a therapeutic purpose.
No
Explanation: The device is described as an intervertebral body fusion device used to facilitate fusion in the cervical spine. Its purpose is to maintain disc space distraction and allow bone graft placement, not to diagnose medical conditions.
No
The device description clearly states it is an "intervertebral body fusion device" and "implants," which are physical hardware components, not software.
Based on the provided information, 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 description clearly states that the ACIF system is an implantable device used in surgery to facilitate fusion in the cervical spine. It is a physical device placed within the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The information does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing.
Therefore, the ACIF system falls under the category of a surgical implant or medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The ACIF system is indicated for use as an intervertebral body fusion device in skeletally mature patients at one or two contiguous levels of the cervical spine (C2-T1) to facilitate fusion in case of degenerative disc disease (DDD) defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The ACIF implants are placed via an anterior approach using autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The ACIF implants are to be used with supplemental fixation. Patients should have at least six weeks of non-operative treatment prior to surgery.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The coLigne ACIF system are used to maintain disc space distraction in skeletally mature adults requiring anterior cervical interbody fusion (ACIF). This system includes two design configurations: ACIF oscar, and ACIF oscar dome. The implants are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of bone graft.
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 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)
Non-clinical Test Summary: The following analyses were conducted: Static and dynamic compression per ASTM F2077 Static and dynamic torsion per ASTM F2077 Subsidence per ASTM F2267 The results of these evaluations indicate that the coLigne ACIFare equivalent to predicate devices.
Clinical Test Summary: No clinical studies were 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.
K081917, K073351, P980048 S3, K091088, P000028
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.
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December 1, 2017
coLigne, AG % Mr. J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd. Round Rock, Texas 78681
Re: K173148
Trade/Device Name: ACIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: September 25, 2017 Received: September 29, 2017
Dear Mr. Webb:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 medical devices and radiation-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)
K173148
Device Name
ACIF
Indications for Use (Describe)
The ACIF system is indicated for use as an intervertebral body fusion device in skeletally mature patients at one or two contiguous levels of the cervical spine (C2-T1) to facilitate fusion in case of degenerative disc disease (DDD) defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The ACIF implants are placed via an anterior approach using autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The ACIF implants are to be used with supplemental fixation. Patients should have at least six weeks of non-operative treatment prior to surgery.
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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510(k) Summary: ACIF
| Date Prepared | September 25, 2017 |
|---|---|
| Submitted By | Robert Lange |
| coLigne, AG | |
| Utoquai 43 | |
| CH 8008 Zurich | |
| Switzerland | |
| Telephone: +41 43 343 8000 | |
| e-mail: robert.lange@coligne.com | |
| Primary Contact | J.D. Webb |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| Telephone: 512-388-0199 | |
| e-mail: jdwebb@orthomedix.net | |
| Trade Name | ACIF |
| Common Name | Intervertebral body fusion device |
| Classification Name | Intervertebral body fusion device - cervical |
| Class | II |
| Product Code | ODP |
| CFR Section | 21 CFR section 888.3080 |
| Device Panel | Orthopedic |
| Primary Predicate | |
| Device | DePuy, BENGAL System (K081917) |
| Secondary Predicate | |
| Devices | Spinal Elements, Crystal Cervical Cage (K073351) |
| Zimmer, BAK/C Vista Interbody Fusion (P980048 S3) | |
| LDR Spine Cervical Interbody Fusion System (K091088) | |
| Medtronic, Affinity Anterior Cervical Cage (P000028) | |
| Reference Device | ostaPek® VBR System (K072326) |
| Device Description | The coLigne ACIF system are used to maintain disc space distraction in skeletally mature |
| adults requiring anterior cervical interbody fusion (ACIF). This system includes two design | |
| configurations: ACIF oscar, and ACIF oscar dome. The implants are available in a range | |
| of footprints and heights to suit the individual pathology and anatomical conditions of | |
| the patient. The implants have a hollow center to allow placement of bone graft. | |
| Materials | Polyether ketone ether ketone ketone (ASTM F1876-98) |
| Fiber carbon filaments | |
| Gold (ASTM B562-95) | |
| Intended Use | The coLigne ACIF system is used to maintain disc space distraction in skeletally mature |
| adults requiring anterior cervical interbody fusion (ACIF). | |
| Substantial | |
| Equivalence Claimed | |
| to Predicate Devices | The coLigne ACIF system is substantially equivalent to the predicate devices in terms |
| of intended use, design, materials used, mechanical safety and performances. | |
| Indications for Use | The ACIF system is indicated for use as an intervertebral body fusion device in skeletally |
| mature patients at one or two contiguous levels of the cervical spine (C2-T1) to facilitate | |
| fusion in case of degenerative disc disease (DDD) defined as discogenic pain with | |
| degeneration of the disc confirmed by patient history and radiographic studies. The ACIF | |
| implants are placed via an anterior approach using autogenous bone graft and/or allograft | |
| comprised of cancellous and/or corticocancellous bone graft. The ACIF implants are to be | |
| used with supplemental fixation. Patients should have at least six weeks of non-operative | |
| treatment prior to surgery. | |
| Technological | |
| Characteristics | Intended Use |
| The subject ACIF system and all the predicates have similar intended uses. | |
| Materials | |
| The subject device is composed of the same materials as the reference device. | |
| Design Features/Functions | |
| The subject ACIF system and cited predicate devices share similar basic design features | |
| and functions. | |
| Dimensions | |
| The subject ACIF system is dimensionally similar to cited predicate devices. | |
| Sterilization | |
| The subject ACIF system is provided non-sterile and cited predicate devices are sterile | |
| and non-sterile for single use only. | |
| Performance Specification | |
| Mechanical testing confirmed the ACIF system demonstrated equivalent performance to | |
| the cited predicate device under the same test conditions. | |
| Non-clinical Test | |
| Summary | The following analyses were conducted: |
| Static and dynamic compression per ASTM F2077 Static and dynamic torsion per ASTM F2077 Subsidence per ASTM F2267 The results of these evaluations indicate that the coLigne ACIFare equivalent to predicate devices. | |
| Clinical Test | |
| Summary | No clinical studies were performed |
| Conclusions: Non- | |
| clinical and Clinical | coLigne, AG considers the coLigne ACIF Cervical Cages to be equivalent to the |
| predicate devices listed above. This conclusion is based upon the devices' similarities in | |
| principles of operation, technology, materials and indications for use |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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