(372 days)
No
The 510(k) summary describes a physical implant system and surgical instruments, with no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies are based on mechanical testing, not algorithmic performance.
Yes
The device is an implant system designed to support intervertebral body spinal fusion procedures, which is a therapeutic intervention for patients with degenerative disc disease.
No
This device is an implant system (ACRON™ TLIF System) used for spinal fusion procedures, specifically intervertebral body fusion. While its indication relies on prior diagnosis of degenerative disc disease (DDD) using patient history and radiographic studies, the device itself is a surgical implant designed to provide stability, restore height, and optimize fusion, not to diagnose a condition.
No
The device description explicitly states it is an "implant system" comprised of "implantable cages" and "stainless steel surgical instruments," which are physical hardware components.
Based on the provided text, 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.
- Device Description: The ACRON™ TLIF System is an implantable device (a cage) used in spinal fusion surgery. It is physically inserted into the patient's body.
- Intended Use: The intended use is for intervertebral body spinal fusion procedures, which is a surgical intervention, not a diagnostic test performed on a sample outside the body.
- No Mention of Samples: The description does not mention the device being used to test any biological samples.
Therefore, the ACRON™ TLIF System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ACRON™ TLIF System is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. The ACRON™ TLIF System is to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The ACRON™ TLIF System is an implant system for a unilateral posterior transforaminal approach (TLIF). It is specially designed for small incision (minimally invasive), resulting in a relatively atraumatic operation for the patient. Implants, used with supplemental fixation and autogenous bone graft, provide improved stability, height restoration and lordosis to optimize fusion. The system is comprised of implantable cages and stainless steel surgical instruments, both general and system specific.
The ACRON™ TLIF System cages are manufactured from radiolucent polymer PEEK-OPTIMA® Optima LT1 (Polyether-ether-ketone) conforming to ASTM standard F2026, to allow for clear assessment of bone fusion. Two radiopaque markers constructed from Tantalum conforming to ASTM standard F560 allow for radiographic visualization of the implant orientation and placement.
The implants have a convex shape and are offered in 4 sizes, in 2mm increments, ranging in height from 7mm to 13mm with lordotic angle of 8°, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Teeth on the superior and inferior surfaces help the implant to resist expulsion and migration. The geometry includes openings to allow for the packing of autogenous bone graft into the axial canal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, L2-S1
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)
Nonclinical testing was performed to demonstrate that the subject SpineMED ACRON™ TLIF System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic axial compression and compression shear per ASTM F2077
- Subsidence testing and analysis per ASTM F2267
The results demonstrate that the subject SpineMED ACRON™ TLIF System meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicate. No clinical studies were conducted.
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.
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
SpineMED Ges.m.b.H % John Kapitan CEO Kapstone Medical, LLC PO Box 969 Leicester, North Carolina 28748 April 27, 2018
Re: K171151
Trade/Device Name: ACRON™ TLIF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: March 21, 2018 Received: March 29, 2018
Dear Mr. Kapitan:
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
1
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.
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) K171151
Device Name ACRON™ TLIF System
Indications for Use (Describe)
The ACRON™ TLIF System is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. The ACRON™ TLIF System is to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
| 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) |
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510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR 807.92, the following summary of information is provided.
1. Applicant
SpineMED Ges.m.b.H Twarochgasse 11 Vienna A-1170 Austria
2. Official Correspondent
Kapstone Medical LLC PO Box 969 Leicester, NC 28748
Contact Person: John Kapitan, CEO Tel: (704) 843-7852 Fax: (704) 831-5316 Email: jkapitan@kapstonemedical.com
3. Device Name
Trade: ACRON™ TLIF System Common/Usual Name: Intervertebral Fusion Device, Lumbar Classification Name: Intervertebral body fusion device Regulation Number: 888.3080 Product Code: MAX Classification: II Panel: Orthopedic
4. Predicate Devices
The SpineMED ACRON™ TLIF System is substantially equivalent to the NuVasive CoRoent System produced by NuVasive, Inc, as shown in Table 1-1.
| Predicate | 510(k) Number | Device | Manufacturer |
|---|---|---|---|
| Primary | K071795 | NuVasive CoRoent System | NuVasive, Inc |
| Reference | K141665 | NuVasive CoRoent System | NuVasive, Inc |
Table 1-1: Predicate devices
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5. Device Description
The ACRON™ TLIF System is an implant system for a unilateral posterior transforaminal approach (TLIF). It is specially designed for small incision (minimally invasive), resulting in a relatively atraumatic operation for the patient. Implants, used with supplemental fixation and autogenous bone graft, provide improved stability, height restoration and lordosis to optimize fusion. The system is comprised of implantable cages and stainless steel surgical instruments, both general and system specific.
The ACRON™ TLIF System cages are manufactured from radiolucent polymer PEEK-OPTIMA® Optima LT1 (Polyether-ether-ketone) conforming to ASTM standard F2026, to allow for clear assessment of bone fusion. Two radiopaque markers constructed from Tantalum conforming to ASTM standard F560 allow for radiographic visualization of the implant orientation and placement.
The implants have a convex shape and are offered in 4 sizes, in 2mm increments, ranging in height from 7mm to 13mm with lordotic angle of 8°, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Teeth on the superior and inferior surfaces help the implant to resist expulsion and migration. The geometry includes openings to allow for the packing of autogenous bone graft into the axial canal.
6. Intended Use
The ACRON™ TLIF System is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. The ACRON™ TLIF System is to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
7. Technological Characteristics
As was established in this subject SpineMED ACRON™ TLIF System 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 its predicate devices through comparison in areas including design, intended use, material composition, function and sterilization method.
8. Performance Data
Nonclinical testing was performed to demonstrate that the subject SpineMED ACRON™ TLIF System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic axial compression and compression shear per ASTM F2077
- Subsidence testing and analysis per ASTM F2267
5
The results demonstrate that the subject SpineMED ACRON™ TLIF System meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicate. No clinical studies were conducted.
9. Conclusions
Based on the indications for use, technological characteristics, and comparison to predicate devices, the ACRON™ TLIF System has been shown to be substantially equivalent to legally marketed predicate devices.