(239 days)
No
The summary describes a passive interbody fusion device made of a composite material. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The device's function is purely structural and mechanical.
Yes
The device is described as an "Interbody System" intended for "interbody fusion" to treat conditions like "cervical disc degeneration," "cervical spinal instability," and "lumbar degenerative disc disease." These are medical conditions that the device aims to treat, indicating its therapeutic purpose.
No
The device is an interbody fusion system designed for surgical implantation to facilitate spinal fusion, not to diagnose medical conditions.
No
The device description clearly states that the device is an interbody fusion system made of a physical material (carbon fiber reinforced PEKEKK polymer) and is designed for surgical implantation. It also mentions mechanical testing of the physical implants. This indicates it is a physical medical device, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for interbody fusion in the spine, a surgical procedure. IVDs are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is an implantable interbody fusion device made of a polymer material. This is a medical device used in the body, not a diagnostic tool used on specimens from the body.
- No mention of in vitro testing: The description focuses on the surgical application and mechanical properties of the implant. There is no mention of analyzing biological samples or performing tests outside of the body.
The information provided clearly describes a surgical implant used to treat spinal conditions, which falls under the category of a medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Acro Composites Interbody System is intended for interbody fusion. The devices are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion and are to be used with supplemental fixation cleared for the implanted level.
The Acro Composites cervical devices are intended for anterior interbody fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The cervical devices are indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The hyperlordotic implants (≥ 10°) are required to be used with an anterior cervical plate.
The Acro Composites lumbar devices are indicated for use at one or two contiguous levels in the lumbar spine from L2-S1, in skeletally mature patients who have had at least six months of non-operative treatment. The lumbar devices are indicated to treat lumbar degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by imaging studies (radiographs, CT, MRI). Additionally, the lumbar devices can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The hyperlordotic implants (≥ 20°) should be used with anterior supplemental fixation.
Product codes
MAX, ODP
Device Description
The Acro Composites Interbody System includes interbody fusion devices for cervical and lumbar implantation manufactured from AcroPek – a carbon fiber reinforced PEKEKK polymer (CFRP) material. The implants are designed as a solid frame to provide surgical stabilization of the spine. Each interbody incorporates a central cavity that can be packed bone graft material. The implants are available in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances. The implants are sold sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographs, CT, MRI
Anatomical Site
Cervical spine (C2-T1), Lumbar spine (L2-S1)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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)
Mechanical testing of the worst case Acro Composites Interbody System implants included static and dynamic axial compression, static and dynamic compression-shear, and static and dynamic torsion according to ASTM F2077. In addition, subsidence tests according to ASTM F2267 were performed. The mechanical test results demonstrate that the Acro Composites Interbody System performance is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K191537, K173148, K181963, K160125, K172009
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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October 19, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
Acro Composites, LLC % Karen Warden President BackRoads Consulting Inc. PO Box 566 Chesterland, Ohio 44026
Re: K230478
Trade/Device Name: Acro Composites Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, ODP Dated: August 29, 2023 Received: August 30, 2023
Dear Karen Warden:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality 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: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K230478
Device Name
Acro Composites Interbody System
Indications for Use (Describe)
The Acro Composites Interbody System is interbody fusion. The devices are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion and are to be used with supplemental fixation cleared for the implanted level.
The Acro Composites cervical devices are interior interbody fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The cervical devices are indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radioulopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The hyperlordotic implants (≥ 10°) are required to be used with an anterior cervical plate.
The Acro Composites lumbar devices are indicated for use at one or two contiguous levels in the lumbar spine from L2-S1, in skeletally mature patients who have had at least six months of non-operative treatment. The lumbar devices are indicated to treat lumbar degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved spinal level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by imaging studies (radiographs, CT, MRI). Additionally, the lumbar devices can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The hyperlordotic implants (≥ 20°) should be used with anterior supplemental fixation.
| 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
| Date: | 21 February 2023 |
|---|---|
| Sponsor: | Acro Composites, LLC |
| 6950 W Snowville Road | |
| Brecksville, OH 44141 | |
| Sponsor Contact: | Mitchell Bass, President |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting Inc. | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Proposed Trade Name: | Acro Composites Interbody System |
| Common Name: | Cervical and lumbar interbody fusion devices |
| Device Classification: | Class II |
| Regulation Name, | |
| Classification Number, | |
| Product Code: | Intervertebral fusion device with bone graft, cervical, 888.3080, ODP |
| Intervertebral fusion device with bone graft, lumbar, 888.3080, MAX | |
| Device Description: | The Acro Composites Interbody System includes interbody fusion devices |
| for cervical and lumbar implantation manufactured from AcroPek – a carbon | |
| fiber reinforced PEKEKK polymer (CFRP) material. The implants are | |
| designed as a solid frame to provide surgical stabilization of the spine. Each | |
| interbody incorporates a central cavity that can be packed bone graft | |
| material. The implants are available in a variety of height, length, width and | |
| lordotic angulation combinations to accommodate the patient specific | |
| anatomy and clinical circumstances. The implants are sold sterile. | |
| Indications for Use: | The Acro Composites Interbody System is intended for interbody fusion. |
| The devices are designed for use with autogenous and/or allogeneic bone | |
| graft comprised of cancellous and/or corticocancellous bone and/or | |
| demineralized allograft bone with bone marrow aspirate to facilitate fusion | |
| and are to be used with supplemental fixation cleared for the implanted | |
| level. | |
| The Acro Composites cervical devices are intended for anterior interbody | |
| fusion in skeletally mature patients who have had at least six weeks of non- | |
| operative treatment. The cervical devices are indicated to treat cervical disc | |
| degeneration and/or cervical spinal instability, as confirmed by imaging | |
| studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, | |
| and/or pain at multiple contiguous levels from C2-T1. The hyperlordotic | |
| implants (≥ 10°) are required to be used with an anterior cervical plate. | |
| The Acro Composites lumbar devices are indicated for use at one or two | |
| contiguous levels in the lumbar spine from L2-S1, in skeletally mature | |
| patients who have had at least six months of non-operative treatment. The | |
| lumbar devices are indicated to treat lumbar degenerative disc disease | |
| (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved | |
| spinal level(s). DDD is defined as back pain of discogenic origin with | |
| degeneration of the disc confirmed by imaging studies (radiographs, CT, | |
| MRI). Additionally, the lumbar devices can be used as an adjunct to fusion | |
| in patients diagnosed with degenerative scoliosis. The hyperlordotic | |
| implants (≥ 20°) should be used with anterior supplemental fixation. | |
| Materials: | The Acro Composites Interbody System implants are manufactured from |
| PEKEKK resin (ASTM F1876) and carbon fiber filaments. Integral markers | |
| are manufactured from gold wire (per ASTM B562). The Acro Composites | |
| instruments are manufactured from medical grade stainless steel per ASTM | |
| F899; some of which include silicone handles. | |
| Primary Predicate: | eCarbon IBDs (Back 2 Basics Direct, LLC – K191537) |
| Additional Predicates: | ostaPek Interbody Fusion Cages (coLigne, AG – K173148 & K181963), |
| Cascadia Interbody System (K2M, Inc. – K160125 & K172009) | |
| Performance Data: | Mechanical testing of the worst case Acro Composites Interbody System |
| implants included static and dynamic axial compression, static and | |
| dynamic compression-shear, and static and dynamic torsion according to | |
| ASTM F2077. In addition, subsidence tests according to ASTM F2267 were | |
| performed. | |
| The mechanical test results demonstrate that the Acro Composites | |
| Interbody System performance is substantially equivalent to the predicate | |
| devices. | |
| Technological | |
| Characteristics: | The Acro Composites Interbody System possesses the same technological |
| characteristics as one or more of the predicate devices. These include: | |
| • basic design (structural column), | |
| • material (reinforced polymer) and | |
| • sizes (dimensions are comparable to those offered by the predicate | |
| systems) | |
| Conclusion: | Therefore the fundamental scientific technology of the Acro Composites |
| Interbody System is the same as previously cleared devices. | |
| The Acro Composites Interbody System possesses the same intended use | |
| and technological characteristics as the predicate devices. Therefore the | |
| Acro Composites Interbody System is substantially equivalent for its | |
| intended use. |
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