(56 days)
Not Found
No
The summary describes a mechanical interbody fusion system made of titanium alloy. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are mechanical tests, not related to data analysis or prediction.
Yes.
The device is used in spinal fusion procedures to treat conditions like degenerative disc disease, degenerative spondylolisthesis, and spinal stenosis, aiming to alleviate symptoms and restore function.
No
This device is a surgical implant designed for spinal fusion procedures to treat degenerative disc disease, spondylolisthesis, and/or spinal stenosis. It does not perform diagnostic functions.
No
The device description clearly states it is an expandable lumbar intervertebral body fusion system manufactured from titanium alloy and includes various hardware components like interbody spacers, inserters, trials, and instruments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The Calibrate CCX Interbody System is a physical implant designed for surgical insertion into the spine to facilitate fusion. Its purpose is to provide structural support and promote bone growth, not to analyze biological specimens.
- Lack of Specimen Handling: The description does not mention any interaction with biological specimens for diagnostic purposes.
- Performance Studies: The performance studies described are mechanical tests (compression, shear, push-out, subsidence) related to the physical properties and stability of the implant, not diagnostic accuracy or analytical performance.
Therefore, the Calibrate CCX Interbody 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 Callbrate CCX Interbody System is indicated for spinal fusion procedures from L1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Additionally, the Calibrate CCX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
The Calibrate CCX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone marrow aspirate and supplemental fixation systems that are cleared by FDA for use in the lumbar spine.
Product codes
MAX
Device Description
The subject Calibrate CCX Interbody System is an expandable lumbar intervertebral body fusion system designed to be inserted through a posterior or transforaminal surgical approach. The subject interbody spacers are manufactured from titanium alloy (Ti-6AI-4V ELI) per ASTM F136. The Calibrate CCX Interbody System consists of a variety of shapes and sizes of interbody spacers, inserters, trials, and general instruments to create parallel expansion, restore sagittal alignment, and provide indirect decompression. Implants are offered with anti-migration teeth and grit-blast treatment on the bone-contacting endplate surfaces.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L1 to S1 (lumbar spine)
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 performed on the Calibrate CCX Interbody System supports substantial equivalence to other predicate devices. The following testing was performed:
- I Static and Dynamic Axial Compression (per ASTM F2077)
- . Static and Dynamic Compression-Shear (per ASTM F2077)
- . Static Push-Out
- . Static Subsidence (per ASTM F2267)
The results demonstrate that the subject Calibrate CCX Interbody System is substantially equivalent to other predicate devices for nonclinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K231438, K171848, K180480, K222028
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out as "U.S. Food & Drug Administration".
October 13, 2023
Alphatec Spine, Inc. Neha Mohindroo Associate, Regulatory Affairs 1950 Camino Vida Roble Carlsbad, California 92008
Re: K232504
Trade/Device Name: Calibrate CCX Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 17, 2023 Received: August 18, 2023
Dear Ms. Mohindroo:
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/cdrb/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).
1
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 QS regulation requires device manufacturers to review and approve changes to device design and production (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-devices/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).
Sincerelv.
Brent Showalter -S
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
Indications for Use
510(k) Number (if known)
Device Name Calibrate CCX Interbody System
Indications for Use (Describe)
The Callbrate CCX Interbody System is indicated for spinal fusion procedures from L1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Additionally, the Calibrate CCX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
The Calibrate CCX Interbody System is intents who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone marrow aspirate and supplemental fixation systems that are cleared by FDA for use in the lumbar spine.
| 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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Image /page/3/Picture/0 description: The image shows the logo for "atec". The "a" is green and the "tec" is dark blue. There is a trademark symbol to the right of the "c". There is a black line underneath the logo.
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
| I. | SUBMITTER: | Alphatec Spine, Inc.
1950 Camino Vida Roble
Carlsbad, CA 92008
Phone: (760) 431-9286 |
|----|------------------------|-----------------------------------------------------------------------------------------------|
| | Contact Person: | Neha Mohindroo
Associate, Regulatory Affairs
Contact Phone: (760) 356-6596 |
| | Date Summary Prepared: | October 3, 2023 |
II. DEVICE
| Name of Device: | Calibrate CCX Interbody System |
|---|---|
| Common or Usual Name: | Intervertebral body fusion device |
| Classification Name: | Intervertebral fusion device with bone graft, lumba |
| Regulation Number: | 21 CFR 888.3080 |
| Regulatory Class: | Class II |
| Product Code: | MAX |
III. LEGALLY MARKETED PREDICATE DEVICES
| 510(k) | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| Primary Predicate Device | |||
| K231438 | MAX | Calibrate PSX Interbody System | Alphatec Spine |
| Additional Predicate Devices | |||
| K171848 | MAX | Globus Rise Spacers | Globus Medical |
| K180480 | MAX, PHM | ATEC Universal Spacer System | Alphatec Spine |
| K222028 | MAX, PHM, OVD | IdentiTi and Transcend Interbody System | Alphatec Spine |
DEVICE DESCRIPTION IV.
The subject Calibrate CCX Interbody System is an expandable lumbar intervertebral body fusion system designed to be inserted through a posterior or transforaminal surgical approach. The subject interbody spacers are manufactured from titanium alloy (Ti-6AI-4V ELI) per ASTM F136. The Calibrate CCX Interbody System consists of a variety of shapes and sizes of interbody spacers, inserters, trials, and general instruments to create parallel expansion, restore sagittal alignment, and provide indirect decompression. Implants are offered with anti-migration teeth and grit-blast treatment on the bone-contacting endplate surfaces.
K232504 510k Summary Page 1 of 3
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Image /page/4/Picture/1 description: The image shows the word "atec" in a stylized font. The "a" is green, while the "tec" is dark blue. There is a trademark symbol to the upper right of the "c". A black line is underneath the word.
The purpose of this 510(k) is to receive clearance for Calibrate CCX Interbody System.
V. INDICATIONS FOR USE
The Calibrate CCX Interbody System is indicated for spinal fusion procedures from L1 to S 1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Additionally, the Calibrate CCX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
The Calibrate CCX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate and supplemental fixation systems that are cleared by FDA for use in the lumbar spine.
TECHNOLOGICAL COMPARISON TO PREDICATES VI.
The technological design features of the subject Calibrate CCX Interbody System are substantially equivalent to the primary predicate Calibrate PSX Interbody Systems (K231438) and additional predicates Globus Rise Spacers (K171848), ATEC Universal Spacer System (K180480), and IdentiTi and Transcend Interbody System (K222028). The technological design features of the subject implants were compared to the predicates in intended use, indications for use, design, function, and technology and it was demonstrated that they are substantially equivalent.
VII. PERFORMANCE DATA
Nonclinical testing performed on the Calibrate CCX Interbody System supports substantial equivalence to other predicate devices. The following testing was performed:
- I Static and Dynamic Axial Compression (per ASTM F2077)
- . Static and Dynamic Compression-Shear (per ASTM F2077)
- . Static Push-Out
- . Static Subsidence (per ASTM F2267)
The results demonstrate that the subject Calibrate CCX Interbody System is substantially equivalent to other predicate devices for nonclinical testing.
Clinical Information
K232504 510k Summary Page 2 of 3
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Image /page/5/Picture/0 description: The image shows the word "atec" in a stylized font. The "a" is green, and the rest of the letters are dark blue. There is a trademark symbol to the right of the "c". A black line is underneath the word.
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
VIII. CONCLUSION
Based upon the information provided in this 510(k) submission, it has been determined that the subject devices are substantially equivalent to legally marketed devices in regard to indications for use, intended use, design, technology, and performance.
K232504 510k Summary Page 3 of 3