(95 days)
Not Found
No
The device description focuses on the materials, mechanical properties, and surgical application of an interbody fusion system. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an interbody fusion system used in spinal fusion procedures to treat conditions like degenerative disc disease and disc herniation, which are medical conditions, making it a therapeutic device.
No
The device is an interbody fusion system designed for spinal fusion procedures, specifically for replacing a degenerated disc and promoting bone fusion. It is a therapeutic device, not one used for diagnosis.
No
The device description clearly states that the system consists of physical implants (interbody spacers made of titanium alloy and PEEK) and instruments, indicating it is a hardware medical device, not software-only.
Based on the provided information, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Calibrate LTX Interbody System is a surgical implant designed to be inserted into the spine to facilitate fusion. It is a physical device used in the body, not a test performed on samples from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVDs.
Therefore, the Calibrate LTX Interbody System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Calibrate LTX Interbody System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.
Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).
Lumbar: L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
The Calibrate LTX 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 allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. Calibrate LTX spacers expanded greater than 20° must be used with the provided bone screws in addition to supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
MAX, OVD, PHM
Device Description
The subject Calibrate LTX Interbody System is a lordotic expandable thoracolumbar intervertebral body fusion system designed to be inserted through a lateral or anterolateral surgical approach. The subject interbody spacers are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and polyetheretherketone (PEEK) Optima LT1 per ASTM F2026. The Calibrate LTX System consists of a variety of shapes and sizes of interbody spacers, inserters, trials, and general instruments to create lordotic expansion, restore sagittal alignment, and provide indirect decompression. Implants are offered with antimigration teeth and grit-blast treatment on the bone-contacting endplate surfaces. Certain Calibrate LTX Interbody System offerings also accept fixation bone screws manufactured from titanium alloy per ASTM F136. The purpose of this submission is to gain 510(k) clearance to the Calibrate LTX Interbody System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1); Lumbar: L1-L2 to L5-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 performed on the Calibrate LTX Interbody System supports substantial equivalence to other predicate devices. The following testing was performed:
- Static and Dynamic Axial Compression (per ASTM F2077)
- Static and Dynamic Compression Shear (per ASTM F2077)
- Push-out (per ASTM F04-25-02-02 Draft)
- Subsidence analysis
The results demonstrate that the subject Calibrate LTX Interbody System is substantially equivalent to other predicate devices for nonclinical testing.
Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
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.
K211805, K211873, K161379, K191005, K183705
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.
Not Found
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.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 18, 2022
Alphatec Spine, Inc. Cynthia Dorne Sr. Manager, Regulatory Affairs 1950 Camino Vida Roble Carlsbad, California 92008
Re: K222455
Trade/Device Name: Calibrate LTX Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD, PHM Dated: October 25, 2022 Received: October 26, 2022
Dear Cynthia Dorne:
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. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/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.
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 LTX Interbody System
Indications for Use (Describe)
The Callbrate LTX Interbody System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.
Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc herniation (myelopathy with or without axial pain).
Lumbar: L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
The Calibrate LTX 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 allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. Callbrate LTX spacers expanded greater than 20° must be used with the provided bone screws in addition to 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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3
Image /page/3/Picture/0 description: The image shows the logo for a company called "atec". The first letter of the company name is a green alpha symbol. The rest of the letters are in a dark blue color. There is a trademark symbol in the upper right corner of 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
Fax: (760) 431-0289 |
|-----|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Cynthia Dorne
Manager, Regulatory Affairs
Contact Phone: (760) 494-6740 |
| | Date Summary Prepared: | August 12, 2022 |
| II. | DEVICE | |
| | Name of Device:
Common or Usual Name:
Classification Name: | Calibrate LTX Interbody System
Intervertebral body fusion device
Intervertebral fusion device with bone graft, lumbar
Intervertebral fusion device with integrated fixation
lumbar
Intervertebral fusion device with bone graft, thoracic |
| | Regulation Number:
Regulatory Class:
Product Code: | 21 CFR 888.3080
Class II
MAX, OVD, PHM |
III. LEGALLY MARKETED PREDICATE DEVICES
| 510(k) | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| Primary Predicate Device | |||
| K211805 | MAX, PHM, | ||
| OVD, ODP | IdentiTi and Transcend Interbody | ||
| Systems | Alphatec Spine | ||
| Additional Predicate Devices | |||
| K211873 | MAX | PSX Interbody System | Alphatec Spine |
| K161379 | OVD, MAX | ELSATM Spacers | Globus Medical |
| K191005 | MAX | Prolift Expandable System | Life Spine |
| K183705 | MAX, PHM, | ||
| OVD, ODP | IdentiTi Porous Ti Interbody | ||
| System | Alphatec Spine |
IV. DEVICE DESCRIPTION
The subject Calibrate LTX Interbody System is a lordotic expandable thoracolumbar intervertebral body fusion system designed to be inserted through a lateral or anterolateral
4
Image /page/4/Picture/0 description: The image shows the logo for "atec". The "a" is green, while the "tec" is dark blue. There is a trademark symbol to the right of the "c". There is a black line underneath the logo.
surgical approach. The subject interbody spacers are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and polyetheretherketone (PEEK) Optima LT1 per ASTM F2026. The Calibrate LTX System consists of a variety of shapes and sizes of interbody spacers, inserters, trials, and general instruments to create lordotic expansion, restore sagittal alignment, and provide indirect decompression. Implants are offered with antimigration teeth and grit-blast treatment on the bone-contacting endplate surfaces. Certain Calibrate LTX Interbody System offerings also accept fixation bone screws manufactured from titanium alloy per ASTM F136. The purpose of this submission is to gain 510(k) clearance to the Calibrate LTX Interbody System.
V. INDICATIONS FOR USE
The Calibrate LTX Interbody System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.
Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).
Lumbar: L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
The Calibrate LTX 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 allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. Calibrate LTX spacers expanded greater than 20° must be used with the provided bone screws in addition to supplemental fixation.
VI. TECHNOLOGICAL COMPARISON TO PREDICATES
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 LTX Interbody System supports substantial equivalence to other predicate devices. The following testing was performed:
- · Static and Dynamic Axial Compression (per ASTM F2077)
- · Static and Dynamic Compression Shear (per ASTM F2077)
- · Push-out (per ASTM F04-25-02-02 Draft)
5
Image /page/5/Picture/0 description: The image shows the logo for "actec". The "a" is green and the rest of the letters are black. There is a trademark symbol in the upper right corner of the logo. There is a black line underneath the logo.
- Subsidence analysis
The results demonstrate that the subject Calibrate LTX Interbody System is substantially equivalent to other predicate devices for nonclinical testing.
Clinical Information
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.