(117 days)
Not Found
No
The document describes a mechanical spinal implant system and its components, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is an intervertebral body fusion system used in spinal fusion procedures to treat various spinal conditions, indicating a therapeutic purpose.
No
The Calibrate LTX Interbody System is an implantable medical device used for spinal fusion procedures, rather than a device designed to identify or diagnose a condition.
No
The device description clearly states it is a system of physical implants (interbody spacers, plates, screws) and instruments made from titanium alloy, intended for surgical implantation. There is no mention of software as a component of the device itself.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Calibrate LTX Interbody System is a surgical implant designed to be placed in the spine (T1 to S1) to facilitate spinal fusion. It is a physical device used in the body during surgery, not a device used to test samples outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic testing.
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 from T1 to S1 in skeletally mature patients for the treatment of a symptomative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and or thoracic disc herniation (myelopathy with or without axial pain) 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 LTX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
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 to be used 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 thoracic and lumbar spine.
Calibrate LTX spacers expanded greater than 20° must be used with the provided bone screws in addition to supplemental fixation. Calibrate LTX spacers without integrated fixation features may be used with AMP-X System as integrated fixation in addition to supplemental fixation.
Product codes
MAX, PHM, OVD
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. 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 anti-migration 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.
This purpose of this 510(k) is to receive clearance for an anti-migration plate ("AMP-X") which may be used with certain LTX interbody offerings. AMP-X includes fixation plates. center locking screws, and bone screws manufactured from titanium alloy per ASTM F136. Additionally, the purpose of this 510(k) is to receive clearance for expanded indications for the treatment of degenerative spondylolisthesis, multilevel degenerative scoliosis, spinal stenosis, and sagittal deformity, and use of allogenic bone consisting of cortical bone, as well as allogenic bone consisting of demineralized allograft bone with bone marrow aspirate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
T1 to S1 (thoracic and lumbar spine)
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
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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:
- Dynamic Axial Compression (per ASTM F2077)
- Dynamic Compression-Shear (per ASTM F2077)
- Static Screw Push-Out Testing
Since the technological characteristics of the subject Calibrate LTX Interbody System is substantially equivalent to the predicate systems, no further clinical or non-clinical testing is required to support the expanded indications for use of the subject system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 29, 2023
Alphatec Spine, Inc. Neha Mohindroo Regulatory Affairs Associate 1950 Camino Vida Roble Carlsbad, California 92008
Re: K223611
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, PHM, OVD Dated: December 22, 2022 Received: December 23, 2022
Dear Neha 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 (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
1
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) 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,
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
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Indications for Use
510(k) Number (if known) K223611
Device Name Calibrate LTX Interbody System
Indications for Use (Describe)
The Calibrate LTX Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of a symptomative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and or thoracic disc herniation (myelopathy with or without axial pain) 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 LTX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
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 to be used 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 thoracic and lumbar spine.
Calibrate LTX spacers expanded greater than 20° must be used with the provided bone screws in addition to supplemental fixation. Calibrate LTX spacers without integrated fixation features may be used with AMP-X System as integrated fixation 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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Image /page/3/Picture/0 description: The image shows the logo for "atec". The "a" is green, while the "tec" is black. 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: | February 28, 2023 |
| 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 | |||
| K222028 | MAX, OVD, | ||
| PHM | IdentiTi and Transcend Interbody | ||
| Systems | Alphatec Spine | ||
| Additional Predicate Devices | |||
| K222455 | MAX, OVD, | ||
| PHM | Calibrate LTX 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 surgical approach. The subject interbody spacers are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The Calibrate LTX System consists of a variety of shapes and sizes of interbody spacers, inserters, trials, and general instruments to create lordotic
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Image /page/4/Picture/0 description: The image shows the logo for a company called "atec". The "a" is green, and the "tec" is dark blue. There is a trademark symbol next to the "c". There is a black line underneath the logo.
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. Certain Calibrate LTX Interbody System offerings also accept fixation bone screws manufactured from titanium alloy per ASTM F136.
This purpose of this 510(k) is to receive clearance for an anti-migration plate ("AMP-X") which may be used with certain LTX interbody offerings. AMP-X includes fixation plates. center locking screws, and bone screws manufactured from titanium alloy per ASTM F136. Additionally, the purpose of this 510(k) is to receive clearance for expanded indications for the treatment of degenerative spondylolisthesis, multilevel degenerative scoliosis, spinal stenosis, and sagittal deformity, and use of allogenic bone consisting of cortical bone, as well as allogenic bone consisting of demineralized allograft bone with bone marrow aspirate.
V. INDICATIONS FOR USE
The Calibrate LTX Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of a symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain) 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 LTX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
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 to be used 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 thoracic and lumbar spine.
Calibrate LTX spacers expanded greater than 20° must be used with the provided bone screws in addition to supplemental fixation. Calibrate LTX spacers without integrated fixation features may be used with AMP-X System as integrated fixation in addition to supplemental fixation.
VI. TECHNOLOGICAL COMPARISON TO PREDICATES
The technological design features of the subject implants were compared to the predicate IdentiTi and Transcend Interbody Systems (K222028) and additional predicate Calibrate LTX Interbody System (K222455) in intended use, indications for use, design, function, and technology, and it was demonstrated that they are substantially equivalent. Calibrate LTX interbody implants are substantial equivalent in design, material, and function as predicate Calibrate LTX interbody implants (K222455). The new modular AMP-X plate that must be used with Calibrate LTX is substantially equivalent in design, materials, and
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Image /page/5/Picture/0 description: The image shows the logo for a company called "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.
function to the integrated fixation features of the predicate Calibrate LTX (K222455) as well as LIF AMP that must be used with ATEC LIF interbody implants (K222028).
VII. PERFORMANCE DATA
Nonclinical testing performed on the Calibrate LTX Interbody System supports substantial equivalence to other predicate devices. The following testing was performed:
- · Dynamic Axial Compression (per ASTM F2077)
- · Dynamic Compression-Shear (per ASTM F2077)
- · Static Screw Push-Out Testing
Since the technological characteristics of the subject Calibrate LTX Interbody System is substantially equivalent to the predicate systems, no further clinical or non-clinical testing is required to support the expanded indications for use of the subject system.
Clinical Information
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
CONCLUSION VIII.
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,