(59 days)
Not Found
No
The summary describes a physical medical device (spinal interbody system) and its materials, intended use, and nonclinical testing. There is no mention of software, algorithms, image processing, AI, ML, or data sets, which are typically associated with AI/ML technologies in medical devices.
Yes
The device is an intervertebral body fusion system indicated for spinal fusion procedures to treat degenerative disc disease, which clearly falls under the definition of a therapeutic device as it treats a medical condition.
No
Explanation: The device is an intervertebral body fusion system designed for spinal fusion procedures. It is an implant used for treatment, not for diagnosing a condition.
No
The device description clearly details physical implants made from various materials (PEEK, titanium, tantalum) and includes components like plates and screws. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The ATEC Lateral Interbody System is a surgical implant designed for spinal fusion procedures. It is physically implanted into the patient's body to provide structural support and promote bone growth.
- Lack of Specimen Analysis: There is no mention of this device analyzing any biological specimens from the patient. Its function is mechanical and biological (promoting fusion).
Therefore, the ATEC Lateral Interbody System falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ATEC Lateral 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). The lateral approach is limited to levels T5-6 to T11-T12.
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 ATEC Lateral 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.
LIF Anti-Migration Plate (AMP) may be used with ATEC Lateral Interbody spacers to provide integrated fixation. Spacers with >20° lordosis must be used with LIF AMP integrated fixation in addition to supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
MAX, PHM, OVD
Device Description
The ATEC Lateral Interbody System is an intervertebral body fusion system implanted from an anterolateral or lateral approach. The interbody implants consist of various lengths, widths, heights and degrees of lordosis to accommodate individual patient anatomy. These implants are manufactured PEEK (polyetheretherketone) Optima LT1 per ASTM F2026, titanium coating per ASTM F1580, tantalum per ASTM F560, titanium alloy (Ti- 6AI-4V ELI) per ASTM F136, and commercially pure titanium (CPTi Grade 2) per ASTM F67. The device includes rows of teeth on the surface of each end of the device which serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Additionally, the commercially pure titanium implants are offered with a microstructure due to the layering of material that forms the porous geometry. This porous geometry extends to the superior and inferior surfaces of the device for implant fixation. All interbody implants feature an internal graft aperture for placement of graft material to promote fusion through the cage.
The ATEC Lateral Interbody System includes LIF Anti-Migration Plate (AMP) integrated fixation that may be used with all ATEC Lateral Interbody offerings. The LIF AMP integrated fixation includes fixation plates, center locking screws and bone screws manufactured from titanium alloy per ASTM F136.
This 510(k) submission includes sterile packaged AMP plates and screws. The ATEC Lateral Interbody System includes IdentiTi LIF Porous Ti Interbody, Battalion LLIF Spacer System and Transcend LIF Interbody System. Any of the three subsystems may be used with LIF AMP integrated fixation and all implants are offered sterile packaged.
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 ATEC Lateral Interbody System supports substantial equivalence to other predicate devices. The following testing was performed:
- Bacterial Endotoxin Test per ANSI/AAMI ST72
The results demonstrate that the subject ATEC Lateral 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
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). 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 6, 2020
Alphatec Spine, Inc. Sandy Gill Regulatory Affairs Associate 5818 El Camino Real Carlsbad, California 92008
Re: K202587
Trade/Device Name: ATEC Lateral Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, PHM, OVD Dated: September 4, 2020 Received: September 8, 2020
Dear Sandy Gill:
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
1
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 (OS) 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 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,
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name ATEC Lateral Interbody System
Indications for Use (Describe)
The ATEC Lateral 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). The lateral approach is limited to levels T5-6 to T11-T12.
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 ATEC Lateral 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.
LIF Anti-Migration Plate (AMP) may be used with ATEC Lateral Interbody spacers to provide integrated fixation. Spacers with >20° lordosis must be used with LIF AMP 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/1 description: The image shows the word "atec" in a stylized font. The "a" is green, while the "tec" is a dark blue. There is a trademark symbol to the right of the "c". A black line is underneath the word.
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.
5818 El Camino Real
Carlsbad, CA 92008
Phone: (760) 431-9286
Fax: (760) 431-0289 |
|-----|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Sandy Gill
Regulatory Affairs Associate
Contact Phone: (760) 431-9286 |
| | Date Summary Prepared: | September 4, 2020 |
| II. | DEVICE | |
| | Name of Device:
Common or Usual Name:
Classification Name: | ATEC Lateral Interbody System
Intervertebral body fusion device
Intervertebral fusion device with bone graft, 1 |
Regulatory Class: Product Code:
Intervertebral fusion device with bone graft, lumbar (21 CFR 888.3080) Class II MAX, PHM, OVD
III. LEGALLY MARKETED PREDICATE DEVICES
| 510(k) | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| Primary Predicate Device | |||
| K191311 | MAX, PHM, OVD | ATEC Lateral Interbody System | Alphatec Spine |
| Additional Predicate Device | |||
| K160646 | MAX, MQP | XYcor Spinal Interbody | Alphatec Spine |
IV. DEVICE DESCRIPTION
The ATEC Lateral Interbody System is an intervertebral body fusion system implanted from an anterolateral or lateral approach. The interbody implants consist of various lengths, widths, heights and degrees of lordosis to accommodate individual patient anatomy. These implants are manufactured PEEK (polyetheretherketone) Optima LT1 per ASTM F2026, titanium coating per ASTM F1580, tantalum per ASTM F560, titanium alloy (Ti- 6AI-4V ELI) per ASTM F136, and commercially pure titanium (CPTi Grade 2) per ASTM F67. The device includes rows of teeth on the surface of each end of the device which serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Additionally, the commercially pure titanium implants are offered with a microstructure due to the
4
Image /page/4/Picture/1 description: The image shows the logo for "atec". The "a" is green, and the rest of the letters are dark blue. There is a horizontal line under the logo. The logo is simple and modern.
layering of material that forms the porous geometry. This porous geometry extends to the superior and inferior surfaces of the device for implant fixation. All interbody implants feature an internal graft aperture for placement of graft material to promote fusion through the cage.
The ATEC Lateral Interbody System includes LIF Anti-Migration Plate (AMP) integrated fixation that may be used with all ATEC Lateral Interbody offerings. The LIF AMP integrated fixation includes fixation plates, center locking screws and bone screws manufactured from titanium alloy per ASTM F136.
This 510(k) submission includes sterile packaged AMP plates and screws. The ATEC Lateral Interbody System includes IdentiTi LIF Porous Ti Interbody, Battalion LLIF Spacer System and Transcend LIF Interbody System. Any of the three subsystems may be used with LIF AMP integrated fixation and all implants are offered sterile packaged.
V. INDICATIONS FOR USE
The ATEC Lateral 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). The lateral approach is limited to levels T5-6 to T11-T12.
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 ATEC Lateral 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.
LIF Anti-Migration Plate (AMP) may be used with ATEC Lateral Interbody spacers to provide integrated fixation. Spacers with >20° lordosis must be used with LIF AMP integrated fixation 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.
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Image /page/5/Picture/1 description: The image shows the logo for a company called "atec". The "a" is green, while the rest of the letters are a dark blue. There is a horizontal line underneath the logo.
VII. PERFORMANCE DATA
Nonclinical testing performed on the ATEC Lateral Interbody System supports substantial equivalence to other predicate devices. The following testing was performed:
- Bacterial Endotoxin Test per ANSI/AAMI ST72
The results demonstrate that the subject ATEC Lateral 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 regards to indications for use, intended use, design, technology, and performance.