(108 days)
Not Found
No
The document describes a physical implantable device for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
This device is a spinal implant system used for fusion procedures to treat degenerative disc disease, which directly addresses a medical condition and aims to improve patient health.
No
Explanation: The IdentiTi™ ALIF Standalone Interbody System is an implantable device used for spinal fusion procedures, not for diagnosing medical conditions.
No
The device description clearly states it is an "integrated intervertebral body fusion device" manufactured from titanium and includes interbody spacers, screws, and bolts. This indicates a physical implant, not a software-only device.
No, 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: The provided text describes a physical implant (an intervertebral body fusion device) made of titanium. It is surgically implanted into the lumbar spine.
- Intended Use: The intended use is for spinal fusion procedures to treat degenerative disc disease. This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
The device is a medical device used for surgical treatment, not an IVD.
N/A
Intended Use / Indications for Use
The IdentiTiTM ALIF Standalone Interbody System is indicated for spinal fusion procedures in skeletally mature patients. The IdentiTi ALIF Standalone Interbody System implants of ≤20° are a standalone system. The IdentiTi ALIF Standalone Interbody System implants of >20° must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated screws.
The IdentiTi ALIF Standalone Interbody System is intended for use at one or two contiguous levels in the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis 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 IdentiTi ALIF Standalone 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 comprised of cancellous and/or corticocancellous bone graft.
Product codes
OVD
Device Description
The IdentiTiTM ALIF Standalone (SA) Interbody System is an integrated intervertebral body fusion device implanted from an anterior or anterolateral approach. The IdentiTi ALIF Standalone Interbody System interbody spacers are manufactured from a combination of commercially pure porous titanium (CP Ti Grade 2) per ASTM F67 and titanium alloy (Ti-6A1-4V ELI) per ASTM F136. The IdentiTi ALIF Standalone Interbody System interbody spacers are provided in multiple footprints with varying lengths, widths, heights, and angles of lordosis to accommodate individual patient anatomy. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage. The interbody spacer includes three screw holes to accept bone screws and bolts that are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F136 in varying lengths and diameters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine (L2-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 IdentiTiTM ALIF Standalone Interbody System supports substantial equivalence to the predicate devices. The following testing/analysis was performed:
- ASTM F2077 static & dynamic axial compression, static & dynamic 0 compression-shear
- ASTM F1877 - particulate analysis
- ASTM F1714 gravimetric analysis .
- ASTM F2267 subsidence ●
- Static push-out ●
- Screw push-out .
The results demonstrate that the proposed IdentiTi™ ALIF Standalone Interbody System is substantially equivalent to the predicate devices for nonclinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K182139, K183705, K150643, K083475, K180480, K182746, K011556, K102334, K073109, K181818, K162236, K202812, K203056, K161363
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 USA seal. To the right of the seal 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.
April 9, 2021
Alphatec Spine Inc. Cynthia Dorne Manager. Regulatory Affairs 5818 El Camino Real Carlsbad, California 92008
Re: K203742
Trade/Device Name: IdentiTi™ ALIF Standalone Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: March 18, 2021 Received: March 19, 2021
Dear Cynthia Dorne:
We have reviewed vour 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/cdrl/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 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 -S
Brent L. 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) K203742
Device Name IdentiTiTM ALIF Standalone Interbody System
Indications for Use (Describe)
The IdentiTi™ ALIF Standalone Interbody System is indicated for spinal fusion procedures in skeletally mature patients. The IdentiTi ALIF Standalone Interbody System implants of ≤20° are a standalone system. The IdentiTi ALIF Standalone Interbody System implants of >20° must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated screws.
The IdentiTi ALIF Standalone Interbody System is intended for use at one or two contiguous levels in the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis 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 IdentiTi ALIF Standalone 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 comprised of cancellous and/or corticocancellous bone graft.
| 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 logo is in a sans-serif font, with the "a" in green and the rest of the letters in black. There is a trademark symbol after the "c". A gray line is 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.
5818 El Camino Real
Carlsbad, CA 92008
Phone: (760) 431-6884
Fax: (760) 431-0289 |
|-----|------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Cynthia Dorne
Manager, Regulatory Affairs
Contact Phone: (760) 494-6740 |
| | Date Summary Prepared: | December 20, 2020 |
| II. | DEVICE | |
| | Name of Device:
Common or Usual Name: | IdentiTiTM ALIF Standalone Interbody System
Intervertebral Fusion Device with Integrated
Fixation, Lumbar |
| | Classification Name: | Intervertebral Body Fusion Device
(21 CFR 888.3080) |
| | Regulatory Class: | Class II |
| | Product Code: | OVD |
III. LEGALLY MARKETED PREDICATE DEVICES
| 510(k) | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| Primary Predicate | |||
| K182139 | OVD | AXTiTM Titanium Stand-Alone | |
| ALIF System | Innovasis® | ||
| Additional Predicates | |||
| K183705 | ODP, PHM, | ||
| MAX, OVD | IdentiTiTM Porous Ti Interbody | ||
| System | Alphatec Spine® | ||
| K150643 | OVD | Centinel Spine STALIF TT, | |
| STALIF MIDLINE, MIDLINE | |||
| II, MIDLINE II-Ti | Centinel Spine® | ||
| K083475 | MAX | Lucent® Magnum+ | Spinal Elements® |
| K180480 | PHM,MAX | ATEC Universal Spacer System | Alphatec Spine® |
| K182746 | MAX,PHM,OVD | ATEC ALIF and LLIF Spacer | |
| System | Alphatec Spine® | ||
| K011556 | KWQ | Aesculap MACS HMA Spinal | |
| Stabilization System | Aesculap® |
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Image /page/4/Picture/1 description: The image shows the logo for A-TEC. The logo is comprised of the letters 'a-tec' in a stylized font. The 'a' is green, while the 'tec' is dark blue. There is a trademark symbol to the right of the 'c'.
| 510(k) | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| K102334 | KWQ | Quandary Medical Trans1 | |
| AxiaLIF Plus | Trans1® | ||
| K073109 | OVD | STALIF TT Intervertebral Body | |
| Fusion System | Surgicraft® | ||
| K181818 | OVD, MAX | Spineart Scarlet AL-T | Spineart® |
| K162236 | OVD | Ax Stand-Alone ALIF System | Innovasis® |
| K202812 | OVE | IdentiTi Cervical Standalone | |
| Interbody System | Alphatec Spine® | ||
| K203056 | NKB,KWP | Invictus Spinal Fixation System | Alphatec Spine® |
| K161363 | NKB,OSH,MNI,M | ||
| NH,KWP | Arsenal Spinal Fixation System | Alphatec Spine® |
IV. DEVICE DESCRIPTION
The IdentiTiTM ALIF Standalone (SA) Interbody System is an integrated intervertebral body fusion device implanted from an anterior or anterolateral approach. The IdentiTi ALIF Standalone Interbody System interbody spacers are manufactured from a combination of commercially pure porous titanium (CP Ti Grade 2) per ASTM F67 and titanium alloy (Ti-6A1-4V ELI) per ASTM F136. The IdentiTi ALIF Standalone Interbody System interbody spacers are provided in multiple footprints with varying lengths, widths, heights, and angles of lordosis to accommodate individual patient anatomy. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage. The interbody spacer includes three screw holes to accept bone screws and bolts that are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F136 in varying lengths and diameters.
V. INDICATIONS FOR USE
The IdentiTill ALIF Standalone Interbody System is indicated for spinal fusion procedures in skeletally mature patients. The IdentiTi ALIF Standalone Interbody System implants of ≤20° are a standalone system. The IdentiTi ALIF Standalone Interbody System implants of >20° must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated screws.
The IdentiTi ALIF Standalone Interbody System is intended for use at one or two contiguous levels in the lumbar spine (L2-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 IdentiTi ALIF Standalone 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.
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Image /page/5/Picture/0 description: The image shows the logo for ATEC Spine. The logo is comprised of the word "atec" in a stylized font. The "a" is green, while the "tec" is dark blue. There is a trademark symbol to the right of the "c".
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 IdentiTiTM ALIF Standalone Interbody System supports substantial equivalence to the predicate devices. The following testing/analysis was performed:
- ASTM F2077 static & dynamic axial compression, static & dynamic 0 compression-shear
- ASTM F1877 - particulate analysis
- ASTM F1714 gravimetric analysis .
- ASTM F2267 subsidence ●
- Static push-out ●
- Screw push-out .
The results demonstrate that the proposed IdentiTi™ ALIF Standalone Interbody System is substantially equivalent to the 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 the 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.