(88 days)
No
The 510(k) summary describes a passive interbody fusion device made of physical materials with no mention of software, algorithms, or any computational processing, let alone AI/ML. The device relies on radiographic markers for visualization, which is a standard, non-AI imaging aid.
Yes
The device is indicated for intervertebral body fusion of the lumbar spine for the treatment of degenerative disc disease, which is a therapeutic purpose.
No
This device is an interbody fusion device intended for aiding spinal fixation, not for diagnosing medical conditions.
No
The device description clearly states that the device is an implantable interbody fusion device, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for intervertebral body fusion of the lumbar spine. This is a surgical procedure performed in vivo (within the body) to fuse vertebrae.
- Device Description: The device is described as implants (interbody fusion devices) that are hollow, rectangular implants with features for fixation and visualization. These are physical devices implanted into the body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on biological samples.
The information provided describes a surgical implant used to treat a structural issue in the spine, not a diagnostic test performed on biological specimens.
N/A
Intended Use / Indications for Use
The Advantage Lumbar System - ALIF, PLIF, TLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels 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 device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Product codes
MAX
Device Description
The Advantage Lumbar – ALIF, PLIF, TLIF's implants are interbody fusion devices intended for use as an aid in spinal fixation. These hollow, rectangular implants are offered in a variety of widths, lengths, heights, and lordotic angles designed to adapt to a variety of patient anatomies. They have serrations on the superior and inferior surfaces designed for fixation, ergonomically shaped anterior edges, and flat posterior edges. Radiopaque markers have been embedded within the implants, which are designed to allow for visualization in radiographic images.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, from L2 to 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)
The subject and predicate devices are identical and therefore, no performance testing is required. Submission is only transferring names of systems that have already been cleared under K121567 and K131981. No testing is required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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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October 29, 2021
Intelivation LLC % Barry E. Sands President RQMIS, Inc. 110 Haverhill Road, Suite 524 Amesbury, Massachusetts 01913
Re: K212389
Trade/Device Name: Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: July 29, 2021 Received: August 2, 2021
Dear Barry Sands:
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
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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,
Brent L. Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Produce Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212389
Device Name
Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF
Indications for Use (Describe)
The Advantage Lumbar System - ALIF, PLIF, TLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels 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 device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
| 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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510(k) SUMMARY
Intelivation LLC's Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF
l. Submitter
Amit Sinha Intelivation LLC 70 Gruber Lane Saint Simons Island, GA. 31522 Phone: (484) 343-3075 Email: asinha@intelivationtech.com
CONTACT PERSON NAME AND ADDRESS
Barry E. Sands RQMIS, Inc. 110 Haverhill Road, Suite 524 Amesbury, MA. 01913 Phone: (978) 358-7307 Email: barrysands@rqmis.com Date Prepared: 10/22/2021
II. Subject Device
| Trade name: | Advantage Lumbar System- ALIF, PLIF, DLIF, TLIF |
|---|---|
| Common name: | Intervertebral body fusion device |
| Classification name: | Intervertebral Body Fusion Device, Lumbar |
| Regulation number: | 21 C.F.R. §888.3080 |
| Classification: | Class II |
| Product code: | MAX |
III. Predicate Devices
Cezanne Lumbar Interbody Fusion Cage System (primary predicate) (K121567) Cezanne II Interbody Fusion System (additional predicate) (K131981)
IV. Device Description
The Advantage Lumbar – ALIF, PLIF, TLIF's implants are interbody fusion devices intended for use as an aid in spinal fixation. These hollow, rectangular implants are offered in a variety of widths, lengths, heights, and lordotic angles designed to adapt to a variety of patient anatomies. They have serrations on the superior and inferior surfaces designed for fixation, ergonomically shaped anterior edges, and flat posterior edges. Radiopaque markers have been embedded within the implants, which are designed to allow for visualization in radiographic images.
Surqical approach
- . PLIF (Posterior Lumbar Interbody Fusion) PEEK Cage System is to be implanted via posterior approach.
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- . TLIF (Transforaminal Lumbar Interbody Fusion) PEEK Cage System is to be implanted via transforaminal approach.
- ALIF (Anterior Lumbar Interbody Fusion) PEEK Cage System is to be implanted via anterior approach.
- . DLIF (Direct Lateral Interbody Fusion) PEEK Cage System is to be implanted via direct lateral approach. It can be used in an open approach and a percutaneous approach with MIS instrumentation.
Intended Use / Indications for Use:
The Advantage Lumbar - ALIF, PLIF, DLIF, TLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels 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 device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Technological Characteristics:
The Advantage Lumbar System - ALIF, PLIF, TLIF consists of PEEK+Tantalum which is identical to its predicate devices. The design, material composition and manufacturing are same as the predicate devices.
V. Comparison of Technological Characteristics with the Predicate Devices: (Substantial Equivalence)
The Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF and the Cezanne Lumbar Interbody Fusion Cage System (primary predicate) and Cezanne II Interbody Fusion System (additional predicate) have identical intended use/indications for use, technological characteristics, and principles of operation. There are no technological differences between the Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF and its predicate devices resulting in no new issues of safety or effectiveness. Thus, the subject device is identical to predicate devices.
VI. Performance Data
The subject and predicate devices are identical and therefore, no performance testing is required. Submission is only transferring names of systems that have already been cleared under K121567 and K131981. No testing is required.
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VII. Conclusion
The Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF and its predicate devices have identical intended use/indications for use, technological characteristics, and principles of operation. Thus, the subject device is substantially equivalent to its primary predicate, the Cezanne Lumbar Interbody Fusion Cage System (K121567).