(66 days)
Not Found
No
The document describes a physical interbody fusion system made of PEEK or Titanium, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as an "Interbody Fusion System" used in spinal fusion procedures to provide "structural stability" and aid in fusing vertebrae, which directly treats a medical condition (degenerative disc disease and scoliosis).
No.
The Ali Interbody Fusion System is a surgical implant designed to provide structural stability and maintain disc space distraction during intervertebral body fusion. It is a treatment device, not a diagnostic one.
No
The device description explicitly states the device is fabricated from PEEK or Titanium and is an implant, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion procedures. It is used to provide structural stability and maintain disc space distraction. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials (PEEK, Titanium) and design of a physical implant (cage assembly) that is surgically placed in the body. This is consistent with a medical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies mentioned are engineering analyses to demonstrate substantial equivalence to a predicate device, which is typical for medical implants, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Ali Interbody Fusion System is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L1-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. The Ali Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Ali Interbody Fusion is to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft, and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
Product codes
MAX
Device Description
The Ali Interbody Fusion System is used to provide structural stability and maintain disc space distraction during intervertebral body fusion in the lumbosacral spine. The Subject Device implants are fabricated from PEEK (ASTM F2026) or Titanium (ASTM F136) with Titanium endplates. The Ali Interbody Fusion System implants are available in a range of sizes and shapes, and are designed to accommodate variations in surqical approach and patient anatomy. Each cage assembly has a hollow center to allow placement of autograft and/or allograft. Fixation ridges on the superior and inferior endplates of the device help to grip the endplates and prevent expulsion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral spine, L1-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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Engineering analysis was performed for the Subject Device. Evaluation demonstrated the Subject Device is substantially equivalent to the predicate device.
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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January 15, 2021
Raed M. Ali, M.D., Inc. % Kristen Allen Founder and Principal Consultant AllenBridge Consulting 2221 Oleander Drive Wilmington, North Carolina 28403
Re: K203308
Trade/Device Name: Ali Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 10, 2020 Received: December 16, 2020
Dear Kristen Allen:
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.
1
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 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, 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) K203308
Device Name
Ali Lumbar Interbody Fusion System
Indications for Use (Describe)
The Ali Interbody Fusion System is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L1-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. The Ali Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Ali Interbody Fusion is to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft, and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
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
Ali Interbody Fusion System
| Submitter: | Raed M. Ali, M.D., Inc.
6 Starcatcher
Newport Coast, CA 92657 |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kristen Allen
Founder and Principal Consultant, AllenBridge Consulting
910-612-4153 (P)
Kristen@allenbridgeconsulting.com |
| Date Prepared: | December 16, 2020 |
| Trade Name: | Ali Interbody Fusion System |
| Common Name: | Intervertebral body fusion device |
| Device Product Code
and Classification: | Regulation Number: 21 CFR 888.3080
MAX, Class II, Intervertebral Fusion Device with Bone Graft,
Lumbar |
| Primary Predicate: | Ali Interbody Fusion System (K191516) |
Device Description:
The Ali Interbody Fusion System is used to provide structural stability and maintain disc space distraction during intervertebral body fusion in the lumbosacral spine. The Subject Device implants are fabricated from PEEK (ASTM F2026) or Titanium (ASTM F136) with Titanium endplates. The Ali Interbody Fusion System implants are available in a range of sizes and shapes, and are designed to accommodate variations in surqical approach and patient anatomy. Each cage assembly has a hollow center to allow placement of autograft and/or allograft. Fixation ridges on the superior and inferior endplates of the device help to grip the endplates and prevent expulsion.
Indications and Intended use:
The Ali Interbody Fusion System is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L1-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. The Ali Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Ali Interbody Fusion System is to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft, and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
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K203308 Page 2 of 2
Summary of Technological Characteristics:
The subject devices are substantially equivalent to the predicate device as well as other similar devices cleared by FDA for commercial distribution in the United States. The Subject Device was shown to have the same technological characteristics as its predicate devices through comparison of characteristics including design, intended use, performance specifications and function.
Summary of Performance Testing:
Engineering analysis was performed for the Subject Device. Evaluation demonstrated the Subject Device is substantially equivalent to the predicate device.
Conclusion:
Based on the comparison to predicate device, the Subject Device has been shown to be substantially equivalent to the legally marketed predicate device.