(85 days)
No
The summary describes a physical implantable device (interbody fusion cage) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The focus is on the material, design, and intended use for spinal fusion.
Yes
The device is described as an anterior lumbar interbody fusion device intended to improve spinal stability and support fusion for degenerative disc disease, which are therapeutic actions.
No
The device description clearly states that SOLO-L is an "anterior lumbar interbody fusion device (ALIF) intended to improve stability of the spine while supporting fusion." Its purpose is to facilitate fusion and improve stability, not to diagnose a condition.
No
The device description clearly states that SOLO-L is an anterior lumbar interbody fusion device made from titanium alloy (Ti-6Al-4V ELI) with an optional PEEK component. This indicates a physical implant, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The SOLO-L is described as an anterior lumbar interbody fusion device (ALIF) made of titanium alloy or PEEK. It's a physical implant used in spinal surgery.
- Intended Use: The intended use is for intervertebral body fusion of the spine, a surgical procedure.
- No Mention of Samples or Testing: The description and intended use do not involve analyzing samples from the body or performing diagnostic tests.
The SOLO-L is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
SOLO-L is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device system is designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space.
SOLO-L is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
SOLO-L 2-screw cages may be used as a standalone device only when two vertebral body bone screws are used. SOLO-L 4-screw cages may be used as a standalone device only when at least two vertebral body bone screws are inserted in the two medial fixation holes with one inferior and one superior screw trajectory. If the physician chooses to use SOLO-L anterior cages with fewer than two screws in the two medial fixation holes with one inferior and one superior screw trajectory, then an additional supplemental spinal fixation system cleared for use in the lumbosacral spine must be used.
Product codes
OVD
Device Description
SOLO-L is an anterior lumbar interbody fusion device (ALIF) intended to improve stability of the spine while supporting fusion. The SOLO-L constructs are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1. The cages include a central graft window which may be packed with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft prior to implantation. Components are offered in different shapes and sizes to meet the requirements of the individual patient anatomy. SOLO-L is made from titanium alloy (Ti-6Al-4V ELI). An optional interbody component composed of polyetheretherketone (PEEK) with tantalum markers is available for modular cages.
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 device has identical technological characteristics as the standalone anterior constructs cleared in K201671, including design, dimensions, materials, and manufacturing processes. Therefore, no additional non-clinical testing was provided to demonstrate substantial equivalence. No clinical data were provided in order to demonstrate substantial equivalence.
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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May 27, 2022
Aurora Spine Inc % Lucie Dalet Senior Regulatory Consultant ROM+ 2251 San Diego Avenue, Suite B-257 San Diego, California 92110
Re: K220610
Trade/Device Name: SOLO-L Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: February 8, 2022 Received: March 3, 2022
Dear Lucie Dalet:
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.
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) K220610
Device Name
SOLO-L
Indications for Use (Describe)
SOLO-L is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device system is designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space.
SOLO-L is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
SOLO-L 2-screw cages may be used as a standalone device only when two vertebral body bone screws are used. SOLO-L 4-screw cages may be used as a standalone device only when at least two vertebral body bone screws are inserted in the two medial fixation holes with one inferior and one superior screw trajectory. If the physician chooses to use SOLO-L anterior cages with fewer than two screws in the two medial fixation holes with one inferior and one superior screw trajectory, then an additional supplemental spinal fixation system cleared for use in the lumbosacral spine must be used.
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/2 description: The image shows the logo for Aurora Spine. The logo has the word "AURORA" in large, bold, sans-serif font. The letters are black, except for the bottom part of the "A" which is purple. To the right of the word "AURORA" is a purple compass rose. Below the compass rose is the word "SPINE" in black, sans-serif font.
510(k) Summary
DATE PREPARED
May 5, 2022
MANUFACTURER AND 510(k) OWNER
Aurora Spine, Inc. 1930 Palomar Point Way, Suite #103, Carlsbad, CA 92008, USA Telephone: Official Contact: Laszlo Garamszegi, CTO
REPRESENTATIVE/CONSULTANT
Lucie Dalet, Ph.D. Allison C. Komiyama, Ph.D., RAC RQM+ 2251 San Diego Ave. Ste B-257, San Diego, CA 92110, USA +1 (412) 816-8253 Telephone: Email: ldalet@rqmplus.com; akomiyama@rqmplus.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | SOLO-L |
|---|---|
| Common Name: | Intervertebral Fusion Device With Integrated Fixation, |
| Lumbar | |
| Regulation Number: | 21 CFR 888.3080 |
| Class: | II |
| Product Code: | OVD |
| Premarket Review: | OHT6/Spinal Devices (DHT6B) |
| Review Panel: | Orthopedic |
PREDICATE DEVICE IDENTIFICATION
The SOLO-L is substantially equivalent to the following predicate:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K201671 | A-Link Z / Acuity Surgical Devices, LLC | ✓ |
The predicate device has not been subject to a design related recall.
DEVICE DESCRIPTION
SOLO-L is an anterior lumbar interbody fusion device (ALIF) intended to improve stability of the spine while supporting fusion. The SOLO-L constructs are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1. The cages include a central graft window which may be packed with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft prior to implantation. Components are offered in
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Image /page/4/Picture/2 description: The image shows the logo for Aurora Spine. The logo features the word "AURORA" in large, bold, black letters, with a stylized compass rose in purple between the "A" and the "R". Below the word "AURORA" is the word "SPINE" in smaller, black letters. The logo is clean and modern, and the use of purple and black gives it a professional look.
different shapes and sizes to meet the requirements of the individual patient anatomy. SOLO-L is made from titanium alloy (Ti-6Al-4V ELI). An optional interbody component composed of polyetheretherketone (PEEK) with tantalum markers is available for modular cages.
INDICATIONS FOR USE
SOLO-L is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device system is designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space.
SOLO-L is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
SOLO-L 2-screw cages may be used as a standalone device only when two vertebral body bone screws are used. SOLO-L 4-screw cages may be used as a standalone device only when at least two vertebral body bone screws are inserted in the two medial fixation holes with one inferior and one superior screw trajectory. If the physician chooses to use SOLO-L anterior cages with fewer than two screws in the two medial fixation holes with one inferior and one superior screw trajectory, then an additional supplemental spinal fixation system cleared for use in the lumbosacral spine must be used.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Aurora Spine believes that the SOLO-L is substantially equivalent to the predicate device based on the information summarized here:
The subject device has identical intended use, design and dimensions and uses identical materials and manufacturing processes as the standalone anterior constructs cleared in K201671.
SUMMARY OF NON-CLINICAL TESTING
The subject device has identical technological characteristics as the standalone anterior constructs cleared in K201671, including design, dimensions, materials, and manufacturing processes. Therefore, no additional non-clinical testing was provided to demonstrate substantial equivalence.
SUMMARY OF CLINICAL TESTING
No clinical data were provided in order to demonstrate substantial equivalence.
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Image /page/5/Picture/2 description: The image shows the logo for Aurora Spine. The logo features the word "AURORA" in a bold, sans-serif font, with a stylized compass rose in the center. The word "SPINE" is written in a smaller, sans-serif font below the compass rose. The logo is primarily black and purple.
CONCLUSION
Since the subject and predicate devices have the same intended use and similar indications, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate device. The similar indications for use and identical technological characteristics for the proposed SOLO-L are assessed to be substantially equivalent to the predicate device.