(61 days)
Not Found
No
The summary describes a mechanical implant (lumbar cage) and its associated instruments. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The performance studies focus on mechanical testing.
Yes
The sagAlign Lumbar Cage System is used for intervertebral body fusion procedures to treat degenerative disc disease and restore disc height, which directly addresses a medical condition and aims to improve patient health.
No
This device is a lumbar cage system intended for intervertebral body fusion procedures, acting as an implant to restore disc height and achieve fusion, rather than to diagnose a condition.
No
The device description clearly states it is an "interbody expandable lumbar cage" made of titanium alloy, which is a physical implantable device, not software.
Based on the provided text, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The sagAlign Lumbar Cage System is an implantable medical device used in surgical procedures for spinal fusion. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use is for intervertebral body fusion procedures in patients with degenerative disc disease. This is a surgical treatment, not a diagnostic test.
Therefore, the sagAlign Lumbar Cage System falls under the category of an implantable surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The sagAlign Lumbar Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).
sagAlign Lumbar Cage implants are to be used with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an open posterior approach. saqAlian Lumbar Cage implant is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The sagAlign Lumbar Cage System is an interbody expandable lumbar cage. It is implanted by a posterior approach and supplemented by posterior fixation which is required to achieve fusion. The lumbar cages can be gradually expanded to reach the height chosen by the surgeon, allowing restoration of disc height and the ideal lordosis.
The sagAlign Lumbar Cages are delivered non-sterile packaged. The cages are available in several sizes in different heights, widths, and lengths. One or two cages may be implanted for each treated level. The sagAlign Lumbar Cages will be composed of titanium alloy and may have a surface treating of Promimic HAnano Surface (hydroxyapatite (HA) coating). The Promimic HAnano Surface coated cages are only available sterile.
Reusable instruments to support implantation of the subject device are provided with non-sterilization trays.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine at one or two contiguous levels from 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)
The subject device underwent verification (static compression, static compression, static compression-shear, dynamic compression-shear per ASTM F2077 Test Methods for Intervertebral Body Fusion Devices, and subsidence testing per ASTM F2267 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression) to ensure that the design features met the required mechanical strength criteria for their intended use.
It was verified that the new modifications of the subject device were demonstrated not to the predicate device.
The results on the non-clinical testing demonstrated that the substantially equivalent to the predicate devices.
Based on the results of mechanical testing conducted on the worst-case devices according to FDA Class II Special Controls Guidance, the subject device is considered substantially equivalent to the predicate devices cleared in K080537 and does not safety or effectiveness compared to the predicate device.
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 number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
0
Image /page/0/Picture/0 description: The image shows 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 in blue. Underneath the FDA logo is the word "ADMINISTRATION".
July 17, 2024
Acuity Surgical Devices, LLC Chuck Forton Director of Engineering and Regulatory Affairs 8710 N. Royal Lane Irving, Texas 75063
Re: K241413
Trade/Device Name: sagAlign Lumbar Cage System (Various PNs) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: May 17, 2024 Received: May 17, 2024
Dear Chuck Forton:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Aakash Jain -S
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
2
Indications for Use
Submission Number (if known)
Device Name
sagAlign Lumbar Cage System (Various PNs)
Indications for Use (Describe)
The sagAlign Lumbar Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).
sagAlign Lumbar Cage implants are to be used with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via an open posterior approach. saqAlian Lumbar Cage implant is to be used with 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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K241413 Page 1 of 2
Prepared on: 2024-07-11
Contact Details
21 CFR 807.92(a)(1)
21 CFR 807.92(a)(5)
| Applicant Name | Acuity Surgical Devices LLC | |||
|---|---|---|---|---|
| Applicant Address | 8710 N. Royal Lane Irving TX 75063 United States | |||
| Applicant Contact Telephone | 512-585-3537 | |||
| Applicant Contact | Mr. Chuck Forton | |||
| Applicant Contact Email | cforton@acuitysurgical.com | |||
| Device Name | 21 CFR 807.92(a)(2) | |||
| Device Trade Name | sagAlign Lumbar Cage System (Various PNs) | |||
| Common Name | Intervertebral body fusion device | |||
| Classification Name | Intervertebral Fusion Device With Bone Graft, Lumbar | |||
| Regulation Number | 888.3080 | |||
| Product Code(s) | MAX | |||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | ||
| K080537 | L-Varlock Lumbar Cages | MAX | ||
| K222561 | Align | MAX | ||
| K221535 | Align Lumbar Interbody Fusion System | MAX | ||
| Device Description Summary | 21 CFR 807.92(a)(4) |
umbar Cage System is an interbody expandable lumbar cage. It is implanted by a posterior approach and supp by posterior fixation which is required to achieve fusion. The lumbar cages can be gradually expanded to reach thosen by the surgeon, allowing restoration of disc height and the ideal lordosis.
The sagAlign Lumbar Cages are delivered non-sterile packaged. The cages are available in several sizes in different heights, widths, and lengths. One or two cages may be implanted for each treated level. The sagAlign Lumbar Cages will be composed of titanium alloy and may have a surface treating of Promimic HAnano Surface (hydroxyapatite (HA) coating). The Promimic HAnano Surface coated cages are only available sterile.
Reusable instruments to support implantation of the subject device are provided with non-sterilization trays.
Intended Use/Indications for Use
The sagAlign Lumbar Cage System is indicated for intervertebral body fusion procedures in skeletally mature pative disc disease (DDD) of the lumbar spine at one or two
contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc
confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).
sagAlign Lumbar Cage implants are to be used with allogenic bone graft comprised of cancellous bone graft
4
and/or autograft and implanted via an open posterior approach. sagAlign Lumbar Cage implant is to be used with supplementa fixation. Patients should have at least six (6) months of non-operative treatment with an intervertel
Indications for Use Comparison
The sagAlign Lumbar Cage System has the similar indications for use as the devices cleared in K080537, K222561. The difference in indications for use between the subject device (K080537) is the description of the bone graft material.
Technological Comparison
Acuity Surgical Devices LLC believes that the sagAlign Lumbar Cage System is substantially equivalent to the primary predicate and additional predicate devices based on information summarized here:
For the sagAlign Lumbar Cage System, all devices have similar indications for use as the devices cleared in K080537.
The sagAlign Lumbar Cage System has the same surgical approach, implanted via an open posterior surgical approach in the lumbar spine at one or two contiguous levels from L2-S1, as the primary predicate device cleared in K080537. Both the subject device and primary predicate (K080537) also require supplement fixation. The subject device, sagAlign Lumbar design, rectangular shape, and dimensions as the primary predicate device (K080537) and additional predicate devices (K22256). The subject device is the same design as the primary predicate device (K080537) with expanded range of sizes. The subject device and primary predicate device (K080537) have the same expansion mechanism and instrument. The subject device has graft windows and same ridges / teeth to resist migration and increase surface contact as the primary predicate device cleared in K080537. The subject device and primary predicate devices (K080537) implants are material, titanium alloy per ASTM F136/ISO 5832-2, except the subject device's implants may have an optional implant coating for the subject device and additional predicate device (K222561) are the same material, hydroxapatite coating (Promimic HAnano Surface). The subject device and additional predicate devices (K222561 and K221535) may be sterilized using either gamma or steam sterilization.
In order to ensure that the different technological characteristics do not affectiveness of the subject device, a performance evaluation was performed to demonstrate that the mechanical strength and fatigue endurance of the sagAlign Lumbar Cage is comparable to the primary predicate and additional predicate devices.
The sagAlign Lumbar Cage System is substantially equivalent to and is as safe and as effective as, the legally marketed predicate device, L-Varlock Lumbar Cages (K080537) under regulation 21CFR 888,3080, product code MAX.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The subject device underwent verification (static compression, static compression, static compression-shear, dynamic compression-shear per ASTM F2077 Test Methods for Intervertebral Body Fusion Devices, and subsidence testing per ASTM F2267 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression) to ensure that the design features met the required mechanical strength criteria for their intended use.
It was verified that the new modifications of the subject device were demonstrated not to the predicate device.
The results on the non-clinical testing demonstrated that the substantially equivalent to the predicate devices.
Based on the results of mechanical testing conducted on the worst-case devices according to FDA Class II Special Controls Guidance, the subject device is considered substantially equivalent to the predicate devices cleared in K080537 and does not safety or effectiveness compared to the predicate device.