(28 days)
No
The document describes a physical interbody fusion device and surgical instruments, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is used to treat degenerative disc disease and facilitate fusion between vertebrae, which is a therapeutic purpose.
No
The device is described as an interbody fusion device, indicated for treating degenerative disc disease, and made of titanium alloy for implantation. There is no mention of it being used for diagnosis, only for treatment.
No
The device description explicitly states the device is manufactured out of medical grade Ti-6A1-4V (Grade 5) and Ti-6A-4V (ELI) alloy, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for interbody fusion in patients with degenerative disc disease, which is a surgical procedure involving the implantation of a device into the body. IVDs are used to examine specimens taken from the body (like blood, urine, tissue) to provide information about a patient's health.
- Device Description: The device is a physical implant made of titanium alloy. IVDs are typically reagents, kits, instruments, or software used for testing biological samples.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
The SpineEX Sagittae® Lateral Lumbar Interbody Fusion Device is a surgical implant used to treat a specific medical condition through a physical intervention.
N/A
Intended Use / Indications for Use
The SpineEX Sagittae® Lateral Lumber Interbody Fusion Devices are indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. Supplemental fixation is required with SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices. Additionally, the SpineEX devices are intended to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
Product codes
MAX
Device Description
The SpineEX Sagittae® Lateral Lumber Interbody Fusion Devices are manufactured out of medical grade Ti-6A1-4V (Grade 5) and Ti-6A-4V (ELI) alloy that conforms to ASTM F1472 and ASTM F136 respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1
Indicated Patient Age Range
skeletally mature
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)
Since all modifications to the SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices from what was cleared in K181531 are additions to the surgical instrumentation, performance testing is not required. However, risk analysis was conducted on the additional instruments.
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.
0
March 4, 2019
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SpineEX Inc. % Meredith May Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K190193
Trade/Device Name: SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: February 1, 2019 Received: February 4, 2019
Dear Ms. May:
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 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Melissa Hall -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMANSERVICES
Food and Drug Administration
Indications for Use
510(k) Number (if known) K190193
Device Name SpineEX Sagittae® Lateral Lumbar Interbody Fusion Device
Indications for Use (Describe)
The SpineEX Sagittae® Lateral Lumber Interbody Fusion Devices are indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. Supplemental fixation is required with SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices. Additionally, the SpineEX devices are intended to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
| Submitter's Name: | SpineEX, Inc. |
|---|---|
| Submitter's Address: | 4046 Clipper Court |
| Fremont, CA 94538 | |
| Submitter's Telephone: | (510) 573-6165 |
| Company Contact Person: | Andrew Rogers |
| Contact Person: | Meredith Lee May MS, RAC |
| Empirical Consulting LLC | |
| 719-337-7579 | |
| MMAy@EmpiricalConsulting.com | |
| Date Summary was Prepared: | 01 February 2019 |
| Trade or Proprietary Name: | SpineEX Sagittae® Lateral Lumbar Interbody Fusion |
| Devices | |
| Common or Usual Name: | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | MAX, OVD |
| Classification Panel: | Division of Orthopedic Devices |
510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The SpineEX Sagittae® Lateral Lumber Interbody Fusion Devices are manufactured out of medical grade Ti-6A1-4V (Grade 5) and Ti-6A-4V (ELI) alloy that conforms to ASTM F1472 and ASTM F136 respectively.
INDICATIONS FOR USE
The SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices are indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. Supplemental fixation is required with SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices. Additionally, the SpineEX devices are intended to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
The indications for use for the SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices are identical to that of the clearance of K181531.
TECHNICAL CHARACTERISTICS
4
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness when compared to the predicate. Specifically, the following characteristics are identical between the subject and predicates:
- . Indications for use
- Materials of manufacture .
- Structural support mechanism ●
- . Principles of operation
Table 5-1 Predicate Device
| 510k Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K181531 | SpineEX Sagittae® Lateral Lumbar | |
| Interbody Fusion Devices | SpineEX, Inc. |
PERFORMANCE TESTING SUMMARY
Since all modifications to the SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices from what was cleared in K181531 are additions to the surgical instrumentation, performance testing is not required. However, risk analysis was conducted on the additional instruments.
CONCLUSION
The modified SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices are very similar to previously cleared SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices. The subject has identical uses, indications, technological characteristics, and principles of operation as the predicate device. The modifications raise no new types of safety or effectiveness questions when compared with the predicate device. The overall technological characteristics lead to the conclusion that SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices are substantially equivalent to the predicate device.