(64 days)
No
The 510(k) summary describes a mechanical spinal fixation system and does not mention any AI or ML components or functionalities.
Yes.
The device is intended to treat specific medical conditions, including spondylolisthesis, trauma, tumor, degenerative disc disease, or lumbar spinal stenosis, with the purpose of achieving supplemental fusion. This aligns with the definition of a therapeutic device designed to treat or alleviate a disease or condition.
No
The device is a posterior non-pedicle supplemental fixation system intended for surgical intervention, not for diagnosing conditions.
No
The device description explicitly states it consists of physical components like plates, set screws, and instruments made of titanium alloy, which are hardware.
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. It is used in the body to provide structural support and aid in bone fusion.
- Device Description: The description details a physical implant made of titanium alloy, designed to be attached to the spinous process.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. This device is an implantable medical device used inside the body.
N/A
Intended Use / Indications for Use
The Inspan ScrewLES Fusion System is a posterior non-pedicle supplemental fixation system intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion for the following indications: spondylolisthesis, trauma (fracture or dislocation), tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radios), or lumbar spinal stenosis. The device is intended for use with bone graft material and is not intended for stand-alone use.
Product codes
PEK
Device Description
The Inspan ScrewLES Fusion System, previously cleared (under K102020) and marketed as, "Vega™ SPANTM Spinous Process Plate System", consists of varying length and hub diameters, set screws, and instruments required for implantation. Spikes are present on the sides of the plate that interface with the spinous process to restrain the plate from rotating postoperatively. The device is offered with varying lengths and hub diameters to accommodate anatomical needs. Set screws are used to secure the two sides of the device into the final compressed and implanted construct.
System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine (T1-S1)
Indicated Patient Age Range
Not Found
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
A retrospective review of prospectively collected data was performed by Chin et al. (2020). In total, 56 patients received the subject device for degenerative disc disease with lumbar spinal stenosis where the authors reported statistically significant improvements in patients receiving the subject device for lumbar spinal stenosis at 24 months postoperatively for VAS back pain and ODI.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing Summary:
Pre-clinical testing data submitted, referenced or relied upon to demonstrate substantial equivalence includes biocompatibility, sterilization, and non-clinical testing data.
Clinical Performance Testing Summary:
A retrospective review of prospectively collected data was performed by Chin et al. (2020). In total, 56 patients received the subject device for degenerative disc disease with lumbar spinal stenosis where the authors reported statistically significant improvements in patients receiving the subject device for lumbar spinal stenosis at 24 months postoperatively for VAS back pain and ODI.
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
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
December 3, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
LESspine Innovations % Mr. Justin Eggleton VP, Spine Regulatory Affairs MCRA, LLC 803 7th Street NW Washington, District of Columbia 20141
Re: K213266
Trade/Device Name: Inspan® ScrewLES® Fusion System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: Class II Product Code: PEK Dated: September 30, 2021 Received: September 30, 2021
Dear Mr. Eggleton:
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/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 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,
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213266
Device Name Inspan® ScrewLES® Fusion System
Indications for Use (Describe)
The Inspan ScrewLES Fusion System is a posterior non-pedicle supplemental fixation system intended for use in the noncervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion for the following indications: spondylolisthesis, trauma (fracture or dislocation), tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radios), or lumbar spinal stenosis. The device is intended for use with bone graft material and is not intended for stand-alone use.
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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3
510(k) Summary
| Device Trade Name: | Inspan® ScrewLES® Fusion |
|---|---|
| Manufacturer: | LESspine Innovations |
| 350 Main Street, 2nd Floor | |
| Malden, MA 02148, USA | |
| Contact: | John Sullivan |
| VP, Global Quality & Regulatory | |
| LESspine Innovations | |
| 350 Main Street, 2nd Floor | |
| Malden, MA 02148, USA | |
| Email: johnsullivan@kicventures.com | |
| Date Prepared: | November 24, 2021 |
| Classifications: | Interlaminal spinal fixation orthosis (21 CFR §888.3050) |
| Class: | II |
| Product Code: | PEK |
Indications for Use:
The Inspan ScrewLES Fusion System is a posterior non-pedicle supplemental fixation system intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion for the following indications: spondylolisthesis, trauma (fracture or dislocation), tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), or lumbar spinal stenosis. The device is intended for use with bone graft material and is not intended for stand-alone use.
Device Description:
The Inspan ScrewLES Fusion System, previously cleared (under K102020) and marketed as, "Vega™ SPANTM Spinous Process Plate System", consists of varying length and hub diameters, set screws, and instruments required for implantation. Spikes are present on the sides of the plate that interface with the spinous process to restrain the plate from rotating postoperatively. The device is offered with varying lengths and hub diameters to accommodate anatomical needs. Set screws are used to secure the two sides of the device into the final compressed and implanted construct.
System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136.
4
Primary Predicate Device:
The subject device, Inspan ScrewLES Fusion System has been demonstrated to be substantially equivalent to the primary predicate device.
| Subject Device | Primary Predicate | ||
|---|---|---|---|
| Device Name | Manufacturer | K-Number | |
| Inspan ScrewLES Fusion System | VegaTM SPANTM Spinous | ||
| Process Plate System * | SpineFrontier, Inc.** | K102020 |
Table 1: Primary Predicate Device
*Since the original 510(k) clearance, Vega Span has been rebranded as Inspan ScrewLES Fusion System ** Since the original 510(k) clearance, SpineFrontier is now operating as, "LESspine, LLC."
Non-Clinical Performance Testing Summary:
Pre-clinical testing data submitted, referenced or relied upon to demonstrate substantial equivalence includes biocompatibility, sterilization, and non-clinical testing data.
Clinical Performance Testing Summary:
A retrospective review of prospectively collected data was performed by Chin et al. (2020). In total, 56 patients received the subject device for degenerative disc disease with lumbar spinal stenosis where the authors reported statistically significant improvements in patients receiving the subject device for lumbar spinal stenosis at 24 months postoperatively for VAS back pain and ODI.
Substantial Equivalence:
The subject device was demonstrated to be substantially equivalent to the predicate devices cited in the passage above with respect to indications, design, materials, function, manufacturing, and performance.
Conclusion:
The subject device is substantially equivalent to the cited predicate device with respect to indications for use, design, function, materials, and performance. Additionally, the provided clinical data related to the subject device, supports this traditional 510(k).