(85 days)
Not Found
No
The summary describes a mechanical fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for sacroiliac joint fusion to treat conditions like sacroiliac joint disruptions and degenerative sacroiliitis, which indicates a therapeutic purpose.
No
The device is a fixation system consisting of screws intended for sacroiliac joint fusion, which is a treatment or surgical procedure, not a diagnostic one.
No
The device description explicitly states it consists of physical components (screws) made from titanium alloy, which are hardware, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Life Spine SIMPACT Sacroiliac Joint Fixation System is a system of screws designed for surgical implantation to fuse the sacroiliac joint. It is a physical implant used within the body, not a device that analyzes samples outside the body.
- Intended Use: The intended use is for "sacroiliac joint fusion," which is a surgical procedure, not a diagnostic test performed on a specimen.
The information provided clearly describes a surgical implant system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Life Spine SIMPACT Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Product codes
OUR, HWC
Device Description
The Life Spine SIMPACT Sacroiliac Joint Fixation System consists of fully threaded screws and partially threaded cannulated screws in various diameters and lengths to enhance sacroiliac joint fusion. The purpose of this submission is to add the Tri-Fin Screw to the SIMPACT Sacroiliac Joint Fixation System. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Life Spine SIMPACT Sacroiliac Joint Fixation System components with components from any other system or manufacturer. The Life Spine SIMPACT Sacroiliac Joint Fixation System components should never be reused under any circumstances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sacroiliac joint
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Engineering analyses and Static Screw Pull-Out & Screw Driving Torque testing to ASTM F543 (A2 & A3) were presented to demonstrate the substantial equivalency of the Life Spine Sacroiliac Joint Fixation System (K141246).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Life Spine Sacroiliac Joint Fixation System (K141246)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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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, which consists of a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 15, 2018
Life Spine Inc. Mr. Randy Lewis General Manager 13951 South Quality Drive Huntley, Illinois 60142
Re: K180749
Trade/Device Name: Life Spine SIMPACT Sacroiliac Joint Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR, HWC Dated: March 12, 2018 Received: March 22, 2018
Dear Mr. Lewis:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 medical devices and radiation-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.
Ronald P. Jean -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180749
Device Name
Life Spine SIMPACT Sacroiliac Joint Fixation System
Indications for Use (Describe)
The Life Spine SIMPACT Sacroiliac Joint Fixation System is intended for sacroillac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
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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510(k) Summary Life Spine SIMPACT Sacroiliac Joint Fixation System
| Submitted By: | Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Randy Lewis
Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
| Date Prepared: | June 12th, 2018 |
| Trade Name: | Life Spine SIMPACT Sacroiliac Joint Fixation System |
| Common Name: | Spinal Sacroiliac Device |
| Purpose: | Life Spine SIMPACT Sacroiliac Joint Fixation System |
| Classification: | OUR, CFR 888.3040 Smooth or threaded metallic bone fixation fastener, Class II
HWC, CFR 888.3040 Smooth or threaded metallic bone fixation fastener, Class II |
| Primary Predicate: | Life Spine Sacroiliac Joint Fixation System (K141246) |
Device Description:
The Life Spine SIMPACT Sacroiliac Joint Fixation System consists of fully threaded screws and partially threaded cannulated screws in various diameters and lengths to enhance sacroiliac joint fusion. The purpose of this submission is to add the Tri-Fin Screw to the SIMPACT Sacroiliac Joint Fixation System. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Life Spine SIMPACT Sacroiliac Joint Fixation System components with components from any other system or manufacturer. The Life Spine SIMPACT Sacroiliac Joint Fixation System components should never be reused under any circumstances.
Indications for Use:
The Life Spine SIMPACT Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroilitis.
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Technological Characteristics:
The Life Spine SIMPACT Sacroiliac Joint Fixation System is substantially equivalent to the predicate systems in terms of design, materials, indications for use and sizing.
Material:
This submission seeks clearance of a device made from implant grade (Ti-6AL-4V) Titanium alloy according to F136. This this is the same material used in the predicate devices.
Performance Data:
Engineering analyses and Static Screw Pull-Out & Screw Driving Torque testing to ASTM F543 (A2 & A3) were presented to demonstrate the substantial equivalency of the Life Spine Sacroiliac Joint Fixation System (K141246).
Substantial Equivalence:
The Life Spine SIMPACT Sacroiliac Joint Fixation System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance.
Conclusion:
The information presented demonstrates the substantial equivalency of The Life Spine SIMPACT Sacroiliac Joint Fixation System.