(178 days)
Not Found
No
The 510(k) summary describes a mechanical implant system and its performance testing, with no mention of AI or ML technology.
Yes
The device is an implant system intended for sacroiliac joint fusion, which is a therapeutic intervention.
No
The device is an implant system designed for sacroiliac joint fusion, which is a treatment, not a diagnostic process. The provided text describes its mechanical properties and intended use in treating conditions, not in diagnosing them.
No
The device description explicitly states it is a "Sacroiliac Implant system composed of dual-lead sacroiliac screws manufactured from titanium". This indicates a physical hardware device, 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Entasis™ Dual-Lead Sacroiliac Implant system is a physical implant (screws) made of titanium, designed to be surgically placed in the body.
- Intended Use: Its intended use is for sacroiliac joint fusion, which is a surgical procedure to stabilize a joint within the body.
The device is a surgical implant, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The Entasis™ Dual-Lead Sacroiliac Implant system is intended for sacroiliac joint fusion for conditions including degenerative sacroilitis and sacroiliac joint disruptions.
Product codes (comma separated list FDA assigned to the subject device)
OUR
Device Description
The Entasis™ Dual-Lead Sacroiliac Implant system is composed of dual-lead sacroiliac screws manufactured from titanium (Ti-6AI-4V ELI) per ASTM F136. The screws are available in lengths of 30-70mm and diameters of 7-11.5mm.
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)
The Entasis™ Dual-Lead Sacroiliac Implant has been tested in the following test modes:
- Static torsion per ASTM F543
- Static pullout per ASTM F543
- Static driving torque per ASTM F543
- Static three-point bending per ASTM F2193
- Dynamic three-point bending per ASTM F2193
The results of this non-clinical testing show that the strength of the Entasis™ Dual-Lead Sacroiliac Implant is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is an abstract image of a bird-like figure, composed of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 4, 2016
CoreLink, LLC % Kenneth Maxwell II Regulatory and Quality Specialist Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K152237
Trade/Device Name: The Entasis™ Dual-Lead Sacroiliac Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR Dated: December 31, 2015 Received: January 4, 2015
Dear Mr. Maxwell:
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| Indications for Use | See PRA Statement on last page. |
| 510(k) Number (if known) | K152237 |
| Device Name | Entasis™ Dual-Lead Sacroiliac Implant |
| Indications for Use (Describe) |
The Entasis™ Dual-Lead Sacroiliac Implant system is intended for sacroiliac joint fusion for
conditions including degenerative sacroilitis and sacroiliac joint disruptions.
| 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) |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
|---|---|
| ------------------------------------------------------------------------------ | -- |
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This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration
Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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5.510(K) SUMMARY
| Submitter's Name: | CoreLink, LLC |
|---|---|
| Submitter's Address: | 7606 Forsyth Blvd |
| St. Louis, MO 63105 | |
| Submitter's Telephone: | (888) 349-7808 |
| Contact Person: | Kenneth C. Maxwell II |
| Empirical Testing Corp. | |
| 719.291.6874 | |
| Date Summary was Prepared: | 04 February 2016 |
| Trade or Proprietary Name: | Entasis™ Dual-Lead Sacroiliac Implant |
| Common or Usual Name: | Smooth or threaded metallic bone fixation fastener |
| Classification: | Class II per 21 CFR §888.3040 Device Classification |
| Product Code: | OUR |
| Classification Panel: | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION
The Entasis™ Dual-Lead Sacroiliac Implant system is composed of dual-lead sacroiliac screws manufactured from titanium (Ti-6AI-4V ELI) per ASTM F136. The screws are available in lengths of 30-70mm and diameters of 7-11.5mm.
INDICATIONS FOR USE
The Entasis™ Dual-Lead Sacroiliac Implant system is intended for sacroiliac joint fusion for conditions including degenerative sacroilitis and sacroiliac joint disruptions.
The indications for use for the CoreLink, LLC Entasis™ Dual-Lead Sacroiliac Implant is similar to that of the predicates listed in Table 5-1 Predicate Devices.
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have similar technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. The following characteristics are similar between the subject and predicate devices:
- Indications for Use
- Materials of Manufacture ●
- Principles of Operation
Table 5-1: Predicate Devices
| 510k Number | Trade or Proprietary or Model
Name | Manufacturer | Predicate
Type |
|-------------|---------------------------------------|--------------|-------------------|
| K021932 | 6.5mm Cannulated Screw | Synthes | Primary |
| K140079 | Silex | X-spine | Additional |
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Performance Data
The Entasis™ Dual-Lead Sacroiliac Implant has been tested in the following test modes:
- Static torsion per ASTM F543 ●
- Static pullout per ASTM F543 ●
- Static driving torque per ASTM F543 ●
- Static three-point bending per ASTM F2193 ●
- Dynamic three-point bending per ASTM F2193 ●
The results of this non-clinical testing show that the strength of the Entasis™ Dual-Lead Sacroiliac Implant is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Entasis™ Dual-Lead Sacroiliac Implant is substantially equivalent to the predicate device.