(85 days)
Not Found
No
The description focuses on the mechanical properties and materials of the implants and instruments, with no mention of AI or ML capabilities.
Yes
The device is intended for sacroiliac joint fusion to treat conditions like sacroiliac joint disruptions and degenerative sacroiliitis, which directly addresses a medical condition and aims to provide therapeutic benefit by immobilizing the joint.
No
This device is a fusion system intended for sacroiliac joint fusion, which is a treatment or therapeutic procedure, not a diagnostic one.
No
The device description explicitly states it is comprised of "threaded fusion implants" made of titanium alloy and includes "instruments" for insertion, indicating it is a hardware-based medical device.
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 Harvester SI Fusion System is a system of threaded implants designed to be surgically inserted into the sacroiliac joint to fuse the bones together. It is a physical implant used within the body, not a device used to test samples outside the body.
- Intended Use: The intended use is for sacroiliac joint fusion, a surgical procedure to stabilize a joint. This is a therapeutic intervention, not a diagnostic test.
The provided information clearly describes a surgical implant system, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The Harvester SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroillac joint disruptions and degenerative sacroillitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
Product codes
OUR
Device Description
The Harvester SI: Sacroiliac Fixation System (also called Harvest SI Sacroiliac Joint Fusion System and Harvester SI Fusion System) is comprised of threaded fusion implants for coupling and fusing the ilium to the sacroiliac fusion). The goal of the fusion arthrodesis is to immobilize the sacroiliac joint with two (2) or more threaded implants. The procedure may or may not be bilateral. The Harvester SI System Fusion implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The Harvester SI Fusion System is offered in various diameters and lengths to accommodate patient anatomy. Instruments are provided that facilitate the insertion of the implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sacroiliac joint, ilium
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 Harvester SI: Sacroiliac Fixation System has been tested in the following test modes:
- Axial pullout per ASTM F543 ●
- Torsional properties per ASTM F543
- Static cantilever bending per ASTM F2193
- o Dynamic cantilever bending per ASTM F2193
The results of this non-clinical testing show that the strength of the Harvester SI: Sacroiliac Fixation System 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)
K152237, K121148, K183342, K201538, K161210
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.
0
March 23, 2021
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Spinus International, Inc. % Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs. Colorado 80918
Re: K203780
Trade/Device Name: Harvester SI: Sacroiliac Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: January 26, 2021 Received: January 27, 2021
Dear Nathan Wright:
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 probibitions 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 (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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement on last page. |
|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | K203780 |
| Device Name | Harvester SI: Sacroiliac Fixation System |
| Indications for Use (Describe) | |
The Harvester SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroillac joint disruptions and degenerative sacroillitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (7/17)
3
510(K) SUMMARY
| Submitter's Name: | Spinus International, Inc. |
|---|---|
| Submitter's Address: | 7200 North Interstate Highway 35 |
| Building 1, Suite 101 | |
| Georgetown, TX 78626 | |
| Submitter's Telephone: | 254-760-4173 |
| Contact Person: | Nathan Wright MS |
| Empirical Testing Corp. | |
| 719-351-0248 | |
| nwright@empiricaltech.com | |
| Date Summary was Prepared: | December 23, 2020 |
| Trade or Proprietary Name: | Harvester SI: Sacroiliac Fixation System |
| Common or Usual Name: | Sacroiliac Joint Fixation |
| Classification: | Class II per 21 CFR §888.3040 |
| Product Code: | OUR |
| Classification Panel: | Orthopedic |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Harvester SI: Sacroiliac Fixation System (also called Harvest SI Sacroiliac Joint Fusion System and Harvester SI Fusion System) is comprised of threaded fusion implants for coupling and fusing the ilium to the sacroiliac fusion). The goal of the fusion arthrodesis is to immobilize the sacroiliac joint with two (2) or more threaded implants. The procedure may or may not be bilateral. The Harvester SI System Fusion implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The Harvester SI Fusion System is offered in various diameters and lengths to accommodate patient anatomy. Instruments are provided that facilitate the insertion of the implants.
INDICATIONS FOR USE
The Harvester SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:
- Indications for Use
- Materials of manufacture
- Structural support mechanism ●
4
- Sizes ●
- Surgical approach ●
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type |
|---|---|---|---|
| K152237 | Entasis™ Dual-Lead Sacroiliac Implant | CoreLink | Primary |
| K121148 | SAMBA™ Screw System | Medical Designs LLC | Additional |
| K183342 | SambaScrew 3D SI Fusion System | Orthofix Inc. | Additional |
| K201538 | Life Spine SIMPACT Sacroiliac Joint Fixation System | Life Spine Inc. | Additional |
| K161210 | Rialto™ SI Fusion System | Medtronic Sofamor Danek | Additional |
Table 5-1 Predicate Devices
PERFORMANCE DATA
The Harvester SI: Sacroiliac Fixation System has been tested in the following test modes:
- Axial pullout per ASTM F543 ●
- Torsional properties per ASTM F543
- Static cantilever bending per ASTM F2193
- o Dynamic cantilever bending per ASTM F2193
The results of this non-clinical testing show that the strength of the Harvester SI: Sacroiliac Fixation System 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 Harvester SI: Sacroiliac Fixation System is substantially equivalent to the predicate device.