(59 days)
Not Found
No
The summary describes a mechanical fixation system (screws) 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 is a therapeutic purpose.
No
Explanation: The device is a sacroiliac joint fixation system consisting of screws designed for joint fusion, not for diagnosing conditions.
No
The device description explicitly states it consists of "screws designed to enhance sacroiliac joint fusion" and is offered in "various diameters, lengths, and three screw types in cannulated form." This clearly indicates a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis." This describes a surgical procedure to treat a physical condition, not a test performed on samples from the body to diagnose or monitor a disease.
- Device Description: The device consists of "screws designed to enhance sacroiliac joint fusion." These are physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The UNITY Sacroiliac Joint Fixation System is indicated for use in skeletally mature patients for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Product codes (comma separated list FDA assigned to the subject device)
OUR
Device Description
The UNITY Sacroiliac Joint Fixation System consists of screws designed to enhance sacroiliac joint fusion. The UNITY Sacroiliac Joint Fixation System is offered in various diameters, lengths, and three screw types in cannulated form to accommodate patient anatomy. The three design types of the subject device are:
- Standard Thread Screw (with and without slots)
- Lag Screw (with and without slots) and
- Washer Screw (with slots)
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
skeletally mature patients
Intended User / Care Setting
Prescription Use
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 UNITY Sacroiliac Joint Fixation does not create a new worst case for device performance; additional testing is not needed.
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
October 13, 2022
Image /page/0/Picture/1 description: The image contains 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 features the agency's acronym in a blue square, followed by the full name "U.S. Food & Drug Administration" in blue text.
Dio Medical Corporation Milan George VP of R&D 2100 Campus Lane Suite 100 East Norriton, Pennsylvania 19403
Re: K222448
Trade/Device Name: UNITY 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 Dated: August 12, 2022 Received: August 15, 2022
Dear Milan George:
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
1
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) 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 (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 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,
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below. |
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------- |
|---|
Indications for Use
| 510(k) Number (if known) | K222448 |
|---|---|
| Device Name | UNITY Sacroiliac Joint Fixation System |
| Indications for Use (Describe) | The UNITY Sacroiliac Joint Fixation System is indicated for use in skeletally mature patients for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. |
| 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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| FORM FDA 3881 (6/20) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 |
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510(k) SUMMARY
Dio Medical UNITY Sacroiliac Joint Fixation System
| Sponsor: | Manufacturer: | Dio Medical Corp.
2100 Campus Lane, Suite 100
East Norriton, PA 19403 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| | Official Contact:
Email:
Phone: | Milan George
mgeorge@dio-us.com
1-877-394-5407 ext.102 |
| Date Prepared: | August 12, 2022 | |
| Device Name:
Common Name: | UNITY Sacroiliac Joint Fixation System
Sacroiliac Joint Fixation Screw | |
| Classification
Name: | Smooth or threaded metallic bone fixation fastener | |
| Classification
Number: | 21 CFR 888.3040 | |
| Product Code/
Classification: | OUR, class II | |
| Description: | The UNITY Sacroiliac Joint Fixation System consists of screws
designed to enhance sacroiliac joint fusion. The UNITY Sacroiliac
Joint Fixation System is offered in various diameters, lengths, and
three screw types in cannulated form to accommodate patient
anatomy. The three design types of the subject device are:
- Standard Thread Screw (with and without slots)
- Lag Screw (with and without slots) and
- Washer Screw (with slots) | |
| Indications
for Use: | The UNITY Sacroiliac Joint Fixation System is indicated for use in
skeletally mature patients for sacroiliac joint fusion for conditions
including sacroiliac joint disruptions and degenerative sacroiliitis. | |
| Predicate
Device: | Huvexel Co. Ltd. - UNITY Sacroiliac Joint Fixation System
(K173201) | |
| Substantial
Equivalence: | The UNITY Sacroiliac Joint Fixation System has the same intended
use, indications for use, and principles of operation as the primary
predicate device. It has similar technological characteristics as its
predicate device. There are no technological differences between
the subject device and its predicate device resulting in no new
issues of safety or effectiveness. Thus, the UNITY Sacroiliac Joint
Fixation System is substantially equivalent to the predicate. | |
| Performance
Data: | The UNITY Sacroiliac Joint Fixation does not create a new worst
case for device performance; additional testing is not needed. | |
| Conclusion: | Based upon a comparison of technological characteristics,
intended use, design features, and mechanical performance, the
Dio Medical UNITY Sacroiliac Joint Fixation System does not raise
any new safety or efficacy concerns and has demonstrated | |
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substantial equivalence to the identified predicates.