The Huvex Interspinous Fusion System is a single-level, posterior, non-pedicle supplemental fixation device intended for use in the lumbar spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to the Huvex Interspinous Fusion System for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The Huvex Interspinous Fusion System is intended for use at one level, in conjunction with autogenous bone graft, and not intended for stand-alone use.

Device Description

The HUVEX Interspinous Fusion System consists of a left plate, a right plate, pin, bolt, inner cap, center bar, and set screw. Each of these components is provided in several sizes to allow for the construction of five different HUVEX Interspinous Fusion implant sizes. The left plate is provided assembled with the poly axial bar. The bar has a bone graft window to allow fusion between spinous process. Poly axial bar is also designed to fit the anatomical characteristics of the spinous process. The right plate is designed to be combined with left plate fixed to spinous process. Right plate contains a set screw to lock the right plate to the poly axial bar. The HUVEX Interspinous Fusion System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136. In addition to the implants a set of reusable surgical instruments are provided. Both implant and instruments have trays that are used for handling and storage.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called the "Huvex Interspinous Fusion System." This document is a clearance letter from the FDA, and as such, it does not include the detailed study reports or acceptance criteria for the device's technical performance. Instead, it confirms that the FDA has found the device to be substantially equivalent to a previously marketed predicate device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for this specific submission (K223790).

Here's what the document does state regarding performance data and equivalence:

1. A table of acceptance criteria and the reported device performance

No specific acceptance criteria or performance data are provided in this document directly from a study for device K223790.
The document states: "The subject and predicate devices are identical and therefore, no performance testing is required. Submission is only transferring name of a system that has already been cleared under K162849."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable as no performance testing was conducted for K223790. The device is claimed to be identical to a previously cleared device (K162849).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable as no performance testing was conducted for K223790.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable as no performance testing was conducted for K223790.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical implant, not an AI software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable as no performance testing was conducted for K223790.

8. The sample size for the training set

Not applicable as no algorithmic training dataset is relevant for this physical implant.

9. How the ground truth for the training set was established

Not applicable as no algorithmic training dataset is relevant for this physical implant.

Key takeaway from the document:

The FDA determined that the Dio Medical Huvex Interspinous Fusion System (K223790) is substantially equivalent to the Huvexel Co. Ltd. - Huvex Interspinous Fusion System (K162849). This determination is based on the claim that the current device is identical to the predicate device in its intended uses, indications, technological characteristics, and principles of operation. Therefore, no new performance testing was deemed necessary for this submission. The detailed performance data and acceptance criteria would have been part of the original K162849 submission.

Summary

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March 9, 2023

Image /page/0/Picture/1 description: The image contains 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 is 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.

Dio Medical Corp. Milan George VP of R&D 2100 Campus Lane, Suite 100 East Norriton, Pennsylvania 19403

Re: K223790

Trade/Device Name: Huvex Interspinous Fusion System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: Class II Product Code: PEK Dated: March 2, 2023 Received: March 3, 2023

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 medical devices and radiation-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 -S

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

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K223790

Device Name Huvex Interspinous Fusion System

Indications for Use (Describe)

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)

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510(k) SUMMARY

Dio Medical Huvex Interspinous Fusion System

Sponsor:	Manufacturer:	Dio Medical Corp.2100 Campus Lane, Suite 100East Norriton, PA 19403
	Official Contact:	Milan George
	Email:	mgeorge@dio-us.com
	Phone:	1-877-394-5407 ext.102
Date Prepared:	December 16, 2022
Device Name:	Huvex Interspinous Fusion System
Common Name:	Spinous Process Plate
Classification Name:	Spinal interlaminal fixation orthosis
Classification Number:	21 CFR 888.3050
Product Code/Classification:	PEK, class II
Description:	The HUVEX Interspinous Fusion System consists of a left plate, aright plate, pin, bolt, inner cap, center bar, and set screw. Each ofthese components is provided in several sizes to allow for theconstruction of five different HUVEX Interspinous Fusion implantsizes. The left plate is provided assembled with the poly axial bar.The bar has a bone graft window to allow fusion between spinousprocess. Poly axial bar is also designed to fit the anatomicalcharacteristics of the spinous process. The right plate is designedto be combined with left plate fixed to spinous process. Right platecontains a set screw to lock the right plate to the poly axial bar.The HUVEX Interspinous Fusion System components are suppliednon-sterile, are single use and are fabricated from titanium alloy(Ti-6Al-4V ELI) that conforms to ASTM F 136.In addition to the implants a set of reusable surgical instruments
Indications ForUse:	The Huvex Interspinous Fusion System is a single-level, posterior,non-pedicle supplemental fixation device intended for use in thelumbar spine (T1-S1) as an adjunct to fusion in skeletally maturepatients. It is intended for plate fixation/attachment to the HuvexInterspinous Fusion System for the purpose of achievingsupplemental fusion in the following conditions: degenerative discdisease (defined as back pain of discogenic origin withdegeneration of the disc confirmed by history and radiographicstudies), spondylolisthesis, trauma (i.e., fracture or dislocation),and/or tumor. The Huvex Interspinous Fusion System is intendedfor use at one level, in conjunction with autogenous bone graft,and not intended for stand-alone use.
PredicateDevice:	Primary predicate:Huvexel Co. Ltd. - Huvex Interspinous Fusion System (K162849)
SubstantialEquivalence:	The Huvex Interspinous Fusion System is identical to the predicatedevice and is as safe and effective as the Huvexel - HuvexInterspinous Fusion System. The Subject device has the sameintended uses and similar indications, technological characteristics,and principles of operation as its predicate device. There are notechnological differences between the Subject device and itspredicate devices resulting in no new issues of safety oreffectiveness. Thus, the Dio Medical- Huvex Interspinous FusionSystem is identical/substantially equivalent to the predicates.
PerformanceData:	The subject and predicate devices are identical and therefore, noperformance testing is required. Submission is only transferringname of a system that has already been cleared under K162849.No testing is required.
Conclusion:	The Dio Medical Huvex Interspinous Fusion System has the sameintended uses and similar indications, technological characteristics,and principles of operation as its predicate device. Thus, thesubject device is identical/substantially equivalent to the predicatedevice.

are provided. Both implant and instruments have trays that are used for handling and storage.

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Regulation Number and Section

§ 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.