(80 days)
No
The device description and intended use focus solely on the mechanical components and surgical application of a spinal fusion system, with no mention of AI or ML capabilities. The performance study section also indicates no testing was required as the device is identical to a previously cleared predicate, further suggesting no new technological features like AI/ML are present.
Yes
The device is described as a "supplemental fixation device intended for use in the lumbar spine (T1-S1) as an adjunct to fusion" for conditions like degenerative disc disease, spondylolisthesis, trauma, and tumor, which directly addresses medical conditions.
No
The device is described as a "supplemental fixation device intended for use in the lumbar spine (T1-S1) as an adjunct to fusion." Its components are physical implants used for stabilization and fusion, not for diagnosing conditions.
No
The device description explicitly lists physical components made of titanium alloy, such as plates, pins, bolts, and screws, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The Huvex Interspinous Fusion System is a physical implant designed to be surgically placed in the lumbar spine to aid in fusion. It is a mechanical device used in vivo (within the body), not in vitro (in a lab setting).
- Lack of Mention of Biological Specimens or Lab Testing: The description focuses on the physical components of the implant and its surgical application. There is no mention of analyzing biological samples or performing laboratory tests.
Therefore, the Huvex Interspinous Fusion System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
PEK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine (T1-S1)
Indicated Patient Age Range
skeletally mature patients
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 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. No testing is required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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)
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.
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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 Huvex Interspinous Fusion System
| Sponsor: | Manufacturer: | Dio Medical Corp.
2100 Campus Lane, Suite 100
East 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, 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 | |
| Indications For
Use: | 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. | |
| Predicate
Device: | Primary predicate:
Huvexel Co. Ltd. - Huvex Interspinous Fusion System (K162849) | |
| Substantial
Equivalence: | The Huvex Interspinous Fusion System is identical to the predicate
device and is as safe and effective as the Huvexel - Huvex
Interspinous Fusion System. The Subject device has the same
intended uses and similar indications, technological characteristics,
and principles of operation as its predicate device. There are no
technological differences between the Subject device and its
predicate devices resulting in no new issues of safety or
effectiveness. Thus, the Dio Medical- Huvex Interspinous Fusion
System is identical/substantially equivalent to the predicates. | |
| Performance
Data: | 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.
No testing is required. | |
| Conclusion: | The Dio Medical Huvex Interspinous Fusion System has the same
intended uses and similar indications, technological characteristics,
and principles of operation as its predicate device. Thus, the
subject device is identical/substantially equivalent to the predicate
device. | |
are provided. Both implant and instruments have trays that are used for handling and storage.
4