(128 days)
Not Found
No
The description focuses on the mechanical components and materials of a spinal fixation system and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes.
The device is intended for use as an adjunct to fusion for conditions like degenerative disc disease, spondylolisthesis, trauma, and tumor, all of which are medical conditions that the device aims to treat.
No
The device is described as a "supplemental fixation device intended for use in the non-cervical spine... as an adjunct to fusion," not for diagnosing conditions.
No
The device description explicitly details physical components made of titanium alloy (plates, pins, bolts, etc.) and reusable surgical instruments, indicating it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Huvex Interspinous Fixation System is a physical implant designed to be surgically placed in the spine to aid in fusion. It is made of titanium alloy and consists of plates, pins, bolts, and other mechanical components.
- Intended Use: The intended use clearly states it is a "supplemental fixation device intended for use in the non-cervical spine (TI-S1) as an adjunct to fusion." This describes a surgical implant, not a diagnostic test.
The provided information describes a medical device used in vivo (within the body) for structural support and fixation, not a test performed in vitro (outside the body) on biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Huvex Interspinous Fixation System is a single-level, posterior, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to the spinous processes 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 Fixation 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 Fixation 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 Fixation 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 Fixation System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-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
non-cervical spine (T1-S1), spinous processes
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)
Static & Dynamic compression, Static torsion, and Static tension testing in accordance with a modified ASTM F1717 setup, in addition Static grip testing with a modified ASTM F1798 setup were conducted to demonstrate substantial equivalence to the predicate system(s).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K102195, K032037, K131238, K143388, K103205, K140236
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 16, 2017
DIO Medical Co., Ltd. Mr. Jaewon Jang Manager 8770 West Bryn Mawr Avenue, Suite 1250 Chicago, Illinois 60631
Re: K162849
Trade/Device Name: Huvex Interspinous Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: January 27, 2017 Received: January 30, 2017
Dear Mr. Jang:
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 Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
1
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" (21 CFR 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162849
Device Name Huvex Interspinous Fixation System
Indications for Use (Describe)
The Huvex Interspinous Fixation System is a single-level, posterior, non-pedicle supplemental fixation device intended for use in the non-cervical spine (TI-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to the spinous processes 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 Fixation 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) |
|---|
| ------------------------------------------------- |
Registration for Part 40 CFR 266, Subpart S Burner
On-Site Combustion Unit (No CFR)
|× | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
3
510(k) SUMMARY
DIO Medical Co., Ltd.
Huvex Interspinous Fixation System
Sponsor: DIO Medical Co., Ltd. 8770 West Bryn Mawr Avenue, Suite 1250 Chicago, Illinois 60631 Official Contact: Jaewon Jang Phone: 847-795-1078 ext. 103 Date Prepared: February 15, 2017 Device Name: Huvex Interspinous Fixation System Common Name: Spinous Process Plate Classification Spinal interlaminal fixation orthosis Name: Classification 21 CFR 888.3050 Number: Product PEK, class II Code/Classification: Description: The Huvex Interspinous Fixation 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 Fixation 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 Fixation System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-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.
4
| Intended Use: | The Huvex Interspinous Fixation System is a single-level, posterior, non-pedicle
supplemental fixation device intended for use in the non-cervical spine (T1-S1) as ar
adjunct to fusion in skeletally mature patients. It is intended for plate
fixation/attachment to the spinous processes 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 Fixation System is
intended for use at one level, in conjunction with autogenous bone graft, and not
intended for stand-alone use. |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data: | Static & Dynamic compression, Static torsion, and Static tension testing in
accordance with a modified ASTM F1717 setup, in addition Static grip testing
with a modified ASTM F1798 setup were conducted to demonstrate substantial
equivalence to the predicate system(s). |
| Predicate Device: | Primary predicate: Globus Medical- Sp-Fix Spinous Process Fixation Plate
(K102195)
Additional predicates: Medtronic - CD Horizon SPIRE™ Spinous Process Plate
(K032037), NuVasive - Affix I & II Spinous Process Plate system (K131238 &
K143388), Alphatec Spine - Bridgepoint Spinous Process System (K103205) and Life
Spine - Aileron posterior fusion system (K140236) |
| Performance and
SE Determination: | The Huvex Interspinous Fixation System has been demonstrated to be
substantially equivalent to the predicate system(s) with respect to technical
characteristics, performance, and intended use. The information provided within
this premarket notification supports substantial equivalence of the subject device
to the predicate device(s). |