(107 days)
No
The description focuses on the mechanical components and intended use of a spinal plate system, with no mention of AI or ML capabilities.
Yes
The device is described as a "Lumbar Plate System" intended for temporary fixation in spine instability due to various conditions like fracture, tumor, and degenerative disc disease, which falls under the definition of a therapeutic device.
No
The provided text states that the BALTEUM™ and BALTEUM - ONE™ Lumbar Plate System is intended for "temporary fixation device until fusion is achieved" in the treatment of spine instability, and describes it as consisting of "rigid plates and bone screws." This indicates it is an implantable surgical device for treatment, not for diagnosing a condition.
No
The device description explicitly states that the system consists of "rigid plates and bone screws of varying sizes and lengths" and "instrumentation which assists in the surgical implantation of the device," indicating it is a hardware-based implant and surgical system, not software only.
No, 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, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The BALTEUM™ and BALTEUM - ONE™ Lumbar Plate System is a surgical implant. It is a physical device that is surgically placed inside the body to provide structural support to the spine.
- Intended Use: The intended use clearly states it's for treating spine instability and is a "temporary fixation device until fusion is achieved." This is a therapeutic and structural function, not a diagnostic one based on analyzing bodily specimens.
The information provided describes a medical device used for surgical intervention and support, not for laboratory testing of samples.
N/A
Intended Use / Indications for Use
The BALTEUM™ and BALTEUM - ONE™ Lumbar Plate System are intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.
Product codes
KWO, KWQ
Device Description
The BALTEUM - ONE™ Lumbar Plate System consists of non-sterile, single use, rigid plates and bone screws of varying sizes and lengths to fit the anatomical needs of a wide variety of patients. The plate attaches by means of screws to the vertebral body of the thoracolumbar spine (T1-L5) either through an antero-lateral, or lateral approach and to the lumbar/lumbosacral spine (L1-S1) through an anterior approach. The system includes instrumentation which assists in the surgical implantation of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar (T1-L5) spine, lumbar and lumbosacral (L1-S1) spine
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)
Non-clinical testing was performed to demonstrate that the subject BALTEUM - ONE™ Lumbar Plate System is substantially equivalent to the predicate device. The following testing was performed in accordance with the ASTM F1717:
- Static compression
- Dynamic compression
- Static Torsion
The nonclinical tests demonstrate that the BALTEUM - ONE™ Lumbar Plate System is substantially equivalent to the legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BALTEUM™ Lumbar Plate System (K200846), Globus Medical – Plymouth™ Thoracolumbar Plate System (K120092), Globus Medical – TRUSST™ Thoracolumbar Plate System (K092108), NuVasive Lateral Plate System (K091071)
Reference Device(s)
Globus Medical - REVERE™ Stabilization System (K061202)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
March 25, 2022
Huvexel Co., Ltd % Milan George Vice President, R&D Dio Medical Corporation 2100 Campus Lane, Suite 100 East Norriton, Pennsylvania 19403
Re: K213820
Trade/Device Name: BALTEUM – ONE™ Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: December 23, 2021 Received: December 27, 2021
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
1
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 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,
for 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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Indications for Use
510(k) Number (if known) K213820
Device Name BALTEUM - ONE™ Lumbar Plate System
Indications for Use (Describe)
The BALTEUM™ and BALTEUM - ONE™ Lumbar Plate System are intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.
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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C)
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510(k) SUMMARY
HUVEXEL Co., Ltd's BALTEUM - ONE™ Lumbar Plate System
| Sponsor: | |
|---|---|
| Manufacturer | HUVEXEL Co., Ltd. |
| 101-105 Megacenter, SKn Technopark | |
| 124 Sagimakgol-ro, Jungwon-gu | |
| Seongnam-si | |
| Gyeonggi-do, South Korea | |
| Official Contact | |
| Phone: | Milan George |
| 877-394-5407x102 | |
| Date: | December 7, 2021 |
| Device Name: | BALTEUM - ONE™ Lumbar Plate System |
| Common Name: | Anterior Thoracolumbosacral Plate |
| Classification | |
| Name: | Spinal intervertebral body fixation orthosis, 21 CFR 888.3060 |
| Classification | |
| Number: | Class II |
| Product | |
| Code/Classification: | KWQ |
| Description: | The BALTEUM - ONE™ Lumbar Plate System consists of non-sterile, |
| single use, rigid plates and bone screws of varying sizes and lengths | |
| to fit the anatomical needs of a wide variety of patients. The plate | |
| attaches by means of screws to the vertebral body of the | |
| thoracolumbar spine (T1-L5) either through an antero-lateral, or | |
| lateral approach and to the lumbar/lumbosacral spine (L1-S1) | |
| through an anterior approach. The system includes instrumentation | |
| which assists in the surgical implantation of the device. | |
| Intended Use: | The BALTEUM™ and BALTEUM - ONE™ Lumbar Plate Systems are |
| intended for use via a lateral or anterolateral surgical approach | |
| above the bifurcation of the great vessels in the treatment of | |
| thoracic and thoracolumbar (T1-L5) spine instability or via the | |
| anterior surgical approach, below the bifurcation of the great vessels | |
| in the treatment of lumbar and lumbosacral (L1-S1) spine instability | |
| as a result of fracture (including dislocation and subluxation), tumor, | |
| degenerative disc disease (defined as back pain of discogenic origin |
4
| | with degeneration of the disc confirmed by patient history and
radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or
a failed previous spine surgery. The device is intended as a
temporary fixation device until fusion is achieved. |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data: | Non-clinical testing was performed to demonstrate that the
subject BALTEUM - ONE™ Lumbar Plate System is substantially
equivalent to the predicate device. The following testing was
performed in accordance with the ASTM F1717:
- Static compression
- Dynamic compression
- Static Torsion
The nonclinical tests demonstrate that the BALTEUM - ONE™
Lumbar Plate System is substantially equivalent to the legally
marketed predicate devices. |
| Predicate Device: | Primary predicate: BALTEUM™ Lumbar Plate System (K200846) -
HUVEXEL Co., Ltd
Additional predicates: Globus Medical – Plymouth™ Thoracolumbar
Plate System (K120092), Globus Medical – TRUSST™ Thoracolumbar
Plate System (K092108), NuVasive Lateral Plate System (K091071)
and Globus Medical - REVERE™ Stabilization System (K061202) |
| Technological
Characteristics | The BALTEUM - ONE™ Lumbar Plate System was shown to be
substantially equivalent and has equivalent technological
characteristics to its predicate and reference devices through
comparison in areas including design, labeling/intended use,
material composition, function, range of sizes, and packaging. |
| Performance and
SE Determination: | The BALTEUM - ONE™ Lumbar Plate System have 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). |