(35 days)
No
The summary describes a mechanical implant system for spinal fixation and does not mention any software, algorithms, or AI/ML capabilities.
No.
The document indicates "The device is intended as a temporary fixation device until fusion is achieved," which describes a structural support rather than a therapeutic action.
No
Explanation: The device is described as a "Lumbar Plate System" which is a "temporary fixation device" used for spinal instability. This indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description explicitly states it 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 system, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The BALTEUM™ Lumbar Plate System is a physical implantable device (plates and screws) used for spinal fixation during surgery. It is a temporary fixation device until fusion is achieved.
- Intended Use: The intended use is to provide stability to the spine in cases of instability due to various conditions like fracture, tumor, degenerative disc disease, etc. This is a surgical intervention, not a diagnostic test performed on a sample.
The description clearly indicates a surgical implant used for structural support, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The BALTEUM™ Lumbar Plate System is 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 with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The BALTEUM™ 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
thoracic and 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™ 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™ Lumbar Plate System is as safe, as effective, and performs as well as or better than the legally marketed predicate devices.
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.
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
§ 888.3060 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
May 5, 2020
Image /page/0/Picture/1 description: The image shows 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 text logo on the right. The FDA text logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
Huvexel Co., Ltd % Milan George Vice President, R&D Dio Medical Corporation 2900 Potshop Lane, Suite 200 Eagleville, Pennsylvania 19403
Re: K200846
Trade/Device Name: Balteum™ Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 12, 2020 Received: March 31, 2020
Dear Mr. 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 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. Acting 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: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K200846
Device Name BALTEUM™ Lumbar Plate System
Indications for Use (Describe)
The BALTEUM™ Lumbar Plate System is 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 with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (7/17) Services (301) 443-6740 EF
Page 1 of 1
PSC Publishing
3
510(k) SUMMARY
HUVEXEL Co., Ltd's BALTEUM™ 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 | Milan George |
| Phone: | 267-737-9496 x102 |
| Fax: | 847-795-1079 |
| Date: | March 12, 2020 |
| Device Name: | BALTEUM™ Lumbar Plate System |
| Common Name: | Spinal Implant |
| Classification Name: | Spinal intervertebral body fixation orthosis |
| Classification Number: | Class II |
| Product Code/Classification: | KWQ |
| Description: | The BALTEUM™ 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™ Lumbar Plate System is 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 |
4
(defined as back pain of discogenic origin 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™ 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™ Lumbar Plate System is as safe, as effective, and performs as well as or better than the legally marketed predicate devices.
- Predicate Device: Primary predicate: Globus Medical – Plymouth™ Thoracolumbar Plate System (K120092) Additional predicates: NuVasive Lateral Plate System (K091071) and Synthes Anterior Tension Band (ATB) System (K022791)
- Reference Device: K111362 – Rexious Spinal Fixation System
Technological The BALTEUM™ Lumbar Plate System was shown to be substantially Characteristics 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 The BALTEUM™ Lumbar Plate System have been demonstrated to SE Determination: 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).