(24 days)
Not Found
No
The device description and performance studies focus on mechanical components and testing, with no mention of AI/ML, image processing, or data sets for training/testing.
Yes
The device is intended to immobilize and stabilize spinal segments as an adjunct to fusion for treating various medical conditions and deformities of the spine, which aligns with the definition of a therapeutic device.
No
The device, the NOVA Minimally Invasive System, is intended for immobilization and stabilization of spinal segments as an adjunct to fusion, not for diagnosing conditions.
No
The device description explicitly lists physical components made of titanium alloy (cannulated polyaxial screw, straight and pre-bent rods, and set screws), indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a surgical implant system (screws, rods, set screws) made of titanium alloy, intended for stabilizing the spine during fusion surgery.
- Intended Use: The intended use is to provide immobilization and stabilization of spinal segments in vivo (within the body) as an adjunct to fusion. This is a surgical procedure, not a diagnostic test performed on a specimen in vitro.
The NOVA Minimally Invasive System is a surgical implant, not a diagnostic device.
N/A
Intended Use / Indications for Use
The NOVA Minimally Invasive System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:
- Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
-
- Spondylolisthesis,
-
- Trauma (i.e., fracture or dislocation),
-
- Spinal stenosis.
-
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
-
- Tumor,
-
- Pseudoarthrosis, and
-
- Failed previous fusion
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
The NOVA Minimally Invasive System consists of cannulated polyaxial screw, straight and pre-bent rods and set screws. The components are manufactured from titanium alloy per ASTM F136. The screws range in diameter from 5.5 mm to 7.0 mm and in length from 20 mm to 70 mm. The implants are not compatible with components or metal from any other manufacturer's system. The NOVA Minimally Invasive System can be used for both percutaneous and mini-open surgery
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine
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 mechanical testing performed for the subject NOVA Minimally Invasive System with its components and the predicate devices is in accordance with ASTM F1717. There are no design change are involved for the design verification tests. The performance data for design control activities are unnecessary this time.
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.
Not Found
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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Image /page/0/Picture/0 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" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size.
October 17, 2024
BAUI Biotech Co., Ltd. Herman Jhan Regulatory Affairs Asst. Manager 6F., No.6, Sec.1, Zhongxing Rd., Wugu Dist. New Taipei City, 24872 Taiwan
Re: K242899
Trade/Device Name: NOVA Minimally Invasive System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: August 30, 2024 Received: September 23, 2024
Dear Herman Jhan:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Ronald P. Jean -S
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
3
Indications for Use
Submission Number (if known)
Device Name
NOVA Minimally Invasive System
Indications for Use (Describe)
The NOVA Minimally Invasive System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:
- Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
-
- Spondylolisthesis,
-
- Trauma (i.e., fracture or dislocation),
-
- Spinal stenosis.
-
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
-
- Tumor,
-
- Pseudoarthrosis, and
-
- Failed previous fusion
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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510(k) SUMMARY
This 510(k) summary information is being submitted in accordance with the requirements of 21 C.F.R. §807.92.
| Preparation Date: | August 30, 2024 |
|---|---|
| Applicant/Sponsor: | BAUI BIOTECH CO., LTD. |
| 6F., No.8, Sec.1, Zhongxing Rd., Wugu Dist., 24872 | |
| New Taipei City, Taiwan(R.O.C.) | |
| Contact Person: | Herman Jhan |
| Phone: +886-2-8976-9538 #154 | |
| Fax: +886-2-8976-9608 | |
| Email: herman@baui.com.tw | |
| Proprietary Name: | NOVA Minimally Invasive System |
| Common Name: | Pedicle Screw Fixation System |
| Classification Name: | Thoracolumbosacral pedicle screw system (21 CFR |
| 888.3070) | |
| Classification Identification: Class II | |
| Product codes: | NKB |
Primary Predicate Device: NOVA Minimally Invasive System (K182416)
Device Description:
The NOVA Minimally Invasive System consists of cannulated polyaxial screw, straight and pre-bent rods and set screws. The components are manufactured from titanium alloy per ASTM F136. The screws range in diameter from 5.5 mm to 7.0 mm and in length from 20 mm to 70 mm. The implants are not compatible with
5
components or metal from any other manufacturer's system. The NOVA Minimally Invasive System can be used for both percutaneous and mini-open surgery
Indications for Use:
The NOVA Minimally Invasive System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:
- Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
-
- Spondylolisthesis,
-
- Trauma (i.e., fracture or dislocation),
-
- Spinal stenosis,
-
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
-
- Tumor,
-
- Pseudoarthrosis, and
-
- Failed previous fusion
Substantial Equivalence:
- A. Predicate device name: NOVA Minimally Invasive System
- B. Predicate K number: K182416
- C. Comparison with predicate:
Modified reference number in labeling, including IFU and labels.
Package labels and insert information hasn't been changed for this modification, the indication is the same as predicate device. It has the following similarities to predicate device:
- Same operating principle
- Same fundamental scientific technology
- Incorporate the same materials
- Same shelf life
- Packaged using the same materials
- Manufactured by the same process
6
The modifications encompass:
- Modified reference number
- Labeling change due to above modifications
The NOVA Minimally Invasive System is substantially equivalent to the predicate devices listed above based on intended use, materials, designs, and operational principles.
Performance Characteristics:
The mechanical testing performed for the subject NOVA Minimally Invasive System with its components and the predicate devices is in accordance with ASTM F1717. There are no design change are involved for the design verification tests. The performance data for design control activities are unnecessary this time.
Conclusion:
Based on the information provided in this submission, the NOVA Minimally Invasive System is substantially equivalent to the predicate NOVA Minimally Invasive System.
The NOVA Minimally Invasive System is substantially equivalent to predicate device with respect to intended use, materials, technological characteristics, and mechanical performance.