(28 days)
No
The device description and performance studies focus on the mechanical properties and intended use of a spinal fixation system, with no mention of AI or ML capabilities.
Yes
The device is described as an anterior vertebral screw fixation system for the cervical spine, indicated for temporary stabilization during the development of cervical spine fusions in patients with various conditions such as degenerative disc disease, trauma, and spinal stenosis. This direct involvement in treating medical conditions to improve health outcomes aligns with the definition of a therapeutic device.
No
The device is an anterior vertebral screw fixation system used for temporary stabilization of the spine during fusion, not for diagnosing medical conditions.
No
The device description explicitly states that the system consists of bone plates, screws, and associated instruments made from titanium alloy, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "anterior vertebral screw fixation of the cervical spine" and "temporary stabilization of the anterior spine during the development of cervical spine fusions." This describes a surgical implant used in vivo (within the body) for structural support and stabilization.
- Device Description: The description details bone plates, screws, and instruments made from titanium alloy, designed for insertion into the vertebral body. This further confirms its nature as a surgical implant.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information contains none of these characteristics.
Therefore, the ASPIRON™ S ACP System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The ASPIRON™ S ACP System is intended for anterior vertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
· Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration disc confirmed by patient history and radiographic studies);
- · Spondylolisthesis
- · Trauma (including fractures, dislocation)
- · Spinal stenosis
- · Tumors
- · Deformity (defined as scoliosis, kyphosis, or lordosis)
- · Pseudoarthrosis
- · Failed previous fusion
Product codes
KWQ
Device Description
The ASPIRON™ S ACP System consists of a variety of shapes and sizes of bone plates, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. All implant components are made from titanium alloy (Ti-6AI-4V ELI) in accordance with ASTM F136. All implants are single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine at levels C2-T1
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
The following tests were performed for the predicate device (K190053) and the performance of the proposed device is substantially equivalent to the predicate device (K190053).
- (1) Static compression bending test according to ASTM F1717
- (2) Static torsion test according to ASTM F1717
- (3) Compression bending fatigue test according to ASTM F1717
Key Metrics
Not Found
Predicate Device(s)
K182055, K190053, K131200, K140234
Reference Device(s)
Not Found
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
February 16, 2022
Image /page/0/Picture/1 description: The image shows 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 consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
U&I Corporation So-Yeon Jang RA Specialist 20. Sandan-ro 76beon-gil(Rd) Uijeongbu-si, Gyeonggi-do 11781 Korea, South
Re: K220147
Trade/Device Name: Aspiron S ACP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 14, 2022 Received: January 19, 2022
Dear So-Yeon 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. 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,
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
2
Indications for Use
510(k) Number (if known) K220147
Device Name ASPIRON S ACP System
Indications for Use (Describe)
The ASPIRON™ S ACP System is intended for anterior vertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
· Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration disc confirmed by patient history and radiographic studies);
- · Spondylolisthesis
- · Trauma (including fractures, dislocation)
- · Spinal stenosis
- · Tumors
- · Deformity (defined as scoliosis, kyphosis, or lordosis)
- · Pseudoarthrosis
- · Failed previous fusion
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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6. 510(k) Summary
| Manufacturer: | U&i Corporation
20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,
11781, Korea, |
|----------------------|----------------------------------------------------------------------------------------------|
| Sponsor: | U&i Corporation
20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,
11781, Korea, |
| Sponsor Contact: | So-Yeon Jang, RA Specialist
+82 31 860 6836
soyeon@youic.com |
| Date Prepared: | January 14, 2022 |
| Device Name: | Trade name: ASPIRON™ S ACP SYSTEM |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Common Name: | Anterior Cervical Plate |
| Product Code: | KWQ |
| Predicate Devices: | |
Primary - SECULOK™ ACP SYSTEM(K182055, K190053) Secondary - ASPIRON™ ACP System (K131200, K140234)
Description of Device:
The ASPIRON™ S ACP System consists of a variety of shapes and sizes of bone plates, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. All implant components are made from titanium alloy (Ti-6AI-4V ELI) in accordance with ASTM F136. All implants are single use only. The trade name is changed compared to the predicate devices (K182055, K190053).
4
Indications For Use:
The ASPIRON™ S ACP System is intended for anterior vertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
- Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration disc confirmed by patient history and radiographic studies);
- Spondylolisthesis ●
- . Trauma (including fractures, dislocation)
- Spinal stenosis
- Tumors
- Deformity (defined as scoliosis, kyphosis, or lordosis)
- Pseudoarthrosis
- Failed previous fusion
Substantial Equivalence:
ASPIRON™ S ACP System is substantially equivalent to SECULOK™ ACP System (K182055, K190053) and ASPIRON™ ACP System (K131200, K140234) in the intended use and the technological characteristics such as the design, material, chemical composition and manufacturing process.
-
- Comparison Technological Characteristics
The predicate and proposed device have the similar intended use and basic fundamental scientific technology and share the following similarities;
- Comparison Technological Characteristics
-
The similar indications for use
-
Similar design features ●
-
Incorporate the same materials ●
-
The equivalent mechanical performance
5
-
- Performance evaluation
Between the proposed device and the predicate device (K190053), the trade name is changed from SECULOK™ ACP System to ASPIRON™ S ACP System. There is no change or modification in the device that could affect the performance testing result. Therefore, the performance evaluation stays the same as the predicate device(K190053).
- Performance evaluation
The following tests were performed for the predicate device (K190053) and the performance of the proposed device is substantially equivalent to the predicate device (K190053).
- (1) Static compression bending test according to ASTM F1717
- (2) Static torsion test according to ASTM F1717
- (3) Compression bending fatigue test according to ASTM F1717
-
- Conclusion
The data and information provided in this submission support the conclusion that the ASPIRON™ S ACP System is substantially equivalent to predicate devices with respect to indications for use and technological characteristics.