(122 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural integrity of the bone plates, screws, and instruments, with no mention of AI or ML capabilities.
Yes.
The device is intended for temporary stabilization of the anterior spine to facilitate cervical spine fusions, which directly addresses various medical conditions such as degenerative disc disease, trauma, and spinal stenosis.
No
The device is a system for spinal fixation, providing temporary stabilization to the anterior spine during cervical spine fusions. It is a surgical implant, not a diagnostic tool.
No
The device description explicitly states that the ASPIRON™ ACP System consists of bone plates, screws, and associated instruments, all made from a titanium alloy. This indicates a hardware-based medical device, not a software-only one.
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 ASPIRON™ ACP System is for "anterior inter-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) to provide structural support.
- Device Description: The description details bone plates, screws, and instruments made from titanium alloy. These are physical components designed for surgical implantation.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests on biological samples.
The ASPIRON™ ACP System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The ASPIRON™ ACP System is intended for anterior inter-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
WARNING: The device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
ASPIRON™ ACP System consists of a variety of shapes and size of bone plates, screws and associated instruments. All implant components are made from a titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136. ASPIRON ™ ACP System is intended to provide stabilization of the cervical vertebra for various indications. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C2-T1
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)
The ASPIRON™ ACP System was tested in a non clinical setting (bench testing) to assess that to no new safety and efficiency issues were raised with this device. The testing met all acceptance criteria and verifies that performance of the ASPIRON™ ACP System is substantially equivalent to the predicate devices.
The following tests were performed:
-
- Construct Test (ASTM F1717)
- (1) Static compression bending test
- (2) Static torsion test
- (3) Compression bending fatigue test
- (4) Torsion fatigue test
-
- Component Test
- (1) Screw back out test
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.
MaximaTM Anterior Cervical Plate System (K061002), Blackstone TM III° Anterior Cervical Plating System (K012184), ZEPHIR TM Anterior Cervical Plate System (K994239)
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
§ 888.3060 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
K131200 Page 1 of 3
5. 510(k) Summary
| Manufacturer: | U & I Corporation
20, Sandan-ro, 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,
Korea, 480-859 | |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Sponsor: | U & I Corporation
20, Sandan-ro, 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,
Korea, 480-859 | |
| Sponsor Contact: | Gyeong-Je Kwon, Regulatory Affairs Specialist
+82 31 852 0102 (ext.610)
kkjane@youic.com | AUG 2 9 2013 |
| Date Prepared: | April 25, 2013 | |
| Device Name: | Trade Name: ASPIRONTM ACP System | |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis, per 21 CFR
888.3060 | |
| Common Name: | Anterior Cervical Plate | |
| Product Code: | KWQ | |
| Predicate Devices: | MaximaTM Anterior Cervical Plate System (K061002)
Blackstone TM III° Anterior Cervical Plating System
(K012184)
ZEPHIR TM Anterior Cervical Plate System (K994239) | |
Description of Device:
ASPIRON™ ACP System consists of a variety of shapes and size of bone plates, screws and associated instruments. All implant components are made from a titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136. ASPIRON ™ ACP System is intended to provide stabilization of the cervical vertebra for various indications. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.
U&i CORPORATION
ASPIRON™ ACP System
1
Intended Use:
The ASPIRON™ ACP System is intended for anterior inter-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
WARNING: The device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Substantial Equivalence:
The ASPIRON™ ACP System is substantially equivalent to Maxima™ Anterior Cervical Plate System (K061002), Blackstone™ III° Anterior Cervical Plating System (K012184) and ZEPHIR™ Anterior Cervical Plate System (K994239) in design, material, mechanical performance, function and intended use.
The mechanical performance of ASPIRON™ ACP System met the acceptance criteria which have been established from the predicate devices.
-
- Comparison Technological Characteristics
The predicate and proposed devices 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 or similar materials ●
-
. The equivalent mechanical performance
-
- Performance Testing
ASPIRON™ ACP System
U&i CORPORATION
Page 10 of 46
2
The ASPIRON™ ACP System was tested in a non clinical setting (bench testing) to assess that to no new safety and efficiency issues were raised with this device. The testing met all acceptance criteria and verifies that performance of the ASPIRON™ ACP System is substantially equivalent to the predicate devices.
The following tests were performed:
-
- Construct Test (ASTM F1717)
- (1) Static compression bending test
- (2) Static torsion test
- (3) Compression bending fatigue test
- (4) Torsion fatigue test
-
- Component Test
- (1) Screw back out test
3. Conclusion
The data and information provided in this submission support the conclusion that the ASPIRON™ ACP System is substantially equivalent to its predicate devices with respect to indications for use and technological characteristics.
U&i CORPORATION
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 29, 2013
Gyeong-Je Kwon Regulatory Affairs Specialist U & I Corporation 20, Sandan-ro, Uijeongbu-si, Gyeonggi-do, Korea 480-859
Re: K131200
Trade/Device Name: ASPIRIONTM ACP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: July 1, 2013 Received: July 3, 2013
Dear Gyeong-Je Kwon:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Gyeong-Je Kwon
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.
If you desire specific advice for your device on our labeling reculation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MIDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/Reportal"roblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDeviecs/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Erin I. Keith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known):
Device Name: ASPIRON™ ACP System
Indications for Use:
The ASPIRON™ ACP System is intended for anterior inter-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
WARNING: The device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Over-The-Counter Use × Prescription Use ----------------------------------------------------------------------AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Anton E. Dmitriev, PhD Division of Orthopedic Devices
ASPIRON™ ACP System
Image /page/5/Picture/19 description: The image shows the logo for U&I Corporation. The logo consists of the letters "U&I" in a stylized font, followed by the word "CORPORATION" in a blocky, sans-serif font. The text is black and the background is white.
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