(105 days)
Not Found
No
The summary describes a mechanical implant system (plates and screws) and its intended use and mechanical testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No.
The device is an anterior cervical plate system used for spinal fixation (C2-C7) in various conditions like degenerative disc disease, trauma, and deformities, aiming to stabilize the spine rather than directly treating a disease or condition in a therapeutic manner.
No
This device is a surgical implant designed for anterior cervical fixation, not for diagnosing medical conditions. Its purpose is to stabilize the spine after a diagnosis has already been made.
No
The device description explicitly states that the system consists of "an assortment of plates and screws," which are physical hardware components.
No, 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 cervical fixation (C2-C7)" for various spinal conditions. This is a surgical implant used in vivo (within the body) to stabilize the spine.
- Device Description: The description details plates and screws used to secure them to vertebral bodies. This is consistent with a surgical implant, not a device used to test samples in vitro (outside the body).
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
The information provided describes a surgical implant for spinal fixation.
N/A
Intended Use / Indications for Use
The Pioneer Aspect Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin 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
KWO
Device Description
The Pioneer Aspect Anterior Cervical Plate System consists of an assortment of plates and screws. The screws are used to secure the plates to the vertebral bodies of the cervical spine through an anterior approach. The system consists of static plates in lengths that range from 10-105mm and include one, two, three, four, and five level designs. The plates have an integrated screw retention mechanism. The system includes fixed/variable self-tapping and self-drilling screws in 04.0 or 04.5mm, ranging from 10-20mm in length. The purpose of this submission is to communicate the next generation Aspect Anterior Cervical Plate System to the Agency.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-C7)
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
For a determination of substantial equivalence, non-clinical mechanical tests including ASTM F1717 dynamic and static compression bending and torsion static testing were completed. In addition, ASTM F543 screw pull-out testing and testing per internal protocols to assess screw pull through and retention characteristics were performed. Performance testing showed that the mechanical strength of the subject system is equivalent to or better than predicate devices and is therefore sufficient for the intended use.
Key Metrics
Not Found
Predicate Device(s)
K111528, K 100708, K083663, K971883, K 103491/K052552
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
510(k) SUMMARY (as required by 21 CFR 807.92(c))
Sponsor: Manufacturer: Pioneer Surgical Technology, Inc. 375 River Park Circle Marquette, MI 49855 Official Contact: Sarah McIntyre, Regulatory Affairs Associate II Phone: (906) 225-5861 Fax: (906) 226-4459 Date prepared: May 20, 2013 Name: Trade/Device Name: Pioneer Aspect Anterior Cervical Plate System Common Name: Anterior Cervical Plate System Classification: Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Product Code: KWO Regulatory Class: Class II Description: The Pioneer Aspect Anterior Cervical Plate System consists of an assortment of plates and screws. The screws are used to secure the plates to the vertebral bodies of the cervical spine through an anterior approach. The system consists of static plates in lengths that range from 10-105mm and include one, two, three, four, and five level designs. The plates have an integrated screw retention mechanism. The system includes fixed/variable self-tapping and self-drilling screws in 04.0 or 04.5mm, ranging from 10-20mm in length. The purpose of this submission is to communicate the next generation Aspect Anterior Cervical Plate System to the Agency. Intended Use: The Pioneer Aspect Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin 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. The plates and screws are manufactured from ASTM F 136 titanium alloy. The screw Material: retention mechanism ("retaining clip") of the plate is manufactured from ASTM F2063 Nitinol. Performance For a determination of substantial equivalence, non-clinical mechanical tests including ASTM Data: F1717 dynamic and static compression bending and torsion static testing were completed. In addition, ASTM F543 screw pull-out testing and testing per internal protocols to assess screw pull through and retention characteristics were performed. Performance testing showed that the mechanical strength of the subject system is equivalent to or better than predicate devices
K 130427 Pioneer Aspect Anterior Cervical Plate System
Page 1 of 2
and is therefore sufficient for the intended use.
JUN 5 2013
1
| Comparison to
Predicate Devices | The Sponsor is claiming substantial equivalence to the following legally marketed predicate
devices: |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K111528 Pioneer Aspect Anterior Cervical Plate System (24-series, SE 8/24/11)
K 100708 Pioneer Anterior Cervical Plate System (SE 6/4/10)
K083663 Pioneer PACP (SE 2/25/09)
K971883 Synthes Spine Small Stature Anterior Cervical Plate System (SE 10/16/97)
�
K 103491/K052552 DePuy Spine, Inc. SKYLINE Anterior Cervical Plate System
(SE 2/14/11) |
| | The subject Pioneer Aspect Anterior Cervical Plate System (27-series) has indications for use
identical to those of the predicate Pioneer Anterior Cervical Plate Systems and employs the
same principles of operation. Identical materials are used in predicate systems. A vailable
screw lengths, screw diameters, plate prominence and width, and plate types (one, two, three,
four and five-level; static) fall within the range of predicate devices. The differences between
the subject and predicate device do not affect the substantial equivalence of the device, as
demonstrated by a full battery of performance testing. |
| Performance and
SE .
Determination: | Based on the supporting documentation within this premarket notification, the subject system
demonstrates substantial equivalence to the listed predicate devices and is expected to be as
safe, as effective, and perform as well as or better than the predicate devices. |
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:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
June 5, 2013
Pioneer Surgical Technology, Incorporated % Ms. Sarah MoIntyre Regulatory Affairs Associate II 375 River Park Circle Marquette, Michigan, 49855
Re: K130427
Trade/Device Name: Pioneer Aspect Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 5, 2013 Received: March 7, 2013
Dear Ms. McIntyre:
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
3
Page 2 - Ms. Sarah McIntyre
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 regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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/MedicalDevices/Resourcesfor You/Industry/default.htm.
For
Sincerely yours,
rin Keith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K130427
Device Name: Pioneer Aspect Anterior Cervical Plate System
Indications:
The Pioneer Aspect Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin 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.
V Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton-E-Dmitriev, PhD-Division of Orthopedic Devices