(49 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any AI or ML components or functions.
Yes
The intended use explicitly states conditions like "Degenerative disk disease", "Trauma (i.e.: fracture or dislocation)", "Spinal stenosis", and "Curvatures (i.e.: scoliosis, kyphosis, and/or lordosis)", which are diseases or medical conditions that the device treats or mitigates.
No
Explanation: The device is described as a surgical implant system (Pedicle Screw System) used for spinal fixation in treating various spinal conditions, not for diagnosing them. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly states that the system consists of physical components like rods, screws, and caps, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for spinal fixation. It addresses various spinal conditions and is used in vivo (within the body) during surgery.
- Device Description: The device is described as a system of titanium alloy components (rods, screws, caps, connectors) used to create a surgical construct. This is a physical implant, not a diagnostic test performed on biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a surgical implant used to treat spinal conditions directly.
N/A
Intended Use / Indications for Use
The Accin™ Pedicle Screw System components are intended for noncervical and nonpedicle anterolateral fixation of:
- Degenerative disk disease (defined as back pain of discogenic origin with degeneration . of the disc confirmed by history and radiographic studies);
- Spondylolisthesis (grade 3 or 4)
- Trauma (i.e.: fracture or dislocation) ●
- Spinal stenosis ●
- Curvatures (i.e.: scoliosis, kyphosis, and/or lordosis) ●
- Tumor
- Pseudoarthrosis .
- Failed previous fusion. ●
The Accin™ Pedicle Screw System components are intended for non-cervical pedicle fixation of:
- Spondylolisthesis (grade 3 or 4) .
- Trauma (i.e .: fracture or dislocation) .
- Spinal stenosis
- Curvatures (i.e. scoliosis, kyphosis, and/or lordosis) .
- Tumor ●
- Pseudoarthrosis
- Failed previous fusion. .
These components are single use only and are intended for use in skeletally mature patients.
Product codes (comma separated list FDA assigned to the subject device)
MNH, MNI, KWQ
Device Description
The Accin™ Pedicle System consists of titanium alloy rods, cannulated, multi-axial and standard screws, locking caps, and cross-connector components. The surgeon uses the components to make a construct for spinal fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
noncervical and nonpedicle (for anterolateral fixation); non-cervical pedicle (for pedicle fixation)
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)
Tests were performed on the pedicle screw system. The testing was performed in accordance with ASTM F1717, Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model.
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.
K033352, K043152, K051716 and K071376
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.
0
Summary of Safety and Effectiveness
| Submitter: | Michael Kvitnitsky
Accelerated Innovation, LLC
1033 US Highway 46, Suite A204
Clifton, NJ 07103 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | December 10, 2007 |
| Device: | Accin™ Pedicle Screw System |
| Classification: | 87MNI - Orthosis, Spinal Pedicle Fixation 21CFR 888.3070, Class II
87MNH - Orthosis, Spondylolisthesis Spinal Fixation, 21CFR 880.3070, Class II
87KWQ - Appliance, Fixation, Spinal Intervertebral Body, 21CFR 880.3060,
Class II |
| Predicate Device: | Vertebron PSS System - K033352, K043152, K051716 and K071376 |
| Device Description: | The Accin™ Pedicle System consists of titanium alloy rods, cannulated, multi-
axial and standard screws, locking caps, and cross-connector components. The
surgeon uses the components to make a construct for spinal fixation. |
| Intended Use: | The Accin™ Pedicle Screw System components are intended for noncervical and
nonpedicle anterolateral fixation of: degenerative disk disease (defined as back pain of
discogenic origin with degeneration of the disc confirmed by history and radiographic
studies); spondylolisthesis (grade 3 or 4); trauma (i.e.: fracture or dislocation); spinal
stenosis; curvatures (i.e.: scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis;
failed previous fusion in skeletally mature patients. |
The Accin™ Pedicle Screw System components are intended for non-cervical pedicle fixation of: Spondylolisthesis (grade 3 or 4); trauma (i.e.: fracture or dislocation); spinal stenosis; curvatures (i.e.: scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; failed previous fusion in skeletally mature patients.
Comparison to Predicates:
The Accin™ Pedicle Screw System consists of cannulated, multi-axial and standard screws, rods, crossconnectors, and locking caps manufactured from titanium alloy. The device is equivalent to the Vertebron PSS System, which also has the same components manufactured from the same materials.
Accin™ has determined that any differences in the proposed device will not impact the safety or effectiveness of the pedicle screw system for its intended use. Testing has shown that the proposed device meets the requirements of the current FDA Guidance document entitled "Spinal System 510(k)s" dated May 3, 2004, and that the proposed device is equivalent to the predicate device.
Synopsis of Test Methods and Results:
Tests were performed on the pedicle screw system. The testing was performed in accordance with ASTM F1717, Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectorny Model.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized design featuring three curved lines that resemble a human figure or abstract symbol.
Public Health Service
FEB - 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Accelerated Innovations, LLC % Mr. Michael Kvitnitsky Chief Operating Officer 1033 US Highway 46, Suite A204 Clifton, NJ 07103
Re: K073531
Trade/Device Name: Accin™ Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNH, MNI, KWQ Dated: December 7, 2007 Received: December 17, 2007
Dear Mr. Kvitnitsky:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.
2
Page 2 -- Mr. Michael Kvitnitsky
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Mulkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Form
510(k) Number (if known): K073531
Device Name: Accin™ Pedicle Screw System
Indications for Use:
The Accin™ Pedicle Screw System components are intended for noncervical and nonpedicle anterolateral fixation of:
- Degenerative disk disease (defined as back pain of discogenic origin with degeneration . of the disc confirmed by history and radiographic studies);
- Spondylolisthesis (grade 3 or 4)
- Trauma (i.e.: fracture or dislocation) ●
- Spinal stenosis ●
- Curvatures (i.e.: scoliosis, kyphosis, and/or lordosis) ●
- Tumor
- Pseudoarthrosis .
- Failed previous fusion. ●
The Accin™ Pedicle Screw System components are intended for non-cervical pedicle fixation of:
- Spondylolisthesis (grade 3 or 4) .
- Trauma (i.e .: fracture or dislocation) .
- Spinal stenosis
- Curvatures (i.e. scoliosis, kyphosis, and/or lordosis) .
- Tumor ●
- Pseudoarthrosis �
- Failed previous fusion. .
These components are single use only and are intended for use in skeletally mature patients.
Prescription Use × (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Soulaue MrellPage 1 of 1
510(k) Number K07353)