(252 days)
Not Found
No
The device description and intended use focus on the mechanical components and their function in spinal stabilization. There is no mention of AI/ML, image processing, or data-driven analysis. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is described as providing "immobilization and stabilization of spinal segments... as an adjunct to fusion" in the treatment of various spinal conditions, which directly relates to treating or mitigating disease or injury.
No
Explanation: The device is described as a spinal fixation system, consisting of implants like rods, screws, and connectors, intended for immobilization and stabilization of spinal segments as an adjunct to fusion. Its purpose is to treat various spinal conditions, not to diagnose them.
No
The device description explicitly states it consists of physical components like rods, screws, connectors, and caps made of titanium alloy and nitinol, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The description clearly states that the Quantum-MIS Cannulated System is a spinal implant system consisting of rods, screws, connectors, and caps. Its intended use is to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various spinal conditions.
- Mechanism of Action: The device works by providing mechanical support and stabilization to the spine, not by analyzing biological specimens.
The text describes a surgical implant used directly within the body for structural support, which is fundamentally different from an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Quantum-MIS Cannulated 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and /or lordosis), spinal tumor, and failed previous fusion (pseudoarthrosis). In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3-S1) with removal of the implants after the attainment of a solid fusion.
The Quantum Spinal System components are non-cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw system (T1 - S2), posterior hook (TI-L5) sacral/iliac screw fixation or as an anterolateral fixation system (T8 - L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications regardless of the intended use: 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), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.
Product codes
NKB, MNI, MNH, KWP, KWQ
Device Description
The Quantum Spinal System (including MIS) consists of a variety of rods, fixed and polyaxial screws, transverse connectors, and locking caps used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.
The Quantum Spinal System (including MIS) are intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic and/or lumbar spine. The implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
The Quantum Spinal System (including MIS) components are comprised of Titanium Alloy Ti6A14V per ASTM F136. A subcomponent of the locking cap, a spring clip, is comprised of nitinol (NiTi) per ASTM F 2063. All components of the Quantum Spinal System (including MIS) HA Coated Pedicle Screws (Non-Cannulated and Cannulated) are comprised of Titanium Alloy Ti6Al4V per ASTM F136 and have a hydroxyapatite (HA) coating.
The purpose of this submission is to include HA coated pedicle screws to the Quantum Spinal System (including MIS).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine, L5-S1 vertebra, L3-S1, T1-S2, T1-L5, T8-L5
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)
For a determination of substantial equivalence, the following non-clinical mechanical tests were performed:
• Pedicle Screw Insertion and Removal Torques
• Static Flexion-Extension Test
• Dynamic Flexion-Extension of HA Coated and Uncoated Cannulated Screws
Existing testing was also provided to demonstrate the requirements of the FDA guidance document "510(k) Information Needed for Hydroxyapatite Coated Implants".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K080518, K080026, K070973, K070551, K041167, K060638, K091797
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAR - 7 2011
510(k) SUMMARY
| Sponsor: | Manufacturer | Pioneer Surgical Technology
375 River Park Circle
Marquette, MI 49855 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| | Official Contact:
Phone:
Fax: | Emily M. Downs
906-225-5602
906-226-4459 |
| | Representative/ Consultant:
Phone:
Fax: | Barry E. Sands
978-363-5277
978-477-0206 |
| | Date prepared: | March 7, 2011 |
| Device Name: | Pioneer Quantum Spinal System (including MIS) HA Coated Pedicle Screws (Non-
Cannulated and Cannulated) | |
| Classification
Name: | Spinal Interlaminal Fixation Orthosis/ Spinal Intervertebral Body Fixation Orthosis / Pedicle
Screw System | |
| Classification
Number: | 21 CFR 888.3050: Spinal Interlaminal Fixation Orthosis (Appliance, Fixation, Spinal
Interlaminal), Product code KWP, Class II;
21 CFR 888.3060: Spinal Intervertebral Body Fixation Orthosis, Product code KWQ, Class
II; and
21 CFR 888.3070(b)(1) & (2): Pedicle Screw Spinal System, Product codes MNH, MNI
Class II, NKB Class III. | |
| Predicate Devices: | Quantum (including MIS) Spinal Implant System Pedicle Screws (K080518, K080026,
K070973, K070551 and K041167);
Dynesys hydroxyapatite-coated screws (K060638); and
TSRH hydroxyapatite-coated screws (K091797). | |
| Description: | The Quantum Spinal System (including MIS) consists of a variety of rods, fixed and
polyaxial screws, transverse connectors, and locking caps used to build a spinal construct.
Instrumentation is also available to facilitate implantation of the device components. | |
| | The Quantum Spinal System (including MIS) are intended to help provide immobilization
and stabilization of spinal segments as an adjunct to fusion of the thoracic and/or lumbar
spine. The implant components can be rigidly locked into a variety of configurations, with
each construct being tailor-made for the individual case. | |
| | The Quantum Spinal System (including MIS) components are comprised of Titanium Alloy
Ti6A14V per ASTM F136. A subcomponent of the locking cap, a spring clip, is comprised
of nitinol (NiTi) per ASTM F 2063. All components of the Quantum Spinal System
(including MIS) HA Coated Pedicle Screws (Non-Cannulated and Cannulated) are comprised
of Titanium Alloy Ti6Al4V per ASTM F136 and have a hydroxyapatite (HA) coating. | |
| | The purpose of this submission is to include HA coated pedicle screws to the Quantum Spinal System (including MIS). | |
| Intended Use: | The Quantum-MIS Cannulated 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 instabilities or deformities of the thoracic, lumbar, and sacral
spine: degenerative spondylolisthesis with objective evidence of neurological impairment,
trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and
/or lordosis), spinal tumor, and failed previous fusion (pseudoarthrosis). In addition, this
device is a pedicle screw system indicated for the treatment of severe spondylolisthesis
(Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by
autogenous bone graft having implants attached to the lumbar and sacral spine (L3-S1) with
removal of the implants after the attainment of a solid fusion.
The Quantum Spinal System components are non-cervical spinal fixation devices intended as
an adjunct to fusion for use as a pedicle screw system (T1 - S2), posterior hook (TI-L5)
sacral/iliac screw fixation or as an anterolateral fixation system (T8 - L5). Pedicle screw
fixation is limited to skeletally mature patients. These devices are indicated for all of the
following indications regardless of the intended use: 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), deformities or curvatures
(i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis,
pseudoarthrosis, and failed previous fusion. | |
| Material: | The Pioneer HA Coated Quantum (including MIS) Spinal System Pedicle Screws (Non-
Cannulated and Cannulated) are composed of Ti Alloy per ASTM F136 and hydroxyapatite
coating. The predicate device is composed of the same material. | |
| Comparison to
Predicate Devices: | The indication for use, material, mechanism of action, and available sizes of the Pioneer HA
Coated Quantum Spinal System (including MIS) are within the range of sizes as the predicate
device. | |
| Performance Data: | For a determination of substantial equivalence, the following non-clinical mechanical tests
were performed:
• Pedicle Screw Insertion and Removal Torques
• Static Flexion-Extension Test
• Dynamic Flexion-Extension of HA Coated and Uncoated Cannulated Screws
Existing testing was also provided to demonstrate the requirements of the FDA guidance
document "510(k) Information Needed for Hydroxyapatite Coated Implants". | |
| Performance and
SE Determination: | Based on the supporting documentation within this premarket notification, the subject device
demonstrates substantial equivalence to the listed predicate devices. | |
·
Pioneer Quantum Spinal System (including MIS) HA Coated Pedicle Screws (Non-Cannulated and
Cannulated)
1
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized image of a bird in flight. The bird is composed of three curved lines, suggesting movement and freedom. The text is arranged in a circular pattern around the bird, with "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" clearly visible.
MAR -- 7 2011
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Pioneer Surgical Technology % ROMIS, Inc. Mr. Barry E. Sands 5 Hemingway Lane West Newbury, Massachusetts 01985
Re: K101790
Trade/Device Name: Quantum Spinal System (including MIS) Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWP, KWQ Dated: February 28, 2011 Received: March 01, 2011
Dear Mr. Sands:
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
3
Page 2 - Mr. Barry E. Sands
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 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/ResourcesforYou/Industry/default.htm:___________
Sincerely yours,
Ary B. D. for
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
| 510(k) Number (if known): | K101790 |
|---|---|
| Device Name: | Quantum Spinal System (including MIS) |
Indications:
The Quantum-MIS Cannulated System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and /or lordosis), spinal tumor, and failed previous fusion (pseudoarthrosis). In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3-S1) with removal of the implants after the attainment of a solid fusion.
The Quantum Spinal System components are non-cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw system (T1 - S2), posterior hook (T1-L5) sacral/iliac screw fixation or as an anterolateral fixation system (T8 – L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-the-Counter Use
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KI01790 510(k) Number_
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