(252 days)
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.
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).
This document describes the acceptance criteria and the study conducted for the Pioneer Quantum Spinal System (including MIS) HA Coated Pedicle Screws (Non-Cannulated and Cannulated). This is a medical device, and the evaluation for substantial equivalence to a predicate device is based on non-clinical mechanical tests, not an AI/algorithm-based system. Therefore, many standard AI/ML study components (like sample sizes for test/training sets, ground truth by experts, MRMC studies, standalone algorithm performance) are not applicable.
Here's the breakdown based on the provided text, focusing on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Pedicle Screw Insertion and Removal Torques | Performance comparable to or better than predicate devices, and within acceptable industry standards. | Performed. Results were sufficient to demonstrate substantial equivalence. |
| Static Flexion-Extension Test | Performance comparable to or better than predicate devices, and within acceptable industry standards. | Performed. Results were sufficient to demonstrate substantial equivalence. |
| Dynamic Flexion-Extension of HA Coated and Uncoated Cannulated Screws | Performance comparable to or better than predicate devices, and within acceptable industry standards. | Performed. Results were sufficient to demonstrate substantial equivalence. |
| Compliance with FDA Guidance for HA Coated Implants | Meet "510(k) Information Needed for Hydroxyapatite Coated Implants" requirements. | Existing testing provided and deemed compliant. |
Note: The document implicitly states that the performance met the criteria by concluding "the subject device demonstrates substantial equivalence to the listed predicate devices" based on the performed mechanical tests. Specific numerical acceptance criteria are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
Since this is a mechanical device evaluation, the "test set" refers to the physical devices and components subjected to testing, not a dataset of patient information.
- Sample Size for Test Set: Not explicitly stated as a number of devices/components, but the described tests would have involved multiple samples to ensure reproducibility and statistical significance.
- Data Provenance: The tests were conducted by the manufacturer, Pioneer Surgical Technology. The data is based on laboratory mechanical testing (non-clinical) of prototype or production-representative devices. There is no information about country of origin of data or retrospective/prospective in the context of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This is a mechanical device. "Ground truth" in this context would be physical measurements and engineering analyses, not expert medical opinion on clinical data.
4. Adjudication Method for the Test Set
- Not Applicable. As per point 3, there's no "adjudication" in the sense of reconciling expert opinions on medical cases. The evaluation is based on objective mechanical testing results against engineering standards and comparison with predicate devices.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No. This is a medical device, not an AI/algorithm. MRMC studies are used for evaluating diagnostic software/algorithms.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Mechanical Performance Standards and Predicate Device Comparison: The "ground truth" for the device's performance is its ability to withstand specific forces, torques, and cycles as demonstrated by the mechanical tests (Pedicle Screw Insertion and Removal Torques, Static Flexion-Extension Test, Dynamic Flexion-Extension) and its equivalence to the previously cleared predicate devices in terms of material properties and performance. Compliance with FDA guidance for hydroxyapatite-coated implants also serves as a "ground truth" for material safety and performance.
8. The Sample Size for the Training Set
- Not Applicable. This is a medical device, not an AI/algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. This is a medical device, not an AI/algorithm. Design and manufacturing processes are iteratively developed and tested against engineering specifications, but there isn't a "training set" in the machine learning sense.
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MAR - 7 2011
510(k) SUMMARY
| Sponsor: | Manufacturer | Pioneer Surgical Technology375 River Park CircleMarquette, MI 49855 |
|---|---|---|
| Official Contact:Phone:Fax: | Emily M. Downs906-225-5602906-226-4459 | |
| Representative/ Consultant:Phone:Fax: | Barry E. Sands978-363-5277978-477-0206 | |
| Date prepared: | March 7, 2011 | |
| Device Name: | Pioneer Quantum Spinal System (including MIS) HA Coated Pedicle Screws (Non-Cannulated and Cannulated) | |
| ClassificationName: | Spinal Interlaminal Fixation Orthosis/ Spinal Intervertebral Body Fixation Orthosis / PedicleScrew System | |
| ClassificationNumber: | 21 CFR 888.3050: Spinal Interlaminal Fixation Orthosis (Appliance, Fixation, SpinalInterlaminal), Product code KWP, Class II;21 CFR 888.3060: Spinal Intervertebral Body Fixation Orthosis, Product code KWQ, ClassII; and21 CFR 888.3070(b)(1) & (2): Pedicle Screw Spinal System, Product codes MNH, MNIClass 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); andTSRH hydroxyapatite-coated screws (K091797). | |
| Description: | The Quantum Spinal System (including MIS) consists of a variety of rods, fixed andpolyaxial 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 immobilizationand stabilization of spinal segments as an adjunct to fusion of the thoracic and/or lumbarspine. The implant components can be rigidly locked into a variety of configurations, witheach construct being tailor-made for the individual case. | ||
| The Quantum Spinal System (including MIS) components are comprised of Titanium AlloyTi6A14V per ASTM F136. A subcomponent of the locking cap, a spring clip, is comprisedof nitinol (NiTi) per ASTM F 2063. All components of the Quantum Spinal System(including MIS) HA Coated Pedicle Screws (Non-Cannulated and Cannulated) are comprisedof 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 andstabilization of spinal segments in skeletally mature patients as an adjunct to fusion in thetreatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacralspine: 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, thisdevice 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 byautogenous bone graft having implants attached to the lumbar and sacral spine (L3-S1) withremoval of the implants after the attainment of a solid fusion.The Quantum Spinal System components are non-cervical spinal fixation devices intended asan 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 screwfixation is limited to skeletally mature patients. These devices are indicated for all of thefollowing indications regardless of the intended use: degenerative disc disease (defined asdiscogenic back pain with degeneration of the disc confirmed by history and radiographicstudies), 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 hydroxyapatitecoating. The predicate device is composed of the same material. | |
| Comparison toPredicate Devices: | The indication for use, material, mechanism of action, and available sizes of the Pioneer HACoated Quantum Spinal System (including MIS) are within the range of sizes as the predicatedevice. | |
| Performance Data: | For a determination of substantial equivalence, the following non-clinical mechanical testswere performed:• Pedicle Screw Insertion and Removal Torques• Static Flexion-Extension Test• Dynamic Flexion-Extension of HA Coated and Uncoated Cannulated ScrewsExisting testing was also provided to demonstrate the requirements of the FDA guidancedocument "510(k) Information Needed for Hydroxyapatite Coated Implants". | |
| Performance andSE Determination: | Based on the supporting documentation within this premarket notification, the subject devicedemonstrates substantial equivalence to the listed predicate devices. |
·
Pioneer Quantum Spinal System (including MIS) HA Coated Pedicle Screws (Non-Cannulated and
Cannulated)
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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
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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
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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_
Page 1 of 1
§ 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.