(24 days)
No
The summary describes a traditional spinal fixation system and does not mention any AI or ML components, image processing, or data sets typically associated with AI/ML device submissions.
Yes
The device is described as spinal fixation intended as an adjunct to fusion for various back conditions, which are treatments for diseases or injuries.
No
Explanation: The device is described as a spinal fixation system, used as an adjunct to fusion for various spinal conditions. Its purpose is to stabilize the spine, not to identify or diagnose diseases.
No
The device description explicitly states it consists of "implants and instruments," which are hardware components, not software.
No, 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. This is a device used in vivo (within the body) to provide structural support and aid in fusion.
- Device Description: The description focuses on the physical components of the system (implants and instruments) and the materials used.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Providing information about a patient's health status based on the analysis of these samples.
- Any form of diagnostic testing or measurement performed in vitro (outside the body).
IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This spinal system does not fit that description.
N/A
Intended Use / Indications for Use
The Quantum Spinal System components are non-cervical spinal fixation devices intended for use as an adjunct to fusion as a pedicle screw system (T1 - S2), a posterior hook and sacral/iliac screw fixation system 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, KWQ, KWP, MNH, MNI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spinal (T1 - S2) for pedicle screw system, T8 - L5 for anterolateral fixation system
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)
Testing per recognized ASTM standards was presented. Comparisons of device performance data, materials, indications and design/function to predicate devices were provided in making a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Koso518
510(k) Summary 3.0
| Sponsor: | Pioneer Surgical Technology
375 River Park Circle
Marquette, MI 49855
(906) 226-4812
Contact: Jonathan M. Gilbert | MAR 20 2008 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Device Name: | Quantum Spinal System | |
| Classification Name: | Spinal Interlaminal Fixation Orthosis - §888.3050, Spinal
Inter-vertebral Body Fixation Orthosis - §888.3060,
Spondylolisthesis Spinal Fixation Device System and Pedicle Screw
Spinal System - §888.3070, Class III. | |
| Product Codes: | NKB, KWQ, KWP, MNH, MNI, Panel Code 87 | |
| Predicate Device: | K070973 - Quantum Spinal System (SE date - July 3, 2007)
K072187 - Pioneer LowTop (SE date - October 12, 2007) | |
| Intended Use: | The Quantum Spinal System components are non-cervical spinal
fixation devices intended for use as an adjunct to fusion as a pedicle
screw system (T1 - S2), a posterior hook and sacral/iliac screw
fixation system 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: | Materials used to manufacture the implants and instruments of this
system are in conformance with ASTM Standard Specifications. | |
| Performance Data: | Testing per recognized ASTM standards was presented. | |
| Performance and SE
Determination: | Comparisons of device performance data, materials, indications and
design/function to predicate devices were provided in making a
determination of substantial equivalence. | |
pg lofl
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
MAR 2 0 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pioneer Surgical Technology % Mr. Jonathan M. Gilbert VP of Clinical & Regulatory Affairs 375 River Park Circle Marquette, Michigan 49855
Re: K080218
Trade/Device Name: Quantum Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: NKB, KWP, KWQ, MNH, MNI Dated: February 22, 2008 Received: February 25, 2008
Dear Mr. Gilbert:
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. Jonathan M. Gilbert
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 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.litml.
Sincerely yours,
Mark M. Milliman
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 Statement 2.0
| 510(k) Number (if known): | K080518 |
|---|---|
| Device Name: | Quantum Spinal System |
| Indications for Use: | The Quantum Spinal System components are non-cervical spinal |
| fixation devices intended for use as an adjunct to fusion as a pedicle | |
| screw system (T1 - S2), a posterior hook and sacral/iliac screw | |
| fixation system 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. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use √ OR Over-the-Counter Use __
(Per 21 CFR 801.109)
(Division Sign-Off)
for Division of General, Restorative,
and Neurological Devices
510(k) Number K080518