(80 days)
N/A
None
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on mechanical spinal fixation components.
No
Explanation: This device is a spinal fixation device, which is used to provide stability to the spine. While it treats conditions that cause pain and dysfunction (degenerative disc disease, spondylolisthesis, trauma, etc.), its primary function is mechanical support. Therapeutic devices generally refer to those that directly treat or mitigate a disease or condition, often through physiological or biochemical means. This device's role is structural rather than directly therapeutic in the sense of healing or curing the underlying disease.
No
Explanation: The provided text describes the Quantum Spinal System as a "spinal fixation device" used for treating various spinal conditions by mechanically stabilizing the spine. Its indications for use are for conditions such as degenerative disc disease, spondylolisthesis, trauma, etc., which are problems that have already been diagnosed. There is no mention of the device being used to identify or analyze a condition.
No
The device description explicitly states "Quantum Spinal System components are non-cervical spinal fixation devices," indicating physical hardware components are involved.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a "posterior pedicle screw system" and an "anterolateral fixation system" for the spine. These are surgical implants used to stabilize the spine.
- Device Description: The device is described as a "Quantum Spinal System," which aligns with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are typically laboratory tests or kits.
Therefore, the Quantum Spinal System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Quantum Spinal System components are non-cervical spinal fixation devices intended for use as a posterior pedicle screw system (T1 - S2) 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, pseudoarthosis, and failed previous fusion.
Product codes
NKB, 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 posterior pedicle screw system, T8 - L5 for anterolateral fixation system)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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)
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)
Not Found
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
JUL 2 3 2004
Summary of Safety and Effectiveness Information 3.0
| SPONSOR: | PIONEER SURGICAL TECHNOLOGY
375 River Park Circle
Marquette, MI 49855
(906) 226-4812
Contact: Jonathan M. Gilbert |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Quantum Spinal System |
| CLASSIFICATION
NAME: | Spinal Interlaminal Fixation Orthosis, Spinal
Intervertebral Body Fixation Orthosis,
Spondylolisthesis Spinal Fixation Device System
and Pedicle Screw Spinal System, Class II. |
| INTENDED USE: | The Quantum Spinal System components are
non-cervical spinal fixation devices intended for
use as a posterior pedicle screw system (T1 - S2)
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,
pseudoarthosis, and failed previous fusion. |
| 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* |
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 2004
Mr. Jonathan M. Gilbert Director, Regulatory Affairs Pioneer Surgical Technology 375 River Park Circle Marquette, Michigan 49855
K041167 Re:
Trade Name: Pioneer Quantum Spinal System Regulation Number: 21 CFR 888.3050, 888.3060, 888.3070 Regulation Name: Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation Orthosis, Pedicle Screw Spinal System Regulatory Class: Class III Product Code: NKB, KWP, MNH and MNI Dated: April 30 and July 1, 2004 Received: May 4 and July 6, 2004
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.
2
Page 2 - Mr. Jonathan M. Gilbert
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i hat FDA has made a determination that your device complies with other requirements of the Act that I 127 has made a cond regulations administered by other Federal agencies. You must or uny I edolul bakator and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set el R Furt 607); adoling (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in and quant on control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product railled would begin marketing your device as described in your Section 510(k) I mis letter will and in your le FDA finding of substantial equivalence of your device to a legally premated 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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Mark A. Milburn
Celia M. Witten, Ph.D., M.D. 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
Indications For Use Statement
Page 1 of 1
K041167 510(k) Number (if known):
Quantum Spinal System Device Name:
Indications:
The Quantum Spinal System components are non-cervical spinal fixation devices intended for use as a posterior pedicle screw system (T1 - S2) 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, pseudoarthosis, 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)
for Mack n Meller
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Numb__ K04 116.7