K Number
K070973
Device Name
QUANTUM SPINAL SYSTEM
Date Cleared
2007-07-03

(88 days)

Product Code
Regulation Number
888.3070
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantum Spinal System components are non-cervical spinal fixation devices intended for use 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.
Device Description
Not Found
More Information

No
The 510(k) summary describes a mechanical spinal fixation system and does not mention any AI or ML components, image processing, or data-driven performance metrics typically associated with AI/ML devices.

No
The device is described as a non-cervical spinal fixation device, which is used to stabilize the spine, not to directly treat a disease or condition. It is a structural support device rather than a therapeutic intervention.

No

This device is described as a spinal fixation device, intended for surgical implantation to treat various spinal conditions, not to diagnose them. Its indications for use are conditions like degenerative disc disease, spondylolisthesis, and trauma, which are already diagnosed conditions requiring physical intervention.

No

The device description explicitly states "The Quantum Spinal System components are non-cervical spinal fixation devices," indicating physical hardware components (screws, hooks, etc.) are involved, not just software.

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 system of spinal fixation devices used for surgical implantation to treat various spinal conditions. This is a therapeutic device, not a diagnostic one.
  • Device Description (though not found): The description of the intended use points to physical implants used in surgery.
  • Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis, which are hallmarks of IVD devices.

Therefore, the Quantum Spinal System is a medical device used for surgical treatment, 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 as an adjunct to fusion for use as a pedicle screw (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, 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, KWQ, KWP, MNI, MNH

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, 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

Testing per recognized ASTM standards was presented.

Key Metrics

Not Found

Predicate Device(s)

K041167 - Quantum Spinal System, K070551 - Quantum Spinal System, K052151 - Synthes Pangea Monoaxial System, K031175 - Synthes Click'X Monoaxial System

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

Summary of Safety and Effectiveness Information
---------------------------------------------------

K070973

| Sponsor: | Pioneer Surgical Technology
375 River Park Circle
Marquette, MI 49855
(906) 226-4812
Contact: Jonathan M. Gilbert

JUL - 3 2007 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 III. |
| Predicate Device: | K041167 - Quantum Spinal System, K070551 - Quantum Spinal
System, K052151 - Synthes Pangea Monoaxial System, K031175 -
Synthes Click'X Monoaxial System |
| Intended Use: | The Quantum Spinal System components are non-cervical spinal
fixation devices intended as an adjunct to fusion for use as a pedicle
screw (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, 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. |
| Material: | Materials used to manufacture the implants (titanium alloy) and
instruments (medical grade stainless steel) 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. |

1

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 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 perimeter. Inside the circle is a stylized eagle emblem, depicted with flowing lines to suggest movement or flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pioneer Surgical Technology % Mr. Jonathan Gilbert VP, Clinical and Regulatory Affairs 375 River Park Circle Marquette, MI 49855

Re: K070973

Trade/Device Name: OUANTUM Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, KWQ, KWP, MNI, MNH Dated: April 4, 2007 Received: April 6, 2007

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

111 - 3 2007

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 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 Office of Compliance at (240) 276-0120. 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 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,

Sincerely, yours,
for

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):K070973
Device Name:Quantum Spinal System
Indications for Use:The Quantum Spinal System components are non-cervical spinal
fixation devices intended for use 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.

Prescription Use
(Per 21 CFR 801.109) √

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

P.M.
(Division Sign-Off)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K070973
Original 4/4/07
Revised 6/8/07

Pioneer Surgical Technology Premarket Notification