(24 days)
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.
The Quantum Spinal System components are non-cervical spinal fixation devices. Materials used to manufacture the implants and instruments of this system are in conformance with ASTM Standard Specifications.
The provided 510(k) summary for the K080518 Quantum Spinal System does not contain information on acceptance criteria for a device, diagnostic or AI algorithm, nor a study proving it meets such criteria. Instead, it describes a medical device (spinal fixation system) and its intended use, material, and regulatory classification.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering performance data (e.g., mechanical testing) for spinal implants, rather than clinical performance data from studies involving human subjects in the way an AI/diagnostic device would be evaluated.
Therefore, I cannot provide the requested information in the table format or answer the specific questions related to AI/diagnostic device evaluation, as these details are not present in the provided text.
The "Performance Data" section states: "Testing per recognized ASTM standards was presented." This refers to laboratory-based mechanical and materials testing according to established engineering standards for medical implants. These tests usually evaluate properties like fatigue strength, pull-out strength, and corrosion resistance, which is different from a diagnostic performance study.
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Koso518
510(k) Summary 3.0
| Sponsor: | Pioneer Surgical Technology375 River Park CircleMarquette, MI 49855(906) 226-4812Contact: Jonathan M. Gilbert | MAR 20 2008 |
|---|---|---|
| Device Name: | Quantum Spinal System | |
| Classification Name: | Spinal Interlaminal Fixation Orthosis - §888.3050, SpinalInter-vertebral Body Fixation Orthosis - §888.3060,Spondylolisthesis Spinal Fixation Device System and Pedicle ScrewSpinal 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 spinalfixation devices intended for use as an adjunct to fusion as a pediclescrew system (T1 - S2), a posterior hook and sacral/iliac screwfixation system or as an anterolateral fixation system (T8 - L5).Pedicle screw fixation is limited to skeletally mature patients. Thesedevices are indicated for all of the following indications regardlessof the intended use: degenerative disc disease (defined asdiscogenic back pain with degeneration of the disc confirmed byhistory 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 thissystem are in conformance with ASTM Standard Specifications. | |
| Performance Data: | Testing per recognized ASTM standards was presented. | |
| Performance and SEDetermination: | Comparisons of device performance data, materials, indications anddesign/function to predicate devices were provided in making adetermination of substantial equivalence. |
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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.
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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
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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 spinalfixation devices intended for use as an adjunct to fusion as a pediclescrew system (T1 - S2), a posterior hook and sacral/iliac screwfixation 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 indicationsregardless of the intended use: degenerative disc disease (defined asdiscogenic back pain with degeneration of the disc confirmed byhistory 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
N/A