(112 days)
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No
The document describes a mechanical implant system for spinal fixation and fusion, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as providing "stabilization and immobilization of spinal segments as an adjunct to fusion" and is intended for the treatment of various "acute and chronic instabilities or deformities" of the spine, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
This device is an internal fixation implant used for stabilizing and immobilizing spinal segments as an adjunct to fusion. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly states that the PILOT™ Plating System consists of physical components like bone screws, plates, washers, nuts, and collets, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "internal fixation implants" to stabilize and hold alignment in the spine. This is a surgical implant used in the body.
- Device Description: The description details components like bone screws, plates, washers, nuts, and collets made from medical grade titanium. These are physical implants.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any such use or interaction with biological specimens outside the body.
Therefore, the PILOT™ Plating System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Internal fixation implants are load-sharing devices intended to stabilize and hold an alignment in place until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.
The PILOT™ Plating System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization
The PILOT™ Postcrior Lumbar Plating 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 and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) spondylolisthesis, (3) trauma (1.e., fracture or dislocation) (4) spinal stenosis, (5) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) (6) tumor, (7) pseudoarthrosis, (8) failed previous fusion,
Product codes (comma separated list FDA assigned to the subject device)
MNI, MNH
Device Description
When implanted in the thoracic, lumbar, and/or sacral spine, the PILOT™ Plating System provides additional support during spinal fusion. The PILOT™ Plating System consists of bone screws, plates, washers, nuts, and collets in various shapes and sizes. The PILOTTM Plating System is manufactured from medical grade titanium and will be sold non-sterile.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
thoracic, lumbar, and/or sacral spine; non-cervical posterior spine
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biomechanical testing in accordance with ASTM F1717 was conducted to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Image /page/0/Picture/0 description: The image shows the words "Life Spine" in a stylized font. The word "Life" is in bold, while the word "Spine" is in a thinner font. There is a curved line underneath the word "Spine", and a circled R symbol to the right of the word "Spine".
761264
510(k) Summary of Safety and Effectiveness
| 510(k) Summary - PILOT™ Posterior Lumbar Plating System | SEP - 5 2006 | |
|---|---|---|
| Submitted By: | Life Spine | |
| 2400 Hassell Road, Suite 370 | ||
| Hoffman Estates, IL 60195 | ||
| Telephone: 847-884-6117 | ||
| Fax: 847-884-6118 | ||
| 510(k) Contact: | Erin Malloy | |
| Life Spine | ||
| 2400 Hassell Road, Suite 370 | ||
| Hoffman Estates, IL 60195 | ||
| Telephone: 847-884-6117 | ||
| Fax: 847-884-6118 | ||
| Date Prepared: | August 2, 2006 | |
| Trade Name: | PILOT™ Posterior Lumbar Plating System | |
| Common Name: | Posterior Pedicle screw system | |
| Classification: | 21 CFR 888.3070 | |
| Pedicle Screw Spinal System | ||
| Class II | ||
| Device Product Code: | MNI: Orthosis, Spinal, Pedical Fixation | |
| MNH: Orthosis, spondylolisthesis spinal fixation | ||
| Predicate Device: | Predicate device information is included in this premarket | |
| notification |
Device Description:
When implanted in the thoracic, lumbar, and/or sacral spine, the PILOT™ Plating System provides additional support during spinal fusion. The PILOT™ Plating System consists of bone screws, plates, washers, nuts, and collets in various shapes and sizes. The PILOTTM Plating System is manufactured from medical grade titanium and will be sold non-sterile.
Intended Use of the Device:
Internal fixation implants are load-sharing devices intended to stabilize and hold an alignment in place until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.
The PILOT™ Plating System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization
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and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities.
The PILOT™ Postcrior Lumbar Plating 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 and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) spondylolisthesis, (3) trauma (1.e., fracture or dislocation) (4) spinal stenosis, (5) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) (6) tumor, (7) pseudoarthrosis, (8) failed previous fusion,
Material:
The PILOT™ Plating System is manufactured from medical grade titanium alloy described by ASTM F136 (Ti 6AL-4V-ELI).
Performance Data:
Biomechanical testing in accordance with ASTM F1717 was conducted to demonstrate substantial equivalence.
Substantial Equivalence:
The Life Spine PILOT™ Plating System was shown to be substantially equivalent to a previously cleared device in indications for use, design, function, and materials used.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Life Spine % Ms. Erin Malloy Project Engineer 2400 Hassell Road, Suite 370 Hoffman Estates, Illinois 60195
SEP - 5 2006
Re: K061364
Trade/Device Name: PILOTTM Posterior Lumbar Plating System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: August 2, 2006 Received: August 4, 2006
Dear Ms. Malloy:
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 - Ms. Erin Malloy
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 its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buchund
for
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
510(k) number (if known):
Device Name: PILOT™ Posterior Lumbar Plating System
Internal fixation implants are load-sharing devices intended to stabilize and hold an alignment in place until normal healing occurs. Implants are not intended to replace anguinent in practures or bear the weight of the body in the presence of incomplete bone healing.
The PILOT™ Posterior Lumbar Plating System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally posterior poents. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities.
The PILOT™ Posterior Lumbar Plating 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 and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) spondylolisthesis, (3) trauma (i.e., fracture or dislocation) (4) spinal stenosis, (5) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) (6) tumor, (7) pseudoarthrosis, (8) failed previous fusion.
Prescription Use x (Part 21 CFR 801 Subpart D) And/Or
Over-the-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Division of General, Restorative. and Neurological Devices
510(k) Number K061364
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