(36 days)
The LAGUNA® Size 8 Pedicle Screw System is intended to be used as an adjunct to fusion in skeletally mature patients using autograft or allograft in posterior, non-cervical fixation for the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies): spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor pseudarthrosis; and/or failed previous fusion.
The LAGUNA® Size 8 Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. The LAGUNA® Size 8 Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. Polyaxial screws are supplied in winged and non-winged configurations, in a variety of different length, ranging from 35 mm to 100 mm and 8mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. The LAGUNA® Size 8 Pedicle Screw System implant components are fabricated from medical grade titanium alloy per ASTM F136.
The provided text describes a medical device, the Allez Spine LAGUNA® Size 8 Pedicle Screw System, and its 510(k) premarket notification (K091995) to the FDA. The document focuses on the regulatory clearance process and includes information about the device's indications for use and equivalence to a previously marketed device.
However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.
The section "Performance data" states: "Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading." This is a general statement and does not provide numerical acceptance criteria or detailed study results.
Therefore, I cannot populate the requested table or answer the specific questions about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as this information is not present in the provided document.
To summarize the requested categories:
- Table of acceptance criteria and reported device performance: Not provided in the text. The text only vaguely states "test results were equivalent to other similar implants and are sufficient for in vivo loading."
- Sample size used for the test set and data provenance: Not provided in the text.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable, as no clinical study with expert ground truth is described.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable, as this device is a physical spinal fixation system, not an AI or imaging diagnostic device. The concept of "human readers improve with AI vs without AI assistance" does not apply here.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical medical device.
- The type of ground truth used: Not explicitly stated for performance testing beyond "biomechanical tests."
- The sample size for the training set: Not applicable, as this is not an AI/ML device with a training set.
- How the ground truth for the training set was established: Not applicable.
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| Contact: | Mr. Hartmut LochVice President, Regulatory AffairsAllez Spine, LLC.2301 Dupont Drive, Suite 510Irvine CA 92612 | AUG 07 2009 |
|---|---|---|
| Trade name: | Allez Spine LAGUNA® Size 8 Pedicle Screw System | |
| Common name: | Spinal Fixation System | |
| Classificationname: | Appliance, Fixation, Spinal Interlaminal - § 888.3050 (KWP) - class IIOrthosis, Spinal Pedicle Fixation - § 888.3070 (MNI) - class IIOrthosis, Spondylolisthesis Spinal Fixation - § 888.3070 (MNH) - class IIOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease- § 888.3070 (NKB) - class III | |
| All Orthopedic Device Panel 87 | ||
| Product Code: | KWP, MNI, MNH & NKB | |
| Device Descriptionand Characteristics: | The LAGUNA® Size 8 Pedicle Screw System is intended to help providecorrection, immobilization and stabilization of spinal segments as an adjunctto fusion of the thoracic, lumbar and/or sacral space. | |
| The LAGUNA® Size 8 Pedicle Screw System consists of a variety of rodsand screws, which can be rigidly locked into a variety of configurations, witheach construct being tailor made for the individual case. Polyaxial screwsare supplied in winged and non-winged configurations, in a variety ofdifferent length, ranging from 35 mm to 100 mm and 8mm diameter sizes.All sizes are able to receive 5.5mm connecting rods only. | ||
| The LAGUNA® Size 8 Pedicle Screw System implant components arefabricated from medical grade titanium alloy per ASTM F136. | ||
| Equivalence: | The modified LAGUNA® Size 8 Pedicle Screw System is substantiallyequivalent to the original LAGUNA® Size 8 Pedicle Screw System, which ismanufactured and marketed by Allez Spine, LLC. | |
| Indications: | The LAGUNA® Size 8 Pedicle Screw System is intended to be used as anadjunct to fusion in skeletally mature patients using autograft or allograft inposterior, non-cervical fixation for the following conditions: degenerative discdisease (defined as back pain of discogenic origin with degeneration of thedisc confirmed by history and radiographic studies); spondylolisthesis;trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis,kyphosis and/or lordosis); tumor pseudarthrosis; and/or failed previousfusion. | |
| Performance data: | Biomechanical tests have been performed. The test results were equivalentto other similar implants and are sufficient for in vivo loading. |
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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" written around it. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
AUG 0 7 2009
Allez Spine, LLC Mr. Hartmut Loch 2301 Dupont Drive, Suite 510 Irvine, CA 92612
Re: K091995
Trade/Device Name: Laguna Size 8 Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWP Dated: June 30, 2009 Received: July 8, 2009
Dear Mr. Loch:
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.
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. Hartmut Loch
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K091995
LAGUNA® Size 8 Pedicle Screw System Device Name(s):
Indications for Use:
The LAGUNA® Size 8 Pedicle Screw System is intended to be used as an adjunct to fusion in skeletally mature patients using autograft or allograft in posterior, non-cervical fixation for the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies): spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor pseudarthrosis; and/or failed previous fusion.
(The device name is intended to be used with autograft and/or allograft as an adjunct to fusion.)
Prescription Use
Over-The-Counter-Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_1995
Page
§ 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.