(73 days)
The DEL MAR® Monoaxial Pedicle Screw System is intended for 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 DEL MAR® Monoaxial Pedicle Screw System is intended to be used with autograft and/or allograft as an adjunct to fusion.
The DEL MAR® Monoaxial 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. Monoaxial screws are supplied in winged and non-winged configurations, in a variety of different length, and in 5mm, 6mm, and 7mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. The DEL MAR® Monoaxial Pedicle Screw System implant components are fabricated from medical grade titanium alloy per ASTM F136.
This K091219 document describes a spinal fixation system, not an AI/ML powered medical device. Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, specifically in the context of AI/ML performance, cannot be extracted from the provided text.
The document discusses the Allez Spine Del Mar® Monoaxial Pedicle Screw System and focuses on its substantial equivalence to a predicate device based on material, design, and intended use for spinal fixation. The "Performance data" section (in {0}) states: "Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading." This indicates that the device's performance was evaluated through biomechanical testing to ensure it meets the mechanical requirements for spinal implants, but it does not involve any AI/ML components or associated acceptance criteria and study designs that would typically be described for such systems.
Therefore, I cannot provide the requested table and details as they pertain to AI/ML device performance.
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510(k) Summarv
[in accordance with SMDA of 1990, 21 CFR 807.92(c)]
Contact: Mr. Hartmut Loch Vice President, Regulatory Affairs Allez Spine, LLC. 2301 Dupont Drive, Suite 510 Irvine CA 92612
Trade name: Allez Spine Del Mar® Polyaxial Pedicle Screw System
Common name: Spinal Fixation System
Classification Appliance, Fixation, Spinal Interlaminal - § 888.3050 (KWP) - class II Orthosis, Spinal Pedicle Fixation - § 888.3070 (MNI) - class II name: Orthosis, Spondylolisthesis Spinal Fixation - § 888.3070 (MNH) - class II Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease - § 888.3070 (NKB) - class III
All Orthopedic Device Panel 87
Product Code: KWP, MNI, MNH & NKB
Device Description and Characteristics:
The Del Mar® Monoaxial 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 DEL MAR® Monoaxial 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. Monoaxial screws are supplied in winged and non-winged configurations, in a variety of different length, and in 5mm, 6mm, and 7mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only.
The DEL MAR® Monoaxial Pedicle Screw System implant components are fabricated from medical grade titanium alloy per ASTM F136.
Equivalence:
The modified Del Mar® Monoaxial Pedicle Screw System is substantially equivalent to the original LAGUNA® Monoaxial Pedicle Screw System. which is manufactured and marketed by Allez Spine, LLC.
The DEL MAR® Monoaxial Pedicle Screw System is intended for posterior. Indications: 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 DEL MAR® Monoaxial Pedicle Screw System is intended to be used with autograft and/or allograft as an adjunct to fusion.
Performance data: Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Allez Spine, LLC % Mr. Hartmut Loch Vice President, Regulatory Affairs 2301 Dupont Drive, Suite 510 Irvine, California 92612
JUL - 9 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K091219
Trade/Device Name: DEL MAR® Monoaxial Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNH, MNI, KWP Dated: June 4, 2009 Received: June 9, 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, 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
Olubase Inelus
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): K091219
DEL MAR® Monoaxial Pedicle Screw System Device Name(s):
Indications for Use:
The DEL MAR® Monoaxial Pedicle Screw System is intended for posterior, non-cervical fixation for the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration the disc confirmed by history and radiographic studies); of 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 DEL MAR® Monoaxial Pedicle Screw System is intended to be used with autograft and/or allograft as an adjunct to fusion.
Prescription Use X X AND/OR
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)
E ____________________________________________________________________________________________________________________________________________________________________________ 1 LEXT Forman)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091219
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