(69 days)
The LAGUNA® 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); tumors; pseudarthrosis; and/or failed previous fusion.
The LAGUNA® 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® 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 30 mm to 100 mm and 5 mm, 6 mm, 7 mm and 8mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. The LAGUNA® Pedicle Screw System implant components are fabricated from medical grade titanium alloy per ASTM F136.
The provided text describes a spinal fixation system, not an AI/ML device. Therefore, many of the requested criteria, such as those related to AI algorithm performance (standalone performance, MRMC studies, training/test set details, ground truth establishment for AI), are not applicable.
However, I can extract information related to the device's performance testing based on the provided text.
The device is the "LAGUNA® Pedicle Screw System," a spinal fixation system.
Acceptance Criteria and Device Performance:
The provided text states that the device was evaluated through biomechanical tests. The acceptance criteria are implicitly that the device performs equivalently to other similar implants.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biomechanical Strength | Equivalent to other similar implants |
| Static Compression Bending | Sufficient for in vivo loading |
| Static Torsion | Sufficient for in vivo loading |
| Dynamic Compression Bending | Sufficient for in vivo loading |
Study Details (Non-AI/ML specific):
- Sample size used for the test set and the data provenance: Not explicitly stated in terms of number of devices tested, but the tests were "Biomechanical tests per ASTM F1717-10". These are laboratory tests on device components, not human or clinical data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for biomechanical testing is defined by the ASTM F1717-10 standard, which specifies test methodologies and performance characteristics. It does not involve human expert consensus for "ground truth" in the way an AI assessment would.
- Adjudication method for the test set: Not applicable for biomechanical testing. The results are quantitative measurements against a standard.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used: The ground truth is defined by the performance requirements and methodologies outlined in the ASTM F1717-10 standard for biomechanical testing.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
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K103748
MAR - 2 2011
510(k) Summary
[in accordance with SMDA of 1990, 21 CFR 807.92(c)]
Contact: Mr. Hartmut Loch Vice President, Regulatory Affairs & Quality Assurance Phygen. LLC. 2301 Dupont Drive. Suite 510 Irvine CA 92612
February 23, 2011 Date Prepared:
LAGUNA® Pedicle Screw System Trade name:
Common name: Spinal Fixation System
Classification Appliance, Fixation, Spinal Interlaminal -§ 888.3050 (KWP) - class II name: Orthosis, Spinal Pedicle Fixation - - -§ 888.3070 (MNI) - class II 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
Product Code (s): KWP, MNI, MNH & NKB
Device Description and Characteristics:
The LAGUNA® 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® 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 30 mm to 100 mm and 5 mm, 6 mm, 7 mm and 8mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only.
The LAGUNA® Pedicle Screw System implant components are fabricated from medical grade titanium alloy per ASTM F136.
The modified LAGUNA® Pedicle Screw System is substantially equivalent to Equivalence: the original LAGUNA® Pedicle Screw System (K083826, K091995, K050060, K072678), which are manufactured and marketed by Phygen,LLC.
- The LAGUNA® Pedicle Screw System is intended to be used as an adjunct Indications: to fusion in skeletally mature patients using autograft 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); tumors; pseudarthrosis; and/or failed previous fusion.
Biomechanical tests per ASTM F1717-10 (Static Compression Bending, Performance data: Static Torsion, and Dynamic Compression Bending) 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, depicted in black, with its wings forming a shape that resembles human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Phygen, LLC % Mr. Hartmut Loch Vice President, Regulatory Affairs and Quality Assurance 2301 Dupont Drive, Suite 510 · Irvine, California 92612
MAR - 2 2011
Re: K103748
Trade/Device Name: LAGUNA® Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWP, KWQ Dated: December 22, 2010 Received: December 23, 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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.
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Page 2 – Mr. Hartmut Loch
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.
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/ReportalProblem/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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Aling B. Rth
for
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): K103748
Device Name(s): LAGUNA® Pedicle Screw System
Indications for Use:
The LAGUNA® 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 disc confirmed by history and radiographic studies); the of spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumors; pseudarthrosis; and/or failed previous 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)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KI03748 510(k) Number_
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