(72 days)
The PASS LP Spinal System is a pedicle screw fixation system intended for immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.
Except for rod plates and caps for sacral plates, when used for posterior non-cervical pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to treat adolescent idiopathic scollosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis and fracture caused by tumor and/or trauma. The PASS LP Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The PASS LP is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.
The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rods, nuts, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 and ISO 5832-3.
A subset of PASS LP components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. The PASS LP components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.
The purpose of this submission is to extend to the PASS LP range, with the addition of those new components:
- TULIP GENESIS Non-cannulated Pedicle Screws
- TULIP GENESIS Non-cannulated Iliac Screws
- TULIP GENESIS Cannulated Pedicle Screws
- TULIP GENESIS Cannulated Iliac Screws
- TULIP GENESIS Breakable Setscrew
This document is a 510(k) Pre-Market Notification from the FDA for the PASS LP Spinal System. It is an approval letter and a summary of the device and its intended use, not a study evaluating its performance against acceptance criteria in the context of an AI/ML medical device.
Therefore, I cannot provide the requested information as the document does not contain details about:
- Acceptance criteria and reported device performance related to an AI/ML model. This document is for a medical implant (spinal fixation system), not a software device that relies on performance metrics like accuracy, sensitivity, or specificity.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Stand-alone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data) for an AI/ML model.
- Sample size for a training set.
- How ground truth for the training set was established.
The "Performance Data" section (g) only mentions mechanical testing according to ASTM F1717-18 for static compression bending, static torsion, and dynamic compression bending tests, concluding that the products are "as mechanically sound as other devices commercially available." This refers to the physical properties of the spinal implants, not the performance of an AI or Machine Learning algorithm.
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May 2, 2019
Medicrea International S.A. Mr. David Ryan Chief Operating Officer 5389 Route De Strasbourg Rillieux-La-Pape, 69140 FRANCE
Re: K190376
Trade/Device Name: PASS LP Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP Dated: February 20, 2019 Received: February 22, 2019
Dear Mr. Ryan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K190376
Device Name PASS LP Spinal System
Indications for Use (Describe)
The PASS LP Spinal System is a pedicle screw fixation system intended for immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.
Except for rod plates and caps for sacral plates, when used for posterior non-cervical pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to treat adolescent idiopathic scollosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis and fracture caused by tumor and/or trauma. The PASS LP Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
| Type of Use (Select one or both, as applicable) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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V. 510(K) SUMMARY
The Company's 510(k) Summary is provided on the following pages.
a. DEVICE SUBMITTER
MEDICREA® INTERNATIONAL S.A. 5389, route de Strasbourg 69140 RILLIEUX-LA-PAPE - France Phone: +33 4 72 01 87 87 Fax: +33 4 72 01 87 88 Contact Person: David RYAN VP Product Development and Marketing dryan@medicrea.com Date Prepared: 04/18/2019
b. DEVICE
Name of Device: PASS LP Spinal System Common or Usual Name: Spinal Fixation System Classification Name: > thoracolumbosacral pedicle screw system per NKB 888.3070
spinal interlaminal fixation orthosis KWP 888.3050 Regulatory Class: II
Product Code: NKB, KWP
C. PREDICATE DEVICE
Primary Predicate device is: CREO™ Stabilization System, K124058 Additional predicate devices are:
- PASS LP Spinal System, K182240
- . TSRH Spinal System, K010720
- Titanium MOSS MIAMI Spinal System, K955348
- . PASSmed Spinal System, K070530
Those devices have not been subject to a design-related recall.
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d. DEVICE DESCRIPTION
The PASS LP is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.
The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rods, nuts, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 and ISO 5832-3.
A subset of PASS LP components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. The PASS LP components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.
The purpose of this submission is to extend to the PASS LP range, with the addition of those new components:
- TULIP GENESIS Non-cannulated Pedicle Screws
- TULIP GENESIS Non-cannulated Iliac Screws ●
- TULIP GENESIS Cannulated Pedicle Screws ●
- TULIP GENESIS Cannulated Iliac Screws
- TULIP GENESIS Breakable Setscrew
e. INDICATIONS FOR USE
The PASS LP Spinal System is a pedicle screw fixation system intended for 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: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (e.g., fracture or dislocation), deformity or curvature (e.g., scoliosis, kyphosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.
Except for rod plates and caps for sacral plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolysis and fracture caused by tumor and/or trauma. The PASS LP Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The Indications For Use statement for the PASS LP Spinal System is identical to the predicate device. Both the subject and predicate device have the same intended use for the treatment of acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine.
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE f.
The table below compares the features and characteristics of the PASS LP Spinal System to its predicate devices.
| Device | Globus CREO™Stabilization System | Medicrea®InternationalPASS LP Spinal System'TOP LOADING' | Medicrea®InternationalPASS LP Spinal System'TULIP GENESIS' |
|---|---|---|---|
| 510(k) number | K124058 | K182240 | K190376 |
| Intended use | Immobilization andstabilization of spinalsegments in skeletallymature or pediatricpatients | Immobilization andstabilization of spinalsegments in skeletallymature or pediatricpatients | Immobilization andstabilization of spinalsegments in skeletallymature or pediatricpatients |
| Components | |||
| Implants | - Pedicle screw- Iliac screw | - Pedicle screw- Iliac screw- Cannulated version- Breakable Setscrew | - Pedicle screw- Iliac screw- Cannulated version- Breakable Setscrew |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI &Co-Cr28Mo6 | Ti-6Al-4V ELI |
PERFORMANCE DATA g.
The following performance data were provided in support of the substantial equivalence determination.
Mechanical testing
According to the ASTM F1717-18, static compression bending, static torsion and dynamic compression bending tests have been performed on the new components. The results obtained indicate that the products are as mechanically sound as other devices commercially available.
h. CONCLUSION
MEDICREA® INTERNATIONAL S.A. PASS LP and its new components are equivalent to its predicate devices in terms of indications for use, material and function and substantially equivalent to its predicate devices in terms of design.
N/A