(29 days)
No
The description focuses on the materials, components, and intended use of a spinal fixation system, including patient-specific rods that are bent by the manufacturer based on surgeon-defined profiles. There is no mention of AI or ML being used in the design, manufacturing, or function of the device.
Yes
The device is described as a spinal system intended for immobilization and stabilization of spinal segments as an adjunct to fusion for treating various acute and chronic instabilities or deformities. These are all conditions treated within the scope of therapeutic devices.
No
This device describes a spinal system (rods, screws, hooks, etc.) used for surgical stabilization and correction of the spine as an adjunct to fusion. It is an implantable device to treat conditions like fractures, dislocations, or spinal deformities, rather than a tool for diagnosis.
No
The device description clearly states the system consists of physical components like pedicle screws, hooks, rods, and plates made of titanium and cobalt-chromium alloys. It is a hardware-based spinal implant system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the PASS LP Spinal Systems are implants made of titanium alloy and cobalt-chromium molybdenum alloy. They are physical devices intended for surgical implantation to stabilize the spine.
- Intended Use: The intended use describes the surgical application of these implants to treat various spinal conditions. This involves direct intervention within the body, not testing samples outside the body.
Therefore, the PASS LP Spinal System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PASS LP Spinal Systems include a pedicle system intended to provide immobilization 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 thoracic, lumbar, and sacral spine:
- · Fractures
- · Dislocation
- · Failed previous fusion (Pseudarthrosis)
- · Spinal Stenosis
- · Degenerative spondylolisthesis with objective evidence of neurological impairment
- · Spinal deformations such as scoliosis or kyphosis.
- · Loss of stability due to tumors.
The PASS LP Spinal Systems are also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The PASS LP also include hooks and sacral/iliac screws indicated for degenerative disc disease (DDD) 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, deformities or curvatures (i.e., scoliosis, kyhosis, and/or lordosis), tumor. Pseudarthrosis and failed previous fusion.
Except for rod 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. The PASS LP Spinal System is intended to be used with allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Product codes
MNI, KWP, MNI, OSH (from page 0)
MNI; MNH; KWP; OSH (from page 3)
Device Description
The UNiD Rods have to be used with the PASS LP Spinal System designed to contribute to correction and surqical stabilization of the thoracic, lumbar and sacral spine. The Patient Specific Rod is a rod bent before the surgery by MEDICREA, following the profile defined by the surgeon only, specific to a unique patient.
The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136 and ISO 5832-3 or cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.
The purpose of this submission is to offer the existing cleared reference in sterile version.
A subset of PASS LP Spinal System components may be used for posterior pedicle screw fixation. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. These components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.
Materials: Titanium alloy and Cobalt-chromium-molybdenum alloy
This Special 510(k) premarket notification is submitted for the additional offering of gamma sterilzed UNiD Rods.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine
Indicated Patient Age Range
skeletally mature patients, pediatric patients (for adolescent idiopathic scoliosis)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference device was used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/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 a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, line-art style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 10, 2015
Medicrea International Ms. Audrev Vion Regulatory Affairs Manager 14 Porte du Grand Lyon 01700 Neyron FRANCE
Re: K150049
Trade/Device Name: PASS LP Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, KWP, MNI, OSH Dated: January 8, 2015 Received: January 12, 2015
Dear Ms. Vion:
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.
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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150049
Device Name PASS LP Spinal System
Indications for Use (Describe)
The PASS LP Spinal Systems include a pedicle system intended to provide immobilization 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 thoracic, lumbar, and sacral spine:
- · Fractures
- · Dislocation
- · Failed previous fusion (Pseudarthrosis)
- · Spinal Stenosis
- · Degenerative spondylolisthesis with objective evidence of neurological impairment
- · Spinal deformations such as scoliosis or kyphosis.
- · Loss of stability due to tumors.
The PASS LP Spinal Systems are also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The PASS LP also include hooks and sacral/iliac screws indicated for degenerative disc disease (DDD) 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, deformities or curvatures (i.e., scoliosis, kyhosis, and/or lordosis), tumor. Pseudarthrosis and failed previous fusion.
Except for rod 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. The PASS LP Spinal System is intended to be used with 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)
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VI. 510(K) SUMMARY
1. DEVICE SUBMITTER
MEDICREA® INTERNATIONAL 14 Porte Du Grand Lyon 01700 NEYRON- France
Phone: +33 4 72 01 87 87 Fax: +33 4 72 01 87 88
Contact Person: Jean-Denys MARECHAL Regulatory Affairs Manager jdmarechal@medicrea.com
Date Prepared: 08/01/2014
2. DEVICE
| Name of Device: | PASS LP Spinal System |
|---|---|
| Common or Usual Name: | Spinal Fixation Appliances |
| Orthosis, spinal pedicle fixation | |
| Orthosis, spondylolisthesis spinal fixation | |
| Appliance, fixation, spinal interlaminal | |
| Pedicle screw spinal system, Adolescent Idiopathic Scoliosis | |
| Classification Name: | Pedicle Screw Spinal System 888.3070 (Class II) |
| Spinal interlaminal fixation orthosis 888.3050 (Class II) |
Regulatory Class: Orthosis, spinal pedicle fixation Orthosis, spondylolisthesis spinal fixation Appliance, fixation, spinal interlaminal Pedicle screw spinal system, Adolescent Idiopathic Scoliosis
Product Code: MNI; MNH; KWP; OSH.
4
PREDICATE DEVICE 3.
The primary predicate of this submission is
-
· PASS LP Patient Specific Rods(MEDICREA INTERNATIONAL, K140738)
An additional predicate for this submission is -
· PASS LP Spinal System (MEDICREA INTERNATIONAL, K123138)
These predicates have not been subject to a design-related recall. No reference device was used in this submission.
4. DEVICE DESCRIPTION
The UNiD Rods have to be used with the PASS LP Spinal System designed to contribute to correction and surqical stabilization of the thoracic, lumbar and sacral spine. The Patient Specific Rod is a rod bent before the surgery by MEDICREA, following the profile defined by the surgeon only, specific to a unique patient.
The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136 and ISO 5832-3 or cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.
The purpose of this submission is to offer the existing cleared reference in sterile version.
A subset of PASS LP Spinal System components may be used for posterior pedicle screw fixation. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. These components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.
Materials: Titanium alloy and Cobalt-chromium-molybdenum alloy
This Special 510(k) premarket notification is submitted for the additional offering of gamma sterilzed UNiD Rods.
5. INDICATIONS FOR USE
The PASS LP Spinal Systems include a pedicle system intended to provide immobilization and stabilization of spinal seqments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine:
- . Fractures
- · Dislocation
- . Failed previous fusion (Pseudarthrosis)
5
- · Spinal stenosis
- . Deqenerative spondylolisthesis with objective evidence of neurological impairment
- Spinal deformations such as scoliosis or kyphosis. .
- Loss of stability due to tumors. .
The PASS LP Spinal Systems are also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The PASS LP also include hooks and rods and sacral/illac screws indicated for degenerative disc disease (DDD) 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, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, Pseudarthrosis and failed previous fusion.
Except for rod 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. The PASS LP Spinal System is intended to be used with allograff and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.