(224 days)
Not Found
No
The document describes a spinal implant system with a "Patient Specific Rod" that is bent before surgery based on a surgeon's design. There is no mention of AI or ML being used in the design, manufacturing, or function of the device. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes.
The device is described as a spinal system intended for immobilization and stabilization of spinal segments, used as an adjunct to fusion for treating various acute and chronic spinal instabilities or deformities, which directly addresses a medical condition.
No
Explanation: The PASS LP Spinal System is an implantable device used for surgical stabilization and correction of the spine as an adjunct to fusion. It is a treatment device, not a diagnostic one. While it mentions "radiographic studies" to confirm conditions, the device itself does not perform diagnostics.
No
The device description clearly states the system consists of physical components like pedicle screws, hooks, plates, and rods, which are made of titanium or cobalt-chromium alloys. The addition of a "Patient Specific Rod" further emphasizes the hardware nature of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system designed to provide immobilization and stabilization of the spine as an adjunct to fusion. This is a therapeutic device used in vivo (within the body).
- Device Description: The device is described as a system of physical components (screws, hooks, rods, etc.) made from specific alloys, intended for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
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:
- Fracture
- Dislocation
- Failed previous fusion (Pseudarthrosis)
- Spinal stenosis
- Degenerative spondylolisthesis with objective evidence of neurological impairment
- Spinal deformities 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 fate the attainment of a solid fusion.
The PASS LP also includes hooks and sacral/ilac screws indicated for degenerative disc disease (DD) 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, kyphosis, and/or lordosis), tumor, pseudoarthrosis 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 (comma separated list FDA assigned to the subject device)
MNI, MNH, KWP, OSH
Device Description
The PASS LP Spinal System 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, 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 or cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537. The purpose of this submission is to add to the PASS LP range the new component: 'Patient Specific Rod'. The Patient Specific Rod is a rod bent before the surgery by MEDICREA, following the design defined by the surgeon only, specific to a unique patient. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies (for degenerative disc disease confirmation)
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)
Non-clinical Test Summary: For the UNiD rods, static and dynamic compression and static torsion tests following the ASTM F1717 were conducted on two worst cases: one on UNiD Rods with an extreme lordosis and this other one with an extreme kyphosis. No test was conducted following the ASTM F1798.
Clinical Test Summary: No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 features a stylized depiction of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 4, 2014
Medicrea International Mr. David N. Ryan Director Marketing & Product Development 14 Porte du Grand Lyon Neyron 01700 France
Re: K140738
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, MNH, KWP, OSH Dated: September 22, 2014 Received: October 1, 2014
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. 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
1
Page 2 - Mr. David N. Ryan
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 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" (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 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) K140738
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:
- Fracture
- Dislocation
- Failed previous fusion (Pseudarthrosis)
- Spinal stenosis
- Degenerative spondylolisthesis with objective evidence of neurological impairment
- Spinal deformities 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 fate the attainment of a solid fusion.
The PASS LP also includes hooks and sacral/ilac screws indicated for degenerative disc disease (DD) 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, kyphosis, and/or lordosis), tumor, pseudoarthrosis 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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3
510(k) SUMMARY
MEDICREA INTERNATIONAL's PASS LP Gd]bU GmghYa
In accordance with 21 CFR 807.92 of the Federal Code of Requlations the following 510(k) summary is submitted for the PASS LP Spinal System - Patient Specific QVÞŽDRods.
Date Prepared: 0H森「 ç^{ à^¦ 2014
-
- Submitter:
Contact Person:
MEDICREA INTERNATIONAL 14 Porte du Grand Lyon NEYRON 01700 FR
Audrey VION MEDICREA INTERNATIONAL 14 Porte du Grand Lyon NEYRON 01700 FR
-
- Trade name: ÚŒÙÙÆÚÂчã æÁ¹ˆ·¢√
Common Name: Spinal Fixation Appliances
- Trade name: ÚŒÙÙÆÚÂчã æÁ¹ˆ·¢√
Classification Name: Pedicle Screw Spinal System §888.3070
Classification and Regulation: Ôlæ•Á®
MNI: orthosis, spinal pedicle fixation MNH: orthosis, spondylolisthesis spinal fixation KWP: appliance, fixation, spinal interlaminal OSH: pedicle screw spinal system, Adolescent Idiopathic Scoliosis
-
- Primary Predicate or legally marketed devices which are substantially equivalent:
- . PASS LP Spinal System, (MEDICREA INTERNATIONAL, K123138)
4. Description of the device:
TheAJNiD 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 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-6Al-4V ELI) that conforms to ASTM F136 or cobaltchromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.
The purpose of this submission is to add to the PASS LP range the new component: ' Patient Specific Rod'. The Patient Specific Rod is a rod bent before the surgery by MEDICREA, following the design defined by the surgeon only, specific to a unique patient.
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
4
components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.
Materials: Titanium allov and Cobalt-chromium-molybdenum allov
Function: The PASS LP was developed as an implant:
- To provide immobilization and stabilization of posterior spinal segments
- to augment the development of a solid spinal fusion
- to provide stability to ease fusion
- to be mechanically resistant to allow the fusion of the operated level
5. Intended 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)
- · 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 rods 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, 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 and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
6. Substantial equivalence claimed to predicate devices
The primary predicate device used to demonstrate SE is the PASS LP Spinal System (K123138). The UNID Rods are substantially equivalent to the already cleared PASS LP pre-bent rods in terms of intended use, materials used, mechanical safety and performances
5
The table below compares the features and characteristics of UNiD Rods to their predicate devices.
| Device | MEDICREA
INTERNATIONAL
Patient Specific Rods | PASS LP
Pre-bent Rods
(MEDICREA
INTERNATIONAL) | PASS LP
Straight Rods
(MEDICREA
INTERNATIONAL) |
|------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| 510(k)
number | Unknown | K123138 | K123138 |
| Intended
use | | | |
| Thoracic | Yes | Yes | Yes |
| Lumbar | Yes | Yes | Yes |
| Design | | | |
| Diameters | Ø5.5 and Ø6 mm | Ø5.5 and Ø6 mm | Ø5.5 and Ø6 mm |
| Lengths | 30 mm à 500 mm | 30 à 180mm | 30 à 600mm |
| Curvatures | Directly adapted to the
operated patient. No
need of additional
bending during surgery | Pre-Bent, but will need to
be bent to be adapted to
the patient anatomy
during the surgery. | Straight so need to be
bent to be adapted to the
patient anatomy during
the surgery. |
| Materials | | | |
| | Ti-6Al-4V (ASTM F136
& ISO 5832-3)
Or Co-Cr 28Mo6 alloy
1 (following the
ASTMF1537 and ISO
5832-12) | Ti-6Al-4V (ASTM F136 &
ISO 5832-3) | Ti-6Al-4V (ASTM F136 &
ISO 5832-3)
Or Co-Cr 28Mo6 alloy 1
(following the
ASTMF1537 and ISO
5832-12) |
7. Non-clinical Test Summary:
For the UNiD rods , static and dynamic compression and static torsion tests following the ASTM F1717 were conducted on two worst cases: one on UNiD Rods with an extreme lordosis and this other one with an extreme kyphosis.
No test was conducted following the ASTM F1798, because this standard described a way to test the connection components of a system in sliding. MEDICREA INTERNATIONAL UNiD Rods have the same diameters as the already cleared PASS LP rods (diameter) the contact area between the UNiD Rods and the different connectors of the ranges is strictly identical. Therefore the results obtained following this standard with the already cleared PASS LP components are still are valuable for the PASS LP Patient Specific Rods.
8. Clinical Test Summary
No clinical studies were performed
9. Conclusions Non clinical and Clinical
The UNiD Rods or Patient Specific Rods are substantially equivalent to its predicate devices in terms of indications for use, design, material, mechanical performances and function.