(46 days)
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is described as a pedicle screw fixation system intended to be used as an adjunct to fusion for treating various spinal instabilities or deformities, which are conditions that benefit from therapeutic intervention.
No
The device is a pedicle screw fixation system intended for immobilization and stabilization of spinal segments, not for diagnosis.
No
The device description explicitly states that the system consists of physical components like pedicle screws, hooks, rods, etc., made from titanium and cobalt-chromium alloys. It is a hardware-based spinal fixation system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for stabilizing the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components like screws, rods, and connectors, which are used in surgical procedures.
- Performance Studies: The performance studies focus on biocompatibility and mechanical testing, which are relevant for implantable devices, not IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, or tissue) to provide diagnostic information.
Therefore, the PASS LP Spinal System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 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, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or 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 treat adolescent idiopathic scolosis. Additionally, the system is intended to treat pediatic 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.
Product codes (comma separated list FDA assigned to the subject device)
NKB, OSH, MNH, MNI, KWP
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, connectors, 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-6AI-4V ELI) that conforms to ISO 5832-3 ASTM F136 and cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.
A subset of PASS LP Spinal System 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, connectors, 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 the PASS LP Spinal System, with the addition of new components:
- 'Top loading, cannulated pedicle screws'
- 'Top loading, non-cannulated pedicle screws'
- 'Top loading, cannulated iliac screws'
- 'Top loading, non-cannulated iliac screws'
- 'Closed, cannulated iliac screws'
- 'Closed, non-cannulated iliac screws'
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
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)
Biocompatibility Testing:
The biocompatibility evaluation for the PASS LP system was conducted in accordance with the FDA blue book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
- Systemic toxicity
- Pyrogen Testing
According to the standard ISO 10993-1, the PASS LP Spinal System is defined as implantable device in contact with tissue and bone and as a permanent contact with the patient. For chemical composition, the material conform to Ti-6Al-4V ELI, following standards ASTM F136 and ISO 5832-3.
Mechanical testing:
When applicable, the tests performed on the additional components (static bending, static torsion, dynamic compression bending (according to ASTM F1717), indicate that the products are as mechanically sound as other devices commercially available.
Finite Element Analysis:
No Finite Element Analysis were performed.
Clinical study:
No clinical studies were performed.
Animal study:
No animal 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 consists of the department's name encircling a symbol. The symbol is a stylized representation of human profiles facing right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 29, 2016
Medicrea® International S.A. Mr. David Rvan VP Product Development and Marketing 14 Porte du Grand Lyon 01700 Neyron FRANCE
Re: K161627
Trade/Device Name: PASS LP Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNH, MNI, KWP Dated: June 8, 2016 Received: June 13, 2016
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 Parts 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/ResourcesforYou/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,
VincentJ. Devlin -S
for 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) K161627
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 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, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or 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 treat adolescent idiopathic scolosis. Additionally, the system is intended to treat pediatic 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) |
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3
510(K) SUMMARY
1. DEVICE SUBMITTER
MEDICREA® INTERNATIONAL S.A. 14 Porte du Grand Lyon 01700 Neyron 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: 07/27/2016
2. DEVICE
Name of Device: PASS LP Spinal System Common or Usual Name: Pedicle Screw Spinal Lumbar System
Classification Name:
Pedicle Screw Spinal System, 21 CFR 888.3070
Regulatory Class: III Classification Product Code: NKB, Subsequent Product Code: KWP, MNH, MNI, and OSH
3. PREDICATE DEVICE
Primary Predicate:
-
v PASS LP Spinal System, MEDICREA INTERNATIONAL, K141398 This predicate has not-been subject to a design-related recall.
Additional Predicates: -
V MOSS Miami Spinal System, DEPUY, K964024
-
√ CD HORIZON Spinal System, MEDTRONIC SOFAMOR DANEK, K141494
4
4. 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, connectors, 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-6AI-4V ELI) that conforms to ISO 5832-3 ASTM F136 and cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.
A subset of PASS LP Spinal System 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, connectors, 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 the PASS LP Spinal System, with the addition of new components:
- -'Top loading, cannulated pedicle screws'
- -'Top loading, non-cannulated pedicle screws'
- -'Top loading, cannulated iliac screws'
- -'Top loading, non-cannulated iliac screws'
- 'Closed, cannulated iliac screws' -
- 'Closed, non-cannulated iliac screws' -
5. 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, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or 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. 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.
5
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS AND INDICATIONS WITH THE PREDICATE DEVICE
The table below compares the features and characteristics of the PASS LP Spinal System to its predicate device. The design features, materials and dimensions were found to be substantially equivalent to these systems. The Indications for Use statement is identical to the predicate device.
| Device | PASS LP Spinal
System,
Medicrea – New
Components | PASS LP Spinal
System, Medicrea | CD Horizon /
Solera Spinal
System,
Medtronic | MOSS Miami Spinal
System, Depuy |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
number | NA | K141398 | K141494 | K964024 |
| Intended use | | | | |
| Thoracic,
Lumbar spine | Yes | Yes | Yes | Yes |
| Posterior
Approach | Yes | Yes | Yes | Yes |
| Design | | | | |
| Polyaxial Pedicle Screws | | | | |
| Screw
Diameters | Ø4.5mm to
Ø10.5mm | Ø4.5mm to
Ø10.5mm | Ø4.0mm to
Ø9.5mm | Ø5.0mm to Ø7.0mm |
| Screw
Lengths | From 25mm to
60mm with a 5mm
increment | From 25mm to
60mm with a 5mm
increment | From 20mm to
100mm with a 5mm
increment | From 30mm to 60mm |
| Cannulated
screws | Yes | Yes | Yes | No |
| Color Coded | Color-code on the
screw shank.
Identical to
existing PASS LP
pedicle screws | Color code on the
threaded extension | Color code on the
tulip saddle. | No |
| Shape of the
screw shank | Conical outline.
Dual lead thread
with two
segments
(proximal and
distal) having
variable thread
pitch. | Conical thread
outline.
Spherical head for
connection with
other PASS LP
components.
Breakable threaded
part after Nut
tightening | Conical outline.
Dual lead thread
with two segments
(proximal and
distal) having
variable thread
pitch. | Cylindrical outline.
Single lead thread. |
| Polyaxial
Range of
Motion | +/-26° (+/-1°) | +/-13° | +/-25° | +/-25° |
| () Range Of Motion (ROM) was considered substantially equivalent due to that of predicate devices
(K141494 and K964024), due to the (+/-1°) precision of the ROM measurement. | | | | |
| Compatibility
with rods | Ø5.5 mm and
Ø6.0 mm | Ø5.5 mm and Ø6.0
mm | Ø4.75 mm Ø5.5
mm and Ø6.35 mm | Ø5.0mm or Ø5.5 mm |
| Threaded
extension | No | Yes | No | No |
| Torque-
calibrated
breakable
set-screw | Yes | Yes | Yes | No |
| Device | PASS LP Spinal System, Medicrea - New Components | PASS LP Spinal System, Medicrea | CD Horizon / Solera Spinal System, Medtronic | MOSS Miami Spinal System, Depuy |
| Polyaxial Iliac Screws | | | | |
| Screw Diameters | Ø4.5mm to Ø10.5mm | Ø4.5mm to Ø10.5mm | Ø5.5mm to Ø8.5mm | Ø5.0mm to Ø7.0mm |
| Screw Lengths | From 25mm to 100mm with a 5mm increment | From 25mm to 100mm with a 5mm increment | From 40mm to 90mm with a 5mm increment | From 30mm to 60mm |
| Cannulated screws | Yes | No | No | No |
| Color Coded | Color-code on the screw shank.
Identical to existing PASS LP pedicle and iliac screws | Color code on the threaded extension | Color code on the tulip saddle. | No |
| Shape of the screw shank | Conical outline. Single lead thread. | Cylindrical thread outline.
Spherical head for connection with other PASS LP components.
Breakable threaded part after Nut tightening | Cylindrical outline. Single lead thread. | Cylindrical outline. Single lead thread. |
| Polyaxial Range of Motion | +/-26° | +/-13° | +/-25° | +/-25° |
| () Range Of Motion (ROM) was considered substantially equivalent due to that of predicate devices (K141494 and K964024), due to the (+/-1°) precision of the ROM measurement. | | | | |
| Compatibility with rods | Ø5.5 mm and Ø6.0 mm | Ø5.5 mm and Ø6.0 mm | Ø4.75 mm Ø5.5 mm and-Ø6.35 mm | Ø5.0mm or Ø5.5 mm |
| Threaded extension | No | Yes | No | No |
| Torque-calibrated breakable set-screw | Yes | Yes | Yes | No |
| Materials | | | | |
| Components | Titanium alloy (Ti-6Al-4V ELI, following standards ASTM F136 and ISO 5832-3).
Cobalt Chrome alloy (CoCr28Mo, following standards ASTM F1537 and ISO 5832-12) | Titanium alloy (Ti-6AI-4V ELI, following standards ASTM F136 and ISO 5832-3).
Cobalt Chrome alloy (CoCr28Mo, following standards ASTM F1537 and ISO 5832-12) | Manufactured from biocompatible:
Titanium alloy (Ti-6Al-4V ELI, following standards ASTM F136 and Cobalt Chrome alloy (CoCr28Mo, following standards ASTM F1537 and | Manufactured from biocompatible:
Titanium alloy (Ti-6Al-4V ELI, following standards ASTM F136 and Stainless steel conforming to ASTM F-138 |
Table 1 Comparison Of Technological Characteristics
6
Material composition is identical to other MEDICREA® INTERNATIONAL products, MEDTRONIC CD HORIZON or DEPUY MOSS Miami system that have been cleared via the 510(k) process.
7
7. PERFORMANCE DATA
Biocompatibility Testing
The biocompatibility evaluation for the PASS LP system was conducted in accordance with the FDA blue book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
- √ Cytotoxicity
-
Sensitization
-
Irritation
-
Systemic toxicity
-
Pyrogen Testing
According to the standard ISO 10993-1, the PASS LP Spinal System is defined as implantable device in contact with tissue and bone and as a permanent contact with the patient.
For chemical composition, the material conform toTi-6Al-4V ELI, following standards ASTM F136 and ISO 5832-3.
Mechanical testing
When applicable, the tests performed on the additional components (static bending, static torsion, dynamic compression bending (according to ASTM F1717), indicate that the products are as mechanically sound as other devices commercially available.
Finite Element Analysis
No Finite Element Analysis were performed.
Clinical study
No clinical studies were performed.
Animal study
No animal studies were performed.
8. CONCLUSION
MEDICREA® INTERNATIONAL S.A. PASS LP Spinal System is substantially equivalent to its predicate device in terms of indications for use, design, material and function.