(216 days)
Not Found
No
The summary describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as providing "immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of instabilities or deformities." This directly aligns with the definition of a therapeutic device, which is intended to treat or alleviate a medical condition.
No
This device is a spinal system (pedicle screws, hooks, rods, etc.) intended for immobilization and stabilization of spinal segments as an adjunct to fusion. It is a surgical implant, not a diagnostic tool.
No
The device description explicitly states it consists of physical components like screws, hooks, rods, etc., made of titanium and cobalt-chrome alloys. This is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body for immobilization and stabilization of the spine. This is a surgical implant.
- Device Description: The device consists of physical components like screws, hooks, rods, etc., made of titanium or cobalt-chrome alloy. These are materials used for implants, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would be performed in vitro (in glass or outside the living organism).
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to treat structural issues within the body.
N/A
Intended Use / Indications for Use
The PASS LP Spinal System includes a pedicle system 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 thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.
The PASS LP Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae 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 includes hooks, 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, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
MNI, MNH, KWP
Device Description
The Medicrea PASS LP Spinal System consists of pedicle screws, hooks, sacral plates, illac screws, clamps, rods, nuts, rod plates and crosslink members. 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-chrome alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.
The purpose of this submission is to add an axial connector and to deliver the implants of the PASS LP Spinal System sterile.
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
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)
The following tests were conducted:
- ASTM F1798 Dynamic flexion/extension
- ASTM F1717 Dynamic compression bending, static compression bending, static torsion
- ISO 11737 "Sterilization of medical devices: Estimation of the population of microorganisms on product"
- ISO 11137-1 (2006) Sterilization of health care products Radiation Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices.
- ISO 11137-2:2008, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
The results of these tests indicate that the PASS LP Spine System is equivalent to predicate devices in terms of mechanical strength and sterilization.
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.
K062136, K080099, K082069, K082577, K083308, K083810, K100297
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
510(k) SUMMARY
February 15, 2011
SFP 2 6 2011
| 1. GENERAL INFORMATION | |
|---|---|
| Trade Name | PASS LP Spinal System |
| Common Name | ✓ Posterior pedicle screw system |
| ✓ Hooks | |
| ✓ Sacral plate | |
| ✓ Iliac screw | |
| Classification Name | ✓ orthosis, spinal pedicle fixation per MNI 888.3070 |
| ✓ orthosis, spondylolisthesis spinal fixation per MNH 888.3070 | |
| ✓ appliance, fixation, spinal interlaminal per KWP 888.3050 | |
| Class | Class II |
| Product Code | MNI / MNH / KWP |
| CFR section | 888.3070 / 888.3050 |
| Device panel | Orthopedic |
| Legally marketed predicate devices | PASS LP Spinal System (MEDICREA) = K062136, K080099, K082069, K082577, K083308, K083810, K100297 |
| Reason for Special 510(k) | Addition of a component and implants delivered sterile |
| Submitter | MEDICREA International |
| 14 Porte du Grand Lyon | |
| 01700 Neyron, France | |
| +33 (0)4 72 01 87 87 | |
| Contact | J.D. Webb |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| 512-388-0199 | |
| E-Mail: ortho.medix@sbcglobal.net |
2. PREDICATE DEVICE DESCRIPTION
The Medicrea PASS LP Spinal System consists of pedicle screws, hooks, sacral plates, illac screws, clamps, rods, nuts, rod plates and crosslink members. 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-chrome alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.
3. DESCRIPTION OF DEVICE MODIFICATION
The purpose of this submission is to add an axial connector and to deliver the implants of the PASS LP Spinal System sterile.
4. INTENDED USE
f ... The PASS LP Spinal System includes a pedicle system 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 thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.
The PASS LP Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae 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 includes hooks, rods and sacrai/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,
1
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.
SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES 5.
The sterile PASS LP Spinal System is the non-sterile PASS LP Spinal System. The PASS LP axial connector similar to the PASS LP derotation connector in terms of material and intended use.
| | Device
Name
Items | PASS LP Spinal System
-derotation connector | PASS LP Spinal System
-axial connector |
|----------------------------------|------------------------------------------------------|------------------------------------------------|-------------------------------------------|
| Sponsor | Medicrea | | |
| 510(k) Number | K082577 | | In progress |
| Device
Classification
Name | Orthosis, Spinal Fixation System | | |
| Product Code | MNI / MNH / KWP | | |
| Indications for
Use | Same | | |
| Material | Titanium alloy conforming to ASTM F136 or ISO 5832-3 | | |
| Size | For Ø5.5mm rod or Ø6mm rod | | |
| Description | To connect one screw to 1 rod | | To connect one screw to 2 rods |
| | | Same screw attachment feature | |
| | | Same connection to the rod | |
| | | One plug to tight one rod | One plug on both rod |
| | | The plug uses a torx T30 | The plugs use a torx T30 |
NON-CLINICAL TEST SUMMARY 6.
The following tests were conducted:
- ASTM F1798 Dynamic flexion/extension 1.
- ASTM F1717 Dynamic compression bending, static compression bending, static torsion 2.
-
- ISO 11737 "Sterilization of medical devices: Estimation of the population of microorganisms on product"
-
- ISO 11137-1 (2006) Sterilization of health care products Radiation Part 1: Requirements for development, validation, and routine control of a sterilization process for medical . devices.
- ഗ് ISO 11137-2:2008, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
The results of these tests indicate that the PASS LP Spine System is equivalent to predicate devices in terms of mechanical strength and sterilization.
CLINICAL TEST SUMMARY 7.
No clinical studies were performed.
8. CONCLUSIONS: NON-CLINICAL AND CLINICAL
The PASSLP Spinal System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MEDICREA International % The OrthoMedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock. Texas 78681
SEP 2 6 2011
Re: K110497
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: MNH, MNH, KWP Dated: September 07, 2011 Received: September 13, 2011
Dear Mr. Webb:
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
3
Page 2 - Mr. J.D. Webb
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 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.lda.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/Safetv/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
yours,
for
Del C.C.A
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: PASS LP Spinal System
PASS LP Spinal System Indications for Use
The PASS LP Spinal System includes a pedicle system 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 thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.
The PASS LP Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae 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 includes hooks, 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, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.
Prescription Use ✔ (Part 21 CFR 801 Subpart D)
ﻴﺮ ﺍﻟﻤﺘ
Over-The-Counter AND/OR (21 CFR 801 Subpart C)
Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
__, Division Sign-Off
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KII0497 510(k) Number_
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