(364 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural integrity of the spinal fixation system components, with no mention of AI or ML.
Yes.
The device is an anterolateral screw fixation system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for various conditions, which are therapeutic interventions.
No
The device is a spinal fixation system, intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion, not to diagnose medical conditions.
No
The device description explicitly states it consists of screws, rods, plates, staples, connection and locking devices, all of which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "anterolateral screw fixation system intended to provide immobilization and stabilization of spinal segments... as an adjunct to fusion." This describes a surgical implant used in vivo (within the body) to treat structural problems.
- Device Description: The description details physical components like screws, rods, plates, and staples made of titanium alloy. These are all physical implants, not reagents or instruments used to test biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The device's function is purely mechanical and structural.
In summary, the PASS Anterior Spinal System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PASS Anterior Spinal System is an anterolateral screw fixation system intended to provide immobilization and stabilization of spinal segments from T4 to L5 in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic and lumbar spine:
- Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- · Traumatism (ex: fracture, dislocation)
- · Tumor
- · Spinal deformation such as scoliosis or kyphosis
- · Failed previous fusion (Pseudoarthrosis)
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Medicrea PASS Anterior Spinal System consists of screws, rods, plates, staples, connection and locking devices. It can be used for single or multiple level fixations, with one or two rods. This system has been developed to accommodate a left or right anterior approach. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ISO 5832-3 specifications and ASTM F136 specifications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spinal segments from T4 to L5
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 according to ASTM F1717:
- Static testing in a load to failure mode in axial compression bending 1.
-
- Static testing in a load to failure mode in torsion
- Cyclical axial compression bending testing.
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.
K991031, K041205, K964024 / K982011, K920116, K012871, K980485, K024125
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
510(K) SUMMARY
AUG 2 3 2011
GENERAL INFORMATION
| Trade Name | PASS Anterior Spinal System |
|---|---|
| Common Name | • Anterolateral screw system |
| • Anterolateral plate | |
| Classification Name | Spinal intervertebral body fixation orthosis per KWQ 888.3060 |
| Class | II |
| Product Code | KWQ |
| CFR section | 888.3060 |
| Device panel | Orthopedic |
| Legally marketed predicate devices | Colorado II Spinal System (Medtronic Sofamor Danek) = K991031 |
| Expedium Anterior Spine System (Depuy Spine) = K041205 | |
| Moss Miami (DePuy Spine) = K964024 / K982011 | |
| PWB (Cross Medical) = K920116 | |
| Synergy VLS (Interpore Cross) = K012871 | |
| ISOLA (Acromed) = K980485 | |
| Halm Zielke Instrumentation System (Micomed Ortho) = K024125 | |
| Date prepared | May 16, 2011 |
| Submitter | MEDICREA® INTERNATIONAL |
| 14 Porte du Grand Lyon | |
| 01700 NEYRON, France | |
| Contact | J.D. Webb |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| 512-388-0199 | |
| E-Mail: ortho.medix@sbcglobal.net |
DEVICE DESCRIPTION
The Medicrea PASS Anterior Spinal System consists of screws, rods, plates, staples, connection and locking devices. It can be used for single or multiple level fixations, with one or two rods. This system has been developed to accommodate a left or right anterior approach. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ISO 5832-3 specifications and ASTM F136 specifications.
INTENDED USE
The PASS Anterior Spinal System is an anterolateral screw fixation system intended to provide immobilization and stabilization of spinal segments from T4 to L5 in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic and lumbar spine:
- Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- · Traumatism (ex: fracture, dislocation)
- · Tumor
- · Spinal deformation such as scoliosis or kyphosis
- · Failed previous fusion (Pseudoarthrosis)
1
SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES
The PASS Anterior Spinal System is similar to the Moss Miami and the Halm Zielke Instrumentation System.
| Device
Name
Items | PASS Anterior Spinal
System | Moss Miami | Halm Zielke
Instrumentation System |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | / | K982011 | K024125 |
| Sponsor | Medicrea | Depuy Spine | Micomed |
| Device
Classification
Name | Spinal intervertebral body
fixation orthosis | 888.3060/ Spinal
intervertebral body
fixation orthosis | 888.3060/ Spinal
intervertebral body
fixation orthosis |
| Product Code | KWQ | KWQ | KWQ |
| Intended use | Per KWQ | Per KWQ | Per KWQ |
| Material | Ti6Al4V alloy per ASTM
F-136 or ISO 5832-3 | Manufactured from
biocompatible Stainless
Steel or Titanium | Manufactured from
biocompatible Stainless
Steel (316 LS) according
to ASTM F1314 or
Titanium (Ti 6Al 4V)
according to ASTM F136 |
| Components | - simple screws Ø5.5,
6.5 or 7.2mm, L=25 to
50mm
- rods Ø5.5, L=60 to
280mm - staples
- plates
- nuts
- dual connectors | The MOSS Miami is
composed of the following
major components: rod,
screws and bolts. | The HALM ZIELKE
Instrumentation system is
composed of the followed
major components: rod,
screws and nuts, |
NON-CLINICAL TEST SUMMARY
The following tests were conducted according to ASTM F1717:
- Static testing in a load to failure mode in axial compression bending 1.
-
- Static testing in a load to failure mode in torsion
- Cyclical axial compression bending testing ని.
CLINICAL TEST SUMMARY
No clinical studies were performed.
CONCLUSIONS: NON-CLINICAL AND CLINICAL
The PASS Anterior Spinal System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern 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
AUG 2 3 2011
Re: K102406
Trade/Device Name: Pass Anterior Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal invertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: July 27, 2011 Received: August 02, 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.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/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/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 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 vours.
Sincerely, yours,
Euin Keith
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
. :
Device Name: PASS Anterior Spinal System
Indications for use:
The PASS Anterior Spinal Systems is an anterolateral screw fixation system intended to provide ime 1 ASS hillization of spinal segments from T4 to L5 in skeletally mature patients as inningbination and callery of the following acute and chronic instabilities or deformities of thoracic and lumbar spine:
- Degenerative disc disease {DDD} (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- Traumatism (ex: fracture, dislocation)
- Tumor
- Spinal deformation such as scoliosis or kyphosis
- = Failed previous fusion (Pseudoarthrosis)
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(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
510(k) Number K102406