(127 days)
No
The summary describes a mechanical implant for spinal surgery and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device "aids in the repair of bone fractures" and provides temporary stabilization during bony fusion development, which are therapeutic actions.
No.
The device is described as a temporary implant for stabilization during orthopedic surgery and repair of bone fractures, with its intended use being as a surgical aid, not for diagnosing conditions.
No
The device description clearly states it is a temporary implant composed of physical components (connectors, set screws, band) for use in orthopedic surgery, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the LigaPASS is a "temporary implant for use in orthopedic surgery" to provide "temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures." This describes a surgical device used in vivo (within the body) for structural support and repair.
- Device Description: The description details the physical components of the implant (connectors, set screws, band) and how they function to connect a rod to a vertebra. This is consistent with a surgical implant.
- 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 treatment. IVDs are typically used in laboratories or point-of-care settings for testing biological samples.
Therefore, the LigaPASS is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LigaPASS is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. LigaPASS system is indicated for the following applications:
-
Spinal trauma surgery, used in sublaminar, or facet wiring techniques;
-
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 10 years of age and older, adult scoliosis, and kyphosis;
-
Spinal degenerative surgery, as an adjunct to spinal fusions;
Product codes (comma separated list FDA assigned to the subject device)
OWI
Device Description
The LigaPASS connectors connect a rod to a vertebra. These connectors can independently tighten the rod and the bone anchor. The LigaPASS connectors are composed by a connector body, a rod set screw, a locking set screw for the band and a polyester band.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal
Indicated Patient Age Range
10 years of age and older
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)
Mechanical testing of the MEDICREA - INTERNATIONAL LigaPASS implants was conducted following the ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model" and following the ASTM F1798 "Standard Guide for Evoluating the Static and Fotigue Properties of Interconnection Mechanism and Subassemblies Used In Spinal Arthrodesis Implants" to characterize their mechanical properties. These data was compared to the mechanical performance for other devices cleared for surgical fixation of the skeletal system (LigaPASS, MEDICREA INTERNATIONAL, K112736).
Accordingly, the mechanical performance of MEDICREA INTERNATIONAL LigaPASS implants has been established via these cleared devices (LigaPASS, MEDICREA INTERNATIONAL, K112736).
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
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
0
510(k) Summary for the MEDICREA® INTERNATIONAL LigaPASS
| 1. GENERAL INFORMATION | |
|---|---|
| 510(k) | Traditionnal |
| Date Prepared | December 05, 2013 |
| Trade Name | LigaPASS |
| Common Name | ✓ Bone Fixation Cerclage, Sublaminar |
| Classification Name | ✓ Bone Fixation Cerclage per OWI 888.3010 |
| Class | Class II |
| Product Code | OWI |
| CFR section | 888.3010 |
| Device panel | Orthopedic |
| Legally marketed predicate devices | Universal Clamp Spinal Fixation System (Zimmer Spine)= K110348 |
| LigaPASS (MEDICREA INTERNATIONAL) = K112736 | |
| Submitter | MEDICREA International |
| 14 Porte du Grand Lyon | |
| 01700 Neyron, France | |
| Contact Person | Audrey VION |
| 14 Porte du Grand Lyon | |
| 01700 NEYRON | |
| FRANCE | |
| +33(0)4 72 01 87 87 | |
| E-mail : avion@medicrea.com |
2. PREDICATE DEVICE DESCRIPTION
, The Universal Clamp System (K110348) and LigaPASS (K112736) are temporary orthopedic implants intended to provide stabilization during the development of solid bony fusion and aid in the repair of bone fractures. The Universal Clamp System (K110348) and LigaPASS (K112736) are designed to be incorporated into constructs and used in conjunction with other medical implants.
The indications for use for the Universal Clamp System (K110348) include, but are not limited to, the following applications: Spinal trauma surgery; Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis and, spondylolisthesis; Spinal degenerative surgery, as an adjunct to spinal fusions.
The indications for use for the LigaPASS (K112736) include, but are not limited to, the following applications: Spinal trauma surgery, Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as scoliosis, spondylolisthesis; Spinal degenerative surgery, as an adjunct to spinal fusions.
The Universal Clamp System (K110348) and LigaPASS (K112736) may also be used with other medical implants made of titanium or cobalt chrome alloy whenever "wiring" may help secure the attachment of other implants.
3. DEVICE DESCRIPTION
The LigaPASS connectors connect a rod to a vertebra. These connectors can independently tighten the rod and the bone anchor. The LigaPASS connectors are composed by a connector body, a rod set screw, a locking set screw for the band and a polyester band.
1
4. INTENDED USE
The ligapass is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilziation as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. LigaPASS system is indicated for the following applications:
-
Spinal trauma surgery, used in sublaminar,or facet wiring techniques;
-
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 10 years of age and older, adult scoliosis, and kyphosis;
-
Spinal degenerative surgery, as an adjunct to spinal fusions;
5. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES
MEDICREA® INTERNATIONAL LigaPASS is substantially equivalent to the ZIMMER SPINE Universal Clamp® System (K110348), in terms of intended use, materials used, mechanical safety and performances.
2
:
and the state of the same of the states of the states
and the state of the same
and the comments of the country
| Device | Universal Clamp® System
(ZIMMER SPINE) | LigaPASS |
|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K110348 | In progress |
| Intended use | The Universal Clamp® System is a
temporary implant for use in
orthopedic surgery. The system is
intended to provide temporary
stabilization as a bone anchor
during the development of solid
bony fusion and aid in the repair of
bone fractures. The indications for
use include, but are not limited to,
the following applications:
Spinal trauma surgery, used in
sublaminar, interspinous, or facet
wiring techniques;
Spinal reconstructive surgery,
incorporated into constructs for the
purpose of correction of spinal
deformities such as scoliosis,
kyphosis, spondylolisthesis;
Spinal degenerative surgery, as an
adjunct to spinal fusions;
The universal Clamp® System may
also be used in adjunction with
other medical implants made of
titanium alloy whenever "wiring"
may help secure the attachment of
other implants. | The LigaPASS is a temporary
implant for use in orthopedic
surgery. The system is intended to
provide temporary stabilization as
a bone anchor during the
development of solid bony fusion
and aid in the repair of bone
fractures. LigaPASS system is
indicated for the following
applications:
- Spinal trauma surgery, used in
sublaminar, or facet wiring
techniques; - Spinal reconstructive surgery,
incorporated into constructs for
the purpose of correction of
spinal deformities such as
idiopathic and neuromuscular
scoliosis in patients 10 years of
age and older, adult scoliosis, and
kyphosis; - Spinal degenerative surgery, as
an adjunct to spinal fusions;
LigaPASS system may also be used
in conjunction with other medical
implant grade implants made of
titanium or cobalt chrome alloy
whenever "wiring" may help
secure the attachment of other
implants. |
| Design | | |
| Components | Connector with polyester band:
To circle a vertebra as a bone
anchor and connect to a Ø5.5mm
or Ø6mm rod. | Connectors with polyester band:
To circle a vertebra as a bone anchor
and connect to a Ø5.5mm or Ø6mm
rod. |
| Range | A connector and a band. | Connectors and a band. |
| Materials | | |
| Device | Universal Clamp System
(ZIMMER SPINE) | LigaPASS |
| | Universal clamp system is made
from titanium alloy conforming to
ASTM F136 or ISO 5832-3, with the
exception of the band which is
manufactured from polyethylene
terephtalate (PET) and pure
titanium conforming to ASTM F67. | LigaPASS connectors are made from
titanium alloy conforming to ASTM
F136 or ISO 5832-3, with the
exception of the band which is
manufactured from polyethylene
terephtalate (PET) and pure titanium
conforming to ASTM F67. |
・
.
3
Material composition is identical to other MEDICREA® INTERNATIONAL products that have been cleared via the 510(k) process.
6. NON-CLINICAL TEST SUMMARY
The LigaPASS submitted by MEDICREA in this 510(k) includes components that have been approved by the FDA in the previous 510(k) (K112736) for the following indications:
The LigaPASS is a temporary implant for use in orthopedic surgery on skeletally mature patients. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
- Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques; .
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of . spinal
- deformities such as scoliosis, kylphosis, spondylolisthesis;Spinal degenerative surgery, as an . adjunct to spinal fusions;
The LigaPASS may also be used in conjunction with other medical implants made of titanium or cobalt chrome alloy whenever "wiring" may help secure the attachment of other implants.
The purpose of this new submission is to extend the indications for use to idiopathic and neuromuscular scoliosis treatment in patients 10 years of age and holder. No other changes in terms of design characteristics, principles of operation, packaging, sterility, biocompatibility or mechanical performances have undergone.
Mechanical testing of the MEDICREA - INTERNATIONAL LigaPASS implants was conducted following the ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model" and following the ASTM F1798 "Standard Guide for Evoluating the Static and Fotigue Properties of Interconnection Mechanism and Subassemblies Used In Spinal Arthrodesis Implants" to characterize their mechanical properties. These data was compared to the mechanical performance for other devices cleared for surgical fixation of the skeletal system (LigaPASS, MEDICREA INTERNATIONAL, K112736).
Accordingly, the mechanical performance of MEDICREA INTERNATIONAL LigaPASS implants has been established via these cleared devices (LigaPASS, MEDICREA INTERNATIONAL, K112736).
7. CLINICAL TEST SUMMARY
No clinical studies were performed.
8. CONCLUSIONS: NON-CLINICAL AND CLINICAL
The LigaPASS is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drun Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MID 20993-0002
December 6, 2013
Medicrea International Ms. Audrey Vion Regulatory Affairs Manager 14 Porte du Grand Lyon 01700 Neyron France
Re: K132395
Trade/Device Name: LigaPASS Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: November 7, 2013 Received: November 12, 2013
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 of medical
5
Page 2 -- Ms. Audrey Vion
device-rclated 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Lori A. Wigqins
for
:
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known): ___ Device Name: LigaPASS
INDICATIONS FOR USE
The LigaPASS is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. LigaPASS system is indicated for the following applications:
-
Spinal trauma surgery, used in sublaminar, or facet wiring techniques;
-
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 10 years of age and older, adult scoliosis, and kyphosis;
-
Spinal degenerative surgery, as an adjunct to spinal fusions;
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
Ronald P. Jean -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132395