(141 days)
Not Found
No
The summary describes a mechanical implant for spinal surgery and does not mention any AI or ML components, image processing, or data analysis capabilities.
Yes
The device aids in the repair of bone fractures and provides temporary stabilization during spinal fusion, both of which are therapeutic functions.
No
The LigaPASS system is a temporary implant used in orthopedic surgery to provide stabilization and aid in bone fracture repair. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is a temporary implant made of titanium and PET, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "temporary implant for use in orthopedic surgery" to provide "temporary stabilization as a bone anchor" and "aid in the repair of bone fractures." This describes a surgical device used in vivo (within the body).
- Device Description: The description details a system of connectors and bands made of titanium and PET, designed to connect a rod to a vertebral body. 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) to provide information for diagnosis, monitoring, or screening.
Therefore, the LigaPASS system 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. The indications for use include the following applications:
-Spinal trauma, used in sublaminar, or facet wiring techniques
-Spinal reconstruction 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, and kyphosis; -Spinal degenerative surgery, as an adjunct to spinal fusions;
The LigaPASS system 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.
Product codes (comma separated list FDA assigned to the subject device)
OWI
Device Description
The LigaPASS System connects a rod to a vertebral body using a specific type of connector and a flexible band. This connector can independently tighten the rod and the bone anchor. It is comprised by a connector body, a rod set screw, a locking set screw for the band and a polyester band.
The purpose of this submission is to introduce the LigaPASS 2.0 Band - B08110005 and the LigaPASS 2.0 Dual Band - B08110010.
MATERIALS: Components in these bands are manufactured from pure titanium that conforms to ASTM F67 and biocompatible Polyethylene Terephthalate (PET).
Function: The LigaPASS spinal system was developed as an implant:
• To provide temporary stabilization as bone anchor during the development of solid bony fusion.
• To aid the repair of bone fracture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, vertebral body
Indicated Patient Age Range
patients 8 years of age and older
Intended User / Care Setting
orthopedic surgery / 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:
Biocompatibility Testing
The LigaPASS 2.0 Band – B08110005 and the LigaPASS 2.0 Dual Band – B08110010 are made from the same materials as its predicates and the manufacturing processes are similar to the ones of the predicates.
Mechanical testing
The tests performed on the LigaPASS 2.0 Dual Band – B08110010 (static traction according to standard NF EN ISO 13934-1) indicate that the product is mechanically equivalent to its predicates.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
April 3, 2018
Medicrea International S.A. Mr. David Ryan Chief Operating Officer 5389 route de Strasbourg - Vancia Rillieux-la-Pape 69140 FRANCE
Re: K173506
Trade/Device Name: LigaPASS Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: March 5, 2018 Received: March 12, 2018
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 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);
1
Page 2 - Mr. David Ryan
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ronald P. Jean -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) K173506
Device Name LigaPASS
Indications for Use (Describe)
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. The indications for use include the following applications:
-Spinal trauma, used in sublaminar, or facet wiring techniques
-Spinal reconstruction 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, and kyphosis; -Spinal degenerative surgery, as an adjunct to spinal fusions;
The LigaPASS system 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY MEDICREA INTERNATIONAL's LigaPASS additional components
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the LigaPASS System- Additional Components:
Date Prepared: November 9th 2017
1. Submitter:
MEDICREA INTERNATIONAL S.A. 5389 route de Strasbourg -Vancia RILLIEUX-LA-PAPE 69140 FR
Contact Person: David RYAN MEDICREA INTERNATIONAL S.A. 5389 route de Strasbourg - Vancia RILLIEUX-LA-PAPE 69140 FR
-
- Trade name: LigaPASS
Regulatory Identification/ Classification
Bone fixation cerclage Regulation Number : 21 CFR 888.3010 Product Code: OWI Class II
3. Predicate or legally marketed devices which are substantially equivalent:
Primary predicate device:
- . LigaPASS, (MEDICREA INTERNATIONAL, K172021)
4. Description of the device:
The LigaPASS System connects a rod to a vertebral body using a specific type of connector and a flexible band. This connector can independently tighten the rod and the bone anchor. It is comprised by a connector body, a rod set screw, a locking set screw for the band and a polyester band.
The purpose of this submission is to introduce the LigaPASS 2.0 Band - B08110005 and the LigaPASS 2.0 Dual Band - B08110010.
MATERIALS: Components in these bands are manufactured from pure titanium that conforms to ASTM F67 and biocompatible Polyethylene Terephthalate (PET).
Function: The LigaPASS spinal system was developed as an implant:
• To provide temporary stabilization as bone anchor during the development of solid bony fusion.
• To aid the repair of bone fracture.
4
5. Indication 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. The indications for use include 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 8 years of age and older, adult scoliosis, and kyphosis;
-
Spinal degenerative surgery, as an adjunct to spinal fusions;
The 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.
6. Substantial equivalence claimed to predicate devices
The LigaPASS 2.0 Band – B08110005 components are technologically similar to the already cleared LigaPASS 2.0 Band – B08100005 in terms of intended use, material used, mechanical safety and performances.
-
LigaPASS 2.0 Band B08100005 (MEDICREA INTERNATIONAL, K172021) ı
The LigaPASS 2.0 Dual Band – B08110010 components are technologically similar to the already cleared LigaPASS 2.0 Band - B08100010 in terms of intended use, material used, mechanical safety and performances. -
LigaPASS 2.0 Dual Band B08100010 (MEDICREA INTERNATIONAL, K172021) ।
The table below compares the features and characteristics of the submitted LigaPASS 2.0 Bands components to their predicate devices.
| Device | MEDICREA
INTERNATIONAL
LigaPASS 2.0 Band -
B08110005 | MEDICREA
INTERNATIONAL
LigaPASS 2.0 Dual
Band- B08110010 | MEDICREA
INTERNATIONAL
LigaPASS 2.0 Band | MEDICREA
INTERNATIONAL
LigaPASS 2.0 Dual
Band |
|------------------|---------------------------------------------------------------|-------------------------------------------------------------------|------------------------------------------------|--------------------------------------------------------|
| 510(k) number | To be
determined | To be
determined | K172021 | K172021 |
| Intended use | | | | |
| Thoracic | Yes | Yes | Yes | Yes |
| Lumbar | Yes | Yes | Yes | Yes |
| Components | | | | |
| Number of braids | One | Two | One | Two |
| Braid shape | Flat tubular | Flat tubular | Flat tubular | Flat tubular |
| Tips | Pure titanium
malleable tips | Pure titanium
malleable tips | Pure titanium
malleable tips | Pure titanium
malleable tips |
| Material | | | | |
| | PET & | PET & | PET & | PET & |
| | Pure titanium | Pure titanium | Pure titanium | Pure titanium |
| | (T40) conforming | (T40) conforming | (T40) conforming | (T40) conforming |
| | to ASTM F67. | to ASTM F67. | to ASTM F67. | to ASTM F67. |
5
7. Non-clinical Test Summary:
The following performance data was provided in support of the substantial equivalence determination.
Biocompatibility Testing
The LigaPASS 2.0 Band – B08110005 and the LigaPASS 2.0 Dual Band – B08110010 are made from the same materials as its predicates and the manufacturing processes are similar to the ones of the predicates.
Mechanical testing
The tests performed on the LigaPASS 2.0 Dual Band – B08110010 (static traction according to standard NF EN ISO 13934-1) indicate that the product is mechanically equivalent to its predicates.
8. Conclusions
The LigaPASS 2.0 Band - B08110005 and the LigaPASS 2.0 Dual Band - B08110010 are substantially equivalent to legally marketed predicate devices.