(56 days)
No
The summary describes a mechanical implant system 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 is intended to provide temporary stabilization as a bone anchor during the development of a solid bony fusion and aid in the repair of bone fractures, which is a therapeutic purpose.
No
Explanation: The LigaPASS is described as a temporary implant for use in orthopedic surgery, intended to provide stabilization and aid in fracture repair. Its purpose is mechanical support and connection, not diagnosis.
No
The device description explicitly states it is comprised of physical components made from titanium alloy, pure titanium, and Polyethylene Terephthalate (PET), which are hardware materials.
Based on the provided text, 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" and is used for "temporary stabilization as a bone anchor during the development of a solid bony fusion and aid in the repair of bone fractures." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details the physical components of the implant (connector body, set screws, band) and the materials used.
- 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 compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. The LigaPASS is an in vivo (inside the body) device used for structural support.
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 a 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 implants made of titanium or cobalt chrome alloy whenever "wiring" may help secure the attachment of other implants.
Product codes
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 1) to introduce the LigaPASS 2.0 Medial Connector and 2) to introduce the LigaPASS 2.0 Medial Open Connector.
MATERIALS: Components in this connector are manufactured from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136, pure titanium that conforms to ASTM F67 and 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
Indicated Patient Age Range
patients 8 years of age and older
Intended User / Care Setting
orthopedic surgery
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 performance data was provided in support of the substantial equivalence determination.
Biocompatibility Testing
The LigaPASS 2.0 Medial Connector is made from the same materials as its predicates and the manufacturing processes are identical to the ones of the predicates.
Mechanical testing
No additional mechanical testing. Finite element analysis and device descriptive information were sufficient to establish the substantially equivalent mechanical performance of the subject components.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medicrea International S.A. Mr. David Rvan VP Product Development and Marketing 5389 route de Strasbourg - Vancia Rillieux-La-Pape, 69140 France
August 30, 2017
Re: K172021
Trade/Device Name: LigaPASS Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: June 30, 2017 Received: July 5, 2017
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
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1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education (DICE) 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 (DICE) 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.
Katherine D. Kavlock -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172021
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 a 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 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)
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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: August 29th 2017
| 1. Submitter: | Contact Person: |
|---|---|
| David RYAN | |
| MEDICREA INTERNATIONAL S.A. | MEDICREA INTERNATIONAL S.A. |
| 5389 route de Strasbourg - | 5389 route de Strasbourg - Vancia |
| Vancia RILLIEUX-LA-PAPE 69140 | RILLIEUX-LA-PAPE 69140 |
| FR | 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, K160698) .
Reference device:
- PASS LP Spinal System, (MEDICREA INTERNATIONAL, K100297) .
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 1) to introduce the LigaPASS 2.0 Medial Connector and 2) to introduce the LigaPASS 2.0 Medial Open Connector.
MATERIALS: Components in this connector are manufactured from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136, pure titanium that conforms to ASTM F67 and 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 Medial Connector components are technologically similar to the already cleared LigaPASS 2.0 LP Connector in terms of intended use, material used, mechanical safety and performances.
-
i LigaPASS 2.0 LP Connector (MEDICREA INTERNATIONAL, K160698, primary)
The LigaPASS 2.0 Medial Open Connector components are technologically similar to the already cleared LigaPASS 2.0 LP Connector in terms of intended use and material used. It is similar to the already cleared PASS LP Open Connector in terms of mechanical safety and performances. -
LigaPASS 2.0 LP Connector (MEDICREA INTERNATIONAL, K160698, primary)
-
। PASS LP Open Connector (MEDICREA INTERNATIONAL, K100297, reference)
7. Non-clinical Test Summary:
The following performance data was provided in support of the substantial equivalence determination.
Biocompatibility Testing
The LigaPASS 2.0 Medial Connector is made from the same materials as its predicates and the manufacturing processes are identical to the ones of the predicates.
Mechanical testing
No additional mechanical testing. Finite element analysis and device descriptive information were sufficient to establish the substantially equivalent mechanical performance of the subject components.
8. Conclusions
The LigaPASS 2.0 Medial and LigaPASS 2.0 Medial Open Connectors components are substantially equivalent to legally marketed predicate devices.