(172 days)
No
The document describes a mechanical implant system and its components, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies focus on biocompatibility and mechanical testing.
No
The device, LigaPASS, is an orthopedic implant designed to provide temporary stabilization and aid in bone repair, which falls under surgical devices rather than therapeutic devices aimed at treating diseases or conditions without surgical intervention.
No.
The LigaPASS is an orthopedic implant designed to provide temporary stabilization and aid in the repair of bone fractures, not to diagnose medical conditions.
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:
- Definition of IVD: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The LigaPASS is described as a temporary implant used in orthopedic surgery for spinal stabilization and fracture repair. It is a physical device implanted into the body.
- Lack of Mention of Biological Samples or Testing: The text does not mention the device being used to test biological samples or provide diagnostic information based on such testing.
Therefore, the LigaPASS falls under the category of 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 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. Components in this connector are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136, pure titanium that conforms to ASTM F67 and Polyethylene Terephthalate (PET).
The purpose of this submission is 1) to introduce the LigaPASS 2.0 XS Connector which accommodates a 4.5mm rod and 2) to modify the LigaPASS indications to align with those of its primary predicate.
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
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
The following performance data was provided in support of the substantial equivalence determination.
Biocompatibility Testing: The LigaPASS 2.0 XS is made from the same materials as its predicates.
Mechanical testing: The tests performed on the LigaPASS 2.0 XS connector (axial and torsional grip, and static and dynamic band tension according to ASTM F1798) indicate that the product is as mechanically sound as other devices commercially available.
Animal study: No animal studies were performed.
Clinical study: No clinical studies were performed.
Key Metrics
Not Found
Predicate Device(s)
Zimmer Spine Universal Clamp, K142053
Reference Device(s)
Medicrea LigaPass, K132395
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, formed by three human profiles facing the same direction.
September 2, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
MEDICREA INTERNATIONAL S.A. Mr. David Ryan VP Product Development and Marketing 14 Porte du Grand Lyon 01700 Neyron FRANCE
Re: K160698
Trade/Device Name: LigaPASS Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: August 8. 2016 Received: August 10, 2016
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 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" (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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
IV. STATEMENT OF INDICATIONS FOR USE
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
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 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)
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
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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EP
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510(k) Summary
DEVICE SUBMITTER
MEDICREA INTERNATIONAL S.A. 14 Porte Du Grand Lyon 01700 NEYRON- France Phone: +33 4 72 01 87 87 Fax: +33 4 72 01 87 88
Contact Person: David RYAN MANAGER R&D dryan@medicrea.com
Date Prepared: 08/08/2016
DEVICE
Name of Device: LigaPASS Common or Usual Name: Bone Fixation Cerclage, Sublaminar Classification Name: 888.3010 - Bone Fixation Cerclage Regulatory Class: II Product Code: OWI
PREDICATE DEVICES
Medicrea LigaPass, K132395. Zimmer Spine Universal Clamp, K142053 (primary).
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. Components in this connector are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136, pure titanium that conforms to ASTM F67 and Polyethylene Terephthalate (PET).
The purpose of this submission is 1) to introduce the LigaPASS 2.0 XS Connector which accommodates a 4.5mm rod and 2) to modify the LigaPASS indications to align with those of its primary predicate.
4
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 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.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The LigaPASS 2.0 XS connector is technologically equivalent to the Medicrea LigaPass (K132395) and mechanically to the Zimmer Spine Universal Clamp (K142053). The LigaPASS 2.0 XS connector has the same intended use and similar indications for use as both of these systems. Performance testing has demonstrated comparable safety and performance to the cleared posterior fixation device. Thus, the LigaPASS 2.0 XS connector is substantially equivalent to the Zimmer Spine Universal Clamp (K142053).
PERFORMANCE DATA
The following performance data was provided in support of the substantial equivalence determination.
Biocompatibility Testing
The LigaPASS 2.0 XS is made from the same materials as its predicates.
Mechanical testing
The tests performed on the LigaPASS 2.0 XS connector (axial and torsional grip, and static and dynamic band tension according to ASTM F1798) indicate that the product is as mechanically sound as other devices commercially available.
Animal study
No animal studies were performed.
Clinical study
No clinical studies were performed.
CONCLUSION
The LigaPASS System is substantially equivalent to its predicate systems in terms of indications for use, design, material and function.