(84 days)
No
The device description and performance studies focus on the mechanical properties, materials, and sterilization of a sternal fixation system, with no mention of AI or ML.
Yes
The device is described as a "Fixation System" intended for "stabilization of fractures of the anterior chest wall," which indicates it is used to treat or stabilize a medical condition.
No
The Thorecon Fixation System is described as a system intended for the stabilization of fractures, primarily for sternal fixation after reconstructive surgery. It is a surgical implant designed to provide mechanical support and stability, not a tool for diagnosing medical conditions.
No
The device description explicitly details physical components made of stainless steel, including plates, screws, needles, and instruments, which are hardware.
Based on the provided information, the Thorecon Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the stabilization of fractures of the anterior chest wall, including sternal fixation following surgery. This is a surgical implant used directly on the patient's body.
- Device Description: The description details plates, screws, and instruments made of stainless steel, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body. The Thorecon Fixation System is a surgical implant used to physically stabilize bone fractures.
N/A
Intended Use / Indications for Use
The Thorecon Fixation System is intended for use in the stabilization of fractures of the anterior chest wall including sternal fixation following sternal reconstructive surgical procedures. The system is intended for use in patients with normal and/or poor bone quality.
Product codes
JDQ, HRS, HWC, GAQ
Device Description
The Thorecon Fixation System may be implanted via an open or minimally invasive approach. Where additional stability is desired, devices can be used with traditional monofilament wire or Pioneer Sternal Cable of similar material.
The Thorecon Fixation System includes plates (some with integrated cable subassemblies) manufactured from 316L stainless steel (ASTM F138) and screws comprised of 22Cr-13Ni-5Mn stainless steel (ASTM F1314). Non-implantable needles, used to guide the cable around the sternum are manufactured from 420 or Custom 470 stainless steel.
Thorecon Fixation System devices are all single-use. The plates, complete with the necessary screws and instruments (screw driver and tensioner/cutter) required for completion of the surgery are provided sterile in a kit. Sterile instruments and screw multi-packs and a non-sterile cable/ plate cutter instrument are also available as replacements and for use during emergent re-entry, if necessary. The devices should be implanted using only the manual surgical instruments designed specifically for the implants in the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior chest wall (sternal)
Indicated Patient Age Range
Not Found
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 nonclinical tests were submitted and relied on in this premarket notification submission for a determination of substantial equivalence. Testing identified in this summary has all passed acceptance criteria established by predicate devices or test standards.
Mechanical Performance
- Screw Push-Out of Plate Force Test
- Bone Screw Pull-Out Test per ASTM F543
- Static Tension Testing
- Dynamic Tension Testing
Packaging, Sterility and Shelf Life Validations completed per:
- ISO 11607 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems
- ISO 11137-2 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
- ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ISO 17665-1 Sterilization of health care products -- Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Biocompatibility Evaluation per:
- ISO 10993 Biological evaluation of medical devices – Parts 1, 5, 10, and 11
Pyrogenicity Evaluation
- Pyrogenicity of the sterile devices was evaluated using the Limulus amebocyte lysate (LAL) assay. The device was tested to ensure the endotoxin level meets the requirements of maximum endotoxin limit for implantable medical devices [20 EU per device].
Key Metrics
Not Found
Predicate Device(s)
K161876 Tritium Sternal Cable Plate System, K931271 Ethi-pack Surgical Stainless Steel Suture, K151019 SternaLock 360 Sternal Closure System, K150581 Tritium Sternal Cable Plate System, K111908 Biomet Microfixation Sternal Closure System
Reference Device(s)
K974016 Cerclage Cable with Hex Button, K935481 Songer Cable System, Modification
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/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services, which features a stylized human figure. To the right of that is the logo for the U.S. Food & Drug Administration (FDA). The FDA logo has the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
February 12, 2018
A&E Medical Corporation % Sarah Pleaugh Regulatory Affairs Specialist RTI Surgical Inc. 375 River Park Circle Marquette, Michigan 49855
Re: K173579
Trade/Device Name: Thorecon™ Fixation System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone Fixation Cerclage Regulatory Class: Class II Product Code: JDQ, HRS, HWC, GAQ Dated: January 22, 2018 Received: January 24, 2018
Dear Sarah Pleaugh:
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 (OS) regulation (21 CFR Part 820);
1
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 medical devices and radiation-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,
Katherine D. Kavlock -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)
K173579
Device Name Thorecon Fixation System
Indications for Use (Describe)
The Thorecon Fixation System is intended for use in the stabilization of fractures of the anterior chest wall including sternal fixation following sternal reconstructive surgical procedures. The system is intended for use in patients with normal and/or poor bone quality.
| 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
"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
Image /page/3/Picture/1 description: The image shows the logo for A&E Medical. The logo consists of a black oval shape on the left side, with a white "A&E" symbol inside. To the right of the oval is the word "MEDICAL" in a simple, sans-serif font. A small registered trademark symbol is located to the right of the "L" in "MEDICAL".
510(k) Summary
Prepared on: February 12, 2018
| 510(k) Owner/
Manufacturer: | A&E Medical Corporation
5206 Asbury Road, PO Box 758
Farmingdale, NJ 07727 USA | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact
Person/
Consultant: | Sarah Pleaugh, RAC
Sr. Specialist, Regulatory Affairs
RTI Surgical, Inc.
Telephone: 1(906)226-9909 x 5861
Fax: (386) 418-1627
Email: spleaugh@rtix.com | |
| Trade name: | Thorecon™ Fixation System | |
| Common
name: | Sternal Fixation System | |
| Classification: | Class II;
21 CFR 888.3010 (JDQ, Cerclage, Fixation)
21 CFR 888.3030 (HRS, Plate, Fixation, Bone)
21 CFR 888.3040 (HWC, Screw, Fixation, Bone)
21 CFR 878.4495 (GAQ, Suture, Nonabsorbable, Steel,
Monofilament and multifilament, Sterile) | |
| Panel: | Panel Code 87 | |
| Predicates: | K161876 Tritium Sternal Cable Plate System
K931271 Ethi-pack Surgical Stainless Steel Suture
K151019 SternaLock 360 Sternal Closure System
K150581 Tritium Sternal Cable Plate System
K111908 Biomet Microfixation Sternal Closure System
K974016 Cerclage Cable with Hex Button (REFERENCE)
K935481 Songer Cable System, Modification (REFERENCE) | |
| Description: | The Thorecon Fixation System may be implanted via an open or
minimally invasive approach. Where additional stability is desired,
devices can be used with traditional monofilament wire or Pioneer
Sternal Cable of similar material.
The Thorecon Fixation System includes plates (some with integrated
cable subassemblies) manufactured from 316L stainless steel
(ASTM F138) and screws comprised of 22Cr-13Ni-5Mn stainless
steel (ASTM F1314). Non-implantable needles, used to guide the
cable around the sternum are manufactured from 420 or Custom 470
stainless steel.
Thorecon Fixation System devices are all single-use. The plates,
complete with the necessary screws and instruments (screw driver
and tensioner/cutter) required for completion of the surgery are | |
| Indications for Use: | Summary of Technological Characteristics: | Discussion of Supporting Clinical Evidence and Non-Clinical Testing: |
| The Thorecon Fixation System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures. The system is intended for use in patients with normal and/or poor bone quality. | The subject devices were found to have similar technological characteristics as the predicate devices. Similarities to the predicate device include: Same intended use/ indications for use and contraindications Similar materials (metallic, stainless steel) Similar principles of operation and fundamental technology (plates, pre-assembled cerclage(s) and/or screws for fracture fixation) Similar instrumentation (e.g. screw driver, cable tensioner, cutters) Same general surgical technique method (sizing, cable insertion, approximation, tensioning, screw placement, final locking, removal of excess cerclage, closure; emergent re-entry available if necessary) Same sterility (gamma irradiation) and packaging (double sterile barrier) Same bacterial endotoxin evaluation and limit (20 EU/device) Similar / substantially equivalent mechanical performance There are minor differences in the design of the device and subject package configurations. However, the non-clinical testing completed supports that these differences do not raise different questions of safety or effectiveness. | No clinical evidence was provided in this submission.
The following nonclinical tests were submitted and relied on in this premarket notification submission for a determination of substantial equivalence. Testing identified in this summary has all passed acceptance criteria established by predicate devices or test standards.
Mechanical Performance Screw Push-Out of Plate Force Test |
| provided sterile in a kit. Sterile instruments and screw multi-packs and a non-sterile cable/ plate cutter instrument are also available as replacements and for use during emergent re-entry, if necessary. The devices should be implanted using only the manual surgical instruments designed specifically for the implants in the system. | | |
| | Bone Screw Pull-Out Test per ASTM F543 Static Tension Testing Dynamic Tension Testing | |
| | Packaging, Sterility and Shelf Life Validations completed per: ISO 11607 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems ISO 11137-2 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices ISO 17665-1 Sterilization of health care products -- Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices | |
| | Biocompatibility Evaluation per: ISO 10993 Biological evaluation of medical devices – Parts 1, 5, 10, and 11 | |
| | Pyrogenicity Evaluation
Pyrogenicity of the sterile devices was evaluated using the Limulus amebocyte lysate (LAL) assay. The device was tested to ensure the endotoxin level meets the requirements of maximum endotoxin limit for implantable medical devices [20 EU per device]. | |
| Conclusion: | The supporting evidence in this submission concludes the subject Thorecon Fixation System is substantially equivalent to the predicate devices. There are no new risks to safety or effectiveness raised | |
4
Image /page/4/Picture/1 description: The image shows the logo for A&E Medical. The logo consists of a black circle with a white design inside, followed by the text "MEDICAL" in black. The design inside the circle appears to be two intertwined letters, possibly "A" and "E", creating a unique and recognizable symbol for the company.
5
Image /page/5/Picture/1 description: The image shows the logo for "A&E MEDICAL". The logo consists of a black circle with a white "A&E" symbol inside, followed by the word "MEDICAL" in black, sans-serif font. A small "®" symbol is present to the right of the word "MEDICAL".