(226 days)
No
The document describes a mechanical fixation device made of titanium and UHMWPE. There is no mention of software, algorithms, or data processing, which are typically associated with AI/ML in medical devices. The performance studies are bench tests focused on mechanical properties and sterilization, not algorithmic performance.
Yes
The device is intended for fixation of bone or soft tissue for repair and reconstruction, which are therapeutic medical procedures.
No
The device is described as a system for fixation of bone or soft tissue to bone, used in orthopedic procedures such as ACL/PCL repair and reconstruction, and fracture repair. Its function is to physically connect tissues, not to diagnose a condition.
No
The device description explicitly states it is a family of titanium buttons and includes physical components like loops, sutures, and needles made of specific materials. It is a physical implantable device, not software.
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 device is for the fixation of bone or soft tissue to bone in surgical procedures. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The device is a system of titanium buttons and associated components used for physical fixation. It does not involve the examination of specimens derived from the human body for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing information for diagnosis, monitoring, or prognosis of a disease or condition.
In summary, the Megaloop Button System is a surgical implant used for mechanical fixation, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Megaloop Button System - Megaloop Button with Megaloop Adjustable Loop
The device is intended to be used for fixation of bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. For example, ACL/PCL repair and reconstruction.
Megaloop Button System - Megaloop AD Device
The device is intended to be used for fixation of bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. For example, ACL/PCL repair and reconstruction.
Megaloop Button System - Megaloop FLB Device, Megaloop FLW Device, Megaloop XL Button
Megaloop FLB Device and Megaloop FLW Device are used for fixation of soft tissue to bone in orthopedic procedures such as ACL repair.
When used in conjunction with the Megaloop FLB Device or Megaloop FLW Device, the Megaloop XL Button is intended for fixation of soft tissue to bone in orthopedic procedures such as ACL repairs.
Megaloop Button System - Megaloop DB Device, Megaloop AC Button with Megaloop Adjustable Loop
The Megaloop DB Device and Megaloop AC Button are intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
Specifically:
-
The Megaloop DB Device is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.
-
The Megaloop AC Button is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
Product codes (comma separated list FDA assigned to the subject device)
MBI, HTN
Device Description
The Megaloop Button System is a family of titanium buttons for the fixation of bone to bone or soft tissue to bone. The system includes a variety of buttons made of Ti-6AI-4V ELI titanium alloy, with or without pre-assembled nonabsorbable loops, sutures and needles. The loops and sutures are offered in non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE) material. The long straight needles are offered in XM-16 stainless steel material. The sutures and needles are not implantable and are discarded after assisting with button placement.
The Megaloop Button System is provided sterile, non-absorbable, for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospitals/clinics
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 bench tests were conducted in support of the substantial equivalence determination.
Material Standards:
ISO 5832-3:2021 Implants for surgery - Metallic materials Part 3: Wrought titanium 6aluminium 4-vanadium alloy
ASTM F2848-17: Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns.
Biocompatibility testing:
Biocompatibility of the Megaloop Button System was evaluated in accordance with ISO 10993-1: 2018 for the body contact category of "Implant medical device - Tissue/ bone" with a contact duration of "Long term ( > 30 d)" and "Externally communicating medical device - Tissue/ bone/ dentin" with a contact duration of "Limited (≤24 h)".
Bacterial endotoxin testing:
Bacterial endotoxins for the implantable components are determined using LAL testing to meet endotoxin limit specifications.
Mechanical performance testing:
The following are the mechanical tests that have been performed on the Subject device (i.e. The Megaloop AD Device) and Predicate device (i.e. Arthrex's ACL TightRope RT implant):
-
- Pullout test
-
- Fatigue test
Sterilization and Shelf-life testing:
The sterilization method has been validated according to ISO 11135 to a SAL of 10-8, which has thereby determined the routine control and monitoring parameters, 5-year shelf-life of the device has been evaluated by accelerated aging test.
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.
K110123, K112990, K130814, K190774, K980155, K043248, K052776
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.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is a circular emblem with an abstract design. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size below.
May 3, 2024
Suzhou Endophix Co., Ltd. Juan Wu Regulatory Affairs Specialist No. 151, Fengli Road, SIP Suzhou, Jiangsu 215000 China
Re: K232941
Trade/Device Name: Megaloop Button System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HTN Dated: April 3, 2024 Received: April 3, 2024
Dear Juan Wu:
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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Image /page/2/Figure/3 description: The image shows a digital signature of Jesse Muir. The signature includes the name "Jesse Muir -S" in a large font. The signature also includes the text "Digitally signed by Jesse Muir -S Date: 2024.05.03 13:44:55 -04'00'".
Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Megaloop Button System
Indications for Use (Describe)
Megaloop Button System - Megaloop Button with Megaloop Adjustable Loop The device is intended to be used for fixation of bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. For example, ACL/PCL repair and reconstruction.
Megaloop Button System - Megaloop AD Device
The device is intended to be used for fixation of bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. For example, ACL/PCL repair and reconstruction.
Megaloop Button System - Megaloop FLB Device, Megaloop FLW Device, Megaloop XL Button Megaloop FLB Device and Megaloop FLW Device are used for fixation of soft tissue to bone in orthopedic procedures such as ACL repair.
When used in conjunction with the Megaloop FLB Device or Megaloop FLW Device, the Megaloop XL Button is intended for fixation of soft tissue to bone in orthopedic procedures such as ACL repairs.
Megaloop Button System - Megaloop DB Device, Megaloop AC Button with Megaloop Adjustable Loop
The Megaloop DB Device and Megaloop AC Button are intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
Specifically:
-
The Megaloop DB Device is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.
-
The Megaloop AC Button is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
Type of Use (Select one or both, as applicable)
Megaloop XL Button
Button: 5.5mm × 20mm | K190774
Button: 5.5mm × 20mm | | |
| Sterilization | EO sterilization | EO sterilization | Identical as predicate device. | |
| Shelf-life | 5 Years | 5 Years | Identical as predicate device. | |
| Single Use/Reuse | Single Use | Single Use | Identical as predicate device. | |
| Operating Principle | Megaloop FLB Device, Megaloop FLW Device
The loop pass through tunnels and allows attachment of the button against the bone cortex. The sutures assist the button passing through tunnels and ensure flipping of the button. | (K130814, K980155)
The loop pass through tunnels and allows attachment of the button against the bone cortex. The sutures assist the button passing through tunnels and ensure flipping of the button. | Identical as predicate device. | |
| | Megaloop XL Button
Pass the Megaloop FLB Device or Megaloop FLW Device through the hole in the Megaloop XL Button from the bottom to provide additional width to the Megaloop FLB Device or Megaloop FLW Device. | (K190774)
Pass the Standard Implant through the hole in the XL Implant from the bottom to provide additional width to the Standard Implant. | | |
| Environment of Use | Hospitals/clinics | Hospitals/clinics | Identical as predicate device. | |
| Characteristics | Subject
Device
(Megaloop DB Device) | Predicate Device | Remarks | |
| | | K043248,
Knotless
TightRope™ Syndesmosis
Repair Kit | | |
| Product Code | HTN | HTN | Identical as
predicate
device. | |
| Regulation
Number | 21 CFR 888.3030 | 21 CFR 888.3030 | Identical as
predicate
device. | |
| Regulatory
Class | Class II | Class II | Identical as
predicate
device. | |
| Intended Use | The Megaloop DB Device and Megaloop
AC Button are intended as an adjunct in fracture
repair involving metaphyseal and
periarticular small bone fragments where
screws are not indicated, and as an
adjunct in external and intramedullary fixation
systems involving plates and rods, with
fracture braces and casting.
Specifically:
- The Megaloop DB Device is intended to
provide fixation during the healing process
following a syndesmotic trauma, such as fixation
of syndesmosis (syndesmosis
disruptions) in connection with Weber | The Arthrex TightRope™ Syndesmosis Device is
intended as an adjunct in fracture repair involving
metaphyseal and periarticular small bone
fragments where screws are not indicated, and as
an adjunct in external and intramedullary
fixation systems involving plates and rods, with fracture
braces and casting.
Specifically, the Arthrex
TightRope™ Syndesmosis Device is intended to
provide fixation during the healing process following a
syndesmotic trauma, such as fixation of syndesmosis
(syndesmosis disruptions) in connection with Weber B
and C ankle fractures. | Identical as
predicate
device. | |
| | | B and C ankle fractures. - The Megaloop AC
Button is intended to
provide fixation during
the healing process
following a syndesmotic
trauma, such as fixation
of acromioclavicular
separations due to
coracoclavicular
ligament disruptions. | | Page 12 of |
| Composition | Implantable part:
Button, loop
Non-implantable part:
Suture, needle | Implantable part: Button, loop
Non-implantable part:
Suture, needle | Identical as
predicate
device. | |
| Key Patient
Contacting
Material | Button: Ti-6Al-4V ELI
titanium alloy
Loop: UHMWPE | Button: Ti-6Al-4V ELI
titanium alloy
Loop: UHMWPE | Identical as
predicate
device. | |
| Button type | One round button with
four round holes, and
one oblong button with
one round hole and one
drop type hole | One round button with four
round holes, and one
oblong button with one
round hole and one drop
type hole | Identical as
predicate
device. | |
| Dimensional
Verification | Round button: $Φ$ 6.5mm
Oblong button: 3.4mm
$x$ 13mm | Round button: $Φ$ 6.5mm
Oblong button: 3.5mm $x$
13mm | Substantially
equivalent. | |
| | Loop length: adjustable,
after pretensioning the
loop length is 520mm | Loop length: adjustable,
after pretensioning the
loop length is 520mm | | |
| Sterilization | EO sterilization | EO sterilization | Identical as
predicate
device. | |
| Shelf-life | 5 Years | 5 Years | Identical as
predicate
device. | |
| Single
Use/Reuse | Single Use | Single Use | Identical as
predicate
device. | |
| Operating | The needle and suture | The needle and suture | Identical as | |
| Principle | assist the oblong button to pass through bone tunnels, the round button slides down to the bone by tensioning the loop. | assist the oblong button to pass through bone tunnels, the round button slides down to the bone by tensioning the loop. | predicate device. | |
| Environment of Use | Hospitals/clinics | Hospitals/clinics | Identical as predicate device. | |
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K232941
Page 9 of 16
13
14
Table 4 Substantial equivalence discussion – Megaloop DB Device
15
K232941
Page 12 of 16
16
K232941 Page 13 of 16
Table 5 Substantial equivalence discussion – Megaloop AC Button
| Characteristics | Subject Device
(Megaloop AC Button) | Predicate Device
K052776, Dog Bone™ Button | Remarks |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Product Code | HTN | HTN | Identical as predicate device. |
| Regulation Number | 21 CFR 888.3030 | 21 CFR 888.3030 | Identical as predicate device. |
| Regulatory Class | Class II | Class II | Identical as predicate device. |
| Intended Use | The Megaloop DB Device and Megaloop AC Button are intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Specifically:
- The Megaloop DB Device is intended to provide fixation during the healing process following | The TightRope™ Acromioclavicular (AC) Device is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Specifically, the Arthrex TightRope Acromioclavicular (AC) Device is intended to | Identical as predicate device. |
| a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures. - The Megaloop AC Button is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions. | | provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions. | Page 14 of 1 |
| Composition | Button | Button | Identical as predicate device. |
| Key Patient Contacting Material | Button: Ti-6Al-4V ELI titanium alloy | Button: Ti-6Al-4V ELI titanium alloy | Identical as predicate device. |
| Button type | In the shape of a four-leaf clover, with two symmetric slots | In the shape of a four-leaf clover, with two symmetric slots | Identical as predicate device. |
| Dimensional Verification | Button: 8mm×10mm | Button: 8mm×10mm | Substantially equivalent. |
| Sterilization | EO sterilization | EO sterilization | Identical as predicate device. |
| Shelf-life | 5 Years | 5 Years | Identical as predicate device. |
| Single Use/Reuse | Single Use | Single Use | Identical as predicate device. |
| Operating Principle | The loop pass through bone tunnels and allows attachment of the button against the bone cortex | The loop pass through bone tunnels and allows attachment of the button against the bone cortex. | Identical as predicate device. |
| Environment of Use | Hospitals/clinics | Hospitals/clinics | Identical as predicate device. |
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K232941
Page 14 of 16
18
VII Performance data
Non-clinical bench tests were conducted in support of the substantial equivalence determination.
Material Standards
The material standards are the essential part to be complied with first, as it is the basis of manufacturing surgical implants.
We have complied with the following material standards:
ISO 5832-3:2021 Implants for surgery - Metallic materials Part 3: Wrought titanium 6aluminium 4-vanadium alloy
ASTM F2848-17: Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns.
Biocompatibility testing
Biocompatibility of the Megaloop Button System was evaluated in accordance with ISO 10993-1: 2018 for the body contact category of "Implant medical device - Tissue/ bone" with a contact duration of "Long term ( > 30 d)" and "Externally communicating medical device - Tissue/ bone/ dentin" with a contact duration of "Limited (≤24 h)".
Bacterial endotoxin testing
Bacterial endotoxins for the implantable components are determined using LAL testing to meet endotoxin limit specifications.
The device is not labeled as non-pyrogenic or pyrogen free.
Mechanical performance testing
The following are the mechanical tests that have been performed on the Subject device (i.e. The Megaloop AD Device) and Predicate device (i.e. Arthrex's ACL TightRope RT implant):
-
- Pullout test
-
- Fatigue test
Sterilization and Shelf-life testing
The sterilization method has been validated according to ISO 11135 to a SAL of 10-8, which has thereby determined the routine control and monitoring parameters, 5-year shelf-life of the device has been evaluated by accelerated aging test.
19
VIII Conclusion
The Megaloop Button System is substantially equivalent to the predicate devices. The nonclinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.