(226 days)
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.
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.
The provided text describes a 510(k) premarket notification for the "Megaloop Button System," which is a family of titanium buttons used for fixation of bone or soft tissue to bone. The submission asserts that the device is substantially equivalent to several predicate devices.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence are primarily based on comparing the subject device's characteristics and performance to legally marketed predicate devices. The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., minimum pullout strength in Newtons, minimum cycles for fatigue life). Instead, it relies on demonstrating that the subject device's non-clinical test results are comparable to or perform as well as the predicate devices.
Therefore, the table below outlines the general performance aspects evaluated and the reported outcomes:
| Performance Aspect | Acceptance Criteria (Implied) | Reported Device Performance and Remarks |
|---|---|---|
| Material Standards | Compliance with relevant ISO and ASTM standards for medical-grade materials. | Complied with ISO 5832-3:2021 (Wrought titanium 6aluminium 4-vanadium alloy) and ASTM F2848-17 (Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns). |
| Biocompatibility | Meeting biocompatibility requirements for long-term implantable devices. | Evaluated according to ISO 10993-1:2018 for "Implant medical device - Tissue/bone" (Long term > 30 d) and "Externally communicating medical device - Tissue/bone/dentin" (Limited ≤ 24 h). Specific results are not provided, but the statement implies compliance. |
| Bacterial Endotoxin | Meeting endotoxin limit specifications for implantable components. | Determined using LAL testing to meet endotoxin limit specifications. Specific values are not provided. |
| Mechanical Performance | Demonstrated comparable or equivalent mechanical performance to predicate devices (Pullout, Fatigue). | Pullout test: Performed on the subject device (Megaloop AD Device) and predicate device (Arthrex's ACL TightRope RT implant). Specific quantitative results of the pullout strength for both subject and predicate devices are not provided, only that the test was performed. |
| Fatigue test: Performed on the subject device (Megaloop AD Device) and predicate device (Arthrex's ACL TightRope RT implant). Specific quantitative results (e.g., cycles to failure) for both subject and predicate devices are not provided, only that the test was performed. | ||
| Sterilization Efficacy | Sterilization to a Sterility Assurance Level (SAL) of 10^-6 or better. | Validated according to ISO 11135 to a SAL of 10^-8. |
| Shelf-life | Demonstrated stability and performance over the claimed shelf-life. | 5-year shelf-life evaluated by accelerated aging test. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Non-clinical bench tests were conducted in support of the substantial equivalence determination."
- Sample Size: The document does not specify the sample size used for the pullout or fatigue tests, or any other non-clinical bench tests.
- Data Provenance: The nature of "non-clinical bench tests" implies that the data was generated in a controlled laboratory environment, likely by the manufacturer (Suzhou Endophix Co., Ltd.) or a contracted testing facility. There is no information regarding the country of origin of the data beyond the manufacturer's location (China), nor any mention of retrospective or prospective human data. This entire submission relies on bench testing, not human or clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this submission. The "ground truth" for the non-clinical bench tests would be the measured physical properties of the materials and devices under specific testing conditions, as determined by laboratory instruments and protocols. There is no mention of human experts establishing a "ground truth" for the test set, as these are mechanical and material property tests.
4. Adjudication Method for the Test Set
This is not applicable. Since the evaluation is based on non-clinical bench tests measuring objective physical properties, there is no need for an adjudication method by human reviewers. The test results are quantitative measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic medical devices where expert readers evaluate cases. The Megaloop Button System is a surgical implantable device, and its evaluation is based on non-clinical bench testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The Megaloop Button System is a physical surgical implant, not a software algorithm or an AI-powered device. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical bench tests consists of:
- Material Specifications: Compliance with established international standards (ISO, ASTM) for the chemical composition and mechanical properties of the materials (titanium alloy, UHMWPE).
- Biocompatibility Standards: Compliance with ISO 10993-1.
- Mechanical Test Results: Measured load-to-failure (pullout) and cycles-to-failure (fatigue) data, which are compared against general performance expectations for such devices and, implicitly, against the predicate device's performance. The "ground truth" here is the objectively measured physical behavior of the device under stress.
- Sterilization Validation: Demonstrated SAL of 10^-8.
- Shelf-life Data: Results from accelerated aging tests.
No pathology, expert consensus, or outcomes data were used for establishing ground truth in this non-clinical submission.
8. The Sample Size for the Training Set
This is not applicable. The Megaloop Button System is a physical medical device, not an AI or machine learning model. Therefore, there is no "training set" in the context of algorithm development. The design and manufacturing process would involve internal testing and iteration, but not "training data" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
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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.
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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).
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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
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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)
< Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
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510(k) Summary
I Submitter
Device submitter: Suzhou Endophix Co., Ltd. NO.151, Fengli Road, SIP, 215000 Suzhou, Jiangsu Province PEOPLE'S REPUBLIC OF CHINA
| Primary contact person: | Juan WuRegulatory Affairs SpecialistPhone: +86-17521559984Email: Juan.Wu@microport.com |
|---|---|
| Date of preparation: 2023-09-18 |
II Device
| Trade | Name | of Megaloop Button System |
|---|---|---|
| Device: | ||
| Common Name: | Titanium Button | |
| Classification Name: | Fastener, Fixation, Non-degradable, Soft Tissue | |
| Regulatory Class: | II | |
| Product Code: | MBI, HTN | |
| Review Panel: | Orthopedic | |
| Regulation Number: | 21 CFR 888.3040, 21 CFR 888.3030 |
III Predicate Devices
| Trade Name: | Arthrex PCL Tightrope |
|---|---|
| Common Name: | Fastener, fixation, nondegradable, soft tissueSuture, Nonabsorbable, synthetic, polyethylene |
| Classification: | Class II, 21 CFR 888.3040, 21 CFR 878.5000 |
| Product Code: | HTY, GAT |
| Premarket Notification: | K110123 |
| Manufacturer: | Arthrex, Inc. |
| Trade Name: | ACL TightRope; ACL TightRope Double Bundle |
| Common Name: | Pin, fixation, smoothSuture, Nonabsorbable, synthetic, polyethylene |
| Classification: | Class II, 21 CFR 888.304021 CFR 878.5000 |
| Product Code: | HTY, GAT |
| Premarket Notification: | K112990 |
| Manufacturer: | Arthrex, Inc. |
| Trade Name: | RIGIDLOOP Cortical Fixation System |
| Common Name: | Fastener, Fixation, Soft Tissue |
| Classification: | Class II, 21 CFR 888.3040 |
| Product Code: | MBI |
| Premarket Notification: | K130814 |
| Manufacturer: | Medos International SARL, part of DePuy Mitek, Inc. |
| Trade Name: | RIGIDLOOP™ Titanium Button, RIGIDLOOP™ CorticalFixation System XL |
| Common Name: | ImplantFixation Device |
| Classification: | Class II, 21 CFR 888.3040 |
| Product Code: | MBI |
| Premarket Notification: | K190774 |
| Manufacturer: | Medos International SARL, part of DePuy Mitek, Inc. |
| Trade Name: | EndoButton Continous Loop |
| Common Name: | Suture Retention Device; Surgical Button; RetentionBridgePolyester Surgical Suture |
| Classification: | Class II, 21 CFR 888.3040, 21 CFR 878.5000 |
| Product Code: | MBI, GAT |
| Premarket Notification: | K980155 |
| Manufacturer: | Smith & Nephew, Inc., Endoscopy Division |
| Trade Name: | TightRope™ Syndesmosis Device |
| Common Name: | Button/Suture |
| Classification: | Class II, 21 CFR 888.3030 |
| Product Code: | HTN |
| Premarket Notification: | K043248 |
| Manufacturer: | Arthrex, Inc. |
| Trade Name: | TightRope™ Acromioclavicular (AC) |
| Common Name: | Button/Suture |
| Classification: | Class II, 21 CFR 888.3030 |
| Product Code: | HTN |
| Premarket Notification: | K052776 |
| Manufacturer: | Arthrex, Inc. |
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Reference device
| Trade Name: | Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor |
|---|---|
| Classification: | Class II, 21 CFR 888.3040 |
| Product Code: | MBI |
| Premarket Notification: | K232725 |
| Manufacturer: | Suzhou Endophix Co., Ltd. |
IV 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.
V 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.
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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 (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.
VI Comparison of technological characteristics with the predicate devices
Suzhou Endophix Megaloop Button System has similar technological characteristics and fundamental design as the predicate device. The differences between the subject device and predicate device do not alter suitability of the proposed device for its intended use. Table 1 Substantial equivalence discussion - Megaloop Button with Megaloop Adjustable
| Characteristics | Subject(Megaloop Button withMegaloop AdjustableLoop) | Predicate DeviceK110123, TightRopeABS Button withTightRope ABS Loop | Remarks |
|---|---|---|---|
| Product Code | MBI, HTN | HTY, GAT | Different |
| RegulationNumber | 21 CFR 888.3030 | 21 CFR 888.3040 | Different |
| RegulationNumber | 21 CFR 888.3040 | 21 CFR 878.5000 | |
| RegulatoryClass | Class II | Class II | Identical aspredicatedevice. |
| Intended Use | The device is intended tobe used for fixation ofbone to bone or softtissue to bone, and isintended as fixationposts, a distributionbridge, or for distributingsuture tension over areasof ligament or tendonrepair. For example, | The Arthrex PCLTightRope is intended tobe used for fixation ofbone to bone or softtissue to bone, and isintended as fixationposts, a distributionbridge, or for distributingsuture tension over areasof ligament or tendon | Identical aspredicatedevice. |
| ACL/PCL repair andreconstruction. | repair. For example,ACL/PCL repair andreconstruction. | ||
| Composition | Buttoncompatible Loop | Buttoncompatible Loop | Identical aspredicatedevice. |
| Key PatientContactingMaterial | Button: Ti-6Al-4V ELItitanium alloyLoop: UHMWPE | Button: Ti-6Al-4V ELItitanium alloyLoop: UHMWPE | Identical aspredicatedevice. |
| Button Type | Standard button with twosymmetric slots;Round button with twosymmetric slots;Oblong button with twoslots. | Standard button with twosymmetric slots;Round button with twosymmetric slots;Oblong button with twoslots. | Identical aspredicatedevice. |
| DimensionalVerification | Standard button: 8 mm ×11 mm,Round button: Φ14mm,Oblong button: 3.4 mm ×13 mmLoop length: adjustable,170mm | Standard button: 8 mm ×12 mm,Round button: Φ14mm,Oblong button: 3.4 mm ×13 mmLoop length: adjustable,170mm | Substantiallyequivalent. |
| Sterilization | EO sterilization | EO sterilization | Identical aspredicatedevice. |
| Shelf-life | 5 Years | 5 Years | Identical aspredicatedevice. |
| SingleUse/Reuse | Single Use | Single Use | Identical aspredicatedevice. |
| OperatingPrinciple | The loop pass throughbone tunnels and allowsattachment of the buttonagainst the bone cortex. | The loop pass throughbone tunnels and allowsattachment of the buttonagainst the bone cortex. | Identical aspredicatedevice. |
| Environment ofUse | Hospitals/clinics | Hospitals/clinics | Identical aspredicatedevice |
| Characteristics | SubjectDevice(Megaloop AD Device) | Predicate DeviceK112990, ACL TightRopeRT implant | Remarks |
| Product Code | MBI, HTN | HTY, GAT | Different |
| RegulationNumber | 21 CFR 888.303021 CFR 888.3040 | 21 CFR 888.304021 CFR 878.5000 | Different |
| RegulatoryClass | Class II | Class II | Identical aspredicatedevice. |
| Intended Use | The device is intended tobe used for fixation ofbone to bone or softtissue to bone, and isintended as fixationposts, a distributionbridge, or for distributingsuture tension over areasof ligament or tendonrepair. For example,ACL/PCL repair andreconstruction. | The ACL TightRope andACL TightRope DoubleBundle are to be used forfixation of bone to boneor soft tissue to bone, andare intended as fixationposts, a distributionbridge, or for distributingsuture tension over areasof ligament or tendonrepair.Specifically,Arthrex will be offeringthese for ACL/PCL repairand reconstruction. | Identical aspredicatedevice. |
| Composition | Implantable part: Button,loopNon-implantable part:Sutures | Implantable part: Button,loopNon-implantable part:Sutures | Identical aspredicatedevice. |
| Key PatientContactingMaterial | Button: Ti-6Al-4V ELItitanium alloyLoop: UHMWPE | Button: Ti-6Al-4V ELItitanium alloyLoop: UHMWPE | Identical aspredicatedevice. |
| Button Type | The button is providedwith two round holes andone drop type hole | The button is providedwith two round holes andone drop type hole | Identical aspredicatedevice. |
| DimensionalVerification | Button: $3.4mm\times13mm$Loop length: adjustable,after pretensioning theloop length is 600mm | Button: $3.4mm\times13mm$Loop length: adjustable,after pretensioning theloop length is 540mm | Substantiallyequivalent. |
| Sterilization | EO sterilization | EO sterilization | Identical as |
| Shelf-life | 5 Years | 5 Years | Identical aspredicatedevice. |
| SingleUse/Reuse | Single Use | Single Use | Identical aspredicatedevice. |
| OperatingPrinciple | The loop pass throughbone tunnels and allowsattachment of the buttonagainst the bone cortex.The sutures assist thebutton passing throughtunnels and ensureflipping of the button. | The loop pass throughbone tunnels and allowsattachment of the buttonagainst the bone cortex.The sutures assist thebutton passing throughtunnels and ensureflipping of the button. | Identical aspredicatedevice. |
| Environment ofUse | Hospitals/clinics | Hospitals/clinics | Identical aspredicatedevice. |
Loop
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Table 2 Substantial equivalence discussion – Megaloop AD Device
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K232941 Page 6 of 16
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Page 7 of 16
Table 3 Substantial equivalence discussion – Megaloop FLB Device, Megaloop FLW Device, Megaloop XL Button
| Characteristics | SubjectDevice(Megaloop FLB Device,Megaloop FLW Device,Megaloop XL Button) | Predicate Device | Remarks | |
|---|---|---|---|---|
| K130814, RIGIDLOOP™Fixed Loop(primary predicate) | ||||
| K980155, EndoButtonCL UltraK190774, RIGIDLOOP™XL Button(additional predicate) | ||||
| Product Code | MBI | MBI (K130814)GAT, MBI (K980155)MBI (K190774) | Identical aspredicatedevice. | |
| RegulationNumber | 21 CFR 888.3040 | 21 CFR 888.3040(K130814)21 CFR 888.304021 CFR 878.5000 | Identical aspredicatedevice. | |
| (K980155)21 CFR 888.3040(K190774) | Page 8 of | |||
| RegulatoryClass | Class II | Class II | Identical aspredicatedevice. | |
| Intended Use | Megaloop FLB Deviceand Megaloop FLWDevice are used forfixation of soft tissue tobone in orthopedicprocedures such as ACLrepair.When used in conjunctionwith the Megaloop FLBDevice or Megaloop FLWDevice, the Megaloop XLButton is intended forfixation of soft tissue tobone in orthopedicprocedures such as ACLrepairs. | The RIGIDLOOPTMCortical Fixation System(K130814) is used for thefixation of soft tissue tobone in orthopedicprocedures such as ACLrepair.The EndoButtonContinuous Loop(K980155) is used forfixation of tendons andligaments duringorthopedic reconstructionprocedures such asAnterior CruciateLigament (ACL)Reconstruction.When used inconjunction with theRIGIDLOOP CorticalFixation System, theRIGIDLOOP CorticalFixation System XLImplant (K190774) isintended for fixation ofsoft tissue to bone inorthopedic proceduressuch as ACL repairs. | Identical aspredicatedevice. | |
| Composition | Megaloop FLB Device,Megaloop FLW DeviceImplantable part: Button,Loop | (K130814, K980155)Implantable part: Button,loopNon-implantable part: | Identical aspredicatedevice. | |
| Non-implantable part: Sutures | Sutures | |||
| Megaloop XL ButtonImplantable part: Button | (K190774)Implantable part: Button | |||
| KeyPatientContactingMaterial | Button: Ti-6Al-4V ELItitanium alloyLoop: UHMWPE | K130814Button: Ti-6Al-4V ELItitanium alloyLoop: UHMWPEK980155Button: Ti-6Al-4V ELItitanium alloyLoop: PolyethyleneTerephthalate (PET)K190774Button: Ti-6Al-4V ELItitanium alloy | Substantiallyequivalent. | |
| Button Type | Megaloop FLB Device,Megaloop FLW DeviceThe button is providedwith four round holesMegaloop XL ButtonThe button consists of anelongated titanium platewith a recess and twosymmetrical lateral slots | (K130814, K980155)The button is providedwith four round holes(K190774)The button consists of anelongated titanium platewith a recess and twosymmetrical lateral slots | Identical aspredicatedevice. | |
| Loop Type | Megaloop FLW Device:weaved loopMegaloop FLB Device:blended loop | K130814: weaved loopK980155: blended loop | Identical aspredicatedevice. | |
| DimensionalVerification | Megaloop FLB Device,Megaloop FLW DeviceButton: 4mm × 12mmLoop length: 15-60mm in5mm increments | K130814Button: 4mm × 12mmLoop length: 15-60mm in5mm incrementsK980155Button width: from 4 to | Substantiallyequivalent. | |
| Page 10 of | ||||
| 6mmButton length: from 12 to 18mmLoop length: 10-80 mm | ||||
| Megaloop XL ButtonButton: 5.5mm × 20mm | K190774Button: 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 DeviceThe 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 ButtonPass 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 | SubjectDevice(Megaloop DB Device) | Predicate Device | Remarks | |
| K043248,KnotlessTightRope™ SyndesmosisRepair Kit | ||||
| Product Code | HTN | HTN | Identical aspredicatedevice. | |
| RegulationNumber | 21 CFR 888.3030 | 21 CFR 888.3030 | Identical aspredicatedevice. | |
| RegulatoryClass | Class II | Class II | Identical aspredicatedevice. | |
| Intended Use | The Megaloop DB Device and MegaloopAC Button are intended as an adjunct in fracturerepair involving metaphyseal andperiarticular small bone fragments wherescrews are not indicated, and as anadjunct in external and intramedullary fixationsystems involving plates and rods, withfracture braces and casting.Specifically:- The Megaloop DB Device is intended toprovide fixation during the healing processfollowing a syndesmotic trauma, such as fixationof syndesmosis (syndesmosisdisruptions) in connection with Weber | The Arthrex TightRope™ Syndesmosis Device isintended as an adjunct in fracture repair involvingmetaphyseal and periarticular small bonefragments where screws are not indicated, and asan adjunct in external and intramedullaryfixation systems involving plates and rods, with fracturebraces and casting.Specifically, the ArthrexTightRope™ Syndesmosis Device is intended toprovide fixation during the healing process following asyndesmotic trauma, such as fixation of syndesmosis(syndesmosis disruptions) in connection with Weber Band C ankle fractures. | Identical aspredicatedevice. | |
| B and C ankle fractures.- The Megaloop ACButton is intended toprovide fixation duringthe healing processfollowing a syndesmotictrauma, such as fixationof acromioclavicularseparations due tocoracoclavicularligament disruptions. | Page 12 of | |||
| Composition | Implantable part:Button, loopNon-implantable part:Suture, needle | Implantable part: Button, loopNon-implantable part:Suture, needle | Identical aspredicatedevice. | |
| Key PatientContactingMaterial | Button: Ti-6Al-4V ELItitanium alloyLoop: UHMWPE | Button: Ti-6Al-4V ELItitanium alloyLoop: UHMWPE | Identical aspredicatedevice. | |
| Button type | One round button withfour round holes, andone oblong button withone round hole and onedrop type hole | One round button with fourround holes, and oneoblong button with oneround hole and one droptype hole | Identical aspredicatedevice. | |
| DimensionalVerification | Round button: $Φ$ 6.5mmOblong button: 3.4mm$x$ 13mm | Round button: $Φ$ 6.5mmOblong button: 3.5mm $x$13mm | Substantiallyequivalent. | |
| Loop length: adjustable,after pretensioning theloop length is 520mm | Loop length: adjustable,after pretensioning theloop length is 520mm | |||
| Sterilization | EO sterilization | EO sterilization | Identical aspredicatedevice. | |
| Shelf-life | 5 Years | 5 Years | Identical aspredicatedevice. | |
| SingleUse/Reuse | Single Use | Single Use | Identical aspredicatedevice. | |
| 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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Table 4 Substantial equivalence discussion – Megaloop DB Device
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Table 5 Substantial equivalence discussion – Megaloop AC Button
| Characteristics | Subject Device(Megaloop AC Button) | Predicate DeviceK052776, 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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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.
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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.
§ 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.