The INFILOOP® Fixed Loop UHMWPE Suture Titanium Button is indicated in surgical procedures for soft tissue fixation to the bone. It is used for fixation of tendons and ligaments during orthopaedic reconstruction procedures such as Knee ligament reconstruction which includes anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), medial collateral ligament (MCL), and lateral collateral ligament (LCL).

Device Description

The use of the INFILOOP® Fixed Loop UHMWPE Suture Titanium Button provides the orthopaedic surgeon a means of accurate fixation in ligament reconstructive surgery of soft tissue to bone fixation. The fixation device allows for arthroscopic ligament reconstruction approaches.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the INFILOOP® Fixed Loop UHMWPE Suture Titanium Button, based on the provided FDA 510(k) summary.

Note: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed de novo clinical study with specific acceptance criteria in the vein of a novel AI/software device. Therefore, the information provided will reflect the nature of a medical device clearance process for a predicate-based device, emphasizing non-clinical performance and material equivalence.

Acceptance Criteria and Device Performance

The acceptance criteria for this device are primarily demonstrated through non-clinical performance testing and material equivalence to predicate devices. The "performance data" acceptance criteria are implicitly tied to demonstrating comparable or superior mechanical properties and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly based on Predicate Device Performance and Standards)	Reported Device Performance (INFILOOP® Fixed Loop UHMWPE Suture Titanium Button)
Mechanical Performance	Pull Out Strength: Comparable to predicate devices (Conmed Linvatec XO Button™, RIGIDLOOP™ Cortical Fixation System).	"Pull Out Testing" performed and results demonstrated suitability for intended use. (Exact values not provided in summary, but deemed acceptable by FDA).
	Cyclic Loading: Comparable to predicate devices.	"Cyclical Loading" performed and results demonstrated suitability for intended use. (Exact values not provided in summary, but deemed acceptable by FDA).
Biocompatibility	Non-toxic, non-irritating, non-sensitizing, and biologically inert when implanted.	Skin Sensitization, Intracutaneous reactivity, Material Mediated Pyrogenicity, Acute Systemic Toxicity, In-vitro cytotoxicity, Bone Implantation, Intramuscular Implantation, Bacterial Endotoxin USP <85> tests performed. All results deemed acceptable.
Material Equivalence	Button and Loop materials (Titanium, UHMWPE) are the same as predicate devices.	Button: TitaniumLoop: UHMWPE(Similar to predicate devices)
Suture Material Equivalence/Superiority	Acceptable mechanical properties for suture material (UHMWPE) for soft tissue fixation.	UHMWPE suture used. Literature study cited indicating "Pure UHMWPE suture had higher ultimate failure load than sutures composed of either polyester or polyester plus UHMWPE." This suggests superiority or at least equivalence to predicate suture materials.
Sterilization	Effective sterilization validated.	ETO (Ethylene Oxide) sterilization validated. (Similar to predicate devices)
Shelf Life	Validated shelf life.	5 Years validated. (Similar to predicate devices)
Single Use	Device designed for single use.	Single Use. (Similar to predicate devices)
MRI Compatibility	No contraindications or adverse effects in MRI environment.	MRI Compatibility testing performed. Results deemed acceptable.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes for each individual non-clinical test (e.g., number of specimens for pull-out strength or cyclic loading, number of animals for biocompatibility studies).

The data provenance is from non-clinical laboratory testing conducted by the manufacturer, Healthium Medtech Limited, likely in India, as that is the submitter's location. The studies are retrospective in the sense that they are conducted on manufactured devices as part of the clearance process, but they are not clinical studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable in the context of this 510(k) submission. For non-clinical performance and biocompatibility testing of a medical device like this button and suture system, "ground truth" is established by adherence to recognized ASTM/ISO standards for mechanical testing and biocompatibility. There isn't an "expert" panel establishing a diagnostic ground truth as there would be for an AI/software device interpreting medical images.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication typically refers to the process of resolving discrepancies among expert interpretations in clinical studies, particularly for diagnostic devices. For mechanical and biocompatibility testing, results are quantitative and compared against predefined specifications from relevant standards or predicate device performance. Deviation from these specifications would lead to failure, not "adjudication."

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 devices, especially those involving human interpretation of medical images, to assess reader performance with and without AI assistance. The INFILOOP® Fixed Loop UHMWPE Suture Titanium Button is a surgical implant, not a diagnostic imaging device or an AI-assisted interpretation tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance evaluation in the context of a "human-in-the-loop" scenario is not applicable. This device is a physical surgical implant. The concept of "standalone" typically applies to AI algorithms that can perform a task without human intervention or interpretation (e.g., an AI that directly diagnoses an illness from an image).

7. The Type of Ground Truth Used

For this device, the "ground truth" is predominantly based on:

Established industry standards: ASTM/ISO standards for mechanical testing (e.g., tensile strength, fatigue) and biocompatibility (ISO 10993 series).
Performance of legally marketed predicate devices: The "Conmed Linvatec XO Button™" and "RIGIDLOOP™ Cortical Fixation System" set the precedent for acceptable performance and safety profiles.
Material properties data: Scientific literature and material specifications for UHMWPE and Titanium.

8. The Sample Size for the Training Set

This is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical implant; there is no AI model involved in its function that would require a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for this type of device.

Summary

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November 8, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.

Healthium Medtech Limited Pankaj Dawar, PhD Deputy General Manager Regulatory Affair 472-D, 13th Cross, 4th Phase, Peenya Industrial Area Bangalore, Karnataka 560058 India

Re: K232886

Trade/Device Name: INFILOOP® Fixed Loop UHMWPE Suture Titanium Button Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: September 13, 2023 Received: September 18, 2023

Dear Dr. Dawar:

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 (the 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.

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"

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(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 OS 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).

Sincerely.

Digitally signed by Jesse Muir -S Jesse Muir -S

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

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Enclosure

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Indications for Use

510(k) Number (if known) K232886

Device Name

INFILOOP® Fixed Loop UHMWPE Suture Titanium Button

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "SIRONIX" is written in large, bold, sans-serif letters, with the "O" in "SIRONIX" being a red circle. Below the word "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller, sans-serif font. The logo is simple and modern, and the red circle adds a pop of color.

510(k) Summary INFILOOP® Fixed Loop UHMWPE Suture Titanium Button

Image /page/4/Picture/2 description: The image contains the alphanumeric string "K232886" in the upper left corner. Below this is the word "Healthium" in a stylized font. To the right of the word is a logo consisting of two overlapping circles, one orange and one blue, with a white cross shape in the center.

510(k) Summary based on the 21 CFR 807.92

Date Prepared	12 September 2023
510(k) Number	K232886
Submitter	Healthium Medtech Limited472-D, 13th Cross, 4th Phase,Peenya Industrial Area,Bangalore, India, 560058Ph: +91 - 80 - 41868000
Contact Person	Pankaj DawarDeputy General ManagerRegulatory AffairsPh: +91 - 80 - 41868000pankaj.d@healthiummedtech.com
Name of Device	INFILOOP® Fixed Loop UHMWPE Suture Titanium Button
Common Name	Fixed Loop UHMWPE Suture Titanium Button
Product Code	MBI
Classification Name	21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener
Regulatory Class	II
Predicate Device	Conmed Linvatec XO Button™ (Continous Loop) (K070780)-Primary PredicateRIGIDLOOPTM Cortical Fixation System (K130814)-Additional Predicate
Reference Device	No reference device used
Purpose of Submission	Traditional 510(k) is submitted to obtain clearance for the INFILOOP® Fixed LoopUHMPWE suture Titanium Button
Device Description	The use of the INFILOOP® Fixed Loop UHMWPE Suture Titanium Button providesthe orthopaedic surgeon a means of accurate fixation in ligament reconstructivesurgery of soft tissue to bone fixation. The fixation device allows for arthroscopicligament reconstruction approaches.
Intended Use/Indications for Use	The INFILOOP® Fixed Loop UHMWPE Suture Titanium Button is indicated insurgical procedures for soft tissue fixation to the bone. It is used for fixation oftendons and ligaments during orthopaedic reconstruction procedures such as Kneeligament reconstruction which includes anterior cruciate ligament (ACL), posteriorcruciate ligament (PCL), medial collateral ligament (MCL), and lateral collateralligament (LCL)

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Image /page/5/Picture/0 description: The image shows the logo for Sironix. The logo consists of the word "SIRONIX" in a sans-serif font, with the "O" in "SIRONIX" being a red circle. Below the word "SIRONIX" is the text "Arthroscopy Solutions" in a smaller font.

Image /page/5/Picture/2 description: The image contains the text "K232886" at the top left corner. Below the text is a logo for a company called "Healthium". The logo consists of the company name in a stylized font and a circular graphic with a cross shape in the middle.

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Comparison of the Technological Characteristics with Predicate Device

S. No	Parameters	Conmed LinvatecXO Button™(Continous Loop)(K070780)(Primary Predicate)	RIGIDLOOP™Cortical FixationSystem(K130814)(Additional Predicate)	INFILOOP® FixedLoop UHMWPESuture TitaniumButton(Subject Device)	Comments
1.	Manufacturer	ConMed Linvatec	Medos InternationalSARL	Healthium MedtechLimited	-
2.	Product Code	MBI (ClassificationProduct Code)GAT (SubsequentProduct Code)	MBI	MBI	Similar topredicatedevice
3.	RegulationNumber	21 CFR 888.3040	21 CFR 888.3040	21 CFR 888.3040	Similar topredicatedevice
4.	Classification	Class II	Class II	Class II	Similar topredicatedevice
5.	Intended Use/Indications forUse	The Conmed LinvatecXO Button™ withcontinuos loop isintended to providesuspension fixation forsoft tissue to bone inthe repair of thenatural ligament ortendon disruption orreconstruction of aligament using softtissue grafts. Examplesof such proceduresinclude anteriorcruciate ligament,posterior cruciateligament, medialcollateral ligament,and lateral collateralligament.	The RIGIDLOOP™Cortical FixationSystem is used forthe fixation of softtissue to bone inorthopedicprocedures such asACL repair	The INFILOOP®Fixed LoopUHMWPE SutureTitanium Button isindicated in surgicalprocedures for softtissue fixation to thebone. It is used forfixation of tendonsand ligaments duringorthopaedicreconstructionprocedures such asKnee ligamentreconstruction whichincludes anteriorcruciate ligament(ACL), posteriorcruciate ligament(PCL), medialcollateral ligament(MCL), and lateralcollateral ligament(LCL).	Similar topredicatedevice
6.	Button andLoop Material	Button: TitaniumLoop: UHMWPE	Button: TitaniumLoop: UHMWPE	Button: TitaniumLoop: UHMWPE	Similar topredicatedevice
S.No	Parameters	Conmed LinvatecXO Button™(Continous Loop)(K070780)(Primary Predicate)	RIGIDLOOP™Cortical FixationSystem(K130814)(AdditionalPredicate)	INFILOOP® FixedLoop UHMWPESuture TitaniumButton(Subject Device)	Comments
7.	SutureMaterial	Polyester, USP#5 UHMWPE,USP#3-4	UHMWPE,USP#5 Polyester,USP#5	UHMWPE,USP#5 UHMWPE,USP#5	Refer theSEAnalysis
8.	SingleUse/Reuse	Single Use	Single Use	Single Use	Similar topredicatedevice
9.	Shelf Life	5 Years	5 Years	5 Years	Similar topredicatedevice
10.	SterilizationMethod	ETO	ETO	ETO	Similar topredicatedevice
11.	PerformanceData	Pull Out Testing Cyclical Loading	Pull Out Testing	Pull Out Testing Cyclical Loading	Similar topredicatedevice
12.	Safety Data	No Data Available	No DataAvailable	Skin Sensitization Intracutaneous reactivity Material Mediated Pyrogenicity Acute Systemic Toxicity In-vitro cytotoxicity Bone Implantation Intramuscular Implantation Bacterial Endotoxin USP<85> MRI Compatibility	-

Registered Office: 472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Bengaluru – 560058, India

www.healthiummedtech.com | CIN : U03311KA1992PLC013831

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510(k) Summary INFILOOP® Fixed Loop UHMWPE Suture Titanium Button

Image /page/6/Picture/1 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "SIRONIX" is written in a bold, sans-serif font, with the "O" in "SIRONIX" being a red circle. Below the word "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller, sans-serif font. The logo is simple and modern, and the red circle adds a pop of color.

Image /page/6/Picture/2 description: The image contains the text 'K232886' in the upper left corner. Below this text is the word 'Healthium' in a stylized font. To the right of 'Healthium' is a logo consisting of a blue circle with a white cross inside, partially obscured by an orange circle with a white cross inside.

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Image /page/7/Picture/1 description: The image shows the logo for Healthium, a medical device company. The logo consists of the word "Healthium" in a blue, sans-serif font, with a stylized graphic to the right. The graphic is composed of two overlapping circles, one orange and one blue, with a white cross shape in the center where they intersect. The text "K232886" is located in the upper left corner of the image.

SE Analysis

Predicate devices are preloaded with one UHMWPE suture and one Polyester Suture, whereas the subject device is preloaded with UHMWPE sutures. From the literature study, it can be inferred that the Polyester suture had lower ultimate load than all groups of sutures used in the study except the suture composed of polyester and UHMWPE (P<. 05).

Pure UHMWPE suture had higher ultimate failure load than sutures composed of either polyester or polyester plus UHMWPE (P<.05). Predominant failure mode was suture cutting through the meniscus for the groups except for polyester suture which failed by suture rupture. This literature study shows that Pure UHMWPE material has better ultimate load than the material used in predicate and this change is not raising any questions on the safety and efficacy of the subject device.

Comparison and summary of the technological characteristics

The proposed INFILOOP® Fixed Loon UHMWPE Suture Titanium Button (referred to as the "subjected device") shares similar basic design features and materials of construction for the button and loop when compared to the predicate devices. The specifications and dimensions of the subjected device fall within the range of those of the predicate devices. Minor differences in technological characteristics do not raise any safety or effectiveness concerns.

Comparison and summary of the safety, performance and non-clinical testing data

Verification activities were performed on the implant and its predicates. Testing assessments included biocompatibility, pyrogenicity (both material andotoxin) in accordance with USP <85>, sterility, shelf life, pull-out testing, and cyclic loading (as mentioned in the comparison table). The results of performance testing have demonstrated that the proposed devices are suitable for their intended use.

Conclusion

The INFILOOP® Fixed Loop UHMWPE Suture Titanium Button is substantially equivalent to the predicate devices. Any differences between the subject device and the predicate devices do not raised questions concerning safety and effectiveness.

Based on the indications for use, technological characteristics, and the summary of data submitted, it is determined that the proposed device is substantially equivalent to the currently marketed predicate devices.

Regulation Number and Section

N/A