(51 days)
No reference device used
No
The 510(k) summary describes a mechanical fixation device (suture and button) and does not mention any AI or ML components or functionalities.
Yes
The device is described as being used in surgical procedures for soft tissue fixation to the bone, specifically for fixation of tendons and ligaments during orthopedic reconstruction procedures, which are therapeutic interventions.
No
Explanation: The device is a surgical implant designed for soft tissue fixation to the bone in orthopedic reconstruction procedures. It is used in treatment, not for diagnosis.
No
The device description clearly states it is a physical implant (suture and titanium button) used in surgical procedures, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the INFILOOP® Fixed Loop UHMWPE Suture Titanium Button is a surgical implant used for soft tissue fixation to the bone during orthopedic reconstruction procedures. It is a physical device used within the body during surgery, not a test performed on a sample outside the body.
The information provided focuses on the surgical application and mechanical performance of the implant, which is consistent with a non-IVD medical device.
N/A
Intended Use / Indications for Use
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).
Product codes
MBI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee for ligament reconstruction (anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), medial collateral ligament (MCL), and lateral collateral ligament (LCL)).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Orthopaedic surgeon in surgical procedures.
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)
Verification activities were performed on the implant and its predicates. Testing assessments included biocompatibility, pyrogenicity (both material andotoxin) in accordance with USP , 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Conmed Linvatec XO Button™ (Continous Loop) (K070780), RIGIDLOOPTM Cortical Fixation System (K130814)
Reference Device(s)
No reference device used
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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"
1
(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
2
Enclosure
3
Indications for Use
510(k) Number (if known) K232886
Device Name
INFILOOP® Fixed Loop UHMWPE Suture Titanium Button
Indications for Use (Describe)
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).
| 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) |
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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 Limited |
| 472-D, 13th Cross, 4th Phase, | |
| Peenya Industrial Area, | |
| Bangalore, India, 560058 | |
| Ph: +91 - 80 - 41868000 | |
| Contact Person | Pankaj Dawar |
| Deputy General Manager | |
| Regulatory Affairs | |
| Ph: +91 - 80 - 41868000 | |
| pankaj.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 Predicate |
| RIGIDLOOPTM 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 Loop |
| UHMPWE suture Titanium Button | |
| 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. | |
| Intended Use/Indications for Use | 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) |
5
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.
Page 2 of 4
Comparison of the Technological Characteristics with Predicate Device
| S. No | Parameters | Conmed Linvatec
XO Button™
(Continous Loop)
(K070780)
(Primary Predicate) | RIGIDLOOP™
Cortical Fixation
System
(K130814)
(Additional Predicate) | INFILOOP® Fixed
Loop UHMWPE
Suture Titanium
Button
(Subject Device) | Comments |
|----------|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| 1. | Manufacturer | ConMed Linvatec | Medos International
SARL | Healthium Medtech
Limited | - |
| 2. | Product Code | MBI (Classification
Product Code)
GAT (Subsequent
Product Code) | MBI | MBI | Similar to
predicate
device |
| 3. | Regulation
Number | 21 CFR 888.3040 | 21 CFR 888.3040 | 21 CFR 888.3040 | Similar to
predicate
device |
| 4. | Classification | Class II | Class II | Class II | Similar to
predicate
device |
| 5. | Intended Use/
Indications for
Use | The Conmed Linvatec
XO Button™ with
continuos loop is
intended to provide
suspension fixation for
soft tissue to bone in
the repair of the
natural ligament or
tendon disruption or
reconstruction of a
ligament using soft
tissue grafts. Examples
of such procedures
include anterior
cruciate ligament,
posterior cruciate
ligament, medial
collateral ligament,
and lateral collateral
ligament. | The RIGIDLOOP™
Cortical Fixation
System is used for
the fixation of soft
tissue to bone in
orthopedic
procedures such as
ACL repair | 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). | Similar to
predicate
device |
| 6. | Button and
Loop Material | Button: Titanium
Loop: UHMWPE | Button: Titanium
Loop: UHMWPE | Button: Titanium
Loop: UHMWPE | Similar to
predicate
device |
| S.
No | Parameters | Conmed Linvatec
XO Button™
(Continous Loop)
(K070780)
(Primary Predicate) | RIGIDLOOP™
Cortical Fixation
System
(K130814)
(Additional
Predicate) | INFILOOP® Fixed
Loop UHMWPE
Suture Titanium
Button
(Subject Device) | Comments |
| 7. | Suture
Material | Polyester, USP#5 UHMWPE,
USP#3-4 | UHMWPE,
USP#5 Polyester,
USP#5 | UHMWPE,
USP#5 UHMWPE,
USP#5 | Refer the
SE
Analysis |
| 8. | Single
Use/Reuse | Single Use | Single Use | Single Use | Similar to
predicate
device |
| 9. | Shelf Life | 5 Years | 5 Years | 5 Years | Similar to
predicate
device |
| 10. | Sterilization
Method | ETO | ETO | ETO | Similar to
predicate
device |
| 11. | Performance
Data | Pull Out Testing Cyclical Loading | Pull Out Testing | Pull Out Testing Cyclical Loading | Similar to
predicate
device |
| 12. | Safety Data | No Data Available | No Data
Available | Skin Sensitization Intracutaneous reactivity Material Mediated Pyrogenicity Acute Systemic Toxicity In-vitro cytotoxicity Bone Implantation Intramuscular Implantation Bacterial Endotoxin USP
MRI Compatibility | - |
Registered Office: 472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Bengaluru – 560058, India
www.healthiummedtech.com | CIN : U03311KA1992PLC013831
6
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.
7
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, 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.