(89 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical fixation device, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used for fixation of tendons and ligaments during orthopaedic reconstruction procedures, which suggests it is a structural support device rather than one that treats or cures a disease or condition.
No
The device description clearly states it is used for "fixation of tendons and ligaments during orthopaedic reconstruction procedures," indicating it is a surgical implant. There is no mention of it being used to diagnose a condition.
No
The device description clearly states it is a physical fixation device made of UHMWPE and titanium alloy, used for surgical procedures. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of tendons and ligaments during orthopaedic reconstruction procedures. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant used to secure tissue within the body.
- Lack of Diagnostic Function: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such diagnostic function.
The information provided clearly describes a surgical implant used for structural support within the body, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The XTREME-LOOP is used for fixation of tendons and ligaments during orthopaedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction.
Product codes
MBI
Device Description
The XTREME-LOOP fixation device consists of a Ultra High Molecular Weight Polyethylene (UHMWPE) continuous loop captured on a titanium alloy button sits on the exit to a bone tunnel on the cortex, suspending the continuous loop inside the tunnel to provide secure, strong fixation for ligament reconstruction. The XTREME-LOOP fixation device is supplied with sutures that are used to pull the graft assembly into place and then flip the button allowing ligament reconstruction to be performed arthroscopically.
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The XTREME-LOOP when tested against the SECURE-LOOP (K151601) for strength, stiffness, strength after fatigue, extension at predicate UTS, cyclic fatigue testing, and functional testing, was determined to be substantially equivalent. The device has been tested for pyrogenicity using the turbidimetric Limulus Amoebocyte Lysate (LAL) method in line with the requirements of ANSI/AAMI ST72:2011. It was found to have a result of , Pyrogen test with a result of a total rise in temperature for three animals over 3 hours of 0.5°C with no single animal above 0.5℃, and was therefore judged to be non-pyrogenic. The testing demonstrated that the differences between the new device and the predicate device do not raise any new issues of safety and efficacy. The performance data benefit/risk analysis concluded that the differences encountered do not affect the safety and efficacy of the new device in relation to the predicate..
Summary: Based on the pre-clinical testing performance, the XTREME-LOOP is found to have a safety and effectiveness profile that is similar to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Xiros Ltd Stephen Seed Compliance Director Springfield House Whitehouse Lane Leeds. West Yorkshire LS17 7UE United Kingdom
Re: K191053
Trade/Device Name: XTREME--LOOP Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: April 17, 2019 Received: April 19, 2019
Dear Mr. Seed:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 located at https://www.accessdata.fda.gov/scripts/cdrb/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.
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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,
Laurence D. Coyne, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191053
Device Name XTREME-LOOP
Indications for Use (Describe)
The XTREME-LOOP is used for fixation of tendons and ligaments during orthopaedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the word "XIROS" in a rounded rectangle with a gray color. The text is in a bold, sans-serif font. The rectangle has rounded corners and a small extension on the right side, giving it a unique shape. The overall design is simple and clean.
K191053 510(k) SUMMARY
In accordance with 21 CFR 807.92, the following information constitutes Xiros Ltd. 510(k) summary for the XTREME-LOOP.
I.SUBMITTER INFORMATION
| Submitter`s Name: | Xiros Limited |
|---|---|
| Address: | Springfield House |
| Whitehouse Lane | |
| Leeds LS19 7UE | |
| England | |
| Telephone Number: | +44 (0)113 238 7200 |
| Fax Number: | +44 (0)113 238 7201 |
| Contact Person: | Stephen Seed (Compliance Director) |
| Date: | 17 April 2019 |
II. DEVICE IDENTIFICATION
| Name of Device: | XTREME-LOOP |
|---|---|
| Trade Name: | XTREME-LOOP |
| Common or usual name: | Suture retention device; Surgical Button, Polyester Surgical |
| Suture, ACL suspension fixation. | |
| Classification Name: | Fastener, fixation, non-degradable, soft tissue |
| Regulatory Class: | Class II |
| Product Code: | MBI |
| Regulation: | 888.3040 |
| Panel: | Orthopaedic |
III. PREDICATE DEVICE
SECURE-LOOP manufactured by Xiros, K151601. This predicate has not been subject to a design related recall.
Reference device market leader for essentially the same indications for use; Endobutton Continuous Loop (ECL) manufactured by Smith and Nephew, K980155.
Reference device for loop material for essentially the same indications for use; XO Button manufactured by Conmed Linvatec, K070780.
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Image /page/4/Picture/1 description: The image shows the word "XIROS" in a rounded, gray box. The box has a thick outline and the word is written in a bold, sans-serif font. The background is plain white. The box is connected to a line on the right side.
IV. DEVICE DESCRIPTION
The XTREME-LOOP fixation device consists of a Ultra High Molecular Weight Polyethylene (UHMWPE) continuous loop captured on a titanium alloy button sits on the exit to a bone tunnel on the cortex, suspending the continuous loop inside the tunnel to provide secure, strong fixation for ligament reconstruction. The XTREME-LOOP fixation device is supplied with sutures that are used to pull the graft assembly into place and then flip the button allowing ligament reconstruction to be performed arthroscopically.
V. INDICATIONS FOR USE
The XTREME-LOOP fixation device is used for fixation of tendons and ligaments during orthopaedic reconstruction procedures such as anterior cruciate ligament (ACL) reconstruction.
VI. COMPARISIONS OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The XTREME-LOOP has the same technological characteristics as the predicate SECURE-LOOP, with respect to intended use, labelling, composition of all components except for the continuous loop material, basic design, functionality and uses essentially the same manufacturing methods except for differences in the button manufacture and sterilization method.
VII. PERFORMANCE DATA
The XTREME-LOOP when tested against the SECURE-LOOP (K151601) for strength, stiffness, strength after fatigue, extension at predicate UTS, cyclic fatigue testing, and functional testing, was determined to be substantially equivalent. The device has been tested for pyrogenicity using the turbidimetric Limulus Amoebocyte Lysate (LAL) method in line with the requirements of ANSI/AAMI ST72:2011. It was found to have a result of , Pyrogen test with a result of a total rise in temperature for three animals over 3 hours of 0.5°C with no single animal above 0.5℃, and was therefore judged to be non-pyrogenic. The testing demonstrated that the differences between the new device and the predicate device do not raise any new issues of safety and efficacy. The performance data benefit/risk analysis concluded that the differences encountered do not affect the safety and efficacy of the new device in relation to the predicate..
Summary: Based on the pre-clinical testing performance, the XTREME-LOOP is found to have a safety and effectiveness profile that is similar to the predicate device.
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VIII.CONCLUSION
The XTREME-LOOP is composed of the same materials with the exception of the continuous loop material (manufactured from a different fibre of polymeric material) and has essentially the same basic design as the predicate device. It is manufactured in the same manner and uses essentially the same methods of that used to manufacture the predicate device.
Testing performed demonstrate that the XTREME-LOOP is substantially equivalent to the SECURE-LOOP fixation device.
Xiros therefore conclude the XTREME-LOOP is substantially equivalent to the SECURE-LOOP also manufactured by Xiros.