(28 days)
The G-Lok® and G-Lok® XL Extender are intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption or assist in reconstruction surgeries and to assist in the management of reconstructive surgeries.
The G-Lok® suspension fixation device is a single-use, titanium implant used for fixation of soft tissue to bone. The G-Lok® has two configurations: One has a Continuous Loop, made of ultra high molecular weight polyethylene, offered in several sizes to accommodate various bone tunnel lengths. The second configuration does not have a loop, and enables custom loop lengths to be tied using an appropriate material (not included). Both of these configurations have a Lead Suture and an optional Flipping Suture. The G-Lok® XL Extender is a single-use, titanium implant used for providing additional button width and length to the G-Lok®.
This document is a 510(k) premarket notification for the G-Lok® and G-Lok® XL Extender, which are metallic bone fixation fasteners. The purpose of this 510(k) is to demonstrate substantial equivalence to a predicate device (K101616 - GrappLR™ and GrappLR™ Extender).
The information provided does not describe clinical acceptance criteria or a study that proves the device meets such criteria in the way typically expected for an AI/CADe device. This document is for a medical implant (a bone fixation fastener), and the evaluation focuses on mechanical performance and substantial equivalence to a predicate device, not on diagnostic accuracy metrics like sensitivity or specificity.
Therefore, many of the requested points are not applicable to the information contained in this document. However, I will answer the applicable questions based on the provided text.
1. A table of acceptance criteria and the reported device performance
The document explicitly states: "The purpose of this 510(k) was to add an optional Flipping Suture. With respect to technology, the design is similar as confirmed by comparison, and the performance is the same as verified by validation. Based upon this, T.A.G. Medical Products Corporation, Ltd. believes that its device is safe and effective because it performs the same function in the same manner."
The "performance" referred to here is largely mechanical and functional equivalency to the predicate device. The Acceptance Criteria are implicitly that the modified device's mechanical performance is equivalent to or better than the predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Mechanical performance equivalent to the predicate device | "The performance is the same as verified by validation." |
| Ability to provide suspension fixation for soft tissue to bone | "Intended to provide suspension fixation for soft tissue to bone..." (Same as predicate) |
| Ability to assist in reconstruction surgeries | "...assist in reconstruction surgeries and to assist in the management of reconstructive surgeries." (Same as predicate) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "performance testing indicated equivalency to the predicate device," but it does not specify the sample size, data provenance, or whether the testing involved human subjects or was purely mechanical/bench testing. Given the nature of a bone fixation fastener, it's highly likely this refers to bench testing rather than clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. The "ground truth" for a mechanical device like this would be its physical and mechanical properties, not expert-labeled clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no "test set" in the context of diagnostic performance requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This is not an AI/CADe device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an AI/CADe device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given the context of a 510(k) for a medical implant, the "ground truth" would be related to material properties, mechanical strength, biocompatibility, and functional performance as determined by engineering tests and regulatory standards. The document doesn't explicitly state the type of ground truth, but it would be based on validated scientific and engineering principles for mechanical functionality and safety.
8. The sample size for the training set
This is not applicable. There is no mention of a training set as this is not an AI/CADe device.
9. How the ground truth for the training set was established
This is not applicable. There is no mention of a training set.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized emblem. The emblem depicts a stylized caduceus with three human profiles forming the staff. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 16, 2014
T.A.G. Medical Products Corporation, Limited % George J. Hattub, RAC, CQE MedicSense, USA 291 Hillside Avenue Somerset, Massachusetts 02726
Re: K142653
Trade/Device Name: G-Lok® and G-Lok® XL Extender Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: September 11, 2014 Received: September 18, 2014
Dear Mr Hattub:
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 (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. 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Ronald DAJean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K142653
Device Name: The G-Lok® and G-Lok® XL Extender
Indications For Use: The G-Lok® and G-Lok® XL Extender are intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption or assist in reconstruction surgeries and to assist in the management of reconstructive surgeries.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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Special 510(k) Summary of Safety & Effectiveness
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
| 1. (a) | SubmitterAddress: | George J. HattubMedicSense, USA291 Hillside AvenueSomerset, MA 02726www.medicsense.com |
|---|---|---|
| 1. (b) | ManufacturerAddress: | T.A.G. Medical Products Corporation, Ltd.D. N. AshratKibbutz Gaaton 25130, Israel |
| Mfg. Phone: | Tel.: 972-4-985-8400 | |
| Contact Person: | Erez Adiv RA/QA Director | |
| Date: | October 12, 2014 | |
| 2. | Device &ClassificationName: | Smooth or threaded metallic bone fixation fastener, class II device (productcode MBI). |
| G-Lok® and G-Lok® XL Extender | ||
| 3. | Predicate Devices: | K101616- GrappLR™ and GrappLR™ Extender |
| 4. | Description: | The G-Lok® suspension fixation device is a single-use, titanium implantused for fixation of soft tissue to bone. The G-Lok® has two configurations:One has a Continuous Loop, made of ultra high molecular weightpolyethylene, offered in several sizes to accommodate various bone tunnellengths. The second configuration does not have a loop, and enablescustom loop lengths to be tied using an appropriate material (not included).Both of these configurations have a Lead Suture and an optional FlippingSuture.The G-Lok® XL Extender is a single-use, titanium implant used for providingadditional button width and length to the G-Lok®. |
| 5. | Intended Use: | The G-Lok® and G-Lok® XL Extender are intended to provide suspensionfixation for soft tissue to bone in the repair of the natural ligament or tendondisruption or assist in reconstruction surgeries and to assist in themanagement of reconstructive surgeries. |
| 6. | Comparison ofTechnologicalCharacteristics: | With respect to its indication for use, the G-Lok® and G-Lok® XL Extenderis substantially equivalent to its predicate devices in that it intended for thesame clinical purpose. The purpose of this 510(k) was to add an optionalFlipping Suture. With respect to technology, the design is similar asconfirmed by comparison, and the performance is the same as verified byvalidation. Based upon this, T.A.G. Medical Products Corporation, Ltd.believes that its device is safe and effective because it performs the samefunction in the same manner.The following table depicts the similarities and differences between thepredicate device and the submitted device. In addition, the performancetesting indicated equivalency to the predicate device. |
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| Feature andCharacteristic | Modified DeviceThe G-Lok Button and G-Lok XLExtender | Predicate DeviceThe GrappLR and GrappLRExtender |
|---|---|---|
| Button Material | Same | Titanium |
| Button Length | Same | 13 mm |
| Button Width | Same | 3.81 mm |
| Button Thickness | Same | 2.20 mm |
| Button HoleDiameter(s) | 1.5 mm and 1.2 mm | 1.5 mm |
| Optional Extender | yes | yes |
| Extender Material | Same | Titanium |
| Extender Length | 19.8 mm | 19 mm |
| Extender Width | Same | 5.0 mm |
| ExtenderThickness | Same | 3.3 mm |
| Extender HoleDiameter(s) | 1.5 mm and 1.5 mm | 1.5 mm |
| Loop Size | Same | 15-50 mm |
| Loop Material | Same | Braided Polyethylene |
| Capability to beused with No Loop | yes | yes |
| Suture(s) | Two Tevdek™ Polyester Sutures (forleading and flipping) | One Tevdek™ Polyester Suture (forleading) |
| DeliveryMechanism | Same | Passing Pin |
| (not provided) | ||
| DeploymentMechanism | Flip with Push Rod and/or Flip Suture | Flip with Push Rod |
| Feature andCharacteristic | Modified DeviceThe G-Lok Button and G-Lok XLExtender | Predicate DeviceThe GrappLR and GrappLRExtender |
|---|---|---|
| SurgicalPreparation(Tunnel Drilling) | Same | Same |
| Graft Preparation | Same | Same |
| Graft Attachment(Proximal) | Same | Same |
| Provided SinglePatient Use Sterile | yes | yes |
| 510(k) Number | Pending | K101616 |
§ 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.