(211 days)
The GrappLR™ and GrappLR™ Extender are intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament of tendon disruption or assist in reconstruction surgeries and to assist in the management of reconstructive surgeries.
The GrappLR™ suspension fixation device is a single-use, titanium implant used for fixation of soft tissue to bone. The GrappLR™ 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. The GrappLR Extender™ is a single-use, titanium implant used for providing additional button width and length to the GrappLR™
The provided text is a 510(k) summary for the GrappLR™ and GrappLR™ Extender, which are metallic bone fixation fasteners. It focuses on demonstrating substantial equivalence to predicate devices. As such, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the way typically expected for an AI/algorithm-based medical device.
Therefore, I cannot provide the requested information in the table format or answer specific questions related to AI/algorithm performance.
However, I can extract the relevant information about the device and its regulatory submission:
Device Information:
- Device Name: GrappLR™ and GrappLR™ Extender
- Regulatory Class: Class II
- Product Code: MBI (Smooth or threaded metallic bone fixation fastener), HWC
- Intended Use: 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.
- Description: Single-use, titanium implants for fixation of soft tissue to bone. Available in two configurations: one with a Continuous Loop (ultra-high molecular weight polyethylene) and one without a loop, allowing for custom loop lengths. Both have a Lead Suture. The Extender provides additional button width and length.
- Predicate Devices:
Regulatory Basis for Substantial Equivalence:
The manufacturer, T.A.G. Medical Products Corporation, Ltd., claims substantial equivalence based on:
- Same Indication for Use: The GrappLR™ and GrappLR™ Extender are intended for the same clinical purpose as the predicate devices.
- Similar Technology: "the design is similar as confirmed by comparison."
- Same Performance (Verified by Validation): "the performance is the same as verified by validation."
Key Missing Information for AI/Algorithm Studies:
The document does not describe the following:
- Acceptance criteria for an algorithm's performance (e.g., sensitivity, specificity, AUC).
- Any studies involving a test set, data provenance, ground truth establishment, or sample sizes related to an AI/algorithm.
- Multi-reader multi-case (MRMC) studies or standalone algorithm performance.
- Training set details for an algorithm.
This is expected as the document describes a mechanical bone fixation device, not an AI/software device.
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510(k) Summary of Safety & Effectiveness
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
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| 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.: 972-3-647-4840 | |
| Contact Person: | Dan Moor | |
| Date: | May 30, 2010 | |
| 2. | Device &ClassificationName: | Smooth or threaded metallic bone fixation fastener, class II device (productcode MBI).GrappLR™ and GrappLR™ Extender |
| 3. | Predicate Devices: | K070167- Smith & Nephew EndoButton DirectK081098- Smith & Nephew EndoButton Continuous LoopK070780- ConMed Linvatec XO Button |
| 4. | Description: | The GrappLR™ suspension fixation device is a single-use, titanium implantused for fixation of soft tissue to bone. The GrappLR™ has twoconfigurations: One has a Continuous Loop, made of ultra high molecularweight polyethylene, offered in several sizes to accommodate various bonetunnel lengths. 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.The GrappLR Extender™ is a single-use, titanium implant used for providingadditional button width and length to the GrappLR™ |
| 5. | Intended Use: | The GrappLR™ and GrappLR™ Extender are intended to providesuspension fixation for soft tissue to bone in the repair of the naturalligament or tendon disruption or assist in reconstruction surgeries and toassist in the management of reconstructive surgeries. |
| 6. | Comparison ofTechnologicalCharacteristics: | With respect to its indication for use, the GrappLR™ and GrappLR™Extender is substantially equivalent to its predicate devices in that itintended for the same clinical purpose. With respect to technology, thedesign is similar as confirmed by comparison, and the performance is thesame as verified by validation. Based upon this, T.A.G. Medical ProductsCorporation, Ltd. believes that its device is safe and effective because itperforms the same function in the same manner. |
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Image /page/1/Picture/1 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Mail Center - WO66-G609, Silver Spring, MD 20993-0002. The text is left-aligned and uses a simple font.
T.A.G. Medical Products Corporation Ltd. c/o Mr. George Hattub Regulatory Consultant 291 Hillside Avenue Somerset, MA 02726
JAN 6 2011
Re: K101616
Trade/Device Name: GrappLR and GrappLR Extender Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories. Regulatory Class: Class II Product Code: MBI, HWC Dated: December 21, 2010 Received: December 29, 2010
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 such 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
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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
A. D. VS. Rh
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: GrappLR™ and GrappLR™ Extender
Indications For Use: The GrappLR™ and GrappLR™ Extender are intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament of 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)
for M. Melkersm
(Division Sign-Oft) (Division Sign-Orio), Orthopedic, Divisionative Devices
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510(k) Number 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.