(211 days)
Not Found
No
The device description and intended use describe a mechanical implant for soft tissue fixation, with no mention of AI or ML capabilities.
No
The device is described as an implant used for fixation of soft tissue to bone in repair and reconstruction surgeries, not for treating a disease or condition in a therapeutic manner.
No
The device description and intended use indicate it is an implant for surgical fixation of soft tissue to bone, not for diagnosing medical conditions.
No
The device description clearly states that the GrappLR™ and GrappLR™ Extender are single-use, titanium implants, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "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." This describes a surgical implant used in vivo (within the body) to physically repair or reconstruct tissues.
- Device Description: The description details a "single-use, titanium implant" with features like a loop and sutures. This is consistent with a surgical device, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MBI, HWC
Device Description
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™
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K070167- Smith & Nephew EndoButton Direct, K081098- Smith & Nephew EndoButton Continuous Loop, K070780- ConMed Linvatec XO Button
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
, l.
510(k) Summary of Safety & Effectiveness
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
ن جي نيپ ا
| 1. (a) | Submitter
Address: | George J. Hattub
MedicSense, USA
291 Hillside Avenue
Somerset, MA 02726
www.medicsense.com |
|--------|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. (b) | Manufacturer
Address: | T.A.G. Medical Products Corporation, Ltd.
D. N. Ashrat
Kibbutz Gaaton 25130, Israel |
| | Mfg. Phone: | Tel.: 972-3-647-4840 |
| | Contact Person: | Dan Moor |
| | Date: | May 30, 2010 |
| 2. | Device &
Classification
Name: | Smooth or threaded metallic bone fixation fastener, class II device (product
code MBI).
GrappLR™ and GrappLR™ Extender |
| 3. | Predicate Devices: | K070167- Smith & Nephew EndoButton Direct
K081098- Smith & Nephew EndoButton Continuous Loop
K070780- ConMed Linvatec XO Button |
| 4. | Description: | 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™ |
| 5. | Intended Use: | The GrappLR™ and GrappLR™ 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. |
| 6. | Comparison of
Technological
Characteristics: | With respect to its indication for use, the GrappLR™ and GrappLR™
Extender is substantially equivalent to its predicate devices in that it
intended for the same clinical purpose. 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. |
1
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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Page 2 – Mr. George Hattub
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
3
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