(115 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and material of a bone staple, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an implantable staple designed for bone fixation and reconstructive surgical procedures, explicitly stating its intended use for managing bone fractures and providing constant compression over a fracture site. These functions directly contribute to the healing and restoration of damaged tissue, aligning with the definition of a therapeutic device.
No
The device is described as an implant used for bone fixation and reconstructive surgical procedures to manage bone fractures by providing constant compression. Its purpose is therapeutic intervention, not diagnosis.
No
The device description explicitly states it is an implant made from Nickel-Titanium Alloy, which is a hardware component. The performance studies also focus on the mechanical properties of this hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The provided description clearly states that the Clench® Compression Staple is an implant used for bone fixation and reconstructive surgical procedures. It is a physical device inserted into the body to stabilize bone fractures.
- Intended Use: The intended use is focused on the surgical fixation of bones in various parts of the body. This is a surgical procedure performed directly on the patient, not an analysis of a specimen outside the body.
The information provided describes a surgical implant, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
- Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
- Fixation of proximal tibial metaphysis osteotomy
- Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
- Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.
Product codes (comma separated list FDA assigned to the subject device)
JDR
Device Description
The Clench® Compression Staple is an implant for use in bone fixation and reconstructive surgical procedures for the management of bone fractures. The implant is designed to provide constant compression over a bone fracture site. Implants are made from Nickel-Titanium Alloy per ASTM F2063 and range in size from 7mm to 20mm wide with two equal length legs ranging from 5mm to 20mm long.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand, foot, proximal tibial metaphysis, long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Static axial pull-out, Static Four-Point bending, and Dynamic Four-Point bending testing (per ASTM F564-10) confirmed that the Subject device performed as intended. Corrosion Susceptibility testing (per ASTM F2129) confirmed that the Subject device performed as intended. Transformation Temperature testing (per ASTM F2082) confirmed that the Subject device performed as intended.
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.
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 6, 2018
F & A Foundation LLC d.b.a. Reign Medical % Daniel Lanois Member and Engineer SurgOp Support LLC 3270 Walton Riverwood Lane SE #4025 Atlanta, Georgia 30339
Re: K173775
Trade/Device Name: Clench Compression Staple Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDR Dated: February 21, 2018 Received: February 27, 2018
Dear Daniel Lanois:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the name "Katherine D. Kavlock -S" in a simple, sans-serif font. The text is horizontally aligned and appears to be part of a document or label. The letters are clear and legible, with consistent spacing between the words and characters.
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Clench Compression Staple
Indications for Use (Describe)
-
Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
-
Fixation of proximal tibial metaphysis osteotomy
-
Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
-
Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| 510(k) Summary (as required by 21 CFR 807.92) | |||
|---|---|---|---|
| Date Prepared | December, 9, 2017 | ||
| Manufacturer | F & A Foundation LLC d.b.a. Reign Medical | ||
| Address | 6303 E 102nd Street | ||
| Suite 200 | |||
| Tulsa, OK 74137 | |||
| Telephone | 918-302-9546 | ||
| Fax | 918-863-8996 | ||
| Contact Person | Daniel Lanois | ||
| Member and Engineer | |||
| Address | SurgOp Support LLC | ||
| 3270 Walton Riverwood Lane SE | |||
| Unit 4025 | |||
| Atlanta, GA 30339 | |||
| Telephone | 678-371-3605 | ||
| Fax | 918-863-8996 | ||
| daniel@surgopsupport.com | |||
| Trade Name | Clench® Compression Staple | ||
| Common Name | Bone Staple | ||
| Panel Code | Orthopaedic/87 | ||
| Classification Name | Staple, Fixation, Bone | ||
| Class | Class II | ||
| Regulation Number | 21 CFR 888.3030 | ||
| Product Code | JDR | ||
| Name of Predicate Device | 510(k) # | Manufacturer | |
| Speed™ | K142292 | BioMedical Enterprises, Incorporated | |
| Memodyn Staple | K002695 | Telos Medical Equipment | |
| Description | The Clench® Compression Staple is an implant for use in bone fixation and | ||
| reconstructive surgical procedures for the management of bone fractures. The | |||
| implant is designed to provide constant compression over a bone fracture site. | |||
| Implants are made from Nickel-Titanium Alloy per ASTM F2063 and range in size | |||
| from 7mm to 20mm wide with two equal length legs ranging from 5mm to 20mm long. | |||
| Indications and | • Fracture and osteotomy fixation and joint arthrodesis of the hand and foot. | ||
| Intended Use | • Fixation of proximal tibial metaphysis osteotomy | ||
| • Hand and foot bone fragment and osteotomy fixation and joint arthrodesis. | |||
| • Fixation of small bone fragments (i.e. small fragments of bone which are not | |||
| comminuted to the extent to preclude staple placement). These fragments may be | |||
| located in long bones such as the femur, fibula and tibia in the lower extremities; | |||
| the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in | |||
| flat bone such as the pelvis, scapula and sternum. | |||
| Technological | Documentation was provided to demonstrate that the Subject device, is substantially | ||
| Characteristics/ | equivalent to the Predicate. The Subject device is substantially equivalent to the | ||
| Substantial | Predicate device in intended use, indications for use, materials, technological | ||
| Equivalence | characteristics, and labeling. | ||
| Performance Data | Static axial pull-out, Static Four-Point bending, and Dynamic Four-Point bending | ||
| testing (per ASTM F564-10) confirmed that the Subject device performed as | |||
| intended. Corrosion Susceptibility testing (per ASTM F2129) confirmed that the | |||
| Subject device performed as intended. Transformation Temperature testing (per | |||
| ASTM F2082) confirmed that the Subject device performed as intended. | |||
| Conclusion | Based on the intended use, indications for use, technological characteristics, | ||
| materials, and comparison to Predicate devices, the Subject device has been shown | |||
| to be substantially equivalent to legally marketed Predicate devices. |