(115 days)
- 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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Clench Compression Staple, formatted as requested.
Note: The provided FDA 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and mechanical performance testing, rather than clinical efficacy studies often seen with AI/clinical decision support devices. Therefore, many of the requested categories related to human-in-the-loop performance, expert consensus on ground truth for clinical cases, and multi-reader multi-case studies are not applicable to this type of device submission.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Clench Compression Staple are based on demonstrating mechanical performance equivalent to or better than predicate devices, and conformance to recognized industry standards. The reported performance refers to the device meeting these established standards.
| Acceptance Criteria Category | Specific Criteria / Standard | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Static axial pull-out (per ASTM F564-10) | Confirmed that the Subject device performed as intended. |
| Mechanical Performance | Static Four-Point bending (per ASTM F564-10) | Confirmed that the Subject device performed as intended. |
| Mechanical Performance | Dynamic Four-Point bending (per ASTM F564-10) | Confirmed that the Subject device performed as intended. |
| Material Properties | Corrosion Susceptibility (per ASTM F2129) | Confirmed that the Subject device performed as intended. |
| Material Properties | Transformation Temperature (per ASTM F2082) | Confirmed that the Subject device performed as intended. |
| Substantial Equivalence | Comparison to predicate devices (K142292, K002695) in intended use, indications for use, materials, technological characteristics, and labeling. | Documentation provided demonstrating substantial equivalence. |
Study Details:
-
Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in terms of clinical data or patient cases. The testing conducted was mechanical (bench testing) of the device itself.
- The sample size for each mechanical test (static axial pull-out, static four-point bending, dynamic four-point bending, corrosion susceptibility, transformation temperature) is not explicitly stated in this summary but would have been defined by the ASTM standards and validated through the testing.
- Data provenance is from bench testing of the manufactured device.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for mechanical testing is established by the specified ASTM standards and measurement protocols, not by expert medical opinion. Engineers and lab technicians conduct and interpret these tests according to the standards.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This type of adjudication is typically used for clinical image interpretation or expert consensus on patient outcomes, not for mechanical bench testing.
-
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:
- No. This device is a bone staple, an orthopedic implant, not an AI or diagnostic imaging device. Therefore, an MRMC study is not relevant or performed.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (implant), not an algorithm or software. Standalone performance is evaluated through the mechanical and material tests described.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mechanical and material testing, the "ground truth" is defined by the established performance criteria and methodologies within the relevant ASTM standards (ASTM F564-10, ASTM F2129, ASTM F2082). These standards define how the device should behave under specific conditions.
-
The sample size for the training set:
- Not applicable. There is no "training set" in the context of mechanical testing for a physical implant. The design and manufacturing processes are refined through engineering principles, not machine learning training.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device submission.
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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);
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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,
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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)
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)
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| 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 inflat 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. |
N/A