(108 days)
The Compressyn™ Staple is intended for: 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy, 3) adjunctive fixation of small bone fragments. These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremity; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in the flat bones such as the pelvis, scapula and sternum.
The Compressyn™ Staple consists of a stainless steel staple held on a carriage delivered by a pneumatic delivery device. The staple is offered in several sizes with barbs to prevent back out. It is a compression staple fixation device that is placed into two tissue segments using pre-drilled holes to provide stabilized fixation. The Compressyn Staple is provided sterile in a kit with accessories.
This 510(k) submission for the Compressyn™ Staple does not include a study that proves the device meets specific acceptance criteria in terms of performance metrics.
Instead, the submission relies on demonstrating substantial equivalence to an existing legally marketed device. The core argument is based on the Technical Characteristics and Performance Data section, which states: "The Compressyn™ Staple is identical to the predicate and therefore has the same physical and technical characteristics."
This means that the device's acceptance is based on the assumption that if it is identical to a predicate device, it inherently meets the acceptance criteria previously established for that predicate.
Therefore, the requested information cannot be fully provided as a performance study with specific acceptance criteria and results is not present in the provided document.
Here's a breakdown of what can be gleaned:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical properties (e.g., strength, stiffness, fatigue resistance) | "Identical to the predicate" in physical and technical characteristics, implying it meets the same performance as the predicate. |
| Biocompatibility | "Identical to the predicate," implying the same biocompatibility as the predicate. |
| Sterility | "Provided sterile in a kit with accessories." (This is a statement of provision, not a performance test outcome in this context) |
| Fixation capabilities for specified indications (hand/foot bone, tibial metaphysis, small bone fragments) | "Identical to the predicate," implying it offers comparable fixation capabilities as the predicate. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable, as no new performance test data is presented. The substantial equivalence relies on the established performance of the predicate device.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no new performance study with a test set requiring expert ground truth was conducted for this submission.
4. Adjudication method for the test set:
- Not applicable.
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:
- Not applicable. This is a medical device (staple) for fixation, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Not applicable, as substantial equivalence relies on the existing performance data of the predicate device.
8. The sample size for the training set:
- Not applicable, as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established:
- Not applicable.
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3 0 .2013 DE
This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
GENERAL INFORMATION
Product Description:
The Compressyn™ Staple consists of a stainless steel staple held on a carriage delivered by a pneumatic delivery device. The staple is offered in several sizes with barbs to prevent back out. It is a compression staple fixation device that is placed into two tissue segments using pre-drilled holes to provide stabilized fixation. The Compressyn Staple is provided sterile in a kit with accessories.
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K132875 (2/2)
Indications for Use:
The Compressyn™ Staple is intended for: 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy, 3) adjunctive fixation of small bone fragments. These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremity; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in the flat bones such as the pelvis, scapula and sternum.
Technical Characteristics and Performance Data:
The Compressyn™ Staple is identical to the predicate and therefore has the same physical and technical characteristics.
Basis for Determination of Substantial Equivalence:
Upon reviewing the documentation provided in this submission and comparing intended use, principle of operation, performance data, and overall technological characteristics, the Compressyn™ Staple is determined by Dallen Medical to be substantially equivalent to existing legally marketed devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 30, 2013
Dallen Medical. Incorporated Mr. Al Memmolo Chief Operating Officer 1046 Calle Recodo, Suite G San Clemente, California 92673
Re: K132875
Trade/Device Name: Compressyn™ 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: November 20, 2013 Received: November 21, 2013
Dear Al Memmolo:
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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Page 2 - Mr. Al Memmolo
:
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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,
Mark N. Melkerson -S
- 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 Statement
Indications for Use Statement
K132875 510(k) Number (if known):
Device Name: Compressyn™ Staple
Indications for Use:
The Compressyn™ Staple is intended for: 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy, 3) adjunctive fixation of small bone fragments. These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremity; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in the flat bones such as the pelvis. scapula and sternum.
Prescription Use _ X (Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
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Dallen Medical, Inc. Compressyn™ Staple, Sterile Kit
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Section 4
§ 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.