(141 days)
Not Found
No
The device description and performance studies focus on mechanical properties and equivalence to predicate devices, with no mention of AI/ML or related concepts.
No
The device is a surgical staple used for fixation of bone fragments and osteotomies, which is a medical device but not classified as a therapeutic device. It fixes and stabilizes, rather than treats or cures.
No
Explanation: The device, a compression staple, is used for fixation of bone fragments and osteotomies, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states it consists of a stainless steel staple and a pneumatic delivery device, 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 describes a surgical device used for fixing bone fragments and performing arthrodesis. This is a therapeutic and structural function within the body.
- Device Description: The description details a physical staple and delivery system used for mechanical fixation of bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical fixation.
N/A
Intended Use / 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.
Product codes
JDR
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and foot, proximal tibial metaphysis, 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.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Verification testing has been performed with the Compressyn™ Staple to assure substantial equivalence to the predicate devices. Comparative testing in comparison to predicate devices included the following tests: The Compressyn™ Staple conforms to ASTM F564-10 Standard Specification and Test Methods for Metallic Bone Staples. Comparative compression force testing was also performed and the Compressyn Staple was shown to be substantially equivalent to the predicates. The testing demonstrated that the Compressyn™ Staple is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K043059, K993714, K001354, K840566
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Dallen Medical, Inc. 510(k) K122871 – Amendment 1 November 30, 2012 -- Compressyn™ Staple 2
Image /page/0/Figure/1 description: The image shows the date February 7, 2013. The month is abbreviated to "FEB". The day is the number 7, and the year is 2013. The text is in a simple, sans-serif font.
This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
GENERAL INFORMATION
| APPLICANT: | Dallen Medical, Inc. |
|---|---|
| 1046 Calle Recodo, Suite G | |
| San Clemente, CA 92673 | |
| (949) 218-0030 | |
| (949) 218-0040 Fax |
Al Memmolo CONTACT PERSON: Chief Operating Officer
DATE PREPARED: September 17, 2012
DEVICE DESCRIPTION:
Compressyn™ Staple TRADE NAME:
Fixation Staple GENERIC/COMMON NAME
Single/multiple component metallic bone fixation appliances CLASSIFICATION NAME: and accessories, CFR 888.3030 (code JDR) DEVICE CLASSIFICATION: Class II Wright Medical Compression Staple (K043059) PREDICATE DEVICES: Biomedical Enterprises OSStaple Staple System (K993714, K001354) 3M Bone Stapling Fixation System (K840566)
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.
1
Dallen Medical, Inc. 510(k) K122871 – Amendment 1 November 30, 2012 - 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.
Technical Characteristics:
The Compressyn™ Staple has similar physical and technical characteristics to the predicate devices.
Performance Data:
Verification testing has been performed with the Compressyn™ Staple to assure substantial equivalence to the predicate devices. Comparative testing in comparison to predicate devices included the following tests:
The Compressyn™ Staple conforms to ASTM F564-10 Standard Specification and Test Methods for Metallic Bone Staples. Comparative compression force testing was also performed and the Compressyn Staple was shown to be substantially equivalent to the predicates.
The testing demonstrated that the Compressyn™ Staple is substantially equivalent to the predicate devices.
Basis for Determination of Substantial Equivalence:
Upon reviewing the safety and efficacy information 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.
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and is likely part of a document header or title. The words are all capitalized and evenly spaced.
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized symbol consisting of three abstract shapes that resemble human figures or flowing forms. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: February 7, 2013
Dallen Medical, Incorporated % Mr. Al Memmolo Chief Operating Officer 1046 Calle Recodo, Suite G San Clemente, California 92673
Re: K122871
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: December 21, 2012 Received: December 26, 2012
Dear Mr. 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. Iisting 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
3
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 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,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Dallen Medical, Inc. 510(k) K122871 - Amendment 1 November 30, 2012 - Compressyn™ Staple
Indications for Use Statement
510(k) Number (if known):
Page 1 of 1
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) : 2013.02.06 14:18:48 Anton E. Dmitriev, PhD Division of Orthopedic Devices , ' = 05'00'
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________