(110 days)
No
The device description and performance studies focus on the mechanical properties and delivery system of a surgical staple, with no mention of AI or ML.
No
The device is described as a surgical fixation device used to stabilize bone fragments, which is a structural and mechanical function rather than a therapeutic one that would directly treat a disease or condition.
No
This device is described as a surgical staple intended for bone fixation, not for diagnosing conditions. Its function is to provide mechanical support rather than to identify or analyze diseases or conditions.
No
The device description explicitly states it is a "fully integrated system that consists of a stainless steel staple preloaded on a handheld ABS and polycarbonate mechanical delivery device," indicating it is a physical hardware device, not software only.
Based on the provided information, the Compressyn™ Staple is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device used for the fixation of bone fragments and osteotomies within the human body. This is an in-vivo application, meaning it is used directly on living tissue.
- Device Description: The description details a surgical implant (staple) and its delivery system, designed for physical fixation of bone. This aligns with surgical devices, not devices used to examine specimens outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (like blood, urine, tissue) outside of the body. IVD devices are specifically designed for this purpose to provide information about a patient's health status.
Therefore, the Compressyn™ Staple is a surgical implant and delivery system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Compressvn™ 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 is a fully integrated system that consists of a stainless steel staple preloaded on a handheld ABS and polycarbonate mechanical 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 disposable tray with a drill bit and drill guide.
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
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
The preloaded mechanical delivery device was tested for impact force, staple delivery, compressive force and bond strength, and was shown to be equivalent to the predicate.
Key Metrics
Not Found
Predicate Device(s)
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
510(k) Summary
llen
MEDICAL
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 |
|------------------------|----------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Al Memmolo
Chief Operating Officer |
| DATE PREPARED: | February 11, 2014 |
| DEVICE DESCRIPTION: | |
| TRADE NAME: | Compressyn™ Staple |
| GENERIC/COMMON NAME | Fixation Staple |
| CLASSIFICATION NAME: | Single/multiple component metallic bone fixation appliances
and accessories, CFR 888.3030 (code JDR) |
| DEVICE CLASSIFICATION: | Class II |
| PREDICATE DEVICES: | Dallen Medical, Inc. Compressyn™ Staple (K122871)
Dallen Medical, Inc. Compressyn™ Staple (K132875) |
Product Description:
The Compressyn™ Staple is a fully integrated system that consists of a stainless steel staple preloaded on a handheld ABS and polycarbonate mechanical 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 disposable tray with a drill bit and drill guide.
1
510(k) Summary
Image /page/1/Picture/4 description: The image shows the logo for Dallen Medical. The word "dallen" is written in a simple, sans-serif font, with the "d" being significantly taller than the other letters. Below "dallen" is the word "MEDICAL" in a blocky, sans-serif font, with each letter being capitalized. The overall design is clean and modern.
Indications for Use:
The Compressvn™ 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. The preloaded mechanical delivery device was tested for impact force, staple delivery, compressive force and bond strength, and was shown to be equivalent to the predicate.
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.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features the department's emblem, which is a stylized representation of a human figure with outstretched arms, symbolizing care and protection. The emblem is accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G609 Silver Spring, MD 20993-0002
June 2. 2014
Dallen Medical, Incorporated Mr. Al Memmolo Chief Operating Officer 1046 Calle Recodo. Suite G San Clemente, California 92673
Re: K140358
1140558
Trade/Device Name: Compressyn "M Staple Regulation Number: 21 CFR 888.3030 Regulation Number: 21 CFK 866.5050
Regulation Name: Single/Multiple Component Metallic Bonc Fixation Appliances and Accessories Regulatory Class: Class II Product Code: JDR Dated: April 24, 2014 Received: April 25, 2014
Dear Mr. Memmolo:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 3 IQ(x) premilated to equivalent (for the indications
referenced above and have determined the devices marked in interstate referenced above and have deemined the usedicate devices marketed in interstate
for use stated in the enclosure) to legally marketed previces marketed in interstate for use stated in the enclosure) to legily market accrises Device Amendments, or to
commerce prior to May 28, 1976. the ensections of the Medical Device Amends, Drug, commerce prior to May 28, 1976. the enactinent and of the Federal Food, Drug,
devices that have been reclassified in accordance with the provisions of the Federal (PMA) devices that have been reclassified in accordance will the proval application (PMA).
and Cosmetic Act (Act (Act (Act require approval of a premarket approval application of t and Cosmetic Act (Act) that do not require applied on the general controls of the Act. The Act. The Act. The Act. The Act. The Act. The Act. The Act. The You may, therefore, market the device, subject to the may begistration, listing of
general controls provisions of the Act include requirements for and general controls provisions of the Accurentiality tor manust misbranding and adulteration. Please note: CDRH docs not evaluate information related to contract liability
adulteration. Please note: CDRH docs not evaluate information related in adulteration. Please note: CDRH does not evaluate information roads to 17.
warranties. We remind you, however, that device labeling must be truthful and not misleading.
lf your device is classified (see above) into either class II (Special Controls) or class III (PMA). it
ed be If your device is classified (see above) mio entire class if (spicent Gention) your device can be
may be subject to additional controls. Existing major regulations affective may be subject to additional controls. Exismig major regalations and one of the may
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may found in the Code of Federal Regulations. This 21, Parts 30
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
ts of the Active in the since that your device complies with other requirement Please be advised that FDA's issuance of a substintial equirements of the Act
that FDA has made a determination that your device complies with other comply that FDA has made a determination that your develevels. When evenes. You must comply
or any Federal statutes and regulations administered by other Federal and listing (21 CFR or any Federal statues and regulations administered by oncertains and listing (2) CFR Part
with all the Act's requirements, including, but not limited to: registration and l with all the Act's requirements, including, but not millied to: registration and the one of the Access of the
3
Page 2 - Mr. Al Memmolo
adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the auvoise ovents) (21 CFR Part 820); and if applicable, the electronic product quality Systems (Sections (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 If you desire specific advice for your dovies on our lebening on Consumer Assistance at its toll-Comace the Division of S041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note highww.lda.g0v/McdicalDevices/1v/ress/100 by reference to premarket notification" (21 CFR Part the regulation entitled, "Misoranoing of receivents under the MDR regulation (21 CFR Part 803), please go to
CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/deficult.html/home ntlp.//www.ida.governmentics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the You may obtain other general Information on your responsibility of the more of its toll-free number
Division of Small Manufacturers, International and Consumer Assistance at Division of Sinan Manazao, From or at its Internet address
(800) 638 204 l of (301) 776-7100 or at hs internet and of the street on the many of the street of the man
Sincerely yours,
Lori A. Wiggins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4
Indications for Use Statement
Page I of 1
K140358 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 3) I he Compressyn" Stapie is intention of proximal tibial metaphysis osted in long fixation and joint arthrodests, 2) fradion of proximal size be located in long bones
adjunctive fixation of small bone fragments. These fragments adjunctive fixation of small bolle naghiems. The something may as the pelvis in the such as the femur, Ilbula and tible in the flower extremity the halterials, and the pelvis, scapula and sternum.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
| Casey L. Hanley, Ph.D. |
|---|
| ________________________________ |
| Division of Orthopedic Devices |
Page 1/1
Dallen Medical, Inc. Danell Neches Staple, Preloaded Sterile System Premarket Notification 510(k)
17