(35 days)
Not Found
No
The summary describes a purely mechanical implant device and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an implant used for fixation of fractures, osteotomies, fusions, and stabilization for the treatment of digital deformities, which are all therapeutic interventions aimed at treating a medical condition.
No
The device description and intended use clearly state that the Arthrex PIP Dart is an implant used for fixation of bony or chondral fragments and fractures, and for stabilization or fusion. It describes a physical device implanted into the body to treat conditions, not to diagnose them.
No
The device description clearly states that the Arthrex PIP Dart is an implant made of PEEK OPTIMA, which is a physical material and not software.
Based on the provided information, the Arthrex PIP Dart is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. The intended use and device description of the Arthrex PIP Dart clearly state it is an implantable device used to fix bones and fragments within the body.
- The description focuses on surgical procedures and anatomical fixation. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
The Arthrex PIP Dart is a surgical implant used for orthopedic fixation.
N/A
Intended Use / Indications for Use
The Arthrex PIP Dart is intended to fix small bony or apical chondral fragments in the foot, ankle, upper extremities, hand, and wrist, where such fragments are not under tension or load-bearing. These devices are used in cases of osteochondritis dissecans and osteochondral fragments, fixation of fractures, 1st metatarsal (bunionectomy osteotomies), cuneiform bones, inherently stable osteotomies, and fusions of the phalanges, metatarsals, metacarpals, carpal bones, tarsal bones, ankle, and wrist. The devices can be used for inherently stable intramedullary stabilization of joint arthroplasty (resection) or fusion for the treatment of digital deformities of the foot or hand. This device is also used in inherently stable long bone fractures such as the femur, fibula, tibia, radius and ulna, including the diaphyseal, epiphyseal, and metaphyseal areas.
Product codes
HTY
Device Description
The Arthrex PIP Dart is an implant with a barbed design that is inserted between the proximal and middle-phalanges so the barbs fixate on the phalangeal canal of the toe. The PIP Darts are made of PEEK OPTIMA, offered in straight and 10 degree variations, and range from 2.5mm to 3.0mm in diameter and 25mm to 30mm in length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, ankle, upper extremities, hand, wrist, phalanges, metatarsals, metacarpals, carpal bones, tarsal bones, femur, fibula, tibia, radius and ulna, including the diaphyseal, epiphyseal, and metaphyseal areas.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Shear testing and pull-out testing data was submitted, demonstrating no significant difference in mechanical strength between the Arthrex PIP Dart and the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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JUL 1 8 2014
| 2.6 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS | |
|---|---|
| Date Summary Prepared | June 11, 2014 |
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | David L Rogers |
| Regulatory Affairs Associate | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 71924 | |
| Fax: 239/598.5508 | |
| Email: david.rogers@Arthrex.com | |
| Trade Name | Arthrex PIP Dart |
| Common Name | Pin |
| Product Code -Classification Name | HTY - Pin, Fixation, Smooth |
| CFR | 21 CFR 888.3040: Smooth or threaded metallic bone |
| fixation fastener | |
| Predicate Device | K050259: Arthrex Bio-Pin |
| Purpose of Submission | This special 510(k) premarket notification is submitted to |
| obtain FDA clearance for the Arthrex PIP Dart. | |
| Device Description | The Arthrex PIP Dart is an implant with a barbed design |
| that is inserted between the proximal and middle- | |
| phalanges so the barbs fixate on the phalangeal canal of | |
| the toe. | |
| The PIP Darts are made of PEEK OPTIMA, | |
| offered in straight and 10 degree variations, and range | |
| from 2.5mm to 3.0mm in diameter and 25mm to 30mm | |
| in length. | |
| Intended Use | The Arthrex PIP Dart is intended to fix small bony or |
| apical chondral fragments in the foot, ankle, upper | |
| extremities, hand, and wrist, where such fragments are | |
| not under tension or load-bearing. These devices are | |
| used in cases of osteochondritis dissecans and | |
| osteochondral fragments, fixation of fractures, 1st | |
| metatarsal (bunionectomy osteotomies), cuneiform | |
| bones, inherently stable osteotomies, and fusions of the | |
| phalanges, metatarsals, metacarpals, carpal bones, tarsal | |
| bones, ankle, and wrist. The devices can be used for | |
| inherently stable intramedullary stabilization of joint | |
| arthroplasty (resection) or fusion for the treatment of | |
| digital deformities of the foot or hand. This device is also | |
| used in inherently stable long bone fractures such as the | |
| femur, fibula, tibia, radius and ulna, including the | |
| diaphyseal, epiphyseal, and metaphyseal areas. | |
| Substantial Equivalence Summary | The Arthrex PIP Dart is substantially equivalent to the |
| predicate devices in which the basic design features and | |
| intended uses are the same. Any differences between | |
| the Arthrex PIP Dart and the predicate are considered | |
| minor and do not raise questions concerning safety and | |
| effectiveness. | |
| The shear testing and pull-out testing data submitted | |
| demonstrates that there is no significant difference in | |
| mechanical strength between the Arthrex PIP Dart and | |
| the predicate. | |
| Based on the indications for use, technological | |
| characteristics, and the summary of data submitted, | |
| Arthrex, Inc. has determined that the Arthrex PIP Dart is | |
| substantially equivalent to the predicates. |
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 18, 2014
Arthrex, Inc. Mr. David L. Rogers Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K141577
Trade/Device Name: Arthrex PIP Dart Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: June 27, 2014 Received: July 3, 2014
Dear Mr. Rogers:
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
3
Page 2 - Mr. David L. Rogers
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 Industry and Consumer Education 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. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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, Lori A. Wigqins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K141577 page 1 of 1
INDICATIONS FOR USE
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-01 Expiration Date: December 31, 201 See PRA Statement on last page
510(k) Number (if known) K141577
Device Name
Arthrex PIP Dart
Indications for Use (Describe)
The Arthrex PIP Dart is intended to fix small bony or apical chondral fragments in the foot, ankle, upper extremities, hand, and wrist, where such fragments are not under tension or lood-bearing. These devices are used in coses of osteochondritis dissecans and asteochondral frogments, fixation of fractures, 1st metatarsal (bunionectomy osteotomies), cuneiform bones, inherently stable osteotomies, and fusions of the phalanges, metatarsals, metacarpals, carpal bones, tarsal bones, ankle, and wrist. The devices con be used for inherently stable intramedullary stabilization of joint arthroplasty (resection) or fusion for the treatment of the foot or hand. This device is also used in inherently stable long bone froctures such as the femur, fibulo, tibia, radius ond ulno, including the diaphyseal, epiphyseal, and metaphyseal areas.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Elizabethill@Frank -
Division of Orthopedic Devices
FORM FDA 3881 (9/13)