(321 days)
The Intended Use of the Cannulated Screw and Kirschner (Kwire) System is for the treatment and fixation of bone fractures and osteotomies of various bones including the, acetabulum, pelvis, humerus, radius, ulna, femur, tibia, phalanges, carpals, metacarpals, tarsals, metatarsals and fibula
Cannulated Screws and Kwires are a self-tapping, self-drilling screw with a cortico/cancellous or cancellous thread that can be guided into position by Kwire placement. Partial or fully threaded screws are available in various different lengths and diameters to provide fixation in various size bones. The screws are made of Stainless Steel. The Kirschner Wires (Kwires) are threaded, spaded or blunt ranging from 0.8mm to 1.4mm of an inch in diameter and 150mm in length and made of 316L Stainless Steel.
The provided text is a 510(k) Premarket Notification for a Cannulated Screw and Kirschner (K-wire) System, a type of orthopedic implant used for bone fixation. For this type of device, the "acceptance criteria" and "study" are not typically presented in the same way as for diagnostic AI software. Instead, the performance is demonstrated through substantial equivalence to predicate devices, focusing on design, materials, and dimensional comparisons rather than a clinical performance study with specific metrics like sensitivity or specificity.
Therefore, many of the requested sections (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of medical device submission.
Here's the information parsed from the document based on your request, with a clear indication of sections that are not applicable:
Acceptance Criteria and Device Performance Study for the Cannulated Screw and Kirschner (K-wire) System
For the Cannulated Screw and Kirschner (K-wire) System (K130613), acceptance criteria and performance were established through demonstrating substantial equivalence to legally marketed predicate devices, as is common for Class II medical devices of this nature. The "study" in this context refers to the comparison of design and material specifications rather than a clinical trial or AI performance study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly Met by Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Design Equivalence | The design of the Cannulated Screw and Kirschner (K-wire) System should be similar to legally marketed predicate devices to ensure equivalent function and safety. | The Cannulated Screw and Kirschner (K-wire) System is determined to be substantially equivalent to the predicate devices with respect to design. This implies the device shares fundamental design principles (e.g., self-tapping, self-drilling, cannulated screws, K-wire guidance) with the predicates. |
| Material Equivalence | The materials used in the device should be biocompatible and possess mechanical properties comparable to those in legally marketed predicate devices. | The Cannulated Screw and Kirschner (K-wire) System is determined to be substantially equivalent to the predicate devices with respect to material. Specifically, the screws are made of Stainless Steel, and Kirschner Wires (Kwires) are made of 316L Stainless Steel, similar to accepted orthopedic implants. |
| Dimensional Equivalence | The varying lengths and diameters of the screws and K-wires should fall within acceptable ranges established by predicate devices to allow for safe and effective use across different anatomical sites and fracture types. | The Cannulated Screw and Kirschner (K-wire) System is determined to be substantially equivalent to the predicate devices with respect to dimensional comparison. This indicates the available sizes of screws (partial or fully threaded, various lengths/diameters) and K-wires (0.8mm to 1.4mm diameter, 150mm length) are comparable to the predicate devices. |
| Intended Use | The device should be indicated for the same or similar uses as the predicate devices. | The Intended Use of the Cannulated Screw and Kirschner (K-wire) System is for the treatment and fixation of bone fractures and osteotomies of various bones, consistent with the function of bone fixation fasteners. |
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable. This device demonstrated substantial equivalence through comparison of design, materials, and dimensions to predicate devices, not through a "test set" of patient data in the manner of AI or diagnostic devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Ground truth in the context of expert consensus or pathological findings is not relevant for demonstrating substantial equivalence for this orthopedic implant. The "ground truth" here is the established safety and effectiveness of the predicate devices.
4. Adjudication Method for the Test Set
- Not applicable. No formal adjudication method was used for a "test set" as described for AI or diagnostic performance studies. The FDA reviewed the comparison presented by the manufacturer.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- Not applicable. This type of study is not relevant for an orthopedic implant device seeking substantial equivalence based on design and material comparisons.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This is a hardware medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established safety and effectiveness of the predicate devices themselves, confirmed through their prior clearance by the FDA. The manufacturer provided a detailed comparison of the new device to these predicates based on:
- Design characteristics: How the screws and K-wires are constructed, their features (self-tapping, self-drilling, cannulated, thread types).
- Material composition: Type of Stainless Steel used.
- Dimensional specifications: Ranges of diameters and lengths available.
The predicate devices cited are:
- Internal Fixation Systems, Inc. Bone Fixation Devices (K071035)
- Internal Fixation Systems, Inc Cannulated Bone Screw (K061620)
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of an AI algorithm for this orthopedic implant. The "training" for the device design would implicitly come from general engineering principles and existing knowledge of bone fixation.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, this question does not apply.
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510(k) Premarket Notification
Laura Cattabriga
Cannulated Screw and Kirschner (Kwire) System
K130613
Page 1 of 2
510(k) Summary
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Smooth or threaded metallic bone fixation fastener device is provided below.
Device Common Name: Cannulated Bone Screw, Bone Fixation Fasteners
JAN 2 2 2 2014
Device Proprietary Name: Cannulated Screw and Kirschner (K wire) System
Submitter: Laura Cattabriga 7430 Center Bay Drive N. Bay Village, Florida 33141
Contact:
Laura Cattabriga 7430 Center Bay Drive North Bay Village, Florida 33141 Phone: 305-481-5588 laurac@Core-orthopaedics.com
Classification
21 CFR 888.3030 Single /multiple component metallic bone fixation Regulation: appliances and accessories
21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener
Orthopedic Panel:
Product Code: HTN, HWC, HTY
Indication for Use: The Intended Use of the Cannulated Screw and Kirschner (Kwire) System is for the treatment and fixation of bone fractures and osteotomies of various bones including the, acetabulum, pelvis, humerus, radius, ulna, femur, tibia, phalanges, carpals, metacarpals, tarsals, metatarsals and fibula
Device Description: Cannulated Screws and Kwires are a self-tapping, self-drilling screw with a cortico/cancellous or cancellous thread that can be guided into position by Kwire placement. Partial or fully threaded screws are available in various different lengths and diameters to provide fixation in various size bones. The screws are made of Stainless Steel. The Kirschner Wires (Kwires) are threaded, spaded or blunt ranging from 0.8mm to 1.4mm of an inch in diameter and 150mm in length and made of 316L Stainless Steel.
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510(k) Premarket Notification
Laura Cattabriga
Cannulated Screw and Kirschner (Kwire) System
Page 2 of 2
Performance Data: The Cannulated Screw and Kirschner (K wire) System are substantially equivalent to the predicate devices with respect to design and material and dimensional comparison.
Substantial Equivalence:
- Internal Fixation Systems, Inc. Bone Fixation Devices (K071035) .
Internal Fixation Systems, Inc Cannulated Bone Screw (K061620) .
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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
January 22, 2014
Ms. Laura H. Cattabriga 7430 Center Bay Drive North Bay Village, Florida 33141
Re: K130613
Trade/Device Name: Cannulated Screw and Kirschner (K wire) System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HTY, HTV, HTN Dated: December 17, 2013 Received: December 18, 2013
Dear Ms. Cattabriga:
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 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.
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Page 2 - Ms. Laura H. Cattabriga
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/McdicalDevices/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 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.
Ronald#AJean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Premarket Notification Laura Cattabriga Cannulated Screw and Kirschner (Kwire) System
-------------ﺪﺳ
Indications for Use Statement
510(k) Number (if known): K130613
Device Name: Cannulated Screw and Kirschner (Kwire) System
Indications For Use:
The Intended Use of the Cannulated Screw and Kirschner (Kwire) System is for the treatment and fixation of bone fractures and osteotomies of various bones including the acetabulum, pelvis, humerus, radius, ulna, femur, tibia, phalanges, carpals, tarsals, metatarsals and fibula
x Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
Page 1 of
Division of Orthopedic Devices
§ 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.