(112 days)
Not Found
No
The device description and intended use are for a mechanical implant (screws) and there is no mention of AI/ML or related concepts in the provided text.
No
The device is described as cannulated screws for bone reconstruction, fracture repair, and fixation, which are mechanical devices, not therapeutic in function in the sense of actively treating a disease or condition beyond structural support.
No
Explanation: The device is a cannulated screw intended for bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation. These are therapeutic and structural uses, not diagnostic.
No
The device description clearly states that the device is a physical screw manufactured from titanium alloy or stainless steel, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical procedures involving bone (reconstruction, osteotomies, fracture repair, etc.). This is a therapeutic and structural use, not a diagnostic one.
- Device Description: The description details a physical implant made of titanium or stainless steel, designed to be surgically inserted into bone. This is consistent with a medical device used in surgery, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to treat bone conditions.
N/A
Intended Use / Indications for Use
The Medline Cannulated Screws are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.
Product codes
HWC
Device Description
The Medline Cannulated Screws are manufactured from titanium alloy or stainless steel. The screws are offered in various diameters, lengths, and thread lengths. Both headed and headless screw options are available as well as optional washers for the headed screws. A comparison of the materials and design features of the subject and predicate screws reflects substantial equivalence. The Medline Cannulated Screw sizes are within the currently marketed sizes, diameter and length, of the identified predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones appropriate for the size of the device
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)
Functional performance testing of the Medline Cannulated Screws demonstrated device effectiveness in accordance with relevant ASTM F382 and F543 test methods.
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.
0
K130319 (pg 1/2)
510(k) Summary
MAY 3 1 2013
Summary Preparation Date
May 17, 2013
Submitter / 510(k) Sponsor
Medline Industries, Inc. One Medline Place Mundelein, IL 60060
Contact Person
Matt Clausen Sr. Regulatory Affairs Specialist Phone: 847-643-4785 Fax: 847-643-4482
Device Name / Classification
Device Name: Orthopedic Cannulated Screw Proprietary Name: Medline Cannulated Screw Common Name: Bone Screw Classification Name: Screw, Fixation, Bone (21 CFR 888.3040, product code - HWC)
Predicate Device (primary)
Wright Compression Screws (Wright Medical), K082320
Device Description
The Medline Cannulated Screws are manufactured from titanium alloy or stainless steel. The screws are offered in various diameters, lengths, and thread lengths. Both headed and headless screw options are available as well as optional washers for the headed screws. A comparison of the materials and design features of the subject and predicate screws reflects substantial equivalence. The Medline Cannulated Screw sizes are within the currently marketed sizes, diameter and length, of the identified predicate devices.
Indications for Use
The Medline Cannulated Screws are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.
1
Summary of Technological Characteristics
Information within this Premarket Notification demonstrates that there are no significant differences in technological characteristics between Medline's Cannulated Screws and the cited predicate devices.
Summary of Non-Clinical Testing
The safety and effectiveness of Medline's Cannulated Screws is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification. Functional performance testing of the Medline Cannulated Screws demonstrated device effectiveness in accordance with relevant ASTM F382 and F543 test methods.
Summary of Clinical Testing
N/A
Conclusion
In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline Cannulated Screw is safe, effective and substantially equivalent as described herein.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
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
May 31, 2013
Medline Industries, Incorporated % Mr. Matt Clausen . Sr. Regulatory Affairs Specialist One Medline Place Mundelein, Illinois 60060
Re: K130319
Trade/Device Name: Medline Cannulated Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: March 6, 2013 Received: March 7, 2013
Dear Mr. Clausen:
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. Matt Clausen
forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm.
| Sincerely yours, | Erin Keith |
|---|---|
| For | Mark N. Melkerson |
| Director | |
| Division of Orthopedic Devices | |
| Office of Device Evaluation | |
| Center for Devices and | |
| Radiological Health |
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in a stylized, italicized font. Above and below the text are two parts of a compass, with the top part pointing upwards and the bottom part pointing downwards. The logo is in black and white.
Medline Industries, Inc. www.medline.com
One Medline Place Mundelein, II. 60060 1.847.643.4736
Indications for Use
510(k) Number (if known): K130319 (pg 1/1)
Device Name: Medline Cannulated Screws
Indications for Use:
The Medline Cannulated Screws are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.
Prescription Use X (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||司册ank -S
Division of Orthopedic Devices