(81 days)
Not Found
No
The device description and performance studies focus on mechanical properties and material modifications of a surgical screw, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML devices.
Yes
The device is described as a "SLIC Screw Repair System" intended to "provide fixation and anatomically reduce two bones or bone portions" for conditions like ligament repair and carpal instability. This directly indicates a therapeutic function of repairing or stabilizing a biological structure.
No
Explanation: The device is described as a "repair system" intended to provide "fixation and anatomically reduce two bones or bone portions." The intended use indicates it's for surgical procedures like ligament repair and reduction, which are treatments, not diagnoses. The "Device Description" and "Summary of Performance Studies" further support its function as a physical implant for treatment rather than for identifying or analyzing a medical condition.
No
The device description explicitly states it is a "headless, cannulated two-piece screw assembly" made of stainless steel, indicating it is a physical implantable device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide fixation and anatomically reduce two bones or bone portions." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "headless, cannulated two-piece screw assembly" made of stainless steel. This is a physical implant used in surgery.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
The SLIC Screw Repair System is a surgical implant used to treat carpal instability by fixing and reducing bones. It does not involve testing samples from the body.
N/A
Intended Use / Indications for Use
The SLIC Screw Repair System is intended to provide fixation and anatomically reduce two bones or bone portions. Specifically, these indications include scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The SLIC Screw Repair System consists of a headless, cannulated two-piece screw assembly. The two-piece design incorporates the use of distal and proximal screw components to anatomically reduce two bones.
The purpose of this Special 510(k) is to modify the material, interconnection geometry and available sizes of the SLIC Screw. All components are made of 22-13-5 stainless steel conforming to ASTM F1314. These modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones or bone portions, scapholunate, lunotriquetral, carpal
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)
Preclinical Testing: The new components were subjected to insertion testing, pull-apart testing and pull-out strength testing. The results demonstrate that the acceptance criteria defined in the Design Control Activities Summary were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KIII 608 (112)
AUG 2 9 2011
5. 510(k) Summary
| Device Trade Name: | SLIC Screw Repair System |
|---|---|
| Manufacturer: | Acumed, LLC |
| 5885 NW Cornelius Pass Road | |
| Hillsboro, OR 97124 | |
| Contact: | Ms. Lino Tsai |
| Regulatory Specialist | |
| Phone: 503.627.9957 | |
| Prepared by: | Musculoskeletal Clinical Regulatory Advisers, LLC |
| 1331 H Street NW, 12th Floor | |
| Washington, DC 20005 | |
| Phone: (202) 552-5800 | |
| Fax: (202) 552-5798 | |
| Date Prepared: | June 8, 2011 |
| Classification: | 21 CFR 888.3040, Smooth or threaded metallic bone |
| fixation fastener | |
| Class: | II |
| Product Code: | HWC |
Indications For Use:
The SLIC Screw Repair System is intended to provide fixation and anatomically reduce two bones or bone portions. Specifically, these indications include scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability.
Device Description:
The SLIC Screw Repair System consists of a headless, cannulated two-piece screw assembly. The two-piece design incorporates the use of distal and proximal screw components to anatomically reduce two bones.
The purpose of this Special 510(k) is to modify the material, interconnection geometry and available sizes of the SLIC Screw. All components are made of 22-13-5 stainless steel conforming to ASTM F1314. These modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device.
1
Predicate Device:
The modified SLIC Screw Repair System is substantially equivalent to the predicate ARC Surgical Bone Reduction System (K063244) with respect to indications, design, function, and materials.
Preclinical Testing:
The new components were subjected to insertion testing, pull-apart testing and pull-out strength testing. The results demonstrate that the acceptance criteria defined in the Design Control Activities Summary were met.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper half of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Acumed, LLC % Ms Lino Tsai Regulatory Specialist 5885 North West Cornelius Pass Road Hillsboro, Oregon 97124
AUG 2 9 2011
Re: K111608
Trade/Device Name: SLIC Screw Repair System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bond fixation fastener Regulatory Class: II Product Code: HWC Dated: August 5, 2011 Received: August 8, 2011
Dear Ms. Tsai:
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
3
Page 2 - Ms Lino Tsai
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.
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/ReportalProblem/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.
http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson Director
Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use 4.
510(k) Number (if known): _
y
.
Device Name: SLIC Screw Repair System
The SLIC Screw Repair System is intended to provide fixation and anatomically reduce two bones or bone portions. Specifically, these indications include scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability.
Prescription Use ﮯ (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)
for M.Melleem
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111608