(126 days)
Not Found
No
The device description and performance studies focus solely on the mechanical properties and intended use of a physical screw for sacroiliac joint fixation. There is no mention of software, algorithms, or data processing that would indicate the presence of AI/ML.
No
Explanation: A therapeutic device is used to treat or manage a disease or condition. This device is a fixation device for sacroiliac joint disruptions, which stabilizes the joint. Therefore, it is a therapeutic device.
No
Explanation: The SAMBA™ Screw System is described as a fixation device intended for stabilizing sacroiliac joint disruptions, indicating a therapeutic or treatment function rather than a diagnostic one. Its description details its physical characteristics and mechanical testing, not its ability to detect or identify a medical condition.
No
The device description clearly states it is a cannulated metallic bone screw made of Titanium, indicating it is a physical hardware device, not software.
Based on the provided information, the SAMBA™ Screw System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- SAMBA Screw System Function: The SAMBA Screw System is a surgical implant designed for the mechanical fixation of the sacroiliac joint. It is a physical device inserted into the body to provide structural support.
- Lack of Diagnostic Activity: The description does not mention any analysis of biological samples or any diagnostic purpose. Its function is purely therapeutic/structural.
Therefore, the SAMBA™ Screw System falls under the category of a surgical implant or orthopedic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SAMBA™ Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.
Product codes
HWC, OUR
Device Description
The SAMBA screw is a cannulated metallic bone screw designed to stabilize the sacroiliac (SI) joint. The SAMBA screw is composed of implant-grade Titanium, Ti-6Al-4V ELI, conforming to ASTM F-136. The SAMBA screw is 9 mm in diameter and offered in 25-50 mm lengths with multiple longitudinal slots on its shaft. Each slot set consists of four (4) holes oriented 90 degrees apart around the circumference of the screw at specified axial location. It will be provided as sterile, single units packaged in a sealed tray and pouch. The screw is a single use device and is not intended to be resterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sacroiliac (SI) joint
Indicated Patient Age Range
skeletally mature patients
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)
To verify that device design met it's functional and performance requirements, representative samples of the device underwent mechanical testing for static axial pull out strength, static torsion, static cantilever bending, and dynamic cantilever bending in accordance with the following standards:
• ASTM F2193-02 (2007) Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
• ASTM F543-07 Standard Specification and Test Methods for Metallic Medical Bone Screw
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
. K121148
510(k) Summary .
AUG 200 2012
| Submitter: | Medical Designs LLC
6709 S. Minnesota Ave. Suite 204
Sioux Falls, SD 57108-2593 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kristi Vondra
Vice President of Operations
Telephone: (605) 275-1032
Fax: (605) 335-3734
e-mail: kvondra@medicaldesignsllc.com |
| Date Prepared: | April 13, 2012 |
| Trade Name: | SAMBA™ Screw System |
| Classification: | Class II, Smooth or threaded metallic bone fixation fastener (21
CFR 888.3040) |
| Product Code: | HWC, OUR |
| Predicate Device(s): | The subject device is equivalent to the following devices:
• Synthes 6.5mm Cannulated Screw (K021932)
• SI-LOK Sacroiliac Joint Fixation System (K112028) |
| Device Description: | The SAMBA screw is a cannulated metallic bone screw
designed to stabilize the sacroiliac (SI) joint. The SAMBA
screw is composed of implant-grade Titanium, Ti-6Al-4V ELI,
conforming to ASTM F-136. The SAMBA screw is 9 mm in
diameter and offered in 25-50 mm lengths with multiple
longitudinal slots on its shaft. Each slot set consists of four (4)
holes oriented 90 degrees apart around the circumference of the
screw at specified axial location. It will be provided as sterile,
single units packaged in a sealed tray and pouch. The screw is a
single use device and is not intended to be resterilized. |
| Intended Use: | The SAMBA™ Screw System is intended for fixation of
sacroiliac joint disruptions. This fixation device is to only be
used in skeletally mature patients. |
| Functional and
Safety Testing: | To verify that device design met it's functional and performance
requirements, representative samples of the device underwent
mechanical testing for static axial pull out strength, static
torsion, static cantilever bending, and dynamic cantilever
bending in accordance with the following standards:
• ASTM F2193-02 (2007) Standard Specifications and
Test Methods for Components Used in the Surgical
Fixation of the Spinal Skeletal System
• ASTM F543-07 Standard Specification and Test
Methods for Metallic Medical Bone Screw |
| Conclusion: | Medical Designs considers the SAMBA Screw System to be
equivalent to the predicate device listed above. This conclusion
is based upon the devices' similarities in principles of operation,
technology, materials and indications for use. |
- (1
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
AUG 2 0 2012
Medical Designs, LLC. % Kristi Vondra Vice President of Operations 6709 S. Minnesota Ave. Suite 204 Sioux Falls, South Dakota 57108-2593
Re: K121148
Trade/Device Name: SAMBA1M Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, OUR Dated: July 16, 2012 Received: July 19, 2012
Dear Ms. Kristi Vondra:
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.
2
Page 2 - Ms. Kristi Vondra
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.
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/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,
Mark A. Mulkison
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement 4.
Device Name: SAMBA™ Screw System
Indications for Use:
The SAMBA™ Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.
Prescription Use X (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)
A. S
(Division Sign-Off) Division of Surgical, Orthopsdic, and Restorative Devices
510(k) Number K921148