(244 days)
Not Found
No
The device description and intended use clearly define a mechanical bone screw and washer system. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML. The performance studies are based on mechanical testing, not algorithmic performance.
Yes
The device is a bone screw and washer system intended for fixation of fractures, arthrodesis, and osteotomies, which directly treats and alleviates medical conditions or symptoms.
No
The device is a cancellous bone screw and washer, an orthopedic implant for fracture fixation and arthrodesis, not for diagnosing conditions.
No
The device description clearly states it is a physical bone screw and washer made of medical grade stainless steel, intended for fracture fixation. It does not mention any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the SMV Scientific Cancellous Bone Screw and Washer is a physical implant intended for the fixation of bone fractures and arthrodeses. It is a surgical device used within the body, not a test performed on a sample from the body.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The 4.0 SMV Scientific Cancellous Bone Screw and Washer is intended for fixation of fractures with medium fragments, e.g .: - tarsal and metatarsal fractures and fixation in metatarsal and phalangeal osteotomies - tarsometatarsal and metatarsophalangeal arthrodeses - ligament fixations - hallux valgus corrections. Additionally, the 4.0 SMV Scientific Cancellous Screw and Washer is intended for arthrodesis and osteotomies of small joints, including scaphoid and other carpal bones, metacarpals, tarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
The 6.5 SMV Scientific Cancellous Bone Screw and Washer is intended for fixation of fractures with large fragments, e.g.: - femoral neck fractures - intercondylar femoral fractures epiphyseolysis of the femoral head - ankle arthrodeses. Additionally, the 6.5 SMV Scientific Cancellous Screw and Washer is intended for reconstruction, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device including joint fusions (arthrodesis) in the foot and ankle.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HTN
Device Description
The SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer are manufactured from medical grade stainless steel. The SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer are offered in various diameters and lengths. The SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer are intended to provide fracture fixation. Implants are provided nonsterile with instructions for sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tarsal, metatarsal, phalangeal, tarsometatarsal, metatarsophalangeal, scaphoid, carpal bones, metacarpals, patella, ulnar styloid, capitellum, radial head, radial styloid, femoral neck, intercondylar femoral, femoral head, ankle, foot
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)
The SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer has been tested in the following test modes:
- Static Torsion per ASTM F543
- Static Axial Pullout per ASTM F543
- Static Removal Torque per ASTM F543
The results of this non-clinical testing show that the strength of the SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
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.
K111994, K000089, K963192, K061621, K052483
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles, suggesting themes of health, well-being, and human connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 5, 2016
SMV Scientific % Kenneth Maxwell II Regulatory and Quality Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs. Colorado 80918
Re: K160946
Trade/Device Name: 4.0 and 6.5 Cancellous Bone Screw and Washer Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HTN Dated: October 21, 2016 Received: October 24, 2016
Dear Kenneth Maxwell II:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name
4.0 and 6.5 Cancellous Bone Screw and Washer
Indications for Use (Describe)
The 4.0 SMV Scientific Cancellous Bone Screw and Washer is intended for fixation of fractures with medium fragments, e.g .: - tarsal and metatarsal fractures and fixation in metatarsal and phalangeal osteotomies - tarsometatarsal and metatarsophalangeal arthrodeses - ligament fixations - hallux valgus corrections. Additionally, the 4.0 SMV Scientific Cancellous Screw and Washer is intended for arthrodesis and osteotomies of small joints, including scaphoid and other carpal bones, metacarpals, tarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
The 6.5 SMV Scientific Cancellous Bone Screw and Washer is intended for fixation of fractures with large fragments, e.g.: - femoral neck fractures - intercondylar femoral fractures epiphyseolysis of the femoral head - ankle arthrodeses. Additionally, the 6.5 SMV Scientific Cancellous Screw and Washer is intended for reconstruction, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device including joint fusions (arthrodesis) in the foot and ankle.
| Type of Use (Select one or both, as applicable) | ||||
|---|---|---|---|---|
| > Prescription Use (Part 21 CFR 801 Subpart D) | ||||
| 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)
3
510(K) SUMMARY
| Submitter's Name: | SMV Scientific |
|---|---|
| Submitter's Address: | 111 Sandra Muraida Way |
| Unit 18A | |
| Austin, TX 78703 | |
| Submitter Contact Person: | Nephi Zufelt |
| Chief Technology Officer | |
| 512-750-8622 | |
| Empirical Consulting Contact Person: | Kenneth C. Maxwell II |
| Empirical Testing Corp. | |
| 719.291.6874 | |
| Submitter's Name: | SMV Scientific |
| Date Summary was Prepared: | 30 November 2016 |
| Trade or Proprietary Name: | 4.0 and 6.5 Cancellous Bone Screw and Washer |
| Common or Usual Name: | Smooth or threaded metallic bone fixation fastener |
| Classification: | Class II per 21 CFR §888.3040 |
| Product Code: | HWC, HTN |
| Classification Panel: | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer are manufactured from medical grade stainless steel. The SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer are offered in various diameters and lengths. The SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer are intended to provide fracture fixation. Implants are provided nonsterile with instructions for sterilization.
INDICATIONS FOR USE
The 4.0 SMV Scientific Cancellous Bone Screw and Washer is intended for fixation of fractures with medium fragments, e.g.: - tarsal and metatarsal fractures and fixation in metatarsal and phalangeal osteotomies – tarsometatarsal and metatarsophalangeal arthrodeses – ligament fixations - hallux valgus corrections. Additionally, the 4.0 SMV Scientific Cancellous Screw and Washer is intended for arthrodesis and osteotomies of small joints, including scaphoid and other carpal bones, metacarpals, tarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
The 6.5 SMV Scientific Cancellous Bone Screw and Washer is intended for fixation of fractures with large fragments, e.g.: - femoral neck fractures - intercondylar femoral fractures epiphyseolysis of the femoral head - ankle arthrodeses. Additionally, the 6.5 SMV Scientific Cancellous Screw and Washer is intended for reconstruction, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device including joint fusions (arthrodesis) in the foot and ankle.
4
The indications for use for the Cancellous Screw and Washer is similar to that of the predicate devices listed in Table 5-1.
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Type |
|---|---|---|---|
| K111994 | 4.0 Cannulated Screws | Smith & Nephew | Primary |
| K000089 | 4.0mm and 5.0mm Locking Screws | Synthes | Additional |
| K963192 | 3.5mm and 4.0mm Cannulated Screws | Synthes | Additional |
| K061621 | 6.5mm Cancellous Screw | Synthes | Additional |
| K052483 | Spherical Washers | Synthes | Additional |
PERFORMANCE DATA
The SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer has been tested in the following test modes:
- Static Torsion per ASTM F543 ●
- Static Axial Pullout per ASTM F543 ●
- Static Removal Torque per ASTM F543 ●
The results of this non-clinical testing show that the strength of the SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer is substantially equivalent to the predicate device.