(137 days)
Not Found
No
The description focuses on the material properties (nitinol) and mechanical design of the implant, with no mention of AI or ML.
Yes
The device is indicated for fracture and osteotomy fixation and joint arthrodesis, which are therapeutic interventions.
No
The device is described as an implant for fracture and osteotomy fixation and joint arthrodesis, which are therapeutic functions, not diagnostic ones.
No
The device description clearly states that the Speed Shift™ is a nitinol implant, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Fracture and osteotomy fixation and joint arthrodesis of the hand and foot." This describes a surgical implant used to physically stabilize bones and joints.
- Device Description: The description details a nitinol implant that changes shape with body heat to provide fixation. This is a mechanical device used within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support.
N/A
Intended Use / Indications for Use
The Speed Shift™ is indicated for: Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
Product codes (comma separated list FDA assigned to the subject device)
JDR
Device Description
The Speed Shift™ is a nitinol implant that comes in a range of sizes and models for use in extremity bone fragment fixation, osteotomy fixation, and joint arthrodesis. The implant is delivered to the operating room in an "open" martensitic state. The implant is then transformed by ambient and body heat after insertion, and contracts to a "closed" austenitic state. The implants do not require any external heating; they are completely transformed by body heat. This configuration change for the Speed Shift™ consists of a step bend of the staple back where the bend is in line with the legs of the staple rather than perpendicular to the legs as in the predicate devices. This in line bend allows Speed Shift™ to be useful for step osteotomies such as in the calcaneal slide procedure and other various mid-foot procedures reducing the prominence of the staple back after implantation as compared to the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and 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)
Standard ASTM F564-10 (2010) was used to compare the pull-out strength of the new Speed Shift™ to the predicatc OSStaple™. Specimens of the largest and smallest sizes of the Speed Shift"M were used and compared to a comparably sized predicate OSStaple™M. The results showed that the Specd Shift™ has higher pull-out resistance than the predicate OSStaple™ Standard ASTM F564-10 (2010) was used to compare the mechanical strength ™. The results showed that the Speed Shift™ achieve greater bending strength when compared to the predicate OSStaple™. Standard ASTM F2129-08 was used to compare the corrosion resistance of representative samples of the new Speed Shift™ to the predicate OSStaple™. Test results demonstrate the corrosion resistance is equivalent to the predicate OSStaple Chill™
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
(510(k) Summary)
Product: Speed Shift™
Submitter Information
BioMedical Enterprises, Inc. 14785 Omicron Drive, Ste. 205 San Antonio, Texas 78245 Telephone: (210) 677-0354 Fax: (210) 677-0355 Contact: Joe W. Soward
Date Prepared: January 17, 2013
Classification name: Smooth or Threaded Metallic Bone Fastener (21 CFR 888.3040)
| Classification: | Class II |
|---|---|
| Product Code: | JDR |
| Common/Usual Name: | Bone Staple |
| Proprietary Name: | Speed Shift™ |
Intended Use:
The Speed Shift™ is indicated for:
Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
Substantial Equivalence:
The Speed Shift™ is substantially equivalent to the predicate BME OSS1aple™ cleared in K993714 and the OSStaple™ Chill cleared in K102107. The predicates also include an intended use of fixation of proximal tibial metaphysis osteotomy which is not included in this submission.
Device Description.
The Speed Shift™ is a nitinol implant that comes in a range of sizes and models for use in extremity bone fragment fixation, osteotomy fixation, and joint arthrodesis. The implant is delivered to the operating room in an "open" martensitic state. The implant is then transformed by ambient and body heat after insertion, and contracts to a "closed" austenitic state. The implants do not require any external heating; they are completely transformed by body heat.
This configuration change for the Speed Shift™ consists of a step bend of the staple back where the bend is in line with the legs of the staple rather than perpendicular to the legs as in the predicate devices. This in line bend allows Speed Shift™ to be useful for step osteotomies such as in the calcaneal slide procedure and other various mid-foot procedures reducing the prominence of the staple back after implantation as compared to the predicate devices.
2-1
1
| Product Name: | Speed Shift™ | Predicate
OSStaple™
(K993714) | Predicate
OSStaple Chill
(K102107) |
|-----------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------------------|
| Raw Material: | Nitinol, per ASTM
F2063-05 | Nitinol, per ASTM
F2063-05 | Nitinol, per ASTM
F2063-05 |
| Bridge Lengths
(mm): | 15 and 20 | 9, 11, 13, 15, 18, 20,
and 30 | 9, 11, 13, 15, 18, and
20 |
| Leg Lengths (mm): | 20 | 7, 8, 10, 12, 15, 18,
20, and 30 | 7, 8, 10, 12, 15, 18,
and 20 |
| Cross-section
Dimensions (mm): | 1.8 x 1.8 square | Min 1.2 x 1.2
Max 2.0 x 3.0 | Min 1.2 x 1.2
Max 2.0 x 3.0 |
| Barbs: | Barbs on the legs | Smooth legs | Barbs on the legs |
| Heat Source: | Fully transformed
at room temperature | OSSforce™ electrical
heating unit | Body temperature |
| Surface Finish: | Mechanical tumbling,
acid cleaning, and
chemical passivation. | Mechanical tumbling,
acid cleaning, and
chemical passivation. | Mechanical tumbling,
acid cleaning, and
chemical passivation. |
| Storage: | Sterile packaged
stored at room temp
until used. | Sterile packaged,
stored at room temp
until used. | Sterile packaged, and
requires storage in
freezer prior to use. |
Technological Characteristics Comparison to the Predicates
Performance Bench Testing:
Standard ASTM F564-10 (2010) was used to compare the pull-out strength of the new Speed Shift™ to the predicatc OSStaple™. Specimens of the largest and smallest sizes of the Speed Shift"M were used and compared to a comparably sized predicate OSStaple™M. The results showed that the Specd Shift™ has higher pull-out resistance than the predicate OSStaple™
Standard ASTM F564-10 (2010) was used to compare the mechanical strength ™. The results showed that the Speed Shift™ achieve greater bending strength when compared to the predicate OSStaple™.
Standard ASTM F2129-08 was used to compare the corrosion resistance of representative samples of the new Speed Shift™ to the predicate OSStaple™. Test results demonstrate the corrosion resistance is equivalent to the predicate OSStaple Chill™
2
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
Letter dated: May 14, 2013
BioMedical Enterprises, Incorporated % Mr. Joe Soward Director, Ouality Assurance and Regulatory Affairs 14785 Omicron Drive, Suite 205 San Antonio, Texas 78245
Re: K124022
Trade/Device Name: Speed Shift™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JDR Dated: April 12, 2013 Received: April 16, 2013
Dear Mr. Soward:
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. Joe Soward
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark N.Mielkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K124022
Device Name: Speed Shift™
Indications For Use:
The Speed Shift™ Fixation system is indicated for fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
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)
| Casey L. Hanley, Ph.D. |
|---|
| Division of Orthopedic Devices |
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