(97 days)
The Speed XLTM is indicated for: Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
The Speed XLTM is for use in fracture and osteotomy fixation and joint arthrodesis of the hand and foot. The implant is designed so that it is delivered to the operating room in an "open" martensitic state. The implant is then transformed by room temperature after insertion, and contracts to a "closed" austenitic state. The implant does not require any external heating; it is completely transformed by room temperature. This configuration change for the Speed XL™ consists of a change in device shape, including flattened bridge with wider dimension to be used in hand and foot procedures.
This document describes the Speed XLTM bone staple and its substantial equivalence to a predicate device, the Speed ShiftTM.
Here's an analysis of the provided text based on your request:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as quantitative thresholds in the provided text. Instead, the approach taken for the Speed XLTM is based on demonstrating "substantial equivalence" to a legally marketed predicate device (Speed ShiftTM) through performance bench testing. The reported device performance is measured against this predicate.
| Test Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| ASTM F564-10 (Pull-out) | Substantially equivalent pull-out resistance to predicate (Speed Shift™) | "The results for the Speed XLTM yielded substantially equivalent pull-out resistance than the comparable predicate Speed Shift™ for similar sizes." (TR-02-129-1316) |
| ASTM F564-10 (Bending) | Substantially equivalent bending stiffness to predicate (Speed Shift™) | "The Speed XLTM devices yielded substantially equivalent bending stiffness when compared to the Speed Shift™ predicates." (TR-01-129-1315) |
| ASTM F2129-08 (Corrosion) | Equivalent corrosion resistance to predicate (Speed Shift™) | "Test results demonstrate the corrosion resistance is equivalent to the predicate Speed Shift™." (FWM # 13-08-30946, FWM # 13-08-31279, & FWM # 13-10-31866) |
2. Sample Size and Data Provenance
- Sample Size for Test Set:
- For the pull-out strength test (ASTM F564-10), "Two lots with three samples each (n=3)" were compared for the Speed XLTM to the predicate. This refers to 3 samples for each of the two different lots of Speed XLTM, compared against similarly sized Speed ShiftTM predicates.
- For the bending strength test (ASTM F564-10), "The largest and smallest Speed XL™ sizes were tested" and compared to similar Speed Shift™ predicates. The exact number of samples for each size isn't specified, but it's likely a small number similar to the pull-out test based on the context of bench testing for substantial equivalence.
- For corrosion resistance (ASTM F2129-08), "representative samples of the new Speed XLIM" were compared to the predicate. The exact number of samples isn't specified.
- Data Provenance: The data is from "Performance Bench Testing" conducted by the manufacturer (BioMedical Enterprises, Inc.). This is prospective testing specifically for the 510(k) submission. The country of origin is implicitly the USA, where the submitting company is based and where the FDA approval process occurred.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This submission is for a medical device (bone staple) and relies on objective, repeatable physical and mechanical bench testing according to established ASTM standards, not on expert interpretation of data or images to establish ground truth.
4. Adjudication Method for Test Set
Not applicable. As this is bench testing of a physical device, there is no expert adjudication of results in the traditional sense. The results are obtained from standardized laboratory tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic devices where human readers interpret medical images or data. The Speed XLTM is a bone staple, a physical implant.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This is not an algorithm or AI device.
7. Type of Ground Truth Used
The ground truth for the performance tests (pull-out strength, bending stiffness, corrosion resistance) is based on objective, quantifiable measurements obtained through standardized ASTM (American Society for Testing and Materials) test protocols. These standards define the methods for measuring these properties.
8. Sample Size for Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI. The design and manufacturing processes are likely informed by engineering principles and previous device designs, but not in a "training set" manner.
9. How Ground Truth for Training Set was Established
Not applicable, as there is no training set mentioned or implied for this physical device.
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(510(k) Summary)
MAR 1 9 2014
Speed XLTM Product:
Submitter Information
BioMedical Enterprises, Inc. 14785 Omicron Drive, Ste. 205 San Antonio, Texas 78245 Telephone: (210) 677-0354 (210) 677-0355 Fax: Joe W. Soward Contact:
Date Prepared: December 3, 2013
Classification name: Single/multiple component metallic bone fixation appliances and accessories (21 CFR 888.3030)
| Classification: | Class II |
|---|---|
| Product Code: | JDR |
| Common/Usual Name: | Bone Staple |
| Proprietary Name: | Speed XLTM |
Intended Use:
The Speed XLTM is indicated for: Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
Substantial Equivalence:
The Speed XL™ is substantially equivalent to the predicate Speed Shift™ cleared in K124022.
Device Description
The Speed XLTM is for use in fracture and osteotomy fixation and joint arthrodesis of the hand and foot. The implant is designed so that it is delivered to the operating room in an "open" martensitic state. The implant is then transformed by room temperature after insertion, and contracts to a "closed" austenitic state. The implant does not require any external heating; it is completely transformed by room temperature.
This configuration change for the Speed XL™ consists of a change in device shape, including flattened bridge with wider dimension to be used in hand and foot procedures.
Technological Characteristics Comparison to the Predicates
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| Product Name: | New DeviceSpeed XLTM | Predicate Speed ShiftTM(K124022) |
|---|---|---|
| Raw Material: | Nitinol, per ASTMF2063-12 | Nitinol, per ASTMF2063-12 |
| Bridge Lengths (mm): | 20 and 25 | 15 and 20 |
| Leg Lengths (mm): | 20 | 20 |
| Cross-section Dimensions (mm): | Leg: 1.80 x 2.06Bridge: 1.85 x 3.52 | 1.80 x 2.00 |
| Barbs: | Barbs on the legs | Barbs on the legs |
| Pilot Drill Hole Sizes (mm): | 2.65 | 2.65 |
| Heat Source: | Fully transformedat room temperature | Fully transformedat room temperature |
| Surface Finish: | Mechanical tumbling, acid cleaning, andchemical passivation. | Mechanical tumbling,acid cleaning, andchemical passivation. |
| Storage: | Sterile packaged and can be stored atroom temp until used. | Sterile packaged andcan be stored at roomtemp until used. |
Performance Bench Testing:
Standard ASTM F564-10 (2010) was used to compare the pull-out strength of the new Speed XLTM to the predicate Shift™. Two lots with three samples each (n=3) were compared to similarly sized Speed Shift™ predicates. The results for the Speed XLTM yielded substantially equivalent pull-out resistance than the comparable predicate Speed Shift™ for similar sizes. (TR-02-129-1316)
Standard ASTM F564-10 (2010) was used to compare the mechanical strength of the Speed XL™ to the Speed Shift™. The largest and smallest Speed XL™ sizes were tested and compared to similar Speed Shift™ predicates. The Speed XLTM devices yielded substantially equivalent bending stiffness when compared to the Speed Shift™ predicates. (TR-01-129-1315)
Standard ASTM F2129-08 was used to compare the corrosion resistance of representative samples of the new Speed XLIM to the predicate Speed Shift™. Test results demonstrate the corrosion resistance is equivalent to the predicate Speed Shift™. (FWM # 13-08-30946, FWM # 13-08-31279, & FWM # 13-10-31866)
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. 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 resembling an eagle or bird in flight, composed of three curved lines that suggest wings and a tail.
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
March 19, 2014
BioMedical Enterprises, Incorporated Mr. Joe W. Soward Director, Quality, Compliance and Regulatory Affairs 14785 Omicron Drive, Suite 205 San Antonio, Texas 78245
Re: K133780
Trade/Device Name: Speed XLTM Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR Dated: January 22, 2014 Received: January 23, 2014
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 docs 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 vour 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
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Page 2 - Mr. Joe W. 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" (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 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.
Ronald P. Jean -S for
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Device Name: Speed XLTM
Indications for Use
The Speed XL™ is indicated for:
Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
§ 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.