(113 days)
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Not Found
No
The device description and performance studies focus solely on the mechanical properties and design of a surgical screw, with no mention of AI or ML.
No.
The device description clearly states it is a "Cannulated Cancellous Screw," which is an orthopedic implant used for internal fixation of bone fractures. Such devices are structural supports, not instruments that deliver or modulate therapeutic energy/substances or rehabilitate.
No
Explanation: The device described is a cannulated cancellous screw, which is an orthopedic implant used for surgical fixation, not for diagnosing conditions.
No
The device description clearly describes a physical implantable screw made of titanium alloy, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly details a surgical screw made of titanium alloy, designed for orthopedic use (likely bone fixation). It describes its physical characteristics, dimensions, and features for surgical insertion.
- Intended Use/Indications for Use: While this section is "Not Found," the device description strongly suggests a surgical implant, not a diagnostic test.
- Performance Studies: The performance studies described focus on the mechanical properties of the screw (bending strength and stiffness), which are relevant to its function as a surgical implant, not a diagnostic test.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or any other activity associated with in vitro diagnostics.
Therefore, the Northwest Precision Technologies Ø6.5 mm Cannulated Cancellous Screw is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
87HRS
Device Description
The Northwest Precision Technologies Ø6.5 mm Cannulated Cancellous Screw will be offered in two versions of an identical configuration. Both versions are identical with the exception of the overall thread length . One will be 16 mm and the second will be 32 mm in length. The length is measured from the distal tip up the shank. The screws will be fabricated from Titanium alloy Ti-6Al-4V, which complies with ASTM F-136. The device is of a single thread profile with a nominal major diameter of Ø6.5 mm (.256 in.) and a nominal shank, or minor diameter, of 4.82 mm (.190 in.). The lengths offered at this time are 30 mm through 150 mm, in 5 mm increments. The overall length is measured from the underside of the head to the distal tip. The cannula, or inner diameter, is a nominal Ø3.26 mm (1285 in.) bore which will allow the use of a Ø2.5 mm Guide Pin ensuring safe and accurate placement of the screw. The "head" portion off the screw will embody an internal hexagon pocket to facilitate the insertion / extraction instrumentation. The distal tip embodies a self reaming / self tapping design. The self reaming feature incorporates three cutting teeth, while the self tapping is accomplished with three cutting flutes. Two cutting flutes will be located at the thread runout to the shank. They will be located at 180° to each other. These flutes are provided to ease extraction of the device. The self reaming and self tapping cannulated screws simplify the surgical procedure by allowing the surgeon to place the screw directly over the guide pin which is holding the reduced fracture in place.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Device and system testing consisted of computer generated analysis that determined the bending strength and stiffness through a three point bend per ASTM E-8555. The results of all testing revealed that the Northwest Precision Technologies Ø6.5 mm Cannulated Cancellous Screws are suitable for the indications noted and the anticipated conditions of use imposed on the device. Comparison test values for the Northwest Precision Technologies Ø6.5 mm Cannulated Cancellous Screws and the Ace Medical and Alphatec Manufacturing Ø6.5 mm Cannulated Cancellous Screws were equivalent at all times. Test reports demonstrated that the Northwest Precision Technologies Ø6.5 mm Cannulated Cancellous Screws have been adequately designed to perform in a manner equivalent to that of the comparison device(s). Based on the testing, the Northwest Precision Technologies Ø6.5 mm Cannulated Cancellous Screws are equal in performance to the Ace Medical and Alphatec Manufacturing Ø6.5 mm Cannulated Cancellous Screws. The results of the three point bend test show that the Northwest Precision Technologies devices posses equivalent strength to the comparative devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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
JAN 22 1997
Section 510(k) Summary of Safety and Effectiveness Information
Requiatory Authority:
Safe Medical Devices Act of 1990, 21 CFR 807.92
Company Name / Contact
Northwest Precision Technologies Company: 812 West 6th Street, Suite 8144 The Dalles, OR. 97058 (541) 298-1088 (541) 296-1124 Fax
Contact: Dave Stinson Owner (541) 298-1088 (541) 296-1124 Fax
Establishment Registration Number: Pending
Device Name:
| Trade Name: | Northwest Precision Technologies
Ø6.5 mm Cannulated Cancellous Screw |
|----------------------|-----------------------------------------------------------------------------------|
| Common Name: | Cannulated Screw for Large Bones |
| Classification Name: | Single / Multiple component metallic bone fixation
appliances and accessories. |
| Classification Code: | 87HRS |
Substantially Equivalent Device(s)
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- Ace Medical Ø6.5 mm Cannulated Cancellous Screw
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- Alphatec Manufacturing Ø6.5 mm Cannulated Cancellous Screw
Device Description
The Northwest Precision Technologies Ø6.5 mm Cannulated Cancellous Screw will be offered in two versions of an identical configuration. Both versions are identical with the exception of the overall thread length . One will be 16 mm and the second will be 32 mm in length. The length is measured from the distal tip up the shank. The screws will be fabricated from Titanium alloy Ti-6Al-4V, which complies with ASTM F-136. The device is of a single thread profile with a nominal major diameter
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of Ø6.5 mm (.256 in.) and a nominal shank, or minor diameter, of 4.82 mm (.190 in.). The lengths offered at this time are 30 mm through 150 mm, in 5 mm increments. The overall length is measured from the underside of the head to the distal tip. The cannula, or inner diameter, is a nominal Ø3.26 mm (1285 in.) bore which will allow the use of a Ø2.5 mm Guide Pin ensuring safe and accurate placement of the screw. The "head" portion off the screw will embody an internal hexagon pocket to facilitate the insertion / extraction instrumentation. The distal tip embodies a self reaming / self tapping design. The self reaming feature incorporates three cutting teeth, while the self tapping is accomplished with three cutting flutes. Two cutting flutes will be located at the thread runout to the shank. They will be located at 180° to each other. These flutes are provided to ease extraction of the device. The self reaming and self tapping cannulated screws simplify the surgical procedure by allowing the surgeon to place the screw directly over the guide pin which is holding the reduced fracture in place. The efficiency of this simplified, time saving technique is well documented on other approved cannulated screw systems (Alphatec Manufacturing, Ace Medical, et., al).
Contraindications and Cautions
In the presence of ongoing sepsis and situations in which malignant primary or metastatic tumors or severe osteoporosis preclude bone support for the device. A comprehensive list of the indications, contraindications, adverse effects, warnings and precautions for this device may be found in the package insert. Be advised that only the package insert is to be considered definitive or accurate.
Instrumentation
We offer a complete line of instrumentation designed specifically to facilitate the placement and removal of our device(s). The current list includes:
- Cannulated Hexdriver Shaft 1.
- Cannulated Countersink Shaft 2.
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- Easy-Out Shaft
- Power Pin Guide 4.
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- Depth Gauge
- 135° Drill Guide e.
- Conical Handle(s) 7.
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- T-Handle(s)
- ். Washer
- Guide Pin(s) 10.
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- Sterilization Case(s)
Packaging:
The screws will be individually labeled and packaged in a container similar to the predicate devices noted. A polymer tube encapsulated with polymer caps at each end. The label will be affixed to the tube portion. Commercial grade shrink-wrap will encompass the entire package. This will reduce the possibility of the contamination and the label becoming unfixed.
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Sterilization / Re-sterilization:
Sterilization must be accomplished by the end user of the device prior to use. High temperature steam sterilization with a cycle such as recommended by AORN or ACS is appropriate. This cycle should be performed with live steam at a temperature of at least 270° F. for a minimum of 15 minutes duration. Such a cycle has been validated by the manufacturer using the overkill method. Strict adherence to this sterility recommendation provides assurance of a reproducible 106 level kill.
Other sterility cvcle temperatures and times or methods such as ETO gas may also be appropriate. The materials of the device will withstand virtually any steam or ETO gas cycle. However, individual hospitals and or physicians should validate any deviation from the manufacturer recommended sterility method and cycle times.
Testing / Analysis:
Device and system testing consisted of computer generated analysis that determined the bending strength and stiffness through a three point bend per ASTM E-8555. The results of all testing revealed that the Northwest Precision Technologies Ø6.5 mm Cannulated Cancellous Screws are suitable for the indications noted and the anticipated conditions of use imposed on the device. Comparison test values for the Northwest Precision Technologies Ø6.5 mm Cannulated Cancellous Screws and the Ace Medical and Alphatec Manufacturing Ø6.5 mm Cannulated Cancellous Screws were equivalent at all times.
Test reports demonstrated that the Northwest Precision Technologies Ø6.5 mm Cannulated Cancellous Screws have been adequately designed to perform in a manner equivalent to that of the comparison device(s). Based on the testing, the Northwest Precision Technologies Ø6.5 mm Cannulated Cancellous Screws are equal in performance to the Ace Medical and Alphatec Manufacturing Ø6.5 mm Cannulated Cancellous Screws
Equivalence:
For comparison purposes, no geometrically equivalent device exists. Therefore, the Ace Medical and Alphatec Manufacturing Ø6.5 mm Cannulated Cancellous Screws, a device of alike material , design, and manufacturing method were selected for comparison.
The results of the three point bend test show that the Northwest Precision Technologies devices posses equivalent strength to the comparative devices.
Northwest Precision Technologies Ø6.5 mm Screws will be used on indications that have common usage with the Ace Ø6.5 mm Screws and the Alphatec Ø6.5 mm Screws. Maintaining the same indications for use provides two specific benefits. First the Northwest Precision Technologies is not promoting the safe use of the implant in any new or unfamiliar methods, so, the expected physiological loads and performance are well known. Clinical performance of similar screws used in these well known conditions is extensively reported in medical literature. Second, important device design characteristics have been refined over literally tens of thousands of uses with equivalent predicate devices. The clinical utility of a Ø6.5 mm Screw for treatment of such conditions is basic to orthopaedic surgery. Assuming appropriate materials and manufacturing conditions, the clinical performance of a new Ø6.5 mm Screw should be fairly predictable.
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Therefore, based on the test results and indication demands, Northwest Precision Technologies believes that this device possesses sufficient strength and that parallel equivalency has been fully achieved.
Conclusion:
Our similar configuration to the predicated devices, validated by the testing results, and standardized manufacturing methods controlled by Good Manufacturing Practice regulations help to assure that the Northwest Precision Technologies Ø6.5 mm Cannulated Cancellous Screw is safe, effective, and substantially equivalent to the referenced comparison device(s).
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