(61 days)
Not Found
Not Found
No
The description focuses on the mechanical design and materials of a drill bit, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a tool used in surgical procedures and is not intended to provide therapy or treatment for a disease or condition.
No
Explanation: The device description states its use is for drilling bone in preparation for bone screw placement, indicating a therapeutic or surgical function rather than a diagnostic one.
No
The device description clearly describes a physical drill bit made of stainless steel, which is a hardware component. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to predrill bone in preparation for bone screw placement" in general orthopedic procedures. This is a surgical tool used directly on the patient's body.
- Device Description: The description details a physical drill bit designed for cutting bone.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This drill bit is a surgical instrument used for a mechanical purpose during a procedure.
N/A
Intended Use / Indications for Use
The Sterile Modular Drill Bit is indicated for use in general orthopedic procedures to predrill bone in preparation for bone screw placement
Product codes
HTW
Device Description
The Exactech Sterile Drill Bit is intended for use in orthopedic procedures for drilling bone. The drill bit is designed with a 120° point angle for smooth, effective, bone cutting. The 30° helix angle maintains strength, but provides an efficient channel by which cut bone may escape. The outer diameter (OD) tolerance and associated drill bit guide geometry minimize drill bit damage.
The five (5) modular bits are designed in long and short versions. They have a high tolerance press fit cross pin that provides easy assembly and disassembly with positive bayonet style locking capability in both the flexible and fixed angle drill bit drivers.
All bits are constructed of 455 stainless steel for strength, hardness and resistance to wear.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DePuy Drill Bit
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
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SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION FOR THE PREMARKET NOTIFICATION FOR THE Exactech Sterile Modular Drill Bit
960720
Exactech®. Inc. Establishment Registration Number 1038671
APR 2 3 1956
4613 NW 6th Street Gainesville, FL 32609 352/377-1140 Tel: Fax: 352/378-2617
Martha C. Miller Contact Person: Director Regulatory Affairs
Exactech Sterile Modular Drill Bit
The Exactech Sterile Modular Drill Bit is made of similar materials and is of a similar design to devices that were on the market before May 28, 1976. Additionally, the Sterile Drill Bit is of a similar design to other devices on the market that have been determined to be equivalent to devices on the market prior to May 28, 1976. These predicates include, but are not limited to:
- DePuy Drill Bit .
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Similarities/Dissimilarities:
The DePuy drill system is similar to the Exactech system in that the cross pin in the bit and the bayonet locking mechanism operate in a like fashion. The flex shafts are both multiple wrapped springs. They differ in the diameters and lengths of the bits that are offered in the system. The DePuv flex shaft is slightly longer and the Exactech flex shaft is slightly stiffer. The DePuy shaft has a Hudson locking end and the Exactech flex shaft has a Trinkle locking end. The 45° fixed angle drivers are similar in all fashions.
Exactech, Inc. has supplied advertisements, brochures and/or catalog information from these companies to the FDA as evidence of equivalency. This literature is in the public domain. In addition, Exactech has provided the FDA design drawings, material specifications and photos of the Sterile Modular Drill Bit.
1
1. Classification
This device is appropriately placed in FDA classification:
Bit, Drill. Number 87HTW, Class I device, under 21 CFR 888.4540. Drill:
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- Common Name: Drill Bit
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- Exactech Sterile Modular Drill Bit Trade Name:
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- Device Description
The Exactech Sterile Drill Bit is intended for use in orthopedic procedures for drilling bone. The drill bit is designed with a 120° point angle for smooth, effective, bone cutting. The 30° helix angle maintains strength, but provides an efficient channel by which cut bone may escape. The outer diameter (OD) tolerance and associated drill bit guide geometry minimize drill bit damage.
The five (5) modular bits are designed in long and short versions. They have a high tolerance press fit cross pin that provides easy assembly and disassembly with positive bayonet style locking capability in both the flexible and fixed angle drill bit drivers.
All bits are constructed of 455 stainless steel for strength, hardness and resistance to wear.
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- Material Specifications
The Sterile Drill Bits are constructed of Custom 455® stainless steel.
- Material Specifications
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- Mechanical Properties
Typical mechanical properties can be found in the Carpenter Technology manual: Custom 455® Stainless section
- Mechanical Properties
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- Sterilization
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- Sterilization
Station Article
The Exactech Sterile Drill Bits will be supplied sterile. They will be sterilized in their final, sealed packages by gamma irradiation at a contract sterilization facility. The sterilization protocol will be based on the Guidelines for Radiation Sterilization of Medical Devices, issued by the Association for Advancement of Medical Instrumentation Process Control.
2
Indications:
The Sterile Modular Drill Bit is indicated for use in general orthopedic procedures to predrill bone in preparation for bone screw placement
Manufacturing/Packaging/Sterilization Sites:
Manufacturing/Packaging:
| Exactech® Inc. | |
|---|---|
| 4613 NW 6th Street | |
| Gainesville, FL 32609 | |
| Phone: | 352/ 377-1140 |
| Fax: | 352/ 378-2617 |
| FDA Establishment No: | 1038671 |
Contract Sterilization Sites:Sterigenics International 305 Enterprise Drive Westerville, Ohio 43081-8827 Phone: (614) 888-4077 (614) 888-4223 Fax:
Sterigenics International 18011 Withers Cove Park Drive Charlotte, North Carolina 28273 (704) 588-6877 Phone: (704) 588-8355 Fax:
1526534
FDA Establishment No:
FDA Establishment No: 1058584
Applicant or Sponsor:
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Exactech®, Inc. 4613 NW 6th Street Gainesville, FL 32609 FDA Establishment No: 1038671
Contact Person:
Martha C. Miller Director, Regulatory Affairs 352/ 377-1140 Telephone: 352/378-2617 Fax:
Fax: 602.678.2511
Signature
2/20/96
Date