(210 days)
Mahe Surgical Drill Bits (Class I)
No
The summary describes a mechanical surgical drill bit and does not mention any software, algorithms, or AI/ML capabilities.
No
This device is a surgical tool used to cut bone for the insertion of bone screws or guide pins, not to treat a condition or disease.
No
This device is a surgical drill bit used to cut bone, which is an interventional/therapeutic action, not a diagnostic one.
No
The device is a physical drill bit made of surgical grade stainless steel with a hard carbon coating, clearly indicating it is a hardware device.
Based on the provided information, the Renovo Life Hard Carbon Coated Drill Bit is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "cut bone prior to insertion of bone screws or guide pins." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a surgical tool (a drill bit) used for mechanical action on bone.
- Anatomical Site: The device is used on "bone and other bone-related tissue," which are parts of the human body.
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This device does not perform such an examination.
The device is clearly a surgical instrument used in vivo (within the living body) during a surgical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Renovo Life Hard Carbon Coated Drill Bit is used to cut bone prior to insertion of bone screws or guide pins.
Product codes (comma separated list FDA assigned to the subject device)
HTW
Device Description
Renovo Life Hard Carbon Coated Drill Bits are available in diameters ranging from 1.1 mm to 8.0 mm, lengths ranging from 60 mm to 300 mm, and either solid or cannulated. The drill bits are designed with a standard connections. Renovo Life Hard Carbon Coated Drill Bits are made of surgical grade stainless steel. The bone-cutting portion of the drill is coated with a hard carbon coating. Renovo Life Hard Carbon Coated Drill Bits are provided non-sterile and are intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone and other bone-related tissue
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)
Mechanical testing was performed on uncoated, coated, and aged coated Renovo Life drill bits to show Non-Clinical substantial equivalence to the predicate device. The tests aimed to determine if the coating provided an adequate interface for drilling bone and demonstrated reduced heating and improved resistance to fatigue (longevity). Biocompatibility testing was conducted according to ISO 10993 standards (Cytotoxicity, Maximization Sensitization, Intracutaneous Study, Systemic Toxicity). Steam Sterilization (ANSI/AAMI/ISO 17665-1:2006) and Accelerated Aging (ASTM F1980-07) tests were also performed. Mechanical Integrity of Coating and Wear surface Analysis of Drill Bits (ASTM F1877 - guideline for methods and comparison) were also conducted. No clinical testing was performed.
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.
Mahe Surgical Drill Bits (Class I)
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.
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
§ 888.4540 Orthopedic manual surgical instrument.
(a)
Identification. An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.(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 the limitations in § 888.9.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 15, 2016
Renovo Life LLC % Mr. Donald Gunther Regulatory Consultant Orgenix LLC 111 Hill Road Douglassville, Pennsylvania 19518
Re: K151661
Trade/Device Name: Renovo Life Hard Carbon Coated Drill Bit Regulation Number: 21 CFR 888.4540 Regulation Name: Orthopedic Manual Surgical Instrument Regulatory Class: I Product Codes: HTW Dated: December 5, 2015 Received: December 8, 2015
Dear Mr. Gunther:
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.
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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 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 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/Resourcesfor You/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 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
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Indications for Use
510(k) Number (if known) K151661
Device Name
Renovo Life Hard Carbon Coated Drill Bit
Indications for Use (Describe)
The Renovo Life Hard Carbon Coated Drill Bit is used to cut bone prior to insertion of bone screws or guide pins.
Type of Use (Select one or both, as applicable)
| × Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
| Manufacturer: | Renovo Life LLC
1104 Spruce Street
Belmont, NC 28012 |
|----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | January 14, 2016 |
| Submitted by: | Renovo Life LLC |
| Company Contact | Harold Crowder
+1(704) 224-4136
hcrowder@renovolife.com |
| Official Correspondent | Orgenix LLC
Mr. Donald W. Guthner
111 Hill Road
Douglassville, PA 19518
+1-646-460-2984
+1-484-363-5879 (FAX)
dg@orgenix.com |
| Proprietary Name: | Renovo Life Hard Carbon Coated Drill Bit |
| Performance standards: | The Renovo Life Hard Carbon Coated Drill Bits are made of
surgical grade stainless steel conforming to ASTM F899. |
| Regulation:
Common/Usual Name:
Classification name:
Review Panel:
Primary Product Code:
Device Class: | 21 CFR 888.4540
Drill Bit
Orthopedic manual surgical instrument
Orthopedic
HTW
Class I |
| Substantial Equivalence: | Substantial equivalence for the Renovo Life Hard Carbon Coated
Drill Bits is based on its similarities in indications for use, design
features, operational principles and material composition when compared
to the predicate devices. |
| Primary Predicate Device
Reference Device: | Mahe Surgical Drill Bits (Class I)
K990846 Nobel Biocare Amorphous Diamond Coated Drill (Class II)
The subject device is substantially equivalent to similar previously
cleared devices. |
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| Device Description: | Renovo Life Hard Carbon Coated Drill Bits are available in diameters ranging from 1.1 mm to 8.0 mm, lengths ranging from 60 mm to 300 mm, and either solid or cannulated. The drill bits are designed with a standard connections.
Renovo Life Hard Carbon Coated Drill Bits are made of surgical grade stainless steel. The bone-cutting portion of the drill is coated with a hard carbon coating.
Renovo Life Hard Carbon Coated Drill Bits are provided non-sterile and are intended for single use only. |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use:: | The Renovo Life Hard Carbon Coated Drill Bit is used to cut bone prior to insertion of bone screws or guide pins. |
| Common use of drill bits: | |
Drill bits are intended for use in the drilling of bone and other bonerelated tissue in a variety of surgical procedures. Procedures for use on bone are often used in orthopedic, dental, oral surgery, maxillofacial, plastics, ENT, and neurological surgeries. Drill bits are also used in the placement of screws, wires, pins, and other fixation devices.
The Renovo Life Hard Carbon Coated Drill Bits are designed to drill holes in bones
The Renovo Life Hard Carbon Coated Drill Bits have undergone mechanical testing to show Non-Clinical substantial equivalence to the predicate device.
Testing A comprehensive series of tests were conducted on the Renovo Life drill bits coated with a hard carbon coating (manufactured by BioMedFlex LLC.). Testing was performed on uncoated, coated, and aged coated Renovo Life drill bits. The test results were analyzed and are summarized in the body of this report to determine if the coating provided an adequate interface for drilling bone and demonstrated reduced heating and improved resistance to fatigue (longevity). Table 1 outlines the series of tests conducted on the coated drill bit to assess biocompatibility and mechanical integrity of the coating.
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| TEST METHOD | TEST STANDARDS |
|---|---|
| Biocompatibility ISO 10993 | |
| Cytotoxicity | ISO 10993 |
| Maximization Sensitization | ISO 10993 |
| Intracutaneous Study | ISO 10993 |
| Systemic Toxicity | ISO 10993 |
| Steam Sterilization - Part I | ANSI/AAMI/ISO 17665-1:2006 |
| (EN ISO 17665-1:2006) | |
| Steam Sterilization - Part II | ANSI/AAMI/ISO 17665-1:2006 |
| (EN ISO 17665-1:2006) | |
| Accelerated Aging - 1 year | ASTM F1980-07 |
| Mechanical Integrity of Coating - | No Standards for this test |
| Wear surface Analysis of Drill Bits | ASTM F1877 - guideline for |
| methods and comparison |
TABLE 1: - SUMMARY OF TESTS AND ANALYSES CONDUCTED
No clinical testing was performed.
Clinical Testing Comparison Table
| Information | Subject Device | Primary Predicate | Reference Device |
|---|---|---|---|
| Manufacturer | Renovo Life LLC | Mahe Medical | Nobel Biocare |
| Trade Name | Renovo Life Hard | ||
| Carbon Coated Drill | |||
| Bits | Mahe Surgical Drill | ||
| Bits | Amorphous Diamond | ||
| Coated Drill Bits | |||
| 510(k) Number | K151661 | N/A (Class I) | K990846 |
| Product Code | HTW | HTW | DZI |
| Classification | 888.4540 | 888.4540 | 872.4120 |
| Materials | Stainless Steel | ||
| Hard Carbon Coating | Stainless Steel | Stainless Steel | |
| Amorphous Diamond | |||
| Indications for Use | The Renovo Life Hard | ||
| Carbon Coated Drill | |||
| Bit is used to cut bone | |||
| prior to insertion of | |||
| bone screws or guide | |||
| pins | Drill Bits are used to | ||
| cut bone prior to | |||
| insertion of bone | |||
| screws or guide pins | The drill is used to | ||
| cut into the maxima or | |||
| mandible to create an | |||
| osteotomy for endosseous | |||
| dental implant placement. | |||
| Design | Standard square head | Standard square head | Latch end to use with hand |
| piece | |||
| Diameters | 1.1 to 8.0 mm | 1.1 to 8.0 mm | 2.0 mm |
| Lengths | 60 to 300 mm | 60 to 300 mm | 18 mm |
| Styles | Solid, Cannulated | Solid, Cannulated | |
| Cutting Flutes | Two | Two | Three |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| Packaging | Plastic bag | Plastic Bag | Plastic vial with foam |
| inserts |
Substantial equivalence for the Renovo Life Hard Carbon Coated Drill Bits is based on its similarities in indications for use, design features, operational
6
principles and material composition when compared to the primary and reference predicate devices:
-
- Mahe Surgical Drill Bits (Class I)
Substantial equivalence for the Renovo Life Hard Carbon Coated Drill Bits is based on its similarities in material composition when compared to the reference device:
- Mahe Surgical Drill Bits (Class I)
-
- Nobel Biocare Amorphous Diamond Coated Drill (K990846)
A search of the MDR and MAUDE databases showed no reported incidences with these materials for this indication, indicating a certain level of performance of the product.
- Nobel Biocare Amorphous Diamond Coated Drill (K990846)
Thus, the Renovo Life Hard Carbon Coated Drill Bits are substantially equivalent to the predicate devices.