Renovo Life Hard Carbon Coated Drill Bit

K151661 · Renovo Life, LLC · HTW · Jan 15, 2016 · Orthopedic

Device Facts

• Record ID: K151661
• Device Name: Renovo Life Hard Carbon Coated Drill Bit
• Applicant: Renovo Life, LLC
• Product Code: HTW · Orthopedic
• Decision Date: Jan 15, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.4540
• Device Class: Class 1

Intended Use

The Renovo Life Hard Carbon Coated Drill Bit is used to cut bone prior to insertion of bone screws or guide pins.

Device Story

Manual surgical drill bit; used to create holes in bone for screw or pin fixation. Device consists of surgical grade stainless steel (ASTM F899) with hard carbon coating on cutting portion. Available in solid or cannulated configurations; diameters 1.1-8.0 mm; lengths 60-300 mm. Operated by surgeons in clinical settings (OR, clinic). Coating intended to reduce bone heating and improve fatigue resistance. Device provided non-sterile; intended for single use.

Clinical Evidence

No clinical testing was performed. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993), steam sterilization validation (ANSI/AAMI/ISO 17665-1), accelerated aging (ASTM F1980-07), and mechanical integrity/wear surface analysis (ASTM F1877).

Technological Characteristics

Surgical grade stainless steel (ASTM F899) with hard carbon coating. Manual surgical instrument; standard connection; solid or cannulated form factor. Sterilization via steam (ANSI/AAMI/ISO 17665-1).

Indications for Use

Indicated for cutting bone prior to insertion of bone screws or guide pins in orthopedic, dental, oral, maxillofacial, plastic, ENT, and neurological surgical procedures.

Regulatory Classification

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.

Predicate Devices

• Mahe Surgical Drill Bits (Class I)

Reference Devices

• Nobel Biocare Amorphous Diamond Coated Drill (K990846)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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<br>1104 Spruce Street<br>Belmont, NC 28012 |
|----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | January 14, 2016 |
| Submitted by: | Renovo Life LLC |
| Company Contact | Harold Crowder<br>[phone]<br>[e-mail] |
| Official Correspondent | Orgenix LLC<br>Mr. Donald W. Guthner<br>111 Hill Road<br>Douglassville, PA 19518<br>[phone]<br>[phone] (FAX)<br>[e-mail] |
| Proprietary Name: | Renovo Life Hard Carbon Coated Drill Bit |
| Performance standards: | The Renovo Life Hard Carbon Coated Drill Bits are made of<br>surgical grade stainless steel conforming to ASTM F899. |
| Regulation:<br>Common/Usual Name:<br>Classification name:<br>Review Panel:<br>Primary Product Code:<br>Device Class: | 21 CFR 888.4540<br>Drill Bit<br>Orthopedic manual surgical instrument<br>Orthopedic<br>HTW<br>Class I |
| Substantial Equivalence: | Substantial equivalence for the Renovo Life Hard Carbon Coated<br>Drill Bits is based on its similarities in indications for use, design<br>features, operational principles and material composition when compared<br>to the predicate devices. |
| Primary Predicate Device<br>Reference Device: | Mahe Surgical Drill Bits (Class I)<br>K990846 Nobel Biocare Amorphous Diamond Coated Drill (Class II)<br>The subject device is substantially equivalent to similar previously<br>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.<br>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.<br>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<br>(EN ISO 17665-1:2006) |
| Steam Sterilization - Part II | ANSI/AAMI/ISO 17665-1:2006<br>(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<br>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<br>Carbon Coated Drill<br>Bits | Mahe Surgical Drill<br>Bits | Amorphous Diamond<br>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<br>Hard Carbon Coating | Stainless Steel | Stainless Steel<br>Amorphous Diamond |
| Indications for Use | The Renovo Life Hard<br>Carbon Coated Drill<br>Bit is used to cut bone<br>prior to insertion of<br>bone screws or guide<br>pins | Drill Bits are used to<br>cut bone prior to<br>insertion of bone<br>screws or guide pins | The drill is used to<br>cut into the maxima or<br>mandible to create an<br>osteotomy for endosseous<br>dental implant placement. |
| Design | Standard square head | Standard square head | Latch end to use with hand<br>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<br>inserts |

Substantial equivalence for the Renovo Life Hard Carbon Coated Drill Bits is based on its similarities in indications for use, design features, operational

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principles and material composition when compared to the primary and reference predicate devices:

- 1. 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:

- 2. 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.

Thus, the Renovo Life Hard Carbon Coated Drill Bits are substantially equivalent to the predicate devices.