(210 days)
The Renovo Life Hard Carbon Coated Drill Bit is used to cut bone prior to insertion of bone screws or guide pins.
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.
The Renovo Life Hard Carbon Coated Drill Bit is a medical device used to cut bone prior to the insertion of bone screws or guide pins. The device's acceptance criteria are demonstrated through a series of non-clinical tests, as no clinical testing was performed.
Here's an breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Test Standards/Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993 (various parts) | The device's materials (surgical grade stainless steel with a hard carbon coating) are considered biocompatible. The submission indicates these tests were conducted, and based on the substantial equivalence claim, it can be inferred the device met these criteria. The specific results are not detailed in the provided text. |
| Cytotoxicity | ISO 10993 | Performed |
| Maximization Sensitization | ISO 10993 | Performed |
| Intracutaneous Study | ISO 10993 | Performed |
| Systemic Toxicity | ISO 10993 | Performed |
| Sterilization | ANSI/AAMI/ISO 17665-1:2006 (EN ISO 17665-1:2006) (Parts I & II) | Performed. The device is provided non-sterile, but validation of sterilization methods for reprocessing is crucial. |
| Accelerated Aging | ASTM F1980-07 (for 1 year) | Performed. Supports the longevity claims for the device. |
| Mechanical Integrity of Coating | No Standards for this test (implied internal specifications/comparison to predicate) | Performed to show the "coating provided an adequate interface for drilling bone and demonstrated reduced heating and improved resistance to fatigue (longevity)." Specific quantitative results are not detailed. |
| Wear Surface Analysis of Drill Bits | ASTM F1877 - guideline for methods and comparison (implied comparison to predicate) | Performed, specific results not detailed, but contributes to the claim of "reduced heating and improved resistance to fatigue (longevity)." |
| Material Composition | Surgical grade stainless steel conforming to ASTM F899 | Device is made of surgical grade stainless steel. (This is a compliance statement, not a performance test result per se, but fundamental to acceptance). |
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not explicitly state the sample sizes used for each of the non-clinical tests (biocompatibility, sterilization, accelerated aging, mechanical integrity, wear surface analysis). It only mentions "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."
- Data Provenance: The tests were conducted internally/contracted by Renovo Life LLC or BioMedFlex LLC. The country of origin of the data is not specified, but the companies are U.S.-based (Renovo Life LLC in Belmont, NC; Orgenix LLC in Douglassville, PA). The data is prospective in the sense that the tests were specifically designed and executed to evaluate this device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts:
- This information is not applicable as the provided text describes non-clinical performance testing of a physical medical device, not a diagnostic algorithm or imaging system requiring expert interpretation. The "ground truth" for these tests would be objective scientific measurements and compliance with established standards.
4. Adjudication Method for the Test Set:
- This information is not applicable for the same reasons as point 3. Testing involves objective measurements against predefined standards, not expert adjudication of subjective assessments.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This information is not applicable. The device is an orthopedic manual surgical instrument (a drill bit), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. The device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used:
- For biocompatibility: Standardized biological responses as defined by ISO 10993.
- For sterilization: Validation against sterilization cycle parameters and microbial kill as defined by ANSI/AAMI/ISO 17665-1.
- For accelerated aging: Physical and mechanical properties maintained within specified limits after exposure to accelerated aging conditions defined by ASTM F1980-07.
- For mechanical integrity and wear surface analysis: Mechanical performance metrics (e.g., drilling efficiency, force, heat generation, fatigue resistance) and surface characteristics compared against internal specifications or predicate device performance.
- For material composition: Material specifications (e.g., ASTM F899 for stainless steel).
8. The sample size for the training set:
- This information is not applicable, as this device is a physical instrument, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- This information is not applicable for the same reason as point 8.
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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 LLC1104 Spruce StreetBelmont, NC 28012 |
|---|---|
| Date: | January 14, 2016 |
| Submitted by: | Renovo Life LLC |
| Company Contact | Harold Crowder+1(704) 224-4136hcrowder@renovolife.com |
| Official Correspondent | Orgenix LLCMr. Donald W. Guthner111 Hill RoadDouglassville, 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 ofsurgical grade stainless steel conforming to ASTM F899. |
| Regulation:Common/Usual Name:Classification name:Review Panel:Primary Product Code:Device Class: | 21 CFR 888.4540Drill BitOrthopedic manual surgical instrumentOrthopedicHTWClass I |
| Substantial Equivalence: | Substantial equivalence for the Renovo Life Hard Carbon CoatedDrill Bits is based on its similarities in indications for use, designfeatures, operational principles and material composition when comparedto the predicate devices. |
| Primary Predicate DeviceReference Device: | Mahe Surgical Drill Bits (Class I)K990846 Nobel Biocare Amorphous Diamond Coated Drill (Class II)The subject device is substantially equivalent to similar previouslycleared 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 formethods 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 HardCarbon Coated DrillBits | Mahe Surgical DrillBits | Amorphous DiamondCoated 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 SteelHard Carbon Coating | Stainless Steel | Stainless SteelAmorphous Diamond |
| Indications for Use | The Renovo Life HardCarbon Coated DrillBit is used to cut boneprior to insertion ofbone screws or guidepins | Drill Bits are used tocut bone prior toinsertion of bonescrews or guide pins | The drill is used tocut into the maxima ormandible to create anosteotomy for endosseousdental implant placement. |
| Design | Standard square head | Standard square head | Latch end to use with handpiece |
| 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 foaminserts |
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:
-
- 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.
§ 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.