OsteoMed PINNACLE Driver

K162542 · Osteomed · HBE · May 19, 2017 · Neurology

Device Facts

• Record ID: K162542
• Device Name: OsteoMed PINNACLE Driver
• Applicant: Osteomed
• Product Code: HBE · Neurology
• Decision Date: May 19, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PINNACLE Driver is intended for driving screws and for drilling into bone, in conjunction with cranial surgical procedures.

Device Story

Handheld, cordless, battery-operated driver for high-speed screw insertion and pilot hole drilling in cranial surgery. Device uses sterile, single-use lithium battery; operates in forward and reverse directions. Clinician-operated in hospital/healthcare facility. Features torque-limiting software to prevent screw stripping and over-torquing. Output is mechanical rotation of drill bits or driver stems. Benefits include controlled, efficient bone drilling and screw placement. Device is prescription-only.

Clinical Evidence

No clinical studies were conducted. Substantial equivalence is supported by bench testing, including design verification (99-cycle simulated use), screw characterization, sterilization validation (SAL 10^-6), reprocessing validation, packaging/shipping validation (ASTM D4169), battery safety (IEC 60086-4), biocompatibility (FDA G95-1), and electrical/EMC safety (IEC 60601-1, ES60601-1).

Technological Characteristics

Handheld, battery-operated driver. Materials: medical grade stainless steel, aluminum, silicone, PEEK, gold-plated brass, medical plastic. Sterilization: pre-vacuum steam. Connectivity: none. Software: torque-limiting algorithm. Power: single-use lithium battery. Dimensions/form factor: handheld driver with pull-back collet.

Indications for Use

Indicated for drilling into bone and driving screws during cranial surgical procedures in a healthcare facility/hospital setting by a clinician.

Regulatory Classification

Identification

Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.

Predicate Devices

• OsteoMed “B” Power System (K933101)

Reference Devices

• OsteoMed OsteoPower System (K971692)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 19, 2017

OsteoMed Kathryn Jayne Senior Specialist, Regulatory Affairs 3885 Arapaho Road Addison, TX 75001

Re: K162542

Trade/Device Name: OsteoMed Pinnacle Driver Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, and their Accessories Regulatory Class: Class II Product Code: HBE Dated: February 14, 2017 Received: April 18, 2017

Dear Kathryn Jayne:

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.

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 of medical devicerelated 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.

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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Michael J. Hoffmann -S

for

Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K162542

Device Name PINNACLE Driver

Indications for Use (Describe)

The PINNACLE Driver is intended for drilling into bone, in conjunction with cranial surgical procedures.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OSTEOMED" in large, bold letters. The word is in blue, and the letters are slightly slanted to the right. There is a blue swoosh above the word and a gray swoosh below the word.

# 510(k) SUMMARY

#### I. SUBMITTER

OsteoMed 3885 Arapaho Rd. Addison, TX 75001 USA

Phone: [phone] Fax: [phone] Email: [e-mail]

Contact Person: Kathryn A. Jayne Date Prepared: May 12, 2017

#### II. DEVICE

Name of the Device: PINNACLE Driver Common or Usual Name: Battery-operated drill/driver Classification Name: Drill, Bone, Powered Regulation: 882.4310 Regulatory Class: II Product Code: HBE Classification Panel: Neurology

#### III. PREDICATE DEVICE

The OsteoMed "B" Power System, K933101, is the primary predicate. The OsteoMed OsteoPower System, K971692, is the reference predicate.

#### IV. DEVICE DESCRIPTION

The PINNACLE Driver is a handheld, cordless, software driven, battery operated driver for high speed insertion of screws and drilling of pilot holes. The device operates in both the forward and reverse directions. A sterile, single use battery powers the device and is intended for use solely with the PINNACLE Driver. Accessories for the PINNACLE Driver include hex shank drill bits and driver stems. The optional driver stems are reusable while the drill bits are single use. The PINNACLE Driver may be sterilized in a sterilization tray and/or rigid sterilization container, both of which are available from OsteoMed.

The PINNACLE Driver is intended for use in a healthcare facility/hospital for use by a clinician. The PINNACLE is a prescription device.

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Image /page/4/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OsteoMed" in large, bold letters. The word is in blue, and there is a gray oval around the word. The logo is simple and modern.

The PINNACLE Driver and lithium battery is made of medical grade stainless steel, aluminum, silicone, PEEK, gold plated brass, and medical plastic. The driver stems and drill bits are made of medical grade stainless steel. The sterilization trays and rigid sterilization containers are made of aluminum.

The PINNACLE Driver is a battery operated driver/drill that operates in both the forward and reverse directions. The PINNACLE Driver contains torque limiting software to prevent over-torquing and stripping of screws in drive mode.

#### INDICATIONS FOR USE V.

The PINNACLE Driver is intended for driving screws and for drilling into bone, in conjunction with cranial surgical procedures.

#### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

At a high level, the subject and predicate devices are based on the following same technological elements as demonstrated below.

| | Subject Device—<br>OsteoMed PINNACLE<br>Driver & Accessories | Primary Predicate—<br>OsteoMed “B” Power<br>System & Accessories | Reference Predicate—<br>OsteoMed OsteoPower<br>System & Accessories |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | Pending | K933101 | K971692 |
| Regulation No. | 882.4310 | 872.4120 | 872.4120 |
| Product Code | HBE | KIJ | KMW |
| Device Class | II | Unclassified | II |
| Regulatory Panel | Neurology | Dental | Dental |
| Indications for<br>Use | The PINNACLE Driver is<br>intended for driving<br>screws and for drilling<br>into bone, in conjunction<br>with cranial surgical<br>procedures. | The OsteoMed “B” Power<br>Handpiece System is<br>intended for drilling and<br>cutting bone and teeth and<br>for driving pins, screws,<br>and/or wires into bone for<br>dental, craniofacial,<br>orthognathic, mandibular,<br>hand, foot, wrist, or<br>extremity reconstruction<br>surgical procedures. | The OsteoPower System<br>and Accessories are<br>indicated for drilling or<br>cutting bone or teeth, and<br>for driving screws and/or<br>pins and wires into bone,<br>in conjunction with<br>dental, craniofacial,<br>craniotomies,<br>orthognathic, spinal,<br>mandibular, hand, foot,<br>wrist, and extremity<br>reconstruction surgical<br>procedures. |
| Power Source | Battery operated<br>(Lithium, single patient<br>use) | Battery operated<br>(rechargeable NiCad<br>battery) | AC/DC External power<br>supply |
| Material | --Handpiece and<br>battery—Aluminum,<br>PEEK, brass, medical<br>grade stainless steel,<br>silicone | --Handpiece and<br>battery—stainless steel,<br>aluminum, brass, silver,<br>medical grade plastics,<br>fiber reinforced ceramics | --Handpiece only—<br>stainless steel or carbide<br>--Cutting portion of the<br>drills or burrs—stainless<br>steel, carbide, diamond, or<br>fiber reinforced ceramic |
| | Subject Device—<br>OsteoMed PINNACLE<br>Driver & Accessories | Primary Predicate—<br>OsteoMed “B” Power<br>System & Accessories | Reference Predicate—<br>OsteoMed OsteoPower<br>System & Accessories |
| | --accessories—medical<br>grade stainless steel,<br>aluminum | --accessories—medical<br>grade stainless steel or<br>carbide | --Accessories—stainless<br>steel, aluminum, or<br>medical grade plastics |
| Speed | 2,000 RPM forward<br>275 RPM reverse | 120-1800 RPM | 608-70,000 RPM |
| Battery | Disposable, lithium,<br>single use, sterile battery<br>(gamma) | Rechargeable Nickel<br>Cadmium battery | NA |
| Modes | Drill<br>Drive | Drill<br>Drive | Speed ranges SAFETY,<br>100%, 75%, 50%, 25%,<br>and Di (12.5%) of<br>maximum speed |
| Activation<br>Buttons | 1 Forward button<br>1 Reverse button | 1 Forward button<br>1 Reverse button | 1 Forward button<br>1 Reverse button |
| Insertion<br>Material | Bone | Bone | Bone |
| Screw<br>sizes/insertion | 1.2mm, 1.6mm, 2.0mm | 1.6mm, 2.0mm | 1.2mm, 1.6mm, 2.0mm |
| Collet | Pull-back collet | Pull-back collet | Twist collet |
| Accessories | Hex Shank drill bits, Hex<br>Shank driver stems,<br>sterilization trays, rigid<br>sterilization container | Round burrs, oval burrs,<br>twist drills, wire pass<br>twist drills, side cutting<br>burs, and end-cutting<br>drills, saw blades, K-<br>wires and pins, screw<br>drivers, burr racks, blade<br>containers, sterilization<br>trays, battery charger | Round burrs, oval burrs,<br>twist drills, wire pass<br>twist drills, side cutting<br>burrs, end-cutting drills,<br>saws, motor units,<br>modules, footswitches,<br>screw drivers |
| Sterilization of<br>re-usable devices | Pre-vacuum steam<br>(wrapped)—Hand piece<br>only<br>--Min. Temp: 132° C<br>(270°F)<br>--Full Cycle Time: 4<br>minutes<br>--Min Dry Time: 30<br>minutes<br><br>Pre-vacuum steam (rigid<br>container)—<br>1-Driver Case & 2-Driver<br>Case<br>--Min. Temp: 132° C<br>(270°F)<br>--Full Cycle Time: 4<br>minutes<br>--Min Dry Time: 30<br>minutes | Pre-vacuum Hi Vac<br>(wrapped or unwrapped)<br>Temp: 270-270 °F<br>Exposure Time: 4 min<br>Dry Time: min 8 min<br><br>270 °F Gravity<br>(wrapped on tray)<br>Temp: 270-270 °F<br>Exposure Time: 35 min<br>Dry Time: min 8 min | Pre-vacuum steam<br>(wrapped)<br>Temp: 132° C (270°F)<br>Dwell Time: 10 minutes<br>Dry Time: 70 minutes |
| | Subject Device—<br>OsteoMed PINNACLE<br>Driver & Accessories | Primary Predicate—<br>OsteoMed “B” Power<br>System & Accessories | Reference Predicate—<br>OsteoMed OsteoPower<br>System & Accessories |
| Parameter<br>Control<br>Technology | Software | Non-programmable,<br>discrete digital and analog<br>logic | Non-programmable,<br>discrete digital and analog<br>logic |
| Software/safety<br>features | -Senses torque to prevent<br>over-torquing & stripping<br>of screws | NA | Motor unit control switch<br>to temporarily disable the<br>Electric Drive |

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Image /page/5/Picture/0 description: The image shows the OsteoMed logo. The logo is in blue and white, with the word "OsteoMed" in a bold, sans-serif font. The logo is surrounded by a gray and blue oval shape. The logo is simple and modern, and it is likely used to represent a medical company.

### OsteoMed PINNACLE Driver Submission K162542

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Image /page/6/Picture/0 description: The image shows the Osteomed logo. The logo is in blue and gray, with the word "Osteomed" in bold, blue letters. The logo is surrounded by a gray and blue swoosh design. The logo is simple and modern, and it is likely used to represent a medical company.

#### OsteoMed PINNACLE Driver Submission K162542

#### VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

### Biocompatibility Testing

The biocompatibility evaluation for the device was conducted in accordance with the FDA Blue Book Memorandum #G95-1.

- Cytotoxicity
- Sensitization
- Irritation ●
- Systemic toxicity
- Subchronic toxicity ●
- Genotoxicity ●
- Implantation
- Pyrogen testing ●

The device and associated accessories are considered tissue/bone/dentin contacting for a duration of less than 24 hours. However, OsteoMed conducted a biocompatibility evaluation of the exposed material of the driver as worst case. based on an implant device due to the close proximity to the patient. The sterilization trays and rigid containers are considered non-patient contacting.

### Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the device. The system complies with the IEC 60601-1 and IEC 60086-4 standards for safety and the ES60601-1 standard for EMC.

### Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices." The software for this device was considered as "minor" level of concern as documented in this submission.

### Bench Testing

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Image /page/7/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OsteoMed" in a stylized font. The logo is surrounded by a blue and gray oval shape. The logo is simple and modern, and it is likely used to represent the company's brand.

The following bench testing was conducted:

- Simulated Use/Design Verification Testing (DVT) ●
- Sterilization Validation
- . Reprocessing Validation
- . Shipping Validation
- . Battery Safety Testing
- Electrical Safety and Electromagnetic Compatibility .

## Animal Study

No animal studies were needed to demonstrate substantial equivalence to the declared predicate.

### Clinical Studies

No clinical studies were needed to demonstrate substantial equivalence to the declared predicate.

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Image /page/8/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OsteoMed" in a bold, sans-serif font. The logo is surrounded by a gray and blue oval shape. The logo is simple and modern, and it is likely used to represent the company's brand.

| Testing Summary | | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test | Test Method Summary | Results |
| Design Verification<br>Testing (DVT) | Conducted on subject devices with<br>software and powered by single use<br>batteries. The driver was switched<br>to drill mode and a drill bit was<br>used to drill a pilot hole. The mode<br>was switched back to drive mode<br>and a driver stem was used to fully<br>seat a specified screw. Still in drive<br>mode, the driver was used to<br>remove screws. | The cycle was repeated<br>99 times and the subject<br>device performed as<br>intended after the 99<br>cycles. |
| Screw<br>Characterization | Released screws of various length<br>and diameter were used with the<br>subject device. A torque analyzer<br>was used to retrieve the data after<br>the screw was seated or stripping<br>noted. Torque and seat value was<br>then calculated. | The data collected was<br>used as an input into the<br>torque limiting software. |
| Sterilization<br>Validation | Sterilization validation was<br>conducted on subject devices per<br>using overkill sterilization method<br>validating an SAL of 10-6 per<br>AAMI TIR12:2010. The validation<br>was conducted using the<br>sterilization parameters defined in<br>IFU. The validation was conducted<br>on individually wrapped drivers<br>and the driver and accessories<br>placed inside an organizational tray<br>inside a rigid container. | Having met the<br>predetermined acceptance<br>criteria, the method<br>outlined on the IFU was<br>validated as an effective<br>means of sterilizing the<br>subject device. |
| Reprocessing<br>(Cleaning)<br>Validation | Automatic Cleaning Conducted on<br>subject devices in worst case<br>configuration based on FDA<br>Guidance document "Reprocessing<br>Medical Devices in Health Care<br>Settings: Validation Methods and<br>Labeling" issued March 17, 2015.<br>Worst case cleaning processing<br>(minimum durations for the<br>cleaning steps as defined in the<br>IFU). Acceptance criteria was<br>based on AAMI TIR 30. | Automatic cleaning was<br>validated as an effective<br>means of cleaning the<br>subject device. |
| Test | Test Method Summary | Results |
| Packaging &<br>Shipping Validation | Shipping validation was conducted<br>on subject devices using ASTM<br>D4169 after environmental<br>conditioning per ASTM D4332-14. | The packaging fully<br>contained and protected<br>the device from exposure<br>to normal shipping<br>hazards and the device<br>functioned as intended<br>after shipment. |
| Battery Safety<br>Testing | Conducted on subject devices per<br>IEC 60086-4 (ed.3) and Sixth<br>Revised Edition of<br>Recommendations on the Transport<br>of Dangerous Goods, Manual of<br>Tests and Criteria. | The subject devices<br>comply with requirements<br>in the applicable<br>standards. |
| Biocompatibility | The biocompatibility evaluation for<br>the subject device was conducted<br>in accordance with the FDA Blue<br>Book Memorandum #G95-1. | The subject devices are<br>considered non-toxic and<br>biocompatible. |
| Electrical Safety<br>and EMC Testing | Conducted on subject device per<br>IEC 60601-1, IEC 60086-4, and<br>ES60601-1 | Subject device complies<br>with requirements in the<br>applicable standards. |

#### T C 45

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Image /page/9/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OSTEOMED" in bold letters. The word "OSTEO" is in blue, and the word "MED" is in gray. The logo is surrounded by a gray and blue oval shape. The logo is simple and modern.

### VIII. CONCLUSIONS

The basis of substantial equivalence for the device is based on similarities in indications for use, material, function, performance, design, technology, sterilizations, and operating principles. The non-clinical data support the substantial equivalence of the device and the verification and validation demonstrate that the device should perform as intended in the specified use conditions.

(End of Summary)