(204 days)
Not Found
No
The description focuses on the mechanical and software-driven aspects of a surgical driver, with no mention of AI or ML capabilities. The software mentioned is for torque limiting, which is a standard control function, not indicative of AI/ML.
No
The device is described as a driver for screws and a drill for pilot holes, not as delivering therapeutic treatment. Its function is mechanical in surgical procedures.
No
The device is described as a driver for inserting screws and drilling holes into bone, which are therapeutic and surgical actions, not diagnostic.
No
The device description explicitly states it is a "handheld, cordless, software driven, battery operated driver" and lists various hardware components like stainless steel, aluminum, and plastic. While it contains software, it is not solely software.
Based on the provided information, the PINNACLE Driver is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "driving screws and for drilling into bone, in conjunction with dental, orthognathic, and mandibular surgical procedures." This describes a surgical tool used directly on a patient's body.
- Device Description: The description details a handheld, cordless driver/drill for surgical procedures. It mentions accessories like drills and driver stems, and discusses sterilization and battery operation. None of this relates to testing samples taken from the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The PINNACLE Driver does not perform any such function.
The PINNACLE Driver is a surgical instrument used in vivo (within the living body), not in vitro (in glass, referring to testing outside the body).
N/A
Intended Use / Indications for Use
The PINNACLE Driver is intended for driving screws and for drilling into bone, in conjunction with dental, orthognathic, and mandibular surgical procedures.
Product codes
KMW
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 drills and driver stems. The optional driver stems are reusable while the drills are single use. The PINNACLE Driver may be sterilized individually wrapped in two layers of 1-ply polypropylene wrap or unwrapped in a sterilization organizational tray inside a rigid sterilization container, which is 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.
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 drills are made of medical grade stainless steel. The sterilization organizational trays and rigid sterilization containers are made of aluminum.
The PINNACLE Driver is a battery operated driver/drill that operates in the both the forward and reverse directions. The PINNACLE Driver contains torque limiting software to prevent over-torquing and stripping of screws in drive mode.
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
clinician, healthcare facility/hospital
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)
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. Tests included Cytotoxicity, Sensitization, Irritation, and Systemic toxicity. The device and associated accessories are considered tissue/bone/dentin contacting for a duration of less than 24 hours. 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 "moderate" level of concern.
Bench Testing: The following bench testing was conducted:
- Simulated Use
- Sterilization Validation
- Reprocessing Validation
- Shipping Validation
- Battery Leak Testing
- Electrical Safety and Electromagnetic Compatibility
Animal Study: No animals studies were needed to demonstrate substantial equivalence to the predicates.
Clinical Studies: No clinical studies were needed to demonstrate substantial equivalence to the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 4, 2017
Osteomed Kathryn Jayne Senior Specialist, Regulatory Affairs 3885 Arapaho Road Addison, Texas 75001
Re: K162544
Trade/Device Name: Osteomed Pinnacle Driver Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: KMW Dated: February 16, 2017 Received: March 9, 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 (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.
1
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/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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Susan Runno DDS, MA
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162544
Device Name PINNACLE Driver
Indications for Use (Describe)
The PINNACLE Driver is intended for driving screws and for drilling into bone, in conjunction with dental, orthognathic, and mandibular surgical procedures.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 blue, bold letters. The logo is surrounded by a blue and gray swoosh design. The blue swoosh is on top, and the gray swoosh is on the bottom.
510(k) SUMMARY
I. SUBMITTER
OsteoMed 3885 Arapaho Rd. Addison, TX 75001 USA
Phone: 972-677-4766 Fax: 800-390-2620 Email: kjayne@osteomed.com
Contact Person: Kathryn A. Jayne Date Prepared: March 29, 2017
II. DEVICE
Name of the Device: PINNACLE Driver Common or Usual Name: Battery-operated drill/driver Classification Name: Drill, Bone, Powered Regulation: 872.4120 Regulatory Class: II Product Code: KMW
III. PREDICATE DEVICE
The OsteoMed "B" Power System, K933101, is the primary predicate. The OsteoMed OsteoPower System, K971692, is the reference predicate.
This primary predicate and reference predicate have not been subject to a designrelated recall.
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 drills and driver stems. The optional driver stems are reusable while the drills are single use. The PINNACLE Driver may be sterilized individually wrapped in two layers of 1-ply polypropylene wrap or unwrapped in a sterilization organizational tray inside a rigid sterilization container, which is 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.
4
Image /page/4/Picture/1 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OSTEOMED" in blue letters. The logo has a blue swoosh above the word and a gray swoosh below the word. The logo is likely for a medical company that specializes in orthopedics.
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 drills are made of medical grade stainless steel. The sterilization organizational trays and rigid sterilization containers are made of aluminum.
The PINNACLE Driver is a battery operated driver/drill that operates in the both the forward and reverse directions. The PINNACLE Driver contains torque limiting software to prevent over-torquing and stripping of screws in drive mode.
V. INDICATIONS FOR USE
The PINNACLE Driver is intended for driving screws and for drilling into bone, in conjunction with dental, orthognathic, and mandibular surgical procedures.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
At a high level, the subject and predicate devices are based on the following same technological elements as demonstrated below.
| Subject Device- | Primary Predicate- | Reference Predicate- | |
|---|---|---|---|
| OsteoMed PINNACLE | OsteoMed "B" Power | OsteoMed OsteoPower | |
| Driver | System & Accessories | System & Accessories | |
| 510(k) | Pending | K933101 | K971692 |
| Regulation No. | 872.4120 | 872.4120 | 872.4120 |
| Product Code | KMW | KIJ | KMW |
| Device Class | II | Unclassified | II |
| Regulatory Panel | Dental | Dental | Dental |
| Indications for | |||
| Use | The PINNACLE Driver is | ||
| intended for driving | |||
| screws and for drilling | |||
| into bone, in conjunction | |||
| with dental, orthognathic, | |||
| and mandibular surgical | |||
| procedures. | The OsteoMed "B" Power | ||
| Handpiece System is | |||
| intended for drilling and | |||
| cutting bone and teeth and | |||
| for driving pins, screws, | |||
| and/or wires into bone for | |||
| dental, craniofacial, | |||
| orthognathic, mandibular, | |||
| hand, foot, wrist, or | |||
| extremity reconstruction | |||
| surgical procedures. | The OsteoPower System | ||
| and Accessories are | |||
| indicated for drilling or | |||
| cutting bone or teeth, and | |||
| for driving screws and/or | |||
| pins and wires into bone, | |||
| in conjunction with | |||
| dental, craniofacial, | |||
| craniotomies, | |||
| orthognathic, spinal, | |||
| mandibular, hand, foot, | |||
| wrist, and extremity | |||
| reconstruction surgical | |||
| procedures. | |||
| Power Source | Battery operated | ||
| (Lithium, single patient | |||
| use) | Battery operated | ||
| (rechargeable NiCad | |||
| battery) | AC/DC External power | ||
| supply | |||
| Material | --Handpiece and | ||
| battery-Aluminum, | |||
| PEEK, brass, medical | |||
| grade stainless steel, | |||
| silicone | --Handpiece and | ||
| battery-stainless steel, | |||
| aluminum, brass, silver, | |||
| medical grade plastics, | |||
| fiber reinforced ceramics | -- Handpiece only- | ||
| stainless steel or carbide | |||
| --Cutting portion of the | |||
| drills or burrs—stainless | |||
| steel, carbide, diamond, or | |||
| fiber reinforced ceramic | |||
| Subject Device— | |||
| OsteoMed PINNACLE | |||
| Driver | Primary Predicate— | ||
| OsteoMed “B” Power | |||
| System & Accessories | Reference Predicate— | ||
| OsteoMed OsteoPower | |||
| System & Accessories | |||
| --accessories—medical | |||
| grade stainless steel or | |||
| carbide | --Accessories—stainless | ||
| steel, aluminum, or | |||
| medical grade plastics | |||
| Speed | 2,000 RPM forward | ||
| 275 RPM reverse | 120-1800 RPM | 608-70,000 RPM | |
| Battery | Disposable, lithium, | ||
| single use, sterile battery | |||
| (gamma) | Rechargeable Nickel | ||
| Cadmium battery | NA | ||
| Modes | Drill | ||
| Drive | Drill | ||
| Drive | Speed ranges SAFETY, | ||
| 100%, 75%, 50%, 25%, | |||
| and Di (12.5%) of | |||
| maximum speed | |||
| Activation | |||
| Buttons | 1 Forward button | ||
| 1 Reverse button | 1 Forward button | ||
| 1 Reverse button | 1 Forward button | ||
| 1 Reverse button | |||
| Insertion | |||
| Material | Bone | Bone | Bone |
| Screw | |||
| 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 drills, Hex | ||
| Shank driver stems, | |||
| sterilization | |||
| organizational trays, rigid | |||
| sterilization container | Round burrs, oval burrs, | ||
| twist drills, wire pass | |||
| twist drills, side cutting | |||
| burs, and end-cutting | |||
| drills, saw blades, K- | |||
| wires and pins, screw | |||
| drivers, burr racks, blade | |||
| containers, sterilization | |||
| trays, battery charger | Round burrs, oval burrs, | ||
| twist drills, wire pass | |||
| twist drills, side cutting | |||
| burrs, end-cutting drills, | |||
| saws, motor units, | |||
| modules, footswitches, | |||
| screw drivers | |||
| Sterilization of | |||
| re-usable devices | Pre-vacuum steam | ||
| (wrapped)—Hand piece | |||
| only | |||
| --Min. Temp: 132° C | |||
| (270°F) | |||
| --Full Cycle Time: 4 | |||
| minutes | |||
| --Min Dry Time: 30 | |||
| minutes | |||
| Pre-vacuum steam (rigid | |||
| container)— | |||
| 1-Driver Case & 2-Driver | |||
| Case | |||
| Pre-vacuum Hi Vac | |||
| (wrapped or unwrapped) | |||
| Temp: 270-270 °F | |||
| Exposure Time: 4 min | |||
| Dry Time: min 8 min | |||
| 270 °F Gravity | |||
| (wrapped on tray) | |||
| Temp: 270-270 °F | |||
| Exposure Time: 35 min | |||
| Dry Time: min 8 min | Pre-vacuum steam | ||
| (wrapped) | |||
| Temp: 132° C (270°F) | |||
| Dwell Time: 10 minutes | |||
| Dry Time: 70 minutes | |||
| Subject Device— | |||
| OsteoMed PINNACLE | |||
| Driver | Primary Predicate— | ||
| OsteoMed “B” Power | |||
| System & Accessories | Reference Predicate— | ||
| OsteoMed OsteoPower | |||
| System & Accessories | |||
| Parameter | |||
| Control | |||
| Technology | Software | Non-programmable, | |
| discrete digital and analog | |||
| logic | Non-programmable, | ||
| discrete digital and analog | |||
| logic | |||
| Software/safety | |||
| features | -Senses torque to prevent | ||
| over-torquing & stripping | |||
| of screws | |||
| -bit recognition | NA | Motor unit control switch | |
| to temporarily disable the | |||
| Electric Drive |
5
Image /page/5/Picture/1 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 swoosh design. The blue swoosh is on top and the gray swoosh is on the bottom.
6
Image /page/6/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and white, with the word "OsteoMed" in large, bold letters. The logo is surrounded by a gray and white swoosh design. The logo is simple and modern, and it is likely used to represent the company's brand.
The primary predicate device contains non-programmable, discrete digital and analog logic to operate. The subject device contains software to sense torque to prevent over-torquing and stripping of screws. Software validation is located in section 16 of this submission.
The primary predicate and subject devices are similar in basic shape and structure. The main difference between the two devices is the addition of software and the sterilization/reprocessing. The evaluation performed and supporting documentation within this submission demonstrates that the subject is comparable to the predicate device. Whenever possible, testing, located in section 18, was executed using recognized standards to establish product performance.
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
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.
7
Image /page/7/Picture/1 description: The image shows the logo for Osteomed. The logo is in blue and gray, with the word "OSTEOMED" in blue, sans-serif font. The logo is surrounded by a gray and blue swoosh design. The swoosh design is gray on the bottom and blue on the top.
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 "moderate" level of concern as documented in this submission.
Bench Testing
The following bench testing was conducted:
- Simulated Use
- Sterilization Validation
- Reprocessing Validation
- Shipping Validation ●
- o Battery Leak Testing
- Electrical Safety and Electromagnetic Compatibility ●
Animal Study
No animals studies were needed to demonstrate substantial equivalence to the predicates.
Clinical Studies
No clinical studies were needed to demonstrate substantial equivalence to the predicates.
CONCLUSIONS VIII.
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 demonstrates substantial equivalence to the declared predicate and the verification and validation demonstrate that the device should perform as intended in the specified use conditions.
(End of Summary)