(148 days)
Not Found
No
The document describes a surgical drill system with basic electronic controls for speed, direction, and irrigation. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies. The software mentioned is for basic functional control and safety compliance.
No
The device is described as a surgical system for cutting, drilling, sawing, and manipulating tissue and bone, which are direct surgical actions rather than therapeutic interventions designed to treat a disease or condition through non-invasive means or by restoring function.
No
The device is described as an AC-electrically powered surgical system for cutting, drilling, sawing, and manipulating tissue and bone in various surgical procedures. Its functions are related to mechanical action during surgery, not to diagnosing conditions or diseases.
No
The device description clearly outlines multiple hardware components including a Control Unit, Foot Control, various handpieces, and motors. While it mentions software verification/validation, the device is fundamentally a physical surgical system with integrated software, not a standalone software product.
Based on the provided information, the Primado 2 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the Primado 2 is a surgical system for cutting, drilling, sawing, and manipulating tissues and materials during surgical procedures. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism) diagnostic test.
- Device Description: The description details a surgical system with a control unit, foot control, motors, handpieces, and various surgical tools (burs, drills, blades). These are all components used for performing physical manipulations during surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or provide diagnostic information about a patient's condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Primado 2's function is entirely focused on surgical intervention.
N/A
Intended Use / Indications for Use
The Primado 2 is an AC-electrically powered 10tal surgical system that is intended for cutting, drilling, sawing, and otherwise manipulating soft tissue, bone, bone, bone cement, prosthesis, implant, and other bone related tissue in a variety of surgical procedures, including but not limited to Cranial (Craniofacial), ENT, Endoscopic / Arthroscopic / Arthroscopic, Neuro, Orthopedic, Spinal, and General surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
HBC, DZI, DZJ, ERL, GEY, HBE, HWE, GFF, EQJ
Device Description
The Primado2 consists of the Control Unit, the Foot Control (optional) and various handpieces for use with specific motors. Available Motors include Slim, High Torque, Micro Bone Saw, and Wire Pin Driver. Each motor series has handpieces or attachments specific to that series. Burs, drills, blades (saws), and rasps are available for use with specific handpieces / attachments. Handpieces and attachments are available for cranial surgery, trephination, oral surgery, and craniotomy. Sagittal, reciprocating, and oscillation saw blades are available, including for intra oral use.
The control unit drives the motors during procedures and is used to control the functions related to that motor such as speed and rotational direction. Two motors can be connected to the control unit at one time for asynchronous use. The control unit also incorporates the irrigation pump and controls the irrigation functions.
The foot control is an optional additional user interface. The foot control is available as a single or multi control. The single foot control has one button that can be programmed. The multi foot control has three buttons that can be programmed. The features available for allocation to the buttons include Foot Control ON/OFF, A/B Control Switching, Speed Control, Reverse Rotation, Irrigation ON/OFF, Flush, and Disable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cranial (Craniofacial / Maxillofacial), ENT, Endoscopic / Arthroscopic, Neuro, Orthopedic, Spinal, and General
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)
Tests were performed on the Primado2 including verification/validation testing to internal functional specifications (including software) which demonstrated that the device is safe and effective. Documentation was provided demonstrating compliance of the Primado2 to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, including results of verification/validation plus traceability of verification/validation tests to software requirements and software risk hazards. Testing confirmed that the Primado2 complies with relevant voluntary safety standards for Electrical safety and Electromagnetic Compatibility testing, specifically IEC standards 60601-1 and 60601-1-2. In addition, evaluations and validations have been performed to demonstrate compliance to the applicable standards for biocompatibility and sterilization.
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.
K083112 - Nakanishi Primado Surgical Drill, K040369 - Stryker CORE, K040300 - Stryker CORE, K081475 - Medtronic IPC, K053526 - Aesculap microspeed™ uni
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.
Not Found
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
§ 882.4360 Electric cranial drill motor.
(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).
0
132264
5. 510(k) SUMMARY
DEC 1 7 2013
| Comments of the comments of the | ||||
|---|---|---|---|---|
| Submitter: | Nakanishi, Inc. | |||
| 700 Shimohinata | ||||
| Kanuma-Shi, Tochigi-Ken Japan 322-8666 | ||||
| Contact Person: | Ms. Diane Rutherford | |||
| Submissions Manager, Ken Block Consulting | ||||
| TEL: 972-480-9554 | ||||
| FAX: 972-767-4325 | ||||
| rutherford@kenblockconsulting.com | ||||
| Date Prepared: | July 12, 2013 Revised December 17, 2013 | |||
| Trade Name: | Primado2 Total Surgical System | |||
| Common Name: | Electrical Surgical System | |||
| Classification Name: | HBC | 882.4360 | Motor, Drill, Electric, Cranial | |
| Secondary | ||||
| Classification Name: | ERL | 874.4250 | Drill, Surgical, ENT (Electric or Pneumatic), Including | |
| Handpiece | ||||
| Additional Product | ||||
| Codes for | ||||
| Accessories: | DZI | |||
| DZJ | ||||
| ERL | ||||
| GEY | ||||
| HBC | ||||
| HBE | ||||
| HWE | ||||
| GFF | ||||
| EQJ | 872.4120 | |||
| 872.4120 | ||||
| 874.4250 | ||||
| 878.4820 | ||||
| 882.4360 | ||||
| 882.4310 | ||||
| 878.4820 | ||||
| 878.4820 | ||||
| 874.4140 |
- 510(k) Exempt | Class 2
Class 2
Class 2
Class 1*
Class 2
Class 2
Class 1*
Class 1*
Class 1* | Drill, Bone, Powered
Driver, Wire, and Bone Drill, Manual
Drill, Surgical, ENT (Electric or Pneumatic),
Including Handpiece
Surgical instrument motors and accessories
/ attachments
Motor, Drill, Electric, Cranial
Drills, Burs, Trephines & Accessories (Simple,
Powered), cranial
Instrument, Surgical, Orthopedic, AC-Powered
Motor and Accessory/Attachment
Bur, Surgical, General & Plastic surgery
Bur, Ear, nose and throat |
| Predicate Device: | K083112 - Nakanishi Primado Surgical Drill
K040369 - Stryker CORE
K040300 - Stryker CORE
K081475 - Medtronic IPC
K053526 - Aesculap microspeed™ uni | | | |
| Device Description: | The Primado2 consists of the Control Unit, the Foot Control (optional)
and various handpieces for use with specific motors. Available Motors include
Slim, High Torque, Micro Bone Saw, and Wire Pin Driver. Each motor series has
handpieces or attachments specific to that series. Burs, drills, blades (saws), and
rasps are available for use with specific handpieces / attachments. Handpieces and
attachments are available for cranial surgery, trephination, oral surgery, and
craniotomy. Sagittal, reciprocating, and oscillation saw blades are available,
including for intra oral use. | | | |
Image /page/0/Picture/4 description: The image shows a black and white drawing of a bird. The bird is in mid-flight, with its wings spread out. The bird's body is long and slender, and its tail is long and pointed. The bird's head is small and round, and its beak is short and sharp. The bird is flying over a body of water.
Section 5: Page 1 of 2
1
K132264
510(k) SUMMARY (continued)
Device Description: (continued)
The control unit drives the motors during procedures and is used to control the functions related to that motor such as speed and rotational direction. Two motors can be connected to the control unit at one time for asynchronous use. The control unit also incorporates the irrigation pump and controls the irrigation functions.
The foot control is an optional additional user interface. The foot control is available as a single or multi control. The single foot control has one button that can be programmed. The multi foot control has three buttons that can be programmed. The features available for allocation to the buttons include Foot Control ON/OFF, A/B Control Switching, Speed Control, Reverse Rotation, Irrigation ON/OFF, Flush, and Disable.
-
The Primado 2 is an AC-electrically powered total surgical system that is intended Statement of for cutting, drilling, sawing, and otherwise manipulating soft tissue, hard tissue, Intended Use: bone, bone cement, prosthesis, implant, and other bone related tissue in a variety of surgical procedures, including but not limited to Cranial (Craniofacial / Maxillofacial), ENT, Endoscopic / Arthroscopic, Neuro, Orthopedic, Spinal, and General surgical procedures.
As with the predicate devices referenced above, the Primado2 is an AC-electrically Summary of powered software driven total surgical system that powers and controls the Technological functions of compatible motor attachments. The software allows for the control of Characteristics: the device features such as brightness, volume, speed control, rotational direction, irrigation control, priming control, footswitch control and confirmation, and configuration settings. The proposed device shares technological characteristics with the predicate devices. The proposed device also has some differences in technological characteristics from those of the predicate devices. Any differences in the technological characteristics are minor and reflect market strategy and/or perceived user preferences and do not impact the safety, effectiveness, or substantial equivalence of the device. -
Tests were performed on the Primado2 including verification/validation testing Performance to internal functional specifications (including software) which demonstrated Testing: that the device is safe and effective. Documentation was provided demonstrating compliance of the Primado2 to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, verification/validation plus traceability of of including results verification/validation tests to software requirements and software risk hazards. Testing confirmed that the Primado2 complies with relevant voluntary safety standards for Electrical safety and Electromagnetic Compatibility testing, specifically IEC standards 60601-1 and 60601-1-2. In addition, evaluations and validations have been performed to demonstrate compliance to the applicable standards for biocompatibility and sterilization.
-
Nakanishi, Inc. considers the Primado2 to be substantially equivalent to the Conclusion: predicate devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.
Image /page/1/Picture/9 description: The image shows a black and white drawing of a bird in flight. The bird has a long, pointed beak and outstretched wings. The bird's body is detailed with lines to show the feathers. The background is plain, with some text at the bottom of the image.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Nakanishi Incorporated c/o Ms. Diane Rutherford Ken Block Consulting 1201 Richardson Dr., Suite 280 Richardson, Texas 75080
December 17, 2013
Re: K132264
Trade/Device Name: Primado2 Total Surgical System Regulation Number: 21 CFR 882.4360 Regulation Name: Electric cranial drill motor Regulatory Class: Class II Product Code: HBC Additional Product Codes: ERL, HBE, HWE Dated: November 6, 2013 Received: November 7, 2013
Dear Ms. Rutherford:
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. Ilisting 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
3
Page 2 - Ms. Diane Rutherford
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers, International and Consumer Assistance 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,
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
2011 - 12 - 1 - - 1 - - 1 - - - -
510(k) Number: K132264
Device Name: Primado2 Total Surgical System
Indications for Use:
The Primado 2 is an AC-electrically powered 10tal surgical system that is intended for cutting, drilling, sawing, and otherwise manipulating soft tissue, bone, bone, bone cement, prosthesis, implant, and other bone related tissue in a variety of surgical procedures, including but not limited to Cranial (Craniofacial), ENT, Endoscopic / Arthroscopic / Arthroscopic, Neuro, Orthopedic, Spinal, and General surgical procedures.
Prescription Use _ (21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, Office of Device Evaluation (ODE)
Neil R Oge 2013.12.16 # 2 -05'00'
(Division Sign-off)for BSA Division of Surgical Devices K132264 :510(k) Number:
Page 1 of 1
Page 6 of 333