(190 days)
K#080722, K#002523
Not Found
No
The document describes a traditional surgical drill system with various attachments and makes no mention of AI or ML capabilities.
No
The device performs bone dissection; it does not treat a disease or condition.
No
Explanation: The device is described as a "total surgical system" used to "perform delicate bone dissection." Its components are all related to surgical procedures (e.g., drills, microsaws), not to diagnosis or imaging.
No
The device description explicitly lists multiple hardware components including a control unit, foot controller, micromotor, motor cord, AC power cord, and various surgical attachments.
Based on the provided information, the Primado Surgical System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical system for performing bone dissection in vivo (within the living body) during various surgical procedures.
- Device Description: The device components are all related to surgical tools and their control for use during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. The Primado is a surgical tool used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
The Primado Surgical System is an AC-electrically powered total surgical system that allows for the use of multiple attachments to perform delicate bone dissection in neurological, maxillofacial, craniotomy, and spinal procedures, and in the ear, nose, and throat area. A wide range of attachments includes a perforator drive, craniotome, straight/angle/malleable drills, and microsaws.
Product codes (comma separated list FDA assigned to the subject device)
HBC, ERL
Device Description
The Primado Surgical System is an AC-electrically powered total surgical system that allows for the use of multiple attachments to perform delicate bone dissection in neurological procedures. The device consists of a control unit, foot controller, micromotor, motor cord, AC power cord, perforator drive, craniotome, straight/angle/malleable drills, and microsaws. The device does not come sterile and all parts that contact the patient as well as the AC power cord should be sterilized prior to the first use and after each use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurological, maxillofacial, craniotomy, spinal, ear, nose, and throat
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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.
K#080722, K#002523
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
K083112
pg 1 of 3
510(k) SUMMARY
Nakanishi Inc. Primado Surgical System
Name of Device and Name/Address of Sponsor
| Trade or Proprietary Name: | Primado Surgical System |
|---|---|
| Common Name: | electric surgical motorsystem; ENT surgical drill system |
| Classification Name: | motor, drill, electric; ear, nose, and throat electric or pneumatic surgical drill (21 CFR 882.4360 and 874.4250) |
| Product Code: | HBC, ERL |
Nakanishi Inc. 700 Shimohinata Kanuma-shi Tockigi-ken 322-8666 Japan
| Contact: | Ms. Tomoko Hirabayashi |
|---|---|
| Telephone: | 011-81-289-64-3380 |
| Facsimile: | 011-81-289-62-6665 |
| Date Prepared: | April 23, 2009 |
Intended Use
The Primado Surgical System is an AC-electrically powered total surgical system that allows for the use of multiple attachments to perform delicate bone dissection in neurological, maxillofacial, craniotomy, and spinal procedures, and in the ear, nose, and throat area. A wide range of attachments includes a perforator drive, craniotome, straight/angle/malleable drills, and microsaws.
Technological Characteristics and Substantial Equivalence
The Primado Surgical System is an AC-electrically powered total surgical system that allows for the use of multiple attachments to perform delicate bone dissection in neurological procedures. The device consists of a control unit, foot controller, micromotor, motor cord, AC power cord, perforator drive, craniotome, straight/angle/malleable drills, and microsaws. The device does not come sterile and all parts that contact the patient as well as the AC power cord should be sterilized prior to the first use and after each use. The Primado has already been cleared for marketing for "delicate bone dissection in the ear, nose, and throat areas" under K#080722.
The Primado Surgical System is substantially equivalent in terms of safety and effectiveness to NSK's own previously authorized Primado device (K#080722) and the Advantage Drive System (K#002523). A chart comparing the Primado to the predicate devices is attached.
APR 2 9 2009
1
Image /page/1/Picture/0 description: The image shows handwritten text that appears to be part of a document or page numbering system. The text includes the identifier "K083112" at the top, followed by "pg. 2 of 3" below it. The handwriting is in black ink and has a slightly tilted orientation.
Substantial Equivalency Chart
| ITEMS | NEW DEVICE | PREDICATE
DEVICE | PREDICATE
DEVICE |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Classification
No. | HBC, ERL | ERL | HBC, GEY |
| 2. C.F.R. Section
No. | 882.4360 and
874.4250 | 874.4250 | 882.4360 and
878.4820 |
| 3. Classification
Panel | Neurology and Ear,
Nose & Throat | Ear, Nose & Throat | Neurology and
General and Plastic
Surgery |
| 4. Classification
Name | Motor, Drill,
Electric | Drill, Surgical, ENT
(Electric Or
Pneumatic) Including
Handpiece | Motor, Drill, Electric
and Motor, Surgical
Instrument, Ac-
Powered |
| 5. Class | II | II | II |
| 6. 510(k) Number | N/A | K#080722 | K#002523 |
| 7. Manufacturer | NAKANISHI INC. | NAKANISHI INC. | LINVATEC CORP |
| 8. Proprietary
Name | Primado Surgical
System | Primado
Neurological Drill | Advantage Drive
System |
| 9. Description | Electrically
powered drill and
surgical motor
system and
attachments
operated by foot
controller | Identical | Electrically powered
surgical instrument
system and
handpieces operated
by foot controller |
| 10. Intended use | Delicate bone
dissection in
neurological,
maxillofacial,
craniotomy, and
spinal procedures,
and in the ear nose,
and throat areas | Delicate bone
dissection in the ear,
nose, and throat areas | Cutting of soft tissue
and bone in
arthroscopic, foot,
hand, medial
sternotomy,
neurosurgical,
orthopedic,
otolaryngological,
oral/maxillofacial,
plastic/
reconstructive, and
spinal surgical
procedures |
| 11. Compliance
with standards | IEC 60601-1
IEC 60601-1-2 | Identical | IEC 601-1
IEC 601-1-2
UL2601-1 |
| 12. High speed | Up to 100,000 rpm | Identical | Identical |
| 13. Low speed | Up to 234 rpm | Identical | Up to 30 rpm |
| 14. Oscillating
saw | Up to 20,000 cpm | Identical | Identical |
| 15. Sagittal saw | Up to 20,000 cpm | Identical | Identical |
| 16. Reciprocating
saw | Up to 19,300 cpm | Identical | Up to 17,000 cpm |
| 17. Patient contact
materials | Surgical stainless
steel; diamond | Identical | Unknown |
2
40560854.doc
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3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nakanishi, Inc. c/o Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. Suite 1100 Washington, DC 20005
APR 2 9 2009
Re: K083112
Trade/Device Name: Primado Surgical System Regulation Number: 21 CFR 882.4360 Regulation Name: Electric cranial drill motor Regulatory Class: Class II Product Code: HBC Dated: March 10, 2009 Received: March 11, 2009
Dear Mr. Barritt:
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.
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 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.
4
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Eglehus, MD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The text is oriented diagonally, with the characters slightly distorted and overlapping. The text includes the letters 'K' and 'o' along with the numbers '8', '3', '1', and '2'. The overall impression is that the text is a code or identifier of some kind.
Indications for Use 1. 1. 1. 1.
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
510(k) Number (if known): 083112
.. .. ... .. . . . .
Device Name: Primado
Indications For Use:
The Primado is an AC-electrically powered total surgical system that allows for the use of multiple attachments to perform delicate bone dissection in neurological, maxillofacial, craniotomy, and spinal procedures, and in the ear nose, and throat area. A wide range of attachments includes a perforator drive, craniotome, straight/angle/malleable drills, and microsaws.
Prescription Use x (Part 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 CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices | |
|---|---|
| 510(k) Number | K083112 |
4-1
Prescription Use (Per 21 CFR 801.109)