(449 days)
No
The description focuses on mechanical components and materials, with no mention of AI/ML or related concepts.
No.
The device is described as a powered bone cutting and drilling instrument used for surgical procedures, which is an operative function, not a therapeutic one. It shapes and removes bone rather than treating a disease or condition directly.
No
Explanation: The device is intended for cutting, drilling, removal, and shaping of bone, which are surgical functions, not diagnostic ones.
No
The device description clearly outlines physical components made of stainless steel, polytetrafluoroethylene, Copper-Beryllium Alloy, fluorocarbon rubber, and PEEK, and describes it as a powered bone cutting and drilling instrument. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for cutting, drilling, removal, and shaping of bone during surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The description details a powered surgical instrument and its accessories used for mechanical manipulation of bone.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on biological specimens.
- Anatomical Site: The anatomical site is bone, which is being directly operated on, not a specimen derived from the bone for analysis.
The device is a surgical tool used during a procedure, not a diagnostic tool used to analyze samples outside the body.
N/A
Intended Use / Indications for Use
The P300 Attachment is intended to be used with electric and pneumatic surgical instruments and cutting accessories for cutting, drilling, removal, and shaping of bone in the procedures of: Neuro, Spine, Orthopedic, and General Surgery.
NSK Sterile Cutting Accessory(ies) is for single use only. This device is intended for use, in conjunction with P300 Attachment, in cutting, drilling, removal, and shaping of bone in the procedures of: Neuro, Spine, Orthopedic, ENT, Maxillofacial, and General Surgery.
Product codes (comma separated list FDA assigned to the subject device)
HBE, ERL, EOJ, HWE, GFF
Device Description
The P300 Attachment is a powered bone cutting and drilling instruments designed to be used with the Primado2 Total Surgical System (K132264), which provides mechanical power to the attachment. The P300 Attachment is comprised of two families: Standard Attachment 300 and Slim Attachment 300. The Standard Attachment 300 and Slim Attachment 300 consist of angled and straight types of attachments with varying lengths. The Standard Attachment 300 is an attachment to the Primado2 Total Surgical System that can be in either a straight or angled configuration and comes in 5 different tube lengths, ranging from 12 mm to 79 mm. Accessories compatible with the Standard Attachment 300 include 52 NSK Sterile Cutting Accessories, a STD Attachment Beak, and 4 Irrigation Nozzles. The Slim Attachment 300 consists of 2 parts, a Slim Attachment Hub that comes in 2 configurations (straight or angled) and a Slim Tube that comes in 8 configurations and varies in tube lengths from 110 mm to 240 mm, and can be straight, curved, or angled. Accessories compatible with the Slim Attachment 300 include 49 NSK Sterile Cutting Accessories, a Slim Tube Beak and a Slim Tube Hood, and 2 Irrigation Nozzles. The Standard Attachment 300 and Slim Attachment 300 share the same Cleaning Tools for automated cleaning, manual cleaning, and purging. For both the Standard Attachment 300 and the Slim Attachment 300, the length of the bur can be adjusted in six levels. Both the Standard and Slim attachments include a non-slip surface etching on the grip. The attachments consist of stainless steel, polytetrafluoroethylene, Copper-Beryllium Alloy, fluorocarbon rubber, and PEEK.
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
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)
Non-clinical bench performance testing was performed on the P300 Attachment and NSK Sterile Cutting Accessories including verification/validation testing to internal functional specifications which demonstrated that the device is as safe and effective as the predicate device.
The nature and duration of tissue contact for the device was determined to be limited (
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
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.(b)
Classification. Class II (performance standards).
0
March 29, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Nakanishi Inc. % Gregory Woodard Biomedical Engineer Ken Block Consulting LLC 800 East Campbell Road, Suite 202 Richardson, Texas 75081
Re: K202120
Trade/Device Name: P300 Attachment; NSK Sterile Cutting Accessories Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, and Their Accessories Regulatory Class: Class II Product Code: HBE, ERL, EOJ, HWE, GFF
Dear Gregory Woodard:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 22, 2021. Specifically, FDA is updating this SE letter to include the trade name and Indications for Use statement for the NSK Sterile Cutting Accessories as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter, please contact Adam Pierce, Ph.D., OHT5: Office of Neurological and Physical Medicine Devices, 240-402-6128, Adam. Pierce@fda.hhs.gov.
Sincerely,
Xiaolin Zheng -S
Xiaolin Zheng, Ph.D. Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 22, 2021
Nakanishi Inc. % Gregory Woodard Ken Block Consulting LLC 800 East Campbell Road, Suite 202 Richardson. Texas 75081
Re: K202120
Trade/Device Name: P300 Attachment Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, And Their Accessories Regulatory Class: Class II Product Code: HBE, ERL, HWE Dated: September 21, 2021 Received: September 22, 2021
Dear Gregory Woodard:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
2
801; medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Adam D. Pierce -S
Adam D. Pierce, Ph.D. Assistant Director Neurosurgical Devices Team Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices Office of Health Technologies 5, Neurological & Physical Medicine Devices Office of Product Evaluation & Ouality Center for Devices and Radiological Health U.S. Food and Drug Administration
Enclosure
3
Indications for Use
510(k) Number (if known) K202120
Device Name
P300 Attachment; NSK Sterile Cutting Accessories
Indications for Use (Describe)
The P300 Attachment is intended to be used with electric and pneumatic surgical instruments and cutting accessories for cutting, drilling, removal, and shaping of bone in the procedures of: Neuro, Spine, Orthopedic, and General Surgery.
NSK Sterile Cutting Accessory(ies) is for single use only. This device is intended for use, in conjunction with P300 Attachment, in cutting, drilling, removal, and shaping of bone in the procedures of: Neuro, Spine, Orthopedic, ENT, Maxillofacial, and General Surgery.
| 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) |
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."
4
K202120 510(k) SUMMARY
| Submitter: | NAKANISHI INC.
700 Shimohinata
Kanuma, Tochigi 322-8666 Japan | | |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|------------------------------------------------------------------------------|
| Contact Person: | Mr. Masaaki Kikuchi
General Manager, Quality/Regulatory Affairs Dept.
TEL: +81-289-64-7277
FAX: +81-289-62-9738
m-kikuchi@nsk-nakanishi.co.jp | | |
| Date Prepared: | March 25, 2022 | | |
| Submission Type: | Traditional 510(k) Submission | | |
| Trade Name: | P300 Attachment; NSK Sterile Cutting Accessories | | |
| Classification Name: | Powered Simple Cranial Drills, Burrs, Trephines, and Their Accessories | | |
| Primary
Classification: | HBE | 882.4310 | Drills, Burs, Trephines & Accessories (Simple, Powered) |
| Subsequent
Classifications: | ERL | 874.4250 | Drill, Surgical, ENT (Electric or Pneumatic), Including Handpiece |
| | EQJ | 874.4140 | Bur, Ear, Nose and Throat |
| | HWE | 878.4820 | Instrument, Surgical, Orthopedic, AC-Powered, Motor and Accessory/Attachment |
| | GFF | 878.4820 | Bur, Surgical, General & Plastic Surgery |
| Predicate Device: | Nakanishi Primado2 Total Surgical System
510(k) Number: K132264
Product Codes: HBC, ERL
Product Codes for Accessories: DZI, DZJ, ERL, GEY, HBC, HBE, HWE, GFF, EQJ | | |
| Reference Devices: | Stryker MIS Attachments and Cutting Accessories
510(k) Number: K143540
Product Codes: HBE
Subsequent Product Code: ERL
Stryker Elite and Heavy Duty (HD) Attachments
510(k) Number: K143320
Product Code: HBE
Secondary Product Codes: ERL, HBB, DZI | | |
5
K202120
510(k) SUMMARY Device Description: The P300 Attachment is a powered bone cutting and drilling instruments designed to be used with the Primado2 Total Surgical System (K132264), which provides mechanical power to the attachment. The P300 Attachment is comprised of two families: Standard Attachment 300 and Slim Attachment 300. The Standard Attachment 300 and Slim Attachment 300 consist of angled and straight types of attachments with varying lengths. The Standard Attachment 300 is an attachment to the Primado2 Total Surgical System that can be in either a straight or angled configuration and comes in 5 different tube lengths, ranging from 12 mm to 79 mm. Accessories compatible with the Standard Attachment 300 include 52 NSK Sterile Cutting Accessories, a STD Attachment Beak, and 4 Irrigation Nozzles. The Slim Attachment 300 consists of 2 parts, a Slim Attachment Hub that comes in 2 configurations (straight or angled) and a Slim Tube that comes in 8 configurations and varies in tube lengths from 110 mm to 240 mm, and can be straight, curved, or angled. Accessories compatible with the Slim Attachment 300 include 49 NSK Sterile Cutting Accessories, a Slim Tube Beak and a Slim Tube Hood, and 2 Irrigation Nozzles. The Standard Attachment 300 and Slim Attachment 300 share the same Cleaning Tools for automated cleaning, manual cleaning, and purging. For both the Standard Attachment 300 and the Slim Attachment 300, the length of the bur can be adjusted in six levels. Both the Standard and Slim attachments include a non-slip surface etching on the grip. The attachments consist of stainless steel, polytetrafluoroethylene, Copper-Beryllium Alloy, fluorocarbon rubber, and PEEK. Indication for Use: The P300 Attachment is intended to be used with electric and pneumatic surgical instruments and cutting accessories for cutting, drilling, removal, and shaping of bone in the procedures of: Neuro, Spine, Orthopedic, ENT, Maxillofacial, and General Surgery. NSK Sterile Cutting Accessory(jes) is for single use only. This device is intended for use, in conjunction with P300 Attachment, in cutting, drilling, removal, and shaping of bone in the procedures of: Neuro, Spine, Orthopedic, ENT, Maxillofacial, and General Surgery. Summary of As with the attachments in the predicate device referenced above, the P300 Technological Attachment includes standard and slim attachments for use with the Primado2 Characteristics: Total Surgical System. Comparisons with the predicate device show the characteristics of the proposed device to the P300 Attachment to be substantially equivalent to the predicate device. 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. The following table summarizes the comparison of the proposed device with the predicate device for indications for use and technological characteristics.
6
Image /page/6/Picture/0 description: The image shows the logo for NSK, a Japanese manufacturer of bearings. The logo consists of the letters "NSK" in a bold, sans-serif font. The letters are white and are set against a blue background. A white swoosh-like shape is above the letters, adding a dynamic element to the design.
K202120 510(k) SUMMARY
| Proposed Device | Predicate Device | |||
|---|---|---|---|---|
| Trade Name | P300 Attachment; NSK Sterile | |||
| Cutting Accessories | Primado2 | |||
| 510(k) Submitter | ||||
| [Number] | NAKANISHI INC. | |||
| [K202120] | NAKANISHI INC. | |||
| [K132264] | ||||
| Indications for | ||||
| Use | The P300 Attachment is intended to | |||
| be used with electric and pneumatic | ||||
| surgical instruments and cutting | ||||
| accessories for cutting, drilling, | ||||
| removal, and shaping of bone in the | ||||
| procedures of: Neuro, Spine, | ||||
| Orthopedic, ENT, Maxillofacial, | ||||
| and General Surgery. | The Primado2 is an AC-electrically | |||
| powered total surgical system that is | ||||
| intended for cutting, drilling, | ||||
| sawing, and otherwise manipulating | ||||
| soft tissue, hard tissue, 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. | SIMILAR | |||
| Sterile Cutting | ||||
| Accessories | ||||
| Indications for | ||||
| Use | NSK Sterile Cutting Accessory(ies) | |||
| is for single use only. This device is | ||||
| intended for use, in conjunction | ||||
| with P300 Attachment, in cutting, | ||||
| drilling, removal, and shaping of | ||||
| bone in the procedures of: Neuro, | ||||
| Spine, Orthopedic, ENT, | ||||
| Maxillofacial, and General Surgery. | NSK sterilized disposable products | |||
| (burs, saw blades and rasps) are | ||||
| intended for use in bone surgery. | SIMILAR | |||
| Product Codes | HBE, ERL, HWE, GFF, EQJ | HBC, ERL | ||
| Accessories: | ||||
| DZI, DZJ, ERL, GEY, HBC, HBE, | ||||
| HWE, GFF, EQJ | SIMILAR | |||
| Attachments to be | ||||
| Used with | Primado2 | Primado2 | IDENTICAL | |
| Types of | ||||
| Attachments | Standard Attachment Series | |||
| Slim Attachment Series | Slim Attachment Series | |||
| Super Slim Attachment Series | ||||
| Standard Angled Attachment Series | ||||
| Standard Straight Attachment Series | ||||
| Perforator/Craniotome Attachment | ||||
| Series | ||||
| High Speed Attachment Series | ||||
| Contra Angle Attachment Series | SIMILAR | |||
| Energy source to | ||||
| attachments | Mechanical energy from attached | |||
| motor | Mechanical energy from attached | |||
| motor | IDENTICAL | |||
| Maximum rotation | 80,000 min-1 | 80,000 min-1 | IDENTICAL | |
| Attachment Direct | ||||
| or Indirect Patient | ||||
| Contacting | ||||
| Materials | SUS303, SUS304, SUS316F2, | |||
| SUS316F2 (TiCN), PEEK | SUS303, SUS304, SUS316F2, | |||
| SUS316F2 (TiCN), C3604B (NiCr), | ||||
| SUS416F, SUS420J2, C5441B, | ||||
| C5191B, SUS416, SUS420F, | ||||
| ACD34, SUSNSK1 (TiCN), FKM | MODIFIED | |||
| Types of Cutting | ||||
| Accessories for | ||||
| Attachments | Burs | |||
| Drills | Burs | |||
| Drills | ||||
| Saws | ||||
| Rasps | SIMILAR | |||
| Outer Diameters | ||||
| of Cutting | ||||
| Accessories (Burs, | ||||
| Drills) | Ф0.6-7.5 mm | Ф0.6-9.1 mm | SIMILAR | |
| Cleaning | ||||
| Accessories | Yes | No | MODIFIED | |
| Adjustable Bur | ||||
| Length | Yes | No | MODIFIED | |
| Lubrication | PANA Spray Plus (K163483) | PANA Spray Plus (K163483) | IDENTICAL | |
| Automatic Cleaning | ||||
| Or | ||||
| Manual Cleaning | Automatic Cleaning | |||
| Or | ||||
| Manual Cleaning | ||||
| Cleaning | IDENTICAL | |||
| Sterilization | Pre-Vacuum | |||
| (Dynamic Air Removal) | ||||
| 132 °C, 4 min. | ||||
| Drying Time: 20 min. | Pre-Vacuum | |||
| (Dynamic Air Removal) | ||||
| 134 °C, 3 min. | ||||
| Gravity Displacement | ||||
| 132 °C, 15 min | MODIFIED | |||
| Use Environment | Temperature: 0 - 40 °C | |||
| Humidity: 30 - 75 % | Temperature: 0 - 40 °C | |||
| (no condensation) | ||||
| Humidity: 30 - 75 % | ||||
| Atmospheric Pressure: | ||||
| 700 - 1,060 hPa | MODIFIED | |||
| Store and | ||||
| Transportation | ||||
| Environment | Temperature: -10 - 50 °C | |||
| Humidity: 10 - 85 % | ||||
| Atmospheric Pressure: | ||||
| 500 - 1,060 hPa | Temperature: -10 - 50 °C | |||
| Humidity: 10 - 85 % | ||||
| Atmospheric Pressure: | ||||
| 500 - 1,060 hPa | IDENTICAL | |||
| Biocompatibility | ||||
| Testing | Cytotoxicity | |||
| Sensitization | ||||
| Intracutaneous Reactivity | ||||
| Acute Systemic Toxicity | ||||
| Material-Mediated Pyrogenicity | ||||
| Indirect (Extract) Hemolysis | Cytotoxicity | |||
| Sensitization | ||||
| Intracutaneous Reactivity | ||||
| Acute Systemic Toxicity | ||||
| Material-Mediated Pyrogenicity | MODIFIED |
7
K202120 510(k) SUMMARY
The Operation Manuals provide detailed instructions and information for safe and effective use of the device and users are expected to adhere to the instructions and other information. The User's Manual explains how to use the Surgical System and other equipment. Connected medical equipment must comply with IEC 60601-1. Before using the product, be sure to read the manual thoroughly in order to utilize it more effectively.
Performance: Non-clinical bench performance testing was performed on the P300 Attachment and NSK Sterile Cutting Accessories including verification/validation testing to internal functional specifications which demonstrated that the device is as safe and effective as the predicate device.
The nature and duration of tissue contact for the device was determined to be limited (