UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece
Device Facts
| Record ID | K200318 |
|---|---|
| Device Name | UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece |
| Applicant | KARL STORZ Endoscopy-America, Inc. |
| Product Code | ERL · Ear, Nose, Throat |
| Decision Date | Oct 22, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.4250 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The UNIDRIVE® S III ENT system consists of an active control unit used in conjunction with the High-Speed Micro Motor and DrillCut-X® II Shaver handpieces. The system is intended for use by qualified surgeons to provide controlled cutting, drilling, debriding, sawing, and shaving for the ablation, excision, removal, or transection of tissue or bone during head, neck, ENT, or otoneurological surgical procedures.
Device Story
UNIDRIVE S III ENT is a motorized surgical system; consists of active control unit, high-speed micro motor, and DrillCut-X II shaver handpieces. Used by surgeons in OR/clinical settings for cutting, drilling, debriding, sawing, and shaving tissue or bone during head, neck, ENT, or otoneurological procedures. System provides controlled mechanical action; modifications include addition of DrillCut-X II-35 and II-35 N handpieces with increased rotational speed (35,000 RPM). Output is mechanical rotation for surgical instruments; assists surgeons in tissue/bone removal. Benefits include enhanced surgical precision and efficiency in ENT procedures.
Clinical Evidence
No clinical data. Substantial equivalence established via non-clinical bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), risk management (ISO 14971), biocompatibility (ISO 10993), and cleaning/sterilization validation (ANSI/AAMI standards). Bench testing confirmed performance specifications for rotation speed and torque.
Technological Characteristics
Motorized surgical drill system. Components: control unit, high-speed micro motor, shaver handpieces. Rotational speed: up to 35,000 RPM. Electrical safety: Class I. Standards: IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 10993, ANSI/AAMI ST81, ST79, TIR 12, TIR 39, ISO 17665-1/2. Reprocessing: validated cleaning and sterilization methods.
Indications for Use
Indicated for qualified surgeons performing ablation, excision, removal, or transection of tissue or bone during head, neck, ENT, or otoneurological surgical procedures.
Regulatory Classification
Identification
An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.
Predicate Devices
- UNIDRIVE S III ENT (K150969)
Submission Summary (Full Text)
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October 22, 2020
Karl Storz Endoscopy-America, Inc. Alita McElroy Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, California 90245
Re: K200318
Trade/Device Name: UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, nose, and throat electric or pneumatic surgical drill Regulatory Class: Class II Product Code: ERL Dated: July 21, 2020 Received: July 23, 2020
Dear Alita McElroy:
We have reviewed vour 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/cfpmr/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
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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 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 mediation-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(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Joyce C. Lin-S
for Malvina Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K200318
Device Name UNIDRIVE S III ENT
#### Indications for Use (Describe)
The UNIDRIVE® S III ENT system consists of an active control unit used in conjunction with the High-Speed Micro Motor and DrillCut-X® II Shaver handpieces. The system is intended for use by qualified surgeons to provide controlled cutting, drilling, debriding, sawing, and shaving for the ablation, excision, removal, or transection of tissue or bone during head, neck, ENT, or otoneurological surgical procedures.
| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The word "STORZ" is written in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are written in smaller, blue letters.
# K200318 510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Submitter: | KARL STORZ Endoscopy-America, Inc.<br>2151 E. Grand Avenue<br>EI Segundo, CA 90245 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Alita McElroy<br>Regulatory Affairs Specialist<br>Phone: (424) 218-8376<br>Fax: (424) 218-8519 |
| Date of Preparation: | October 22, 2020 |
| Type of 510(k)<br>Submission: | Traditional |
| Device<br>Identification: | Trade Name: UNIDRIVE S III ENT<br>Classification Name: Drill, Surgical, ENT (Electric Or<br>Pneumatic) Including Handpiece |
| Regulatory Class: | II |
| Product Code: | ERL |
| Regulation: | 21 CFR 874.4250 (Ear, nose and throat electric or pneumatic<br>surgical drill) |
| Predicate Device(s): | Predicate Device: UNIDRIVE S III ENT (K150969)<br>The predicate device has not been subject to a design-related<br>recall. |
| Device Description: | The UNIDRIVE S III ENT is a motorized surgical device<br>system used for the excision, ablation, removal or transection<br>of bones/tissues during head, neck, ENT, or otoneurological<br>surgical procedures. The system components include a control<br>unit used in conjunction with the High-Speed Micro Motor that<br>houses the high-speed handpieces and DrillCut-X® II Shaver<br>handpieces.<br>The modifications made to the UNIDRIVE® S III ENT system<br>is the addition of the DrillCut-X® II-35 and DrillCut-X® II-35<br>N Shaver handpieces. Additional accessories used with the<br>UNIDRIVE S III ENT system include the shaver blades, sinus<br>burrs and the sinus burr 35k. |
| Intended Use: | The UNIDRIVE S III ENT system consists of an active control<br>unit used in conjunction with the High-Speed Micro Motor and<br>DrillCut-X® II Shaver handpieces. The system is intended for<br>use by qualified surgeons to provide controlled cutting,<br>drilling, debriding, sawing, and shaving for the ablation,<br>excision, removal, or transection of tissue or bone during head,<br>neck, ENT, or otoneurological surgical procedures. |
| Indications For Use: | The UNIDRIVE S III ENT system consists of an active control<br>unit used in conjunction with the High-Speed Micro Motor and<br>DrillCut-X® II Shaver handpieces. The system is intended for<br>use by qualified surgeons to provide controlled cutting,<br>drilling, debriding, sawing, and shaving for the ablation,<br>excision, removal, or transection of tissue or bone during head,<br>neck, ENT, or otoneurological surgical procedures. |
| Technological<br>Characteristics: | The UNIDRIVE S III ENT is a modification of and<br>substantially equivalent to the UNIDRIVE S III ENT<br>(K150969) in terms of its indication for use, principle of<br>operation, patient-contacting materials and reprocessing<br>methods.<br>The subject device includes the addition of the DrillCut-X® II-<br>35 and DrillCut-X® II-35 N Shaver handpieces that have a<br>maximum rotational speed of 35,000 RPM in comparison with<br>the shaver handpieces of the predicate device that have a<br>maximum rotational speed of 12,000 RPM. |
| Non-Clinical<br>Performance Data: | The device has been tested and passed the electrical safety<br>testing and EMC testing, which is certified to be Class I<br>protection against electrical shock.<br>The UNIDRIVE S III ENT system follows the FDA<br>recognized consensus standards and is tested according to the<br>following standards:<br>• IEC 60601-1<br>• IEC 60601-1-2<br>• ISO 14971<br>• ISO 10993 |
| | |
| | Cleaning and sterilization validations were conducted for<br>patient-contacting components. The reprocessing data<br>submitted complies with the following standards:<br>ANSI/AAMI ST81:2004/(R) 2010 ANSI/AAMI ST79: 2010/A4:2013 AAMI TIR 12:2010 ANSI/AAMI/ISO 17665-1:2006 ANSI/AAMI/ISO 17665-2:2009 AAMI TIR 39:2009 The following bench testing was performed to ensure that the<br>UNIDRIVE S III ENT system meets its design specification Inspection of rotation speed and torque Bench testing demonstrated substantial equivalence to the<br>predicate device. |
| Clinical<br>Performance Data: | Clinical testing was not required to demonstrate the substantial<br>equivalence to the predicate device. Non-clinical bench testing<br>was sufficient to assess safety and effectiveness and to<br>establish the substantial equivalence of the modifications. |
| Substantial<br>Equivalence: | The conclusions drawn from the nonclinical test such as the<br>risk evaluation on the modification of the system, biological<br>evaluation summary, cleaning and sterilization summary<br>demonstrated that the subject device is as safe and as effective<br>as the predicate device. Both systems also comply with<br>identical standards and safety testing, where applicable.<br>As such, we concluded that the substantial equivalence of the<br>subject and the predicate device has been met, and the<br>differences between the subject and predicate do not raise new<br>questions of safety and effectiveness. |
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