Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces

K150969 · Karl Storz Endoscopy America, Inc. · ERL · Jan 8, 2016 · Ear, Nose, Throat

Device Facts

• Record ID: K150969
• Device Name: Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces
• Applicant: Karl Storz Endoscopy America, Inc.
• Product Code: ERL · Ear, Nose, Throat
• Decision Date: Jan 8, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4250
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 handpiece. 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 comprising an active control unit, high-speed micro motor, and DrillCut-X II shaver handpiece. Used by surgeons in head, neck, ENT, or otoneurological procedures to cut, drill, debride, saw, and shave tissue or bone. System provides controlled mechanical power to attached handpieces and blades/burs. Operates as a reusable surgical tool; requires cleaning and sterilization between uses. Output is mechanical action at the surgical site, controlled by the surgeon via the console. Benefits include precise tissue/bone removal during complex ENT surgeries.

Clinical Evidence

Bench testing only. No clinical or animal data required. Performance testing included system verification and validation, cleaning and sterilization validation (SAL 10^-6), and manual cleaning effectiveness for residual protein and hemoglobin.

Technological Characteristics

Motorized, reusable surgical system. Components: active control unit, high-speed micro motor, shaver handpiece, blades, and burs. Sterilization: pre-vacuum steam sterilization for reusable instruments. Connectivity: system-based control unit. Materials: reusable components cleaned/sterilized; disposable tubing/burrs are single-use.

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

• KSEA UNIDRIVE ENT System and Accessories (K053262)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 8, 2016

Karl Storz Endoscopy America, Inc. Jennifer Chambers Regulatory Affairs Specialist 2151 E. Grand Ave El Segundo, California 90245

Re: K150969

Trade/Device Name: Unidrive S IIi Ent 40701601-1 With Karl Storz-scb, Drillcut-x II Shaver Handpiece, High Speed Ec Micromotor II For Use With Intra Drill Handpieces 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: December 4, 2015 Received: December 8, 2015

Dear Ms. Chambers:

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

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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.

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet

address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Eric A. Mann -S

Malvina 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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## Indications for Use

510(k) Number (if known)

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 handpiece. 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)

|X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for STORZ. The logo is in blue and consists of the word "STORZ" in large, bold letters, with a circle in the middle of the "O". Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in smaller letters.

#### 7. 510(k) Summary

Traditional Premarket Notification Submission (510(k)) Summary Prepared in accordance with 21 CFR 807.92

#### 7.1 Submitter Information

| Sponsor name: | KARL STORZ Endoscopy America, Inc. |
|-----------------------------|------------------------------------|
| Sponsor address: | 2151 E. Grand Ave. |
| | El Segundo, CA 90245 USA |
| Sponsor telephone: | 424-218-8100 |
| Sponsor fax: | 424-218-8519 |
| Establishment Registration: | 3010202439 |

| Contact person: | Jennifer Michelle Chambers<br>MPA, MBA, CCRP, CQA, PMP, RAC (US) |
|------------------------|------------------------------------------------------------------|
| Contact title: | Regulatory Affairs Specialist |
| Email direct: | [e-mail] |
| Telephone direct: | 424-218-8457 |
| Date summary prepared: | March 31, 2015 |
| Date summary updated: | January 5, 2016 |

#### 7.2 Device Name

| Trade (proprietary): | UNIDRIVE S III ENT |
|----------------------|------------------------------------------------------------------|
| Common (usual): | Drill, Surgical, ENT (Electric Or Pneumatic) Including Handpiece |
| Classification: | 21 CFR 874.4250 (Class II) |
| FDA Device Code: | ERL: Ear, nose, and throat electric or pneumatic surgical drill |
| Review Panel: | 77 (Ear Nose & Throat) |

#### 7.3 Substantially Equivalent Predicate Device

| Device Name: | KSEA UNIDRIVE ENT System and Accessories |
|----------------|------------------------------------------|
| Device 510(k): | K053262 |

#### 7.4 Device Description

The UNIDRIVE® S III ENT is a motorized surgical device system, consisting of an active control unit used in combination with: the High-Speed Micro Motor and attaching handpiece and the DrillCut-X® II Shaver handpiece (with optional attaching handle). The surgical device system provides 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.

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#### 7.5 Intended 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 handpiece. The system is intended for use by qualified surgeons to provide controlled cutting, drilling, sawing, and shaving for the ablation, excision, removal, or transection of tissue or bone during head, neck, ENT, or otoneurological surgical procedures.

#### 7.6 Technological Characteristics

The UNIDRIVE® S III ENT system and the predicate UNIDRIVE ENT system are both motorized, reusable surgical device systems, used in conjunction with drills, handpieces, blades, and burs. Both systems provide controlled cutting, drilling, sawing, and removal of bone during head, neck, ENT, and or otoneurological surgical procedures. The performance of the new device has undergone system verification and validation testing to ensure it does not introduce new issues of safety or effectiveness.

#### 7.7 Performance Characteristics

Nonclinical performance characteristics evaluated in support of the substantial equivalence of the UNIDRIVE® S III ENT include system verification and validation testing. Study results demonstrate adherence to design specifications. Experiments vielded consistent results. Consistent test conditions were maintained throughout the study. Performance testing reports are provided in the Performance Testing (Bench) of this 510(k). Cleaning and sterilization validations were conducted for patient-contacting components.

#### 7.8 Cleaning and Sterilization

Reusable instruments (i.e. DrillCut-X® II Shaver handpiece, High-Speed Micro Motor and handpieces, plus compatible Straight Shaver Blades) are delivered non-sterile and must be cleaned and sterilized prior to the initial use and before each subsequent use. Compatible sinus burrs and disposable tubings are sterile, single-use products and must be disposed of after patient use. Sterility efficacy demonstrated a sterility assurance level of 106 in a pre-vacuum steam sterilizer. Manual cleaning effectiveness was demonstrated with sufficient recovery efficiency for residual protein and residual hemoglobin.

#### 7.9 Animal and Clinical Performance Data:

Animal and Clinical performance data are not required to demonstrate substantial equivalence for this type of device.

#### 7.10 Conclusion

Based on the information provided in this premarket notification. KARL STORZ concludes that the UNIDRIVE® S III ENT is safe, effective, and substantially equivalent to the predicate UNIDRIVE ENT in its indication for use, device design, materials, performance characteristics, and operational principles.