KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES

K053262 · KARL STORZ Endoscopy-America, Inc. · ERL · Dec 19, 2005 · Ear, Nose, Throat

Device Facts

• Record ID: K053262
• Device Name: KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: ERL · Ear, Nose, Throat
• Decision Date: Dec 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The STAMMBERGER Paranasal Shaver 90° Handpiece, the straight Micro- Shaver or the STAMMBERGER-CASTELNUOVO DrillCut-X Shaver Handpiece in conjunction with the UNIDRIVE ENT control unit is a motorized, reusable surgical device system, intended for use by qualified surgeons to shave, debride, or cut tissue during Head, Neck, ENT and Otoneurological surgical procedures. The KSEA Stammberger-Sachse Intranasal Drill or ENT Drill in conjunction with the UNIDRIVE ENT control unit is a motorized, reusable surgical device system, intended for use by qualified surgeons to provide controlled cutting, drilling, and removal of bone during Head, Neck, ENT and Otoneurological surgical procedures.

Device Story

UNIDRIVE ENT System is a motorized, reusable surgical device system comprising a control unit, footswitch, and various handpieces (shavers and drills). Used by surgeons in ENT, Head, Neck, and Otoneurological procedures. Handpieces connect to the control unit to provide suction and motorized rotation of blades or burs. Surgeons operate the system via footswitch to control speed and mode (Forward, Reverse, Oscillation). System enables controlled tissue shaving, debridement, and bone removal. Benefits include precise surgical access and tissue management in endoscopic procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Motorized surgical system; handpieces include shavers and drills. Materials: surgical grade stainless steel, tungsten carbide, diamond dust. Connectivity: control unit with footswitch. Operation: motorized rotation (FWD/REV/OSC modes). Sterilization: autoclavable. Dimensions: 0.6-7.0 mm diameter range for burs/shavers.

Indications for Use

Indicated for qualified surgeons to shave, debride, or cut tissue and to provide controlled cutting, drilling, and removal of bone during Head, Neck, ENT, and 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 II/II PLUS (K003994)
• XPS 3000 (K041413)
• XPS 3000 Bone Drill (K002224)

Submission Summary (Full Text)

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Karl Storz Endoscopy-America, Inc.

600 Cornorate Pointe 5th Flo Culver City, California 90230-7600 Phone [phone]

Fax [phone]

DEC 1 9 2005

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information 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.

| Applicant: | Karl Storz Endoscopy - America, Inc.<br>600 Corporate Pointe Drive<br>Culver City, CA 90230<br>[phone] |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Yvonne Fernandez/Sr. Regulatory Affairs Specialist |
| Device Identification: | Common Name: Surgical ENT Shaver/ENT Drill<br>Trade Name: UNIDRIVE ENT & Accessories |

Indications: The KSEA Paranasal Sinus Shaver, Micro Shaver or Stammberger-Castelnuovo DrillCut-X Shaver in conjunction with the UNIDRIVE ENT control unit is a motorized, reusable surgical device system, intended for use by qualified surgeons to shave, debride, or cut tissue during Head, Neck, ENT and Otoneurological surgical procedures. The KSEA Stammberger-Sachse Intranasal Drill or the INTRA Drill in conjunction with the UNIDRIVE ENT control unit is a motorized, reusable surgical device system, intended for use by qualified surgeons to provide controlled cutting and removal of bone during Head, Neck, ENT and Otoneurological surgical procedures.

Device Description: The UNIDRIVE ENT System is a motorized, reusable surgical device system that can be used in conjunction with Stammberger Paranasal Sinus Shaver, Micro Shaver, Stammberger-Castelnuovo DrillCut-X Shaver, Stammberger-Sachse Intranasal Drill and INTRA Drill.

Substantial Equivalence: The KSEA Stammberger Paranasal Sinus Shaver, Micro Shaver, Stammberger-Castelnuovo DrillCut-X Shaver, Stammberger-Sachse Intranasal Drill and INTRA Drill are substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in design and dimensions between the subject devices and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices.

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| TABLE 1: SUBSTANTIAL EQUIVALENCE TABLE FOR ENT SHAVER BLADES AND CUTTERS |
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| Device | UNIDRIVE ENT Shaver<br>Handpieces | UNIDRIVE II/II PLUS<br>(K003994) Paranasal Sinus<br>Shaver Handpiece | XPS 3000 (K041413)<br>Magnum II/M4 Microresector |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Basic Features | Handpiece w/Suction<br>Control Unit w/Footswitch | Same | Same |
| | Straight or Angled (90°) Design | Angled (90°) Design | Straight/"Sculpted" |
| Maximum Speed (rpm)/<br>Modes | 3,500 - 12,000/FWD-REV;<br>3,000 - 7,000/OSC | 3,000/FWD;REV;OSC | 15,000/FWD;REV<br>5,000/OSC |
| Blade/<br>Sinus Burr Dimensions | O.D.: 3.0 - 5.0 mm<br>Lengths: 12 cm | O.D.: 2.0 - 4.0 mm<br>Lengths: 7-12 cm | O.D.: 2.0 - 6.0 mm<br>Lengths: unknown |
| Autoclavable | Yes | Yes | Yes |
| Body Contacting<br>Material | Stainless steel | Same | Stainless steel and medical polymer |
| Intended Use | To shave, debride or cut tissue<br>during Head, Neck, ENT and<br>Otoneurological surgical<br>procedures. | To shave, debride or cut<br>tissue during ENT endoscopic<br>surgical procedures. | Shaving, debridement and cutting<br>of soft tissue and bone during<br>Head, Neck, ENT, Otoneurological,<br>Aesthetic and Arthroscopic surgical<br>procedures. |
| | TABLE 2: SUBSTANTIAL EQUIVALENCE TABLE FOR STAMMBERGER SACHSE INTRANASAL DHILL | | |
| Device | JNIDRIVE ENT | UNIDRIVE II/II PLUS | XPS 3000 Bone Drill (K00222 |
| | ntranasal Dril | K003994) Intranasal Dril | |
| asic Features | andpiece w/Suction | Same | Same |
| | Control Unit w/Footswitch | Same | Same |
| | lesigr<br>Straight or Angled (90°) D | Angled (90°) Design | Angled Desigr |
| laximum Speed (rpm | 60,000 | 20,000 | 80,000 |
| Abrader Dimension | Diameters: 2.5 - 5.0 mm | Diameters: 2.5 - 3.0 mn | Unavailable |
| utoclavable | Yes | Yes | Yes |
| | | Same | Titanium; aluminum coated with |
| Body Contacting Material | | | fluoroplastic/carbide; diamond dust |
| ntended Use | Surgical grade stainless steel; diamond dust covered heads To provide contriled contribute and To provide contrilled contribution and Neck, ENT and Otone undering and other a | To provide controlled | To provide controlled shaving, debridement |
| | | cutting and removal of bone | cutting and removal of soft and bone tissue |
| | | issue during ENT | during Head, Neck, ENT and |
| | surgical procedures. | procedures | Otoneurological surgical procedure |
| | | | |
| Device | UNIDRIVE ENT<br>INTRA Drill Handle | UNIDRIVE II/III PLUS (K003994)<br>ENT Drill | XPS 3000 Bone Drill (K002224) |
| Basic Features | Handpiece w/Suction<br>Control Unit w/Footswitch<br>Angled (90°) Design | Same<br>Same<br>Straight or Angled Design | Same<br>Same<br>Angled Design |
| Maximum Speed (rpm) | 40,000 | 40,000 | 80,000 |
| Abrader/Burr | | Diameters: 0.6 - 7.0 mm | Unavailable |
| Dimensions | Diameters: 0.6 - 7.0 mm<br>Lengths: 5.7-12.5 cm | Length: 5.7-12.5 cm | |
| Body Contacting<br>Material | Surgical grade stainless steel;<br>tungsten carbide; diamond dust | Surgical grade stainless steel;<br>tungsten carbide; diamond dust | Titanium; aluminum coated with<br>fluoroplastic/carbide; diamond<br>dust |
| Intended Use | To provide controlled cutting and<br>removal of bone tissue during<br>Head, Neck, ENT and<br>Otoneurological surgical<br>procedures. | To provide controlled cutting and<br>removal of bone tissue during ENT<br>endoscopic surgical procedures. | To provide controlled shaving,<br>debridement, cutting and<br>removal of soft and bone tissue<br>during Head, Neck, ENT and<br>Otoneurological surgical<br>procedures. |

# ANASAI DRIL

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table 3: Substantial Equivalence Table For DRILLS

Signed:

Yvonne Fernandez

Yvonne Fernandez
Sr. Regulatory Affairs Specialist

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing the feathers.

### Public Health Service

DEC 1 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Karl Storz Endoscopy-America, Inc. c/o Ivonne Fernandez Sr. Regulatory Affairs Specialist 600 Corporate Pointe 5th Floor Culver City, California 90230

Re: K053262

Trade/Device Name: KSEA Unidrive ENT System and Accessories 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: November 18, 2005 Received: November 22, 2005

Dear Ms. Fernandez:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for association 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 r ou may, diere, mains of the Act include requirements for annual registration, listing of general oonline profition 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 such additional controls. Existing major regulations affecting your device can may oc subject to back as back 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 r lease oc acrised that i Dr bratian that your device complies with other requirements of the Act that I Dr hand statutes and regulations administered by other Federal agencies. You must of any I cuolul statures than oggaments, including, but not limited to: registration and listing comply with an the Hee req (21 CFR Part 801); good manufacturing practice requirements as set (2) CFR Part 807), acceming (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Ivonne Fernandez

This letter will allow you to begin marketing your device as described in your Section 510(k) Premarket notification. The FDA finding of substantial equivalence of your device to a legally prematicated predicated. The aclassification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please It you attire of Compliance at [phone]. Also, please note the regulation entitled, Contact the Ories of Colling of Colling the mart 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general intermational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

David M. Whipple

Acting 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 black rectangular object with the words "STORZ" and "KARL STORZ ENDOSCOPE" written in white. The word "STORZ" is written in a stylized font, with the letters overlapping each other. The words "KARL STORZ ENDOSCOPE" are written in a simpler font, and are located below the word "STORZ". There is a white circle on the left side of the object.

Karl Storz Endoscopy-America, Inc.

600 Corporate Pointe 5th Floor Culver City, California 90230-7600 Phone [phone]

Toll Free 800 421 0837 Fax [phone]

# 510(k) Number (if known): K053262

Device Name: UNIDRIVE ENT System and Accessories

Indications for Use:

The STAMMBERGER Paranasal Shaver 90° Handpiece, the straight Micro-The OTAMMBERGER or the STAMMBERGER-CASTELNUOVO DrillCut-X Shaver Shaver Handpiece in conjunction with the UNIDRIVE ENT control unit is a motorized, reusable surgical device system, intended for use by qualified surgeons to shave, reasublo burgiour as not of the of the and Otoneurological surgical procedures.

The KSEA Stammberger-Sachse Intranasal Drill or ENT Drill in conjunction with the UNIDRIVE ENT control unit is a motorized, reusable surgical device system, intended for use by qualified surgeons to provide controlled cutting, drilling, intonious of as a removal of bone during Head, Neck, ENT and Otoneurological surqical procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use: | <span></span> ✓ |
|----------------------|--------------------------|
| (Per 21 CFR 801.109) | |
| | OR Over-The-Counter Use: |
| | (Optional Format 1-2-96) |

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

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