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.

AI/ML Overview

This 510(k) premarket notification for the KSEA UNIDRIVE ENT System and Accessories describes the device and its substantial equivalence to predicate devices, but does not contain a study presenting acceptance criteria and device performance results.

The document focuses on demonstrating substantial equivalence based on design features, intended use, and existing predicate device classifications, rather than on specific performance testing with predetermined acceptance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria from the provided text.

Specifically, the following details are missing:

A table of acceptance criteria and the reported device performance: This document provides a "Substantial Equivalence Table" comparing features of the subject device to predicate devices, but it does not list performance metrics or acceptance criteria related to a specific study.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. This device is a surgical shaver/drill, not an AI-powered diagnostic tool, so an MRMC study would not be applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. Again, not applicable for this type of device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

The document indicates that "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." This suggests that the substantial equivalence argument relies on the similarity of the device to already approved devices rather than new performance studies with specific acceptance criteria.

Summary

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Image /page/0/Picture/0 description: The image shows a black and white graphic of the word "STOLPER". The letters are stylized with a double-line effect, giving them a retro or vintage appearance. The word is horizontally oriented, and the contrast between the black background and white letters makes it stand out.

Karl Storz Endoscopy-America, Inc.

600 Cornorate Pointe 5th Flo Culver City, California 90230-7600 Phone 310 338 8100

Fax 310 410 5527

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.600 Corporate Pointe DriveCulver City, CA 90230(310) 338-8100
Contact:	Yvonne Fernandez/Sr. Regulatory Affairs Specialist
Device Identification:	Common Name: Surgical ENT Shaver/ENT DrillTrade 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

Device	UNIDRIVE ENT ShaverHandpieces	UNIDRIVE II/II PLUS(K003994) Paranasal SinusShaver Handpiece	XPS 3000 (K041413)Magnum II/M4 Microresector
Basic Features	Handpiece w/SuctionControl Unit w/Footswitch	Same	Same
	Straight or Angled (90°) Design	Angled (90°) Design	Straight/"Sculpted"
Maximum Speed (rpm)/Modes	3,500 - 12,000/FWD-REV;3,000 - 7,000/OSC	3,000/FWD;REV;OSC	15,000/FWD;REV5,000/OSC
Blade/Sinus Burr Dimensions	O.D.: 3.0 - 5.0 mmLengths: 12 cm	O.D.: 2.0 - 4.0 mmLengths: 7-12 cm	O.D.: 2.0 - 6.0 mmLengths: unknown
Autoclavable	Yes	Yes	Yes
Body ContactingMaterial	Stainless steel	Same	Stainless steel and medical polymer
Intended Use	To shave, debride or cut tissueduring Head, Neck, ENT andOtoneurological surgicalprocedures.	To shave, debride or cuttissue during ENT endoscopicsurgical procedures.	Shaving, debridement and cuttingof soft tissue and bone duringHead, Neck, ENT, Otoneurological,Aesthetic and Arthroscopic surgicalprocedures.
	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
	lesigrStraight 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 ENTINTRA Drill Handle	UNIDRIVE II/III PLUS (K003994)ENT Drill	XPS 3000 Bone Drill (K002224)
Basic Features	Handpiece w/SuctionControl Unit w/FootswitchAngled (90°) Design	SameSameStraight or Angled Design	SameSameAngled 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 mmLengths: 5.7-12.5 cm	Length: 5.7-12.5 cm
Body ContactingMaterial	Surgical grade stainless steel;tungsten carbide; diamond dust	Surgical grade stainless steel;tungsten carbide; diamond dust	Titanium; aluminum coated withfluoroplastic/carbide; diamonddust
Intended Use	To provide controlled cutting andremoval of bone tissue duringHead, Neck, ENT andOtoneurological surgicalprocedures.	To provide controlled cutting andremoval of bone tissue during ENTendoscopic surgical procedures.	To provide controlled shaving,debridement, cutting andremoval of soft and bone tissueduring Head, Neck, ENT andOtoneurological surgicalprocedures.

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 (301) 827-8910. 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 (800) 638-2041 or (301) 443-6597 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 310 338 8100

Toll Free 800 421 0837 Fax 310 410 5527

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:	✓
(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

000003

Regulation Number and Section

§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.

(a)
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.(b)
Classification. Class II.