KURZ Silicone Strips are placed over the tympanic membrane after surgical procedures in the middle ear to reduce the risk of adhesion to the surgical packing and to aid in the prevention of canal granulation and polyp formation.
KURZ Silicone Strips are designed to temporarily cover the tympanic membrane after surgical procedures in the middle ear.

Device Description

KURZ Silicone Strips are manufactured from a medical grade silicone elastomer cut to size specifically for use within the external ear canal following ear surgery. The pliable, soft consistency of the silicone strips adapts itself to the shape of the auricular canal without further shaping by the physician, which saves valuable time in the operating room. KURZ Silicone Strips are intended for single use and are provided sterile. They require no further processing. They will be supplied transparent, white or transparent with blue stripes. Application, use and technical characteristics of the three presentations are identical. Choice of one or the other is entirely a matter of personal preference of the operating surgeon. Some surgeons prefer the transparent silicone strip, since the healing process can be checked without removing the dressing. Others prefer the white silicone strip, since they find it easier to see and handle. The transparent strips imprinted with blue stripes combine both advantages. The healing process can be observed through the transparent parts of the silicone, while the blue stripes make the silicone strips easily visible.

AI/ML Overview

The provided document does not describe any acceptance criteria or the results of a study that proves the device meets specific performance criteria.

Instead, the document is a 510(k) Premarket Notification Summary for the KURZ Silicone Strips. This type of submission to the FDA focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device), rather than presenting new clinical study data with acceptance criteria for device performance.

Therefore, I cannot provide the requested information, as it is not present in the provided text.

Here's why the document doesn't contain the requested information:

510(k) Substantial Equivalence: The core of a 510(k) submission is to show that a new device is as safe and effective as another legally marketed device. This is typically done by comparing technological characteristics, intended use, and materials.
No Clinical Performance Studies: For devices like these silicone strips (classified as Class II, Elastomer, Silicone Block), a detailed clinical performance study with acceptance criteria, sample sizes, expert ground truth, and statistical analysis is generally not required for 510(k) clearance. The comparison is primarily based on material properties, dimensions, and intended use as compared to the predicate.
Biocompatibility Testing: The document mentions biocompatibility testing, but this is a safety test and not a performance study as would be described in terms of diagnostic accuracy or therapeutic efficacy with clear acceptance criteria for a device's functional performance.

To answer your specific points, this document indicates:

A table of acceptance criteria and the reported device performance: Not present. The "SE COMPARISON TABLE" is for Substantial Equivalence comparison of characteristics, not performance criteria.
Sample size used for the test set and the data provenance: Not applicable. No test set for performance evaluation is described.
Number of experts used to establish the ground truth...: Not applicable. No ground truth for performance evaluation is described.
Adjudication method: Not applicable. No performance study requiring adjudication is described.
Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. No such study is described.
Standalone performance study: Not applicable. No standalone performance study is described.
Type of ground truth used: Not applicable. No ground truth for performance evaluation is described.
Sample size for the training set: Not applicable. There is no mention of a training set as this is not an AI/ML device or a device requiring such data.
How the ground truth for the training set was established: Not applicable.

The document states that the KURZ Silicone Strips are substantially equivalent in function, performance and material to Silicone Elastomer Sheeting marketed by Specialty Surgical Products, Inc., K974653. This "substantial equivalence" is the primary "proof" for 510(k) clearance, not a performance study against specific acceptance criteria.

Summary

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'JAN 3 0 2004

K033796

Section 2

510(k) SUMMARY of Safety and Effectiveness

(as required by Section 807.92)

Applicant:	Heinz Kurz GmbH MedizintechnikTübinger Str. 3D-72144 DusslingenGermanyTel. 011-49-7072-91790Fax 011-49-7072-917979E-mail: info@kurzmed.de
Contact Person:	Angelika ScherpBusiness Support InternationalAmstel 320-11017AP AmsterdamThe NetherlandsTel. 011-31-20-428-9591Fax 011-31-20-428-9429E-mail: bsi@xs4all.nl
Proprietary Name:	KURZ Silicone Strips
Common Name:	Silicone Strips
Classification Name:	Elastomer, Silicone Block
SubstantialEquivalence:	KURZ Silicone Strips are substantially equivalent infunction, performance and material to Silicone Elastomer Sheetingmarketed by Specialty Surgical Products, Inc., K974653.
Device Description:General	KURZ Silicone Strips are manufactured from a medical gradesilicone elastomer cut to size specifically for use within the externalear canal following ear surgery. The pliable, soft consistency of thesilicone strips adapts itself to the shape of the auricular canalwithout further shaping by the physician, which saves valuabletime in the operating room.KURZ Silicone Strips are intended for single use and are providedsterile. They require no further processing. They will be suppliedtransparent, white or transparent with blue stripes. Application, useand technical characteristics of the three presentations areidentical. Choice of one or the other is entirely a matter of personalpreference of the operating surgeon. Some surgeons prefer thetransparent silicone strip, since the healing process can bechecked without removing the dressing. Others prefer the whitesilicone strip, since they find it easier to see and handle. Thetransparent strips imprinted with blue stripes combine both

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K033796

	advantages. The healing process can be observed through thetransparent parts of the silicone, while the blue stripes make thesilicone strips easily visible.
Dimensions	0.12 x 45 x 6 mm (thickness, length, width)
Colors	1. Transparent2. White3. Transparent with blue stripes
Packaging	Each package contains ten sterile (10) pouches with threestrips/pouch
Intended Use:	KURZ Silicone Strips are placed over the tympanic membraneafter surgical procedures in the middle ear to reduce the risk ofadhesion to the surgical packing and to aid in the prevention ofcanal granulation and polyp formation. Using conventional otologicpliers and tweezers, the three sterile strips contained in one pouchare placed one over the other covering the tympanic membrane ina star-shaped pattern, with the atraumatic, rounded end toward theanterior meatal flap. The center of the strip is inserted to overly thetympanic membrane.
	Once the wound has healed, the silicone strips are removed fromthe auricular canal by the physician, should they not be expelledwith the tamponage or upon disintegration of the gelatinoustamponage. This usually takes place after 10-21 days.
Predicate Device:	KURZ Silicone Strips are substantially equivalent in material,function and performance to Silicone Elastomer Sheeting marketedby Specialty Surgical Products, Inc. However, they are precut andrarely need additional shaping.
Sterilization:	KURZ Silicone Strips are sterilized by low-temperature gas plasmato avoid the degrading effects of steam or the residues of ethyleneoxide. The sterility assurance level (SAL) for the KURZ SiliconeStrips will be 10-6.
Biocompatibility:	The silicone elastomer, coloring agents and packaging materialwere tested for biocompatibility in conformance with internationaland FDA-recognized standards, including the FDA "Blue BookMemorandum" based on ISO 10993 Part 1 "Biological Evaluationof Medical Devices". KURZ Silicone Strips present no safetyrisks or hazards and are safe and effective for the indicated use.
Information Bearing on Safety and Effectiveness	[807.92(b))3)]There are no additional characteristics known that shouldadversely affect the safety and effectiveness of KURZ SiliconeStrips. The results of design validation raise no issues ofsafety and effectiveness.

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K033796

SE COMPARISON TABLE

	KURZ	SPECIALTYSURGICALPRODUCTSK974653	AESTHETIC &RECONSTRUCTIVETECHNOLOGIESK022223	SE
Material	Silicone sheeting	Silicone sheeting	Silicone sheeting	YES
Sterility	Sterile	Not labeled	Sterile	YES
Indications for Use	Temporary protectivesheathing forthe external earcanal	Temporary protectivesheathing forthe external earcanal	Temporary protectivesheathing for the externalear canal	YES
Measurements	0.12 x 45 x 6 mm	Cut to size by user	Cut to size by user	YES
Reusable	No	No	No	YES
Coloring Agents	1% TitaniumDioxide NuSilMED3-4502(USP Grade)Silicone Coating /Marking InkNuSil R1008-7	Not labeled	Not labeled
Biocompatible	Yes	Yes	Yes	YES

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or waves, stacked vertically.

JAN 3 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Heinz Kurz GmbH Medizintechnik c/o Angelika Scherp Business Support International Amstel 320-1 1017 AP Amsterdam The Netherlands

Re: K033796

Trade/Device Name: KURZ Silicone Strips Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: Class II Product Code: KHJ Dated: December 3, 2003 Received: December 5, 2003

Dear Ms. Scherp:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use suned in also encreated of the Medical Device Amendments, or to devices that proble to thay 20, 1978, and cordance 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 therefore, mainer the 00 1.000 include requirements for annual registration, listing of devices, good ecanofacturing 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 n your device to such additional controls. Existing major regulations affecting your device can be may be subject to sain adata 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 1 tease of advisod that 127 rination that your device complies with other requirements of the Act or that Federal statutes and regulations administered by other Federal agencies. You must comply with ally t oderal blankted une registration of limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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Page 2 - Angelika Scherp

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 marketed predicate device results in a classification 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 contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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/dsma/dsmamain.html

Sincerely yours,

A helyl Rosenthal

A. Ralph Rosenthal, 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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Traditional 510(k) ENT Devices Branch HFZ-460

510(k) Number

K033 796

Device Name

Silicone Strips

INDICATIONS FOR USE

KURZ Silicone Strips are designed to temporarily cover the tympanic AORE Officent after surgical procedures in the middle ear.

Signature

(Division Sign-Off) Division o onthalmic Ear, Nose and ithroat Devis

510(k) Number K033796

(Please Do NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per CFR 801 109) OR

Over-The-Counter Use

(Optional Formal 1-2-96)

A - 1

Regulation Number and Section

§ 874.3620 Ear, nose, and throat synthetic polymer material.

(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.