KURZ precious metal tympanostomy tubes are intended to provide a means of aerating and draining the middle ear in patients with otitis media and to reduce the likelihood of recurrent postoperative middle ear infections for the duration in which the tube remains in situ.

The MINIMAL Ventilation Tube (Benz) has been designed for

temporary ventilation of the middle ear in secretory otitis media in adult patients for whom paracentesis alone is not sufficient, yet retention time of conventional ventilation tubes would be too long.
It can also effectively be applied in cases of narrow meatus, atrophic drum and post-tympanoplasty tube dysfunctions. Due to its tiny size (dia. 0.6 mm), insertion after tympanoplasty considerably reduces risk of permanent tympanum perforation.

Tympanic tubes are inserted into the eardrum (myringotomy) for drainage and temporary ventilation of the middle ear subsequent to acute otitis media.

Tympanic tubes with one or two eyes are designed to increase the retention time in the eardrum.

The substantially shortened passage of the DIABOLO reduces the length of the internal hollow cylinder and the smooth surface of the gold seems to diminish the risk of luminal occlusion.

MINIMAL Tympanic Ventilation Tube (Benz):

Temporary ventilation of the middle ear in serous otitis media in adult patients.
In cases of narrow meatus, atrophic drum or post tympanoplasty tube dysfunction. Due to its tiny size (Diameter 0.6 mm), insertion after tympanoplasty considerably reduces the risk of permanent perforation of the tympanum.

Device Description

Typical bobbin-shaped design made of gold-platinum, gold-plated silver, and titanium; with or without a wire for secure placement and removal. Internal diameter of Size 2 is min. 0.2 mm wider than that of most predicate devices (SE: Reuter Bobbin, Collar Button).
Bobbin shape with unilateral eye extension of inner flange; made of gold-platinum alloy (SE: Spoon Bobbin, Shah Type Tube)
Bobbin shape with bi-lateral eye extensions of inner flange; made of gold-platinum alloy (SE: Most T-Tubes)
External flange is cone-shaped to reduce the length of the internal hollow cylinder; made of gold-platinum alloy (SE: Beveled Bobbin; Shepard Grommets)
Narrow tube with sharpened end for insertion without prior paracentesis. Material: gold-plated stainless steel (1.4301).

The devices are implants for single patient use. They are sold in an individual sterile package in a sealed carton.

AI/ML Overview

The provided text describes a 510(k) summary for various tympanostomy tubes manufactured by Heinz Kurz GmbH Medizintechnik. This document is a pre-market notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. As such, it focuses on demonstrating equivalence rather than presenting an independent study with acceptance criteria and device performance metrics in the typical sense for a novel AI/medical device.

Therefore, much of the requested information cannot be extracted directly from this document, as it pertains to a different type of regulatory submission (i.e., proving substantial equivalence to existing devices rather than proving a device meets specific performance criteria through a new study).

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't define specific quantitative "acceptance criteria" and "reported device performance" in the way a clinical trial or performance study for a novel device would. Instead, the acceptance is based on demonstrating "substantial equivalence" to predicate devices. The performance is implied to be equivalent to these predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Substantial equivalence to predicate devices in:	Device designs (bobbin-shaped, with/without eye extension, cone-shaped, narrow with sharpened end) are comparable to predicate devices.
- Indication for Use	Intended uses are consistent with predicate devices (aerating and draining the middle ear in otitis media, reducing recurrent infections; temporary ventilation for MINIMAL tube).
- Material	Materials (gold-platinum, gold-plated silver, titanium, gold-plated stainless steel) are comparable to predicate devices.
- Design features	Specific design features are described as analogous or improved versions (e.g., internal diameter of Tübingen Size 2 is 0.2mm wider than some predicates; DIABOLO's cone-shape reduces length).

2. Sample Size for the Test Set and Data Provenance:

Not applicable. This is a 510(k) submission based on substantial equivalence, not a new clinical study with a "test set" in the context of device performance evaluation. The data provenance would be a comparison to existing devices on the market.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not applicable. There is no mention of a "test set" requiring ground truth established by experts in this type of submission. The ground truth, in a general sense, is the performance and safety profile of the predicate devices.

4. Adjudication Method:

Not applicable. No clinical study requiring an adjudication method for a test set is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This type of study is not mentioned or relevant to a 510(k) submission for tympanostomy tubes.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This device is a physical medical implant, not an algorithm or AI.

7. Type of Ground Truth Used:

The ground truth used for this 510(k) submission is the established safety and effectiveness profile of the predicate devices already on the market. The submission aims to show that the new devices do not raise different questions of safety and effectiveness.

8. Sample Size for the Training Set:

Not applicable. There is no concept of a "training set" for physical medical devices in this context.

9. How the Ground Truth for the Training Set Was Established:

Not applicable for the same reasons as above. The "ground truth" for the predicate devices' performance would have been established through their own regulatory pathways (e.g., prior 510(k) submissions, pre-market approvals, or market history).

Summary of the Study (Implied by 510(k) process):

The "study" informing the FDA's decision in a 510(k) is a comparison of the new device to existing predicate devices.

Objective: To demonstrate that the Heinz Kurz GmbH Medizintechnik tympanostomy tubes are "substantially equivalent" to legally marketed predicate devices, meaning they have the same intended use and technological characteristics, or have different technological characteristics but do not raise new questions of safety and effectiveness and are as safe and effective as the predicate device.
Methodology: Comparative analysis of design, materials, indications for use, and performance claims against established predicate devices (XOMED, XOMED-TREACE, Smith & Nephew Richards).
"Acceptance Criteria": The FDA's acceptance of "substantial equivalence" is the ultimate acceptance criterion. This is based on a qualitative assessment of the similarities and differences, and a determination that any differences do not negatively impact safety or effectiveness.
"Performance": The performance is implicitly assumed to be equivalent to that of the predicate devices based on comparable design and materials. For example, the MINIMAL Ventilation Tube (Benz) is compared in terms of indication to specific Xomed-Treace tubes. The document also highlights specific features like the Tübingen's wider internal diameter or the DIABOLO's reduced length, implying these are equivalent or minor improvements, not causing new safety issues.

Summary

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KURZ

Heinz Kurz GmbH Medizintechnik

Hausanschrift: Tübinger Straße 3 D-72144 Dußlingen

Telefon (0 70 72) 91 79-0 Telefax (07072) 91 79-7

Heinz Kurz GmbH · Medizintechnik · Postfach 39 · D-72142 Dußlingen

K973226

NOV - 4 1997

6. 510(k) SUMMARY

As required by Section 807.92(c)

Submitter 1807.92(a){ 1)} (1) Dagmar S. Mäser Business Support International Amstel 320-1 Amsterdam, 1017AP The Netherlands
Tel. 011 - 31 - 20 - 428 9591 -428 9429 Fax

bsi@xs4all.nl e-mail

Identification of Devices 1807.92(a)(2)} (2) Tübingen Ventilation Tube Trade Names a. Tympanic Ventilation Tube b. DIABOLO Tympanic Ventilation Tubes C. MINIMAL Typanic Ventilation Tube (Benz) d. Tympanostomy Tube; Ventilation Tube Common Name Tube, Tympanostomy Classification Name Product Code 77 ETD Class II Regulatory Number 874.3880 Classification Panel ENT Branch (HFZ-470)

Identification of Predicate Devices 1807.92(a)(3)] (3)

The KURZ ventilation tubes are substantially equivalent to a wide variety of ventilation tube designs produced by XOMED and XOMED-TREACE, Jacksonville, FL, USA and by Smith & Nephew Richards, Bartlett, TN, USA. In terms of indication, the short-term MINIMAL Ventilation Tube (Benz) is substantially equivalent to the Hubbard Airplane and the Tiny Tytan Vent Tubes, manufactured by Xomed-Treace.

These devices have been found substantially equivalent through the 510(k) premarket notification process.

6-1

Update: 10/06/97

Geschäftsführer: Heinz Kurz Trauce Kurz-Buczki USt - Id. Nr. DE 81 1570328

Volksbank Steinlach-Wiesaz eG 181 7 640 618 541 Konto-Nr. 70 150 001 Baden-Württembergische Bank Tübingen (BLZ 641 200 30) Konto-Nr. 120 140 2300 Amtsgericht Tübingen HRB 1424

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Heinz Kurz GmbH Medizintechnik

510(k) Summary (Cont'd)

Description of Devices 1807.92(a)(4)] (4)

Typical bobbin-shaped design made of gold-platinum, Tübingen a. gold-plated silver, and titanium; with or without a wire for secure placement and removal. Internal diameter of Size 2 is min. 0.2 mm wider than that of most predicate devices ( SE: Reuter Bobbin, Collar Button).

Tympanic Ventilation Tube b.

Bobbin shape with unilateral eye extension of 1 Eye . inner flange; made of gold-platinum alloy (SE: Spoon Bobbin, Shah Type Tube)
Bobbin shape with bi-lateral eye extensions of inner 2 Eyes flange; made of gold-platinum alloy (SE: Most T-Tubes)

DIABOLO Ventilation Tube C.

External flange is cone-shaped to reduce the length of the internal hollow cylinder; made of gold-platinum alloy (SE: Beveled Bobbin; Shepard Grommets)

MINIMAL Ventilation Tube (Benz) d.

Narrow tube with sharpened end for insertion without prior paracentesis. Material: gold-plated stainless steel (1.4301).

The devices are implants for single patient use. They are sold in an indivi dual sterile package in a sealed carton.

Intended Use of Devices [807.92(a)(5)] (5)

The MINIMAL Ventilation Tube (Benz) has been designed for

temporary ventilation of the middle ear in secretory otitis media in adult ﺎ . patients for whom paracentesis alone is not sufficient, yet retention time of conventional ventilation tubes would be too long.
1. It can also effectively be applied in cases of narrow meatus, atrophic drum and post-tympanoplasty tube dysfunctions. Due to its tiny size (dia. 0.6 mm), insertion after tympanoplasty considerably reduces risk of permanent tympanum perforation.

Following surface anaesthesia, the tube is pushed through the tympanic membrane with alligator forceps without prior paracentesis.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is in a bold, sans-serif font. The words are stacked on top of each other. The text is black against a white background.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dagmar S. Maser Business Support International Heinz Kurz GmbH Medisintechnik Amstel 320-1 1017 AP Amsterdam The Netherlands

Re:

NOV - 4 1997

K973226 Tympanostomy Tubes; Tüububgen Ventilation Tubes (Standard) Tympanic Ventilation Tube (with one eye); Tympanic Ventilation Tube ( with 2 eyes); DIABLO Ventilation Tube and MINIMAL Ventilation Tube (Benz) Dated: July 20, 1997 Received: August 27, 1997 Regulatory class: II 21 CFR 874.3880/Procode: 77 ETD

Dear Mr. Maser:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, 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 probibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marked 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 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

William Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Heinz Kurz GmbH Medizintechnik

510(k) Number	K973226
Device Names	Tübingen, Tympanic (1 or 2 eyes), DIABOLO Ventilation Tubes

INDICATIONS FOR USE:

Tympanic tubes are inserted into the eardrum (myringotomy) for drainage and temporary ventilation of the middle ear subsequent to acute otitis media.

Tympanic tubes with one or two eyes are designed to increase the retention time in the eardrum.

The substantially shortened passage of the DIABOLO reduces the length of the internal hollow cylinder and the smooth surface of the gold seems to diminish the risk of luminal occlusion.

Placement:

The tubes are placed in the tympanic membrane to provide the means for drainage of any fluid buildup in the middle ear while creating an avenue for the passage of air to equalize pressure on either side of the drum.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Saylor

(Division Sign-Off Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use (Per CFR 801 109) Over-The-Counter Use _

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Heinz Kurz GmbH Medizintechnik

973226 (10/06/97) 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Device Names MINIMAL Tympanic Ventilation Tube (Benz)

INDICATIONS FOR USE:

Temporary ventilation of the middle ear in serous otitis media in adult patients. 1.
In cases of narrow meatus, atrophic drum or post tympanoplasty tube dysfunction. 2. Due to its tiny size (Diameter 0.6 mm), insertion after tympanoplasty considerably reduces the risk of permanent perforation of the tympanum.

This tympanic ventilation tube, constructed of gold-plated stainless steel (1.4301), has been designed for temporary ventilation in special cases in which paracentesis alone is not sufficient, yet retention time of conventional tubes would be too long. The tube features a sharpened end that can be pushed through the tympanic membrane with alligator forceps without prior paracentesis.

If the effusion is somewhat thicker than expected, an additional small paracentesis beside the tube is recommended, via which the mucous tympanum can easily be aspirated due to the pressure balance which is achieved through the ventilation tube.

Should secretion encrustation occur, the MINIMAL Ventilation Tube can be replaced without the need for surface anaesthesia and without pain to the patient as it has no internal flange but is kept in position through tissue tension.

Placement:

Following surface anaesthesia, the tube is pushed through the tympanic membrane with alligator forceps without prior paracentesis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number	K973226
---------------	---------

Prescription Use	OR	Over-The-Counter Use
(Per CFR 801 109)

KRZ-INDM.ini

(Optional Format 1-2-96)

Regulation Number and Section

§ 874.3880 Tympanostomy tube.

(a)
Identification. A tympanostomy tube is a device that is intended to be implanted for ventilation or drainage of the middle ear. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. A type of tympanostomy tube known as the malleous clip tube attaches to the malleous to provide middle ear ventilation. The device is made of materials such as polytetrafluoroethylene, polyethylene, silicon elastomer, or porous polyethylene.(b)
Classification. Class II.