(231 days)
Temporary implant for ventilation and drainage of middle ear.
Temporary implant for ventilation or drainage of the middle ear.
The umbrella-type implant comes mounted on a tiny single-use trocar point. Its penetrating edge penetrates the tympanic membrane and simultaneously forms a passage to draw the ventilation tube into that passage at a controlled rate until the ventilation tube is implanted. The trocar is immediately withdrawn. The procedure requires the use of a specially designed trocar handle. The tubes are available with or without retention wires.
Here's an analysis of the provided text regarding the acceptance criteria and study for the 77 ETD Trocar Ventilation Tube:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a quantitative or pass/fail format that would be typical for a device performance study. Instead, it justifies the device's safety and effectiveness through a comparison to a predicate device and by highlighting design modifications that are presented as improvements or at least not introducing new risks. Therefore, the "acceptance criteria" inferred here are based on the claims made about the device's design and its impact on the procedure and patient safety.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Safety: Device materials are safe and have a history of safe use. | Met: "The ventilation tube is provided in gilded silver or pure titanium. Both materials have a long history of safe and effective use. The trocar point and handle are manufactured of stainless surgical steel." "Testing in a 7.0 Tesla nuclear magnetic resonance (NMR) tomograph has revealed no implant movement and no adverse tissue effects attributable to MRI-generated heating." |
| Effectiveness (Procedural Efficiency): Eliminates the need for prior paracentesis, leading to a shorter procedure. | Met: "Elimination of need for prior paracentesis. Simultaneous 1. incision of tympanic membrane and implant insertion. Considerably shorter procedure." (Compared to predicate device which requires "Insertion after prior paracentesis.") |
| Effectiveness (Secure Placement & Reduced Complications): Secure placement, precise cut, reduced incrustation, minimal trauma. | Met: "Secure placement due to precise cut. Reduced incrustation susceptibility due to clean and precise cut. Minimal trauma as considerably less invasive than traditional VT placement." "The precise cut and secure placement of the implant should reduce the risk of premature extrusion or dislocation. Reduced incrustation susceptibility due to clean and precise cut." "The simultaneous incision of the tympanic membrane/insertion of the tube significantly shortens the procedure while providing a controlled, precise cut for secure implant placement. This surgical technique should minimize patient trauma and reduce the risks of premature implant extrusion or dislocation." |
| No New Risks: Design modifications do not introduce new safety or effectiveness concerns. | Met: "The umbrella design of the ventilation tube comparable to many others on the market - introduces no new risks. There are no additional characteristics known that should adversely affect the safety and effectiveness of these implants." "The results of design validation raise no new issues of safety and effectiveness." |
| Substantial Equivalence: Device is substantially equivalent to legally marketed predicate devices. | Met: The FDA's 510(k) clearance letter states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." |
2. Sample size used for the test set and the data provenance
The document does not describe a specific clinical study with a test set of human subjects or data. The submission relies on a comparison to a predicate device and statements about the inherent properties of the materials and design. The only "testing" mentioned is MRI compatibility testing, which is a bench test, not a clinical study on a test set.
- Sample Size (Test Set): Not applicable, no clinical test set described.
- Data Provenance: Not applicable, no clinical data described beyond material properties and design rationale.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth for a test set is established as there is no clinical test set described. The evaluation is based on engineering design, material properties, and comparison to existing technology.
4. Adjudication method for the test set
Not applicable, as no test set or clinical study is described.
5. 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 applicable. This is not an AI/software device, and no MRMC study or any clinical comparative effectiveness study is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm, so standalone performance is not relevant in this context.
7. The type of ground truth used
The "ground truth" in this context is implicitly established by:
- Material properties and historical use: The safety of gilded silver, pure titanium, and surgical stainless steel is well-established through their long history of use in medical devices.
- Engineering design principles: Claims about precise cuts, secure placement, and reduced trauma are based on the mechanical design of the device and how it interacts with the tympanic membrane.
- Predicate device comparison: The substantial equivalence argument relies on the established safety and effectiveness of the existing K 973226 models.
- MRI compatibility testing: This bench testing provides "ground truth" for the device's behavior in an MRI environment.
8. The sample size for the training set
Not applicable, as no training set for a machine learning algorithm or clinical data for training is described.
9. How the ground truth for the training set was established
Not applicable, as no training set is described.
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K07 1150.
Special 510(k): 77 ETD Trocar Ventilation Tube
DEC 12 2007.
2. 510(k) SUMMARY of Safety and Effectiveness
As required by Section 807.92(c)
| 2.1 | Submitter: [807.92 (a)(1)] |
|---|---|
| Heinz Kurz GmbH Medizintechnik | |
| Tübinger Str. 3 | |
| D-72144 Dusslingen | |
| Germany | |
| Tel. +49-7072-91 79 0 | |
| Fax +49-7072-91 79 79 | |
| eMail info@kurzmed.de |
| 2.2 | Contact Person: [807.92 (a)(1)] | ||
|---|---|---|---|
| Dagmar S. Mäser | |||
| Business Support International | |||
| Amstel 320-l | Tel. | +31-20-428 95 91 | |
| 1017 AP Amsterdam | Fax | +31-20-428 94 29 | |
| The Netherlands | bsi@xs4all.nl |
2.3 Date Summary Prepared: [807.92 (a)(1)] April 17, 2007
- Device Names: [807.92 (a)(2)] 2.4 Proprietary Trocar Ventilation Tube
| Common | Ventilation, Tympanostomy or MyringotomyTube |
|---|---|
| Classification | Tube, Tympanostomy |
| Product Code | 77 ETD |
| Regulation # | CFR 874.3880 |
2.5 Reason for Submission:
Change in design and inclusion of sterile, single-use trocar point
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2.6 Intended Use: {807.92 (a)(5)] Temporary implant for ventilation and drainage of middle ear.
2.7 Modification of Existing Device: [807.92 (a)(3)]
K 973226 Models: Tuebingen, Tympanic (1 or 2 eyes), Beveled, Minimal Cleared 11/04/1997
2.8 Device Description: [807.92(a)(4)+(6)]
The umbrella-type implant comes mounted on a tiny single-use trocar point. Its penetrating edge penetrates the tympanic membrane and simultaneously forms a passage to draw the ventilation tube into that passage at a controlled rate until the ventilation tube is implanted. The trocar is immediately withdrawn. The procedure requires the use of a specially designed trocar handle.
The tubes are available with or without retention wires.
2.9 Reasons for Device Modification: [807.92 (d)]
- Elimination of need for prior paracentesis. Simultaenous 1. incision of tympanic membrane and implant insertion
-
- Considerably shorter procedure
-
- Secure placement due to precise cut
- Reduced incrustation susceptibility due to clean and 4. precise cut
-
- Minimal trauma as considerably less invasive than traditional VT placement
2.10 Industry Standards: [807.92 (d)]
KURZ certifies compliance with all appropriate industry standards and the validation of methods and processes covered by these standards.
2.11 MRI Environment: [807.92 (d)]
Testing in a 7.0 Tesla nuclear magnetic resonance (NMR) tomograph has revealed no implant movement and no adverse tissue effects attributable to MRI-generated heating.
2.12 Information Bearing on the Safety and Effectiveness:
(807.92 (b)(3)]
The ventilation tube is provided in gilded silver or pure titanium. Both materials have a long history of safe and effective use. The trocar point and handle are manufactured of stainless surgical steel. The trocar point projects just enough to penetrate the membrane and to create the opening for positioning the ventilation tube. The precise cut and secure placement of the implant should reduce the risk of premature extrusion or
13
{2}------------------------------------------------
dislocation. The umbrella design of the ventilation tube comparable to many others on the market - introduces no new risks. There are no additional characteristics known that should adversely affect the safety and effectiveness of these implants.
The results of design valldation raise no new issues of safety and effectiveness.
{3}------------------------------------------------
15
2.13 COMPARISON of DESIGN + SAFETY and EFFECTIVENESS
| Device | Trocar Ventilation Tube | Tübingen, Tympanic w/1 or 2 Eyelets,Beveled |
|---|---|---|
| 510(k) | Pending | K-973226 |
| Catalog # | 1015 074, 1015 0751015 076, 1015 077 w/retention wire | Tübingen 1015 020 - 1015 033T/Eyelets 1015 064 - 1015 065Beveled 1015 051 - 1015 056 |
| IntendedUse | Drainage and ventilation of middle earsubsequent to acute otitis media | Identical |
| Design | Umbrella or conic end on bobbin basemounted on sterile, single-use trocar tipwhich is withdrawn after implantplacement | Typical bobbin shape, with eyelets, beveled opening,and others |
| Accessories | Trocar Handle (reusable)Cat. # 8000 143 | None |
| # of Sizes | 1 | Tübingen 2T/Eyelets 1 eachBeveled 3 |
| Diameters | ID: 1.25 mmOD: 2.80 mm | Tübingen ID 1.25/1.50 OD 2.55/2.80T/Eyelets ID 1.50 OD 2.80/3.80/4.80Beveled ID 0.75/1.25/1.50 OD 1.60/2.55/2.80 |
| ImplantPlacement | Simultaneous Incision and Insertion | Insertion after prior paracentesis |
| Material | Implant:Titanium ASTM F67 & Gilded SilverTrocar Tip & Handle:1.4305/AISI 303 Surg.Stainless Steel | ImplantsGold-Platinum, Gilded Silver, Titanium |
| Single Use | VT & Trocar Tip YesTrocar Handle Reusable | Ventilation Tubes Yes |
| Sterile | VT & Trocar Tip YesTrocar Handle No | Ventilation Tubes Yes |
| DesignComparison | The tip extending into the tympaniccavity is conical; substantiallyequivalent bobbin base | Typical bobbin design, with eyelets, various openings |
| Safety &Effectivenessof DesignChange[807.92(b)(1)] | The simultaneous incision of thetympanic membrane/insertion of thetube significantly shortens theprocedure while providing a controlled,precise cut for secure implantplacement. This surgical techniqueshould minimize patient trauma andreduce the risks of premature implantextrusion or dislocation.There are no additional characteristicsknown that should adversely affect thesafety and effectiveness of theseimplants.The results of design validation raiseno new issues of safety andeffectiveness. | |
| Date 18/04/2007 12:10 | Date 04/19/07Signature | Heinz Kurz GmbHMedizintechnikTübinger Strasse 8D-72144 Dusslingen GermanyPhone +49 (0) 70 72 91 79 - 0Telefax +49 (0) 70 72 91 79 79Uwe Steinhardt kurzmed.com |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEPARTMENT OF HEALTH & HUMAN SERVICES USA
DEC 1 2 2007
Heinz Kurz GmbH Medizintechnik c/o Dagmar Maeser Business Support International Amstel 320-1 Amsterdam, Netherlands D72144
Re: K071150
Trade/Device Name: Trocar Ventilation Tube Regulation Number: 21 CFR 874.3880 Regulation Name: Tympanostomy tube Regulatory Class: Class II Product Codc: ETD Dated: April 19, 2007 Received: April 25, 2007
Dear Ms. Maeser:
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.
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 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 dctermination 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 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 – Dagmar Maeser
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Eglebus, MD
Malvina B. 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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t 11
Indications for Use
510(k) Number (if known):
| Device Name: | Trocar Ventilation Tube |
|---|---|
| Indications for Use: | Temporary implant for ventilation or drainage of themiddle ear. |
| Special Feature: | Design eliminates need for prior paracentesis:Simultaneous incision and implant placement. |
4/23/2007 5:17 PM
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kace A. Bohn
ohthalmic Ear. hroat Devises
umber K071150
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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.