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AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the VITALTEC Rota-Trach Tracheostomy Tube:

This document is a 510(k) premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device. For such submissions, the primary "study" is often a comparison to the predicate device and adherence to recognized standards, rather than a separate clinical trial with specific performance metrics like sensitivity/specificity for diagnostic AI.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in terms of performance metrics commonly seen in diagnostic device studies (e.g., sensitivity, specificity, accuracy). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device and compliance with relevant international standards.

Acceptance Criteria (Implied)	Reported Device Performance
Intended Use Equivalence	Same as predicate device: "Tracheostomy Tubes are intended for use in providing direct tracheal access for airway management."
Material Equivalence	Same as predicate device: "Silicone"
Connector Conformance	Same as predicate device; 15 O.D. per ISO 5356-1.
Sterilization Efficacy	Different method (Moist Heat vs. ETO) was "got the validation." (Implies successful testing against ISO 17665-1).
Dimensional & Design Conformance	Conformed to ISO 5356-1.
Sterility Conformance	Conformed to ISO 17665-1.
Biocompatibility	Compliance with ISO 10993-1, ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and sensitization). Stated as having "excellent biocompatibility."
General Safety & Effectiveness	Based on all the above, demonstrated substantial equivalence to predicate, indicating comparable safety and effectiveness.

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

This document does not describe a "test set" in the context of a typical algorithm or AI study. The evaluation is based on non-clinical data (bench testing, material testing, and standards conformance).

Sample Size for Test Set: Not applicable in the context of an AI study. The evaluation relies on testing of the device itself for compliance with standards and comparison specifications.
Data Provenance: Not applicable. The "data" are results from physical and biological tests conducted on the device, as well as its specifications. The manufacturer is VITALTEC CORPORATION in Taiwan, ROC.

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

Not applicable. This is not an AI or diagnostic device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The device is a medical device (tracheostomy tube), not a diagnostic algorithm where human readers would be assessing performance with or without AI assistance.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical medical device, not an algorithm. The "standalone" evaluation refers to the device's conformance to standards and its specifications.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily established by:

International Standards: ISO 5356-1 (connector dimensions), ISO 10993 series (biological evaluation), ISO 17665-1 (sterilization).
Predicate Device Specifications: The established and accepted performance and design of the previously cleared "Medical Tracheostomy Tubes (K031553)."
Physical and Biological Test Results: Data from tests demonstrating biocompatibility, sterility, and mechanical properties.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/algorithm.

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

Not applicable.

Summary

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VITALTEC CORPORATION

No.12, Lane 4-30, Chyuan Zhou Rd., Hou Li Hsiang, Taichung, 42142, Taiwan, ROC Tel: 886-4-25580886 Fax: 886-4-25568632 Email: info@vitaltec.com.tw

5. 510(K) SUMMARY (as required by 807.92(c))

JUN 11 2010

K100480

DATE OF SUBMISSION: SUBMITTER:

January 27, 2010 president, Mr. Joseph Chang VITALTEC CORPORATION No. 12, Lane 4-30, Chyuan Zhou Rd., Hou Li Hsiang, Taichung, 42142, Taiwan TEL: 886-4-25580886 FAX: 886-4-25568632

ESTABLISHMENT 3003851906 REGISTRATION NO:

OFFICIAL CONTACT: Dr. JEN, KE-MIN ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY No 58, Fu Chiun Street. Hsin Chu City, 30067, Taiwan TEL: 886-3-5208829 FAX:886-3-5209783

VITALTEC Rota-Trach Tracheostomy Tube TRADE NAME:

Tracheostomy Tube COMMON/USUAL

Tube, Tracheostomy (W/Wo connector)

CLASSIFICATION NAME:

NAME:

CLASSIFICATION PANEL:

BTO, Class II, 868.5800

PREDICATED DEVICE: INTENDED USE:

NON-CLINIC DATA:

ISO 5356-1: Anaesthetic and respiratory equipment -. Conical connectors: Part 1: Cones and sockets. 2004.
Tracheostomy Tubes are intended for use in providing direct

Medical Tracheostomy Tubes; 510K No. ( K031553 )

tracheal access for airway management.

ISO 10993-1: Biological Evaluation of medical ● devices, part 1: Evaluation and testing, 2003.
10993-5: Biological Evaluation of medical ● ISO devices, part 5: Tests for in vitro cytotoxicity, 1999.
ISO 10993-10: Biological Evaluation of medical ● devices, part 10: Tests for irritation and sensitization, 2002.

િર

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VITALTEC CORPORATION

No.12, Lane 4-30, Chyuan Zhou Rd., Hou Li Hsiang, Taichung, 42142, Taiwan, ROC Tel: 886-4-25580886 Fax: 886-4-25568632 Email: info@vitaltec.com.tw

ISO 17665-1: Sterilization of health care products, part . 1: validation and control of sterilization process for medical devices, 2006.

DEVICE DESCRIPTION:

ITEM	PREDICATE DEVICE	SUBJECT DEVICE
Name	Medical Tracheostomy Tubes( K031553 )	VITALTEC Rota-TrachTracheostomy Tubes
Intended Use	Tracheostomy Tubes are intendedfor use in providing direct trachealaccess for airway management.	Same
Material	Silicone	Same
Connector	15 O.D. per ISO 5356-1	Same
SterilizationMethod	ETO	Moist Heat
Specification	Various sizes for Pediatric and Adult	Pediatric I.D.: 5.0mm, 6.0mmAdult I.D.:7.0mm, 8.0mm,9.0mm, 10.0mm
Cuff Style	Various types for Pediatric and Adult	Each one type of Air Cuff tomatch with each one size ofTracheostomy Tube

COMPARISON WITH PREDICATE DEVICE:

PERFORMANCE DATA

The dimension, design, material, sterility and packaging of VITALTEC Rota-Trach Tracheostomy Tubes are conformed to ISO 5356-1 and ISO 17665-1.

CONCLUSION

In accordance with the FDA 21 CFR 807 and based on the information provided in this areas In accordance with the I DVD DEC Rota-Trach Tracheostomy Tubes have the same
Premarket notification, VITALTEC Rota-Trach Tracheostomy Tubes worlding intended use, material, and use the same specification of connector which is complied mich ISO 5356-1; and the different sterilization method was also got the validation. I The with 100 950 1, and 11.
main differences of the two devices are the subject device only has one type of air cuff and simpler specifications.

Thus the two devices are substantial equivalence.

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Image /page/2/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes resembling birds in flight, stacked on top of each other.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Vitaltec Corporation C/O Ms. Jen Ke-Min Roc Chinese-European Industry Research Society No. 58, Fu Chiun Street Hsin Chu City China (Taiwan) 30067

JUN 1 1 2010

Re: K100480

Trade/Device Name: Rota-Trach Tracheostomy Tube Model Rota-Trach Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: BTO Dated: June 3, 2010 Received: June 10, 2010

Dear Ms. Ke-Min:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2- Ms. Ke-Min

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Runner

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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VITALTEC CORPORATION

No.12, Lane 4-30, Chyuan Zhou Rd., Hou Li Hsiang, Taichung, 42142, Taiwan, ROC Tel: 886-4-25580886 Fax: 886-4-25568632 Email: info@@vitaltec.com.tw

Indications for Use .

510 (K) Number ( If Known ):

Device Name: VITALTEC Rota-Trach Tracheostomy Tube ●

Indications for Use :

Tracheostomy Tubes are intended for use in providing direct tracheal access for airway management.

CAUTION: U.S. Federal law restricts the use of this device to licensed professionals.

Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultin

Olvision Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: N 100480

Regulation Number and Section

§ 868.5800 Tracheostomy tube and tube cuff.

(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.