The Primed Tracheostomy Tubes consists of various types of tracheostomy tubes, e.g., Primedistom Cannulas w/wo cuff, Silver Cannulas, Priflex Cannulas, Silicone Cannulas (Primedi Silk), and Primedi Star Cannulas. The tracheostomy tubes are made of different materials and offer a variety of inner and outer diameters and varying lengths thus making it possible to meet the individual needs of a patient.

The Primed Tracheostomy Tubes can be obtained sieved or unsieved, with or without speaking valve, cuffed or uncuffed, with or without one or two inner cannulas. The accessories comprise different speaking valves as well as Humid Moist Exchangers (HME) and different types of filters.

AI/ML Overview

The provided 510(k) summary for the Primed Tracheostomy Tubes (K120079) indicates that the device's substantial equivalence was established through performance data related to conformity with recognized international standards, rather than a clinical study comparing device performance against specific acceptance criteria. This means the submission primarily focuses on demonstrating that the device meets established engineering and material standards applicable to tracheostomy tubes.

Here's a breakdown based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance
ISO 5356-1 (Anesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets)	Conforms to ISO 5356-1
ISO 5366-1 (Anesthetic and respiratory equipment — Tracheostomy tubes — Part 1: General purpose tracheostomy tubes)	Conforms to ISO 5366-1

Explanation: The submission states, "The Primed Tracheostomy Tubes conform to ISO 5356-1 and ISO 5366-1." These ISO standards establish requirements for the design, dimensions, materials, and sterile packaging of tracheostomy tubes and their connectors to ensure safety and performance. By conforming to these standards, the manufacturer asserts that their device meets the internationally recognized safety and performance benchmarks for this type of medical device.

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

This information is not provided in the given 510(k) summary. Since the submission relies on conformity to international standards (ISO), the "test set" would likely refer to engineering and material tests performed on samples of the manufactured tracheostomy tubes. The data provenance would be internal laboratory testing by the manufacturer or a certified testing facility, not clinical data from patients.

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

This information is not provided. For standard conformity testing, the "ground truth" is the specifications and testing methods defined by the ISO standards themselves. The experts involved would be engineers and technicians performing the tests according to the standard's protocols, not medical experts establishing clinical ground truth.

4. Adjudication Method for the Test Set

This information is not provided. As explained above, the "test set" refers to engineering and material testing, not a clinical study with human readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, often with and without AI assistance, to assess the AI's impact on diagnostic accuracy. Tracheostomy tubes are mechanical devices for airway management and do not typically involve this kind of comparative effectiveness study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone (algorithm only) performance assessment was not done. This concept applies to AI/software as a medical device (SaMD) where an algorithm provides a diagnosis or outcome without direct human interpretation. Tracheostomy tubes are physical medical devices, not algorithms.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by conformity to established international engineering and material standards (ISO 5356-1 and ISO 5366-1). This is not
expert consensus, pathology, or outcomes data in the clinical sense, but rather adherence to predefined technical specifications and performance characteristics.

8. The Sample Size for the Training Set

This information is not applicable and not provided. Tracheostomy tubes are physical devices, and their development does not involve "training sets" in the context of machine learning. The design and manufacturing processes are guided by engineering principles and standards.

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

This information is not applicable and not provided for the same reasons as #8. The "ground truth" for the design and manufacturing of the device is rooted in established engineering specifications and international standards, which are developed through expert committees and consensus over time, not through data labeling for a "training set."

In summary: K120079 is a 510(k) for a physical medical device (tracheostomy tubes). The demonstration of substantial equivalence relies on proving that the device has the same intended use, materials, and functional specifications as predicate devices, and importantly, conforms to relevant international standards (ISO 5356-1 and ISO 5366-1). This type of submission typically uses engineering and bench testing to demonstrate compliance with these standards, rather than clinical studies involving patient data or AI performance assessments.

Summary

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K120079

510(k) Summary

Primed® Tracheostomy Tubes

MAY 2 4 2012

l. General information
Primed Halberstadt Medizintechnik GmbH . Manufacturer: Straße des 20. Juli 1 38820 Halberstadt / Germany
Establishment .

Registration Number: Must be applied for.

Alexandra Singer Contact Person: Primed Halberstadt Medizintechnik GmbH Straße des 20. Juli 1 38820 Halberstadt / Germany Phone: +49 3941 668 742 Fax: +49 3941 245 65 Email: alexandra.singer@primed-halberstadt.de
Device Identification ll.
Proprietary/Trade .
- Primed Tracheostomy Tubes (multiple) Name:
Common/Usual Name:Tracheostomy tube .
Classification Name: Tracheostomy Tube and Tube Cuff .
Regulations Number: 21 CFR 868.5800 together with .
21 CFR 868.5730 (Tube, Tracheal (W/Wo Connector)
and
21 CFR 868.5260 (Filter, Bacterial, Breathing-Circuit)
Regulatory Class: Class II .
BTO and JOH together with Product Code: .
- BTR and
- CAH

(and also BYD (Class I; 868.5375) and KAC (Class I;

874.4420), which are both 510(k) exempt)

Anesthesiology Device Panel: .

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510(k) Summary

Primed® Tracheostomy Tubes

111. Predicate devices

There are several predicate devices marketed in the US with respect to the following characteristics: size, length, inner and outer diameter, materials including silver, with cuff and without cuff, speaking valve, Humid Moist Exchanger (HME) as well as a suction function. As an example the following predicate devices are mentioned here*:

Tracoe-Vario Tracheostomy Tubes (various) K051587 .
K043160 Tracoe Phone Assist .
Tracheostomy Tubes Tracoe-flex K961449 .
Tracheostomy Tubes K781729 .
Bivona Tracheostomy Tube (silicone) by Smith Medical ASD K083641 .
Tracheal/Thoracic T-Tube by Technical Products, Inc. K013321 .
Filterflo HEPA by ARC Medical, Inc. . K063125

Not mentioned here are the predicates, which are now 510(k) exempt.

Description of device IV.

Indications of use V.

The Primed Tracheostomy Tubes are intended to provide tracheal access for airway management of tracheostomized patients.

Technological characteristics vi.

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510(k) Summary

Primed® Tracheostomy Tubes

The Primed Tracheostomy Tubes do not have any sharp edges and are extremly user friendly. The adoption of the key features of the predicate devices was made intentionally in order to provide efficient and safe products. All Primed Tracheostomy Tubes are manufactured under clean room conditions and thereby fulfill high requirements with respect to cleanliness.

VII. Performance data

The Primed Tracheostomy Tubes conform to ISO 5356-1 and ISO 5366-1.

VIII. Conclusion

The Primed Tracheostomy Tubes have the same intended use as the predicate devices. They use the same materials and have the same specifications with respect to dimensions and functions. The minor changes made to the Primed Tracheostomy Tubes do not raise any new questions of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

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

Ms. Alexandra Singer Regulatory Affairs Primed Halberstadt Medizintechnik GmbH Strasse Des 20. Juli Nr. 1 Halberstadt GERMANY 38820

MAY 2 4 2012

Re: K120079

Trade/Device Name: Primed Tracheostomy Tubes (multiple) Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: BTO Dated: May 8, 2012 Received: May 15, 2012

Dear Ms. Singer:

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. Singer

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/CDRHOffices /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.goy/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,

Wh for

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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Indications for Use

510(k) Number (if known): KL2007 9

Primed Tracheostomy Tubes (multiple) Device Name:

Indications For Use:

The Primed Tracheostomy Tubes are intended to provide tracheal access for airway management of tracheostomized patients.

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (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. Schuller

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

510(k) Number: K120079

Page 1 of 1

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.