The MEDISIZE GOLD Heater and Booster T-Piece is intended to feed additional heat and moisture into the system, through the T-Piece or via the Medisize Gold, during anaesthesia and respiratory care, specifically, when the use of an HME alone is no longer adequate due to the patients moisture deficit.

Device Description

The reusable MEDISIZE GOLD Heater in combination with the disposable single use Medisize Gold Booster T-Piece (or Medisize Gold, 510k number K052615) combines the simplicity of a Heat and Moisture Exchanger (HME) with the features of active humidification. Use of the MEDISIZE GOLD Heater in combination with a HME increases the number of options for humidifying and heating respiratory gases, greatly expanding the field of application for HMEs. When used in combination with a HME, the MEDISIZE GOLD Heater improves the absolute humidity, the relative humidity and the temperature of the respiratory gases. Use of the MEDISIZE GOLD Heater makes it possible to administer additional moisture and heat in a simple way, which is self-regulating. As a result, use of the MEDISIZE GOLD Heater is not particularly labor or knowledge intensive. The ease of use makes it a reliable, stable and effective method to administer additional moisture and heat to patients when required.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Medisize Gold Heater and Booster T-Piece, based on the provided text:

Important Note: This submission is a 510(k) for a modified device, showing substantial equivalence to a predicate device. This often means extensive new clinical trials are not performed if the changes are minor and do not raise new safety or effectiveness concerns. The focus here is on demonstrating compliance with safety standards and similar performance to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance
Electrical Safety:
IEC 60601-1:2005	Passed
IEC 60601-1-2:2007 (EMC)	Passed
Performance Testing:
ISO 8185 (Respiratory Tract Humidifiers for Medical Use - Particular requirements for respiratory humidification systems)	Acceptable results according to ISO 8185 requirements.

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

Sample Size for Test Set: Not explicitly stated in terms of a "test set" for human subjects or a dataset. The testing described is primarily non-clinical device testing. For the electrical safety and performance tests, it implies a sample size of at least one device, or a small number of devices sufficient to carry out the specified standard tests.
Data Provenance: Not applicable in the context of human data. The tests are laboratory-based and conducted on the device itself.

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

Not applicable. The "ground truth" for this device's evaluation is based on compliance with established international standards for medical electrical equipment and respiratory humidifiers (IEC 60601-1, IEC 60601-1-2, ISO 8185). The assessment relies on engineering and testing experts performing and interpreting these standardized tests, rather than clinical experts establishing a ground truth from patient data.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring adjudication by human experts. The evaluation is based on whether the device passed specific, objective engineering and performance tests from recognized standards.

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

No. An MRMC study was not done. This type of study is typically performed for diagnostic imaging devices or other devices where human interpretation of medical data is a critical component of efficacy. This submission is for a respiratory gas humidifier, where the evaluation focuses on physical performance and safety characteristics.

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

Not applicable. This device is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating the device's acceptable performance and safety is its compliance with recognized international standards:
- IEC 60601-1: For general requirements for basic safety and essential performance of medical electrical equipment.
- IEC 60601-1-2: For electromagnetic compatibility (EMC) requirements.
- ISO 8185: For particular requirements for respiratory humidification systems.
Additionally, the ground truth for biocompatibility is established by stating that "the materials are identical to the Medisize Gold Heater and Booster (with T-Piece) cleared under the previous 510(k) clearances K070714 and K052615," meaning previous regulatory approvals serve as the basis.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set."

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

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to this device submission.

Summary

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K12885

Medisize B.V. Traditional 510(k) Premarket Submission Medisize Gold Heater and Booster T-Piece

Section 5 - 510(k) Summary for Medisize Gold Heater and Booster T-Piece

1. Submission Sponsor
  Medisize B.V. Edisonstraat 1 Hillegom 2181 AB The Netherlands Tel: +31 252 576 815 Fax: +31 252 519 825 Contact name: Ms Desire Santiago Title: Regulatory Affairs Manager Email: desire.santiago@phillipsmedisize.com

AUG 2 9 2013

2. Submission Correspondent

Emergo Group Prinsessegracht 20 2514 AP, The Hague THE NETHERLANDS Cell Phone: 508.838.9139 Office Phone: +31 70 345 8570 Fax: +31 70 346 7299 Contact: Richard A. VINCINS, Vice President QA Email: PMTeurope@emergogroup.com

3. Date Prepared

29 August 2013

4. Device Name

Trade/Proprietary Name: Medisize Gold Heater and Booster T-Piece . Common/Usual Name: Respiratory gas humidifier Classification Name: Respiratory Gas Humidifier Classification Regulation: 21 CFR 868.5450 Classification Panel: Anesthesiology Product Code: BTT Device Class: Class II

FDA Establishment Registration #: 3002598726

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Medisize B.V. Traditional 510(k) Premarket Submission Medisize Gold Heater and Booster T-Piece

5. Predicate Devices

MEDISIZE GOLD Heater and Booster manufactured by Medisize B.V., 510(k) number: K070714

6. Device Description

7. Intended Use

8. Technological Characteristics and Substantial Equivalence

The following table compares the predicate Medisize Gold Heater and Booster (with T-Piece) to the modified Medisize Gold Heater and Booster T-Piece with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

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Medisize B.V. Traditional 510(k) Premarket Submission Medisize Gold Heater and Booster T-Piece

Table 5-A: Device Comparison Table

Manufacturer	Medisize B.V.	Medisize B.V.
Trade Name	Medisize Gold Heater andBooster T-Piece	Medisize Gold Heater andBooster (with T-Piece)(Predicate device)
510(k) Number	K122885	K070714
Product Code	BTT	BTT
RegulationNumber	21 CFR 868.5450	21 CFR 868.5450
RegulationName	RESPIRATORY GASHUMIDIFIER	RESPIRATORY GASHUMIDIFIER
Indications foruse:	Feeds additional heat andmoisture into the respiratorysystem when the use of aHME alone is not adequate.	Feeds additional heat andmoisture into the respiratorysystem when the use of aHME alone is not adequate.
Overall Design	Re-usable heater used withsingle use disposablecomponent in gas stream	Re-usable heater used withsingle use disposablecomponent in gas stream
Mode ofOperation	Can administer heat andhumidity to anaesthesia gasstream at temperature ofapproximately 33°C, 33 mg/L	Can administer heat andhumidity to anaesthesia gasstream at temperature ofapproximately 33°C, 33 mg/L
Complies withIEC 60601-1	Yes	Yes
Complies withIEC 60601-1-2	Yes	Yes
Power Supply	FW7660M/09Input:100-240V~/50-60Hz/250mAOutput: 9V --- /1,0A	FW7555M/12Input:100-240~/50-60Hz/400mAOutput: 12V --- /1,25A
OperatingConditions	See Power Supply	See Power Supply
Input Cable	See Power Supply	See Power Supply
Input CableAdapter	See Power Supply	See Power Supply

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9. Non-Clinical Testing

The device has been tested for electrical safety according to IEC 60601-1 and IEC 60601-1-2 and passed all the testing. Details of the specific performance standards used are listed below and test results summarized in Table 1:

Standard	Standard Title	Test Results
IEC 60601-1:2005	Medical Electrical Equipment – Part 1:General requirements for basic safety andessential performance	Passed
IEC 60601-1-2:2007	Medical Electrical Equipment – Part 1-2:General requirements for basic safety andessential performance – Collateralstandard: Electromagnetic Compatibility –Requirements and Tests	Passed

Table 5-B: Summary of Non-Clinical Test Results

The device was tested for the performance testing according to the voluntary standard ISO 8185, Respiratory Tract Humidifiers for Medical Use - Particular requirements for respiratory humidification systems. The testing supports the acceptable results of the device according to ISO 8185 requirements.

No biocompatibility testing was performed on the Medisize Gold Heater and Booster T-Piece as part of this submission because the materials are identical to the Medisize Gold Heater and Booster (with T-Piece) cleared under the previous 510(k) clearances K070714 and K052615.

10. Clinical Testing

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing. The verification and validation testing of the device electrical safety and EMC testing of the device was found to be acceptable and supports the claims of substantial equivalence.

11. Conclusion

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

The modified Medisize Gold Heater and Booster T-Piece, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized symbol resembling a bird or abstract human figure, composed of three curved lines. The symbol is positioned to the right of a circular seal containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.

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

August 29, 2013

Medisize BV C/O Mr. Richard Vincins Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701

Re: KI22885

Trade/Device Name: Medisize Gold Heater and Booster T-Piece Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: August 7, 2013 Received: August 8, 2013

Dear Mr. Vincins:

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 10 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 - Mr. Vincins

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 (2) 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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kwame 0. Ulmer Ar. And an -5

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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85

Medisize B.V. Traditional 510(k) Premarket Submission Medisize Gold Heater and Booster T-Piece

Section 4 - Indications for Use Statement

510(k) Number (if known): Not known

Device Name: MEDISIZE GOLD Heater and Booster T-Piece

Indications for Use:

The MEDISIZE GOLD Heater and Booster T-Piece is intended to feed additional heat and moisture into the system, through the T-Plece or via the Medisize Gold, during anaesthesia and respiratory care, specifically, when the use of an HME alone is no longer adequate due to the patients moisture deficit.

X _____ (Part 21 CFR 801 Subpart D) Prescription Use _ 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)

Anya C Harry

Digitally signed by Anya C. Ham XX: c=US. o=U.S. Government, ou=HHS DA. ou=People, comAnva C. Harr 0.9 2342.19200300.100.1.1=0011315. Date: 2013.08.28 16:48:48 -04'0

Regulation Number and Section

§ 868.5450 Respiratory gas humidifier.

(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).