The Vapotherm 2000h (5000) can mix air with oxygen from an external source and adds heat and moisture to the gas. The Vapotherm 2000h (5000) is for use in home, hospital or sub-acute institutional settings.

Device Description

The Vapotherm 2000i, predicate, and the Vapotherm 2000h (5000) are identical and share the concept of humidification by transpiration of water vapor across a membrane. Both produce a high flow of highly humidified air (relative humidity >95%), virtually free of droplets, at body temperature or above. The water content at 41°C is 40-50 mg/liter, about fourfold higher than can be achieved by humidification at room temperature. The unique combination of high flow and high vapor-phase humidity allow an unusually wide range of clinical applications. Applications previously considered impractical because of limited patient tolerance for high nasal flow can now be routine because of the comfort provided by warmth and high humidity.

The Vapotherm 2000h (5000) is an unmodified Vapotherm 2000i but with an internal air compressor and external oxygen source, wall or cylinder oxygen. There is a single inlet fitting. like the 2000i for connection to an external oxygen source, if desired.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Vapotherm 2000h (5000), a humidifier for respiratory gas. This submission focuses on demonstrating substantial equivalence to a predicate device (Vapotherm 2000i) rather than presenting a study with specific acceptance criteria and performance data in the context of AI/machine learning.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission and the information provided. This is a medical device, not an AI/ML-based diagnostic system, and thus does not involve "ground truth" derived from expert consensus on images or pathology in the way an AI study would.

Here’s the information that can be extracted and a clear explanation for the N/A categories.

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k), the "acceptance criteria" is demonstrating substantial equivalence to the predicate device (Vapotherm 2000i). The "reported device performance" is essentially a comparison of attributes to show similarity.

Attribute	Acceptance Criteria (Predicate: Vapotherm 2000i)	Reported Device Performance (Vapotherm 2000h (5000))
Indications for use	To add moisture to and to warm breathing gases for administration to a patient	Same (Adds "with an air or air/oxygen mixture" for patent population)
Environments of use	Home, Hospital, Sub-acute Institutions, not specified	The same
Patient Population	For use with any patient utilizing supplemental oxygen in which humidification would be beneficial	Add - “ with an air or air/oxygen mixture” Otherwise the same.
Contraindications	None	The same
Dimensions	11" x 5.5" x 4.5"	12" x 15" x 10"
Weight	< 6 lbs without water	25 lbs. without water
Power max.	250 VA (warm-up), 80 VA (continuous)	The same (for Vapotherm), Compressor - 49 watts
Input power	115 VAC, 60 Hz	The same
Gas Source Pressure	4-50 psi, wall source or cylinder	Internal compressor - 8 psi
Gas Source	Wall source or Cylinder	Internal AC compressor or wall or cylinder oxygen
Gas fittings	One	One
Method to regulate flow	Flow meter at wall or cylinder	Flow meter on device for compressor, plus flow meter at oxygen source.
Capable of variable FiO₂	No – set at wall if practitioner desires	No – set at wall if practitioner desires
Monitoring of FiO₂	None	Instructs to verify with an in-line oxygen analyzer
Membrane type	Basic membrane type humidifier, hollow fiber cartridge	The same
Method of humidifying	Warmed water circulated over outside of hollow fibers, air pumped through center. Fibers permeable to water, water transpires as vapor. Water temp software-controlled.	The same
Water type	Common tap water	The same
Compressor - Meets UL 544	Yes (De Vilbiss K963349)	Yes (Proposed Thomas)
Compressor - Portable	Yes (De Vilbiss K963349)	Yes (Proposed Thomas)
Compressor - Max. pressure	90 psi (De Vilbiss K963349)	8.3 psi (Proposed Thomas)
Compressor - Max liter flow	30 lpm (De Vilbiss K963349)	25 lpm in this application (Proposed Thomas)

Conclusion of Substantial Equivalence: The document states that the Vapotherm 2000h (5000) is "substantially equivalent" to the predicate device because:

They have substantially equivalent intended uses.
They have the same environments for use.
They are similar in design.
They employ the same technology.
"There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

N/A: This document pertains to a 510(k) submission for a non-AI medical device (a humidifier). The submission relies on a comparison of device specifications and an assessment of technical and functional equivalence to a predicate device, as opposed to performance studies on a "test set" in the context of diagnostic accuracy or AI/ML. No clinical or performance data from a "test set" is presented in this summary in the way it would be for an AI device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A: Not applicable for a non-AI device demonstrating substantial equivalence. There is no concept of "ground truth" established by experts for this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A: Not applicable for this type of device and submission.

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

N/A: Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was performed or is relevant.

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

N/A: Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

N/A: Not applicable. The "ground truth" concept as defined for AI/diagnostic studies is not relevant here. The device's performance is gauged by meeting physical and functional specifications compared to a predicate.

8. The sample size for the training set

N/A: Not applicable. This document does not describe an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

N/A: Not applicable. This document does not describe an AI/ML device that requires a training set.

Summary

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K013486

MAY 3 0 2003

Vapotherm, Inc. 107 Ridgely Ave. Suite # 9 Annapolis, MD 21401

Summary of Safety and Effectiveness

Non-Confidential Summary of Safety and Effectiveness Page 1 of 4 21-May-03

Vapotherm, Inc.
107 Ridgely Ave., Suite # 9
Annapolis, MD 21401

	Tel – (410) 974-9255Fax – (410) 974-9707
Official Contact:	Robert Storey - President and CEO
Proprietary or Trade Name:	Vapotherm 2000h (5000)
Common/Usual Name:	Humidifier, Respiratory Gas (Direct Patient Interface)
Classification Name:	Humidifier, Respiratory Gas (Direct Patient Interface)
Device:	Vapotherm 2000h (5000)
Predicate Devices:	Vapotherm 2000i – K000401

Device Description:

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Non-Confidential Summary of Safety and Effectiveness Page 2 of 4 21-May-03

Intended Use:
Indicated Use --	The Vapotherm 2000h (5000) can mix air with oxygenfrom an external source and adds heat and moisture tothe gas.
Patient Population --	For use with any patient utilizing high flow supplemental air orair/oxygen mixtures in which humidification would bebeneficial.
Environment of Use --	Home, Hospital, Sub-acute Institutions
Contraindications --	None

Comparison to Predicate Devices:

	Vapotherm 2000iPredicate	Vapotherm 2000h (5000)Proposed
Attributes
Indications for use	To add moisture to and to warmbreathing gases for administrationto a patient	Same
Environments of use	Home, Hospital, Sub-acuteInstitutions, not specified.	The same
Patient Population	For use with any patient utilizingsupplemental oxygen in whichhumidification would bebeneficial	Add - “ with an air or air/oxygenmixture”Otherwise the same.
Contraindications	None	The same
Equipment Design
Dimensions	11" x 5.5" x 4.5"	12" x 15" x 10"
Weight	Vapotherm - < 6 lbs withoutwater	25 lbs. without water
Power max.	Vapotherm - 250 VA (warm-up),80 VA (continuous)	Vapotherm - The sameCompressor - 49 watts
Input power	115 VAC, 60 Hz	The same
Gas Source Pressure	4-50 psi, wall source or cylinder	Internal compressor - 8 psi
Gas Source	Wall source or Cylinder	Internal AC compressor or wallor cylinder oxygen

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Non-Confidential Summary of Safety and Effectiveness Page 3 of 4 21-May-03

	Vapotherm 2000iPredicate	Vapotherm 2000h (5000)Proposed
Equipment Design
Gas fittings	One	One
Method to regulate flowfrom source	Flow meter at wall or cylinder	Flow meter on device forcompressor, plus flow meter atoxygen source.
Capable of variable FiO₂	No – set at wall if practitionerdesires	No – set at wall if practitionerdesires
Monitoring of FiO₂	None	Instructs to verify with an in-lineoxygen analyzer
Technology ofhumidification
Membrane type	Basic membrane type humidifier,hollow fiber cartridge	The same
Method of humidifying	Warmed water is circulated overthe outside of the cartridges hollowfibers while air is pumped throughthe center of the fibers. These fibersare permeable to water and allowwater to transpire into the air streamin the form of gaseous water vapor.Water temperature is software-controlled	The same
Water type	Common tap water	The same

Compressor	De VilbissK963349	Proposed Thomas
Meets UL 544	Yes	Yes
Portable	Yes	Yes
Max. Compressor pressure	90 psi	8.3 psi
Max liter flow	30 lpm	25 lpm in this application

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Non-Confidential Summary of Safety and Effectiveness Page 4 of 4 21-May-03

Differences Between Other Legally Marketed Predicate Devices

The Vapotherm 2000h (5000) system is viewed as substantially equivalent to the following predicate device - Vapotherm 2000i cleared under K000401.

The differences between the Vapotherm 2000h (5000) and the Vapotherm 2000i, the predicate devices, are minimal. There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices. They are viewed as substantially equivalent to the predicate devices since they:

Have the substantially equivalent intended uses 1.
1. Have the same environments for use
Are similar in design 3.
1. They employ the same technology

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

MAY 3 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vapotherm, Inc. c/o Mr. Paul E. Dryden ProMedic, Inc. 6329 West Waterview Ct. McCordsville, IN 46055-9501

Re: K013486

Trade/Device Name: Vapotherm 2000h Regulation Numbers: 21 CFR 868.5450 Regulation Name: Respiratory gas humidifier Regulatory Class: Class II (two) Product Code: 73 BTT; 73 BTI; 73 BZR Dated: March 6, 2003 Received: March 11, 2003

Dear Mr. Dryden:

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 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); good manufacturing practice requirements as set forth in the quality

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Page 2 – Mr. Paul E. Dryden

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. 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 Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Dunne

Susan Runner, DDS, MA Interim 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

Page 1 of 1

510(k) Number:	K013486 (To be assigned)
Device Name:	Vapotherm 2000 h (5000)
Intended Use:	The Vapotherm 2000h (5000) can mix air with oxygenfrom an external source and adds heat and moisture tothe gas. The Vapotherm 2000h (5000) is for use inhome, hospital or sub-acute institutional settings.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per CFR 801.109)

Over-the-counter use __

JHWats h

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

KO13486 510(k) Number:_

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).