VAPOTHERM 2000H

K013486 · Vapotherm, Inc. · BTT · May 30, 2003 · Anesthesiology

Device Facts

• Record ID: K013486
• Device Name: VAPOTHERM 2000H
• Applicant: Vapotherm, Inc.
• Product Code: BTT · Anesthesiology
• Decision Date: May 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

The Vapotherm 2000h (5000) is a respiratory gas humidifier that provides high-flow, highly humidified air (>95% relative humidity) at body temperature or above. It utilizes an internal air compressor and an optional external oxygen source to deliver gas to the patient. The device operates via a hollow fiber membrane cartridge; warmed water circulates outside the fibers while air flows through the center, allowing water to transpire into the gas stream as vapor. This process produces gas virtually free of droplets. The device is intended for use in home, hospital, and sub-acute settings. Healthcare providers or patients use the device to improve patient tolerance for high-flow nasal therapy by providing warmth and moisture. The system is software-controlled to manage water temperature. It does not monitor FiO2, requiring external verification if oxygen is used.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and design comparison to the predicate device.

Technological Characteristics

Respiratory gas humidifier using hollow fiber membrane cartridge technology. Features internal air compressor (8.3 psi max) and external oxygen source capability. Software-controlled water temperature regulation. Dimensions: 12" x 15" x 10"; Weight: 25 lbs. Power: 115 VAC, 60 Hz. Meets UL 544 standards.

Indications for Use

Indicated for patients requiring high flow supplemental air or air/oxygen mixtures where humidification is beneficial. Suitable for use in home, hospital, and sub-acute institutional settings.

Regulatory Classification

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.

Predicate Devices

• Vapotherm 2000i (K000401)

Reference Devices

• De Vilbiss compressor (K963349)

Submission Summary (Full Text)

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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 – [phone]<br>Fax – [phone] |
|----------------------------|--------------------------------------------------------|
| 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:

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.

15

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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 oxygen<br>from an external source and adds heat and moisture to<br>the gas. |
| Patient Population -- | For use with any patient utilizing high flow supplemental air or<br>air/oxygen mixtures in which humidification would be<br>beneficial. |
| Environment of Use -- | Home, Hospital, Sub-acute Institutions |
| Contraindications -- | None |

# Comparison to Predicate Devices:

| | Vapotherm 2000i<br>Predicate | Vapotherm 2000h (5000)<br>Proposed |
|---------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Attributes | | |
| Indications for use | To add moisture to and to warm<br>breathing gases for administration<br>to a patient | Same |
| Environments of use | Home, Hospital, Sub-acute<br>Institutions, not specified. | The same |
| Patient Population | For use with any patient utilizing<br>supplemental oxygen in which<br>humidification would be<br>beneficial | Add - “ with an air or air/oxygen<br>mixture”<br>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 without<br>water | 25 lbs. without water |
| Power max. | Vapotherm - 250 VA (warm-up),<br>80 VA (continuous) | Vapotherm - The same<br>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<br>or cylinder oxygen |

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

| | Vapotherm 2000i<br>Predicate | Vapotherm 2000h (5000)<br>Proposed |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Equipment Design | | |
| Gas fittings | One | One |
| Method to regulate flow<br>from source | Flow meter at wall or cylinder | Flow meter on device for<br>compressor, plus flow meter at<br>oxygen source. |
| Capable of variable FiO₂ | No – set at wall if practitioner<br>desires | No – set at wall if practitioner<br>desires |
| Monitoring of FiO₂ | None | Instructs to verify with an in-line<br>oxygen analyzer |
| Technology of<br>humidification | | |
| Membrane type | Basic membrane type humidifier,<br>hollow fiber cartridge | The same |
| Method of humidifying | Warmed water is circulated over<br>the outside of the cartridges hollow<br>fibers while air is pumped through<br>the center of the fibers. These fibers<br>are permeable to water and allow<br>water to transpire into the air stream<br>in the form of gaseous water vapor.<br>Water temperature is software-<br>controlled | The same |
| Water type | Common tap water | The same |

| Compressor | De Vilbiss<br>K963349 | 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.
- 2. Have the same environments for use
- Are similar in design 3.
- 4. 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 [phone]. 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 [phone] or [phone] 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 oxygen<br>from an external source and adds heat and moisture to<br>the gas. The Vapotherm 2000h (5000) is for use in<br>home, hospital or sub-acute institutional settings. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per CFR 801.109)

or

Over-the-counter use __

JHWats h

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

KO13486 510(k) Number:_