VAPOTHERM MODEL#2000I, 200H

K042245 · Vapotherm, Inc. · BTT · Aug 30, 2004 · Anesthesiology

Device Facts

• Record ID: K042245
• Device Name: VAPOTHERM MODEL#2000I, 200H
• Applicant: Vapotherm, Inc.
• Product Code: BTT · Anesthesiology
• Decision Date: Aug 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

To add moisture to and to warm breathing gases for administration to patients, including neonates/infant, pediatrics, and adults. The flow rates may be from 1 to 40 liters per minute via nasal cannula. Environments of use - Home, Hospital, Sub-acute Institutions

Device Story

Vapotherm 2000h and 2000i are respiratory gas humidifiers; utilize transpiration of water vapor across membrane bundles within a cartridge; produce highly humidified air (>95% relative humidity) virtually free of droplets; deliver at body temperature or above; flow rates 1-40 lpm via nasal cannula. Used in home, hospital, or sub-acute settings; operated by clinicians or patients. High humidity and warmth improve patient tolerance for high nasal flow; enables clinical applications previously considered impractical. Output is warmed, humidified gas mixture; assists in respiratory therapy by providing moisture and heat to breathing gases.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and design similarities to legally marketed predicate devices.

Technological Characteristics

Respiratory gas humidifier; utilizes transpiration of water vapor across hollow fiber membrane cartridge. Delivers 1-40 lpm flow; relative humidity >95%; water content 40-50 mg/liter at 41°C. Mechanical device; no software or electronic algorithm described.

Indications for Use

Indicated for neonate/infant, pediatric, and adult patients requiring high flow supplemental air, air/oxygen, or gas mixtures where humidification is beneficial. No contraindications.

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 2000h (K000401)
• Vapotherm 2000i (K013486)
• Caradyne Guardian (K040862)

Submission Summary (Full Text)

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Vapotherm 2000h and 2000i

#### Summary of Safety and Effectiveness 3.1

## Non-Confidential Summary of Safety and Effectiveness

| Page 1 of 2<br>August 16, 2004 | |
|-------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Vapotherm, Inc.<br>108 Log Canoe Circle<br>Stevensville, MD 21666 | Tel - [phone]<br>Fax - [phone] |
| Official Contact: | William Niland, Chairman |
| Proprietary or Trade Name: | Vapotherm™ 2000h and 2000i |
| Common/Usual Name: | Humidifier, Respiratory Gas (Direct Patient Interface) |
| Classification Name: | Humidifier, Respiratory Gas (Direct Patient Interface) |
| Device: | Vapotherm™ 2000h and 2000i |
| Predicate Devices: | Vapotherm™ 2000h, K000401, and 2000i – K013486<br>Caradyne Guardian - K040862 |

### Device Description:

The Vapotherm 2000i and Vapotherm 2000h are identical and share the concept of humidification by transpiration of water vapor across a membrane by the use of a low or high flow cartridge with membrane bundles. The difference in the cartridges is only the number of membrane bundles included, fewer in the low flow. Both units and cartridges produce a highly humidified air (relative humidity >95%), virtually free of droplets, at body temperature or above at flow rates from 1 to 40 lpm via a nasal cannula. The water content at 41℃ 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.

### Indications:

| Indicated Use -- | To add moisture to and to warm breathing gases for<br>administration to patients, including neonates/infant, pediatrics,<br>and adults. The environment of use include - home, hospital or<br>sub-acute institutional settings | |
|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Patient Population -- | For use with neonate/infant, pediatric and adult patients<br>utilizing high flow supplemental air, air/oxygen, or gas mixtures<br>in which humidification would be beneficial. | |
| Non-Confidential Summary of Safety and Effectiveness<br>Page 2 of 2<br>August 16, 2004 | | |
| Indications: (continued) | | |
| Environment of Use -- | Home, Hospital, Sub-acute Institutions | |
| Contraindications -- | None | |
| Comparison to Predicate Devices: | | |
| | Vapotherm 2000h and 2000i<br>Predicate | Clarification |
| Attributes | | |
| Indications for use | To add moisture to and to warm<br>breathing gases at high flows with an air<br>or air/oxygen mixture for administration<br>to a patient | Same |
| Environments of use | Home, Hospital, Sub-acute Institutions,<br>not specified. | Same |
| Patient Population | For use with any patient utilizing<br>supplemental oxygen in which<br>humidification would be beneficial and<br>with an air or air/oxygen mixture.<br>All patients, non population specific. | Neonate/infant,<br>pediatric and adult |
| | Caradyne - Guardian K040862<br>Neonate / infant | |
| Contraindications | None | Same |
| Equipment Design | | |
| No changes | | |
| Technology of<br>humidification | | |
| Membrane type | Basic membrane type<br>humidifier, hollow fiber<br>cartridge | Low flow - 1 - 8 1pm<br>High flow - 5 - 40 Ipm |

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# AUG 3 0 2004

Vapotherm 2000h and 2000i

Premarket Notification 510(k) Section 3 - Certifications and Summaries

# Differences Between Other Legally Marketed Predicate Devices

There are no differences, only clarification of the indicated populations.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

AUG 3 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vapotherm, Incorporated C/O Mr. Paul E. Dryden President ProMedic, Incorporated 6329 West Waterview Court McCordsville, Indiana 46055-9501

Re: K042245

Trade/Device Name: Vapotherm Model# 2000h and 2000i Regulation Number: 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: August 18, 2004 Received: August 19, 2004

Dear Mr. Dryden:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becases of he 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 mensiale conmitters prior to that have been reclassified in accordance with the provisions of Amendinents, or to do roos and the tic Act (Act) that do not require approval of a premarket the I cuclar I vou, Drag, and County, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the restration, 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 If your device is classified (boo as a rejissal controls. Existing major regulations affecting (FWA), it may of Subjoct to Sach additions, Title 21, Parts 800 to 898. In your device can be found in firsher announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Dryden

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that PDA s issualled on that your device complies with other requirements mean that ITA has made a deceminations administered by other Federal agencies. of the Act of ally I ederal statutes and regarments, including, but not limited to: registration You must comply with an the Fee b requirements)
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and ifsing (21 CFR Part 607), labeling (21 cms (QS) regulation (21 CFR Part 820); and if requirements as sectionic 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) This letter will anow you to begin manietaling your substantial equivalence of your device to a premaired notification. The PDF Imaling or sclassification 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), If you desire specific advice for Jour do at [phone]. Also, please note the regulation prease contact the Other or Ochipments to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general micrimational 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,

Sisa Ruan

Chia-Lin, Ph.D.

\$\mathcal{P}\$

Chiu Lin, Ph.D. 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 3.3

Page 1 of 1 K042245 (To be assigned) 510(k) Number: Vapotherm 2000h and 2000i Device Name: The Vapotherm™ 2000h and 2000i are designed to add Indications for Use: moisture to and to warm breathing gases for administration to patients, including neonates/infant, pediatrics, and adults. The flow rates may be from 1 to 40 liters per minute via nasal cannula. Environments of use - Home, Hospital, Sub-acute Institutions Over-the-counter use Prescription Use XX or (Per CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qum Salrom

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesinlogy, General Hospital
Control Control Dental Devices Division of Ance Dental Dev

510(k) Number: