(11 days)
The Vapotherm™ 2000h and 2000i are designed 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
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.
The provided text primarily consists of regulatory summaries and approval letters for the Vapotherm 2000h and 2000i devices. It details the device's function, indications for use, and a comparison to predicate devices. However, it does not contain information about acceptance criteria, specific studies conducted to demonstrate performance against those criteria, sample sizes, expert involvement, or any statistical evaluation of device performance.
Therefore, I cannot directly answer your request based on the provided input. The document focuses on regulatory equivalence rather than an empirical study demonstrating performance against specific acceptance criteria.
To elaborate, the document states:
- Device Description: The Vapotherm 2000i and 2000h 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..."
- Comparison to Predicate Devices: It highlights "Same" or "No changes" for several attributes when comparing to predicate devices (K000401, K013486, K040862).
These descriptions are technical specifications and comparisons, not acceptance criteria for a validation study. The FDA approval K042245 is based on substantial equivalence to predicate devices, meaning it largely relies on the predicate devices having already met safety and effectiveness standards, rather than requiring extensive new clinical trial data for this specific iteration.
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Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters, specifically "K04245". The characters are written in a bold, sans-serif font, and they appear to be handwritten or drawn with a thick marker. The characters are arranged horizontally, with the letter "K" at the beginning and the number "5" at the end.
Vapotherm 2000h and 2000i
Summary of Safety and Effectiveness 3.1
Non-Confidential Summary of Safety and Effectiveness
| Page 1 of 2August 16, 2004 | |
|---|---|
| Vapotherm, Inc.108 Log Canoe CircleStevensville, MD 21666 | Tel - (410) 604-3977Fax - (410) 974-9707 |
| 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 – K013486Caradyne 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 foradministration to patients, including neonates/infant, pediatrics,and adults. The environment of use include - home, hospital orsub-acute institutional settings | |
|---|---|---|
| Patient Population -- | For use with neonate/infant, pediatric and adult patientsutilizing high flow supplemental air, air/oxygen, or gas mixturesin which humidification would be beneficial. | |
| Non-Confidential Summary of Safety and EffectivenessPage 2 of 2August 16, 2004 | ||
| Indications: (continued) | ||
| Environment of Use -- | Home, Hospital, Sub-acute Institutions | |
| Contraindications -- | None | |
| Comparison to Predicate Devices: | ||
| Vapotherm 2000h and 2000iPredicate | Clarification | |
| Attributes | ||
| Indications for use | To add moisture to and to warmbreathing gases at high flows with an airor air/oxygen mixture for administrationto a patient | Same |
| Environments of use | Home, Hospital, Sub-acute Institutions,not specified. | Same |
| Patient Population | For use with any patient utilizingsupplemental oxygen in whichhumidification would be beneficial andwith an air or air/oxygen mixture.All patients, non population specific. | Neonate/infant,pediatric and adult |
| Caradyne - Guardian K040862Neonate / infant | ||
| Contraindications | None | Same |
| Equipment Design | ||
| No changes | ||
| Technology ofhumidification | ||
| Membrane type | Basic membrane typehumidifier, hollow fibercartridge | Low flow - 1 - 8 1pmHigh 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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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:
§ 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).