(11 days)
Caradyne Guardian - K040862
No
The document describes a humidification device and does not mention any AI or ML capabilities.
Yes.
The device adds moisture and warms breathing gases for administration to patients, which is a therapeutic intervention.
No
Explanation: The device is described as a humidifier that adds moisture and warms breathing gases for patients. Its function is therapeutic, not diagnostic, as it does not gather or process data to identify a medical condition.
No
The device description clearly details physical hardware components (humidification units, cartridges, membrane bundles) and their function in warming and adding moisture to breathing gases. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "add moisture to and to warm breathing gases for administration to patients." This describes a device used directly on a patient for therapeutic purposes (providing humidified breathing gas), not for testing samples taken from the body (in vitro).
- Device Description: The description focuses on the mechanism of humidifying breathing gases and delivering them to the patient via nasal cannula. It does not mention any analysis of biological samples.
- Lack of IVD Indicators: The document does not contain any of the typical characteristics of an IVD, such as:
- Mention of analyzing samples (blood, urine, tissue, etc.)
- Mention of diagnostic purposes (identifying diseases, conditions, etc.)
- Mention of reagents or assays.
This device falls under the category of a medical device used for respiratory support and therapy, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
To add moisture to and to warm breathing gases for administration to patients, including neonates/infant, pediatrics, and adults. The environment of use include - home, hospital or sub-acute institutional settings. For use with neonate/infant, pediatric and adult patients utilizing high flow supplemental air, air/oxygen, or gas mixtures in which humidification would be beneficial.
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.
Product codes (comma separated list FDA assigned to the subject device)
BTT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonates/infant, pediatrics, and adults
Intended User / Care Setting
Home, Hospital, Sub-acute Institutions
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Vapotherm™ 2000h, K000401, 2000i – K013486
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Caradyne Guardian - K040862
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 2
| August 16, 2004 | |
|---|---|
| Vapotherm, Inc. | |
| 108 Log Canoe Circle | |
| Stevensville, MD 21666 | Tel - (410) 604-3977 |
| Fax - (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 – K013486 |
| 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
administration to patients, including neonates/infant, pediatrics,
and adults. The environment of use include - home, hospital or
sub-acute institutional settings | |
|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Patient Population -- | For use with neonate/infant, pediatric and adult patients
utilizing high flow supplemental air, air/oxygen, or gas mixtures
in which humidification would be beneficial. | |
| Non-Confidential Summary of Safety and Effectiveness
Page 2 of 2
August 16, 2004 | | |
| Indications: (continued) | | |
| Environment of Use -- | Home, Hospital, Sub-acute Institutions | |
| Contraindications -- | None | |
| Comparison to Predicate Devices: | | |
| | Vapotherm 2000h and 2000i
Predicate | Clarification |
| Attributes | | |
| Indications for use | To add moisture to and to warm
breathing gases at high flows with an air
or air/oxygen mixture for administration
to a patient | Same |
| Environments of use | Home, Hospital, Sub-acute Institutions,
not specified. | Same |
| Patient Population | For use with any patient utilizing
supplemental oxygen in which
humidification would be beneficial and
with an air or air/oxygen mixture.
All patients, non population specific. | Neonate/infant,
pediatric and adult |
| | Caradyne - Guardian K040862
Neonate / infant | |
| Contraindications | None | Same |
| Equipment Design | | |
| No changes | | |
| Technology of
humidification | | |
| Membrane type | Basic membrane type
humidifier, hollow fiber
cartridge | Low flow - 1 - 8 1pm
High flow - 5 - 40 Ipm |
1
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.
2
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.
3
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
4
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: