(98 days)
No
The summary explicitly states that the software has not been modified and remains identical to the predicate device, and there are no mentions of AI, DNN, or ML.
No
The device is designed to add moisture and warm breathing gases, which provides supportive care rather than directly treating a disease or condition.
No
This device is designed to add moisture to and warm breathing gases for administration to patients; it does not diagnose medical conditions.
No
The device description explicitly states it is a modification to a physical device (Vapotherm 2000i) and describes hardware components (adding moisture and warming breathing gases). While software is mentioned, it is part of a larger hardware system.
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 that directly interacts with the patient's respiratory system to deliver conditioned air, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the device's function in conditioning breathing gases.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are typically used in laboratories or point-of-care settings to analyze samples like blood, urine, tissue, etc., to aid in diagnosis or monitoring. This device's function is entirely focused on preparing and delivering breathing gases to the patient.
N/A
Intended Use / Indications for Use
Both the modified Vapotherm 2000i device and the predicate 2000i device are indicated for use to add moisture to and to warm breathing gases for administration to a patient.
The Vapotherm 2000i and 2000h are designed to add moisture to and to warm breathing gases for administration to patients, including neonates/infants, and adults. The flow rates may be from 1 to 40 liters per minute via nasal cannula. Environments for use -- Home, Hospital, Sub-acute Institutions.
Product codes
BTT
Device Description
The Vapotherm 2000i device is a modification to cleared Vapotherm 2000i device. The base device of the modified Vapotherm 2000i device has the same technological characteristic as the predicate Vapotherm 2000i device. The software contained in the modified device has not been modified as a result of the corrections being effected and remains identical to the software resident in the predicate device. The modifications that have been made to the device, which are the subject of this Special 510(k) Corrective Action Being Effected, do not raise any new issues of safety or effectiveness.
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/infants, 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)
Vapotherm has conducted extensive testing to verify and validate the changes to the previously marketed Vapotherm 2000i device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Vapotherm™ 2000i (K042245)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) SUMMARY
Vapotherm's 2000i Respiratory Gas Humidifier
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Vapotherm, Inc. 198 Log Canoe Circle Stevensville, MD 21666
APR 1 3 2007
Phone: (410) 604-3977 Facsimile: (410) 604-3978
Contact Person: Robert Storey, President and CEO
Date Prepared: 13 December 2006
Name of Device and Name/Address of Sponsor
Vapotherm™ 2000i and 2000h
Vapotherm, Inc. 198 Log Canoe Circle Stevensville, MD 21666
Common or Usual Name: Respiratory Gas Humidifier
Classification Name: Humidifier, Respiratory Gas, (Direct Patient Interface)
Predicate Devices: Vapotherm™ 2000i and 2000h
Vapotherm, Inc. 198 Log Canoe Circle Stevensville, MD 21666
Purpose of the Special 510(k) Corrective Action Being Effected
The Vapotherm 2000i device is a modification to cleared Vapotherm 2000i device.
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Intended Use
Both the modified Vapotherm 2000i device and the predicate 2000i device are indicated for use to add moisture to and to warm breathing gases for administration to a patient.
Technological Characteristics
The base device of the modified Vapotherm 2000i device has the same technological characteristic as the predicate Vapotherm 2000i device. The software contained in the modified device has not been modified as a result of the corrections being effected and remains identical to the software resident in the predicate device. The modifications that have been made to the device, which are the subject of this Special 510(k) Corrective Action Being Effected, do not raise any new issues of safety or effectiveness.
Performance Data
Vapotherm has conducted extensive testing to verify and validate the changes to the previously marketed Vapotherm 2000i device.
Substantial Equivalence
The company's Vapotherm 2000i respiratory gas humidifier that is the subject of this Special 510(k) Corrective Actions Being Effected notice is a modification to the previously marketed Vapotherm 2000i (K042245). The modified Vapotherm 2000i device has the same intended use and indications for use, similar principles of operation, and similar technological characteristics as the previously cleared predicate Vapotherm 2000i device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vapotherm, Incorporated C/O Mr. Johnathan Kahan Regulatory Counsel Hogan & Hartson, L.L.P 555 Thirteenth Street, NW Washington, DC 20004
APR 1 3 2007
Re: K070056
Trade/Device Name: Vapotherm Model #2000i and 2000h Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: March 15, 2007 Received: March 16, 2007
Dear Mr. Kahan:
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.
3
Page 2 – Mr. Kahan
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 systems (OS) 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Snyite Y. Michael O md.
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
K070056 510(k) Number (if known):
Vapotherm Model # 2000i and 2000h Device Name:
Indications for Use: The Vapotherm 2000i and 2000h are designed to add moisture to and to warm breathing gases for administration to patients, including neonates/infants, and adults. The flow rates may be from 1 to 40 liters per minute via nasal cannula. Environments for use -- Home, Hospital, Sub-acute Institutions.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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