(354 days)
Not Found
No
The summary describes humidifier chambers, which are passive components, and there is no mention of AI, ML, or any computational processing.
No.
This device is a humidifier chamber accessory, not a therapeutic device itself. Its function is to hold water for humidifying air delivered to patients by a separate unit, the SCT 3000, which would be the therapeutic device.
No
The device is a humidifier chamber used with a humidifier for respiratory patients, indicating a therapeutic rather than a diagnostic function. Its purpose is to humidify air, not to diagnose medical conditions.
No
The device description explicitly states "humidifier chambers," which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to hold water for humidifying air delivered to patients. This is a supportive function for respiratory therapy, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The description focuses on the physical chambers used with humidifiers.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The device's function is purely mechanical/physical in supporting humidification.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Humidifier Chambers for use with Marquest SCT 3000 Heated Humidifier and Fisher & Paykel MR 700, MR720, and MR730
The humidifier chambers are indicated for use with the Marquest SCT 3000 unit and Fisher & The numiditer Chambers are Indicated for ass with the mo has has being delivered to patients.
Indications for Use: The humidifier chambers for the SCT 3000 are indicated for use with the SCT 3000 unit and to hold water required to humidify the air being delivered to patients.
Product codes (comma separated list FDA assigned to the subject device)
73 BTT
Device Description
The humidifier chambers offered for use with the Marquest SCT 3000 and Fisher & Paykel MR700, MR720, and MR730 Adult– Hi Flow Humidifier Chamber 1130 Adult - Hi Flow Humidifier Chamber with Autofeed 1131 Addit - 11 - Low Compressible Volume Humidifier Chamber 1140 Fediatric - Low Compressible Volume Humidifier Chamber with Autofeed 1141
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
Adult and Pediatric.
Adult and pediatric.
Intended User / Care Setting
Hospital: Anesthesia, ICU, Respiratory Therapy, Homecare
Hospital, anesthesia, ICU, respiratory therapy
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.
Marquest SCT 3000 - K903138 and K962223, HPD Medical - K864173, Fisher & Paykel - K850647, K862923, K934140
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.
Not Found
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
SEP 1 8 2000
Image /page/0/Picture/1 description: The image shows a logo with the letters "iP" in a bold, sans-serif font on the left side. The letters are white and set against a black background. To the right of the letters, there is a white rectangle with the words "medical products" printed in black, with "medical" on the top line and "products" on the bottom line. The font used for "medical products" is also sans-serif, but smaller than the letters "iP".
Division of: INHALATION PLASTICS, INC. INHALATION PEACHISU, CHICAGO, IL 60641 U.S.A. PHONE (773) 777-0900 • FAX (773) 777-0660 E-MAIL: ipimedical@compuserve.com
R H
MED/
CERT
ISO 9001 EN 46001
CE
Premarket Verification [510 (k)] Summary Section 5
Non-Confidential Summary of Safety and Effectiveness
| Official Contact: | Mazh Said, Ph.D.,
Director Regulatory Affairs/Quality Assurance |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Proprietary of Trade Name: | IPI Humidification Chamber for Fisher & Paykel and Marquest
Humidifier Bases |
| Common/Usual Name: | Accessories for Heated Humidifiers |
| Classification Name: | 73 BTT - Respiratory Gas Humidifiers (Direct Patient Interface)
Subsection 868.5450 |
| Classification | Class II (Two) |
| Intended Use: | Humidifier Chambers for use with Marquest SCT 3000 Heated
Humidifier and Fisher & Paykel MR 700, MR720, and MR730 |
| Predicate Devices: | Marquest SCT 3000 - K903138 and K962223
HPD Medical - K864173
Fisher & Paykel - K850647, K862923, K934140 |
| Device Description: | The humidifier chambers offered for use with the Marquest SCT
3000 and Fisher & Paykel MR700, MR720, and MR730 |
| Adult– Hi Flow Humidifier Chamber 1130 | |
Adult - Hi Flow Humidifier Chamber with Autofeed 1131 Addit - 11 - Low Compressible Volume Humidifier Chamber 1140 Fediatric - Low Compressible Volume Humidifier Chamber with Autofeed 1141
Indicated Use:
The humidifier chambers are indicated for use with the Marquest SCT 3000 unit and Fisher & The numiditer Chambers are Indicated for ass with the mo has has being delivered to patients.
Targeted Population:
Any patient utilizing the Marquest SCT 3000 Heated Humidifier or Fisher & Paykel MR700, MR720, and MR730. Adult and Pediatric.
Environment of Use:
Hospital: Anesthesia, ICU, Respiratory Therapy, Homecare
Page 23 of 23
1
Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three heads, depicted in a minimalist, flowing design.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 8 2000
Mr. David Levine I.P.I. Medical Products 3217 N. Kilpatrick Avenue Chicago, IL 60641
K993282 Re: IPI Humidifier Chamber II (two) Requlatory Class: Product Code: 73 BTT August 30, 2000 Dated: September 6, 2000 Received:
Dear Mr. Levine:
We have reviewed your Section 510(k) notification of intent to market we nave reviewed your beceiver.
The device referenced above and we have determined the device is the device ferenced above a the indications for use stated in the Substantially equivalens (color (cate devices marketed in encrosure) to regarif marness way 28, 1976, the enactment date of the Interstate Commerce proble of to devices that have been reclassified riedical bevice imendales, in the Federal Food, Drug, and In accordance with the proving therefore, market the device, subject to the general controls provisions of the Act. The general controls che general concrolo proclude requirements for annual registration, provisions of the not of manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special If your device is offic (Premarket Approval), it may be subject to such Controls) of Crass III (Fredian major regulations affecting your device additional Coller of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. co bos. In babbeanedary offacturing Practice requirements, as set with the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such inopections. Failure to comply with the GMP regulation may result in assumptions. Fullars of Oth-In, FDA may publish further announcements reguratory accron. In in the Federal Register. Please note: this concerning your actification submission does not affect any response co your pat have under sections 531 through 542 of the Act obrigation you might have and the Croduct Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. David Levine
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21 CFR-807-97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
James E. Dillard III
Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section # 3
Labeling (continued)
C. Indications for Use Statement
Pursuant to the Notice of 2/6/96 regarding listing of Indications for Use on a separate sheet, the following is per that request.
510(k) Number K993282 (To be assigned)
Device Name: Humidifier chambers
Indications for Use: The humidifier chambers for the SCT 3000 are indicated for use
with the SCT 3000 unit and to hold water required to humidify
the air being delivered to patients.
Targeted population: Any patient utilizing the SCT 3000 heated humidifier. Adult and
pediatric.
Environment of use: Hospital, anesthesia, ICU, respiratory therapy
Disposable / reusable: Disposable - single use
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bran J
Division of Cardiology or Respiratory Devices
510(k) Numb
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use __
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