IPI HUMIDIFIER CHAMBER

K993282 · I.P.I. Medical Products · BTT · Sep 18, 2000 · Anesthesiology

Device Facts

• Record ID: K993282
• Device Name: IPI HUMIDIFIER CHAMBER
• Applicant: I.P.I. Medical Products
• Product Code: BTT · Anesthesiology
• Decision Date: Sep 18, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Humidifier chambers function as reservoirs for water in heated respiratory gas humidification systems. Device receives water input; maintains water level for evaporation to humidify air delivered to patients via ventilator or respiratory support circuits. Used in hospital settings (ICU, anesthesia, respiratory therapy) and homecare; operated by clinicians or trained caregivers. Output is humidified gas delivered to patient airway. Benefits include prevention of mucosal drying and maintenance of airway moisture during mechanical ventilation or respiratory therapy. Chambers are disposable, single-use components.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and design comparison to legally marketed predicate devices.

Technological Characteristics

Disposable humidifier chambers for heated respiratory gas humidifiers. Models include standard, autofeed, and low compressible volume configurations. Materials are medical-grade plastics. Designed for compatibility with Marquest SCT 3000 and Fisher & Paykel MR700/720/730 bases. Passive humidification principle via water evaporation. Non-electronic, mechanical accessory.

Indications for Use

Indicated for use with Marquest SCT 3000 and Fisher & Paykel MR700, MR720, and MR730 heated humidifiers to hold water for air humidification. Patient population includes adult and pediatric patients requiring respiratory gas humidification. Environment of use includes hospital (anesthesia, ICU, respiratory therapy) and homecare.

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

• Marquest SCT 3000 (K903138, K962223)
• HPD Medical (K864173)
• Fisher & Paykel (K850647, K862923, K934140)

Submission Summary (Full Text)

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# 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 [phone] • FAX [phone] E-MAIL: [e-mail]

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MED/
CERT
ISO 9001 EN 46001
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#### Premarket Verification [510 (k)] Summary Section 5

Non-Confidential Summary of Safety and Effectiveness

| Official Contact: | Mazh Said, Ph.D.,<br>Director Regulatory Affairs/Quality Assurance |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Proprietary of Trade Name: | IPI Humidification Chamber for Fisher & Paykel and Marquest<br>Humidifier Bases |
| Common/Usual Name: | Accessories for Heated Humidifiers |
| Classification Name: | 73 BTT - Respiratory Gas Humidifiers (Direct Patient Interface)<br>Subsection 868.5450 |
| Classification | Class II (Two) |
| Intended Use: | Humidifier Chambers for use with Marquest SCT 3000 Heated<br>Humidifier and Fisher & Paykel MR 700, MR720, and MR730 |
| Predicate Devices: | Marquest SCT 3000 - K903138 and K962223<br>HPD Medical - K864173<br>Fisher & Paykel - K850647, K862923, K934140 |
| Device Description: | The humidifier chambers offered for use with the Marquest SCT<br>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

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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.

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### 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, [phone]. "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 [phone] or [phone], 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

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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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