(354 days)
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.
The humidifier chambers offered for use with the Marquest SCT 3000 and Fisher & Paykel MR700, MR720, and MR730
Here's an analysis of the provided text to extract information about the device's acceptance criteria and studies:
IPI Humidification Chamber for Fisher & Paykel and Marquest Humidifier Bases
1. Acceptance Criteria and Reported Device Performance
The provided document (a 510(k) Premarket Notification summary) does not contain a specific table of acceptance criteria with numerical targets (e.g., specific thresholds for performance metrics) or directly reported quantitative device performance data from a pivotal study.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices. The primary "acceptance criterion" for this type of submission is the determination by the FDA that the new device is as safe and effective as a legally marketed predicate device.
The study proving this "meets acceptance criteria" is the comparison to predicate devices and the absence of new questions of safety or effectiveness. The device description highlights its intended use with specific predicate humidifier bases (Marquest SCT 3000 and Fisher & Paykel MR 700, MR720, and MR730). It's implied that if the device functions as intended with these established systems and doesn't introduce new risks, it meets the inherent "acceptance criteria" of being safe and effective within that context.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size or data provenance for a "test set" in the context of a performance study with human subjects or a large-scale data analysis. This is typical for a 510(k) submission where substantial equivalence is demonstrated primarily through engineering comparisons, material compatibility, and intended use matching, rather than a full clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. As noted, the submission primarily relies on substantial equivalence to predicate devices, not on a new, independent test set requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
This information is not provided as a formal test set requiring adjudication in the typical sense for clinical performance metrics is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the document. The submission focuses on device equivalence, not on the improvement of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical product (humidification chamber), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" in this context is the safety and effectiveness profile of the predicate devices (Marquest SCT 3000, HPD Medical devices, and Fisher & Paykel devices). The new device is deemed "substantially equivalent" if it operates under the same principles, uses similar materials, and achieves the same intended use without raising new safety or effectiveness concerns, thereby relying on the established "truth" of the predicate devices.
8. The Sample Size for the Training Set
This is not applicable as the device is a physical medical product, not an algorithm or AI system that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reason as above.
Summary of Study (Based on 510(k) Nature):
The "study" demonstrating the device meets the "acceptance criteria" (i.e., substantial equivalence) is the Premarket Verification Summary [510(k)] Section 5, which details the comparison of the IPI Humidification Chamber to its predicate devices. This involves demonstrating:
- Identical Intended Use: The IPI Humidification Chambers are intended for use with the specific predicate humidifier bases (Marquest SCT 3000 and Fisher & Paykel MR 700, MR720, MR730) for humidifying air delivered to patients.
- Similar Technological Characteristics: While not explicitly detailed in this summary, a 510(k) submission would typically present data on materials, design, and functional characteristics to show they are similar enough to existing devices as to not raise new questions of safety and effectiveness.
- Matching Classification: The device falls under the same classification (Class II, Respiratory Gas Humidifiers) and product code (73 BTT) as the predicate devices.
The FDA's review of this submission and subsequent clearance (K993282) signifies their agreement that the device is substantially equivalent to the predicates, effectively "proving" that it meets the regulatory "acceptance criteria" for market entry.
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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 (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 MarquestHumidifier 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 HeatedHumidifier and Fisher & Paykel MR 700, MR720, and MR730 |
| Predicate Devices: | Marquest SCT 3000 - K903138 and K962223HPD Medical - K864173Fisher & Paykel - K850647, K862923, K934140 |
| Device Description: | The humidifier chambers offered for use with the Marquest SCT3000 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
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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 (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
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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 __
page 8 of 51
§ 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).