(151 days)
Not Found
No
The summary describes a microprocessor-controlled heated humidifier with standard safety and performance testing, and explicitly states equivalence to a predicate device based on type, configuration, environmental conditions, and control method (software). There is no mention of AI, ML, or related concepts.
No.
The device is described as an accessory to warm and add moisture to the inspiratory gas flow for administration to a patient undergoing CPAP or bi-level therapy, not as a standalone therapeutic device. It supports the therapy rather than providing the therapy itself.
No
This device is described as an accessory intended to warm and add moisture to inspiratory gas flow for patients undergoing CPAP or bi-level therapy, not to diagnose a condition.
No
The device description explicitly states it has an ABS enclosure, a heater plate, a humidification chamber, and controls, indicating it is a physical hardware device with embedded software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to warm and add moisture to inspiratory gas for patients undergoing CPAP or bi-level therapy for Obstructive Sleep Apnea. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a heated passover humidifier that adds water content to breathing gases. This is a mechanical and electrical device for modifying air, not for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Using reagents or assays.
The device is clearly described as an accessory for respiratory therapy equipment, focused on improving patient comfort and compliance by humidifying the air they breathe.
N/A
Intended Use / Indications for Use
The Puritan Bennett GoodKnight H2O is an accessory intended to warm and add moisture to the inspiratory gas flow for administration to a patient undergoing CPAP or bi-level therapy.
It is intended for use with adult patients receiving CPAP or Bi-level therapy for the treatment of Obstructive Sleep Apnea in the homecare and hospital environments.
Product codes (comma separated list FDA assigned to the subject device)
BTT
Device Description
The GoodKnight H2O is a microprocessor-controlled heated passover humidifier used to provide evaporated water content to dry breathing gases, during treatment of Obstructive Sleep Apnea.
The GoodKnight H2O has an ABS enclosure and a heater plate positioned in the front of the unit. A humidification chamber slides onto the heater plate and is held in place by a rim on the enclosure. The unit controls are located at the back of the device.
The technological characteristics of the GoodKnight H2O Heated Humidifier are equivalent to that of the predicate device.
The GoodKnight H2O is equivalent in terms of type (heated passover humidification), configuration (chamber, mounting arrangements), environmental conditions of use and control method (software).
Non-clinical testing of the GoodKnight HyO has been carried out and covered mechanical safety, electrical safety, thermal safety, EMC, software verification and validation and performance.
The GoodKnight H2O meets the performance and safety requirements of ISO 8185 related to humidification systems and which includes also the requirements of IEC 60601-1. The product complies also to the relevant USA deviations from UL 2601-1 and to the applicable requirements of the FDA Reviewers Guidance (November 1993).
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 patients
Intended User / Care Setting
homecare and hospital environments
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)
Non-clinical testing of the GoodKnight HyO has been carried out and covered mechanical safety, electrical safety, thermal safety, EMC, software verification and validation and performance.
The GoodKnight H2O meets the performance and safety requirements of ISO 8185 related to humidification systems and which includes also the requirements of IEC 60601-1. The product complies also to the relevant USA deviations from UL 2601-1 and to the applicable requirements of the FDA Reviewers Guidance (November 1993).
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.
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
JAN 1 0 2005
510(k) SUMMARY
PURITAN BENNETT
GoodKnight H2O Heated Humidifier
1.0 - Submitter Information
Mallinckrodt Développement France 10, allée Pelletier Doisy 54601 Villers-les-Nancy France
| Submitter's Name | : Moustafa Anki |
|---|---|
| Telephone | : +33 383.44.85.00 |
| Fax Number | : +33 383.44.85.01 |
| Preparation Date | : June 2004 |
2.0 - Device Name
| Proprietary Name | : GoodKnight H₂O |
|---|---|
| Common Name | : Heated Humidifier |
| Device Classification Name | : Respiratory Gas Humidifier (BTT), per 21 CFR 868 5450 |
3.0 - Predicate Device Equivalence
We are claiming substantial equivalence to the Respironics H2 Heated for commercial distribution per
K030090.
4.0 - Indications for Use
The Puritan Bennett GoodKnight H20 is an accessory intended to warm and add moisture to the inspiratory gas flow for
administration to a patient undergoing CPAP or bi-level t administration to a patient undergoing CPAP or bi-level therapy.
It is intended for use with adult patients receiving CPAP or Bi-level therapy for the treatment of Obstructive Sleep Apnea in
the homecare and hospital environments. the homecare and hospital environments.
037
1
5.0 - Device Description
The GoodKnight H2O is a microprocessor-controlled heated passover humidifier used to provide evaporated water content to dry breathing gases, during treatment of Obstructive Sleep Apnea.
The GoodKnight H2O has an ABS enclosure and a heater plate positioned in the front of the unit. A humidification chamber slides onto the heater plate and is held in place by a rim on the enclosure. The unit controls are located at the back of the device.
The technological characteristics of the GoodKnight H2O Heated Humidifier are equivalent to that of the predicate device.
The GoodKnight H2O is equivalent in terms of type (heated passover humidification), configuration (chamber, mounting arrangements), environmental conditions of use and control method (software).
Non-clinical testing of the GoodKnight HyO has been carried out and covered mechanical safety, electrical safety, thermal safety, EMC, software verification and validation and performance.
The GoodKnight H2O meets the performance and safety requirements of ISO 8185 related to humidification systems and which includes also the requirements of IEC 60601-1. The product complies also to the relevant USA deviations from UL 2601-1 and to the applicable requirements of the FDA Reviewers Guidance (November 1993).
6.0 - Conclusion
We conclude that the GoodKnight 425 meets the stated performance specifications and criteria outlined in the Reviewers Guidance and standards publications referenced above. We conclude that the device will operate safely in its intended environment and will be effective in fulfilling its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 wavy lines extending from its body, representing the department's mission to protect and promote the health and well-being of Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 0 2005
Mallickrodt Development France C/O Ms. Patricia Murphy Responsible Third Party Official KEMA Quality B.V. 4377 County Line Road Chalfont, Pennsylvania 18914
Re: K042184
Trade/Device Name: Puritan Bennett GoodKnight H2O Regulation Number: 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: December 27, 2004 Received: December 28, 2004
Dear Ms. Murphy:
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 (1 Mr.), it hay ob adjoor in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device oan be roublish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Murphy
Please be advised that FDA's issuance of a substantial equivalence determination does not r lease be act read that be a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or the ret of 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 (QS) regulation (21 CFR Part 820); and if requirely as 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) I mo reter notification. The FDA finding of substantial equivalence of your device to a premained hourselicate 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), 11 you deents the Office of Compliance at (301) 594-0120. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Carls
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
510(k) Number (if known):
Device Name: Puritan Bennett GoodKnight H2O
Indications For Use:
The Puritan Bennett GoodKnight H2O is an accessory intended to warm and add moisture to the inspiratory gas flow for administration to a patient undergoing CPAP or bi-level therapy.
It is intended for use with adult patients receiving CPAP or Bi-level therapy for the treatment of Obstructive Sleep Apnea in the homecare and hospital environments.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sta. Geovill
, General Hospital,
510(k) Number:
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