(151 days)
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.
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).
The provided text is a 510(k) summary for the Puritan Bennett GoodKnight H2O Heated Humidifier. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a specific study proving the device meets those criteria, particularly in the context of an AI-powered device.
The document discusses non-clinical testing for mechanical, electrical, thermal safety, EMC, software verification, validation, and performance. It also states the device "meets the performance and safety requirements of ISO 8185 related to humidification systems and which includes also the requirements of IEC 60601-1."
Since this is a non-AI medical device (a heated humidifier), many of your questions related to AI-specific elements (like sample size for test/training sets, experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable or cannot be answered from the provided text.
Here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category (Derived from Standards) | Reported Device Performance |
|---|---|
| Mechanical Safety (per ISO 8185, IEC 60601-1, UL 2601-1) | Met requirements. Specific parameters not detailed, but likely include structural integrity, material compatibility, and resistance to physical stress during normal use. |
| Electrical Safety (per ISO 8185, IEC 60601-1, UL 2601-1) | Met requirements. Specific parameters not detailed, but likely include leakage currents, dielectric strength, and grounding integrity. |
| Thermal Safety (per ISO 8185, IEC 60601-1, UL 2601-1) | Met requirements. Specific parameters not detailed, but likely include surface temperatures, heating element control, and prevention of overheating. |
| Electromagnetic Compatibility (EMC) (per relevant standards) | Met requirements. Specific parameters not detailed, but likely involve emission and immunity standards. |
| Software Verification and Validation (per relevant standards and FDA Guidance) | Met requirements. Confirms software functions as intended and meets specifications. |
| Humidification Performance (per ISO 8185) | Met performance requirements. Specific humidification output (e.g., water vapor content, temperature) not detailed, but ISO 8185 specifies minimum humidification performance for respiratory gas humidifiers. |
| Overall Safety and Effectiveness (per FDA Reviewers Guidance) | Deemed to operate safely in its intended environment and be effective in fulfilling its intended use. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes non-clinical testing on the device itself, not a machine learning model. Therefore, "test set" and "data provenance" in the AI context are not applicable. The testing was likely conducted in a laboratory setting (Mallinckrodt Développement France).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth for a physical device's performance is established through objective measurements against a standard, not by expert consensus on data interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is for an AI algorithm evaluating data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical medical device, not an AI assistance system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm in the AI sense. The device operates "standalone" in its intended function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance would be established through objective physical measurements against the specified limits and ranges defined in the referenced international standards (ISO 8185, IEC 60601-1, UL 2601-1, and FDA Reviewers Guidance). For example, temperature measurements for thermal safety, electrical measurements for electrical safety, or humidity measurements for humidification performance.
8. The sample size for the training set
Not applicable. There is no AI training set for this physical device.
9. How the ground truth for the training set was established
Not applicable.
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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
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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.
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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.
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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
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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:
Page 1 of 1
§ 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).