GOODKNIGHT H20, MODEL M-114600-00

K042184 · Mallinckrodt Developpement France · BTT · Jan 10, 2005 · Anesthesiology

Device Facts

• Record ID: K042184
• Device Name: GOODKNIGHT H20, MODEL M-114600-00
• Applicant: Mallinckrodt Developpement France
• Product Code: BTT · Anesthesiology
• Decision Date: Jan 10, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended 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 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.

Device Story

GoodKnight H2O is a microprocessor-controlled heated passover humidifier; accessory to CPAP or bi-level therapy devices. Device warms and adds moisture to inspiratory gas flow to improve patient comfort during Obstructive Sleep Apnea treatment. Consists of ABS enclosure, heater plate, and humidification chamber. Operated in home or hospital environments. Microprocessor controls heating levels. Healthcare provider or patient uses device by attaching it to the CPAP/bi-level unit; output is humidified air delivered to patient via breathing circuit. Benefits include reduced airway dryness during respiratory therapy.

Clinical Evidence

Bench testing only. Testing covered mechanical, electrical, and thermal safety, EMC, and software verification and validation. Device complies with ISO 8185 (humidification systems), IEC 60601-1, and applicable FDA Reviewers Guidance.

Technological Characteristics

Heated passover humidifier; ABS enclosure; heater plate; microprocessor-controlled. Complies with ISO 8185, IEC 60601-1, and UL 2601-1. Standalone accessory for CPAP/bi-level devices.

Indications for Use

Indicated for adult patients with Obstructive Sleep Apnea receiving CPAP or bi-level therapy in home or hospital settings.

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

• Respironics H2 Heated (K030090)

Submission Summary (Full Text)

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JAN 1 0 2005

K042184

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 [phone]. 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 [phone] or [phone] 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:

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