KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US

K063501 · Mallinckrodt Developpement France · BZD · Apr 6, 2007 · Anesthesiology

Device Facts

• Record ID: K063501
• Device Name: KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US
• Applicant: Mallinckrodt Developpement France
• Product Code: BZD · Anesthesiology
• Decision Date: Apr 6, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2

Intended Use

The KnightControl is a wired remote control intended for use with a GoodKnight 418, GoodKnight 420, GoodKnight 425, or Knightstar 330 device. This remote control will be used in the sleep breathing disorder patients in order to define parameters of treatment. The KnightControl is not intended for life support or life-sustaining applications.

Device Story

KnightControl is a wired remote control accessory for GoodKnight 418, 420, 425, and Knightstar 330 CPAP devices. Used in clinical settings (hospitals, sleep labs) by physicians, nurses, and technicians. Connects via RS232 serial port to host device. Microprocessor-based system allows clinicians to view/set control parameters, toggle features, and output signals for polysomnography recording. Features LCD screen and keypad interface. Automatically detects connected device and adapts menu accordingly. Powered by AC mains (100-240 VAC) or 12 VDC. Double-insulated; no patient contact components. Facilitates parameter adjustment for sleep breathing disorder treatment; does not provide life support.

Clinical Evidence

Bench testing only. Performance testing confirmed compliance with stated specifications and the November 1993 draft 'Reviewer Guidance for Premarket Notification Submissions'. No clinical data provided.

Technological Characteristics

Wired remote control; RS232 serial connectivity. Microprocessor-based control system. LCD screen and button keypad interface. Powered by 100-240 VAC or 12 VDC. Double-insulated. No patient contact components. Not sterile. Designed for clinical environment use.

Indications for Use

Indicated for use by clinicians to adjust settings of GoodKnight 418, 420, 425, and Knightstar 330 devices for patients with sleep breathing disorders. Not for life-sustaining applications.

Regulatory Classification

Identification

A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

Predicate Devices

• ResControl II Remote Control (K040944)

Submission Summary (Full Text)

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## 510(k) SUMMARY

# PURITAN BENNETT KnightControl

APR - 6 2007

#### Submitter Information

Mallinckrodt Développement France 10, allée Pelletier Doisy 54601 Villers-lès-Nancy France

Submitter's Name

Telephone Fax

Submission Correspondent

Telephone Fax

February 23, 2007

4280 Hacienda Dr.

Jean-Paul Arnould

+33 383.44.85.00

+33 383.44.85.01

James Bonds

925-463-4371

925-463-4020

Regulatory Affairs Specialist

Senior Director Regulatory Affairs Nellcor Puritan Bennett, Inc.

Pleasanton, CA 94588 USA

#### Device Name

Proprietary Name Common Name Classification Name

Date Summary Prepared

KnightControl CPAP Remote Control Non continuous ventilator (21 CFR 868.5905, Product Code BZD)

#### Device Information

The KnightControl is an optional accessory that provides remote control capabilities when used in conjunction with the GoodKnight 418, GoodKnight 420, GoodKnight 425, and Knightstar 330 and is intended for use by a clinician in hospital/sleep laboratory settings where patients suffering from obstructive sleep appea are diagnosed and treated.

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#### Predicate Device Equivalence

This device is substantially equivalent to the ResControl II Remote Control cleared for commercial distribution in K040944. The predicate device is a remote control and data monitoring device intended for use with CPAP systems in the diagnosis and treatment of adult obstructive sleep apnea. It is intended to be used by clinicians in hospital and sleep laboratory environments and is not intended for lifesustaining applications.

Testing was performed to demonstrate that the performance of the KnightControl in its intended environment is as safe and effective as that of the legally marketed predicate device. The safety and effectiveness of the KnightControl was verified through performance related testing that consisted of Electrical Safety, Electromagnetic Compatibility, and Mechanical and Environmental Testing. The KnightControl was found compliant and has been certified to the standards referenced in the "FDA Reviewer Guidance for Premarket Notifications".

#### Device Description

The KnightControl is designed to control the GoodKnight 418, GoodKnight 420, GoodKnight 425, and Knightstar 330 devices in hospital, sleep laboratories, or other clinical settings.

The KnightControl is powered by AC mains (100 VAC to 240 VAC nominal). The KnightControl is doubleinsulated so that grounding is not required.

The KnightControl is set up for use by the clinician according to the instructions provided in the manual. The devices are operated according to the instructions contained in their respective Patient Manual and Clinical Manual.

The KnightControl relies on a microprocessor for setting and viewing main control parameters and status of the attached device, and turning features on and off. The microprocessor is also required for getting data of some signals from the devices in order to output these signals to allow these signals to be recorded.

The KnightControl is linked via an RS232 serial port to one of the following devices: GoodKnight 418 series, GoodKnight 420 series, GoodKnight 425 series, or Knightstar 330.

The KnightControl uses software to recognize the device to which it is connected and automatically adapt its menu to the device.

The KnightControl is not for use in life-supporting or life-sustaining situations. The device and it's accessories are not intended for sterile use.

The KnightControl is for multiple use. The KnightControl contains no patient contact components.

The KnightControl is for use in by physicians, nurses, and sleep lab technicians in a clinical (hospital, sleep laboratory, etc.) environment.

The KnightControl does not contain any drugs or biological products as components.

510 (k) Summary - Puritan Bennett KnightControl

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The KnightControl is not part of a kit.

#### Indication for Use

KnightControl is a remote control for use by clinicians to adjust the GoodKnight 418, GoodKnight 420, GoodKnight 425, and Knightstar 330 devices.

#### Intended Use

The KnightControl is a wired remote control intended for use with a GoodKnight 418, GoodKnight 420, GoodKnight 425, or Knightstar 330 device.

This remote control will be used in the sleep breathing disorder patients in order to define parameters of treatment.

The KnightControl is not intended for life support or life-sustaining applications.

#### Comparison of Technological Characteristics

Both KnightControl and the ResControl II remote control devices have been designed for remote operation and monitoring of CPAP devices by clinicians in clinical environments.

The global architecture of the KnightControl is similar to the ResControl II remote control. The voltage range for the KnightControl is 100 VAC to 240 VAC or 12 VDC. The KnightControl is doubleinsulated.

Both the ResControl II and the KnightControl use a microprocessor to set the various controls.

The user interface of the KnightControl and the ResControl control control are quite similar. Both devices use an LCD screen with button keypad to access and view various device settings, and output signals for polysomnograph data recording. Available settings on the KnightControl depend upon the connected therapeutic device and the mode of operation.

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## Summary of Performance Testing

- 1. Functional testing was performed to confirm that the KnightControl is capable of meeting its stated performance specifications. The device passed all tests.
- 2. Testing was performed to confirm that the KnightControl complies with the November 1993 draft "Reviewer Guidance for Premarket Notification Submissions" published by the Division of Cardiovascular, Respiratory, and Neurological Devices. The device passed all tests.

#### Conclusions

We conclude that the KnightControl meets the stated performance specifications and criteria referenced above. We conclude that the device and its accessories will operate safely in its intended environment and will be effective in fulfilling its intended use.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mallinckrodt Développment France C/O Mr. James Bonds Senior Director Regulatory Affairs Nellcor Puritan Bennett, Incorporated 4280 Hacienda Drive Pleasanton, California 94588

APR - 6 2007

Re: K063501

Trade/Device Name: KnightControl Remote Control Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: March 27, 2007 Received: March 29, 2007

Dear Mr. Bonds:

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 your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Bonds

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply 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 (OS) regulation (21 CFR Part 820); and if applicable, the 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) 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). please contact 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/industry/support/index.html.

Sincerely yours,

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:

Device Name: KnightControl Remote Control

## Indications For Use:

KnightControl is a remote control for use by clinicians to adjust the settings of the GoodKnight 418, GoodKnight 420, GoodKnight 425 and Knightstar 330 devices.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chel Ule

135-1 - 107 sion of Anesthesiology, General Hospital. Juon Control, Dental Devices

2(k) Number K06350

510(k) for the Puritan Bennett KnightControl