(137 days)
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.
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. The KnightControl is not part of a kit.
Here's an analysis of the provided 510(k) summary for the PURITAN BENNETT KnightControl, extracting the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional performance according to specifications | "Functional testing was performed to confirm that the KnightControl is capable of meeting its stated performance specifications. The device passed all tests." |
| Compliance with FDA "Reviewer Guidance for Premarket Notifications" | "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." |
| Electrical Safety | "The safety and effectiveness of the KnightControl was verified through performance related testing that consisted of Electrical Safety... The KnightControl was found compliant and has been certified to the standards referenced in the 'FDA Reviewer Guidance for Premarket Notifications'." |
| Electromagnetic Compatibility (EMC) | "The safety and effectiveness of the KnightControl was verified through performance related testing that consisted of... Electromagnetic Compatibility... The KnightControl was found compliant and has been certified to the standards referenced in the 'FDA Reviewer Guidance for Premarket Notifications'." |
| Mechanical Testing | "The safety and effectiveness of the KnightControl was verified through performance related testing that consisted of... 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'." |
| Environmental Testing | "The safety and effectiveness of the KnightControl was verified through performance related testing that consisted of... 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'." |
| Substantial equivalence to predicate device (ResControl II) | The document explicitly states the device is "substantially equivalent" to the predicate, implying it meets the predicate's established safety and effectiveness. |
Missing Information:
The provided 510(k) summary is a high-level overview and does not contain the detailed quantitative acceptance criteria or specific performance metrics that would typically be found in a comprehensive test report. The summary states that tests were performed and passed, but not what the specific pass/fail thresholds were for each test (e.g., specific voltage limits for electrical safety, EMI/EMC radiation levels).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document refers to "testing" but does not give the number of devices or iterations used for any of the performance tests.
- Data Provenance: Not specified. The summary does not provide details on the country of origin or whether the data was retrospective or prospective. Given the nature of a remote control device and the type of tests conducted (functional, electrical, EMC, mechanical, environmental), it's highly likely these were laboratory-based, prospective tests conducted on the manufactured device samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. The KnightControl is a hardware accessory (remote control) for medical devices, not a diagnostic or AI-driven system requiring expert interpretation or ground truth establishment based on clinical data. The tests focus on engineering performance, safety, and compatibility.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical or image-based studies, which is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable. The KnightControl is not an AI-assisted diagnostic or decision-support device. It's a remote control for CPAP machines. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or would be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The KnightControl does not contain an algorithm that operates "standalone" in a diagnostic or interpretive sense. Its software controls the associated CPAP devices and processes signals, but it doesn't perform diagnostic functions independently of clinician interaction. Performance testing (functional, electrical, etc.) inherently evaluates the device itself (standalone in an engineering context) but not in the sense of a standalone AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device would be its objective engineering specifications and compliance with recognized standards. For example:
- Functional Ground Truth: Whether the commands sent by the remote control are accurately received and executed by the connected CPAP device, and whether the displayed information is accurate.
- Electrical Safety Ground Truth: Compliance with established electrical safety standards (e.g., leakage current within limits, insulation integrity).
- EMC Ground Truth: Compliance with established electromagnetic compatibility standards (e.g., radiated emissions below limits, immunity to interference).
- Mechanical/Environmental Ground Truth: Ability to withstand specified physical stresses (e.g., vibration, temperature) without functional degradation.
These are verified through direct measurement and observation against pre-defined engineering requirements and regulatory standards, not expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
This information is not applicable. The KnightControl is not a machine learning or AI device that requires a "training set." Its software is traditionally programmed and verified, not trained on data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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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
-
- Functional testing was performed to confirm that the KnightControl is capable of meeting its stated performance specifications. The device passed all tests.
-
- 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 (240) 276-0120. 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 (240) 276-3150 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
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
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.(b)
Classification. Class II (performance standards).