(63 days)
The Sandman Duo and Sandman Duo ST are indicated for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing more than 30kg (66lb) within homecare and hospital environments.
The Sandman Duo and Sandman Duo ST are designed to deliver Continuous Positive Airway Pressure between 3 and 20 cmHzO, and may come in different configurations including an optional integrated pass-over or heated humidifier.
The Sandman Duo and Sandman Duo ST are designed to deliver two levels of pressure in Bilevel mode. The positive inspiratory pressure (IPAP) is delivered during the inspiratory phase and can be set up to 25 cm H2O. The positive expiratory pressure (EPAP) is delivered during the expiratory phase and can be set to 20 cm H2O.
The Sandman Duo and Sandman Duo ST can be powered either by AC mains (100 VAC to 240 VAC nominal) or by an external 12 VDC battery. The blower motor nominal voltage is 13 VDC. The Sandman Duo and Sandman Duo ST are double-insulated so that grounding is not required.
The Sandman Duo and Sandman Duo ST are for use by prescription only and displays the appropriate labeling.
The Sandman Duo and Sandman Duo ST are configured for patient use by a homecare dealer according to the prescription using the Clinician Manual provided. The devices are operated according to the instructions contained in the Patient Manual.
The Sandman Duo and Sandman Duo ST do not contain any drugs or biological products as components. However, the devices can be used to provide the patient with supplemental oxygen. The device and accessories are not supplied sterile, nor are they intended to be sterilized.
The Sandman Duo and Sandman Duo ST are for multiple use.
The Sandman Duo and Sandman Duo ST contain no patient contact components.
The Sandman Duo and Sandman Duo ST tubing is equivalent to that of the CPAP predicate devices. The Sandman Duo and Sandman Duo ST and the air filter are for multiple use. Accessories such as the patient circuit and nasal masks are for single patient use.
The Sandman Duo and Sandman Duo ST relv on 1 microprocessor for setting and viewing various control parameters and turning features on and off, and for controlling the heated humidification.
Pressure delivery for The Sandman Duo ST is regulated by a pressure sensor which monitors both ambient and output pressure and provides feedback to the control system.
The Sandman Duo and Sandman Duo ST use software to set the various device parameters such as the prescription pressure and the ramp starting pressure, and to provide heated humidification.
The provided 510(k) summary for the Puritan Bennett Sandman Duo and Sandman Duo ST does not describe a study involving a test set, expert readers, or ground truth in the way typically associated with AI/ML device evaluations. This document pertains to a medical device from 2008, well before the widespread use of AI in medical image analysis or diagnostics, and focuses on demonstrating substantial equivalence to predicate devices through performance testing, not clinical effectiveness studies with explicit acceptance criteria related to a specific medical condition's diagnosis or treatment outcome.
Therefore, many of the requested categories cannot be directly addressed from the provided text. The submission describes functional performance testing against regulatory standards and existing predicate devices.
However, based on the information provided, here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Equivalency) | Reported Device Performance and Compliance |
|---|---|
| Functional Performance Specifications: Capable of meeting stated performance specifications for CPAP and Bilevel modes (3-20 cmH2O CPAP, 3-25 cmH2O IPAP, 3-20 cmH2O EPAP) in spontaneously breathing patients over 30kg for Obstructive Sleep Apnea. | "Functional testing confirms that the Sandman Duo ST are capable of meeting its stated performance specifications. The device passed all tests." |
| Compliance with Regulatory Guidance: Adherence to the November 1993 draft "Reviewer Guidance for Premarket Notification Submissions" (Division of Cardiovascular, Respiratory, and Neurological Devices). | "Testing confirms that the Sandman Duo and Sandman Duo ST comply 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." |
| Software Compliance: Adherence to the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 2005). | "All software is tested in accordance with the 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' dated May 2005. The devices passed all tests." |
| Electrical Safety, Electromagnetic Compatibility, Mechanical and Environmental Testing: Compliance with relevant standards and demonstration of safety and effectiveness. | "The safety and effectiveness of the Sandman Duo and Sandman Duo ST were verified through performance related testing that consisted of Electrical Safety, Electromagnetic Compatibility, Mechanical and Environmental Testing. The Sandman Duo and Sandman Duo ST had been found compliant and had been certified to the standards referenced in the 'FDA Reviewer Guidance for Premarket Notifications'." |
| Equivalence to Predicate Devices: Performance is equivalent to Puritan Bennett Sandman Intro (K071575), Sandman Info (K080439), GoodKnight 425 (K041819), and GoodKnight 425 ST (K050072) for relevant modes/features. | "The Sandman Duo and Sandman Duo ST are equivalent to the Puritan Bennett Sandman Intro (K071575) for all aspects except the Bilevel mode, to the Puritan Bennett Sandman Info (K080439) only for detection of apneas and hypopneas, the Puritan Bennett GoodKnight 425 (K041819) for the Bilevel mode. The Sandman Duo ST is equivalent to the Puritan Bennett GoodKnight 425 ST (K050072) for the Bilevel mode including optional backup frequency." This is a statement of the conclusion of the equivalency assessment rather than specific performance details. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The submission describes laboratory performance testing (e.g., electrical safety, mechanical, software verification), not a clinical study with a patient test set as would be relevant for AI/ML performance evaluation.
- Data Provenance: Not applicable. The document refers to engineering and software validation, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There was no clinical test set requiring expert ground truth for this type of device submission.
4. Adjudication method for the test set:
- Not applicable.
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:
- No. This is not an AI/ML device; it's a non-continuous ventilator/CPAP device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a hardware medical device with embedded control software, not a standalone algorithm. Its "standalone" performance would refer to its physical operation and pressure delivery, which was tested.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of clinical "ground truth" for diagnostic or treatment efficacy. The "ground truth" for the engineering performance tests would be defined by the specifications of the device and the requirements of the standards (e.g., a pressure reading must be within X tolerance of the set pressure).
8. The sample size for the training set:
- Not applicable. This device does not use machine learning that would require a "training set."
9. How the ground truth for the training set was established:
- Not applicable.
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OCT 0 9 2008
510(k) SUMMARY
PURITAN BENNETT Sandman Duo and Sandman Duo ST
Submitter Information
Mallinckrodt Développement France 10, allée Pelletier Doisy 54601 Villers-lès-Nancy France
| Submitter's Name | Jean-Paul Arnould |
|---|---|
| EMEA RA Manager France | |
| Telephone | +33 383.44.85.00 |
| Fax | +33 383.44.85.01 |
| Submission Correspondent | Tina Dreiling |
| Regulatory Affairs Associate II | |
| Covidien, formerly Nellcor Puritan Bennett Inc | |
| 6135 Gunbarrel Ave | |
| Boulder, CO 80301 | |
| Telephone | 303-305-2512 |
| Fax | 303-305-2212 |
Device Name
| Proprietary Name | Puritan Bennett, Sandman Duo and Sandman Duo ST |
|---|---|
| Common Name | CPAP device |
| Classification Name | Non continuous Ventilator (73 BZD), per 21 CFR 868.590 |
Device Information
The Sandman Duo and Sandman Duo ST are designed to deliver Continuous Positive Airway Pressure to patients suffering from obstructive sleep apnea. They may be configured with optional humidification.
Predicate Device Equivalence
The Sandman Duo and the Sandman Duo ST are equivalent to the Puritan Bennett Sandman Intro (K071575) for all aspects except the Bilevel mode, to the Puritan Bennett Sandman Info (K080439) only for detection of apneas and hypopneas, the Puritan Bennett GoodKnight 425 (K041819) for the Bilevel mode. The Sandman Duo ST is equivalent to the Puritan Bennett GoodKnight 425 ST (K050072) for the Bilevel mode including optional backup frequency.
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The Sandman Duo and Sandman Duo ST, like the predicate devices, are intended to provide Continuous Positive Airway Pressure (CPAP) between 3 and 20 cmH2O with a Bilevel mode from 3 to 25 cm H2O to spontaneously breathing patients over 30 Kg for the treatment of Obstructive Sleep Apnea in a hospital and homecare environment, with optional humidification of the delivered air.
Testing was performed to demonstrate that the performance of the Sandman Duo and Sandman Duo ST is equivalent to the legally marketed predicate devices. The safety and effectiveness of the Sandman Duo and Sandman Duo ST were verified through performance related testing that consisted of Electrical Safety, Electromagnetic Compatibility, Mechanical and Environmental Testing. The Sandman Duo and Sandman Duo ST had been found compliant and had been certified to the standards referenced in the "FDA Reviewer Guidance for Premarket Notifications".
Device Description
The Sandman Duo and Sandman Duo ST are designed to deliver Continuous Positive Airway Pressure between 3 and 20 cmHzO, and may come in different configurations including an optional integrated pass-over or heated humidifier.
The Sandman Duo and Sandman Duo ST are designed to deliver two levels of pressure in Bilevel mode. The positive inspiratory pressure (IPAP) is delivered during the inspiratory phase and can be set up to 25 cm H2O. The positive expiratory pressure (EPAP) is delivered during the expiratory phase and can be set to 20 cm H2O.
The Sandman Duo and Sandman Duo ST can be powered either by AC mains (100 VAC to 240 VAC nominal) or by an external 12 VDC battery. The blower motor nominal voltage is 13 VDC. The Sandman Duo and Sandman Duo ST are double-insulated so that grounding is not required.
The Sandman Duo and Sandman Duo ST are for use by prescription only and displays the appropriate labeling.
The Sandman Duo and Sandman Duo ST are configured for patient use by a homecare dealer according to the prescription using the Clinician Manual provided. The devices are operated according to the instructions contained in the Patient Manual.
The Sandman Duo and Sandman Duo ST do not contain any drugs or biological products as components. However, the devices can be used to provide the patient with supplemental oxygen. The device and accessories are not supplied sterile, nor are they intended to be sterilized.
The Sandman Duo and Sandman Duo ST are for multiple use.
The Sandman Duo and Sandman Duo ST contain no patient contact components.
The Sandman Duo and Sandman Duo ST tubing is equivalent to that of the CPAP predicate devices. The Sandman Duo and Sandman Duo ST and the air filter are for multiple use. Accessories such as the patient circuit and nasal masks are for single patient use.
The Sandman Duo and Sandman Duo ST relv on 1 microprocessor for setting and viewing various control parameters and turning features on and off, and for controlling the heated humidification.
Covidien
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Pressure delivery for The Sandman Duo ST is regulated by a pressure sensor which monitors both ambient and output pressure and provides feedback to the control system.
The Sandman Duo and Sandman Duo ST use software to set the various device parameters such as the prescription pressure and the ramp starting pressure, and to provide heated humidification.
The Sandman Duo and Sandman Duo ST comply with certain voluntary standards, specifically the draft ARDB Reviewer Guidance for Premarket Notifications (Nov 1993) and IEC60601-1.
The Sandman Duo and Sandman Duo ST are not part of a kit.
Indication for Use
The Sandman Duo and Sandman Duo ST are indicated for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing more than 30kg (66lb) within homecare and hospital environments.
Conditions of use
The Sandman Duo and Sandman Duo ST are designed for use at home or in sleep centers. These devices are portable and can be powered from both household and automobile power sources. The Sandman Duo and Sandman Duo ST may come with an integrated heated humidifier, which is designed to heat and raise the humidity of the air delivered to the patient. When the device is battery-powered, the heated humidification feature cannot be used, but pass-over humidification is still possible. The water chamber is designed to be filled with water only.
If Sandman Duo and Sandman Duo ST do not come with an integrated heated humidifier, pass-over humidification may be achieved by using a water chamber.
Contraindications
There are no contraindications.
Summary of Performance Testing
-
- Functional testing confirms that the Sandman Duo ST are capable of meeting its stated performance specifications. The device passed all tests.
-
- Testing confirms that the Sandman Duo and Sandman Duo ST comply 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.
-
- All software is tested in accordance with the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 2005. The devices passed all tests.
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Conclusions
We conclude that the Sandman Duo and Sandman Duo ST meet the stated performance specifications and criteria referenced above and that the device and its accessories will operate safely in its intended environment and will be effective in fulfilling the intended use.
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Image /page/4/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird with stylized wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mallinckrodt Développement France C/O Ms. Tina Dreiling Regulatory Affairs Associate II Covidien 6135 Gunbarrel Avenue Boulder, Colorado 80301
Re: K082237
Trade/Device Name: Puritan Bennett, Sandman Duo and Sandman Duo ST Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: September 9, 2008 Received: September 10, 2008
Dear Ms. Dreiling:
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 - Ms. Dreiling
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 (QS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Thamuelle-Lendemy for 11
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: Puritan Bennett, Sandman Duo and Sandman Duo ST
Indications for Use:
The Sandman Duo and Sandman Duo ST are indicated for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing more than 30kg (66lb) within homecare and hospital environments.
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)
La Azim, D.
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082237
§ 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).