(71 days)
The 840 Ventilator System with ET/Tracheostomy Tube Compensation, TC, Option is used to provide continuous ventilation to patients requiring respiratory support. This device is used for a wide range of patients from infant to adult and for a wide variety of clinical conditions.
The 840 Ventilator System is a "Continuous Ventilator", a Class II device, per 21 CFR Part 868.5895. This device is designated as Class I, Type B equipment, per IEC 601-1. The 840 Ventilator's gas delivery system consists of two proportional solenoid valves, PSOLs and an active expiratory valve. Previously cleared modes of ventilation include Assist Control, AC, Synchronized Intermittent Mandatory Ventilation, SIMV and Spontaneous, SPONT. The 840 Ventilator System supplies mandatory or spontaneous breaths with a preset level of positive end expiratory pressure, PEEP, trigger sensitivity and oxygen concentration. A mandatory breath can be either pressure or volume controlled, except in the optional BiLevel mode, when it is always pressure-controlled. A spontaneous breath type allows patient inspiratory flows of up to 200 L/min, with or without pressure support. This 840 Ventilator modification comprises the addition of a new ET/Tracheostomy Tube Compensation, "TC", feature. This feature is implemented on the 840 Ventilator through additional functionality in software and by using the existing User Interface panel. "TC" has been added as a Breath Type choice in the Touch Screen SPONT Type menu. The ventilator's pneumatic design and electrical circuitry remain functionally unchanged.
The provided text is a summary of a 510(k) submission for a medical device, the Puritan-Bennett 840 Ventilator System with ET/Tracheostomy Tube Compensation Option. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study in the way one might for a novel diagnostic AI.
The document does not contain information about acceptance criteria or a study designed to prove the device meets those criteria in the context of a new diagnostic algorithm. Instead, it focuses on demonstrating that the modified ventilator is substantially equivalent to existing predicate devices.
Therefore, many of the requested sections (Table of acceptance criteria, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, sample size for training set, how training ground truth was established) cannot be answered from the provided text. These are typically elements of studies designed to validate the performance of new diagnostic or predictive algorithms, which is not the primary purpose of this 510(k) submission.
The relevant information from the document pertains to the device's intended use and the regulatory pathway.
Here's a breakdown of what can be extracted based on the nature of the submission:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the provided document. The document describes the device modification and its intended use, emphasizing its substantial equivalence to predicate devices. It does not lay out specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity for a diagnostic claim) or report detailed numerical performance metrics for the modified feature. The assessment in a 510(k) is about safety and effectiveness in comparison to predicates, not usually a standalone performance trial against specific numerical targets.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not present in the provided document. The 510(k) does not describe a clinical study with a "test set" in the context of evaluating a new algorithm's performance. The review focuses on design controls, verification, and validation testing (software, etc.) to ensure the modification is safe and effective compared to predicates, but details of such testing, including sample sizes for clinical data, are not provided.
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):
This information is not present in the provided document, as no such "test set" and ground truth establishment are described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not present in the provided document, as no such "test set" and adjudication process are described.
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:
This information is not present in the provided document. This type of study is relevant for AI-powered diagnostic aids, which is not the nature of this ventilator modification.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not present in the provided document. The device is a ventilator, not an AI-only algorithm. The "TC" feature is an integrated software function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not present in the provided document.
8. The sample size for the training set:
This information is not present in the provided document. The "TC" feature is described as an "additional functionality in software" using the existing user interface. It's not presented as a machine learning model requiring a discrete "training set" in the common sense of AI development.
9. How the ground truth for the training set was established:
This information is not present in the provided document.
Summary of what is known from the document:
- Device: Puritan-Bennett 840 Ventilator System with ET/Tracheostomy Tube Compensation (TC) Option.
- Modification: Addition of a new ET/Tracheostomy Tube Compensation, "TC", feature implemented via additional software functionality using the existing User Interface.
- Regulatory Pathway: 510(k) Pre-market Notification, asserting substantial equivalence to predicate devices (Puritan-Bennett 7200 Series Ventilator and Drager Evita 4 Ventilator).
- Basis for Equivalence: The intended use, materials, and design are similar to predicate devices. The technical characteristics of the modification do not introduce new questions of safety or effectiveness. Compensation for ET/Tracheostomy Tube resistance via positive pressure support is common clinical practice.
- Software Development: Followed FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 29, 1998) and internal company requirements for verification and validation testing.
- Intended Use: To provide continuous ventilation for infant, pediatric, and adult patients (tidal volume 25 - 2500 mL) requiring respiratory support in hospitals and hospital-type facilities. Not for transport between facilities or in the presence of flammable anesthetics. For use and servicing by trained and qualified clinicians/persons only, and by prescription.
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993071
SUMMARY OF SAFETY AND EFFECTIVENESS
- Puritan-Bennett Corp., SUBMITTER: A subsidiary of Mallinckrodt Inc.
September 10, 1999 DATE:
Continuous Ventilator COMMON NAME:
PROPRIETARY NAME: 840 Ventilator System with ET/Tracheostomy Tube Compensation Option
David A. C. Green CONTACT: Site Manager, Regulatory Affairs Puritan-Bennett Corp. A subsidiary of Mallinckrodt Inc. 2200 Faraday Avenue Carlsbad, CA 92008 USA
Phone: (760) 603-5978 (760) 603-5907 Fax:
CLASSIFICATION: Class II per 21 CFR 868.5895 Continuous Ventilator
PREDICATED DEVICES:
Predicate devices are identified as the Puritan-Bennett 7200 Series Ventilator and the Drager Evita 4 Ventilator. Both of these predicate devices employs a pressure support feature that approximates the required compensation for the pressure drop across the ET/Tracheostomy Tube. The 840 TC is substantially equivalent to the above mentioned predicate devices.
| Predicate Device | 510(k) Number | Classification |
|---|---|---|
| Puritan-Bennett Corp.7200 Series Ventilator | K902506B | Class II,Continuous VentilatorPer 21 CFR 868.5895 |
| DragerEvita 4 Ventilator | K961687 | Class II,Continuous VentilatorPer 21 CFR 868.5895 |
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DEVICE DESCRIPTION l
The 840 Ventilator System is designed and Manufactured by Puritan-Bennett Corp. at Carlsbad, California, a subsidiary of Mallinckrodt Inc.
The 840 Ventilator System is a "Continuous Ventilator", a Class II device, per 21 CFR Part 868.5895. This device is designated as Class I, Type B equipment, per IEC 601-1.
The 840 Ventilator's gas delivery system consists of two proportional solenoid valves, PSOLs and an active expiratory valve. Previously cleared modes of ventilation include Assist Control, AC, Synchronized Intermittent Mandatory Ventilation, SIMV and Spontaneous, SPONT. The 840 Ventilator System supplies mandatory or spontaneous breaths with a preset level of positive end expiratory pressure, PEEP, trigger sensitivity and oxygen concentration. A mandatory breath can be either pressure or volume controlled, except in the optional BiLevel mode, when it is always pressure-controlled. A spontaneous breath type allows patient inspiratory flows of up to 200 L/min, with or without pressure support.
This 840 Ventilator modification comprises the addition of a new ET/Tracheostomy Tube Compensation, "TC", feature. This feature was developed under the TC Option project at the Puritan-Bennett Corp., facility at Carlsbad, CA. Established design control procedures were followed. Manufacturing implementation of TC will also be conducted at the Puritan-Bennett Corp., Carlsbad, CA, facility in the future.
The TC feature is implemented on the 840 Ventilator through additional functionality in software and by using the existing User Interface panel. "TC" has been added as a Breath Type choice in the Touch Screen SPONT Type menu. The ventilator's pneumatic design and electrical circuitry remain functionally unchanged.
Puritan-Bennett Corp. asserts that:
- a) the intended use of the 840 Ventilator with TC Option, as described in its labeling, has not changed from that of the cleared device, the 840 Ventilator and,
- b) the fundamental scientific technology of the 840 Ventilator with TC Option has not changed from that of the 840 Ventilator.
The device's intended use is the same as that of standard, currently marketed critical care ventilators. The device is a dual-microprocessor controlled, critical care ventilator intended to provide continuous ventilation for infant, pediatric and adult patients who require either invasive ventilation or non-invasive ventilation, via face mask.
Compensation for ET/Tracheostomy Tube resistance, by provision of positive pressure support to ventilated patients, is common clinical practice, providing justification for substantial equivalence.
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II. INTENDED USE:
Purpose and function of the 840 Ventilator System with TC Option:
The device is intended to provide continuous ventilation to patients requiring respiratory support. This product is intended for a wide range of patients from infant to adult and for a wide variety of clinical conditions.
Intended patient population:
The intended patient population includes infant, pediatric and adult patients (tidal volume 25 - 2500 mL) who require continuous respiratory support.
Intended environment of use:
The device is intended for use in hospitals and hospital-type facilities which provide respiratory care for patients requiring respiratory support.
The device may be used for transport within a hospital or hospital-type facility, provided compressed gas is supplied. The device is not intended for transport between hospitals or hospital-type facilities.
The device is not to be used in the presence of flammable anesthetics.
The device is intended for sale by or on the order of a physician only. The device is intended for operation by trained and qualified clinicians only and is intended for servicing by trained and qualified persons only.
III. SUBSTANTIAL EQUIVALENCE:
The intended use of the 840 Ventilator with TC Option is the same as that for standard, currently marketed, critical care ventilators. The materials and design of this device are similar to those of the predicate devices. The technical characteristics of this device modification do not introduce new questions regarding safety or effectiveness of critical care ventilators. Furthermore, the labeling associated with the 840 Ventilator with TC Option provides similar information as the predicate devices.
Information provided in this Special 510(k) submission provides comparative predicate device information and describes development procedures which support the determination of substantial equivalence and the assertion that the modified device is safe and effective for its intended use. Software design and development, including verification and validation testing, were conducted using FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 29 1998, as a guidance and per internal company requirements.
In summary, Puritan-Bennett Corp., has provided information that indicates that the 840 Ventilator with TC Option is safe and effective. This device is considered to be substantially equivalent to currently marketed devices which have been previously cleared by FDA.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol resembling an abstract human figure or a bird-like shape, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 1999
Mr. David A. C. Green Puritan-Bennett Corp. c/o Mallinckrodt Inc. 2200 Faraday Avenue Carlsbad, CA 92008
Re: K993071 840 Ventilator System with ET/Tracheostomy Tube Compensation Option Regulatory Class: II (two) Product Code: СВК October 26, 1999 Dated: Received: October 28, 1999
Dear Mr. Green:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further announcements requlatory action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. David A. C. Green
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Celia C. Day
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
| 510(k) Number: | K993071 |
|---|---|
| ---------------- | --------- |
840 Ventilator System with ET/Tracheostomy Tube Device Name: Compensation, TC, Option.
Ventilator System with ET/Tracheostomy Tube 840 Indications for Use: The Compensation, TC, Option is used to provide continuous ventilation to patients requiring respiratory support. This device is used for a wide range of patients from infant to adult and for a wide variety of clinical conditions.
Prescription Use: Yes (Per 21 CFR 801.109).
Carole C. Cary
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).