(86 days)
The DeVilbiss Suction Unit is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. Configurations of the device will be intended for the home, institutional, and field/transport environments. The device is for use only on the order of a physcian or other lincensed practitioner (e.g. EMT-field use).
The DeVilbiss Suction Unit is a portable AC/DC powered suction pump. It consists of (depending on configuration) a pump unit, collection bottle, relief valve, vacuum gage, bacteria filter, suction tubing, internal battery, and an AC to DC adapter. The device is designed and manufactured to comply with UL 2601-1 and/or CAN/CSA-C22.2 No. 601.1 M90 safety standards.
The manufacturer, Sunrise Medical HHG Inc., states that the DeVilbiss Suction Unit will meet the performance standards per ISO 10079-1:1991, "Medical Suction Equipment", which covers aspects such as vacuum level, flow, construction, life test, and sound level. This standard itself outlines the acceptance criteria for these parameters.
1. Table of Acceptance Criteria and Reported Device Performance:
Since the provided text states the device will meet the performance standards per ISO 10079-1:1991 without providing specific numeric values for the device's performance, the table will reflect the general nature of these criteria as described in the standard.
| Acceptance Criteria (per ISO 10079-1:1991) | Reported Device Performance (per 510(k) Summary) |
|---|---|
| Vacuum Level Requirements | Device "will meet performance standards per ISO 10079-1:1991" |
| Flow Rate Requirements | Device "will meet performance standards per ISO 10079-1:1991" |
| Construction Requirements | Device "will meet performance standards per ISO 10079-1:1991" |
| Life Test Requirements | Device "will meet performance standards per ISO 10079-1:1991" |
| Sound Level Requirements | Device "will meet performance standards per ISO 10079-1:1991" |
2. Sample Size Used for the Test Set and Data Provenance:
The provided 510(k) summary does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply states that "Performance Testing" was conducted to confirm compliance with ISO 10079-1:1991.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the 510(k) summary. The performance testing described relates to engineering standards rather than clinical evaluation requiring expert ground truth establishment.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. The testing relates to objective engineering measurements against a standard, not subjective clinical assessments requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The 510(k) pertains to a non-diagnostic medical device (suction pump) and its performance against engineering standards, not a diagnostic algorithm or image analysis system. Therefore, the concept of human readers improving with AI assistance is not relevant.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, in a sense. The "Performance Testing" described is analogous to a standalone study for the device's physical and functional characteristics. The device (algorithm only, if considering its operational mechanics as an "algorithm") was tested independently against the engineering standard ISO 10079-1:1991. Human-in-the-loop performance is not a relevant concept for a suction pump's primary performance criteria.
7. The Type of Ground Truth Used:
The ground truth used for the performance testing of the DeVilbiss Suction Unit is the objective performance specifications and requirements outlined in the international standard ISO 10079-1:1991, "Medical Suction Equipment." This standard defines measurable targets for vacuum level, flow rate, construction integrity, operational life, and sound levels.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. Suction pumps are not typically developed using "training sets" in the context of machine learning or AI. Their design and manufacturing are based on engineering principles and iterative development/testing, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable. As stated above, a "training set" with established ground truth, as understood in AI/ML, is not relevant for the development and testing of a medical suction pump, which relies on established engineering and safety standards.
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| 510(k) SUMMARY STATEMENT | |
|---|---|
| Submitter: | Sunrise Medical HHG Inc.Respiratory Products Division100 DeVilbiss DriveP.O. Box 635Somerset, Pa. 15501-0635Matt Smith814-443-7531814-443-7571 Fax |
| Date of 510(k) Submittal: | June 12, 1998 |
| Classification Name: | Apparatus, Suction, Ward Use, Portable, AC-Powered |
| Product Code: | JCX |
| FDA Regulation: | 878.4780 |
| FDA Classification: | Class II |
| Common Name: | Suction Pump/Aspirator |
| Proprietary Model #/Name: | DeVilbiss Suction Unit |
| Equivalent to Device(s): | DeVilbiss 7304 FDA 510(k)#K8720094Schuco-Vac FDA 510(k)#K935218 |
Description of Device:
The DeVilbiss Suction Unit is a portable AC/DC powered suction pump. It consists of (depending on configuration) a pump unit, collection bottle, relief valve, vacuum gage, bacteria filter, suction tubing, internal battery, and an AC to DC adapter. The device is designed and manufactured to comply with UL 2601-1 and/or CAN/CSA-C22.2 No. 601.1 M90 safety standards.
Intended Use of Device:
The device is to be used to remove fluids from the airway or respiratory support system and infectious materials from wounds. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection bottle. The fluids are trapped in the collection bottle for proper disposal. It is for use on the order of a physician only.
Performance Testing:
The DeVilbiss Suction Unit (depending on configuration) will meet performance standards per ISO 10079-1:1991, Medical Suction Equipment, including vacuum level, flow, construction, life test, and sound level.
Conclusion:
In terms of construction, function, safety, and effectiveness this device is substantially equivalent to other legally marketed suction pumps used for this application.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 5 1998
Mr. Matt Smith Senior Project Engineer Sunrise Medical HHG, Inc. 100 Devilbiss Dr. Somerset, Pennsylvania 15501
K982304 Re: Trade Name: DeVilbiss Suction Unit Requlatory Class: II Product Code: JCX Dated: June 16, 1998 Received: July 01, 1998
Dear Mr. Smith:
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 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 aqainst 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 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 requlation may result in regulatory In addition, FDA may publish further announcements 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. Matt Smith
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) 594-4595. 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D.
Ph.D., M.D. M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: (if known) Not yet assigned
982304
Device Name: DeVilbiss Suction Unit
Indications for Use:
The DeVilbiss Suction Unit is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. Configurations of the device will be intended for the home, institutional, and field/transport environments. The device is for use only on the order of a physcian or other lincensed practitioner (e.g. EMT-field use).
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982304
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.