(73 days)
Not Found
No
The summary describes a mechanical vacuum pump for aspiration and does not mention any AI or ML components or functionalities.
Yes
The DeVilbiss Model 6305D Heavy Duty AC Aspirator is used for oral, nasal, and pulmonary aspiration, which are therapeutic interventions to remove fluids from the body.
No
The device is described as an aspirator used to provide a vacuum source for oral, nasal, and pulmonary aspiration, which is a therapeutic rather than diagnostic function. It removes substances from the body but does not diagnose conditions.
No
The device description explicitly states it is an "AC powered vacuum pump assembly," which is a hardware component.
Based on the provided information, the DeVilbiss Model 6305D Heavy Duty AC Aspirator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for providing a vacuum source for oral, nasal, and pulmonary aspiration. This is a physical process performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is described as an AC powered vacuum pump assembly used with a collection canister for aspiration. This aligns with a medical device used for physical intervention, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The DeVilbiss Aspirator's function is to remove fluids from the body, which is a therapeutic or procedural action, not a diagnostic one.
N/A
Intended Use / Indications for Use
The DeVilbiss Model 6305D Heavy Duty AC Aspirator provides a vacuum source for home health care or institutional use. The product is used with a suction catheter or handle to clear secretions from the oral, nasal and pulmonary areas. The intended target population for this device consists of both adult and pediatric patients. The intended environment for use of the product is in the patient's home or within an institutional setting on the order of a physician.
The DeVilbiss Model 6305D Heavy Duty AC Aspirator is used primarily to provide a vacuum source for oral, nasal and pulmonary aspiration. The device is used on the order of a physician.
Product codes
JCX, BTA
Device Description
The DeVilbiss Model 6305D Heavy Duty AC Aspirator is an AC powered vacuum pump assembly designed to be used in conjunction with a collection canister to meet the requirements for oral, nasal and pulmonary aspiration. In terms of function, safety and effectiveness, this device is substantially equivalent to other legally marketed aspirators commonly used for the aspiration of the oral, nasal and pulmonary areas. The DeVilbiss 6305D aspirator is constructed of materials, both metal and plastic, that are similar or identical to legally marketed devices. The unit is designed and manufactured to comply with electrical and mechanical safety standards applicable to this type of device (Underwriter's Laboratory Standard UL1431).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral, nasal and pulmonary areas
Indicated Patient Age Range
both adult and pediatric patients
Intended User / Care Setting
home health care or institutional use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing performed on the performance output and suction rate show that the new DeVilbiss Model 6305D Heavy Duty AC Aspirator is substantially equivalent to the existing legally marketed predicate device and that both of these devices will produce similar aspiration treatment. The Comparative Performance Evaluations (Section 7) illustrate that in terms of safety and effectiveness, the new DeVilbiss Model 6305D Heavy Duty AC Aspirator is substantially equivalent to the legally marketed Thomas Industries Pump Aspirator Model 1135.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Jul 1 7 1998
1911 11
| 16. 510(k) Summary | K981602 |
|---|---|
| Submitter's Name: | Sunrise Medical HHG Inc. |
| Respiratory Products Division | |
| 100 DeVilbiss Drive | |
| Somerset, PA 15501 | |
| Allan R. Jones | |
| 814-443-7618 | |
| Date Prepared: | April 30, 1998 |
| Device Name: | AC Powered Suction Apparatus FDA Classification |
| JCX | |
| Common or Usual Name: | Aspirator |
| DeVilbiss Model Number: | 6305D |
| Trade Proprietary Name: | DeVilbiss Model 6305D Heavy Duty AC Aspirator |
| Established Registration Number: | DeVilbiss # 2515872 |
| FDA Classification: | Class II Device |
Equivalent Legally Marketed Predicate Device:
| Legally Marketed Predicate Devices | 510(k) Registration # |
|---|---|
| ------------------------------------ | ----------------------- |
Description of Device:
Thomas Industries Pump Aspirator Model 1135
The DeVilbiss Model 6305D Heavy Duty AC Aspirator is an AC powered vacuum pump assembly designed to be used in conjunction with a collection canister to meet the requirements for oral, nasal and pulmonary aspiration. In terms of function, safety and effectiveness, this device is substantially equivalent to other legally marketed aspirators commonly used for the aspiration of the oral, nasal and pulmonary areas. The DeVilbiss 6305D aspirator is constructed of materials, both metal and plastic, that are similar or identical to legally marketed devices. The unit is designed and manufactured to comply with electrical and mechanical safety standards applicable to this type of device (Underwriter's Laboratory Standard UL1431).
1
Statement of Intended Use:
The DeVilbiss Model 6305D Heavy Duty AC Aspirator provides a vacuum source for home health care or institutional use. The product is used with a suction catheter or handle to clear secretions from the oral, nasal and pulmonary areas. The intended target population for this device consists of both adult and pediatric patients. The intended environment for use of the product is in the patient's home or within an institutional setting on the order of a physician.
The DeVilbiss Model 6305D Heavy Duty AC Aspirator base unit system will be able to obtain a maximum deadhead vacuum pressure of 22.0 in. Hg and a minimum free flow rate (air) of 25.0 LPM at STP conditions.
The DeVilbiss Model 6305D Heavy Duty AC Aspirator is equivalent in both function and indications for use to the Thomas Industries Pump Aspirator Model 1135 which is a legally marketed device.
Technological Characteristics:
The DeVilbiss Model 6305D Heavy Duty AC Aspirator is equivalent in functional characteristics to the existing legally marketed predicate devices both utilize an AC motor driven vacuum pump compressor to provide a source of vacuum pressure for aspiration. Both of the devices are tested and approved to recognized agency safety standards.
Testing performed on the performance output and suction rate show that the new DeVilbiss Model 6305D Heavy Duty AC Aspirator is substantially equivalent to the existing legally marketed predicate device and that both of these devices will produce similar aspiration treatment.
, '
2
Statement of Intended Use 2.0
The DeVilbiss Model 6305D Heavy Duty AC Aspirator provides a vacuum source for home health care or institutional use. The product is used with a suction catheter or handle to clear secretions from the oral, nasal and pulmonary areas. The intended target population for this device consists of both adult and pediatric patients. The intended environment for use of the product is in the patient's home or within an institutional setting on the order of a physician.
The DeVilbiss Model 6305D Heavy Duty AC Aspirator base unit system will be able to obtain a maximum deadhead vacuum pressure of 22.0 in. Hg and a minimum free flow rate (air) of 25.0 LPM at STP conditions.
The DeVilbiss Model 6305D Heavy Duty AC Aspirator is equivalent in both function and indications for use to the Thomas Industries Pump Aspirator Model 1135 which is a legally marketed device. The DeVilbiss aspirator is constructed of materials, both metal and plastic, that are similar to or identical to legally marketed devices. The Table of Comparison (Section 4) and the Comparative Performance Evaluations (Section 7) illustrate that in terms of safety and effectiveness, the new DeVilbiss Model 6305D Heavy Duty AC Aspirator is substantially equivalent to the legally marketed Thomas Industries Pump Aspirator Model 1135.
Legally Marketed Predicate Device Thomas Industries Pump Aspirator Model 1135 510(k) Registration # K952806
3
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing right, stacked on top of each other, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
.1111 17 1998
Mr. Allan R. Jones ·Project Engineer Sunrise Medical HHG, Inc. 100 DeVilbiss Drive Somerset, Pennsylvania 15501
Re: K981602 Trade Name: DeVilbiss Model 6305D Heavy Duty AC Aspirator Regulatory Class: II Product Code: BTA Dated: April 30, 1998 Received: May 5, 1998
Dear Mr. Jones:
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 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 to 895. A 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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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.
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.
4
Page 2 - Mr. Allan R. Jones
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.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510 (k) NUMBER (IF KNOWN) :
DEVICE NAME: DeVilbiss Model 6305D Heavy Duty AC Aspirator
INDICATIONS FOR USE:
The DeVilbiss Model 6305D Heavy Duty AC Aspirator is used primarily to provide a vacuum source for oral, nasal and pulmonary aspiration. The device is used on the order of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE -----IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
(Division\Sign-Off)
Division of General Restorative Devices
510(k) Number K981602