(199 days)
Not Found
No
The description focuses on the mechanical and electrical aspects of a suction pump and does not mention any AI or ML capabilities.
Yes
The device is described as a suction pump intended to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system, which directly involves treatment or mitigation of a disease or condition.
No
Explanation: The device is described as a suction pump used to remove materials from wounds or fluids from airways, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical suction pump with hardware components like a vacuum gauge, power cord, fuses, and vacuum lines. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as "general suction" to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. This is a therapeutic or procedural use, not a diagnostic one.
- 21 CFR 878.4780: This regulation describes "Surgical suction systems," which are devices used for suction during surgery or at the bedside. This classification aligns with the device's intended use and is not an IVD classification.
- Device Description: The description focuses on the mechanical aspects of the suction pump (capacity, noise level, gauge, power cord, etc.). There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
The device is clearly intended for the physical removal of substances from the body, which is a medical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The intended use of this pump is general suction. This is best described under 21 CFR 878,4780, which states that the pump is intended 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
Product codes
JCX
Device Description
" The Aspirator " is a suction pump with a 350mm Hg capacity. It is of low maintenance by design. It provides low noise level. It has an oversized vacuum gauge to allow easy reading. It has a detachable power cord with externally replaceable fuses, and positive detented vacuum lines for fewer leaks. It is available in both 110 and 230 volts. Only UL approved parts are used in the construction.
Recommended accessories are listed below:
Foot Pedal, Silicone Tubing 6 ft, Spare Luer Lock, Metal Tubing Adapter, Spare Glass Reservoir. Neoprene Stopper, and Angled Tube Mounts.
This pump is intended to be used as a general purpose suction pump.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wounds or fluids from a patient's airway or respiratory support system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
during surgery in the operating room or at the patient's bedside.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K930900 Cook Aspiration Pump
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
510(k) Summary MAY | | | 1998 As Require 4 by 21 section 807.92 (c)
| 1-Submitter Name: | A & A Medical, Inc. |
|---|---|
| 2-Address: | 4100 Nine McFarland Drive, suite B |
| Alpharetta, GA 30004 | |
| 3-Phone: | (770) 343- 8400 |
| 4-Fax: | (770) 343- 8985 |
5-Contact Person: Jihad Mansour
6-Date summary prepared: October 24th, 1997
7-Device Trade or Proprietary Name: "The Aspirator "
8-Device Common or usual name: General Aspiration Pump
9-Device Classification Name: Powered Suction Pump
10-Substantial Equivalency is claimed against the following device:
Substantially equivalent product has been found as approved while searching the
FDA web site under product code JCX
Our pump is substantially equivalent to
*K930900 Cook Aspiration Pump from Cook Ob/Gyn It is classified under 79JCX: "Powered Suction Pump"
"The Aspirator" is a preammendment medical device introduced into the U.S interstate commerce prior to 28 May, 1976. It was and is still advertised/labeled rather as an "endometrial aspirator" that follows the product classification of (85HFF) CLASS III device
11-Description of the Device:
" The Aspirator " is a suction pump with a 350mm Hg capacity. It is of low maintenance by design. It provides low noise level. It has an oversized vacuum gauge to allow easy reading. It has a detachable power cord with externally replaceable fuses, and positive detented vacuum lines for fewer leaks. It is available in both 110 and 230 volts. Only UL approved parts are used in the construction.
Recommended accessories are listed below:
Foot Pedal, Silicone Tubing 6 ft, Spare Luer Lock, Metal Tubing Adapter, Spare Glass Reservoir. Neoprene Stopper, and Angled Tube Mounts.
This pump is intended to be used as a general purpose suction pump.
12-Intended use of the device: (Also typed on a separate FDA form as required)
The intended use of this pump is general suction. This is best described under 21 CFR 878,4780, which states that the pump is intended 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
1
13-Safety and Effectiveness of the device:
« The Aspirator " is safe and effective as other predicate devices cited above. It is made out of only UL approved parts. It is made our of only OE approved be parison with the other predicate devices 1 ms is expreboom 14 below ) and also documented in the Appendix
14-Summary comparing technological characteristics with other predicate devices:
Comparison should be done with other predicate devices having ONLY same intended use.
use.
Accordingly, a tabulated comparison with Cook Aspiration Pump is found below. Also, Equivalency overview chart path is attached
Image /page/1/Figure/5 description: The image provides a list of abbreviations used in the document. The abbreviations are defined as follows: E=Equivalent, S=Similar, D=Different, N/A= Not Applicable, DES=Description available, N/I=No Information available, 510(k) Sum=510(k)Summary available, 510(k)=510(k) available, web=fda web printout enclosed. The abbreviations are used to provide a concise way to refer to the different terms.
| FDA file reference number | Attachments inside Notification | Indications for Use | Target Population | Design | Materials | Performance | Sterility | Biocompatibility | Mechanical Safety | Chemical Safety | Anatomical Sites | Human Factors | Energy used and/or delivered | Compatibility w/ environment & other devices | Where used | Standards met | Electrical Safety | Thermal Safety | Radiation Safety | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cook Aspiration Pump | ||||||||||||||||||||
| from Cook Ob/Gyn | K930900 | web 510k approval | E | E | E | S | S | S | N/A | S | N/A | E | S | E | E | E | S | S | S | S |
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the three branches of government. The eagle is surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
MAY | | 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jihad Mansour Quality and Requlatory Manager A&A Medical, Incorporated 4100 Nine McFarland Drive, Suite B Alpharetta, Georgia 30004-3386
Re: K974038 Trade Name: The Aspirator, 6FT Silicone Tubing, Metal Tubing Adapter, Glass Requlatory Class: II Product Code: JCX Dated: April 1, 1998 Received: April 16, 1998
Dear Mr. Mansour:
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. ਚੇ 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 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 requlations.
3
Page 2 - Mr. Mansour
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. Whitten, M.D.
M. Witten, Ph.D., M.D. Celia Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
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y
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ﺏ ﺍﻟ | | 1 |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | -------------- | -- | --- |
|---|
510(k) Number (if known):
The Aspirator Device Name:_
Indications For Use:
The intended use of this pump is general suction. This is best described under 21 CFR 878.4780, which states that the pump is intended 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
(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)
..............................................................................................................................................................................
ાવ
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Page 7 of 14
P. Collyer
(Division Sign-Off) Division of General Restorative Device 510(k) Number
.