(324 days)
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Not Found
No
The provided text describes a medical vacuum source (aspirator) and its power options. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The provided text does not contain enough information to determine if the device is therapeutic. It only mentions the device's portability and power sources, without indicating any treatment or therapeutic function.
No
The device is described as a "portable, battery power medical vacuum source" intended for use in home care or hospital environments, which suggests it is a therapeutic or supportive device (e.g., for aspiration) rather than one used for diagnosis. There is no mention of it being used to identify or analyze conditions or diseases.
No
The device description is not found, but the intended use clearly describes a "portable, battery power medical vacuum device" and mentions being powered from a "standard wall outlet with the use of an AC power adapter." This indicates a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "PORTABLE, BATTERY POWER MEDICAL VALUAM SOLICE" (likely meant to be "vacuum source") and an "ASPIRATOR". This describes a device used to remove fluids or other substances from the body, which is a therapeutic or procedural function, not a diagnostic one.
- Lack of Diagnostic Information: There is no mention of the device being used to analyze samples (like blood, urine, tissue) to diagnose a disease or condition. IVDs are specifically designed for this purpose.
- Care Setting: While it's used in a hospital environment, which can include diagnostic procedures, the function described is not diagnostic.
In summary, the description points to a medical device used for aspiration, which is a treatment or procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The EASy So Aspirator PROVIDES A PORTABLE, BATTERY POWER MEDICAL VALUAM SOLICE. THE EXELLIGO ASPIRATOR CAN ALSO BE POWERED FRIM A STANDARD WALL GUTLET WITH THE USE OF IN AC POWER ADAPTER. IT IS INTENDED FOR USE IN THE HOME CARE OF HOSPITAL ENVIRONMENT
Product codes
BTA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
HOME CARE OF HOSPITAL ENVIRONMENT
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is depicted with a single snake winding around a staff, which is a common symbol associated with medicine and healthcare organizations.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 1 1998
Mr. Conley Wallace Quality Assurance Manager Precision Medical 300 Held Drive Northampton, Pennsylvania 18067
K971749 Re: Trade Name: EasyGo Aspirator Regulatory Class: II Product Code: BTA March 12, 1998 Dated: Received: March 17, 1998
Dear Mr. Wallace:
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 The general controls provisions of the Act 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 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.
1
Page 2 - Mr. Wallace
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 gener 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,
C. Galik, M. Witter, Ph.D., M.
a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page / _ of
510(k) Number (if known): K971749
Device Name: EASYGO ASPIRATOR
Indications For Use:
(Per 21 CFR 801. 09)
The EASy So Aspirator PROVIDES A PORTABLE, BATTERY POWER MEDICAL VALUAM SOLICE. THE EXELLIGO ASPIRATOR CAN ALSO BE POWERED FRIM A STANDARD WALL GUTLET WITH THE USE OF IN AC POWER ADAPTER. IT IS INTENDED FOR USE IN THE HOME CARE OF HOSPITAL ENVIRONMENT
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K971749 |
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | --- | ---- | ---------------------- |
(Optional Format 1-2-96)
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