(25 days)
Not Found
No
The device description lists standard mechanical and electrical components of a suction pump and does not mention any software, algorithms, or processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device is used to remove bodily fluids, which is a supportive function but not a direct therapeutic treatment for a medical condition.
No
The device is described as an aspirator intended to remove bodily fluids, which is a therapeutic or supportive function, not a diagnostic one. It does not analyze or interpret patient data to determine a medical condition.
No
The device description clearly outlines multiple hardware components including a plastic enclosure, vacuum pump, vacuum regulator and gauge, collection jar, filter, and patient tube.
Based on the provided information, the Medi-Pump 1615 aspirator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "remove bodily fluids from a patient's airway or respiratory system." This is a direct intervention on the patient's body, not a test performed on a sample of bodily fluid outside the body to diagnose a condition.
- Device Description: The description details a suction pump and collection system, designed for physical removal of fluids. It doesn't mention any components or processes related to analyzing or testing bodily fluids.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting specific substances (analytes)
- Providing diagnostic information
The Medi-Pump 1615 is a medical device used for therapeutic or supportive purposes (removing obstructions), not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
The Medi-Pump 1615 aspirator is intended to be used to remove bodily fluids from a patient's airway or respiratory system. The aspirator is intended for use in the home by professional home healthcare providers and non-professional caregivers.
The Medi-Pump 1615 aspirator is intended to be used to remove bodily fluids from a patient's airway or respiratory system. The aspirator is a prescription device intended for use in the home by professional home healthcare providers and non-professional caregivers.
Product codes
BTA
Device Description
The Medi-Pump is a portable AC powered home use suction pump.
The device has been designed, tested and certified to UL 1431. The
primary device components include a plastic enclosure, a piston
style vacuum pump, a vacuum regulator and gauge, a 1000cc plastic
collection jar with overflow valve, an in-line hydrophobic bacterial
filter, and a 6' PVC patient tube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway or respiratory system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional home healthcare providers and non-professional caregivers.
home
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)
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
KO41199
JUN - 1 2004
"
Attachment 5: 510(k) Summary
Image /page/0/Picture/3 description: The image shows the logo for Rietschle Thomas, which is "A Thomas Industries Company". The logo is black and white and features a stylized graphic to the left of the company name. The company name is in a bold, sans-serif font.
Rietschie Thomas Sheboygan, Inc. 1419 Illinois Area of Bases Asemue
Phone: 920/451-4891
Fax: 920/457-4237 www.rtpumps.com
| Applicant: | Thomas Industries
1419 Illinois Avenue
Sheboygan, WI 53082-0029
Telephone: 920.451.0463
Fax: 920.451.4357 |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Daniel Pfister, Regulatory Affairs Specialist
Telephone: 920.451.4252
Fax: 920.451.4357 |
| Date Prepared: | April 22, 2004 |
| Trade Name: | Medi-Pump Model 1615 Aspirator |
| Product Classification
and Code: | Powered Suction Pump
21 CFR §878.4780
Classification: II
Product Code: BTA - Pump, Portable, Aspiration |
| Predicate Device: | K944399 - Medi-Pump Model 1210 Aspirator |
| Device Description: | The Medi-Pump is a portable AC powered home use suction pump.
The device has been designed, tested and certified to UL 1431. The
primary device components include a plastic enclosure, a piston
style vacuum pump, a vacuum regulator and gauge, a 1000cc plastic
collection jar with overflow valve, an in-line hydrophobic bacterial
filter, and a 6' PVC patient tube. |
| Intended Use: | The Medi-Pump 1615 aspirator is intended to be used to remove
bodily fluids from a patient's airway or respiratory system. The
aspirator is intended for use in the home by professional home
healthcare providers and non-professional caregivers. |
| Summary of
Technological
Characteristics: | The model 1615 differs from the predicate model 1210 in the
following characteristics; the housing has been modified to provide
a more updated, appealing appearance, the device incorporates a
slightly different style vacuum pump which provides a slightly
higher vacuum, is equipped with a single use (fuse) overload
protector and has a non-polarized power plug. |
| | Both models have been tested and certified to UL 1431 - Standard
for Safety: Personal Hygiene and Health Care Appliances. |
| Conclusion: | In terms of construction, function, safety and effectiveness the
Model 1615 is substantially equivalent to the model 1210 which is
also a portable AC powered home use suction pump. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with wavy lines below them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 1 2004
Mr. Daniel Pfister Regulatory Affairs Specialist Thomas Industries 1419 Illinois Avenue Sheboygan, Wisconsin 53082-0029
Re: K041199
Ko41177
Trade/Device Name: Medi-Pump Model 1615 Aspirator Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: BTA Dated: April 22, 2004 Received: May 7, 2004
Dear Mr. Pfister:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection > re(t) premium is substantially equivalent (for the indications relerenced above and nave decembers and for use stated in the encrosure) to regary management date of the Medical Device American Frank Free began commerce prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been reclassified in acceraapproval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, mercrore, maneer are act include requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 a0010) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations aff may be subject to back additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous neements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I Drivice and that your device complies with other requirements of the Act that I DX has Intact a and regulations administered by other Federal agencies. You must of any I catal statutes und regulations sincluding, but not limited to: registration and listing (21 Comply will an the 11cg (21 CFR Part 801); good manufacturing practice requirements as set CI IT ratt 6077, adomig (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality byosins (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Daniel Pfister
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
ﮟ
510(k) Number (if known): K04 //99
Device Name: Medi-Pump Model 1615 Aspirator
Indications for Use:
The Medi-Pump 1615 aspirator is intended to be used to remove bodily fluids from a patient's airway or respiratory system. The aspirator is a prescription device intended for use in the home by professional home healthcare providers and non-professional caregivers.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K64/199