K Number
K041405
Device Name
ASPIRATION PUMP, MODEL IMD-020
Date Cleared
2004-09-02

(99 days)

Product Code
Regulation Number
878.4780
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Aspiration Pump is indicated for vacuum extractions, aspiration and removal of surgical fluids, bodily fluids, or infection materials during surgical procedures.
Device Description
The Aspirating Pump consists of battery powered microprocessor controlled diaphragm pump, pressure release valve, and disposable collection chamber with bacterial filter and overflow protection. Suction tubing from a patient connected to collection chamber by means of lure connector.
More Information

No
The description mentions a "microprocessor controlled diaphragm pump," which is standard for many medical devices and does not inherently indicate AI/ML. There are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML development and validation.

Yes
The device is described as an "Aspiration Pump" indicated for "vacuum extractions, aspiration and removal of surgical fluids, bodily fluids, or infection materials during surgical procedures," which are therapeutic procedures.

No
The Aspiration Pump is described as a device for the "aspiration and removal of surgical fluids, bodily fluids, or infection materials during surgical procedures," which indicates a therapeutic or procedural function, not a diagnostic one.

No

The device description explicitly lists hardware components such as a "battery powered microprocessor controlled diaphragm pump, pressure release valve, and disposable collection chamber."

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes the device's function as a pump for removing fluids from the body during surgical procedures. This is a therapeutic or surgical device, not a diagnostic one.
  • Device Description: The description details the mechanical components of a pump and collection system. 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 samples (blood, urine, tissue, etc.)
    • Detecting specific analytes (proteins, genes, pathogens, etc.)
    • Providing diagnostic information about a patient's health status.

Therefore, the Aspiration Pump is a surgical device used for fluid management, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The Aspiration Pump is indicated for vacuum extractions, aspiration and removal of surgical fluids, bodily fluids, or infection materials during surgical procedures.

Product codes

BTA

Device Description

The Aspirating Pump consists of battery powered microprocessor controlled diaphragm pump, pressure release valve, and disposable collection chamber with bacterial filter and overflow protection. Suction tubing from a patient connected to collection chamber by means of lure connector.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

K021368

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

SEP = 2 2004

8. 510(k) Summary.

  • 8.1. Submitter's identification.
    • Industrial & Medical Design, Inc. -2570 Corporate Pl., Suite E104 Monterey Park, CA 91754
    • Yevgeniy Kuklin Contact person: -President

8-1

  • Date Summary Prepared: April 9, 2004 -

8.2. Submitted device name.

- Trade name:Aspiration Pump
- Classification name:Powered Suction Pump
21 CFR § 878.4780

8.3. Identification of predicate device.

Company:Medela AG
Device:Basic 30
510(k)K021368

8.4. Device description.

The Aspirating Pump consists of battery powered microprocessor controlled diaphragm pump, pressure release valve, and disposable collection chamber with bacterial filter and overflow protection. Suction tubing from a patient connected to collection chamber by means of lure connector.

8.5. Intended use of the device.

The Aspiration Pump is indicated for vacuum extractions, aspiration and removal of surgical fluids, bodily fluids, or infection materials during surgical procedures.

1

8.6. Rationale for Substantial Equivalence.

The Aspiration Pump shares the same general indications for use, similar design features, and functional features as predicated device. Therefore, the technological differences between Aspiration Pump and predicated device do not raise any new issues of safety, effectiveness, or performance of the product. We believe that Aspiration is substantially equivalent to the above legally marketed predicate device.

2

Image /page/2/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" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three curved lines representing its wings or body.

Public Health Service

SEP = 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Yevgeniy Kuklin President Industrial & Medical Design, Inc. 2570 Corporate Place, Suite E104 Monterey Park, California 91754

Re: K041405

Trade/Device Name: Aspiration Pump Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: BTA Dated: August 6, 2004 Received: August 16, 2004

Dear Mr. Kuklin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for asso bated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conimeres provisions of the provisions of the provisions of the Federal Food, Drug, de noos that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, ateres, sonovisions of the Act include requirements for annual registration, listing of general controls provision practice, 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 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has has and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

3

Page 2 - Mr. Yevgeniy Kuklin

This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and in yourse 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 If you don't specials as not and (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

Colia 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

4

Indications for Use

510(k) Number (if known): K041405

Device Name: Aspiration Pump

Indications For Use:

The Aspiration Pump is indicated for vacuum extractions, aspiration and removal of surgical fluids, bodily fluids, or infection materials during surgical procedures.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number_Ko41405