The Boehringer Laboratories Suction Pump System is intended for the application of low flow suction for the removal of fluids, including irrigation fluids, body fluids and infectious materials.

Device Description

The Boehringer Laboratories Suction Pump System consists of a powered suction pump for the application of low flow suction. A rigid disposable canister for the collection of fluids is included as an accessory.

AI/ML Overview

This document is a 510(k) Summary for a medical device called the "Boehringer Laboratories Suction Pump System". It aims to demonstrate substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance against them in a detailed study.

Therefore, many of the requested categories (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, and training set information) are not applicable or not provided in this type of submission.

Here's what can be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as quantifiable metrics. The device is deemed substantially equivalent based on similarity to predicate devices.
Reported Device Performance: Not quantified. The submission states "Areas of similarity include performance parameters, control mechanisms, power source, canister for use with pumps and dimensions" when comparing to predicates.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not provided. This type of 510(k) submission for this device does not typically involve a clinical "test set" in the way a diagnostic imaging or AI device would. It relies on demonstrating similarity to already approved predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. No "ground truth" establishment in the context of a clinical study is described for this device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not provided. This is a suction pump, not an AI or diagnostic imaging device that would typically undergo MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable/Not provided. This is a hardware device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable/Not provided.

8. The sample size for the training set

Not applicable/Not provided. This is a hardware device, not a machine learning model.

9. How the ground truth for the training set was established

Not applicable/Not provided.

Summary

{0}------------------------------------------------

MAR 3 2006

2. 510(k) Summary

510(k) Summary

Applicant Information:

Name: Boehringer Laboratories Inc.
Address: 500 E. Washington St. Norristown PA 19401
Phone: 610-278-0900 Fax: 610-278-0907 .
Contact: Christopher Radl, Engineering

Trade Name:

Boehringer Laboratories Suction Pump System

Common Name:

Powered Suction Pump

Device Classification:

Class II Product Code: JCX Regulation 878.4780 Classification Panel: General & Plastic Surgery

Predicate Devices:

Allied Healthcare Products Gomco Thermotic Drainage Pump Medela Suction Pumps Median and Vario

Pre-amendment device K983552

Device Description:

Intended Use:

The Boehringer Laboratories Suction Pump System is intended for the application of low flow suction for the removal of fluids, including irrigation fluids, body fluids and infectious materials.

{1}------------------------------------------------

Technological Characteristics:

The Boehringer Laboratories Suction Pump System is similar to the predicate Gomco Thermotic Drainage Pump and Medela Vario and Median pumps. Areas of similarity include performance parameters, control mechanisms, power source, canister for use with pumps and dimensions.

Conclusion:

The Boehringer Laboratories Suction Pump System is substantially equivalent to the predicate Gomco Thermotic Drainage Pump and Medela Vario and Median suction pumps.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter of the circle. The text is written in all capital letters.

2006 MAR 3

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Boehringer Laboratories c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K060277

Trade/Device Name: Boehringer Laboratories Suction Pump System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: JCX Dated: February 21, 2006 Received: February 23, 2006

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in merstate 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) that do not require approval of a premarket approval application (PMA). 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 (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 or any Federal statutes and regulations administered by other Federal agencies. You must comply 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. Job

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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may Jbtain 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/industry/support/index.html.

Sincerely yours,

Mark N. Molverson, M.S.

Mark N. Melkerson, M.S. Acting 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):

K060277

Device Name: Boehringer Laboratories Suction Pump System

Indications for Use:

The Boehringer Laboratories Suction Pump System is intended for the application of low flow suction for the removal of fluids, including irrigation fluids, body fluids and infectious materials.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDF ffice of Device Evaluation (ODE)

urrence of ODRH, Office of Device LV

(Division Sign-Of Division of General, Restorative, and Neurological Devices

510(k) Number_久06ΩՁ77

Regulation Number and Section

§ 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.