The Dornoch Transposal Ultra System is self-powered suction / vacuum pump intended to collect and dispose of liquid waste within Hospital Operating Rooms, Pathology Labs, Surgical Outpatient Centers, and Doctor's Offices.

Device Description

The Transposal Ultra System (Ultra System) collects and disposes of waste fluids produced through surgical procedures. The Ultra System is a closed, self contained reusable suction system.

The Ultra Cart System can simultaneously collect fluids from up to four sources without mixing of the fluids. The Ultra Cart System is composed of two pieces of equipment the Transposal Ultra Cart (suction cylinder unit) and the Transposal Ultra Evac (removal and cleaning unit). The Ultra Carts can be used until 52L of fluids are collected. Once full, the Ultra Cart is attached to the Ultra Evac for automatic disposal into the hospital sanitary sewer and cleaning of the reservoir cylinders. Upon completion of the cleaning process, the cylinder lids are then replaced and the Ultra Cart is ready for use.

The Transposal Ultra Roll Stand consists of a vacuum system and up to four reusable canisters. The fluid can be collected in each canister until 2.8L of fluids are collected. The canisters are then transported to the Transposal Safety Station where they are emptied and cleaned.

AI/ML Overview

The provided text pertains to the FDA 510(k) submission for the "Transposal Ultra System," a medical device designed for collecting and disposing of liquid waste in healthcare settings. However, the document does not contain the detailed study information required to fully answer your request regarding acceptance criteria and performance studies.

Specifically, the document states:
"To verify that device design has meet the functional and performance requirements representative samples of the device underwent electrical, mechanical, software, and functional testing in accordance with IEC-60601-1, IEC-60601-1-1, IEC-60601-1-2, IEC-60529, ISO 10079-1 and ISO 10079-3."

This indicates that testing was performed to verify compliance with relevant standards, but it does not provide the specific acceptance criteria, reported performance, or details of a study setup as requested.

Therefore, I cannot provide the complete answer based on the provided text. I can, however, extract the information that is present:

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

The document does not explicitly present a table of acceptance criteria with reported device performance. It only states that functional and safety testing was conducted to verify that the device design met "functional and performance requirements" in accordance with several IEC and ISO standards. The specific requirements from these standards and the corresponding test results are not detailed in this summary.

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

This information is not provided in the document.

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)

This information is not provided in the document. The device is a physical system for waste collection, not an diagnostic imaging or AI system that typically requires expert-established ground truth.

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

This information is not provided in the document. It is not relevant for this type of device testing.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable and was not done for this device. This type of study is relevant for AI-powered diagnostic or decision-support systems, not for a physical fluid collection and disposal system.

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

This is not applicable as the device is a physical system, not an algorithm.

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

The concept of "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. For this device, "ground truth" would refer to the objective, measurable performance of the system against its stated functional requirements and applicable safety standards (e.g., vacuum pressure, fluid containment, cleaning effectiveness, electrical safety). The document only states that testing was done to verify these requirements.

8. The sample size for the training set

This information is not provided and is not applicable as this is not an AI/machine learning device.

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

This information is not provided and is not applicable as this is not an AI/machine learning device.

Summary of available information regarding the study:

Study Purpose: To verify that the device design meets functional and performance requirements.
Testing Conducted: Electrical, mechanical, software, and functional testing.
Standards Followed: IEC-60601-1, IEC-60601-1-1, IEC-60601-1-2, IEC-60529, ISO 10079-1, and ISO 10079-3.
Device Type: A self-powered suction/vacuum pump system for waste fluid collection and disposal.

The document is a "Non-Confidential Summary of Safety and Effectiveness" for an FDA 510(k) submission, which typically provides high-level information rather than detailed study protocols and results.

Summary

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Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2

APR 2 9 2008

Submitter:	Dornoch Medical Systems Inc.4032 West Riverside St.Riverside, MO 64150
Contact Person:	Anthony MartiniStaff Engineer(816) 916-8458 Phone(816) 505-1050 FaxEmail: amartini@dornoch.com
Date Prepared:	03/13/2008
Trade Name:	Transposal Ultra System consists of two major components. First, a cylinder suction cartand second a disposal & cleaning unit. Three models of the cylinder suction cart will becommercially distributed along with one canister suction unit. The Transposal UltraPowered Roll Stand is identical in its operation except reusable canisters are used inplace of the cylinders. Transposal Ultra Cart System with: Transposal Ultra Quad Cart - 52 liter volume - four cylinders Transposal Ultra Duo Cart - 33 liter volume - two cylinders Transposal Ultra Duo Cart - 26 liter volume - two cylinders Transposal Ultra Evac - removal and cleaning unit. Transposal Ultra Roll Stand: Transposal Ultra Powered Roll Stand - holds up to four 2.8 liter reusable canisters.
Classification:	Class IIApparatus, suction, ward use, portable, ac-powered21 CFR 878.4780
Product Code:	JCX
Predicate Device(s):	The subject device is equivalent to the following devices: Steris - SafeCycle 40 - exempt (GCX) Product & Educational Services - Model 2300 general purpose suction pump - K941527 (JCX) American Immuno Tech (Stryker) Neptune Waste Management System Rover - K990037 (FYD) Stryker - Neptune Waste Management Systems - K012991 (FYD)
Device Description:	The Transposal Ultra System (Ultra System) collects and disposes of waste fluidsproduced through surgical procedures. The Ultra System is a closed, self containedreusable suction system.
	The Ultra Cart System can simultaneously collect fluids from up to four sources withoutmixing of the fluids. The Ultra Cart System is composed of two pieces of equipment theTransposal Ultra Cart (suction cylinder unit) and the Transposal Ultra Evac (removal andcleaning unit). The Ultra Carts can be used until 52L of fluids are collected. Once full,the Ultra Cart is attached to the Ultra Evac for automatic disposal into the hospitalsanitary sewer and cleaning of the reservoir cylinders. Upon completion of the cleaningprocess, the cylinder lids are then replaced and the Ultra Cart is ready for use.
	The Transposal Ultra Roll Stand consists of a vacuum system and up to four reusablecanisters. The fluid can be collected in each canister until 2.8L of fluids are collected.The canisters are then transported to the Transposal Safety Station where they areemptied and cleaned.
Intended Use:	The Dornoch Transposal Ultra System is self-powered suction / vacuum pump intendedto collect and dispose of liquid waste within Hospital Operating Rooms, Pathology Labs,Surgical Outpatient Centers, and Doctor's Offices.
Functional and SafetyTesting:	To verify that device design has meet the functional and performance requirementsrepresentative samples of the device underwent electrical, mechanical, software, andfunctional testing in accordance with IEC-60601-1, IEC-60601-1-1, IEC-60601-1-2,IEC-60529, ISO 10079-1 and ISO 10079-3.
Conclusion:	Dornoch Medical Systems Inc. considers the Transposal Ultra System to be equivalent tothe predicate device listed above. This conclusion is based upon the devices' similaritiesin principles of operation, technology, materials and indications for use.

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STATES

Non-Confidential Summary of Safety and Effectiveness

13-Маг-08 :

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dornoch Medical systems, Inc. % Intertek Testing Services Mr. Daniel W. Lehtonen 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

APR 2 9 2008

Re: K081047

Trade/Device Name: Transposal Ultra System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: JCX Dated: April 10, 2008 Received: April 14, 2008

Dear Mr. Lehtonen:

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 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) 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.

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Page 2 – Ms. Valerie Defiesta-Ng

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Milkman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

Page 1 of 1

510(k) Number:

K081047 (To be assigned)

Device Name:

Transposal Ultra Systems

Indications for Use:

Prescription Use XX (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nital Aglan for mkn

(Division Division of General, Restorative, and Neurological Devices

510(k) Number K081047

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.