← Product Code [JCX](/submissions/SU/subpart-e%E2%80%94surgical-devices/JCX) · K081047 # TRANSPOSAL ULTRA SYSTEMS (K081047) _Dornoch Medical Systems, Inc. · JCX · Apr 29, 2008 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JCX/K081047 ## Device Facts - **Applicant:** Dornoch Medical Systems, Inc. - **Product Code:** [JCX](/submissions/SU/subpart-e%E2%80%94surgical-devices/JCX.md) - **Decision Date:** Apr 29, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4780 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** 3rd-Party Reviewed ## Intended Use 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 Story Transposal Ultra System is a closed, self-contained, powered suction/vacuum pump system for collecting and disposing of surgical liquid waste. System components include cylinder suction carts (various volumes) and a disposal/cleaning unit (Ultra Evac), or a powered roll stand with reusable canisters. Carts collect fluids from up to four sources simultaneously without mixing. Once full, the cart attaches to the Ultra Evac for automatic disposal into the hospital sanitary sewer and automated cleaning of reservoir cylinders. The roll stand version requires manual transport of canisters to a safety station for emptying and cleaning. Used in operating rooms, pathology labs, and surgical centers by clinical staff. The system facilitates waste management, reducing manual handling of biohazardous fluids and improving workflow efficiency in surgical environments. ## Clinical Evidence Bench testing only. The device underwent electrical, mechanical, software, and functional testing to verify design requirements against standards including IEC-60601-1, IEC-60601-1-1, IEC-60601-1-2, IEC-60529, ISO 10079-1, and ISO 10079-3. ## Technological Characteristics Powered suction/vacuum pump system. Components include suction carts (26L, 33L, 52L) and roll stands with 2.8L reusable canisters. Features automated disposal and cleaning cycle. Complies with IEC-60601-1 (electrical safety), IEC-60601-1-2 (EMC), and ISO 10079-1/3 (suction equipment). ## Regulatory 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. ## Predicate Devices - Steris - SafeCycle 40 (GCX) - Product & Educational Services - Model 2300 general purpose suction pump ([K941527](/device/K941527.md)) - American Immuno Tech (Stryker) Neptune Waste Management System Rover ([K990037](/device/K990037.md)) - Stryker - Neptune Waste Management Systems ([K012991](/device/K012991.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ : ## 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 Martini
Staff Engineer
(816) 916-8458 Phone
(816) 505-1050 Fax
Email: amartini@dornoch.com | | Date Prepared: | 03/13/2008 | | Trade Name: | Transposal Ultra System consists of two major components. First, a cylinder suction cart
and second a disposal & cleaning unit. Three models of the cylinder suction cart will be
commercially distributed along with one canister suction unit. The Transposal Ultra
Powered Roll Stand is identical in its operation except reusable canisters are used in
place 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 II
Apparatus, suction, ward use, portable, ac-powered
21 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 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. | | Intended Use: | 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. | | Functional and Safety
Testing: | 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. | | Conclusion: | Dornoch Medical Systems Inc. considers the Transposal Ultra System to be equivalent to
the predicate device listed above. This conclusion is based upon the devices' similarities
in principles of operation, technology, materials and indications for use. | {1}------------------------------------------------ STATES # Non-Confidential Summary of Safety and Effectiveness 13-Маг-08 : {2}------------------------------------------------ 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. {3}------------------------------------------------ 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 {4}------------------------------------------------ ### Indications for Use Statement Page 1 of 1 510(k) Number: k081047 (To be assigned) Device Name: Transposal Ultra Systems ### Indications for Use: 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. 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JCX/K081047](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JCX/K081047) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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