(99 days)
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Not Found
No
The description focuses on the mechanical and automated functions of a suction and disposal system, with no mention of AI or ML capabilities.
No
The device is described as a self-powered suction/vacuum pump intended to collect and dispose of liquid waste, which is a waste management function rather than a direct therapeutic intervention on a patient.
No
The device is described as a self-powered suction/vacuum pump intended to collect and dispose of liquid waste, which is a therapeutic or waste management function, not a diagnostic one. It does not provide any information about the state of a body or health condition.
No
The device description clearly outlines physical hardware components (suction pump, reusable cylinder, cart, evac unit, coupler unit) and mentions testing against hardware standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, ISO 10079-1). While software is mentioned, it is part of a larger hardware system.
Based on the provided information, the Dornoch Transposal Ultra System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "collect and dispose of liquid waste within Hospital Operating Rooms, Pathology Labs, Surgical Outpatient Centers, and Doctor's Offices." This describes a system for managing biological waste, not for performing diagnostic tests on samples taken from the human body.
- Device Description: The description focuses on the mechanical function of collecting, storing, and disposing of fluids. It does not mention any components or processes related to analyzing biological samples for diagnostic purposes.
- 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 or measuring specific analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
- Reagents or test kits
The device is clearly intended for waste management in a healthcare setting, which falls outside the scope of IVD regulation.
N/A
Intended Use / 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.
Product codes
JCX
Device Description
The Transposal Ultra System (Ultra System) provides a closed, self-contained, reusable cylinder suction system intended to collect and dispose of waste fluids produced through surgical procedures.
The Ultra System is composed of two essential components, the Ultra Suction Cart and the Ultra Evac. The Ultra Cart can be used repeatedly until either 33L (Duo) or 52L (Quad) of fluid has been collected. Once full, the Cart is moved from the OR to the Ultra Evac. The two systems are connected together with the coupler unit on the Ultra Evac. The cleaning / wash cycle is then initiated and the automatic emptving and cleaning occurs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital Operating Rooms, Pathology Labs, Surgical Outpatient Centers, and Doctor's Offices.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Dornoch Suction Carts and Evac have completed the following testing and have been found to be compliant to all applicable clauses of each standard:
IEC 60601-1: Medical Electrical Equipment, Part 1: General Requirements for Safety
IEC 60601-1-1: Medical Electrical equipment - Part 1-1: General requirements for safety -Collateral standard: Safety requirements for medical electrical systems
IEC 60601-1-2: Medical Electrical equipment - Part 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility - Requirements and tests required for components used as a system.
ISO 10079-1: Medical Suction Equipment Part 1: Electrically powered suction equipment -Safety requirements
Hardware and Software testing, including validation. Software was proven to be safe and effective when tested to pre-determined acceptance criteria.
Clinical data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
ornoch
510(K) SUMMARY OF SAFETY AND EFFECTIVNESS 3.0
- Dornoch Medical Systems Sponsor: 200 North West Parkway Riverside, MO 64150
- Larry Smith Contact Person: Product Development Manager Telephone: (816) 595-4416 Fax: (816) 505-1050
- November 25, 2013 Date:
Trade Name: Dornoch Ultra Suction Cart and Evac
Product Code / Device: JCX, apparatus, suction, ward use, portable, ac-powered.
Regulation Number / Description: 21 CFR § 878.4780 - Powered suction pump
Device Description:
The Transposal Ultra System (Ultra System) provides a closed, self-contained, reusable cylinder suction system intended to collect and dispose of waste fluids produced through surgical procedures.
The Ultra System is composed of two essential components, the Ultra Suction Cart and the Ultra Evac. The Ultra Cart can be used repeatedly until either 33L (Duo) or 52L (Quad) of fluid has been collected. Once full, the Cart is moved from the OR to the Ultra Evac. The two systems are connected together with the coupler unit on the Ultra Evac. The cleaning / wash cycle is then initiated and the automatic emptving and cleaning occurs.
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.
Comparison to Predicate Device:
The updated Dornoch Ultra Suction cart and Evac (Models DU-2800 QD-2800, DU-500, QD-500 and EV-100) are substantially equivalent to other legally marketed surgical suction systems,
1
Specifically the Dornoch Ultra Suction System Models DU-2800 QD-2800, DU-500, QD-500 and EV-100). The systems are identical in design, materials and indications for use.
Performance Data (Nonclinical and/or Clinical):
The Dornoch Suction Carts and Evac have completed the following testing and have been found to be compliant to all applicable clauses of each standard:
IEC 60601-1: Medical Electrical Equipment, Part 1: General Requirements for Safety
IEC 60601-1-1: Medical Electrical equipment - Part 1-1: General requirements for safety -Collateral standard: Safety requirements for medical electrical systems
IEC 60601-1-2: Medical Electrical equipment - Part 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility - Requirements and tests required for components used as a system.
ISO 10079-1: Medical Suction Equipment Part 1: Electrically powered suction equipment -Safety requirements
Hardware and Software testing, including validation.
Software was proven to be safe and effective when tested to pre-determined acceptance criteria.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
2
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
March 21, 2014
Dornoch Medical System Larry Smith Product Development Manager 200 North West Parkway Riverside. Missouri 64150
Re: K133786
Trade/Device Name: Dornoch Ultra Suction Cart and Evac Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: JCX Dated: March 11, 2014 Received: March 12, 2014
Dear Mr. Smith:
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 for the saverior 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 Cosmatic 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 I no Solieral Controlly practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it your device is enabilities not only in 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 complics with other requirements of the Act that i DA has made a dore used regulations administered by other Federal agencies. You must or any I edela. Station and and submitted to: registration and listing (21 comply with an the Hot 310 the Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Larry Smith
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aguel
Binita Ashar, MD, MBA, FACS for Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Dorn ch
2.0 Indications for Use
Applicant: Dornoch Medical Systems
510(k) Number (if known): _K133786
Device Name: Dornoch Ultra Suction System
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 _ X (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 CDRH, Office of Device Evaluation (ODE)
DSD—DIVISION SIGN-OFF Division of Surgical Devices
lan P. Broverman -S 2014.03.20 16:05:22 -04'00'
K133786 510(k) Number:
2014.03.20 16:05:22 -04'00