(95 days)
USCOM 1A records and monitors beat-to-beat cardiac heamodynamics in paediatric and adult patients. Its recording and storage of patient information provides trending information of cardiovascular performance for quantitative evaluation. The USCOM 1A is for use by clinicians in the hospital environment.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Pediatric (CWD), Cardiac (CWD).
The USCOM 1A is a non-invasive tool that measures and records changes in the heamodynamic status of a patient. It is a portable Continuous Wave Doppler device using an Ultrasonic Transducer to measure blood flow. it is a portable of an easy to use touch screen display with monitoring, trending and storage The GOOM TH consisted on an odo, to a see navigates intuitive and simple screens to enter patient details and perform examinations. Targeting the patient's pulmonary or aortic valves transcutaneously, the blood flow profile can be Targeting the palifically of assisted blood flow profile, the clinician can determine a number of parameters including Stroke Volume and Cardiac Output. The USCOM 1A saves the measures in a patient file. Multiple saved measures over time are displayed The USOW TA Saves the model of the patient's change in heamodynamic status. Reports can be generated on patient measures which can be printed and exported for analysis. The device is portable, weighing less than 7 kilograms and incorporates an internal battery.
The USCOM 1A device is a non-invasive continuous wave Doppler device designed to measure and record changes in a patient's hemodynamic status. It monitors beat-to-beat cardiac hemodynamics in pediatric and adult patients, providing trending information of cardiovascular performance for quantitative evaluation. The device targets the pulmonary or aortic valves transcutaneously to determine parameters like Stroke Volume and Cardiac Output.
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states that no clinical tests were required for the USCOM 1A. Instead, the manufacturer demonstrated substantial equivalence to predicate devices through non-clinical testing and compliance with consensus performance standards. Therefore, there are no specific quantitative acceptance criteria or reported device performance metrics from a clinical study provided in this summary.
The conclusion states: "Testing to consensus performances standards and well proven test methods is sufficient to demonstrate that the Continuous Wave Doppler technology used in the USCOM 1A, can perform clinical requirements as intended by USCOM Ltd."
The non-clinical tests covered:
- Acoustic output
- Electrical safety including thermal properties
- EMC
- Biocompatibility
- Mechanical and environmental characteristics
And the device was found to comply with applicable medical device safety and performance standards.
2. Sample Size Used for the Test Set and Data Provenance:
Since no clinical tests or studies were performed, there is no test set, sample size, or data provenance information from clinical data provided in this submission for the USCOM 1A device's performance claims. The data provenance details provided in the submission refer to the regulatory information and documents, such as the date prepared (9th Nov 2004) and the company's location (Sydney, Australia for USCOM Ltd.).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable, as no clinical test set requiring expert ground truth establishment was conducted for this submission.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring adjudication was conducted for this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
Not applicable. The USCOM 1A is a standalone device for measuring cardiac hemodynamics and does not involve AI assistance for human readers or interpretation of medical images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The document describes the USCOM 1A as a device that "records and monitors beat-to-beat cardiac heamodynamics," and "targeting the patient's pulmonary or aortic valves transcutaneously, the blood flow profile can be determined," and from this, "the clinician can determine a number of parameters including Stroke Volume and Cardiac Output." While the device performs calculations autonomously based on the Doppler signal, there is no mention of a standalone performance study in the context of comparing its algorithmic output to a clinical gold standard directly, as clinical testing was deemed "not required." The performance is implicitly demonstrated by its substantial equivalence to predicate devices and compliance with non-clinical engineering standards.
7. The Type of Ground Truth Used:
For the purpose of regulatory clearance, the "ground truth" for the USCOM 1A appears to be established through:
- Compliance with consensus performance standards: This implies that the device's measurements and functionality meet established engineering and safety benchmarks considered acceptable for medical devices.
- Substantial equivalence to predicate devices: The GE Vivid 3 Expert/Pro Diagnostic Ultrasound System (K020789) for CW Doppler performance and the BioZ.com HemoDynamic Monitor (K011439) for data management were used as benchmarks. This means the device was compared to existing, legally marketed devices, implying that their established performance serves as a form of "ground truth" for what is considered safe and effective.
No clinical "ground truth" (e.g., pathology, outcomes data, or expert consensus on patient diagnoses) was explicitly used in this submission.
8. The Sample Size for the Training Set:
Not applicable, as this device's submission does not mention machine learning or AI components requiring a "training set" in the traditional sense. The device operates based on established physical principles of Doppler ultrasound.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no mention of a training set for machine learning or AI components.
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Image /page/0/Picture/0 description: The image shows the logo for USCOM LTD, a company that specializes in ultrasonic cardiac output monitors. The logo features a circular graphic on the left, followed by the company name in bold, sans-serif font. Below the company name is the tagline "Ultrasonic Cardiac Output Monitors" in a smaller font size. The overall design is clean and professional, conveying a sense of expertise and reliability in the medical technology field.
Ko43139
510(k) Summary - USCOM 1A
510(k) Summary
Per 21 CFR Part 807.92
Section a):
FEB 1 5 2005
| Date Prepared | Tuesday, 9th Nov 2004 |
|---|---|
| Official Contact | Mr Nick SchichtUSCOM LtdLevel 710 Loftus StreetSydney, Australia2000 |
| Classification Reference | 90 IYN |
| Product Code | 21 CFR 892.1550 |
| Common/Usual Name | Pulsed-Doppler |
| Proprietary Name | USCOM 1A |
| Predicate Device(s) | 1): (K020789) GE Vivid 3 Expert/Pro Diagnostic Ultrasound System.Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550,90-IYN2): (K011439) BioZ.com HemoDynamic Monitor, 21 CFR 870.2770,DSB |
| Reason for submission | New Device |
| Indications for Use | USCOM 1A records and monitors beat-to-beat cardiac heamodynamicsin paediatric and adult patients. Its recording and storage of patientinformation provides trending information of cardiovascular performancefor quantitative evaluation.The USCOM 1A is for use by clinicians in the hospital environment. |
Device Description
The USCOM 1A is a non-invasive tool that measures and records changes in the heamodynamic status of a patient.
It is a portable Continuous Wave Doppler device using an Ultrasonic Transducer to measure blood flow. it is a portable of an easy to use touch screen display with monitoring, trending and storage The GOOM TH consisted on an odo, to a see navigates intuitive and simple screens to enter patient details and perform examinations.
Targeting the patient's pulmonary or aortic valves transcutaneously, the blood flow profile can be Targeting the palifically of assisted blood flow profile, the clinician can determine a number of parameters including Stroke Volume and Cardiac Output.
The USCOM 1A saves the measures in a patient file. Multiple saved measures over time are displayed The USOW TA Saves the model of the patient's change in heamodynamic status. Reports can be generated on patient measures which can be printed and exported for analysis.
The device is portable, weighing less than 7 kilograms and incorporates an internal battery.
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Image /page/1/Picture/1 description: The image shows the logo for USCOM LTD, a company that specializes in ultrasonic cardiac output monitors. The logo consists of a circular emblem on the left, featuring a stylized image of sound waves emanating from a central point. To the right of the emblem, the company name "USCOM LTD" is displayed in bold, uppercase letters. Below the company name, the tagline "Ultrasonic Cardiac Output Monitors" is written in a smaller font size.
Comparison with Predicate Device(s)
The USCOM 1A system is of comparable type and is substantially equivalent to the:
- GE Vivid 3 Expert/Pro system for CW Doppler performance having similar technological ﺍﻟﺘ characteristics for safety and effectiveness features, design, construction and materials with the similar Intended Use and clinical application, and;
- BioZ.com HemoDynamic Monitor for patient data storage, and retrieval functionality. ﻟﻠﺰ
Section b):
Non-clinical tests
The device has been tested for acoustic output, electrical safety including thermal properties, EMC, biocompatibility, mechanical and environmental characteristics and has been found to comply with applicable medical device safety and performance standards.
Clinical tests
None required. Testing to consensus performances standards and well proven test methods is sufficient to demonstrate that the Continuous Wave Doppler technology used in the USCOM 1A, can perform clinical requirements as intended by USCOM Ltd.
Conclusion
The intended use and key features are consistent with traditional clinical practice, FDA guidelines and established methods of patient examination. The product development and design of the device conforms to 21 CFR 820 Quality System Regulation (QSR) and ISO 13485 Quality Management System standards for medical device manufacturers. The product is designed to conform to FDA consensus standards such as electrical safety, EMC and performance, compliance has been verified through use of independent test houses. Therefore, it is concluded that the USCOM 1A system is substantially equivalent with respect to safety and effectiveness to the predicate devices, Vivid 3 from GE Medical Systems (K020789) and BioZ from CardioDynamics (K011439)
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 5 2005
USCOM Ltd. % Ms. Christina L. Kichula Manager, Regulatory Affairs PPD Medical Device 1700 Rockville Pike, Suite 400 ROCKVILLE MD 20852
Re: K043139
Trade Name: USCOM 1A Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance plethysmograph Product Code: 74 DSB Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN and ITX Dated: January 27, 2005 Received: January 27, 2005
Dear Ms. Kichula:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your over 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 micrslate commerce pror to that have been reclassified in accordance with the provisions of the Amendinents, of to devices and Cosmetic Act (Act). You may, therefore, market the device, subject to I cleral i ood, Drug, and Oosment 110 et. The general controls provisions of the Act include the general conners provisions of and listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the USCOM 1A, as described in your premarket notification:
Transducer Model Number
2.2MHz 10mm diameter probe 2.2MHz 15mm diameter probe
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3.3MHz 10mm diameter probe
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is exassined (sis a a) =>
it may be subject to such additional controls. Existing major regulations and control It may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the overouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oe advised that I Dri of issualites vour device complies with other requirements of the Act that I DA has made a actuations administered by other Federal agencies. You must Of any I cocharates and regaranents, including, but not limited to: registration and listing (21 comply with an the 11et 31equirements)01); good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed noutication. The I D7X Imanig of succiantial vice and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific auriles in 1988. at (240) 276-0120. Also, please note the regulation entitled, Colliact the Office of Compunance as (21 t notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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
If you have any questions regarding the content of this letter, please contact REVIEWER at (301) 594-1212.
Sincerely yours,
David A. Ingram
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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Image /page/4/Picture/1 description: The image shows the logo for USCOM LTD, a company that specializes in ultrasonic cardiac output monitors. The logo consists of a circular graphic on the left, followed by the company name in bold, uppercase letters. Below the company name is the tagline "Ultrasonic Cardiac Output Monitors" in a smaller font.
Diagnostic Ultrasound Indications for Use Form USCOM 1A
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative(specify) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | N | |||||||||
| Small Organ(specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | N | |||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| PeripheralVascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K043139
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Image /page/5/Picture/0 description: The image shows the logo for USCOM LTD, a company that specializes in Ultrasonic Cardiac Output Monitors. The logo consists of a circular graphic on the left, followed by the company name in bold, uppercase letters. Below the company name is the tagline "Ultrasonic Cardiac Output Monitors" in a smaller font. The logo is simple and professional, and it effectively communicates the company's focus on cardiac output monitoring technology.
Diagnostic Ultrasound Indications for Use Form USCOM 1A with 2.2MHz 10mm diameter probe
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) | ||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative(specify) | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | N | ||||||||||
| Small Organ(specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | N | ||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| PeripheralVascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
(Please do not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Yorick R. Lymm
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
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Image /page/6/Picture/0 description: The image shows the logo for USCOM LTD, a company that specializes in Ultrasonic Cardiac Output Monitors. The logo consists of a circular emblem on the left, followed by the company name in bold, uppercase letters. Below the company name, there is a tagline that describes the company's focus on ultrasonic cardiac output monitors. The logo is simple and professional, and it effectively communicates the company's brand identity.
Diagnostic Ultrasound Indications for Use Form USCOM 1A with 2.2MHz 15mm diameter probe
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) | ||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative(specify) | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | N | ||||||||||
| Small Organ(specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | N | ||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| PeripheralVascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Lorida h. Lynn
(Division Sign Off)
(Division Sign-Off) Durision of Reproductive, Abdominal, ﺔ ﻓ Pornitogical Dence к Матрет 15
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Image /page/7/Picture/1 description: The image shows the logo for USCOM LTD, a company that specializes in Ultrasonic Cardiac Output Monitors. The logo features a circular emblem on the left, containing a stylized representation of sound waves or a fingerprint. To the right of the emblem, the company name "USCOM LTD" is displayed in bold, uppercase letters. Below the company name, the tagline "Ultrasonic Cardiac Output Monitors" is printed in a smaller font size.
Diagnostic Ultrasound Indications for Use Form USCOM 1A with 3.3MHz 10mm diameter probe
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative(specify) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | N | |||||||||
| Small Organ(specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | N | |||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| PeripheralVascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation-(ODE)
David A. Hyon
(Division Sign-Off)
Division of Reproductive, Abdominal മാർ വാർശിന്ത്രിയിരുന്നു. in 145 vumper ________________________________________________________________________________________________________________________________________________________________
N/A