(6 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or related terms, nor does it describe any features or performance metrics typically associated with AI/ML-powered devices.
No
The device is described as a "Diagnostic ultrasound imaging or fluid flow analysis" system, indicating its use is for diagnosis rather than therapy.
Yes
Explanation: The "Intended Use / Indications for Use" explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body".
No
The device description explicitly states "Mediwatch Multiscan Ultrasound System / Scanner," which implies a hardware component (the scanner) is part of the system, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Diagnostic ultrasound imaging or fluid flow analysis of the human body". This describes a device that interacts directly with the patient's body to produce images or analyze flow in vivo.
- Device Description: The device is described as an "Ultrasound System / Scanner". Ultrasound systems are used for imaging within the body.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) outside the body (in vitro) to diagnose conditions. The provided information does not mention any interaction with specimens or analysis performed outside the body.
Therefore, the Mediwatch Multiscan Ultrasound System / Scanner, as described, is a medical imaging device used in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body.
Product codes
IYO, ITX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Small Organ (Testes), Transrectal (Male Rectum/Prostate), Note 1 for Transrectal (likely refers to guidance of a biopsy needle, although not explicitly anatomical site, it points to a procedure within an anatomical region).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 7 2005
Mediwatch Ltd. % Mr. Jeffrey D. Rongero UL International (UK) Ltd. Domestic Correspondent Underwriters Laboratories, Inc. Research Triangle Park Division 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, NC 27709-3995
Re: K053325
Trade Name: Mediwatch Multiscan Ultrasound System / Scanner Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYO and ITX Dated: November 17, 2005 Received: December 1, 2005
Dear Mr. Rongero:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premative 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 interstate commerce prior to May 20, 1770, the entired in accordance with the provisions of the devices aubiog to Amendments, of to devices market been rocks. Sections market the device, subject to Federal Food, Drug, and Cosment Act (Fre.). Fou and controls provisions of the Act include the general controls provisions of the Frein- 116 goines, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for I his determination of Substantal equivalence applies to an esser. as described in your premarket notification:
Transducer Model Number
Abdominal 3.5/5.0 MHz Endocavity EF 5.0/7.5 MHz
1
Page 2 - Mr. Rongero
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), II your device is classified (366 aso co) inro s. Existing major regulations affecting your device (1) in EDA it may be subject to such additional Concessions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Court of Pour cannouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuates of a substained with other requirements of the Act
that FDA has made a determination that your device complies with other requirements o that FDA has made a decornmanon administered by other Federal agencies. You must of any Federal Statutes and regulations and missers or your not limited to: registration and listing (21 comply with an the 7te of requirements, and 801); good manufacturing practice requirements as set CFN in the quality systems (DS) regulation (21 CFR Part 820); and if applicable, the electronic form 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 This letter will anow you to begin manitial equivalence of your device to a legally marketed nonification. THE I D71 midning of succion for your device 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 advice for your as not 2010-01-01 01:00 please note the regulation entitled, and Colliact the Office of Comphanes at (216) 216 cations (21CFR Part 807.97). You may obtain Misolahung by reference to premailsonsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-204) or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez 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)
2
Diagnostic Ultrasound Indications for Use Form
System: Multiscan
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical | ||||||||||
| application | A | B | M | PWD | ||||||
| (D) | Colour | |||||||||
| Doppler | ||||||||||
| (AD) | Amplitude | |||||||||
| Doppler | ||||||||||
| (AD) | Colour | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (Specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | N | |||||||||
| Intraoperative | ||||||||||
| (specify) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Paediatric | ||||||||||
| Small Organ | ||||||||||
| (Testes) | N | |||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transophageal | ||||||||||
| Transrectal | N | Note 1 | ||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral | ||||||||||
| Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculoskeletal | ||||||||||
| Conventional | ||||||||||
| Musculoskeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E N= riew nulcation, T = previously active by + BA = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
David A. Syverson
510k) N
3
Diagnostic Ultrasound Indications for Use Form
System: Multiscan Transducer: Abdominal 3.5/5.0MHz
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical
application | A | B | M | PWD
(D) | Colour
Doppler
(AD) | Amplitude
Doppler
(AD) | Colour
Velocity
Imaging | Combined
(specify) | Other
(Specify) |
|---------------------------------|---|---|---|------------|---------------------------|------------------------------|-------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | | N | | | | | | | |
| Intraoperative
(specify) | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | |
| Paediatric | | | | | | | | | |
| Small Organ
(Testes) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Cardiac | | | | | | | | | |
| Transophageal | | | | | | | | | |
| Transrectal | | | | | | | | | |
| Transvaginal | | | | | | | | | |
| Transurethral | | | | | | | | | |
| Intravascular | | | | | | | | | |
| Peripheral | | | | | | | | | |
| Vascular | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Musculoskeletal
Conventional | | | | | | | | | |
| Musculoskeletal
Superficial | | | | | | | | | |
| Other (specify) | | | | | | | | | |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109),
David A. Larson
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
4
Diagnostic Ultrasound Indications for Use Form
System: Multiscan Transducer: Endocavity EF 5.0/7.5MHz
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical | |||||||||
| application | A | B | M | PWD | |||||
| (D) | Colour | ||||||||
| Doppler | |||||||||
| (AD) | Amplitude | ||||||||
| Doppler | |||||||||
| (AD) | Colour | ||||||||
| Velocity | |||||||||
| Imaging | Combined | ||||||||
| (specify) | Other | ||||||||
| (Specify) | |||||||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intraoperative | |||||||||
| (specify) | |||||||||
| Intraoperative | |||||||||
| Neurological | |||||||||
| Paediatric | |||||||||
| Small Organ | |||||||||
| (Testes) | N | ||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac | |||||||||
| Transophageal | Note 1 | ||||||||
| Transrectal | N | ||||||||
| Transvaginal | |||||||||
| Transurethral | |||||||||
| Intravascular | |||||||||
| Peripheral | |||||||||
| Vascular | |||||||||
| Laparoscopic | |||||||||
| Musculoskeletal | |||||||||
| Conventional | |||||||||
| Musculoskeletal | |||||||||
| Superficial | |||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix ﮯ N= new mulcation, 1 - previously dicatod by TEA, 2 - atatos and assist in the guidance of a biopsy needle.
(PLEASE DO NOT WRITE BFLOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) (PLEASE DO NOT WRITE BELOW THIS CM. " OSINKSE Evauation (ODE)
Concurrence of CDRH, Office of Device Evauation (ODE)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
David C. Simpson
(Division Sign-Division of Reproductive and Radiological Device 510(k) Numb