(241 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic (PWD, CWD), Adult Cephalic (PWD), Peripheral Vascular (CWD).
Not Found
The provided text is a 510(k) clearance letter from the FDA for Rimed Ltd.'s Intra-View and Smart-Lite Transcranial Doppler Devices, along with their respective transducers. The letter primarily focuses on establishing substantial equivalence to previously marketed devices and outlines the intended uses for each transducer based on mode of operation and clinical application.
It's important to note that this document is a regulatory clearance and does not contain details of specific studies, acceptance criteria, or performance metrics in the way a clinical study report would. Instead, it indicates that the device is "substantially equivalent" to legally marketed predicate devices, which implies that the device meets similar safety and effectiveness standards, rather than proving a specific performance against explicit, numerical acceptance criteria within this document.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. The document lists the intended uses which define the scope of the device's application, rather than performance metrics.
Based on the provided information, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
Cannot be provided directly from the document. The document is a 510(k) clearance letter that states "the device is substantially equivalent" to predicate devices. It does not contain specific performance metrics (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio, etc.) or acceptance criteria that were met, which would typically be found in a detailed validation report. The closest information available is the intended use for each transducer, indicating the modes of operation and clinical applications for which the device is cleared.
Here's a summary of the intended uses for the transducers, which implicitly implies they perform adequately for these applications, but without numerical performance data:
| Clinical Application | Intra-View Transducers (2, 4, 8 MHz) | Smart-Lite Transducers (2, 4, 8 MHz) |
|---|---|---|
| Ophthalmic (PWD) | X (2MHz, 4MHz, 8MHz) | X (2MHz, 4MHz) |
| Ophthalmic (CWD) | X (2MHz, 4MHz, 8MHz) | X (8MHz) |
| Adult Cephalic (PWD) | X (2MHz, 4MHz, 8MHz) | X (2MHz) |
| Peripheral Vascular (CWD) | X (2MHz, 4MHz, 8MHz) | X (8MHz) |
| Peripheral Vascular (PWD) | X (4MHz) |
Note: PWD = Pulsed Wave Doppler, CWD = Continuous Wave Doppler. The tables within the document often use 'X' to mark applicable modes/applications. For the purposes of this table, I am consolidating based on the transducer frequencies listed as being cleared for the system.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Cannot be provided from the document. The 510(k) clearance letter does not include details about specific test sets, sample sizes, or data provenance from any studies conducted by the applicant. This information would typically be part of the detailed submission, not the public clearance letter.
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):
Cannot be provided from the document. The letter makes no mention of expert involvement in establishing ground truth for any test data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Cannot be provided from the document. There is no information regarding adjudication methods.
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:
Cannot be provided from the document. This document predates the widespread regulatory consideration of AI/ML devices in the way described. It does not mention any MRMC studies, human reader improvement with AI assistance, or AI components. The devices are Transcranial Doppler devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Cannot be provided from the document. The devices are physical medical devices (Transcranial Doppler systems with transducers); the concept of a "standalone algorithm" or "human-in-the-loop performance" in the context of AI is not applicable to the information provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Cannot be provided from the document. The document does not describe the methodologies or ground truth used in any studies conducted to support the 510(k) submission.
8. The sample size for the training set:
Cannot be provided from the document. As this is a clearance for a medical device (Transcranial Doppler), not an AI/ML algorithm, the concept of a "training set" in the context of machine learning is not applicable, and no such information is provided.
9. How the ground truth for the training set was established:
Cannot be provided from the document. See the explanation for point 8.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 7 1998
Rimed Ltd. c/o A. Stein Regulatory Affairs Consulting P.O.B. 454 Ginot Shomron, 44853 Israel
K974588 Re: Trade Name: Intra-View Bilateral Transcranial Doppler Device and Smart-Lite Portable Bilateral Transcranial Doppler Device Regulatory Class: 1 1 Product Code: 90 IYN/21 CFR 892.1550 Dated: June 18, 1998 Received: June 29, 1998
Dear Ms. Stein:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
This determination of substantial equivalence applies to the following transducers intended for use with the Intra-View and Smart-Lite Transcranial Doppler Systems, as described in your premarket notification:
Transducer Model Number
2MHz, 4MHz, 8MHz
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. ಗಿ substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register.
Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 predicate device results in a classification for your device and thus permits your device to proceed to market.
{1}------------------------------------------------
Page 2 - A. Stein
If you desire specific advice for your device on our labeling regulation (21
CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2] CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ClinicalApplication | A | B | C | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | X | X | ||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative(Specify) | ||||||||||
| Intra-operativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) | ||||||||||
| Neonatal | ||||||||||
| Cephalic | ||||||||||
| Adult Cephalic | X | |||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Luminal | ||||||||||
| PeripheralVascular | X | |||||||||
| Laparoscopic | ||||||||||
| Musculo-SkeletalConventional | ||||||||||
| Muscolo-SkeletalSuperficial | ||||||||||
| Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation
Additional Comments: Intra-View Transcranial Doppler System 2, 4 and 8 MHz Transducers
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Wilianh
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number
{3}------------------------------------------------
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| ClinicalApplication | A | B | C | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | X | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative(Specify) | ||||||||||
| Intra-operative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) | ||||||||||
| Neonatal | ||||||||||
| Cephalic | ||||||||||
| Adult Cephalic | X | |||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Luminal | ||||||||||
| Peripheral | ||||||||||
| Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-SkeletalConventional | ||||||||||
| Muscolo-Skeletal | ||||||||||
| Superficial | ||||||||||
| Other (Specify) |
Additional Comments: Intra-View Transcranial Doppler System 2 MHz Transducer
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Ev
vice Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Deyices 510(k) Number
{4}------------------------------------------------
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ClinicalApplication | A | B | C | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative(Specify) | ||||||||||
| Intra-operativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) | ||||||||||
| Neonatal | ||||||||||
| Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Luminal | ||||||||||
| PeripheralVascular | ||||||||||
| Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-SkeletalConventional | ||||||||||
| Muscolo-Skeletal | ||||||||||
| Superficial | ||||||||||
| Other (Specify) |
Additional Comments: Intra-View Transcranial Doppler System 4 MHz Transducer
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OD
Device Evaluation (ODE)
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number,
{5}------------------------------------------------
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ClinicalApplication | A | B | C | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | X | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative(Specify) | ||||||||||
| Intra-operativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) | ||||||||||
| Neonatal | ||||||||||
| Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Luminal | ||||||||||
| PeripheralVascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-SkeletalConventional | ||||||||||
| Muscolo-SkeletalSuperficial | ||||||||||
| Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation
Additional Comments: Intra-View Transcranial Doppler System 8 MHz Transducer
(PLEASE DO NOT WRITE BELOW THIS LINE-CONȚINUE ON ANOTHER PAGE IF.NEEDED)
Concurrence of CDRH, Office of Device Evaluation (CDE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
{6}------------------------------------------------
Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation
| ClinicalApplication | A | B | C | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | X | X | ||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative(Specify) | ||||||||||
| Intra-operativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) | ||||||||||
| Neonatal | ||||||||||
| Cephalic | ||||||||||
| Adult Cephalic | X | |||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Luminal | ||||||||||
| PeripheralVascular | X | |||||||||
| Laparoscopic | ||||||||||
| Musculo-SkeletalConventional | ||||||||||
| Muscolo-SkeletalSuperficial | ||||||||||
| Other (Specify) |
Additional Comments: Smart-Lite Transcranial Doppler System 2, 4 and 8 Mhz Transducers
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological J 510(k) Numbe
{7}------------------------------------------------
Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ClinicalApplication | A | B | C | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | X | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative(Specify) | ||||||||||
| Intra-operativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) | ||||||||||
| Neonatal | ||||||||||
| Cephalic | ||||||||||
| Adult Cephalic | X | |||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Luminal | ||||||||||
| Peripheral | ||||||||||
| Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-SkeletalConventional | ||||||||||
| Muscolo-SkeletalSuperficial | ||||||||||
| Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation
Additional Comments: Smart-Lite Transcranial Doppler System 2 MHz Transducer
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
vice Evaluation (ODE)
(Division Sign-Off)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K974588
{8}------------------------------------------------
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Oneration
| ClinicalApplication | A | B | C | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Mode of Operation | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative(Specify) | ||||||||||
| Intra-operativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) | ||||||||||
| Neonatal | ||||||||||
| Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Luminal | ||||||||||
| PeripheralVascular | X | |||||||||
| Laparoscopic | ||||||||||
| Musculo-SkeletalConventional | ||||||||||
| Muscolo-SkeletalSuperficial | ||||||||||
| Other (Specify) |
Additional Comments: Smart-Lite Transcranial Doppler System 4 MHz Transducer
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Exaluation (OD)
Willians
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K974588
Prescription Use (Per 21 CFR 801.109)
24
{9}------------------------------------------------
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ClinicalApplication | A | B | C | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | X | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative(Specify) | ||||||||||
| Intra-operativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) | ||||||||||
| Neonatal | ||||||||||
| Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Luminal | ||||||||||
| PeripheralVascular | X | |||||||||
| Laparoscopic | ||||||||||
| Musculo-SkeletalConventional | ||||||||||
| Muscolo-Skeletal | ||||||||||
| Superficial | ||||||||||
| Other (Specify) |
Mode of Oneration
Additional Comments: _Smart-Lite Transcranial Doppler System 8 MHz Transducer
(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)
(Division Sign=Off) Division of Reproductive, Abdominal, B and Radiological Devices 510(k) Number
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.