(63 days)
ULTRAEKOGEL™ is an electroconductive gel media used with ultrasonic pulsed echo imaging system. The gel -once applied on the defined area of the body- facilitates the intended use of the system, which is 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.
ULTRAEKOGEL™ is an electroconductive gel media used with ultrasonic pulsed echo imaging system. The gel -once applied on the defined area of the body- facilitates the intended use of the system, which is 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. It is supplied in 250 grams and 5 Kilograms containers with a 3-year shelf life.
The provided text describes a 510(k) submission for a medical device called ULTRAEKOGEL™, an ultrasound gel. The submission claims substantial equivalence to a predicate device, AQUASONIC 100.
Here's an analysis of the acceptance criteria and the study (or lack thereof) proving device performance, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of numerical performance metrics. Instead, it claims identicality across a range of technological characteristics when compared to the predicate device, AQUASONIC 100 (510k # K802146). The underlying acceptance criterion for this 510(k) submission is that the device is substantially equivalent to the predicate.
| Acceptance Criteria (Stated/Implied by Substantial Equivalence Claim) | Reported Device Performance (ULTRAEKOGEL™) |
|---|---|
| Indications for use (Identical to predicate) | Identical |
| Target population (Identical to predicate) | Identical |
| Design (Identical to predicate) | Identical |
| Materials (Identical to predicate) | Identical |
| Performance (Identical to predicate) | Identical |
| Sterility (Identical to predicate) | Identical |
| Biocompatibility (Identical to predicate) | Identical |
| Mechanical safety (Identical to predicate) | Identical |
| Chemical safety (Identical to predicate) | Identical |
| Anatomical sites (Identical to predicate) | Identical |
| Human factors (Identical to predicate) | Identical |
| Energy used and/or delivered (Identical to predicate) | Identical |
| Compatibility with environment and other devices (Identical to predicate) | Identical |
| Where used (Identical to predicate) | Identical |
| Standards met (Identical to predicate) | Identical |
| Electrical safety (Identical to predicate) | Identical |
| Thermal safety (Identical to predicate) | Identical |
| Radiation safety (Identical to predicate) | Identical |
Study to prove the device meets acceptance criteria:
The study proving the device meets the acceptance criteria is generally implied to be a comparison of technological characteristics against the predicate device. The document explicitly states: "Indeed, this device is IDENTICAL to the predicate device." This is the core of their argument for substantial equivalence.
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the traditional sense of a clinical or performance study involving a sample of patients or physical measurements. The claim of "identical" performance is based on the assertion that the technological characteristics, including performance, are the same as the predicate device. Therefore, no specific sample size for a test set is mentioned. The data provenance would be derived from the specifications and characteristics of both the proposed device (ULTRAEKOGEL™) and the predicate device (AQUASONIC 100), likely through internal testing and material analysis to confirm the stated identicality. The country of origin of this internal data is not specified, nor is whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As no distinct "test set" or clinical study is described, no information is provided regarding the number of experts or their qualifications used to establish a ground truth.
4. Adjudication method for the test set
Since no test set is described, no adjudication method is mentioned.
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
This device is an ultrasound gel, not an AI-powered diagnostic system. Therefore, no MRMC comparative effectiveness study was done, and the concept of human readers improving with or without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is an ultrasound gel and does not involve an algorithm. Therefore, no standalone algorithm performance study was conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For an ultrasound gel, the "ground truth" for performance would likely revolve around its physical and chemical properties that enable effective ultrasound imaging (e.g., acoustic impedance, viscosity, stability, biocompatibility). The document implies that these properties are identical to the predicate device's established characteristics. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this type of device in this submission.
8. The sample size for the training set
This device is an ultrasound gel and does not involve machine learning or AI. Therefore, there is no training set and no sample size is applicable or mentioned.
9. How the ground truth for the training set was established
As there is no training set, this question is not applicable.
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MAY 2 3 2003 510(k) Summary As Required by 21 section 807.92 ( c )
| 1-Submitter Name: | Mansour Consulting LLC |
|---|---|
| 2-Address: | 1308 Morningside Park DrAlpharetta, GA 30022 USA |
| 3-Phone: | (678) 908-8180 |
| 4-Fax: | (425) 795-9341 |
| 5-Contact Person: | Jay Mansour |
| 6-Date summary prepared: | March 18th, 2003 |
| 7-Device Trade or Proprietary Name: | ULTRAEKOGEL™ |
| 8-Device Common or usual name: | ULTRASOUND GEL |
| 9-Device Classification Name: | SYSTEM, IMAGING, PULSED ECHO,ULTRASONIC- GEL |
| 10-Substantial Equivalency is claimed against the following device: | AQUASONIC 100 from Parker Laboratories, Inc. |
- AQUASONIC 100 from Parker Laboratories, Inc 510k # K802146
11-Description of the Device:
ULTRAEKOGEL™ is an electroconductive gel media used with ultrasonic pulsed echo imaging system. The gel -once applied on the defined area of the body- facilitates the intended use of the system, which is 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. It is supplied in 250 grams and 5 Kilograms containers with a 3-year shelf life.
12-Intended use of the device: (refer to FDA form attached)
ULTRAEKOGEL™ is an electroconductive gel media used with ultrasonic pulsed echo imaging system. The gel -once applied on the defined area of the body- facilitates the intended use of the system, which is 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.
13-Safety and Effectiveness of the device:
This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)
14-Summary comparing technological characteristics with other predicate device:
Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached. Indeed, this device is IDENTICAL to the predicate device. Refer to the explanations within the main submission.
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| FDA file reference number | 510k # K802146 |
|---|---|
| Attachments inside notification submission file | 510k summary print out |
| TECHNOLOGICAL CHARACTERISTICS | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Identical |
| Materials | Identical |
| Performance | Identical |
| Sterility | Identical |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Identical |
| Anatomical sites | Identical |
| Human factors | Identical |
| Energy used and/or delivered | Identical |
| Compatibility with environment and other devices | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
| Thermal safety | Identical |
| Radiation safety | Identical |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of an eagle with three lines extending from its head.
Rockville MD 20850
Food and Drug Administration 9200 Corporate Boulevard
MAY 2 3 2003
INMED, LTDA % Mr. Jay Mansour President Mansour Consulting, LLC 1308 Morningside Park Dr. ALPHARETTA GA 30022 Re: K030889
Trade/Device Name: ULTRAEKOGEL™ Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 MUI Dated: March 18, 2003
Received: March 21, 2003
Dear Mr. Mansour:
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 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 t 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.
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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K030 889
Page of
510(k) Number (if known): _ K (3088 9
Device Name: ULTRAEKOGEL TM
Indications for Use:
ULTRAEKOGEL™ is an electroconductive gel media used with ultrasonic pulsed echo imaging system. The gel -----------------------------------------------------------------------------------------------------------------------------------------the body- facilitates the intended use of the system, which is 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.
David R. Ingram
Division Sign-Off ision of Reproductive, Radiological Device
1 ට
Prescription Use √
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
(Optional Format 3-10-98)
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.