(117 days)
ECO SUPERGEL® is a transmission gel media used with ultrasonic pulsed echo imaging systems. The gel, when applied on the defined area of the body, facilitates the 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.
The ECO SUPERGEL is a water-soluble gel (transmission DESCRIT TYON of the I therapies involving ultrasound systems.
This submission describes the ECO SUPERGEL®, an ultrasound gel, and asserts its substantial equivalence to the Parker Laboratories AQUASONIC 100. The provided documents focus on the regulatory approval process and do not include the detailed study design, acceptance criteria, or performance metrics typically found for AI/ML-based medical devices.
Therefore, the following information cannot be extracted or inferred from the provided text:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improvement with or without AI assistance.
- If a standalone (algorithm only) performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for performance evaluation.
- The sample size for the training set.
- How the ground truth for the training set was established.
Based on the provided text, the device is an ultrasound gel, not an AI/ML-based medical device that would have acceptance criteria related to classification, detection, or other diagnostic performance metrics generated by an algorithm interacting with human data.
The "SUMMARY of TESTING" section in the submission outlines the tests performed to demonstrate the safety and fundamental properties of the ultrasound gel, ensuring it is equivalent to the predicate device. These tests are relevant to the physical and biological characteristics of the gel, not its performance in an AI/ML context.
Summary of Testing Performed (as per the document for the ultrasound gel):
| Test Type | Description |
|---|---|
| Bench Testing | Comparative pH and viscosity. |
| Stability Tests | Evaluation of stability to light, ambient temperature, heating, cooling, and thermal shocks. |
| Challenge Test | Evaluation of microbiological stability. |
| TVC Test | "Evaluation of total vital count, of yeast and moulds test." |
| Biocompatibility Test | - Test on the standard ISO 10993. - Repeated Patch Test (Clinical evaluation of irritating potency of a product for the skin and of its sensitization potency). |
The FDA's review confirms substantial equivalence to a legally marketed predicate device (Parker Laboratories AQUASONIC 100) based on these types of tests, indicating that the device meets the safety and
performance characteristics expected for an ultrasound gel.
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510(k) Summary
SUBMITTED ON BEHALF OF:
Ceracarta S.p.A. Company Name: Via Secondo Casadei,14 47122 Forlì-ITALY Address: +39- 0543- 780055 Telephone: +39- 0543- 781404 Fax:
by:
Elaine Duncan, M.S.M.E., RAC President, Paladin Medical, Inc. PO Box 560 Stillwater, MN 55082 715-549-6035 715-549-5380
SEP 1 5 2010
CONTACT PERSON:
Fax:
Telephone:
May 19, 2010
Elaine Duncan
DATE PREPARED: ECO SUPERGEL® (and various other proprietary
R. coey. y. sp.
TRADE NAME:
trade names)
COMMON NAME: CLASSIFICATION NAME: PRO CODE:
ultrasound gel ultrasound gel IYO
ECO SUPERGEL water-soluble gel for SUBSTANTIALLY EQUIVALENT TO: SUBSTANTIALLEY EQUIVALLENT TO: THE Parker Laboratories AQUASONIC 100 (K802146).
ultrasound systems is substantially equivalent to the Parker Laboratories AQUASONIC 100 (K8021
DESCRIPTION of the DEVICE: The ECO SUPERGEL is a water-soluble gel (transmission DESCRIT TYON of the I therapies involving ultrasound systems.
INDICATIONS FOR USE:
ECO SUPERGEL® is a transmission gel media , used with ultrasonic pulsed echo imaging systems.
There is in ECO SUPERGEL® is a transmission get the body, facilitates the use of the system, which is intented The gel, when applied on the defined area of the body, tuchnates the tast of the tissue interfaces and hack to to project a pulsed sound beam into body ussue to decident to the tissue interface and back to the receiver.
SUMMARY of TESTING:
- Bench Testing for comparative pH and viscosity.
-Stability tests to light, ambient temperature ,heating, cooling and thermal shocks.
-Challenge test-evaluation of the microbiological stability.
-TVC test ("Evaluation of total vital count,of yeast and moulds test").
-Biocompatibility test:
- Test on the standard ISO 10993 ;
- The Repeated Patch Test-Clinical evaluation of irritating potency of a product for the skin and of its sensitization potency.
510K Submission:
*** Confidential ***
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Image /page/1/Picture/0 description: The image is a seal for the Department of Health & Human Services-USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ceracarta SPA % Ms. Elaine Duncan President Paladin Medical, Inc. P.O. Box 560 STILLWATER MN 55082
SEP 1 5 2010
Re: K101429
Trade/Device Name: ECO Supergel Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO Dated: August 19, 2010 Received: August 23, 2010
Dear Ms. Duncan:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(l), 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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/cdrh/industry/support/index.html.
Sincerely yours,
Donald J. Trump
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | 101429 |
|---|---|
| Device Name: | ECO Supergel |
SEP 1 5 2010
Indications for Use:
ECO SUPERGEL® is a transmission gel media used with ultrasonic pulsed echo imaging systems. The gel, when applied on the defined area of the body, facilitates the 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.
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, Offices Bewest Production (SDRE) OLVI
Division Sign-Off
(Division Signical F (Division of Radiological Devices Division of Radiogical Device Evaluation and Safety
Office of In Vitro Diagnosic Device Evaluation and Safety
Office of In Vitro Diagnosic Device Evaluation and Safety
Office of In Vitro Drug
510K
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§ 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.