ECO SUPERGEL

K101429 · Ceracarta Spa · IYO · Sep 15, 2010 · Radiology

Device Facts

• Record ID: K101429
• Device Name: ECO SUPERGEL
• Applicant: Ceracarta Spa
• Product Code: IYO · Radiology
• Decision Date: Sep 15, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended 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.

Device Story

ECO SUPERGEL is a water-soluble transmission gel applied to the body surface during ultrasonic pulsed echo imaging. It acts as a coupling medium to facilitate the transmission of pulsed sound beams from the ultrasound transducer into body tissues and back to the receiver. The gel enables accurate determination of tissue interface depth and location by minimizing air gaps between the transducer and skin. It is intended for use in clinical settings where ultrasound imaging is performed. The device provides no diagnostic output itself but is an essential accessory for the operation of ultrasound imaging systems, benefiting patients by ensuring clear, high-quality diagnostic images.

Clinical Evidence

No clinical data. Evidence consists of bench testing for pH, viscosity, and stability (light, temperature, thermal shock); microbiological stability (TVC test for yeast and moulds); and biocompatibility testing per ISO 10993, including a repeated patch test for skin irritation and sensitization.

Technological Characteristics

Water-soluble gel; transmission medium for ultrasonic pulsed echo imaging. Biocompatibility per ISO 10993. No electronic, software, or energy-emitting components.

Indications for Use

Indicated for use as a transmission gel media with ultrasonic pulsed echo imaging systems to facilitate the projection of pulsed sound beams into body tissue for determining tissue interface depth/location and measuring acoustic pulse duration.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Parker Laboratories AQUASONIC 100 (K802146)

Submission Summary (Full Text)

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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: [phone] Telephone: [phone] 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

K101429

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 [phone]. 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. [phone] or [phone] 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

K101429

510K

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