(87 days)
Not Found
No
The device description and intended use clearly define it as a sterile ultrasound coupling gel, with no mention of any software, algorithms, or AI/ML capabilities.
No.
The device is described as a sterile couplant for sound waves in medical diagnostic ultrasound imaging, not for therapeutic purposes. Its function is to facilitate imaging, not to treat a disease or condition.
No
This device is described as a "sterile couplant intended for use as a scanning gel." Its purpose is to "couple sound waves between the patient and medical imaging electronic transducers" during diagnostic ultrasound procedures. It does not perform the diagnostic imaging itself but assists in the process by facilitating sound wave transmission.
No
The device is a sterile gel, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Lubricano is a "scanning gel" and "couplant" used to "couple sound waves between the patient and medical imaging electronic transducers during intraoperative and intracavitary medical diagnostic ultrasound imaging procedures." This describes a device used in vivo (within the living body) to facilitate imaging, not a device used in vitro (outside the living body) to examine specimens.
- Device Description: The description details the composition of a gel used for lubrication and coupling, not a reagent or instrument for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, detection of analytes, or diagnostic information derived from testing samples outside the body.
Therefore, Lubricano is a medical device used in vivo for imaging purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Lubricano is an in vivo biocompatible and bioexcretable sterile couplant intended for use as a scanning gel in surgical procedures, biopsies and similar sterile applications.
Lubricano is used to couple sound waves between the patient and medical imaging electronic transducers during intraoperative and intracavitary medical diagnostic ultrasound imaging procedures, such as transcutaneous ultrasound image guided biopsy and aspiration, intraoperative ultrasound imaging, intracavity ultrasound imaging, and gel infusion sonography.
Lubricano is unit dose packaged, sterilized and intended for use in all diagnostic ultrasound procedures that currently use an ultrasound coupling gel or other fluid, alone or in combination with a transducer cover, where sterility, in vivo biocompatibility and bioelimination are required.
Product codes (comma separated list FDA assigned to the subject device)
MUI
Device Description
Lubricano® Sterile Gel is a sterile, water-soluble gel composed of hydroxyethylcellulose, glycerol, and purified water, which is contained in a 10 mL syringe. Lubricano Sterile Gel is free from fats, latex, disinfectants and preservatives. Lubricano Sterile Gel ensures that catheters and instruments move easily, and it adheres well to the mucosa.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found
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)
Results of in vivo and in vitro testing establishes the safety profile of the device as non-toxic, non-irritating and non-sensitizing, which is comparable to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
l0r3358
510(k) Summary
JAN - 9 2009
Submitted by Farco-Pharma GmbH Pharmazeutische Präparate Address: Gereonsmühlengasse 1 - 11 50670 Köln, Germany Telephone: +49 221 594061 Kornelia Ely-Koort, Regulatory Affairs Dept. Contact Name:
Date Submitted: December 11, 2008
Lubricano® Sterile Gel - Ultrasound Trade Name: Common Name: Ultrasound gel Product Code / Regulation: MUI (21 C.F.R. 892.1570)
Description: Lubricano® Sterile Gel is a sterile, water-soluble gel composed of hydroxyethylcellulose, glycerol, and purified water, which is contained in a 10 mL syringe. Lubricano Sterile Gel is free from fats, latex, disinfectants and preservatives. Lubricano Sterile Gel ensures that catheters and instruments move easily, and it adheres well to the mucosa.
Intended Use:Lubricano is an in vivo biocompatible and bioexcretable sterile couplant intended for use as a scanning gel in surgical procedures, biopsies and similar sterile applications.
Lubricano is used to couple sound waves between the patient and medical imaging electronic transducers during intraoperative and intracavitary medical diagnostic ultrasound imaging procedures, such as transcutaneous ultrasound image guided biopsy and aspiration, intraoperative ultrasound imaging, intracavity ultrasound imaging, and gel infusion sonography.
Lubricano is unit dose packaged, sterilized and intended for use in all diagnostic ultrasound procedures that currently use an ultrasound coupling gel or other fluid, alone or in combination with a transducer cover, where sterility, in vivo biocompatibility and bioelimination are required.
| Substantial Equivalence: | Lubricano® Sterile Gel is substantially equivalent to the following devices:
SonoTech, Inc.'s UltraBio – In Vivo Biocompatible Bioeliminated Sterile Ultrasound Imaging Couplant (K042619 and K033178), and
Farco-Pharma GmbH's Lubricano® Sterile Gel (K081990). |
| -------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Results of in vivo and in vitro testing establishes the safety profile of the device as non-toxic, non-irritating and non-sensitizing, which is comparable to the predicate devices.
1
510(k) Summarv
Submitted by Farco-Pharma GmbH Pharmazeutische Präparate Address: Gereonsmühlengasse 1 - 11 50670 Köln, Germany Telephone: +49 221 594061 Contact Name: Kornelia Ely-Koort, Regulatory Affairs Dept.
Date Submitted: October 1, 2008
Lubricano® Sterile Gel - Ultrasound Trade Name: Common Name: Ultrasound gel Product Code / Regulation: MUI (21 C.F.R. 892.1570)
Description: Lubricano® Sterile Gel is a sterile, water-soluble gel composed of hydroxyethylcellulose, glycerol, and purified water, which is contained in a 10 mL syringe. Lubricano® Sterile Gel is free from fats, latex, disinfectants and preservatives. Lubricano® Sterile Gel ensures that catheters and instruments move easily, and it adheres well to the mucosa.
Intended Use:Sterile gel for acoustic coupling in ultrasound indications
Substantial Equivalence:
Lubricano® Sterile Gel is similar in intended use and technological characteristics to the predicate device reviewed as coupling gels used to couple ultrasound devices to the skin. The device is similar with respect to indications for use and physical characteristics to predicate device in terms of 510(k) substantial equivalency.
Results of in vivo and in vitro testing establishes the safety profile of the device as non-toxic, non-irritating and non-sensitizing, which is comparable to the predicate device.
2
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Lubricano® Sterile Gel – Ultrasound
Indications for Use:
Sterile gel for acoustic coupling in ultrasound indications
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around the perimeter. In the center is a stylized emblem of an abstract bird-like figure, with three curved lines representing its wings or body.
JAN - 9 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FARCO-PHARMA GmbH % Mr. Seth A. Mailhot Attorney Latham & Watkins LLP 555 Eleventh Street, NW WASHINGTON DC 20004-1304
Re: K083358
Trade/Device Name: Lubricano® Sterile Gel - Ultrasound Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: MUI Dated: December 11, 2008 Received: December 12, 2008
Dear Mr. Mailhot:
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 such 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.
4
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 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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 this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.support/index.html.
Sincerely yours,
Laura B. Morris
anine M. M. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
510(k) Number (if known):
Device Name: Lubricano® Sterile Gel -- Ultrasound
Indications for Use:
Lubricano is an in vivo biocompatible and bioexcretable sterile couplant intended for use as a scanning gel in surgical procedures, biopsies and similar sterile applications.
Lubricano is used to couple sound waves between the patient and medical imaging electronic transducers during intraoperative and intracavitary medical diagnostic ultrasound imaging procedures, such as transcutaneous ultrasound image guided biopsy and aspiration, intraoperative ultrasound imaging, intracavity ultrasound imaging, and gel infusion sonography.
Lubricano is unit dose packaged, sterilized and intended for use in all diagnostic ultrasound procedures that currently use an ultrasound coupling gel or other fluid, alone or in combination with a transducer cover, where sterility, in vivo biocompatibility and bioelimination are reauired.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sian-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Page 1 of 1
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