SCANLUBE by SONOTECH, INC. | FDA 510(k) Summary

ScanLube is an in vivo biocompatible and biodegradable sterile ultrasound couplant that will be used in coniunction with hydrogel pads, such as Sonotech's ScanTac Pad, during medical diagnostic ultrasound imaging to couple ultrasound waves between the patient and medical imaging electronics.

ScanLube converts an adhesive hydrogel surface into a lubricous surface by hydrogen bonding with the ScanTac Pad, which then facilitates scanning with an ultrasound transducer.

ScanLube is intended for use with the ScanTac Strip and ScanTac Pad in conjunction with transcutaneous ultrasound image guided biopsy and aspiration, and within a protective sheath (probe cover) for intraoperative and endocavity ultrasound imaging.

ScanLube, when swabbed or similarly applied to the exposed surface of a hydrogel strip, such as the ScanTac Strip, when attached to the face of a transducer, converts the exposed hydrogel adhesive surface to lubricous, thus enabling the easy insertion of the hydrogel covered transducer into a transducer cover or sheath, or for scanning the patient using direct contact of the lubricous hydrogel surface.

ScanLube is unit dose packaged, sterilized and intended for use as a couplant and lubricant in all diagnostic ultrasound procedures which currently use an ultrasound coupling gel or fluid alone or in combination with a latex, polyurethane or polyethylene transducer cover where sterility and in vivo biocompatibility are required.

ScanLube may be used to lubricate the exterior surface of endocavity transducer sheaths or covers prior to insertion into the vagina or rectum. In this application, ScanLube serves both as an ultrasound couplant and instrument lubricant.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device named ScanLubeTM. It primarily focuses on the regulatory approval for this device as a substantially equivalent product to existing ones, rather than providing a detailed study report with specific acceptance criteria and performance data.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and expert involvement is not available in the provided text.

Here's what can be inferred or stated based on the document's content:

A table of acceptance criteria and the reported device performance:
- Not available. The document is a clearance letter, not a study report. It states that the device is "substantially equivalent" to legally marketed predicate devices, implying it met certain regulatory requirements, but it does not detail specific performance metrics or acceptance criteria for those metrics.
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not available. The document does not describe any specific test set or clinical study details.
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):
- Not available. Ground truth establishment related to a test set is not discussed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not available. Adjudication methods are not mentioned as no test set details are provided.
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:
- Not applicable/Not available. ScanLubeTM is an ultrasonic couplant and lubricant, not an AI-powered diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this product.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not available. As above, this device is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not available. The document does not describe clinical study ground truth. The basis for substantial equivalence would likely rely on physical/chemical properties and biocompatibility testing, not diagnostic ground truth as understood for imaging algorithms.
The sample size for the training set:
- Not applicable/Not available. This device is not an AI algorithm requiring a training set.
How the ground truth for the training set was established:
- Not applicable/Not available. This device is not an AI algorithm requiring a training set.

Summary of available information related to equivalence:

Device Name: ScanLubeTM
Regulation Number: 21 CFR 892.1570
Regulation Name: Diagnostic ultrasonic transducer (ScanLube is an accessory to this)
Regulatory Class: II
Product Code: 90 MUI
Indication For Use: ScanLube is an in vivo biocompatible and biodegradable sterile ultrasound couplant and lubricant. It is used in conjunction with hydrogel pads (e.g., Sonotech's ScanTac Pad) during medical diagnostic ultrasound imaging to couple ultrasound waves, convert adhesive hydrogel surfaces to lubricous surfaces for easier scanning with an ultrasound transducer, and facilitate insertion of hydrogel-covered transducers into sheaths or for direct contact scanning. It is unit-dose packaged, sterilized, and intended for use in diagnostic ultrasound procedures where sterility and in vivo biocompatibility are required, including lubricating the exterior surface of endocavity transducer sheaths.
Predicate Device: The letter states the device is substantially equivalent to "legally marketed predicate devices." Specific predicate device names are not provided in this excerpt.
Basis for Approval: Substantial equivalence to existing predicate devices. This implies that the properties, indications for use, and performance characteristics (e.g., acoustical coupling, lubrication, sterility, biocompatibility) were demonstrated to be acceptable and similar to those of previously cleared devices. However, the exact tests and their acceptance criteria are not detailed here.

Summary

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Image /page/0/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the top half of the circle. Inside the circle is a symbol that resembles three stylized birds in flight, stacked on top of each other. The birds are facing to the right, and their wings are curved upwards.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 2003

Ms. Margaret J. Larson SONOTECH, Inc. 774 Marine Drive BELLINGHAM WA 98225 Re: K031222 Trade/Device Name: ScanLubeTM Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II

Product Code: 90 MUI Dated: July 10, 2003 Received: July 14, 2003

Dear Ms. Larson:

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 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

Nancv 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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Page of 17

510(k) Number (if known):_KO3l22222

SCANLUBE - IN VIVO BIOCOMPATIBLE STERILE ULTRASOUND IMAGING Device Name: COUPLANT AND LUBRICANT

Indications For Use:

ScanLube converts an adhesive hydrogel surface into a lubricous surface by hydrogen bonding with the ScanTac Pad, which then facilitates scanning with an ultrasound transducer.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use ાર Over-The-Counter Use (Per 21 CFR 801.109) (Optional Formal 1-2-96)

Regulation Number and Section

§ 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.