SCANTAC MEMBRANE OR SCANTAC STRIP

• K Number: K013170
• Device Name: SCANTAC MEMBRANE OR SCANTAC STRIP
• Manufacturer: SONOTECH, INC.
• Date Cleared: 2001-11-13 ( 50 days)
• Product Code: ITX
• Regulation Number: 892.1570
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The biocompatible ScanTac Strips will be used in diagnostic ultrasound imaging to couple sound waves between the patient's body and medical imaging electronics. ScanTac Strips are biocompatible, sterile, and, being solid, leave no residue. They are single use and disposable. ScanTac Strips are intended for use in sterile fields substituting for an ultrasound coupling gel or fluid, as currently used, in combination with a latex, polyurethane, polypropylene or other polymeric protective transducer cover.

The ScanTac Membrane is used for transcutaneous ultrasound imaging over wounds and to enhance imaging contact over difficult geometries. The ScanTac Membrane has a backing on one side that is removed prior to transcutaneous scanning. The Membrane is placed onto the patient, and is sufficiently adherent to remain in place during the scan due to the adhesive nature of the hydrogel. Either water or ultrasound scanning gel is used on the other side of the Membrane between the transducer and the Membrane.

Device Description

ScanTacTM Membrane and ScanTac™ Strip

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding the "ScanTacTM Membrane and ScanTac™ Strip". It approves the devices for marketing, stating they are substantially equivalent to legally marketed devices. It also outlines the intended use of the devices.

Based on the provided text, there is no study described that proves the device meets acceptance criteria. The document is an FDA clearance letter, which indicates that the FDA has reviewed the submission and found the device substantially equivalent to an existing device, thus permitting its marketing. It does not contain details of a specific study performed by the manufacturer to establish acceptance criteria or device performance in the manner requested.

However, based on the information provided, we can infer some aspects related to what would be considered in such a submission, particularly for the "Acceptance Criteria" and "Reported Device Performance" for biocompatibility and sterility as these are explicitly mentioned in the "Indications For Use" section.

Here's an attempt to answer the questions based on the available text, along with explanations for unavailable information:

1. A table of acceptance criteria and the reported device performance

   The document does not contain a table of acceptance criteria or specific reported device performance metrics in the way one might expect from a clinical or performance study summary. However, it does state key characteristics of the devices that would have been evaluated as part of the substantial equivalence determination.

   Acceptance Criteria (Implied from Indications for Use)	Reported Device Performance (Implied from Device Description/Clearance)
   Biocompatibility	ScanTac Strips are biocompatible. (Stated in Indications For Use)
   Sterility	ScanTac Strips are sterile. (Stated in Indications For Use)
   Non-residue forming	ScanTac Strips, being solid, leave no residue. (Stated in Indications For Use)
   Single-use and disposable	ScanTac Strips are single use and disposable. (Stated in Indications For Use)
   Effective coupling for ultrasound imaging	Intended for use in coupling sound waves between patient's body and medical imaging electronics. (Stated in Indications For Use)
   Adherence during scanning (Membrane)	ScanTac Membrane is sufficiently adherent to remain in place during the scan. (Stated in Indications For Use)
   Transcutaneous imaging over wounds (Membrane)	ScanTac Membrane is used for transcutaneous ultrasound imaging over wounds. (Stated in Indications For Use)
   Enhanced imaging contact over difficult geometries (Membrane)	ScanTac Membrane is used to enhance imaging contact over difficult geometries. (Stated in Indications For Use)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   Not provided in the document. This is an FDA clearance letter and typically does not include the detailed test data or study design.

3. 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 provided in the document. This information would be part of the detailed submission, not the clearance letter.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   Not provided in the document.

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

   Not applicable. The device is an ultrasound coupling agent/membrane, not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

   Not applicable. This is a physical medical device (membrane/strip), not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   Not explicitly stated for performance, but for biocompatibility and sterility, the ground truth would likely be based on established international standards (e.g., ISO 10993 for biocompatibility, ISO 11137/11737 for sterility) and laboratory testing results.

8. The sample size for the training set

   Not applicable. This device is not an AI/machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

   Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUM." is arranged in a circular fashion around the left side of the emblem.

Food and Drug Administration

Public Health Service

9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2001

Ms. Margaret J. Larson President Sonotech, Inc. 774 Marine Drive BELLINGHAM WA 98225 Re: K013170

Kol 3170
Trade/Device Name: ScanTacTM Membrane and ScanTac™ Strip Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: 90 ITX Dated: September 20, 2001 Received: September 24, 2001

Dear Ms. Larson:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premaise is substantially equivalent (for the indications
referenced above and have determined the device is subservarketed in interstate referenced above and have decembed the uneves is socicate devices marketed in interstate for use stated in the enclosites to tegen manent date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactures assists of the Federal Food. Drug, commerce prior to May 28, 1970, the enactinent with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance with the proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) mat do not request approve or a prairols provisions of the Act. The Act. The Act. The You may, therefore, market the device, subjor to the gents for amual registration, listing of
general controls provisions of the Act include requirements for amainet misbrand general controls provisions of the Act monde requirement would be and misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see ablve) and critics major regulations affecting your device can be
it may be subject to additional controls. Existing major resplation EDA it may be subject to additional controls. Little 21, Parts 800 to 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Farts 800 to 898. In additi found in the Code of Federal Regulations, sour device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a subscription with other requirements of the Act
that FDA has made a determination that your device Edgeral accepcies. You must that FDA has made a decemination administered by other Federal agencies. You must or any Federal Statutes and regulations, but not limited to: registration and listing comply with all the Act s requirements, meaning coursective requirements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requiremle, the ele (2) CFR Part 807); labelling (21 CFR Patis 800); and if applicable, the electronic
forth in the quality systems (QS) regulation (2) CFR Patt 820); and if applicable, the elec forth in the quality systems (QS) rogulation (ST -542 of the Act); 21 CFR, 1000-1050.
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 510(k) premakely This letter will allow you to begin marketing your device to a legally marketed
notification. The FDA finding of substantial equivalerse and vice to a legally marketed notification. The FDA finding of substanial equivaled or Jersian 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 If you desire specific advice for your device of our laceming any and on the regulation number at the top of this letter:

8xx.1xxx	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the production and access note the regulation entitled, "Misbranding
Office of Compliance at [phone]. Also, please note the regulation Office of Compliance at (501) 5944057. Also, 2019.97). Other general information of Small Manufacturers by reference to premarket nouncation (21 CL+++ + C+++++ + Division of Small Manufacturers,
your responsibilities under the Act may be obtained from the [phone] or (301 your responsibilities under the Assistance at its toll-fires mumber [phone] or [phone]
International and Consumer Assistance at its toll-fires manner (800) 638-International and Consumer Hesissa.fo's agov/cdrh/dsmaldsmamain.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

Pr

Enclosure

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NOV 1 3 2001

K013170 510(k) Number (il known):_

SCANTAC MEMBRANE (OR) SCANTAC STRIP Device Name:

Indications For Use:

The biocompatible ScanTac Strips will be used diagnostic ultrasound
The biocompatible Scan between the natient's body and medical imaging The biocompatible Scan'tac Strips will be used and medical imaging in imaging to couple sound waves between the palletic boor and being solid, leave no
electronics. ScanTac Strips are biocompatible, sterile, and, being solid, leave no electronics. ScanTac Strips are biocompanie, strips are intended for use intended for use in
residue. They are single use and disposable. ScanTac Strips are intended for used residue. They are single use and disposable. Scarrely used on fluid, as currently used, in
sterile fields substituting for an ultrasound coupling gel or fluid, as currentl sterile fields substituting for an ultrasound Couping gol of Mara, in other polymeric protective
combination with a latex, polyurethane, polypropylene or other polymeric p transducer cover.

The ScanTac Membrane is used for transcutaneous ultrasound imaging over wounds The ScanTac Membrane is used for transcutaneous unascone maging Membrane has
and to enhance imaging contact over difficult geometries. The ScanTac Membrane has and to enhance imaging contact over diments on to transcutaneous scanning. The Membrane
a backing on one side that is removed prior to transcutaneous scanning the scan a backing on one side that is removed proctories and in place during the scan
is placed onto the patient, and is sufficiently adherent to remain in place during gel is is placed onto the patient, and is sumcently adherent or onultrasound scannound scanning gel is
due to the adhesive nature of the hydroge. Either water or ultrasound scannin due to the adnesive hature of the nyarogen. "Lines and the exposure in the exposure in

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

FDA/CDRH/0DE/NC

Ост 5 1 50 Pl! '01

RECEN'D

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use..

(Optional Format 1-2-96)

(Division
Division o
Abdominal,
510(k) Number
2013120

3

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.