(50 days)
Not Found
Not Found
No
The device description and intended use focus solely on the physical properties and function of ultrasound coupling materials (strips and membranes). There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No
The device is used for diagnostic ultrasound imaging, which is a diagnostic procedure, not a therapeutic one. It facilitates imaging by coupling sound waves, it does not treat or alleviate a medical condition.
No
Explanation: The device, ScanTac Strips and Membrane, is described as a coupling agent for ultrasound imaging, designed to facilitate the transmission of sound waves. It does not perform the diagnosis itself but rather aids in the diagnostic process by improving image quality or ease of scanning. It is a consumable accessory for diagnostic ultrasound, not a diagnostic device.
No
The device description explicitly mentions "ScanTac Strips" and "ScanTac Membrane," which are described as physical, biocompatible, solid materials (strips) and a membrane with a backing and hydrogel (membrane). These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnostic purposes.
- Device Function: The ScanTac Strips and Membrane are described as ultrasound coupling agents. Their function is to facilitate the transmission of sound waves between the ultrasound transducer and the patient's body. They are used on the patient's body, not for analyzing specimens from the patient's body.
- Intended Use: The intended use is for "diagnostic ultrasound imaging," which is an in-vivo imaging technique, not an in-vitro diagnostic test.
Therefore, the ScanTac devices are accessories used in an in-vivo diagnostic imaging procedure, not IVDs themselves.
N/A
Intended Use / Indications for Use
The biocompatible ScanTac Strips will be used in 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, or 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 for coupling between the transducer and the Membrane and the exposure in the exposure in
Product codes (comma separated list FDA assigned to the subject device)
90 ITX
Device Description
Not Found
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)
Not Found
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.
Not Found
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
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.
1
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 | (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 Additionally, for questions on the production and access note the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. 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 (200) 633-2041 or (301 your responsibilities under the Assistance at its toll-fires mumber (800) 638-2041 or (301) 443-6597
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
2
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