(35 days)
No
The device description and intended use focus solely on the physical properties and function of a sterile probe cover for ultrasound, with no mention of software, image processing, or AI/ML capabilities.
No
The device is a probe cover, providing a barrier and fluid coupling for an ultrasound transducer, not directly treating a medical condition.
No
The device is a protective cover for an ultrasound probe, facilitating imaging but not performing diagnostic functions itself. It provides a barrier and fluid coupling for an ultrasonic transducer, which is the diagnostic component.
No
The device is a physical ultrasound probe cover made of plastic film, not software.
Based on the provided information, the ClearScan™ ultrasound probe cover is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The ClearScan™ is a protective cover used during an ultrasound procedure, acting as a barrier between the ultrasound probe and the patient's body (eye or skin). It does not analyze any biological samples.
- The intended use and device description clearly state its function as a sterile, single-use protective cover and a water path. Its purpose is to facilitate the ultrasound imaging process and maintain sterility, not to perform diagnostic tests on biological specimens.
- The performance studies mentioned are non-clinical tests related to biocompatibility and distortion of the sac. This aligns with the evaluation of a medical device used externally, not an IVD device which would typically involve performance studies related to the accuracy and reliability of diagnostic results from biological samples.
Therefore, the ClearScan™ ultrasound probe cover is a medical device, but it falls under a different classification than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ClearScan™ ultrasound probe cover is intended to be used as a sterile, single-use protective cover with fluid coupling between the eye or skin and an ultrasonic transducer.
The ClearScan™ ultrasound probe cover is indicated when it is necessary to have a sterile, single-use protective sheath with fluid coupling between the examined sufface and an ultrasonic transducer.
Product codes (comma separated list FDA assigned to the subject device)
ITX
Device Description
The ClearScan™ ultrasound probe cover is intended to be used as a sterile, single-use protective cover with fluid coupling between the examined surface and an ultrasonic transducer. The device provides a microbial barrier between the probe and the patient's tissue, helping to prevent the transfer of microorganisms, body fluids and particulate material to the patient and healthcare personnel. It provides a water path between the trausducer and the surface scanned.
The ClearScan™ material that contacts the eye or skin tissue is made of a soft pliable plastic film. The JlearScan is a sealable plastic sac that encloses the transducer and holds water to make the water path for scanning.
The ClearScan is made of a biologically-compatible, non-latex membrane. It has a special collar that permits it to be sealed around the body of the transducer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye or skin
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)
(a) Non-clinical tests
Biocompatibility tests have been done to evaluate any possible distortion caused by the sac.
(b) Clinical tests
Not required
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.
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
510(k) Submission ESI, Inc ClearScan Transducer Cover
510(k) Summary November 16, 2007
FEB 21 205
(1) Submitter Information
Name: ESI, Inc.
Address: 2915 Everest Lane N. Plymouth, MN 55447
Telephone Number: (763)473-2533
Contact Person: Dr. George Myers Medsys Inc. 377 Rt. 17 S Hasbrouck Heights, NJ 07604 201-727-1703
Date Prepared: November 16, 2007
(2) Name of Device:
Trade Name: ClearScan Common Name: Cover for Ultrasonic Transducer Classification Name: Ultrasonic Diagnostic Transducer Accessories, 90 ITX
(3) Equivalent legally-marketed devices:
Civco Poly Ultrasound Transducer Cover K970573
K992152 Civco Ultrasound Transducer Standoff
(4) Description
The ClearScan™ ultrasound probe cover is intended to be used as a sterile, single-use protective cover with fluid coupling between the examined surface and an ultrasonic transducer. The device provides a microbial barrier between the probe and the patient's tissue, helping to prevent the transfer of microorganisms, body fluids and particulate material to the patient and healthcare personnel. It provides a water path between the trausducer and the surface scanned.
1
Page 5-2
The ClearScan™ material that contacts the eye or skin tissue is made of a soft pliable plastic film. The JlearScan is a sealable plastic sac that encloses the transducer and holds water to make the water path for scanning.
(5) Intended Use
The ClearScan™ ultrasound probe cover is intended to be used as a sterile, single-use protective cover with fluid coupling between the eye or skin and an ultrasonic transducer.
(6) Technological characteristics
The ClearScan is made of a biologically-compatible, non-latex membrane. It has a special collar that permits it to be sealed around the body of the transducer.
(7) Performance data
(a) Non-clinical tests
Biocompatibility tests have been done to evaluate any possible distortion caused by the sac.
(b) Clinical tests
Not required
(8) Conclusions
The ESI ClearScan is equivalent in safety and efficacy to the legally marketed predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
ESI. Incorporated % Mr. George Myers President Medsys, Incorporated 377 Route 17 S HASBROUCK HEIGHTS NJ 07604
Re: K080119
Trade/Device Name: ClearScan™ Transducer Cover Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: January 14, 2008 Received: January 17, 2008
Dear Mr. Myers:
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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the logo. Below that is the acronym "FDA" in a stylized font. The word "Centennial" is below the acronym. There are stars and other decorative elements around the circle.
Protecting and Promoting Public Health
3
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 (OS) 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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (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 Manufacturers. 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 vours.
Nancy C. Brygdon
Nancy C. Brogdon . Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ESI ClearScan
Page 4-1 Indications for Use
510(k) Number (if known):
Device Name: ClearScan
Indications For Use:
The ClearScan™ ultrasound probe cover is indicated when it is necessary to have a sterile, single-use protective sheath with fluid coupling between the examined sufface and an ultrasonic transducer.
080119
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tony Tri Whan
Division of Reproductive, Abdominal. and Radiological Device 510(k) Number