(35 days)
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.
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.
Here's an analysis of the provided text regarding the ESI ClearScan Transducer Cover, focusing on acceptance criteria and study details:
Overall Assessment:
The provided document (K080119) is a 510(k) submission for a device that is essentially a non-latex cover for ultrasound transducers. The primary purpose of this device is to provide a sterile barrier and a water path for ultrasound scanning.
Crucially, this submission does NOT contain acceptance criteria or a study proving that the device meets those criteria, as typically understood for diagnostic or therapeutic efficacy. Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device (Civco Poly Ultrasound Transducer Cover K970573, K992152) and safety through biocompatibility.
Therefore, many of the requested sections below will indicate "Not applicable" or "Not provided" because the nature of this device and its 510(k) submission does not require comprehensive clinical performance studies to establish diagnostic accuracy or treatment effectiveness.
Acceptance Criteria and Reported Device Performance
Given the nature of the device (a sterile cover) and the 510(k) submission type, the "acceptance criteria" are primarily related to safety, sterility, and functional equivalence to its predicate. No specific performance metrics like sensitivity, specificity, or accuracy are provided as this is not a diagnostic algorithm.
| Acceptance Criteria Category | Specific Criteria (Inferred from submission) | Reported Device Performance (from submission) |
|---|---|---|
| Biocompatibility | Non-toxic, non-irritating, non-sensitizing material for contact with eye or skin tissue. | "Biocompatibility tests have been done." (Specific results not detailed in this summary, but implied to be acceptable for 510(k) clearance). |
| Sterility | Capable of maintaining a sterile barrier as a single-use protective cover. | "Intended to be used as a sterile, single-use protective cover." (Implied to meet sterility standards, though specific testing results are not detailed in the summary). |
| Fluid Coupling | Provides a water path for scanning. | "Holds water to make the water path for scanning." "Provides a water path between the transducer and the surface scanned." (Functional description, not a quantitative performance metric). |
| Transducer Enclosure | Effectively encloses the transducer and seals. | "A sealable plastic sac that encloses the transducer." "Special collar that permits it to be sealed around the body of the transducer." (Functional description). |
| Material Properties | Soft, pliable plastic film; non-latex. | "Made of a soft pliable plastic film." "Made of a biologically-compatible, non-latex membrane." |
| Substantial Equivalence | Similar intended use, technological characteristics, and safety/efficacy profile to predicate devices. | "The ESI ClearScan is equivalent in safety and efficacy to the legally marketed predicate device." (FDA concurring with this claim in the clearance letter). |
| No Distortion | Does not cause significant distortion to the ultrasound image. | "Biocompatibility tests have been done to evaluate any possible distortion caused by the sac." (Implied to be acceptable, details not provided). |
Study Details
-
Sample size used for the test set and the data provenance:
- Sample Size: Not applicable / Not provided. The submission states "Non-clinical tests" (biocompatibility and distortion assessment) but does not detail sample sizes for these tests within the provided summary. No clinical test set involving patients or data sets is described, as the submission states "Clinical tests: Not required."
- Data Provenance: Not applicable / Not provided. Since clinical tests were deemed not required, there is no patient data provenance (e.g., country of origin, retrospective/prospective). Non-clinical tests would typically be laboratory-based.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No "ground truth" in the diagnostic or performance sense was established for a test set, as no clinical efficacy study was conducted. The main "truth" being established was around biocompatibility and functional equivalence, which don't typically involve expert panels in this manner for this type of device.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set requiring expert adjudication was described.
-
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. This device is a passive, non-AI-powered accessory (an ultrasound probe cover). No MRMC or AI-related studies were conducted or are relevant.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this type of device primarily relates to whether the material is indeed biocompatible and if the cover functions as intended (e.g., provides a sterile barrier, holds water, doesn't cause artifact for imaging). For biocompatibility, this is typically established by recognized standards (e.g., ISO 10993 series) and laboratory testing. For functional aspects, it's engineering and material science validation. No clinical "ground truth" (e.g., disease presence/absence) was established for this submission.
-
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable. No training set for an algorithm was used.
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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.
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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.
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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
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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
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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
§ 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.