(270 days)
Intraoperative Ultrasound Probe Cover can be used to minimize contamination between the probe during ultrasound scanning procedures for both intact skin and compromised tissue. The cover allows use of the transducer in scanning and needle guided procedures for body surface, Endo cavity, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer.
Intraoperative Ultrasound Probe Cover can be used to minimize contamination between the patient and the probe during ultrasound scanning procedures for both intact skin and compromised tissue. The cover allows use of the transducer in scanning and needle quided procedures for body surface, endocavity, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer.
The probe cover is designed for use in both invasive and non-invasive procedures. It comes in a sterile form only. The sterile cover made used in invasive procedures where it will come into direct contact with compromised tissue. The probe cover may be used with any multiple different probes including, but not limited to, an Endoscope re-usable, any rectal, vaginal, trans-urethral, gastro-entero probes, or pulmonary probe, In-vitro Fertilization instruments, biopsy probes, fiberoptic probes, catheter probes, any probe that is used during a surgical procedure, re-usable vascular (visualization) probes, and re-usable central nervous system (CNS) or cerebral probes.
The provided text describes a 510(k) premarket notification for an "Intraoperative Ultrasound Probe Cover." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness through a comparative effectiveness study. Therefore, the device's acceptance criteria are primarily related to its physical properties, sterility, and performance characteristics consistent with its intended use as a protective barrier, rather than diagnostic accuracy or direct patient outcomes. The study mentioned is a non-clinical performance testing study.
Here's a breakdown of the information requested based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Property | Reported Device Performance |
|---|---|---|
| Barrier Properties | Viral penetration | Met acceptance criteria |
| Water resistance/hydrostatic pressure | Met acceptance criteria | |
| Water resistance/impact penetration | Met acceptance criteria | |
| Synthetic blood penetration | Met acceptance criteria | |
| Material Properties | Tensile strength | Met acceptance criteria |
| Elongation | Met acceptance criteria | |
| Linting | Met acceptance criteria | |
| Sterility | Sterility (via EO Gas, ISO 11135-1:2014) | Met acceptance criteria (SAL 10-6) |
| Ethylene oxide residuals | Met acceptance criteria | |
| Bacterial endotoxins | Met acceptance criteria | |
| Biocompatibility | Biocompatibility | Met acceptance criteria |
| Acoustics | Acoustics performance | Met acceptance criteria |
| Packaging & Shelf Life | Packaging | Testing completed (results applicable from predicate) |
| Shelf life | Testing completed (results applicable from predicate) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes for each non-clinical test conducted. It generally states that "Non-clinical performance testing was conducted." The provenance of the data (country of origin, retrospective/prospective) is also not specified, beyond being part of the 510(k) submission from "Exact Medical Manufacturing" in Lancaster, NY.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of non-clinical performance testing for a medical device cover. The "ground truth" for these tests would be established by standardized testing methods and their associated industry-recognized specifications (e.g., ISO standards for sterility, ASTM standards for material properties), not by expert human interpretation of diagnostic images or clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or adjudication. The results are based on objective physical, chemical, and microbiological testing methods.
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
No, an MRMC comparative effectiveness study was not done. This device is an "Intraoperative Ultrasound Probe Cover," a physical barrier, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This device is not an algorithm or software; it is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests were the established acceptance criteria for each specific test method, derived from recognized industry standards (e.g., ISO for sterility, unspecified standards for material properties, viral penetration, etc.). These criteria define what constitutes an acceptable performance level for the device's physical and barrier properties.
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.
{0}------------------------------------------------
May 12, 2023
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Exact Medical Manufacturing % Madison Wheeler Director of Technical Operations EMMA International Consulting Group 30150 Telegraph Rd.. Suite 120 BINGHAM FARMS MI 48025
Re: K222460
Trade/Device Name: Intraoperative Ultrasound Probe Cover Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: Class II Product Code: ITX Dated: August 5, 2022 Received: April 10, 2023
Dear Madison Wheeler:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
{1}------------------------------------------------
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K222460
Device Name Intraoperative Ultrasound Probe Cover
Indications for Use (Describe)
Intraoperative Ultrasound Probe Cover can be used to minimize contamination between the probe during ultrasound scanning procedures for both intact skin and compromised tissue. The cover allows use of the transducer in scanning and needle guided procedures for body surface, Endo cavity, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) SUMMARY - Traditional 510(k)
A summary of information in accordance with requirements of 21 CFR 807.92.
SUBMITTER'S INFORMATION
| Sponsor: | Exact Medical Manufacturing |
|---|---|
| Address: | 4917 William St #BLancaster, NY 14086 |
| Official Correspondent: | Ryan Power, Vice PresidentExact Medical ManufacturingKpower@exactmm.com716-681-0076 |
| Contact Person: | Madison GreenEMMA International Consulting Group, Inc.248-987-4497Madison.green@emmainternational.com |
Date Summary Prepared: April 01, 2023
DEVICE INFORMATION
Name of Device: Intraoperative Ultrasound Probe Cover Common Name: Invasive Probe Cover Classification Name: 892.1570 Diagnostic Ultrasonic Transducer Product Code: ITX Device Classification: Class II
Predicate Device
The proposed Invasive Prove Cover is substantially equivalent to the following predicate device:
| Predicate Device | Manufacturer |
|---|---|
| Non-Pyrogenic CIV Flex – Non-PyrogenicUltrasound Transducer Cover | CIVCO Medical Instruments Co., Inc |
| K131528 |
Device Description:
Intraoperative Ultrasound Probe Cover can be used to minimize contamination between the patient and the probe during ultrasound scanning procedures for both intact skin and compromised tissue. The cover allows use of the transducer in scanning and needle quided procedures for body surface, endocavity, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer.
The probe cover is designed for use in both invasive and non-invasive procedures. It comes in a sterile form only. The sterile cover made used in invasive procedures where it will come into direct contact with compromised tissue. The probe cover may be used with any multiple
{4}------------------------------------------------
different probes including, but not limited to, an Endoscope re-usable, any rectal, vaginal, trans-urethral, gastro-entero probes, or pulmonary probe, In-vitro Fertilization instruments, biopsy probes, fiberoptic probes, catheter probes, any probe that is used during a surgical procedure, re-usable vascular (visualization) probes, and re-usable central nervous system (CNS) or cerebral probes.
Indications for Use:
Intraoperative Ultrasound Probe Cover can be used to minimize contamination between the patient and the probe during ultrasound scanning procedures for both intact skin and compromised tissue. The cover allows use of the transducer in scanning and needle guided procedures for body surface, Endo cavity, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer.
Technoloqical Characteristics:
No technological characteristics have changed between the proposed device and predicate devices. Both the predicates and the proposed device are comprised of equivalent materials.
Comparison to Predicate Devices:
Intraoperative Ultrasound Probe Cover has the equivalent intended uses and is subject to the same regulation as the CIVCO Medical Instruments Non-Pyrogenic CIV Flex (K131528):
| Description | Intraoperative Ultrasound ProbeCover | PREDICATE DEVICE CIVCO MedicalInstruments - Non-Pyrogenic CIV-Flex |
|---|---|---|
| Indications forUse | Intraoperative Ultrasound Probe Covercan be used to minimize contaminationbetween the patient and the probe duringultrasound scanning procedures for bothintact skin and compromised tissue. Thecover allows use of the transducer inscanning and needle guided proceduresfor body surface, Endo cavity, and intra-operative diagnostic ultrasound, whilehelping to prevent transfer ofmicroorganisms, body fluids, andparticulate material to the patient andhealthcare worker during reuse of thetransducer. | Protective cover or sheath placed overdiagnostic ultrasound transducer / probe /scan head instruments. The cover allows useof the transducer in scanning and needleguided procedures for body surface,endocavity, central nervous system, andintra-operative diagnostic ultrasound, whilehelping to prevent transfer ofmicroorganisms, body fluids, and particulatematerial to the patient and healthcare workerduring reuse of the transducer. The coveralso provides a means for maintenance of asterile field. The cover is single use patient /procedure, non-pyrogenic, and disposable. |
| Classificationand Code | Polyurethane Probe Cover ITX,21CFR892.1570, Class II | Non-Pyrogenic CIV Flex ITX,21CFR892.1570 |
| Material ofConstruction | POLYMER, Polyurethane, tubular, sealed | Polyurethane (CIV-Flex TM) andpolyethylene |
| Sterile (via EOGas) | ISO 11135-1:2014, Sterilization of healthcare products - Ethylene oxide - Part 1.SAL 10-6 | EtO method. SAL 10-6. Non-pyrogenic.Endotoxin Method: LAL Kinetic Method(Chromogenic). Endotoxin ReleaseSpecification: 2.15 EU/device. |
{5}------------------------------------------------
| USE | Disposable, Single Use Only | Single use, non-pyrogenic, and disposable |
|---|---|---|
| ----- | ----------------------------- | ------------------------------------------- |
Non-Clinical Testing:
The Intraoperative Ultrasound Probe Cover is substantially equivalent and meets the same acceptance criteria as the predicate device as in K131528. Non-clinical performance testing was conducted for the following barrier properties, tensile, elongation, linting, sterility, biocompatibility, acoustics performance, ethylene oxide residuals, bacterial endotoxins, viral penetration, water resistance/hydrostatic pressure, water resistance/impact penetration, and synthetic blood penetration. All results of the testing met acceptance criteria. Sterility, packaging, shelf life, biocompatibility, and performance testing completed on the predicate devices remains applicable for the proposed device and this testing is summarized in the submission.
Conclusions:
This premarket submission for the Intraoperative Ultrasound Probe Cover has demonstrated substantial equivalence to the CIVCO Medical Instruments Non-Pyrogenic CIV Flex as defined and understood in the Federal Food, Drug and Cosmetic act and various guidance documents issued by the Center for Devices and Radiological Health. Based on comparison against predicate devices and endotoxin testing, the Intraoperative Ultrasound Probe Cover is safe and effective for its intended use.
§ 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.