Who is the manufacturer of EMM Ultrasonic Transducer Cover?

Exact Medical Manufacturing submitted the Traditional clearance for EMM Ultrasonic Transducer Cover (K211969).

What is the FDA product code for EMM Ultrasonic Transducer Cover?

ITX. It is classified under 21 CFR 892.1570 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for EMM Ultrasonic Transducer Cover?

510(k) clearance (submission type: Traditional).

EMM Ultrasonic Transducer Cover

Q: What are the predicate devices for EMM Ultrasonic Transducer Cover?

MedXPress Pro, EZ-Cover (K191491).

K211969 · Exact Medical Manufacturing · ITX · Aug 13, 2021 · Radiology

Device Facts

Record ID	K211969
Device Name	EMM Ultrasonic Transducer Cover
Applicant	Exact Medical Manufacturing
Product Code	ITX · Radiology
Decision Date	Aug 13, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1570
Device Class	Class 2
Attributes	3rd-Party Reviewed

Intended Use

Exact Medical Manufacturing Ultrasonic Transducer Cover can be used to minimize contamination between patient and ultrasound probe during ultrasound scanning procedures for external intact skin. This may help with easier cleaning and disinfection of the probe. This product is not intended for use of probes with endocavity or intraoperative use. The Exact Medical Manufacturing Ultrasonic Transducer Cover are also sold as bulk non-sterile, single use items, to repackager/ relabeler establishments for further packaging and ethylene oxide sterilization.

Device Story

Device is a 0.05mm thin, 50 GSM, translucent polyurethane film tube (nominally 48" x 6") with a heat-sealed distal end. Applied over ultrasound transducer probes to minimize patient-to-probe contamination during external scanning; facilitates probe cleaning/disinfection. Used in clinical settings by healthcare professionals. Device is single-use; provided either sterile or as bulk non-sterile items for further packaging/sterilization by third parties. Output is a physical barrier; does not affect ultrasound image quality or signal transmission. Benefits include reduced cross-contamination risk and simplified probe maintenance.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via AAMI PB70 Level 3 barrier testing, ISO 527-3 tensile/elongation testing, ISO 10993-5 cytotoxicity, ISO 10993-10 sensitization/irritation, NEMA UD 2-2004 acoustic output, and ISO 10993-7 ethylene oxide residuals.

Technological Characteristics

Material: Polyurethane film (50 GSM). Form factor: Tubular, heat-sealed distal end. Energy source: None (passive barrier). Sterilization: Ethylene oxide (ISO 11135-1). Connectivity: None. Software: None.

Indications for Use

Indicated for use as a protective barrier to minimize contamination between patient and ultrasound probe during ultrasound scanning procedures on external intact skin. Not indicated for endocavity or intraoperative use.

Regulatory Classification

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.

Predicate Devices

MedXPress Pro, EZ-Cover (K191491)

Reference Devices

Konix Sterile Gel (K130581)

Related Devices

K970513 — GENERAL PURPOSE TRANDUCER COVER · CIVCO Medical Instruments Co., Inc. · Jun 20, 1997
K221278 — Transducer Probe Cover · Hony Medical Co., Ltd. · Jan 11, 2023
K241615 — Transducer Probe Cover · Hony Medical Co., Ltd. · Jul 3, 2024
K981069 — ULTRA-COVER PU-TRANSDUCER COVER · International Medical Products B.V. · Sep 23, 1998
K222460 — Intraoperative Ultrasound Probe Cover · Exact Medical Manufacturing · May 12, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in blue, and the full name of the agency, "U.S. Food & Drug Administration," is in a smaller font size below the acronym. Exact Medical Manufacturing % Abdel Halim, PharmD, MSc, PhD, DABCC President, Global Quality and Regulatory Services Global Quality and Regulatory Services 10 Scenic Way MONROE, NEW JERSEY 08831 August 13, 2021 Re: K211969 Trade/Device Name: EMM Ultrasonic Transducer Cover Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: Class II Product Code: ITX Dated: August 10, 2021 Received: August 12, 2021 Dear Dr. Halim: 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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 (QS) 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 medical devices and radiation-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, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K211969 Device Name EMM Ultrasonic Transducer Cover #### Indications for Use (Describe) Exact Medical Manufacturing Ultrasonic Transducer Cover can be used to minimize contamination between patient and ultrasound probe during ultrasound scanning procedures for external intact skin. This may help with easier cleaning and disinfection of the probe. This product is not intended for use of probes with endocavity or intraoperative use. The Exact Medical Manufacturing Ultrasonic Transducer Cover are also sold as bulk non-sterile, single use items, to repackager/ relabeler establishments for further packaging and ethylene oxide sterilization. | 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 for Exact Medical Manufacturing Inc., EMM Ultrasonic Transducer Cover | Date Summary was Prepared | March 31, 2021 | |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Submitter | Ryan Power, Vice President Exact Medical Manufacturing Inc. 4917 William Street, Suite C Lancaster, NY 14086 kpower@exactmm.com (p)716-681-0866, (f) 716-681-4110 | | Primary Contact for this 510(k) Submission | Ryan Power, Vice President Exact Medical Manufacturing Inc. 4917 William Street, Suite C Lancaster, NY 14086 kpower@exactmm.com (p)716-681-0866, (f) 716-681-4110 | | Device Common Name | Cover, Ultrasonic Transducer Cover | | Trade Name | Cover, Disposable, | | Device Product Codes and Classification Name | Diagnostic ultrasonic transducer ITX, 21CFR892.1570, Class II | | Predicate Device | MedXPress Pro, EZ-Cover K 191491 | | Device Description | A 0.05mm thin, 50 GSM (Grams per Square Meter), translucent high strength polyurethane film tube shape, nominally 48" x 6" with heat sealed distal end to be applied over a transducer probe to provide a Transducer Cover that can be used to minimize contamination between patient and ultrasound probe during ultrasound scanning procedures for external intact skin. This may help with easier cleaning and disinfection of the probe. This product is not intended for use of probes with endocavity or intraoperative use. The Exact Medical Manufacturing Ultrasonic Transducer Cover are also sold as bulk non-sterile, single use items, to repackager/relabeler/kit packers establishments for further packaging and ethylene oxide sterilization. | | Indications for Use | Exact Medical Manufacturing Ultrasonic Transducer Cover can be used to minimize contamination between patient and ultrasound probe during ultrasound scanning procedures for external intact skin. This may help with easier cleaning and disinfection of the probe. This product is not intended for use of probes with endocavity or intraoperative use. The Exact Medical Manufacturing Ultrasonic Transducer Cover are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization. | | Technological Characteristics | Exact Medical Ultrasonic Transducer Cover has the same design, material, and performance characteristics of the predicate device. | | Summary of Non-Clinical Testing | Exact Medical Ultrasonic Transducer Cover is substantially equivalent and meets the same acceptance criteria as the predicate device as in K191491. Non-clinical performance testing includes; - barrier properties- AAMI PB70, Level 3, - tensile - elongation - flammability - linting, - sterility - biocompatibility - acoustics performance. - ethylene oxide residuals All results of the testing met acceptance criteria. See following (below) Summary Tables. | | Clinical Testing | None, not applicable | | Substantial Equivalence Conclusion | The transducer cover described in this 510(k) submission are substantially equivalent in all specifications and performance compared to the predicate device identified in K191491 except for minor variations in the widths and lengths. There are no significant differences among the submission device and the predicate device which present concerns concerning safety and effectiveness. | {4}------------------------------------------------ ### Bench Testing Summary | Test Performed & Description of test | Device Description / Sample Size | Reference Standard | FDA Recognition number or Not Recognized (NR) | Acceptance Criteria | Unexpected Results/ Significant Deviations | Result Summary | Conclusion | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Water Resistance: Impact Penetration Test, Level 3 | Final Finished Device (both heat seal and TPU film). Worst case, largest size in the submission. Sample Size N= 32 with C=0 AAMI PB70 Sample Size AQL of 4 %/RQL of 20 %. Test sample exceeds the reference standard requirements (N=32, C=3) | AATCC 42:2017 (AAMI PB70:2003 /(R)2009) | NR | blotter weight gain of no more than 1.0 g | None | Accept 32 samples =/< 1.0g (all samples = 0.0 g) | Ability of a protective product to resist the penetration of liquids and liquid borne Microorganisms accordingly to AAMI PB70, Level 3 Substantially equivalent barrier property compared to the predicate device | | | Test Method for Water Resistance: Hydrostatic Pressure Level 3 | Final Finished Device (both heat seal and TPU film). Worst case, largest size in the submission. Sample Size N= 32 with C=0 AAMI PB70 Sample Size AQL of 4 %/RQL of 20 %. Test sample exceeds the reference standard requirements (N=32, C=3) | AATCC 127:2017 (2018)e (AAMI PB70:2003 /(R)2009) | NR | hydrostatic resistance of at least 50 cm | None | Accept 32 samples > 50cm (all samples =/> 180cm) | Ability of a protective product to resist the penetration of liquids and liquid borne Microorganisms accordingly to AAMI PB70, Level 3 Substantially equivalent barrier property compared to the predicate device | | | Flammability of Clothing Textiles | Polyurethane Film Sample Size per 16CFR1610, 5 replicates are to be tested if no flame spread is observed upon preliminary testing. Material evaluation only for flammability, not relevant to device configuration. | 16CFR1610 | NR | Burn Time >/= 3.5 seconds | None | Accept 5 samples DNI (Did Not Ignite) | Able to meet and claim flammability Class 1 rating in accordance with 16CFR1610 Exceeds predicate device based upon predicate device has not been tested for this attribute. | | | Determination of tensile properties — Part 3: Test conditions for films and sheets (Tensile and Elongation) | Polyurethane Film Material evaluation only, not relevant to device configuration. Sample size per statistical sampling plan ISO2859- 1, based upon lot population quantity | ISO 527-3 | NR | Tensile strength minimum 40N in machine direction Tensile strength minimum 34N in cross direction Elongation 108 % minimum in machine direction Elongation 119% minimum in cross direction | None | Accept All samples must pass acceptance criteria in accordance with statistical sampling plan per ISO2859-1, otherwise, material is rejected (not used in production) | Specification confirmation of tensile and elongation properties of plastic films or sheets less than 1 mm thick to assure compliant device barrier performance. Substantially equivalent tensile and elongation property compared to material specification | | | Lint and other particles generation in the dry state | Polyurethane film Material evaluation only, not relevant to device configuration. Sample size = 10 Standard indicates 5 samples | ISO 9073-10 | NR | IPM =/< 3.5 (Index for Particle Matter) | None | Accept IPM 1.3 (outside) IPM 0.72 (inside) | Material does not significantly generate lint or particles that may shed during an ultrasonic scan procedure. Exceeds predicate device based upon predicate device has not | | | Acoustic Output Measurement Standard for Diagnostic Ultrasound | Final Finished Device Worst case test configuration on distal sealed end where ultrasonic probe is positioned. Polyurethane 50gsm tested. | NEMA UD 2- 2004 (R2009) | 12-105 | negligible effect on the transmission of ultrasound signal and does not degrade signal or image | None | Accept Speed of sound = 1698 m/sec Acoustic Attenuation = 0.51 dB | been tested for this attribute. Based on the acoustic testing results it was concluded that EMM's transducer/probe cover has negligible effect on the transmission of ultrasound signal and that EMM's transducer/probe | | | Equipment, Revision 3 | Sample size 3 ea. Speed of Sound 3 ea. Acoustic Attenuation 3 ea. Acoustic Impedance | | | | | | Acoustic Impedance = 1.63 MRayl | cover does not degrade signal or image. Exceeds predicate device based upon predicate device has not been tested for this attribute. | | Standard Practices for Evaluating the Resistance of Plastics to Chemical Reagents. Compatibility of ultrasonic coupling gel with polyurethane | Polyurethane Probe Cover Samples Sample Size N=45 Tested by Manufacturer of coupling gel, FDA 510K cleared K130581. This element is not an Exact Medical Manufacturing product. Bench Testing is provided to confirm compatibility with polyurethane film | ASTM D543- 20 | NR | Evaluated for Color, Dimension, Weight, Coordinates, Mechanical Properties. Acceptance Criteria Not Defined | None | Accept Color N=9, Pass, Dimension N=9 Pass, Weight N=9 Pass, Coordinates N=9 Pass, Mechanical Properties N=9 Pass | Confirmation that device polyurethane material is not negatively affected by the acoustic coupling gel during an ultrasonic scanning procedure. Exceeds predicate device based upon predicate device does not provide compatibility evaluation of acoustic coupling gel with their device. | | | Ethylene Oxide Residuals | Polyurethane film Worst case, Run the sterilization cycle at the cycle parameters which provide for the highest EO exposure, i.e. high gas induction time and pressure (most pounds of EO), highest length of EO dwell time, least time for post cycle vacuums, lowest amount of aeration time within aeration chamber. Sample Size per sterilization batch N=15 X 3 consecutive sterilization batches = 45 samples | ISO 10993- 7:2008, | 14-408 | tolerable contact limit (TCL) as expressed in units of micrograms per square centimeter for EO at 10ug/cm2 and milligrams per square centimeters for ECH at 5mg/cm2 | None | Accept Actual results for EO Residuals at Time 0 hours = 8.67ug/cm2. Actual results for ECH residuals at Time 0 hours = Not detected (within the limits of detection of 3.7ug/g). | Confirmation of maximum allowable residues for ethylene oxide (EO) within the submission device sterilized with EO and to ensure that the levels of residual EO, ethylene chlorohydrin (ECH) and ethylene glycol (EG) pose a minimal risk to the patient in normal product use. Substantially equivalent to predicate device based upon acceptable testing results that comply with testing standard. | | | In Vitro Cytotoxicity Test | The test article. Probe Cover polyurethane, EO Exposed, was evaluated to determine the biological reactivity of a mammalian cell culture (mouse fibroblast L929 cells) in response to the test article. Sample Size = 4 test article extracts | ISO 10993- 5;2009 | 2-245 | The lower the Viab.% value, the higher the cytotoxic potential of the test article is. If viability is reduced <70% of the blank, it has cytotoxic potential. The Viab.% of 100% extract of the test article is the final result | None | 100% Test article extract 76.5% viability. No Test article extracts are <70% viability. | Testing Conducted on final sterilized device. Study conclusion, "Under the conditions of this study, the test article extract did not show potential toxicity to L929 cells | | | Test protocol description. | Results Summary | Analysis | Conclusion | Objective of test | Test Article | Test method and procedure | Study endpoint | pre-defined acceptance or pass/fail criteria | | ISO 10993- 10:2010:2010 Closed patch Sensitization Study in Guinea Pigs | No skin sensitization reaction was found in the Guinea pigs using extracts of the test article (0.9% sodium chloride, sesame oil). The positive rate of sensitization was 0%. | Dermal Reactions Challenge 24 Hour Score Ten test Guinea pigs, 0 (zero) reactions 48 Hour Score Ten test Guinea pigs, 0 (zero) reactions | Under the conditions of the study, the test article extracts showed no significant evidence of causing skin sensitization in the Guinea pigs. | The purpose of this study was to evaluate the potential of the test article to cause dermal contact sensitization following repeated occlusive patching in the guinea pig. | Probe cover Polyurethane | This study was conducted to evaluate skin sensitization using Guinea pig maximization test based on the ISO 10993- 10:2010:2010, Biological evaluation of medical devices. Part 10: Tests for irritation and skin sensitization. | The test article. Probe Cover polyurethane, EO Exposed, was evaluated for the, was evaluated for the potential skin sensitization in the Guinea pig. | No significant evidence of causing skin sensitization in the guinea pig. Applying grading scales as follows, No visible change = 0 Discrete or patchy erythema = 1 Moderate and confluent erythema =2 Intense erythema and swelling = 3 Substantially equivalent to the predicate device based upon meeting the acceptance criteria of the test standard to evaluate the potential of the test article to cause dermal contact sensitization following repeated occlusive patching in the guinea pig | | ISO 10993- 10:2010:2010 Intracutaneous Reactivity Test | All animals were survived and no abnormal signs were observed during the study. According to what observed | Summary Analysis Test Results of Dermal Observations in Test Article Extract SC 24 hr = 0 | The test result showed that the polar and non- polar extract of the final test sample score is less 1.0, the requirements of the test are met. | To evaluate the potential intracutaneous reactivity caused by intracutaneously inject the extract to rabbit and extrapolating the | Probe cover Polyurethane | To evaluate the potential intracutaneous reactivity caused by intracutaneously inject the extract to rabbit in accordance with Reactivity Test | The test article. Probe Cover polyurethane, EO Exposed, was evaluated for the Intracutaneous Reactivity Test | The requirements of the test are met if the final test article score is 1.0 or less. Substantially equivalent to | {5}------------------------------------------------ {6}------------------------------------------------ # Performance Testing – Animal Summary Table: {7}------------------------------------------------ | the skin reaction of polar and non- polar extract on testing side did not exceed that on the control side. Thus, the final test article score was calculated to be 0. See table 3. | 48 hr = 0 72 hr = 0 Extract SO 24 hr = 0 48 hr = 0 72 hr = 0 | results to humans, but it does not establish the actual risk of irritation. | ISO I 0993- 10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. | in New Zealand white rabbits. | the predicate device based upon meeting the acceptance criteria of the test standard to evaluate the potential intracutaneous reactivity | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------| |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------| {8}------------------------------------------------ # 510K Summary: Submission Device to Predicate Device Comparison | Exact Medical Manufacturing - Transducer Cover | Substantially Equivalent | MedXPress.Pro EZ-Cover K191491 PREDICATE DEVICE | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use: Exact Medical Ultrasonic Transducer Cover can be used to minimize contamination between patient and ultrasound probe during ultrasound scanning procedures for external intact skin. This may help with easier cleaning and disinfection of the probe. This product is not intended for use of probes with endocavity or intraoperative use. The Exact Medical Manufacturing Ultrasonic Transducer Cover are also sold as bulk non- sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization. | Substantially Equivalent | Indications for Use: Probe cover can be used to minimize contamination between patient and ultrasound probe during ultrasound scanning procedures for external intact skin. This may help with easier cleaning and disinfection of the probe. This product is not intended for use of probes with endocavity or intraoperative use. | | Classification & Code Classification & Code Diagnostic ultrasonic transducer ITX, 21CFR892.1570, Class II | Substantially Equivalent | Classification & Code Diagnostic ultrasonic transducer ITX, 21CFR892.1570, Class II | | Barrier properties - AATCC 42:2007, AATCC 127:2008: Liquid Barrier Performance and Classification of Protective Apparel and Drapes intended for Use in Health Care Facilities, AAMI PB70:2003 /(R)2009, Level 3, AATCC 42 ≤ 1.0 g, AATCC 127 ≥ 50 cm | Substantially Equivalent | Water Resistance Polyethylene film can withstand xx hydrostatic pressure time should not be less than XX. Standards not indicated | | Materials & Construction: POLYMER, Polyurethane, tubular, sealed | Substantially Equivalent | Materials & Construction: POLYMER, Polyethylene, tubular, sealed | | Sterile (via EO Gas) ISO 11135-1:2014, Sterilization of health care products - Ethylene oxide - Part 1. SAL 10-6 | Substantially Equivalent | Sterilization Validation (Re-validation of Report of Ethylene Oxide Sterilizer Performance) | | Sterile Barrier Packaging: Chevron peel pouch (coated paper (73gsm), PET12/PE40 film construction), individual internal wrap. | Substantially Equivalent | Aseptic packaging seal test | | Disposable, Single Use Only | Substantially Equivalent | Disposable, Single Use Only | | Non-Sterile, Bulk Pack | | Not offered | | Tensile strength Machine Direction / Cross Direction - ISO 527- 3 Plastics - Determination of tensile properties - Part 3: Test conditions for films and sheets Machine Direction / Cross Direction: 40N per 2.5cm / 34N per 2.5cm | Substantially Equivalent | The maximum tensile strength of polyethylene film for manufacture protective sleeve should be no less than XX, and the maximum tensile force of traverse fracture is no more than XX Test Standard not Indicated | | Elongation - - ISO 527- 3 Plastics - Determination of tensile properties - Part 3: Test conditions for films and sheets Machine Direction / Cross Direction: 108% / 119%…