(50 days)
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.
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.
The provided text describes the acceptance criteria and performance of the EMM Ultrasonic Transducer Cover, which is a medical device.
1. A table of acceptance criteria and the reported device performance:
| Test Performed & Description of test | Acceptance Criteria | Reported Device Performance / Result Summary | Conclusion |
|---|---|---|---|
| Water Resistance: Impact Penetration Test, Level 3 | Blotter weight gain of no more than 1.0 g | 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 according to AAMI PB70, Level 3. Substantially equivalent barrier property compared to the predicate device. |
| Water Resistance: Hydrostatic Pressure Level 3 | Hydrostatic resistance of at least 50 cm | Accept, 32 samples > 50cm (all samples ≥ 180cm) | Ability of a protective product to resist the penetration of liquids and liquid-borne microorganisms according to AAMI PB70, Level 3. Substantially equivalent barrier property compared to the predicate device. |
| Flammability of Clothing Textiles (16CFR1610) | Burn Time ≥ 3.5 seconds | 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. |
| Tensile properties — Part 3: Test conditions for films and sheets (ISO 527-3) | Tensile strength minimum 40N in machine direction, minimum 34N in cross direction. Elongation 108 % minimum in machine direction, 119% minimum in cross direction. | Accept, all samples passed acceptance criteria in accordance with statistical sampling plan per ISO2859-1 (otherwise, material is rejected). | 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 (ISO 9073-10) | IPM =/≤ 3.5 (Index for Particle Matter) | 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 been tested for this attribute. |
| Acoustic Output Measurement Standard for Diagnostic Ultrasound (NEMA UD 2-2004) | Negligible effect on the transmission of ultrasound signal and does not degrade signal or image. | Accept, Speed of sound = 1698 m/sec, Acoustic Attenuation = 0.51 dB, Acoustic Impedance = 1.63 MRayl. | 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 cover does not degrade signal or image. Exceeds predicate device based upon predicate device has not been tested for this attribute. |
| Compatibility of ultrasonic coupling gel with polyurethane (ASTM D543-20) | (Acceptance Criteria Not Defined) | 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 (ISO 10993-7:2008) | Tolerable contact limit (TCL) for EO at 10ug/cm2 and ECH at 5mg/cm2 | 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 (ISO 10993-5;2009) | Viability is reduced <70% of the blank indicates cytotoxic potential. The Viab.% of 100% extract of the test article is the final result. | 100% Test article extract 76.5% viability. No Test article extracts are <70% viability. | Study conclusion, "Under the conditions of this study, the test article extract did not show potential toxicity to L929 cells." |
| Closed patch Sensitization Study in Guinea Pigs (ISO 10993-10:2010) | No significant evidence of causing skin sensitization in the guinea pig. | No skin sensitization reaction was found in the Guinea pigs using extracts of the test article. 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. Substantially equivalent to the predicate device. |
| Intracutaneous Reactivity Test (ISO 10993-10:2010) | The requirements of the test are met if the final test article score is 1.0 or less. | All animals survived and no abnormal signs were observed. The skin reaction of polar and non-polar extract on testing side did not exceed that on the control side. Final test article score was calculated to be 0. Summary Analysis Test Results of Dermal Observations in Test Article Extract SC 24 hr = 0, 48 hr = 0, 72 hr = 0. Extract SO 24 hr = 0, 48 hr = 0, 72 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. Substantially equivalent to the predicate device. |
2. Sample sized used for the test set and the data provenance:
- Water Resistance (Impact Penetration & Hydrostatic Pressure): N=32 for each test, with C=0 (meaning zero failures allowed). The sample size exceeds the reference standard requirements (N=32, C=3 for AAMI PB70 AQL of 4%/RQL of 20%). The provenance is a laboratory test of the Final Finished Device (both heat seal and TPU film).
- Flammability: 5 replicates (Polyurethane Film). The provenance is a laboratory test of the material.
- Tensile and Elongation: Sample size per statistical sampling plan ISO2859-1, based upon lot population quantity (Polyurethane Film). The provenance is a laboratory test of the material.
- Linting: N=10 (Polyurethane film). The provenance is a laboratory test of the material.
- Acoustic Output: 3 samples for Speed of Sound, 3 samples for Acoustic Attenuation, 3 samples for Acoustic Impedance (Final Finished Device). The provenance is a laboratory test of the device.
- Compatibility with Coupling Gel: N=45 (Polyurethane Probe Cover Samples). Tested by the manufacturer of the coupling gel. This is a laboratory test.
- Ethylene Oxide Residuals: N=15 X 3 consecutive sterilization batches = 45 samples (Polyurethane film). The provenance is a laboratory test on sterilized material.
- In Vitro Cytotoxicity Test: N=4 test article extracts (Probe Cover polyurethane, EO Exposed). The provenance is a laboratory test.
- Closed patch Sensitization Study in Guinea Pigs: Ten test Guinea pigs. The provenance is a biological study (animal study).
- Intracutaneous Reactivity Test: Not explicitly stated, but implies multiple animals (rabbits) based on the "all animals survived" phrase. The provenance is a biological study (animal study).
The data provenance is from bench testing and biological studies (animal studies) performed as part of the device submission. There is no indication of country of origin of the data beyond being part of a US FDA submission, nor is there information on whether the studies were retrospective or prospective, though bench and animal studies are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This device is not an AI/ML device that requires human expert interpretation to establish a ground truth. The ground truth for this device is based on objective measurements against established industry standards and biological endpoints. Therefore, no human experts were used to establish a ground truth in the context of diagnostic interpretation.
4. Adjudication method for the test set:
Not applicable. This device does not involve human interpretation or subjective assessments that would require an adjudication method like 2+1 or 3+1. The tests are objective and quantitative.
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:
Not applicable. This is not an AI-assisted diagnostic device, so no MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used:
The ground truth used for the various tests includes:
- Objective measurement against established standards: E.g., blotter weight gain for water resistance, burn time for flammability, tensile strength values for mechanical properties, IPM for linting, speed of sound and acoustic attenuation for acoustic performance, and residual limits for EO residuals.
- Biological endpoints: For biocompatibility tests (cytotoxicity, sensitization, intracutaneous reactivity), the ground truth is based on the observed biological response (e.g., cell viability, skin reactions) against defined criteria.
8. The sample size for the training set:
Not applicable. This device does not involve an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.
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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
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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
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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) |
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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 PresidentExact Medical Manufacturing Inc.4917 William Street, Suite CLancaster, NY 14086kpower@exactmm.com(p)716-681-0866, (f) 716-681-4110 |
| Primary Contact for this 510(k) Submission | Ryan Power, Vice PresidentExact Medical Manufacturing Inc.4917 William Street, Suite CLancaster, NY 14086kpower@exactmm.com(p)716-681-0866, (f) 716-681-4110 |
| Device Common Name | Cover, Ultrasonic Transducer Cover |
| Trade Name | Cover, Disposable, |
| Device Product Codes andClassification 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 strengthpolyurethane film tube shape, nominally 48" x 6" with heat sealed distal end to beapplied over a transducer probe to provide a Transducer Cover that can be used tominimize contamination between patient and ultrasound probe during ultrasoundscanning procedures for external intact skin. This may help with easier cleaningand disinfection of the probe. This product is not intended for use of probes withendocavity or intraoperative use. The Exact Medical Manufacturing UltrasonicTransducer Cover are also sold as bulk non-sterile, single use items, torepackager/relabeler/kit packers establishments for further packaging and ethyleneoxide sterilization. |
| Indications for Use | Exact Medical Manufacturing Ultrasonic Transducer Cover can be used tominimize contamination between patient and ultrasound probe during ultrasoundscanning procedures for external intact skin. This may help with easier cleaningand disinfection of the probe. This product is not intended for use of probes withendocavity or intraoperative use. The Exact Medical Manufacturing UltrasonicTransducer Cover are also sold as bulk non-sterile, single use items, torepackager/relabeler establishments for further packaging and ethylene oxidesterilization. |
| Technological Characteristics | Exact Medical Ultrasonic Transducer Cover has the same design, material, andperformance characteristics of the predicate device. |
| Summary of Non-Clinical Testing | Exact Medical Ultrasonic Transducer Cover is substantially equivalent and meetsthe same acceptance criteria as the predicate device as in K191491. Non-clinicalperformance testing includes;- barrier properties- AAMI PB70, Level 3,- tensile- elongation- flammability- linting,- sterility- biocompatibility- acoustics performance.- ethylene oxide residualsAll results of the testing met acceptance criteria. See following (below) SummaryTables. |
| Clinical Testing | None, not applicable |
| Substantial Equivalence Conclusion | The transducer cover described in this 510(k) submission are substantiallyequivalent in all specifications and performance compared to the predicate deviceidentified in K191491 except for minor variations in the widths and lengths. Thereare no significant differences among the submission device and the predicatedevice which present concerns concerning safety and effectiveness. |
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Bench Testing Summary
| Test Performed& Description oftest | Device Description / Sample Size | ReferenceStandard | FDARecognitionnumber or NotRecognized(NR) | AcceptanceCriteria | UnexpectedResults/SignificantDeviations | Result Summary | Conclusion | |
|---|---|---|---|---|---|---|---|---|
| Water Resistance:ImpactPenetration Test,Level 3 | Final Finished Device (both heat seal and TPUfilm). Worst case, largest size in the submission.Sample Size N= 32 with C=0AAMI PB70 Sample Size AQL of 4%/RQL of 20 %.Test sample exceeds the reference standardrequirements (N=32, C=3) | AATCC42:2017(AAMIPB70:2003/(R)2009) | NR | blotter weight gain ofno more than 1.0 g | None | Accept32 samples =/< 1.0g(all samples = 0.0 g) | Ability of a protective product toresist the penetration of liquidsand liquid borneMicroorganisms accordingly toAAMI PB70, Level 3Substantially equivalent barrierproperty compared to thepredicate device | |
| Test Method forWater Resistance:HydrostaticPressure Level 3 | Final Finished Device (both heat seal and TPUfilm). Worst case, largest size in the submission.Sample Size N= 32 with C=0AAMI PB70 Sample Size AQL of 4%/RQL of 20 %.Test sample exceeds the reference standardrequirements (N=32, C=3) | AATCC127:2017(2018)e(AAMIPB70:2003/(R)2009) | NR | hydrostaticresistance of at least50 cm | None | Accept32 samples > 50cm(all samples =/>180cm) | Ability of a protective product toresist the penetration of liquidsand liquid borneMicroorganisms accordingly toAAMI PB70, Level 3Substantially equivalent barrierproperty compared to thepredicate device | |
| Flammability ofClothing Textiles | Polyurethane FilmSample Size per 16CFR1610, 5 replicates are tobe tested if no flame spread is observed uponpreliminary testing.Material evaluation only for flammability, notrelevant to device configuration. | 16CFR1610 | NR | Burn Time >/= 3.5seconds | None | Accept5 samples DNI (DidNot Ignite) | Able to meet and claimflammability Class 1 rating inaccordance with 16CFR1610Exceeds predicate device basedupon predicate device has notbeen tested for this attribute. | |
| Determination oftensile properties— Part 3: Testconditions forfilms and sheets(Tensile andElongation) | Polyurethane FilmMaterial evaluation only, not relevant to deviceconfiguration.Sample size per statistical sampling plan ISO2859-1, based upon lot population quantity | ISO 527-3 | NR | Tensile strengthminimum 40N inmachine directionTensile strengthminimum 34N incross directionElongation 108 %minimum in machinedirectionElongation 119%minimum in crossdirection | None | AcceptAll samples mustpass acceptancecriteria inaccordance withstatistical samplingplan per ISO2859-1,otherwise, materialis rejected (not usedin production) | Specification confirmation oftensile and elongation propertiesof plastic films or sheets less than1 mm thick to assure compliantdevice barrier performance.Substantially equivalent tensileand elongation propertycompared to material specification | |
| Lint and otherparticlesgeneration in thedry state | Polyurethane filmMaterial evaluation only, not relevant to deviceconfiguration.Sample size = 10Standard indicates 5 samples | ISO 9073-10 | NR | IPM =/< 3.5(Index for ParticleMatter) | None | AcceptIPM 1.3 (outside)IPM 0.72 (inside) | Material does not significantlygenerate lint or particles that mayshed during an ultrasonic scanprocedure.Exceeds predicate device basedupon predicate device has not | |
| Acoustic OutputMeasurementStandard forDiagnosticUltrasound | Final Finished DeviceWorst case test configuration on distal sealed endwhere ultrasonic probe is positioned. Polyurethane50gsm tested. | NEMA UD 2-2004(R2009) | 12-105 | negligible effect onthe transmission ofultrasound signaland does notdegrade signal orimage | None | AcceptSpeed of sound =1698 m/secAcoustic Attenuation= 0.51 dB | been tested for this attribute.Based on the acoustic testingresults it was concluded thatEMM's transducer/probe coverhas negligible effect on thetransmission of ultrasound signaland that EMM's transducer/probe | |
| Equipment,Revision 3 | Sample size3 ea. Speed of Sound3 ea. Acoustic Attenuation3 ea. Acoustic Impedance | Acoustic Impedance= 1.63 MRayl | cover does not degrade signal orimage.Exceeds predicate device basedupon predicate device has notbeen tested for this attribute. | |||||
| StandardPractices forEvaluating theResistance ofPlastics toChemicalReagents.Compatibility ofultrasoniccoupling gel withpolyurethane | Polyurethane Probe Cover SamplesSample Size N=45Tested by Manufacturer of coupling gel, FDA 510Kcleared K130581. This element is not an ExactMedical Manufacturing product. Bench Testing isprovided to confirm compatibility with polyurethanefilm | ASTM D543-20 | NR | Evaluated for Color,Dimension, Weight,Coordinates,MechanicalProperties.Acceptance CriteriaNot Defined | None | AcceptColor N=9, Pass,Dimension N=9Pass, Weight N=9Pass, CoordinatesN=9 Pass,MechanicalProperties N=9 Pass | Confirmation that devicepolyurethane material is notnegatively affected by theacoustic coupling gel during anultrasonic scanning procedure.Exceeds predicate device basedupon predicate device does notprovide compatibility evaluation ofacoustic coupling gel with theirdevice. | |
| Ethylene OxideResiduals | Polyurethane filmWorst case, Run the sterilization cycle at the cycleparameters which provide for the highest EOexposure, i.e. high gas induction time and pressure(most pounds of EO), highest length of EO dwelltime, least time for post cycle vacuums, lowestamount of aeration time within aeration chamber.Sample Size per sterilization batch N=15 X 3consecutive sterilization batches = 45 samples | ISO 10993-7:2008, | 14-408 | tolerable contactlimit (TCL) asexpressed in units ofmicrograms persquare centimeterfor EO at 10ug/cm2andmilligrams persquare centimetersfor ECH at 5mg/cm2 | None | AcceptActual results for EOResiduals at Time 0hours = 8.67ug/cm2.Actual results forECH residuals atTime 0 hours = Notdetected (within thelimits of detection of3.7ug/g). | Confirmation of maximumallowable residues for ethyleneoxide (EO) within the submissiondevicesterilized with EO andto ensure that the levels ofresidual EO, ethylenechlorohydrin(ECH) and ethylene glycol (EG)pose a minimal risk to the patientin normal product use.Substantially equivalent topredicate device based uponacceptable testing results thatcomply with testing standard. | |
| In VitroCytotoxicity Test | The test article. Probe Cover polyurethane, EOExposed, was evaluated to determine the biologicalreactivity of a mammalian cell culture (mousefibroblast L929 cells) in response to the test article.Sample Size = 4 test article extracts | ISO 10993-5;2009 | 2-245 | The lower theViab.% value, thehigher the cytotoxicpotential of the testarticle is. If viability isreduced <70% of theblank, it hascytotoxic potential.The Viab.% of 100%extract of the testarticle is the finalresult | None | 100% Test articleextract 76.5%viability.No Test articleextracts are <70%viability. | Testing Conducted on finalsterilized device. Studyconclusion, "Under the conditionsof this study, the test articleextract did not show potentialtoxicity to L929 cells | |
| Test protocoldescription. | ResultsSummary | Analysis | Conclusion | Objective of test | Test Article | Test method andprocedure | Study endpoint | pre-definedacceptance orpass/fail criteria |
| ISO 10993-10:2010:2010Closed patchSensitizationStudy in GuineaPigs | No skinsensitizationreaction wasfound in theGuinea pigsusing extracts ofthe test article(0.9% sodiumchloride, sesameoil). The positiverate ofsensitization was0%. | Dermal ReactionsChallenge24 Hour ScoreTen test Guineapigs, 0 (zero)reactions48 Hour ScoreTen test Guineapigs, 0 (zero)reactions | Under the conditionsof the study, the testarticle extractsshowed nosignificant evidenceof causing skinsensitization in theGuinea pigs. | The purpose of thisstudy was toevaluate thepotential of the testarticle to causedermal contactsensitizationfollowing repeatedocclusive patchingin the guinea pig. | Probe coverPolyurethane | This study wasconducted toevaluate skinsensitizationusing Guinea pigmaximization testbased on the ISO10993-10:2010:2010,Biologicalevaluation ofmedical devices.Part 10: Tests forirritation and skinsensitization. | The test article.Probe Coverpolyurethane,EO Exposed,was evaluatedfor the, wasevaluated forthe potentialskinsensitization inthe Guinea pig. | No significantevidence ofcausing skinsensitization inthe guinea pig.Applying gradingscales asfollows,No visible change= 0Discrete or patchyerythema = 1Moderate andconfluenterythema =2Intense erythemaand swelling = 3Substantiallyequivalent to thepredicate devicebased uponmeeting theacceptancecriteria of the teststandard toevaluate thepotential of thetest article tocause dermalcontactsensitizationfollowing repeatedocclusivepatching in theguinea pig |
| ISO 10993-10:2010:2010IntracutaneousReactivity Test | All animalswere survivedand noabnormal signswere observedduring thestudy.According towhat observed | SummaryAnalysis TestResults ofDermalObservations inTest ArticleExtract SC24 hr = 0 | The test resultshowed that thepolar and non-polar extract of thefinal test samplescore is less 1.0,the requirementsof the test are met. | To evaluate thepotentialintracutaneousreactivity causedbyintracutaneouslyinject the extractto rabbit andextrapolating the | Probe coverPolyurethane | To evaluate thepotentialintracutaneousreactivitycaused byintracutaneouslyinject the extractto rabbit inaccordance withReactivity Test | The testarticle. ProbeCoverpolyurethane,EO Exposed,was evaluatedfor theIntracutaneousReactivity Test | Therequirements ofthe test are metif the final testarticle score is1.0 or less.Substantiallyequivalent to |
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Performance Testing – Animal Summary Table:
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| the skinreaction ofpolar and non-polar extract ontesting side didnot exceed thaton the controlside. Thus, thefinal test articlescore wascalculated to be0. See table 3. | 48 hr = 072 hr = 0Extract SO24 hr = 048 hr = 072 hr = 0 | results tohumans, but itdoes notestablish theactual risk ofirritation. | ISO I 0993-10:2010Biologicalevaluation ofmedical devices- Part 10: Testsfor irritation andskinsensitization. | in NewZealand whiterabbits. | the predicatedevice basedupon meetingthe acceptancecriteria of thetest standard toevaluate thepotentialintracutaneousreactivity |
|---|---|---|---|---|---|
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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510K Summary: Submission Device to Predicate Device Comparison
| Exact Medical Manufacturing -Transducer Cover | SubstantiallyEquivalent | MedXPress.Pro EZ-Cover K191491PREDICATE DEVICE |
|---|---|---|
| Indications for Use: Exact Medical Ultrasonic TransducerCover can be used to minimize contamination betweenpatient and ultrasound probe during ultrasound scanningprocedures for external intact skin. This may help witheasier cleaning and disinfection of the probe. This productis not intended for use of probes with endocavity orintraoperative use. The Exact Medical ManufacturingUltrasonic Transducer Cover are also sold as bulk non-sterile, single use items, to repackager/relabelerestablishments for further packaging and ethylene oxidesterilization. | SubstantiallyEquivalent | Indications for Use: Probe cover can be used tominimize contamination between patient andultrasound probe during ultrasound scanningprocedures for external intact skin. This may helpwith easier cleaning and disinfection of the probe.This product is not intended for use of probes withendocavity or intraoperative use. |
| Classification & Code Classification & Code Diagnosticultrasonic transducer ITX, 21CFR892.1570, Class II | SubstantiallyEquivalent | Classification & Code Diagnostic ultrasonictransducer ITX, 21CFR892.1570, Class II |
| Barrier properties - AATCC 42:2007, AATCC 127:2008:Liquid Barrier Performance and Classification of ProtectiveApparel and Drapes intended for Use in Health CareFacilities, AAMI PB70:2003 /(R)2009, Level 3, AATCC 42≤ 1.0 g, AATCC 127 ≥ 50 cm | SubstantiallyEquivalent | Water Resistance Polyethylene film can withstandxx hydrostatic pressure time should not be less thanXX.Standards not indicated |
| Materials & Construction: POLYMER, Polyurethane,tubular, sealed | SubstantiallyEquivalent | Materials & Construction: POLYMER, Polyethylene,tubular, sealed |
| Sterile (via EO Gas) ISO 11135-1:2014, Sterilization ofhealth care products - Ethylene oxide - Part 1. SAL 10-6 | SubstantiallyEquivalent | Sterilization Validation (Re-validation of Report ofEthylene Oxide Sterilizer Performance) |
| Sterile Barrier Packaging: Chevron peel pouch (coatedpaper (73gsm), PET12/PE40 film construction), individualinternal wrap. | SubstantiallyEquivalent | Aseptic packaging seal test |
| Disposable, Single Use Only | SubstantiallyEquivalent | 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 MachineDirection / Cross Direction: 40N per 2.5cm / 34N per2.5cm | SubstantiallyEquivalent | The maximum tensile strength of polyethylene filmfor manufacture protective sleeve should be no lessthan XX, and the maximum tensile force of traversefracture is no more than XXTest Standard not Indicated |
| Elongation - - ISO 527- 3 Plastics - Determination oftensile properties - Part 3: Test conditions for films andsheets Machine Direction / Cross Direction: 108% / 119% | SubstantiallyEquivalent | The rupture elongation of the film making theprotective sleeve should be no less than xx%Test Standard not Indicated |
| Cover Acoustic Test - NEMA UD 2-2004 (R2009)Acoustic Output Measurement Standard for DiagnosticUltrasound Equipment, Revision 3.Negligible effect on the transmission of ultrasound signal ,transducer/probe cover does not degrade signal or image. | Exceedspredicate | Not indicated |
| Acoustics Coupling Gel: FDA Cleared via K130581Reference Device: Exact Medical Manufacturing (EMM)intends to include a "sachet" of acoustic coupling gel. EMMdoes not perform any formulation, labeling or unitpackaging for this acoustic coupling gel. The acoustic | ExceedsPredicate | Not indicated |
| coupling gel is provided private labeled and ready to useby the manufacturer and 510k holder of the acousticcoupling gel. The rationale that justifies its use is basedupon the cleared 510K K130581Indications for Use for theacoustic coupling gel with EMM Ultrasonic TransducerCover (from K130581, “Indications for Use: As stated onLabel: Contact medium for ultrasonic and electricaltransmission gel.Konix Sterile Gel is sterilized by gamma irradiation andintended for use in all diagnostic ultrasound proceduresthat currently use an ultrasound coupling gel or other fluid,alone or in combination with a transducer cover , wheresterility and in vivo biocompatibility are required. It can beused on the skin where the risk for infections is especiallyhigh, especially with open tissue Doppler applications; andcan be used for cystoscopic and vaginal Doppler andultrasound examinations.Konix® Sterile Gel can be used on the skin or in opentissue where there is a risk for infections, such as in opentissue Doppler applications. It can be used during surgery;for cystoscopic and vaginal ultrasound and Dopplerexaminations; for cardiac surgery and ultrasoundprocedures; and as a lubricant in biopsy applications”)remains identical as stated in 510K K130581. | ||
| Biocompatibility: Cytotoxicity – ISO 10993-5, Biologicalevaluation of medical devices — Part 5: Tests for in vitrocytotoxicity. Non-Cytotoxic | SubstantiallyEquivalent | Biocompatibility: Cytotoxicity – ISO 10993-5,Biological evaluation of medical devices — Part 5:MEM Elution - Pass |
| Biocompatibility: Skin Irritation – ISO 10993-10:2010,Biological evaluation of medical devices – Part 10: Testsfor irritation and skin sensitization. Categorized as Negligible | SubstantiallyEquivalent | Biocompatibility: Skin Irritation – ISO 10993-10:2010, Biological evaluation of medical devices –Part 10: Tests for irritation and skin sensitization.Reactivity Irritation Test in Rabbits - Pass |
| Biocompatibility: Sensitization – ISO 10993-10:2010,Biological evaluation of medical devices – Part 10: Testsfor irritation and skin sensitization. No evidence of causing delayed dermal reaction at 24h and 48h. | SubstantiallyEquivalent | Biocompatibility: Sensitization – ISO 10993-10:2010, Biological evaluation of medical devices –Part 10: Tests for irritation and skin sensitization.Guinea Pig Maximization Sensitization Test - Pass |
| Flammability of Clothing Textiles - 16CFR1610:2010.Class 1 rating | ExceedsPredicate | Not indicated |
| Lint and other particles generation in the dry state -ISO 9073-10:2003. Index for Particulate Matter( IPM) =/1.30 | ExceedsPredicate | Not indicated |
| Shelf Life: 5-year shelf life both accelerated stabilitystudies and real time stability studies. Testing andevaluation inclusive of, dimensional, basis weight, tensile,elongation, melt index, surface resistance, tensile strengthof heat seal, sterile barrier packaging. | SubstantiallyEquivalent | Shelf life: shelf life time not indicated.Accelerated aging testing was performed in supportof the EZ-Cover.Accelerated Aging Test SummaryAccelerated Aging Test Report - Sterility TestAccelerated Aging Test Report -Aseptic PackagingSeal Test |
| Ethylene Oxide Residuals - ISO 10993-7:2008, EthyleneOxide Sterilization Residuals Results of these testsindicate the EO residual amounts are below the tolerablecontact limit (TCL) as expressed in units of micrograms persquare centimeter for EO at 10ug/cm2 and milligrams persquare centimeters for ECH at 5mg/cm2 (the acceptancecriteria). Actual results for EO Residuals at Time 0 hours =8.67ug/cm2.Actual results for ECH residuals at Time 0hours = Not detected (within the limits of detection of3.7ug/g). | SubstantiallyEquivalent | If the protective sleeve is sterilized by ethylene oxidethe residual ethylene residue should be less than XXug/g at the factory |
{9}------------------------------------------------
{10}------------------------------------------------
| "Not indicated, Exceeds Predicate" explanation | Explanation | A formal written request pursuant to |
|---|---|---|
| discussion specific to, | Discussion | 21CFR807.93(a)(1), "A 510(k) statement submitted |
| •Cover Acoustic Test , | as part of a premarket notification..." was sent to the | |
| •Acoustics Coupling Gel: FDA Cleared via | submitter of 510K K191491 (the predicate, | |
| K130581, | MedXPress.Pro, EZ-Cover). The reference | |
| •Flammability of Clothing Textiles, | regulation 21CFR807.93(a)(1) requires "...will make | |
| •Lint and other particles generation in the dry state | available all information included in this premarket | |
| notification on safety and effectiveness within 30 | ||
| days of reque20st by any person if the device | ||
| described in the premarket notification submission is | ||
| determined to be substantially equivalent. The | ||
| information I agree to make available will be a | ||
| duplicate of the premarket notification submission, | ||
| including any adverse safety and effectiveness | ||
| information, but excluding all patient identifiers, and | ||
| trade secret and confidential commercial | ||
| information...". The predicate device submitter made | ||
| available all information included in this premarketnotification on safety and effectiveness. The | ||
| information as provided by the predicate 510K | ||
| submitter does not include | ||
| • Cover Acoustic Test, | ||
| • Acoustics Coupling Gel: FDA Cleared via | ||
| K130581 | ||
| • Flammability of Clothing Textiles | ||
| • Lint and other particles generation in the dry state | ||
| On this basis and in accordance with the predicate | ||
| submitter compliance to 21CFR807.93(a)(1) and | ||
| Truth and Accuracy signed certification (21 CFR | ||
| 807.87(l), all 510(k)s must include a statement | ||
| certifying that all information submitted in the 510(k) | ||
| is truthful and accurate and that no material fact has | ||
| been omitted) there if no • Cover Acoustic Test, | ||
| • Cover Acoustic Test,• Acoustics Coupling Gel: FDA Cleared via | ||
| K130581 | ||
| • Flammability of Clothing Textiles | ||
| •Lint and other particles generation in the dry state, | ||
| testing for the predicate device and the | ||
| submission device (EMM Ultrasonic Transducer | ||
| Cover) has | ||
| • Cover Acoustic Test, | ||
| • Acoustics Coupling Gel: FDA Cleared via | ||
| K130581, | ||
| • Flammability of Clothing Textiles | ||
| • Lint and other particles generation in the dry statethe submission device exceeds the predicate device |
§ 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.