(50 days)
K 191491
No
The device is a physical barrier (transducer cover) and the description focuses on its material properties and intended use for contamination minimization, with no mention of AI/ML or data processing.
No
This device is a cover for an ultrasound transducer and its stated purpose is to minimize contamination between the patient and the probe, thereby aiding in cleaning and disinfection. It does not exert any direct therapeutic action on the patient.
No
This device is a cover for an ultrasound probe, used to minimize contamination, facilitate cleaning, and provide a barrier. It does not perform any diagnostic function itself; rather, it supports the use of a diagnostic tool (ultrasound probe).
No
The device description clearly states it is a physical product made of polyurethane film, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Exact Medical Manufacturing Ultrasonic Transducer Cover is a physical barrier applied to an ultrasound probe. Its purpose is to minimize contamination and facilitate cleaning, not to analyze biological samples or provide diagnostic information directly from a patient sample.
- Intended Use: The intended use clearly states it's for minimizing contamination during ultrasound scanning procedures on external intact skin. This is a procedural aid, not a diagnostic test.
The device's function and intended use align with a medical device used in a clinical setting, but not specifically an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
ITX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
external intact skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing Summary:
- Water Resistance: Impact Penetration Test, Level 3. Sample Size N= 32 with C=0. Result: Accept 32 samples =/ 50cm (all samples =/> 180cm). Conclusion: Substantially equivalent barrier property compared to the predicate device.
- Flammability of Clothing Textiles. Sample Size: 5 replicates. Result: Accept 5 samples DNI (Did Not Ignite). Conclusion: 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). Sample size per statistical sampling plan ISO2859-1. Result: Accept All samples must pass acceptance criteria. Conclusion: 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. Sample Size = 10. Result: Accept IPM 1.3 (outside), IPM 0.72 (inside). Conclusion: 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. Sample size: 3 ea. Speed of Sound, 3 ea. Acoustic Attenuation, 3 ea. Acoustic Impedance. Result: Speed of sound = 1698 m/sec; Acoustic Attenuation = 0.51 dB; Acoustic Impedance = 1.63 MRayl. Conclusion: Acoustic testing concluded negligible effect on the transmission of ultrasound signal and 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. Sample Size N=45. Result: Accept Color N=9, Pass; Dimension N=9 Pass; Weight N=9 Pass; Coordinates N=9 Pass; Mechanical Properties N=9 Pass. Conclusion: 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. Sample Size per sterilization batch N=15 X 3 consecutive sterilization batches = 45 samples. Result: 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). Conclusion: 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. Sample Size = 4 test article extracts. Result: 100% Test article extract 76.5% viability. No Test article extracts are
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
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) |
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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 =/ 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 =/combination with a transducer cover , where
sterility and in vivo biocompatibility are required. It can be
used on the skin where the risk for infections is especially
high, especially with open tissue Doppler applications; and
can be used for cystoscopic and vaginal Doppler and
ultrasound examinations.
Konix® Sterile Gel can be used on the skin or in open
tissue where there is a risk for infections, such as in open
tissue Doppler applications. It can be used during surgery;
for cystoscopic and vaginal ultrasound and Doppler
examinations; for cardiac surgery and ultrasound
procedures; and as a lubricant in biopsy applications”)
remains identical as stated in 510K K130581. | | |
| Biocompatibility: Cytotoxicity – ISO 10993-5, Biological
evaluation of medical devices — Part 5: Tests for in vitro
cytotoxicity. Non-Cytotoxic | Substantially
Equivalent | 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: Tests
for irritation and skin sensitization. Categorized as
Negligible | Substantially
Equivalent | 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: Tests
for irritation and skin sensitization. No evidence of
causing delayed dermal reaction at 24h and 48h. | Substantially
Equivalent | 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 | Exceeds
Predicate | Not indicated |
| Lint and other particles generation in the dry state -
ISO 9073-10:2003. Index for Particulate Matter( IPM) =/
1.30 | Exceeds
Predicate | Not indicated |
| Shelf Life: 5-year shelf life both accelerated stability
studies and real time stability studies. Testing and
evaluation inclusive of, dimensional, basis weight, tensile,
elongation, melt index, surface resistance, tensile strength
of heat seal, sterile barrier packaging. | Substantially
Equivalent | Shelf life: shelf life time not indicated.
Accelerated aging testing was performed in support
of the EZ-Cover.
Accelerated Aging Test Summary
Accelerated Aging Test Report - Sterility Test
Accelerated Aging Test Report -Aseptic Packaging
Seal Test |
| Ethylene Oxide Residuals - ISO 10993-7:2008, Ethylene
Oxide Sterilization Residuals Results of these tests
indicate the EO residual amounts are below the 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 (the acceptance
criteria). 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). | Substantially
Equivalent | If the protective sleeve is sterilized by ethylene oxide
the residual ethylene residue should be less than XX
ug/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 premarket | ||
| notification 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 state | ||
| the submission device exceeds the predicate device |