Transducer Probe Cover placed over diagnostic ultrasound transducer/ probe scan head instruments. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer. The cover also provides a means for maintenance of a sterile field. Transducer Probe Cover are furnished sterile; single use patient/procedure, disposable.

Device Description

The subject device is composed of transparent thin-walled polyurethane sleeve, rubber ring and (or) tape strip. A conventional 0.05mm thin, 49 GSM (Grams per Square Meter), transparent high strength polyurethane film tube shape, in various dimensions 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 body surface, endocavity and intra-operative diagnostic ultrasound. This may help with easier cleaning and disinfection of the probe.

Ultrasound imaging is not impaired by use of the cover as it is intended. Adequate coupling between the cover and the transducer is required. The Transducer Probe Cover is utilized by applying sterile transmission, coupling, or lubricating gel onto the transducer face or into closed end of cover, inserting ultrasound transducer into closed end of cover and unrolling cover over length of the transducer as desired, and securing open end of cover with bands as necessary the removal process is accomplished by pulling the cover off the transducer in a reverse method from the application.

The subject device is furnished in sterile condition, for single use patient/procedure use, disposable.

As the device is single use device, which is individually packaged sterile devices. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.

AI/ML Overview

This document is a 510(k) summary for a Transducer Probe Cover. It primarily discusses the equivalence of the subject device to a predicate device, focusing on an expanded indication for use. Therefore, the information provided does not describe a study to prove the device meets acceptance criteria in the typical sense of performance metrics for an AI/algorithm-based device.

Instead, the document asserts substantial equivalence based on the device's characteristics and the performance of its predicate, along with additional biocompatibility testing for the expanded use.

Here's an analysis based on the provided text, addressing your questions where applicable and noting where the information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not detail specific acceptance criteria for performance as would be expected for an AI/algorithm. Instead, it compares the subject device's technological characteristics to predicate devices to establish substantial equivalence. The "performance" here refers to the device's characteristics fulfilling its intended purpose (acting as a barrier and not impairing ultrasound imaging).

Characteristic	Subject Device (K241615)	Predicate Device (K221278)	Conclusion (compared to Predicate)
Product Code	ITX	ITX	Same
Regulation No.	21 CFR 892.1570	21 CFR 892.1570	Same
Class	II	II	Same
Intended Use/Indication for Use	Transducer Probe Cover for body surface, endocavity, and intra-operative diagnostic ultrasound. Helps prevent transfer of microorganisms, body fluids, particulate material, and maintains sterile field.	Transducer Probe Cover for external intact skin diagnostic ultrasound. Helps prevent transfer of microorganisms, body fluids, particulate material, and maintains sterile field.	Expanded scope (endocavity, intra-operative)
Materials & Construction	Polyurethane, tubular, sealed	Polyurethane, tubular, sealed	Same
Model	Various Size	Various Size	Same
Microbial Barrier	Meets requirements of ASTM F1671-13 for prevention of blood-borne pathogens	Meets requirements of ASTM F1671-13 for prevention of blood-borne pathogens	Same
Acoustic Performance	Acoustic Impedance: 1.60 x 10^6^ Pa s/m; Acoustic Velocity: 1594 m/s; Acoustic Attenuation: 0.01dB/(cm-MHZ)	Acoustic Impedance: 1.60 x 10^6^ Pa s/m; Acoustic Velocity: 1594 m/s; Acoustic Attenuation: 0.01dB/(cm-MHZ)	Same
Sterile	EO sterilization, SAL 10^-6^	EO sterilization, SAL 10^-6^	Same
Disposable, Single Use Only	Yes	Yes	Same
Shelf Life	3 years	3 years	Same
Biocompatibility	Conform with ISO10993-1 (ISO10993-4, ISO10993-5, ISO10993-10, ISO10993-11) - Additionally, Thrombogenicity and Complement Activation Testing per ISO 10993-4 were performed due to expanded contact level.	Conform with ISO10993-1 (ISO10993-4, ISO10993-5, ISO10993-10, ISO10993-11). Biocompatibility test results for predicate also valid and support proposed device.	Additional tests performed due to expanded indication

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and not provided. This submission is for a physical medical device (transducer probe cover), not an AI/algorithm. Therefore, there isn't a "test set" in the context of data for an algorithm. The evaluation is based on non-clinical testing of the physical properties and biological compatibility of the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. As this is a physical device, not an AI, there is no "ground truth" establishment by experts for a test set of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. As this is a physical device, not an AI, there is no "adjudication method" for a test set of data.

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

This information is not applicable and not provided, as this is a physical device and not an AI or AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable and not provided, as this is a physical device and not an AI/algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable and not provided. For this physical device, "ground truth" would refer to established standards for material properties, sterilization efficacy, biocompatibility, and barrier function, which are evaluated through standardized non-clinical tests (e.g., ASTM F1671-13 for microbial barrier, ISO 10993 for biocompatibility).

8. The sample size for the training set

This information is not applicable and not provided. As this is a physical device, not an AI/algorithm, there is no "training set" in the data science context.

9. How the ground truth for the training set was established

This information is not applicable and not provided. As this is a physical device, not an AI/algorithm, there is no "ground truth" establishment for a "training set."

Summary of the Study and Acceptance Criteria (as interpreted for this device type):

The "study" presented here is a pre-market notification (510(k)) submission seeking to demonstrate substantial equivalence to a previously cleared predicate device (K221278), with an expanded indication for use.

The primary "acceptance criterion" for this submission is that the device is as safe, as effective, and performs as well as the legally marketed predicate device and raises no new questions of safety or effectiveness.

The "study" to prove this involves:

Technological Characteristic Comparison: Detailed comparison of the subject device's design, materials, manufacturing, and performance characteristics (e.g., microbial barrier, acoustic properties, sterilization, shelf life) to the predicate device. The conclusion is that these characteristics are largely identical.
Non-Clinical Testing Confirmation: Because there were no changes in materials, structure, dimensions, or performance that were deemed to impact the previous clearance, no new performance bench testing was considered necessary, except for additional biocompatibility evaluation related to the expanded indications for use.
Biocompatibility Testing: For the expanded scope to include endocavity and intra-operative diagnostic ultrasound, additional biocompatibility tests (Thrombogenicity and Complement Activation Testing per ISO 10993-4) were conducted. The results of these tests, along with the previously reviewed biocompatibility data for the predicate, were deemed valid and supportive.

In essence, the "study" is a comparative analysis and targeted supplementary testing demonstrating that the changes (expanded indications) do not introduce new hazards and that the device remains substantially equivalent to market predicates under the new conditions of use.

Summary

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July 3, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Hony Medical Co., Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. RM.1801, No. 161, East Lujiazui Rd. Pudong, Shanghai 200120 CHINA

Re: K241615

Trade/Device Name: Transducer Probe Cover Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: Class II Product Code: ITX Dated: June 5, 2024 Received: June 5, 2024

Dear Boyle Wang:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Marjan Nabili -S for

Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging And Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K241615

Device Name

Transducer Probe Cover

Indications for Use (Describe)

Transducer Probe Cover placed over diagnostic ultrasound transducer/ probe scan head instruments. The cover allows use of the transducer in scanning and needle quided procedures for body surface, endocavity, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer. The cover also provides a means for maintenance of a sterile field. Transducer Probe Cover are furnished sterile; single use patient/procedure, disposable.

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 K241615

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.

1.0 Submitter's Information

Name:	Hony Medical Co., Ltd.
Address:	No.12,9 Road, Changlong Ind.Zone, Taishan City,Guangdong China 529222
Tel:	+86 15916327827
Contact:	Zhu Huina

Designated Submission Correspondent

Contact:	Mr. Boyle Wang
Name:	Shanghai Truthful Information Technology Co., Ltd.
Address:	Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120China
Tel:	+86-21-50313932
Email:	Info@truthful.com.cn

Date of Preparation: Jun.27,2024

2.0 Device Information

Trade name:	Transducer Probe Cover
Common name:	Ultrasonic Diagnostic Transducer Probe Cover
Classification name:	Transducer, Ultrasonic, Diagnostic.
Model(s):	Various Dimension
Production code:	ITX
Regulation number:	21 CFR 892.1570
Classification:	Class II
Panel:	Radiology

3.0 Predicate and Reference Device Information

Predicate#

Manufacturer:	Hony Medical Co., Ltd.
Trade Device:	Transducer Probe Cover

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510(k) number: K221278

Reference#

Manufacturer:	CIVCO MEDICAL INSTRUMENTS CO., INC.
Trade Device:	GENERAL PURPOSE TRANDUCER COVER
510(k) number:	K970513

4.0 Device Description

The subject device is furnished in sterile condition, for single use patient/procedure use, disposable.

5.0 Indication for Use Statement

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Transducer Probe Cover are furnished sterile; single use patient/procedure, disposable.

6.0 Summary of Non-Clinical Testing

In this current submission, just expand the intended use scope of the subject device. As there were no materials, structure, dimensions or performance changes made to the subject device when compared to the primary predicate device, no additional non-clinical testing was considered necessary to support the substantial equivalence.

Performance Bench Testing

As there are no any technological characteristics changes as part of this submission from the previous clearance, no performance bench testing was included as part of this submission.

There are no differences between the predicate Transducer Probe Cover and the proposed Transducer Probe Cover that could affect the shelf life or sterility; therefore, sterilization and shelf-life evaluations were not required.

Biocompatibility Testing

The proposed Transducer Probe Cover does not introduce any new direct or indirect patient contacting materials, as compared to the previous clearance predicate Transducer Probe Cover.

Since the subject device expand the indication for use scope, it can be used in endocavity, and intra-operative diagnostic ultrasound, additionally biocompatibility evaluation Items including Thrombogenicity and Complement Activation Testing

Per ISO 10993-4 were performed due to the contact level of tissue. And the biocompatibility test results reviewed by the FDA for the predicate Transducer Probe Cover (reference K221278) also valid, can be support the proposed Transducer Probe Cover.

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7.0 Technological Characteristic Comparison Table

Item	Subject Device	Predicate Device	Reference Device	Conclusion
510(k) No.	K241615	K221278	K970513	--
Product Code	ITX	ITX	ITX	Same
Regulation No.	21 CFR 892.1570	21 CFR 892.1570	21 CFR 892.1570	Same
Class	II	II	II	Same
IntendedUse/Indication forUse	Transducer Probe Cover placed overdiagnostic ultrasound transducer/probe scan head instruments. Thecover allows use of the transducer inscanning and needle guidedprocedures for body surface,endocavity and intra-operativediagnostic ultrasound, while helping toprevent transfer of microorganisms,body fluids, and particulate material tothe patient and healthcare workerduring reuse of the transducer. Thecover also provides a means formaintenance of a sterile field.Transducer Probe Cover are furnishedsterile; single use patient/procedure,disposable.	Transducer Probe Cover placed overdiagnostic ultrasound transducer/probe scan head instruments. Thecover allows use of the transducer inscanning and needle guidedprocedures for external intact skindiagnostic ultrasound, while helping toprevent transfer of microorganisms,body fluids, and particulate material tothe patient and healthcare workerduring reuse of the transducer. Thecover also provides a means formaintenance of a sterile field.Transducer Probe Cover are furnishedsterile; single use patient/procedure,disposable.	Protective cover or sheath placedover diagnostic ultrasoundtransducer / probe scan headinstruments. The cover allows use ofthe transducer in scanning andneedle guided procedures for bodysurface, endocavity, andintra-operative diagnostic ultrasound,while helping to prevent transfer ofmicroorganisms, body fluids , andparticulate material to the patient andhealthcare worker during reuse ofthe transducer (both sterile andnon-sterile covers) . The cover alsoprovides a means for maintenance ofa sterile field (sterile covers only) .CIVCO Poly Uitrasound Transducer	Compare to the predicatedevice, the subject deviceexpanded the scope ofthe indication for use. Thesubject deviceadditionally can be usedfor endocavity, andintra-operative diagnosticultrasound.Thrombogenicity andComplement ActivationTesting were performeddue to the contact levelof tissue.
Materials &Construction	Polyurethane, tubular, sealed	Polyurethane, tubular, sealed	Covers are furnished sterile &non-sterile single use patient /procedure, disposable.Polyurethane and polyethyleneextruded thermoplastic film, inone-piece, open on one end, closedon other end.	Same
Model	Various Size	Various Size	Various Size	Same
Microbial Barrier	Meets requirements of ASTMF1671-13 for prevention ofblood-borne pathogens	Meets requirements of ASTMF1671-13 for prevention ofblood-borne pathogens	Not Publicly Available	Same
AcousticPerformance	Acoustic Impedance: 1.60 x 106 Pas/mAcoustic Velocity: 1594 m/sAcoustic Attenuation:0.01dB/(cm-MHZ)	Acoustic Impedance: 1.60 x 106 Pas/mAcoustic Velocity: 1594 m/sAcoustic Attenuation:0.01dB/(cm-MHZ)	Not Publicly AvailableNot Publicly AvailableNot Publicly Available	Same
Sterile	EO sterilization, SAL 10-6	EO sterilization, SAL 10-6	Both in EO sterilization andnon-sterile	Same
Disposable,Single Use Only	Yes	Yes	Yes	Same
Shelf Life	3 years	3 years	Not Publicly Available	Same
Biocompatibility	Conform with ISO10993-1(ISO10993-4, ISO10993-5,ISO10993-10, ISO10993-11)	Conform with ISO10993-1(ISO10993-4, ISO10993-5,ISO10993-10, ISO10993-11)	Conform with ISO 10993 standards	Thrombogenicity,Complement ActivationTesting and PlateletActivation Test per ISO
			10993-4were performed due tothe contact level oftissue.

Table 2- Comparison of Technology Characteristics

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Except the expand the applicable scope of indication for use for the subject device, there is no any changes made on the technological characteristics of the subject device are identical to those of predicate device. The materials, dimensions, sterilization methods, processing and manufacturing are no any changes were made to the subject device.

The subject device is substantially equivalent to the predicate devices with respect to technological characteristics, and performance characteristics. The differences between the applicable scope of the proposed and predicate devices do not alter the substantially equivalent since additional biocompatibility testing evaluation has been performed.

8.0 Conclusion

The conclusions drawn from the comparison and analysis above demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicated device and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.

Regulation Number and Section

§ 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.