(28 days)
No
The device is a physical cover for an ultrasound transducer and does not involve any software or data processing capabilities.
No.
The device is a probe cover designed to prevent cross-contamination during diagnostic ultrasound procedures, not to treat a medical condition.
No
This device is a Transducer Probe Cover, a disposable accessory placed over diagnostic ultrasound transducers. Its purpose is to prevent the transfer of microorganisms, body fluids, and particulate material, and to maintain a sterile field, not to directly diagnose medical conditions.
No
The device description clearly states it is composed of physical materials (polyurethane sleeve, rubber ring, tape strip) and is a physical cover placed over an ultrasound transducer. It is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: An In Vitro Diagnostic device is a medical device intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Function: The described device is a Transducer Probe Cover. Its primary function is to act as a barrier to prevent the transfer of microorganisms, body fluids, and particulate material between the ultrasound transducer and the patient/healthcare worker. It also helps maintain a sterile field.
- Lack of Diagnostic Function: The device itself does not perform any diagnostic test on a specimen. It is an accessory used with a diagnostic ultrasound transducer, which is the device that performs the imaging and provides diagnostic information.
- Intended Use: The intended use clearly states it is placed over a diagnostic ultrasound transducer/probe scan head instruments for use in scanning and needle guided procedures. It facilitates the use of the ultrasound device while providing a barrier.
In summary, the Transducer Probe Cover is a barrier device used in conjunction with a diagnostic ultrasound system. It does not perform any in vitro diagnostic testing on specimens.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
ITX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body surface, endocavity, and intra-operative
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare worker
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)
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.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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).
1
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
2
Indications for Use
Submission Number (if known)
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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3
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, 200120 |
| China | |
| 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 |
4
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 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.
5.0 Indication for Use Statement
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.
5
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.
6
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 |
| Intended | ||||
| Use/Indication for | ||||
| Use | 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. | 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 external intact skin | ||||
| 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. | Protective cover or sheath 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 (both sterile and | ||||
| non-sterile covers) . The cover also | ||||
| provides a means for maintenance of | ||||
| a sterile field (sterile covers only) . | ||||
| CIVCO Poly Uitrasound Transducer | Compare to the predicate | |||
| device, the subject device | ||||
| expanded the scope of | ||||
| the indication for use. The | ||||
| subject device | ||||
| additionally can be used | ||||
| for endocavity, and | ||||
| intra-operative diagnostic | ||||
| ultrasound. | ||||
| Thrombogenicity and | ||||
| Complement Activation | ||||
| Testing were performed | ||||
| due to the contact level | ||||
| of tissue. | ||||
| Materials & | ||||
| Construction | Polyurethane, tubular, sealed | Polyurethane, tubular, sealed | Covers are furnished sterile & | |
| non-sterile single use patient / | ||||
| procedure, disposable. | ||||
| Polyurethane and polyethylene | ||||
| extruded thermoplastic film, in | ||||
| one-piece, open on one end, closed | ||||
| on other end. | Same | |||
| Model | Various Size | 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 | Not Publicly Available | Same | ||
| Acoustic | ||||
| Performance | Acoustic Impedance: 1.60 x 106 Pa | |||
| s/m | ||||
| Acoustic Velocity: 1594 m/s | ||||
| Acoustic Attenuation: | ||||
| 0.01dB/(cm-MHZ) | Acoustic Impedance: 1.60 x 106 Pa | |||
| s/m | ||||
| Acoustic Velocity: 1594 m/s | ||||
| Acoustic Attenuation: | ||||
| 0.01dB/(cm-MHZ) | Not Publicly Available | |||
| Not Publicly Available | ||||
| Not Publicly Available | Same | |||
| Sterile | EO sterilization, SAL 10-6 | EO sterilization, SAL 10-6 | Both in EO sterilization and | |
| non-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 Activation | ||||
| Testing and Platelet | ||||
| Activation Test per ISO | ||||
| 10993-4 | ||||
| were performed due to | ||||
| the contact level of | ||||
| tissue. |
Table 2- Comparison of Technology Characteristics
7
8
9
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.