(81 days)
No
The device is a physical cover for an ultrasound transducer and the summary does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
No
The device is described as an Ultrasound Transducer Cover intended to act as a microbial barrier and cover for an ultrasound transducer. Its function is to facilitate ultrasound scans and provide hygiene, not to treat or prevent a disease or condition.
No
The device is described as an "Ultrasound Transducer Cover" intended to act as a microbial barrier and facilitate ultrasound scans. It is an accessory for an ultrasound transducer, which is the diagnostic device, but it does not perform diagnostic functions itself. Its purpose is to ensure hygiene and proper functioning of the ultrasound equipment without directly contributing to diagnosis.
No
The device description explicitly states it is an "elastic cover made of thermoplastic polyurethane (TPU)" and describes physical characteristics and testing related to a physical object, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "microbial barrier between the patient and the transducer during transvaginal procedures." It facilitates the ultrasound scan itself, but it does not perform any diagnostic testing on biological samples (like blood, urine, tissue, etc.) taken from the patient.
- Device Description: The description confirms it's a physical cover for the ultrasound transducer.
- Lack of IVD Characteristics: The document does not mention any components or functions related to analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
- Performance Studies: The performance studies focus on the physical properties of the cover (acoustic effects, elongation, leakage), biocompatibility, sterility, and packaging integrity. These are typical tests for a medical device that comes into contact with the body, but not for an IVD.
In summary, the device's purpose is to maintain hygiene and facilitate the use of an ultrasound transducer, which is an imaging modality. It does not perform any diagnostic tests on samples outside of the body, which is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended to cover an ultrasound transducer and to act as a microbial barrier between the patient and the transducer during transvaginal procedures within assisted reproductive technology or gynecology, for clinical and hospital use by healthcare professionals in adult patients undergoing these procedures.
Product codes
ITX
Device Description
The Ultrasound Transducer Cover is an elastic cover made of thermoplastic polyurethane (TPU), which is placed over the ultrasound transducer during ultrasound quided procedures within assisted reproductive technology or gynecology. The Ultrasound Transducer Cover is provided sterile (ethylene oxide), for single use, and used with an ultrasound transducer probe to facilitate ultrasound scans.
The Ultrasound Transducer Cover is available in various sizes with different widths of the cover. This is to allow for use with various sizes of ultrasound transducer probe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
transvaginal
Indicated Patient Age Range
adult patients
Intended User / Care Setting
healthcare professionals in clinical and hospital use
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)
- Functional testing:
- Ultrasound imaging effect: No negative effect on ultrasound visibility
- Acoustic impedance, Acoustic Velocity & Acoustic Attenuation: Ultrasound Transducer Cover does not affect the acoustic properties of the ultrasound device
- Elongation properties: Device does not break when pulled onto the transducer probe
- Leakage: Device does not leak
- Biocompatibility- evaluated/tested against ISO 10993-1 and FDA Biocompatibility Guidance endpoints relevant for a limited contact surface medical device in contact with "breached or compromised surface":
- Physical and /or chemical characterization
- Cytotoxicity
- Skin Sensitization
- Irritation (skin/vaginal)/Intracutaneous reactivity
- Material mediated pyrogenicity
- Acute systemic toxicity
- Reproductive and developmental toxicity
- Safety testing:
- Endotoxin testing: Device is nontoxic with regards to endotoxins (
§ 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
August 30, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left 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.
Vitrolife Sweden AB Lin Huldeberg Regulatory Affairs Manager Gustaf Werners gata 2 SE-421 32 Västra Frölunda SWEDEN
Re: K241662
Ultrasound Transducer Cover Trade/Device Name: Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: Class II Product Code: ITX Dated: June 10, 2024 Received: June 10, 2024
Dear Lin Huldeberg:
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 (OS) 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 (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/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-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-devices/medical-device-safety/medical-device-reporting-mdr-how-reportmedical-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/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-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
Yanna Kang Assistant Director 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
Enclosure
2
Indications for Use
510(k) Number (if known) K241662
Device Name Ultrasound Transducer Cover
Indications for Use (Describe)
The device is intended to cover an ultrasound transducer and to act as a microbial barrier between the patient and the transducer during transvaginal procedures within assisted reproductive technology or gynecology, for clinical and hospital use by healthcare professionals in adult patients undergoing these procedures.
| 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
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510(k) Summary — K241662
Date prepared: August 30, 2024
| Submitted by: | Vitrolife Sweden AB
Gustaf Werners gata 2
SE-421 32 Västra Frölunda
Sweden |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lin Huldeberg
Vitrolife Sweden AB
Gustaf Werners gata 2
SE-421 32 Västra Frölunda
Sweden
Phone: +46 31 721 80 00 |
Device Information 1
| Trade Name: | Ultrasound Transducer Cover |
|---|---|
| Common name: | Ultrasound Transducer Cover |
| Regulation number: | 21 CFR 892.1570 |
| Regulation name: | Diagnostic ultrasonic transducer |
| Product code: | ITX (Class 2) - Transducer, Ultrasonic, Diagnostic |
| Class: | II |
Email: Ihuldeberg@vitrolife.com
1.1 Predicate Device:
CIV-Clear cover, Manufactured by CIVCO Medical Instruments Co., Inc. - K211270
The predicate has not been subject to a design-related recall.
1.2 Reference Device:
Transducer Probe Cover, Manufactured by Hony Medical Co., Ltd. - K221278
2 Device description
The Ultrasound Transducer Cover is an elastic cover made of thermoplastic polyurethane (TPU), which is placed over the ultrasound transducer during ultrasound quided procedures within assisted reproductive technology or gynecology. The Ultrasound Transducer Cover is provided sterile (ethylene oxide), for single use, and used with an ultrasound transducer probe to facilitate ultrasound scans.
The Ultrasound Transducer Cover is available in various sizes with different widths of the cover. This is to allow for use with various sizes of ultrasound transducer probe.
Intended use / Indications for Use 2.1
The device is intended to cover an ultrasound transducer and to act as a microbial barrier between the patient and the transducer during transvaginal procedures within assisted reproductive technology or gynecology, for clinical and hospital use by healthcare professionals in adult patients undergoing these procedures.
4
Summary of Non-clinical Testing 3
The following tests have been conducted in order to verify the safety and effectiveness of the device:
- -Functional testing
- Ultrasound imaging effect No negative effect on ultrasound visibility O
- Acoustic impedance. Acoustic Velocity & Acoustic Attenuation Ultrasound O
- Transducer Cover does not affect the acoustic properties of the ultrasound device
- Elongation properties Device does not break when pulled onto the transducer probe O
- Leakage Device does not leak O
- Biocompatibility- evaluated/tested against ISO 10993-1 and FDA Biocompatibility Guidance endpoints relevant for a limited contact surface medical device in contact with "breached or compromised surface":
- Physical and /or chemical characterization o
- Cytotoxicity o
- Skin Sensitization O
- Irritation (skin/vaginal)/Intracutaneous reactivity O
- Material mediated pyrogenicity o
- Acute systemic toxicity o
- Reproductive and developmental toxicity O
- Safetv testing -
- Endotoxin testing Device is nontoxic with regards to endotoxins (