Ultrasound Transducer Cover

K241662 · Vitrolife Sweden AB · ITX · Aug 30, 2024 · Radiology

Device Facts

• Record ID: K241662
• Device Name: Ultrasound Transducer Cover
• Applicant: Vitrolife Sweden AB
• Product Code: ITX · Radiology
• Decision Date: Aug 30, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended 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.

Device Story

Elastic thermoplastic polyurethane (TPU) cover; placed over ultrasound transducer probe; acts as microbial barrier during transvaginal procedures in assisted reproductive technology or gynecology. Provided sterile (ethylene oxide); single-use. Available in various widths (60mm, 80mm, 100mm) to accommodate different probe sizes. Used by healthcare professionals in clinical/hospital settings. Facilitates ultrasound scans while preventing transfer of microorganisms/fluids between patient and transducer. Does not affect acoustic properties (impedance, velocity, attenuation).

Clinical Evidence

Bench testing only. Functional testing verified ultrasound visibility, acoustic properties, elongation, and leakage. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity). Viral penetration tested per ASTM F1671. Sterility, shelf-life, and transport testing validated per ISO 11607, ISO 11135, and ASTM standards.

Technological Characteristics

Material: Thermoplastic Polyurethane (TPU). Form factor: Elastic sleeve, various widths (60-100mm). Energy: Passive (ultrasound transparent). Sterilization: Ethylene Oxide (EO). Connectivity: None. Biocompatibility: ISO 10993 compliant. Microbial barrier: ASTM F1671-22 compliant.

Indications for Use

Indicated for adult patients undergoing transvaginal ultrasound procedures within assisted reproductive technology or gynecology. Used by healthcare professionals in clinical and hospital settings.

Regulatory Classification

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.

Predicate Devices

• CIV-Clear cover (K211270)

Reference Devices

• Transducer Probe Cover (K221278)

Submission Summary (Full Text)

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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).

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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 ([e-mail]) or phone [phone] 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

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### 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) | |
|-------------------------------------------------------------------------------|---------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/1 description: The image shows the logo for Vitrolife, with the company name in a bold, blue font and a stylized blue wave graphic to the right. Below the logo, the text "Traditional 510(k) Premarket submission" is written in a smaller, black font. The text is underlined.

## 510(k) Summary — K241662

Date prepared: August 30, 2024

| Submitted by: | Vitrolife Sweden AB<br>Gustaf Werners gata 2<br>SE-421 32 Västra Frölunda<br>Sweden |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lin Huldeberg<br>Vitrolife Sweden AB<br>Gustaf Werners gata 2<br>SE-421 32 Västra Frölunda<br>Sweden<br>Phone: [phone] |

#### 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: [e-mail]

#### 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.

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#### 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 (< 20 EU/device) o
- Viral penetration No viral penetration, tested according to ASTM F1671 O
- Package validation and testing The sterility is maintained by ensuring that the packaging is in conformance with ISO 11607-1 and ISO 11607-2, and that the packaging methods are validated accordingly. Sterile barrier testing includes:
- Seal strength (ASTM F88 / F88M) O
- Dye penetration (ASTM F1929) O
- Opening characteristics of pouch (EN 868-5) O
- Visual inspection of seals (ASTM F1886 / F1886M) o
- Seal width O
- Shelf-Life testing -
- Aging tests have been performed, concluding that the device and packaging upholds O its functionality over the three-year shelf-life
- -Transport testing
- Transport testing of package according to ASTM D4169 o
- -Ethylene Oxide (EO) Sterilization Validation and Residual testing
- Sterilization validation according to ISO 11135 O
- EO residual levels do not exceed the limits per ISO 10993-7 for a limited exposure O category device

#### ব Clinical Testing

Not applicable.

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Image /page/5/Picture/1 description: The image shows the Vitrolife logo in blue, with a stylized wave-like graphic to the right of the name. Below the logo, the text "Traditional 510(k) Premarket submission" is written in a smaller, sans-serif font. The text is underlined with a thin black line.

## 5 Comparison of Subject and Predicate Device Intended Use and Technological Characteristics

| Description | Subject Device - Ultrasound<br>Transducer Cover (K241662) | Predicate Device - CIV-Clear cover<br>(CIVCO) (K211270) | Reference Device –<br>Transducer Probe Cover<br>(Hony) (K221278) | Differences | |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Product code | ITX | ITX | ITX | Same | |
| Regulation | 21 CFR 892.1570 | 21 CFR 892.1570 | 21 CFR 892.1570 | Same | |
| Class | II | II | II | Same | |
| Intended use / Indications<br>for use | The device is intended to cover an<br>ultrasound transducer and to act<br>as a microbial barrier between the<br>patient and the transducer during<br>transvaginal procedures within<br>assisted reproductive technology<br>or gynecology, for clinical and<br>hospital use by healthcare<br>professionals in adult patients<br>undergoing these procedures. | The cover is intended as a microbial<br>barrier between the patient and medical<br>imaging equipment. The transducer<br>covers are used for adult of all body sizes<br>in sterile and non-sterile fields and for the<br>following applications:<br>- Abdominal - Diagnostic imaging<br>and minimally invasive puncture<br>procedures.<br>- Small Parts - Diagnostic<br>imaging and minimally invasive<br>puncture procedures.<br>- Regional Anesthesia - Minimally<br>invasive puncture procedures.<br>- Vascular Access - Vessel<br>identification and catheter<br>placement.<br>- Surgical - Diagnostic imaging<br>and puncture procedures.<br>- Transesophageal - Diagnostic<br>imaging and monitoring of heart<br>chamber, valves and vessels.<br>- Transrectal - Diagnostic<br>imaging and minimally invasive<br>puncture procedures.<br>- Transvaginal - Diagnostic<br>imaging and minimally invasive<br>puncture procedures<br>When conducting an ultrasound<br>procedure, place an appropriate amount<br>of gel inside cover and/or on transducer<br>face. | Transducer Probe Cover<br>placed over diagnostic<br>ultrasound transducer/ probe<br>scan head instruments. The<br>cover allows use of the<br>transducer in scanning and<br>needle guided procedures for<br>external intact skin diagnostic<br>ultrasound, while helping to<br>prevent transfer of<br>microorganisms, body fluids,<br>and particulate material to the<br>patient and healthcare worker<br>during reuse of the transducer.<br>The cover also provides a<br>means for maintenance of a<br>sterile field. Transducer Probe<br>Cover are furnished sterile;<br>single use patient/procedure,<br>disposable. | Although not phrased the<br>same, the Transvaginal<br>use of the Predicate<br>device is the same as for<br>the Subject device. | |
| | Ultrasound Transducer Cover | Traditional 510(k) Premarket submission | | | |
| Size(s) | Various sizes:<br>- 60X610 mm<br>- 80x610 mm<br>- 100x610 mm | Various sizes (details unknown) | Various sizes:<br>- 60X610 mm<br>- 80x610 mm<br>- 100x610 mm | Different: The size and<br>shape of the Predicate<br>device is not known;<br>however, any differences<br>does not raise different<br>questions of safety and<br>effectiveness (S&E) | |
| Material | Thermoplastic Polyurethane | Ethyl Methyl Acrylate (EMA) and<br>Polyethylene blend | Thermoplastic Polyurethane | Different: The subject<br>and predicate device<br>materials are not the<br>same. Differences in<br>materials does not raise<br>different questions of<br>S&E, since both devices<br>are considered<br>biologically safe. Same<br>material as the reference<br>device. | |
| Biocompatibility | Cytotoxicity (ISO 10993-5) | Cytotoxicity (ISO 10993-5) | Cytotoxicity (ISO 10993-5) | Same, plus more,<br>compared to the<br>Predicate device | |
| | Irritation (ISO 10993-10) | Irritation (ISO 10993-10) | Irritation (ISO 10993-10) | | |
| | Sensitization (ISO 10993-10) | Sensitization (ISO 10993-10) | Sensitization (ISO 10993-10) | | |
| | Intradermal reactivity (ISO 10993-<br>10) | Acute Systemic Toxicity (ISO 10993-11) | Acute Systemic Toxicity (ISO<br>10993-11) | | |
| | Acute systemic toxicity (ISO<br>10993-11) | Material Mediated Pyrogenicity (ISO<br>10993-11) | Material Mediated Pyrogenicity<br>(ISO 10993-11)<br>Hemolysis (ISO 10993-4 | | |
| | Vaginal Irritation (ISO 10993-10) | | | | |
| | Material-mediated Pyrogenicity<br>(ISO 10993-11) | | | | |
| Sterilization | Ethylene Oxide | Ethylene Oxide<br>(Offered in sterile and non-sterile<br>configurations) | Ethylene Oxide | Same | |
| Shelf-life | 3 years | 3 years | 3 years | Same | |
| Single use | Yes | Yes | Yes | Same | |
| Microbial barrier | Meets requirements of ASTM<br>F1671-22 for prevention of blood-<br>borne pathogens | Meets requirements of ASTM F1671-13<br>for prevention of blood-borne pathogens | Meets requirements of ASTM<br>F1671-13 for prevention of<br>blood-borne pathogens | Same | |
| Acoustic<br>Performance | Acoustic<br>Impedance | 1.60 x 106 Pa s/m | $1.54 \pm 0.13 x 10^5$ g/(cm² sec) | 1.60 x 106 Pa s/m | Same |
| | Acoustic<br>Velocity | 1594 m/s | 1630 m/s | 1594 m/s | Same |
| | Acoustic<br>Attenuation | 0.01dB/(cm·MHz) | Unknown | 0.01dB/(cm·MHz) | Same |

Table 1. Predicate comparison table to outline differences and similarities between the subject, predicate and reference devices

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Image /page/6/Picture/0 description: The image shows the word "Vitrolife" in blue font. To the right of the word is a blue swoosh that resembles a wave. The font is a serif font and the color is a dark blue.

## 510(k) Summary – K241662
Ultrasound Transducer Cover

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Image /page/7/Picture/1 description: The image shows the Vitrolife logo in blue, with the text "Traditional 510(k) Premarket submission" underneath. The logo is a stylized, curved shape. The text is underlined.

#### 6 Conclusions

As concluded in the comparison above, the Subject device has the same intended use/indications for use as the Predicate device, and their differences in technological characteristic does not raise different questions of safety and effectiveness. Therefore, the Ultrasound Transducer Cover is concluded substantially equivalent to the legally marketed Predicate device.