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 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.

AI/ML Overview

The provided text is a 510(k) summary for the Vitrolife Ultrasound Transducer Cover. It describes the device, its intended use, and a comparison to predicate devices, along with non-clinical testing performed to demonstrate safety and effectiveness.

However, the document does not contain information about:

Acceptance criteria in the context of a statistical study with specific thresholds for performance metrics.
A study proving the device meets acceptance criteria related to diagnostic accuracy, especially not for an AI/ML-enabled device as implied by the detailed questions about ground truth, expert consensus, MRMC studies, and standalone performance.
Sample sizes for test sets or training sets in the context of an AI/ML study.
Data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types pertaining to an AI/ML diagnostic system.
Training set size or how its ground truth was established.

The document is for a physical medical device (an ultrasound transducer cover) and focuses on biocompatiability, functional performance (e.g., leakage, ultrasound visibility), sterilization, and shelf-life testing, demonstrating substantial equivalence to a predicate device. It explicitly states "Clinical Testing: Not applicable."

Therefore, I cannot populate the requested table and provide answers for the specific points related to AI/ML device validation because the provided text does not contain this information.

The existing text is a regulatory submission for a simple medical device, not an AI/Machine Learning diagnostic device.

Summary

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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 (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

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Indications for Use

510(k) Number (if known) K241662

Device Name Ultrasound Transducer Cover

Indications for Use (Describe)

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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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 ABGustaf Werners gata 2SE-421 32 Västra FrölundaSweden
Contact Person:	Lin HuldebergVitrolife Sweden ABGustaf Werners gata 2SE-421 32 Västra FrölundaSwedenPhone: +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 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

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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 - UltrasoundTransducer Cover (K241662)	Predicate Device - CIV-Clear cover(CIVCO) (K211270)	Reference Device –Transducer Probe Cover(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 / Indicationsfor use	The device is intended to cover anultrasound transducer and to actas a microbial barrier between thepatient and the transducer duringtransvaginal procedures withinassisted reproductive technologyor gynecology, for clinical andhospital use by healthcareprofessionals in adult patientsundergoing these procedures.	The cover is intended as a microbialbarrier between the patient and medicalimaging equipment. The transducercovers are used for adult of all body sizesin sterile and non-sterile fields and for thefollowing applications:- Abdominal - Diagnostic imagingand minimally invasive punctureprocedures.- Small Parts - Diagnosticimaging and minimally invasivepuncture procedures.- Regional Anesthesia - Minimallyinvasive puncture procedures.- Vascular Access - Vesselidentification and catheterplacement.- Surgical - Diagnostic imagingand puncture procedures.- Transesophageal - Diagnosticimaging and monitoring of heartchamber, valves and vessels.- Transrectal - Diagnosticimaging and minimally invasivepuncture procedures.- Transvaginal - Diagnosticimaging and minimally invasivepuncture proceduresWhen conducting an ultrasoundprocedure, place an appropriate amountof gel inside cover and/or on transducerface.	Transducer Probe Coverplaced over diagnosticultrasound transducer/ probescan head instruments. Thecover allows use of thetransducer in scanning andneedle guided procedures forexternal intact skin diagnosticultrasound, while helping toprevent transfer ofmicroorganisms, body fluids,and particulate material to thepatient and healthcare workerduring reuse of the transducer.The cover also provides ameans for maintenance of asterile field. Transducer ProbeCover are furnished sterile;single use patient/procedure,disposable.	Although not phrased thesame, the Transvaginaluse of the Predicatedevice is the same as forthe Subject device.
	Ultrasound Transducer Cover	Traditional 510(k) Premarket submission
Size(s)	Various sizes:- 60X610 mm- 80x610 mm- 100x610 mm	Various sizes (details unknown)	Various sizes:- 60X610 mm- 80x610 mm- 100x610 mm	Different: The size andshape of the Predicatedevice is not known;however, any differencesdoes not raise differentquestions of safety andeffectiveness (S&E)
Material	Thermoplastic Polyurethane	Ethyl Methyl Acrylate (EMA) andPolyethylene blend	Thermoplastic Polyurethane	Different: The subjectand predicate devicematerials are not thesame. Differences inmaterials does not raisedifferent questions ofS&E, since both devicesare consideredbiologically safe. Samematerial as the referencedevice.
Biocompatibility	Cytotoxicity (ISO 10993-5)	Cytotoxicity (ISO 10993-5)	Cytotoxicity (ISO 10993-5)	Same, plus more,compared to thePredicate 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 10993-10)	Acute Systemic Toxicity (ISO 10993-11)	Acute Systemic Toxicity (ISO10993-11)
	Acute systemic toxicity (ISO10993-11)	Material Mediated Pyrogenicity (ISO10993-11)	Material Mediated Pyrogenicity(ISO 10993-11)Hemolysis (ISO 10993-4
	Vaginal Irritation (ISO 10993-10)
	Material-mediated Pyrogenicity(ISO 10993-11)
Sterilization	Ethylene Oxide	Ethylene Oxide(Offered in sterile and non-sterileconfigurations)	Ethylene Oxide	Same
Shelf-life	3 years	3 years	3 years	Same
Single use	Yes	Yes	Yes	Same
Microbial barrier	Meets requirements of ASTMF1671-22 for prevention of blood-borne pathogens	Meets requirements of ASTM F1671-13for prevention of blood-borne pathogens	Meets requirements of ASTMF1671-13 for prevention ofblood-borne pathogens	Same
AcousticPerformance	AcousticImpedance	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
	AcousticVelocity	1594 m/s	1630 m/s	1594 m/s	Same
	AcousticAttenuation	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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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.

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.