This device provides physicians with a tool for performing needle/instrument guided procedures with the use of diagnostic ultrasound endocavity transducers.

Transvaginal Diagnostic ultrasound needle / instrument guided procedures such as tissue biopsy fluid aspiration, catheter placement, treatment, and oocyte retrieval.
Transrectal Diagnostic ultrasound needle / instrument guided procedures such as tissue biopsy, fluid aspiration, catheter placement, treatment.

Device Description

The disposable endocavity needle guides are devices used to direct needles or instruments along a fixed path to a target location with an ultrasound traducer. They are provided in a variety of sizes to fit different equipment and situations. They can be utilized for various types of procedures from tissue biopsy and fluid aspirations to instrument placements and oocyte harvesting.

AI/ML Overview

The provided text describes a 510(k) summary for the VitroPRO, a disposable endocavity needle guide. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance studies with acceptance criteria based on human-in-the-loop and algorithm-only performance metrics typical for AI/ML devices. Therefore, much of the requested information regarding AI/ML study design, such as MRMC studies, effect sizes, training set details, and ground truth establishment methods for AI, is not applicable or present in this specific document, as the VitroPRO is a mechanical device, not an AI/ML diagnostic tool.

However, based on the information provided, here's what can be extracted and presented to align with the prompt, focusing on the available non-clinical test data which serves as the "study" proving the device meets its "acceptance criteria" for substantial equivalence.

Device Name: VitroPRO / Disposable Endocavity Needle Guide (K222052)
Device Type: Mechanical Accessory (Needle Guide), not an AI/ML diagnostic device.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this device are implicitly tied to demonstrating the same safety and effectiveness as the predicate device, K970514, through non-clinical performance testing. The "reported device performance" refers to the results of these non-clinical tests.

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Acceptance Criteria (Implied from testing purpose)	Reported Device Performance (Test Results)
Biocompatibility: Device materials meet ISO 10993-1 requirements for specified contact duration with human tissue.	All materials met ISO 10993-1 biocompatibility requirements. - Cytotoxicity (ISO 10993-5): Met. - Sensitization (ISO 10993-10): Met. - Irritation (ISO 10993-10): Met. (Note: "Not labeled non-pyrogenic" compared to predicate's "non-pyrogenic" but deemed not to affect safety/effectiveness given the application).
Cover Breach and Probe Damage: Device attachment to ultrasound cover/probe does not cause damage.	Water leak testing demonstrated material attachment of needle guide to cover did not cause damage to cover or probe.
Retention and Movement: Minimum force required to dislodge the guide from the transducer.	Force testing demonstrated a minimum force of 8N would not cause the guide to dislodge.
Needle Drag: Force required to pass a cannula through the guide is below a specified threshold, preventing binding.	Force testing demonstrated binding would not occur and force was less than a 1.5N threshold.
Needle Path Verification: Needle path falls within design tolerances.	Needle guides were tested on test fixtures to ensure needle path falls within the design tolerances specified for the design.
Usability: Design conforms to user needs and intended use.	Simulated use evaluations were performed by customers to ensure the design of the needle guide conforms to the user needs and intended use. (Details on specific metrics or acceptance thresholds for usability are not provided beyond general conformance).

Study Details (Non-Clinical Performance Testing)

Given that this is a mechanical device submission, the "study" refers to non-clinical performance testing rather than clinical trials or AI/ML specific studies.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a numerical 'sample size' in the context of distinct cases or images like an AI dataset. Instead, the tests involved physical samples of the VitroPRO device and its components. For instance:
  - Biocompatibility: Samples of materials used in the device.
  - Cover breach/probe damage, Retention/movement, Needle drag, Needle path verification: Likely multiple physical units of the device tested under controlled conditions.
- Data Provenance: The data comes from internal non-clinical performance testing conducted by CIVCO Medical Instruments Co., Inc. The country of origin of the data would be the US, as the company is based in Kalona, IA. The data is prospective in the sense that these tests were performed specifically for this 510(k) submission to demonstrate performance.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable in the context of establishing "ground truth" for diagnostic interpretation in the way it is used for AI/ML or image analysis. These tests are engineering performance validations, where "ground truth" is established by physical measurement standards and engineering specifications rather than expert interpretation of medical data.
- For "Simulated Usability Testing," it states "customers" performed evaluations. The number and specific qualifications (beyond being target users/clinicians) are not detailed.
Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like "2+1" or "3+1" are used for resolving disagreements among human reviewers (e.g., radiologists) in diagnostic studies, especially for establishing ground truth from image interpretations. For mechanical performance testing, results are typically objective measurements against predefined engineering specifications.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. As the VitroPRO is a mechanical needle guide and not an AI/ML diagnostic tool, an MRMC study is not relevant or required for its clearance.
- Therefore, there is no effect size reported for human readers improving with or without AI assistance.
If a Standalone (algorithm only without human-in-the-loop performance) was done:
- No, a standalone assessment was not done. This type of assessment is for AI/ML algorithms operating independently. The VitroPRO is a mechanical device, not an algorithm.
The Type of Ground Truth Used:
- For the non-clinical performance tests, "ground truth" refers to engineering specifications, physical measurements, and well-defined pass/fail criteria established through standard testing methodologies (e.g., ISO, internal engineering standards).
- For Biocompatibility: Adherence to ISO 10993 standards and a "bio-response" indicating safety.
- For Mechanical Tests (e.g., Retention, Needle Drag, Needle Path): Measured forces, paths, or absence of damage against predefined numerical thresholds and design specifications.
- For Usability: User feedback and confirmation that the design meets user needs, although specific metrics are not detailed.
The Sample Size for the Training Set:
- Not applicable. There is no "training set" as this is not an AI/ML device.
How the Ground Truth for the Training Set was Established:
- Not applicable. There is no "training set."

In summary, the provided document is a 510(k) summary for a mechanical medical device, not an AI/ML-driven diagnostic tool. Therefore, the "acceptance criteria" and "study" are defined by non-clinical engineering and biocompatibility testing designed to demonstrate substantial equivalence to a predicate device, rather than the complex clinical or artificial intelligence performance metrics often associated with AI/ML systems.

Summary

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November 22, 2022

Image /page/0/Picture/1 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

CIVCO Medical Instruments Co., Inc. % Jim Leong Regulatory Affairs Manager 102 First Street South KALONA IA 52247

Re: K222052

Trade/Device Name: VitroPRO Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: Class II Product Code: ITX, MOE Dated: October 14, 2022 Received: October 24, 2022

Dear Jim Leong:

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 (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 located 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.

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 803) for

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devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.

Yanna S. Kang -S

Yanna Kang, Ph. D. Assistant Director Mammography and Ultrasound Team DHT 8C: 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)

K222052 Device Name VitroPRO

Indications for Use (Describe)

This device provides physicians with a tool for performing needle/instrument guided procedures with the use of diagnostic ultrasound endocavity transducers.

· Transvaginal Diagnostic ultrasound needle / instrument guided procedures such as tissue biopsy fluid aspiration, catheter placement, treatment, and oocyte retrieval.
· Transrectal Diagnostic ultrasound needle / instrument guided procedures such as tissue biopsy, fluid aspiration, catheter placement, treatment.

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

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

The assigned 510(k) numberis: K222052 .

1. Submitter's Identifications:

Establishment:	CIVCO Medical Instruments Co., Inc.
Address:	102 First Street SouthKalona, IA 52247
Registration Number:	1937223
Operations ManufacturerOwner/Operator:	CIVCO Medical Instruments Co., Inc.
Owner/Operator Number:	1937223
Contact Person:	Jim Leong
Phone:	319-248-6502
e-mail:	James.Leong@civco.com

2. Date 510(k) Summary Prepared: July 5, 2022

3. Name of the Subject Device and Classification Information:

Trade/Device Name	VitroPRO / Disposable Endocavity Needle Guide
Regulation Number	21 CFR 892.157021 CFR 884.6100
Classification Name	Diagnostic ultrasonic transducer Assisted reproduction needles Class II
Regulatory Class	ITX & MQE
Product Code

4. Information for the Predicate Device:

Tradename/Device Name	Disposable Endocavity Needle / Biopsy Guide
Manufacturer	CIVCO Medical Instruments Co., Inc.
510(k) Number	K970514
Regulation Number	892.1570
Classification Name	Diagnostic ultrasonic transducer
Regulatory Class	II
Product Code	ITX

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5. Information for Reference Device:

Tradename/Device Name	Embryon® Ultrasound Needle Guides
Manufacturer	Rocket Medical PLC
510(k) Number	K032015
Regulation Number	884.6100
Regulation Number	892.1560
Classification Name	Diagnostic ultrasonic transducer
Regulatory Class	II
Product Code	MQE & IYO

6. Device Description:

7. Intended Use / Indications for Use:

This device provides physicians with a tool for performing needle/instrument guided procedures with the use of diagnostic ultrasound endocavity transducers.

. Transvaginal - Diagnostic ultrasound needle / instrument guided procedures such as tissue biopsy, fluid aspiration, catheter placement, treatment, and oocyte retrieval.
Transrectal Diagnostic ultrasound needle / instrument guided procedures such as tissue biopsy, ● fluid aspiration, catheter placement, treatment.

Item	Subject DeviceCIVCO DisposableEndocavity Needle GuideK21XXXX	Predicate DeviceCIVCO DisposableEndocavity UltrasoundNeedle / Biopsy GuideK970514
Material	ABS Thermoplastic	ABS Thermoplastic
Cannula: Stainless Steel	Cannula: StainlessSteel

8. Comparison to Legally Marketed Device

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Item	Subject DeviceCIVCO DisposableEndocavity Needle GuideK21XXXX	Predicate DeviceCIVCO DisposableEndocavity UltrasoundNeedle / Biopsy GuideK970514
Biocompatibility	All materials have met therequirements of ISO 10993-1for biocompatibility.Meets ISO 10993-1biocompatibilityrequirements for limitedcontact duration:• surface devices ofbreached orcompromised surface• Externallycommunicating tissuebone/dentinDemonstrated to be non-toxic,non-sensitizing, non-irritating,(not labeled non-pyrogenic)	All materials have met therequirements of ISO 10993-1for biocompatibility.Meets ISO 10993-1biocompatibilityrequirements for limitedcontact duration:• surface devices ofbreached orcompromised surface• Externalcommunicatingindirect bloodpath/tissue contactDemonstrated to be non-toxic,non-sensitizing, non-irritating,non-hemolytic, and non-pyrogenic
Sterilization	Ethylene Oxide	Ethylene Oxide
Shelf-life	3 years	3 years
Accessory	None provided. Intendeduser to provide cover andguides which are IVF usecleared.	Ultrasound gel packet andcovers.

1. Comparison of Indications to the Legally Marketed Device:
  The proposed endocavity needle guides have the same intended use. The language used has been updated for clarity and to add an additional indication for use for oocyte retrieval. The differences in the indications for use statement would not affect the safety or effectiveness of the device because the safety and efficacy related to the indicated procedures is dictated by the use of the underlying ultrasound equipment. Any questions related to safety and effectiveness of the endocavity guides have been addressed using the same testing performed by the legally marketed device, including updated biocompatibility evaluations.

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10. Summary of Non-Clinical Tests Performed:

. Biocompatibility:
The disposable endocavity needle guides devices met ISO 10993-1 biocompatibility requirements for limited contact duration for surface devices of breached or compromised surface and external communicating tissue/bone/dentin contact:
Cytotoxicity ISO 10993-5 —
-Sensitization - ISO 10993-10
Irritation ISO 10993-10 -
Cover breach and probe damage testing ●

Water leak testing was performed to demonstrate material attachment of needle guide to over a cover did not cause damage to cover or probe.

Retention and movement testing Force testing was performed on needle guide attachment to ensure a minimum force of 8N would not cause the guide to dislodge.
Needle drag testing

Force testing was performed by passing a cannula through the needle guide to ensure binding would not occur and force was less than a 1.5N threshold.

Needle path verification testing . Needle guides were tested on test fixtures to ensure needle path falls within the design tolerances specified for the design.
Simulated Usability Testing Simulated use evaluations were performed by customers to ensure the design of the needle guide conforms to the user needs and intended use.

11. Clinical Test Performed:

Clinical tests were not required to demonstrate substantial equivalence.

12. Conclusions:

The disposable endocavity needle guide devices have intended use and its technological characteristics do not raise any different questions of safety or effectiveness, as compared to the legally marketed device. The addition of oocyte harvesting to the indications for use have been tested to show the devices are safe for such usage. Therefore, the endocavity needle guides are substantially equivalent to the legally marketed disposable endocavity needle guide devices marketed by CIVCO.

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.