Who is the manufacturer of VitroPRO?

CIVCO Medical Instruments Co., Inc. filed the 510(k) submission for VitroPRO (K222052).

What is the FDA product code for VitroPRO?

ITX. It is classified under 21 CFR 892.1570 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for VitroPRO?

510(k) clearance (submission type: Traditional).

What are the predicate devices for VitroPRO?

Disposable Endocavity Ultrasound Needle / Biopsy Guide (K970514).

Who can help prepare an FDA 510(k) submission like VitroPRO?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

VitroPRO

K222052 · CIVCO Medical Instruments Co., Inc. · ITX · Nov 22, 2022 · Radiology

Device Facts

Record ID	K222052
Device Name	VitroPRO
Applicant	CIVCO Medical Instruments Co., Inc.
Product Code	ITX · Radiology
Decision Date	Nov 22, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1570
Device Class	Class 2

Intended 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.

Device Story

Disposable endocavity needle guide; attaches to ultrasound transducer to direct needles/instruments along fixed path. Used in transvaginal/transrectal procedures (biopsy, fluid aspiration, catheter placement, oocyte retrieval). Operated by physicians in clinical settings. Device ensures needle path accuracy and stability during ultrasound-guided interventions. Benefits include precise instrument placement and reduced risk of procedure-related complications. No electronic components; purely mechanical guidance tool.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including biocompatibility (ISO 10993-5, ISO 10993-10), cover/probe damage testing, retention force testing (min 8N), needle drag force testing (<1.5N), needle path verification, and simulated usability testing.

Technological Characteristics

Materials: ABS thermoplastic, stainless steel cannula. Principle: Mechanical needle/instrument guidance for ultrasound transducers. Sterilization: Ethylene Oxide. Shelf-life: 3 years. No electronic or software components.

Indications for Use

Indicated for physicians performing needle/instrument guided procedures using diagnostic ultrasound endocavity transducers, including transvaginal (biopsy, fluid aspiration, catheter placement, treatment, oocyte retrieval) and transrectal (biopsy, fluid aspiration, catheter placement, treatment) procedures.

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

Disposable Endocavity Ultrasound Needle / Biopsy Guide (K970514)

Reference Devices

Embryon® Ultrasound Needle Guides (K032015)

Related Devices

K231783 — VitroPRO · CIVCO Medical Instruments Co., Inc. · Nov 14, 2023
K970514 — DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDE · CIVCO Medical Instruments Co., Inc. · Jun 20, 1997
K971722 — TRANS VAGINAL NEEDLE GUIDE · Protek Medical Products, Inc. · Jul 10, 1997
K955668 — INTRACAVITY NEEDLE GUIDE KIT · Arlanda Medicinska Instrument Co. AB · Jul 30, 1997
K971115 — GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE · Protek Medical Products, Inc. · Jun 13, 1997

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |---------------------------------------------------------------------------|--------------------------------------------------------------------------| |---------------------------------------------------------------------------|--------------------------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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 South Kalona, IA 52247 | | Registration Number: | 1937223 | | Operations Manufacturer Owner/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 892.1570 21 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 | {4}------------------------------------------------ # 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: 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. # 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 Device CIVCO Disposable Endocavity Needle Guide K21XXXX | Predicate Device CIVCO Disposable Endocavity Ultrasound Needle / Biopsy Guide K970514 | |--------------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | Material | ABS Thermoplastic | ABS Thermoplastic | | Cannula: Stainless Steel | Cannula: Stainless Steel | | # 8. Comparison to Legally Marketed Device {5}------------------------------------------------ | Item | Subject Device CIVCO Disposable Endocavity Needle Guide K21XXXX | Predicate Device CIVCO Disposable Endocavity Ultrasound Needle / Biopsy Guide K970514 | |------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Biocompatibility | All materials have met the requirements of ISO 10993-1 for biocompatibility. Meets ISO 10993-1 biocompatibility requirements for limited contact duration: • surface devices of breached or compromised surface • Externally communicating tissue bone/dentin Demonstrated to be non-toxic, non-sensitizing, non-irritating, (not labeled non-pyrogenic) | All materials have met the requirements of ISO 10993-1 for biocompatibility. Meets ISO 10993-1 biocompatibility requirements for limited contact duration: • surface devices of breached or compromised surface • External communicating indirect blood path/tissue contact Demonstrated 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. Intended user to provide cover and guides which are IVF use cleared. | Ultrasound gel packet and covers. | - 9. 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. {6}------------------------------------------------ ## 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.