(151 days)
Not Found
No
The device description and performance studies focus on the physical properties and biological safety of a disposable needle guide, with no mention of AI or ML capabilities.
No.
The device is a needle guide used for diagnostic ultrasound-guided procedures such as biopsies and fluid aspirations, which are often diagnostic rather than directly therapeutic. While some mentioned procedures like "treatment" could involve therapeutic actions, the primary function of the device itself as a guide is not to provide therapy.
No
The device is a needle guide used in conjunction with "diagnostic ultrasound endocavity transducers" for procedures like biopsies and aspirations. It facilitates the procedure but does not perform the diagnostic function itself. The diagnostic function is carried out by the ultrasound transducer.
No
The device description explicitly states it is a "disposable endocavity needle guide," which is a physical hardware component used to direct needles. The performance studies also focus on biological and chemical testing of this physical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this device is used to guide needles and instruments within the body during procedures like biopsies, aspirations, and placements. It is a tool for performing procedures on the patient, not for analyzing samples from the patient.
- The performance studies focus on biocompatibility and safety. The tests mentioned (Mouse Embryo Assay and Limulus Amebocyte Lysate) are related to the safety and biological compatibility of the device itself, not its ability to diagnose a condition based on analyzing a sample.
Therefore, this device falls under the category of a surgical or procedural accessory, not an IVD.
N/A
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 quided 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.
Product codes (comma separated list FDA assigned to the subject device)
ITX, MQE
Device Description
The VitroPRO 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Diagnostic ultrasound
Anatomical Site
Transvaginal, Transrectal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians
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)
The disposable endocavity needle guides devices met acceptance threshold requirements and show passing results to the following testing performed:
Mouse Embryo Assay (MEA) - One-cell mouse embryos were incubated in extracts of the subject device and cultured at 37 °C. The percent of embryos developed to the expanded blastocyst stage within 96-hours was assessed in comparison to the control group.
Limulus Amebocyte Lysate (LAL) testing per USP 161.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The acceptance criterion for the 1-Cell MEA was ≥80% embryos expanded to blastocyst at 96 hours.
The acceptance criterion for LAL was ≤ 20 EU/device.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
November 14, 2023
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" in blue, with the word "ADMINISTRATION" in a smaller font size below it.
CIVCO Medical Instruments Co., Inc. % James Leong Regulatory Affairs Manager 102 First Street South KALONA IA 52247
Re: K231783
Trade/Device Name: VitroPRO Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: Class II Product Code: ITX, MQE Dated: November 7, 2023 Received: November 7, 2023
Dear James 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 (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 (QS) 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 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/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 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-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 Assistant Director Mammography and Ultrasound Team 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
2
Indications for Use
Submission Number (if known)
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 quided 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: K231783
-
- Submitter's Identifications:
| Establishment:
Address: | CIVCO Medical Instruments Co., Inc.
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: June 12, 2023
- Name of the Subject Device and Classification Information:
| Trade/Device Name | VitroPRO |
|---|---|
| Regulation Number | 21 CFR 892.1570 |
| Classification Name | Diagnostic ultrasonic transducer |
| Assisted reproduction needles | |
| Regulatory Class | Class II |
| Product Code | ITX & MQE |
4. Information for the Predicate Device:
| Tradename/Device Name | VitroPRO |
|---|---|
| Manufacturer | CIVCO Medical Instruments Co., Inc. |
| 510(k) Number | K222052 |
| Regulation Number | 892.1570 |
| Classification Name | Diagnostic ultrasonic transducer |
| Regulatory Class | II |
| Product Code | ITX & MQE |
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5. Device Description:
The VitroPRO 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.
6. 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
VitroPRO Disposable
Endocavity Needle Guide
K23XXXX | Predicate Device
VitroPRO Disposable
Endocavity Needle Guide
K222052 |
|------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Same | ABS Thermoplastic |
| | Cannula: Same | Cannula: Stainless
Steel |
| Biocompatibility | Same | 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- |
7. Comparison to Legally Marketed Device
5
| Item | Subject Device
VitroPRO Disposable
Endocavity Needle Guide
K23XXXX | Predicate Device
VitroPRO Disposable
Endocavity Needle Guide
K222052 |
|-----------------------------------|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| | | pyrogenic |
| Mouse Embryo
Assay (MEA) | Demonstrated to be non-
toxic for exposure to embryo
development. | N/A |
| Limulus Amebocyte
Lysate (LAL) | Demonstrated to be within
accepted specification for
endotoxin units for exposure. | N/A |
| Sterilization | Same | Ethylene Oxide |
| Shelf-life | Same | 3 years |
| Accessory | Same | None provided. |
8. Comparison of Indications to the Legally Marketed Device:
The proposed endocavity needle guides have the same intended use and indications for use. The labeling has been updated to add additional claims for use with oocyte retrieval. The addition to the labeling would not affect the safety or effectiveness of the device. Any questions related to compliance to the expanded labeling claims safety and effectiveness of the endocavity guides have been addressed using the testing provided showing devices meet acceptance criteria for mouse embryo assay (MEA) and limulus amobocyte lysate (LAL) tests.
9. Summary of Non-Clinical Tests Performed:
The disposable endocavity needle guides devices met acceptance threshold requirements and show passing results to the following testing performed:
- | Mouse Embryo Assay (MEA) - One-cell mouse embryos were incubated in extracts of the subject device and cultured at 37 °C. The percent of embryos developed to the expanded blastocyst stage within 96-hours was assessed in comparison to the control group. The acceptance criterion for the 1-Cell MEA was ≥80% embryos expanded to blastocyst at 96 hours.
- | Limulus Amebocyte Lysate (LAL) testing per USP 161. The acceptance criterion was ≤ 20 EU/device.
10. 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 endocvity
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needle guides are substantially equivalent to the legally marketed disposable endocavity needle guide devices marketed by CIVCO.