(133 days)
No
The summary describes a mechanical needle guide accessory for ultrasound transducers and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a needle guide used for diagnostic and interventional procedures, not for treatment or therapy itself.
No
This device is described as a needle guide used for procedures with diagnostic ultrasound endocavity transducers, not as a diagnostic device itself. Its purpose is to direct needles or instruments, facilitating procedures like biopsies and aspirations, which can be part of a diagnostic process, but the device itself does not perform diagnosis.
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 physical properties like biocompatibility, retention, and needle path verification, further indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: This device is a needle guide used during a medical procedure (biopsy, aspiration, etc.) to direct instruments within the body, guided by ultrasound. It facilitates the collection of specimens or the placement of instruments, but it does not perform any diagnostic testing on those specimens itself.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or any other typical IVD functions.
The device is a surgical accessory or procedural guide used in conjunction with diagnostic ultrasound, but it is not a diagnostic device itself.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
ITX, MQE
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.
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)
- 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. Tests included Cytotoxicity ISO 10993-5, Sensitization ISO 10993-10, and 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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 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)
| 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 .
-
- 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 |
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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:
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. |
-
- 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.
- Comparison of Indications to the Legally Marketed Device:
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.