(86 days)
No
The device description and performance studies focus on mechanical and material properties of a needle guide, with no mention of AI/ML or image processing capabilities.
No.
The device is a needle guide used for biopsies and minimally invasive punctures, which are diagnostic and procedural tools, not therapeutic interventions.
No
This device is a needle guide used for instrument placement to access anatomical structures for biopsy procedures. While biopsies are used to provide samples for diagnosis, the device itself is a tool for obtaining the sample, not for performing the diagnosis.
No
The device description explicitly states it is a "needle guide" and describes physical components and mechanical testing (force testing, assembly/removal force, etc.), indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "instrument placement to access anatomical structures under transrectal ultrasound guidance" for procedures like biopsy and minimally invasive puncture of the prostate. This describes a surgical or interventional procedure, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details a "needle guide" used in conjunction with an ultrasound probe to guide a needle for obtaining specimens from the prostate. This is a tool for a procedure, not a device that analyzes a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device facilitates the collection of a sample, but it doesn't perform the diagnostic test itself.
Therefore, the TP Pivot Pro™ needle guide is a medical device used for guiding instruments during a procedure, not an in vitro diagnostic device.
No
The clearance letter explicitly states: "FDA inadvertently indicated that the SE determination also included review and clearance of a predetermined change control plan (PCCP). However, your 510(k) submission did not include a PCCP, so FDA is providing this administrative correction." This clearly indicates that the device is not authorized under a PCCP.
Intended Use / Indications for Use
Device is intended to be used for instrument placement to access anatomical structures under transrectal ultrasound guidance.
- . Prostate - Biopsy and minimally invasive puncture
- . Surgical (Prostate) - Biopsy and minimally invasive puncture
Product codes
ITX
Device Description
The TP Pivot Pro™ needle guide is a tool for performing freehanded transperineal prostate biopsies, taking advantage of the transperineal path to sample regions of the prostate including the difficult to reach anterior zone. Used in conjunction with an ultrasound probe, users visualize suspect target areas of the prostate, plan and position an access site, and obtain specimens from a precise point in the prostate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
transrectal ultrasound
Anatomical Site
Prostate
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 TP Pivot Pro™ needle guide and accessories are manufactured with materials which meet ISO 10993-1 biocompatibility requirements for limited contact duration for surface devices of breached or compromised surface. These same materials are already utilized on CIVCO cleared medical devices for contact in the same regions. - Cytotoxicity testing in accordance with ISO 10993-5 O
- Sensitization testing in accordance with ISO 10993-10 O
- Irritation testing in accordance with ISO 10993-10 O
- Acute Systemic Toxicity testing in accordance with ISO 10993-11 O
- Material Mediated Pyrogen testing in accordance with ISO 10993-11 O
- Design specification: ●
The TP Pivot Pro™ needle guide and accessories have certain design functionality which was tested internally to verify they meet the established requirements. These criteria are listed as follows: - Guide Tangential Clocking force testing This test confirms that the guide O adequately attaches to the round probe such that it, once clamped, would not rotate around the probe in a typical use.
- O Guide Axial Loading force testing - This test confirms that the guide adequately attaches to the round probe such that it, once clamped, would not slide forward in a typical use.
- Guide Dislodge Force Test This test confirms that the guide adequately O attaches to the round probe such that it, once clamped, would not dislodge when a force is applied to the worst-case location that is furthest from the areas where the guide attaches to the probe.
- Needle Holder Force (horizontal) Test This test confirms that the force to o dislodge the needle holder from a clamped horizontal position shall be at the worst case position which is furthest from where the needle holder attaches to the guide.
- Needle Holder Force (angled) Test This test confirms that the force to o dislodge needle holder from a clamped, angled position of approximately 20° shall and applied at the worst case position which is furthest from where the holder attaches to the guide.
- Assemble/Removal Force with Neoguard Cover Test This tests the force o required to assemble the guide onto or remove the guide from the simulated probe with a Neoguard cover.
- Guide Clamp Knob Torque Test This test confirms that the guide is not O damaged when the user applies torque to the guide clamp knob to attach probe.
- Extract/Insert Needle Holder in Tower Force The force to extract/insert о the needle holder from/into the guide tower.
- Introducer needle initial insertion force The initial insertion force of the O introducer needle into the needle holder.
- Introducer needle In and out of the needle holder force test The force to O move the introducer needle into or out of the needle holder.
- 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.
- Guidance Standards
- The introducer needle was evaluated against BS EN ISO 9626:1995 and believe it complies with the standard.
Clinical tests were not required to demonstrate substantial equivalence.
- The introducer needle was evaluated against BS EN ISO 9626:1995 and believe it complies with the standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
FDA inadvertently indicated that the SE determination also included review and clearance of a predetermined change control plan (PCCP). However, your 510(k) submission did not include a PCCP, so FDA is providing this administrative correction.
§ 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
July 1, 2024
CIVCO Medical Solutions James Leong Regulatory Affairs Manager
102 First Street South Kalona, Iowa 52247
Re: K233109
Trade/Device Name: TP Pivot Pro™ Needle Guide Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: Class II Product Code: ITX
Dear James Leong:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on December 22, 2023. Specifically, FDA is updating this SE Letter because FDA inadvertently indicated that the SE determination also included review and clearance of a predetermined change control plan (PCCP). However, your 510(k) submission did not include a PCCP, so FDA is providing this administrative correction. Please see the attached revised clearance letter.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Yanna Kang, OHT8: Office of Radiological Health, (301)796-6704, Yanna.Kang@fda.hhs.gov.
Sincerely,
Yanna S. Kang -S
Yanna Kang, Ph.D. 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
1
Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
July 1, 2024
CIVCO Medical Solutions James Leong Regulatory Affairs Manager 102 First Street South Kalona, Iowa 52247
Re: K233109
Trade/Device Name: TP Pivot Pro™ Needle Guide Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: Class II Product Code: ITX Dated: September 25, 2023 Received: September 27, 2023
Dear James Leong:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on December 22, 2023.
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/cdrb/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.
2
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).
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 820.70) 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.
3
For comprehensive regulatory information about medical devices and radiation-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 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
4
Indications for Use
Submission Number (if known)
Device Name
TP Pivot Pro™ Needle Guide
Indications for Use (Describe)
Device is intended to be used for instrument placement to access anatomical structures under transrectal ultrasound quidance.
- · Prostate Biopsy and minimally invasive puncture.
- · Surgical (Prostate)- Biopsy and minimally invasive puncture.
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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5
510(k) Summary
This 510(k) Summary is prepared in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) numberis: _K233109 .
-
- 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 |
-
- Date 510(k) Summary Prepared: September 25, 2023
| 3. Name of the Subject Device and Classification Information: | |
|---|---|
| Trade/Device Name | TP Pivot Pro™ Needle Guide |
| Regulation Number | 21 CFR 892.1570 |
| Classification Name | Diagnostic ultrasonic transducer |
| Regulatory Class | Class II |
| Product Code | ITX |
-
- Information for the Predicate Device:
| Tradename/Device Name | PrecisionPoint Biopsy Needle Guide |
|---|---|
| Manufacturer | Corbin Clinical Resources, LLC |
| 510(k) Number | K160414 |
| Regulation Number | 892.1570 |
| Classification Name | Diagnostic ultrasonic transducer |
| Regulatory Class | Class II |
| Product Code | ITX |
6
5. Device Description:
The TP Pivot Pro™ needle guide is a tool for performing freehanded transperineal prostate biopsies, taking advantage of the transperineal path to sample regions of the prostate including the difficult to reach anterior zone. Used in conjunction with an ultrasound probe, users visualize suspect target areas of the prostate, plan and position an access site, and obtain specimens from a precise point in the prostate.
6. Intended Use / Indications for Use:
Device is intended to be used for instrument placement to access anatomical structures under transrectal ultrasound guidance.
- . Prostate - Biopsy and minimally invasive puncture
- . Surgical (Prostate) - Biopsy and minimally invasive puncture
7. Comparison to Legally Marketed Device
| Item | Subject Device
TP Pivot Pro™ Needle Guide
K233109 | Predicate Device
PrecisionPoint Needle
Guide K160414 |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | ABS Thermoplastic | Polymeric material |
| | Introducer needle – 304
stainless steel | Introducer needle –
304 stainless steel |
| Biocompatibility | Meets ISO 10993-1
biocompatibility
requirements for limited
contact duration:
• surface devices of
breached or
compromised surface
• externally
communicating
tissue/bone/dentin | Meets ISO 10993-1
biocompatibility
requirements for limited
contact duration:
• surface devices of
breached or
compromised surface |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Shelf-life | 1 year | 3 years |
| Accessory | Optional NeoGuard transducer
cover (K013721) | Users informed to use
transducer cover |
7
-
- Comparison of Indications to the Legally Marketed Device:
The TP Pivot Pro™ needle guide has the same basic intended use as the predicate, which is to place needle into and anatomical structure using an ultrasound transducer. CIVCO has further added the following indications for use for the TP Pivot Pro™ needle guide which is not specifically called out in the predicate.
- Comparison of Indications to the Legally Marketed Device:
-
· Prostate Biopsy and minimally invasive puncture
-
· Surgical (Prostate) Biopsy and minimally invasive puncture
9. Summary of Non-Clinical Tests Performed:
-
. Biocompatibility:
The TP Pivot Pro™ needle guide and accessories are manufactured with materials which meet ISO 10993-1 biocompatibility requirements for limited contact duration for surface devices of breached or compromised surface. These same materials are already utilized on CIVCO cleared medical devices for contact in the same regions. -
Cytotoxicity testing in accordance with ISO 10993-5 O
-
Sensitization testing in accordance with ISO 10993-10 O
-
Irritation testing in accordance with ISO 10993-10 O
-
Acute Systemic Toxicity testing in accordance with ISO 10993-11 O
-
Material Mediated Pyrogen testing in accordance with ISO 10993-11 O
-
Design specification: ●
The TP Pivot Pro™ needle guide and accessories have certain design functionality which was tested internally to verify they meet the established requirements. These criteria are listed as follows:
- Guide Tangential Clocking force testing This test confirms that the guide O adequately attaches to the round probe such that it, once clamped, would not rotate around the probe in a typical use.
- O Guide Axial Loading force testing - This test confirms that the guide adequately attaches to the round probe such that it, once clamped, would not slide forward in a typical use.
- Guide Dislodge Force Test This test confirms that the guide adequately O attaches to the round probe such that it, once clamped, would not dislodge when a force is applied to the worst-case location that is furthest from the areas where the guide attaches to the probe.
- Needle Holder Force (horizontal) Test This test confirms that the force to o dislodge the needle holder from a clamped horizontal position shall be at the worst case position which is furthest from where the needle holder attaches to the guide.
- Needle Holder Force (angled) Test This test confirms that the force to o dislodge needle holder from a clamped, angled position of approximately 20° shall and applied at the worst case position which is furthest from where the holder attaches to the guide.
8
- Assemble/Removal Force with Neoguard Cover Test This tests the force o required to assemble the guide onto or remove the guide from the simulated probe with a Neoguard cover.
- Guide Clamp Knob Torque Test This test confirms that the guide is not O damaged when the user applies torque to the guide clamp knob to attach probe.
- Extract/Insert Needle Holder in Tower Force The force to extract/insert о the needle holder from/into the guide tower.
- Introducer needle initial insertion force The initial insertion force of the O introducer needle into the needle holder.
- Introducer needle In and out of the needle holder force test The force to O move the introducer needle into or out of the needle holder.
- 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.
- Guidance Standards
- The introducer needle was evaluated against BS EN ISO 9626:1995 and believe it complies with the standard.
10. Clinical Test Performed:
Clinical tests were not required to demonstrate substantial equivalence.
11. Conclusions:
The TP Pivot Pro™ needle guide has the same intended use as compared to the legally marketed device. The design differences do not additional risk to the use of the Therefore, the TP Pivot Pro™ needle guide is substantially equivalent to the device. legally marketed PrecisionPoint needle guide marketed by Corbin Clinical Resources, LLC.