(164 days)
The Triopsy Biopsy System (instrument and needles) is intended for use in obtaining biopsies from the prostate.
The Triopsy Medical Actuator and Biopsy Needle is comprehensive system that aids in the diagnosis and treatment planning of prostate cancer. The system utilizes an actuator instrument and biopsy needle (disposable) with the intention of gathering prostate tissue and properly identifying its pathology. The needle collects full-length, unbroken apex-to-base core samples with patented ridges that hold and protect the sample's integrity. The actuator allows for variable sample lengths for each area of the prostate to be biopsied increasing accuracy and patient safety by avoiding under or overshooting.
This FDA 510(k) summary describes the Triopsy Biopsy System, consisting of the Triopsy Actuator and Triopsy Biopsy Needles, intended for obtaining prostate biopsies. The submission leverages a comparison to a predicate device, the Bard Magnum Reusable Core Biopsy Instrument & Bard Magnum Disposable Biopsy Core Needle (K934370 & K934371), to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly present a table of acceptance criteria with corresponding performance metrics in a clear, quantitative manner. Instead, it lists performance requirements that were verified and states that the device "successfully passed all of the results."
Inferred Acceptance Criteria based on the provided text:
| Acceptance Criterion (Inferred from "performance requirements") | Reported Device Performance |
|---|---|
| Depth Projection | Verified |
| Mechanical Durability | Verified |
| Penetration | Verified |
| Activation Force (Spring) | Verified |
| Sample Extraction | Verified |
| Human Factors/Usability (under clinical conditions) | Validated intended use |
The document concludes that the device is "safe, effective, and performs as well or better than the predicate device," and that "technological differences do not introduce or raise new or different questions of safety and effectiveness."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the verification and validation (V&V) testing (e.g., how many biopsy procedures were simulated, how many actuations were performed for mechanical durability, or how many users participated in human factors studies).
The data provenance is also not explicitly stated in terms of country of origin or whether studies were retrospective or prospective. Given the nature of performance testing (mechanical, human factors), these are typically prospective studies performed in a controlled environment (e.g., a lab or simulated clinical setting).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish a ground truth for the non-clinical and human factors studies described. These types of tests typically rely on objective measurements and established standards rather than expert consensus on diagnostic outcomes. For pathological evaluation of biopsy samples, there is no mention of experts, suggesting the focus was on the physical characteristics of the sample (e.g., full-length, unbroken) rather than the diagnostic accuracy of the device in a clinical context.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method as it pertains to expert reviews of images or data to establish ground truth. The testing mentioned (depth projection, mechanical durability, etc.) would be assessed against predefined engineering specifications and performance targets, not requiring an adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not conducted, or at least not described in this 510(k) summary. These studies typically assess human reader performance with and without AI assistance, which is not relevant to the mechanical and usability testing described for this biopsy system.
6. Standalone Performance Study
A standalone performance study was not conducted in the sense of an algorithm-only performance to derive diagnostic metrics like sensitivity or specificity. The device is a mechanical biopsy system, not an AI or imaging-based diagnostic algorithm. The "standalone" performance here refers to the device's ability to consistently perform its intended mechanical functions (e.g., penetration, sample extraction) and meet safety requirements. The document indicates that the device's performance requirements were verified through performance testing.
7. Type of Ground Truth Used
For the non-clinical tests:
- Engineering specifications and objective measurements were used as the "ground truth" to verify performance criteria such as depth projection, mechanical durability, penetration, activation force, and sample extraction.
- For human factors studies, the "ground truth" was likely the successful and safe completion of tasks by intended users in simulated clinical scenarios, as evaluated against predefined usability criteria.
There is no mention of pathology, outcomes data, or expert consensus serving as a ground truth for diagnostic accuracy, as this submission focuses on the safety and performance of the biopsy instrument itself, not its diagnostic outcome directly.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable to this submission, as the Triopsy Biopsy System is a mechanical device, not a machine learning or AI-driven system that requires training data.
9. How the Ground Truth for the Training Set Was Established
As noted above, a training set is not applicable, so the establishment of ground truth for a training set is not relevant to this submission.
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January 10, 2025
Triopsy Medical, Inc. % John Mann Chief Executive Officer Insight Navigation LLC 501 N Ford Street Golden, Colorado 80403
Re: K242228
Trade/Device Name: Triopsy Actuator (TMSDGB); Triopsy Biopsv Needle (BN-1825-36-01): Triopsy Biopsy Needle (BN-1825-55-01) Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology-Biopsy Instrument Regulatory Class: Class II Product Code: KNW, FCG Dated: December 9, 2024 Received: December 9, 2024
Dear John Mann:
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/ofdocs/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.
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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 (OS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
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 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-regulatory
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assistance/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,
Mark J. Antonino -S
Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology, and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Triopsy Actuator (TMSDGB);
Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01)
Indications for Use (Describe)
The Triopsy Biopsy System (instrument and needles) is intended for use in obtaining biopsies from the prostate.
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) #: | K242228 |
|---|---|
| ----------- | --------- |
| K242228 Page 1 of 2 | |
|---|---|
| Prepared on: 2024-12-07 |
| Contact Details | 21 CFR 807.92(a)(1) |
|---|---|
| ----------------- | --------------------- |
| Applicant Name | Triopsy Medical, Inc. |
|---|---|
| Applicant Address | 151 St. Andrews Ct. Mankato MN 56001 United States |
| Applicant Contact Telephone | (804) 677-8527 |
| Applicant Contact | Dr. David Bostwick |
| Applicant Contact Email | dbostwick@triopsy.com |
| Correspondent Name | Insight Navigation LLC |
| Correspondent Address | 501 N Ford St Golden CO 80403 United States |
| Correspondent Contact Telephone | 7208082416 |
| Correspondent Contact | Mr. John Mann |
| Correspondent Contact Email | john@insightnav.com |
| Device Name | 21 CFR 807.92(a)(2) |
|---|---|
| ------------- | --------------------- |
| Device Trade Name | Triopsy Actuator (TMSDGB);Triopsy Biopsy Needle (BN-1825-36-01);Triopsy Biopsy Needle (BN-1825-55-01) |
|---|---|
| Common Name | Gastroenterology-urology biopsy instrument |
| Classification Name | Instrument, Biopsy |
| Regulation Number | 876.1075 |
| Product Code(s) | KNW, FCG |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) |
|---|---|
| ------------------------------------ | --------------------- |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K934370 | Magnum Reusable Core Biopsy Instrument | KNW |
| K934371 | Magnum Needle | FCG |
| Device Description Summary | 21 CFR 807.92(a)(4) |
|---|---|
| ---------------------------- | --------------------- |
The Triopsy Medical Actuator and Biopsy Needle is comprehensive system that aids in the diagnosis and treatment planning of prostate
cancer. The system utilizes an actuator instrument and biopsy needle (disposable) with the intention of gathering prostate tissue and
properly identifying its pathology. The needle collects full-length, unbroken apex-to-base core samples with patented ridges that holdproperly identifying its pathology. The needle collects full-length, unbroken apex-to-base core samples with patented ridges that hold and protect the sample's integrity. The actuator allows for variable sample lengths for each area of the prostate to be biopsied increasing accuracy and patient safety by avoiding under or overshooting.
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Intended Use/Indications for Use
The Triopsy Biopsy System (instrument and needles) is intended for use in obtaining biopsies from the prostate.
Indications for Use Comparison
The subject and the predicate device have similar indications for use statements and intended use for acquisition of core biopsy samples, device is prescription only.
Technological Comparison
There are no differences between the indications for use of the predicate, Bard Magnum Reusable Core Biopsy Instrument & Bard Magnum Disposable Biopsy Core Needle (K934370 & K934371) and the subject device The Triopsy™ Reusable Biopsy" Single-Use Biopsy Needle. The primary differences between the predicate Bard Magnum Reusable Core Biopsy Instrument & Bard Magnum Disposable Biopsy Core Needle (K934370 & K934371) and the subject device The Triopsy™ Reusable Biopsy " Single-Use Biopsy Needle are the variable penetration depth setting of the Triopsy™ Actuator and the sample length notch of the Triopsy™ Needles. Based on substantial equivalence testing neither of these differences raise new questions of safety or efficacy.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807,92(b)
The performance requirements of the device were verified through performance with the intended use of the device and in accordance with the FDA Guidance Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology (February 1993) including:
- Depth Projection -
- Mechanical Durability -
- -Penetration
- -Activation Force (Spring)
- -Sample Extraction
In Addition, Following FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices (February 3, 2016), the human factors studies were conducted with the intended user population, use scenarios to simulate clinical conditions. Results of the human factors testing demonstrate validation of the intended use. In addition,
Not Applicable
The Triopsy™ Reusable Biopsy Actuator & Triopsy™ Single-Use Biopsy Needle was verified and validated in accordance with 21 CFR §820.30. Testing was completed to demonstrate substantial equivalence and that any technological differences do not raise new or different questions of safety and effectiveness. The device succesfully passed all of the results demonstrate the device is safe, effective, and performs as well or better than the predicate device. The differences between the subject device do not introduce or raise concerns regarding the safe and effective use of the subject device.
The subject device, Triopsy™ Reusable Biopsy Mingle-Use Biopsy Needle, is substantially equivalent to the legally marketed predicate device, Bard Magnum Reusable Core Biopsy Instrument & Bard Magnum Disposable Biopsy Core Needle (1934370 & K934371) with respect to the intended use/indications for use, target populations, treatment method, and technological characteristics.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.