AprioCore plus is intended for use in obtaining core biopsy specimens from soft tissue such as breast, kidney, liver, lung, thyroid, lymph nodes and various soft tissue masses performed under image guidance techniques for soft tissue biopsy.

Device Description

AprioCore plus is a manually operated, sterile, single use, semi-automatic, spring-loaded biopsy needle. AprioCore plus is provided in a variety of sizes (gauge and length) and is compatible with AprioMed devices Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle.

AI/ML Overview

The provided document is a 510(k) summary for the AprioCore plus, a semi-automatic, spring-loaded biopsy needle. The purpose of this summary is to demonstrate substantial equivalence to a predicate device (Quick-Core Biopsy Needle, K973565). The document primarily focuses on non-clinical and bench testing to establish this equivalence, rather than clinical studies involving human subjects or AI algorithms.

Therefore, many of the requested elements regarding acceptance criteria for AI performance, sample sizes for test sets in clinical studies, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, and training set details are not applicable to this submission.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail format alongside reported performance for each criterion. Instead, it states that "Conformity has been demonstrated" for various performance characteristics by comparing the subject device (AprioCore plus) to the predicate device (Quick-Core Biopsy Needle). The acceptance for each test appears to be that the subject device performs "equivalent to" or "equal or lower" or "equivalent or higher" than the predicate, or that it successfully meets a functional goal (e.g., "will not extend over the stylet tip", "can successfully retrieve biopsy specimen").

Table: Acceptance Criteria and Reported Device Performance (as inferred from the text)

Test	Acceptance Criteria (Inferred)	Reported Device Performance
Depth projection	Subject device will not extend over the stylet tip (over-throw) during use.	Conformity has been demonstrated.
Penetration force	Penetration force of the subject device is equivalent to or lower than the predicate device.	Conformity has been demonstrated.
Loading force	Loading force of the subject device is equivalent to the predicate device and the user is able to load the device.	Conformity has been demonstrated.
Activation force	Force to activate the subject device is not too low, preventing unintentional activation, and is equivalent to or higher than the predicate device.	Conformity has been demonstrated.
Mechanical durability	Subject device withstands the forces applied during normal use.	Conformity has been demonstrated.
Tissue sample extraction test	Subject device can successfully retrieve biopsy specimen multiple times.	Conformity has been demonstrated.
Tip configuration	Subject device has a tip dead-space that is shorter compared to the predicate device, allowing biopsy closer to sensitive anatomy/structure.	Conformity has been demonstrated.
Visibility	Invasive part of subject device is visible in CT, Fluoroscopy, and Ultrasound.	Conformity has been demonstrated.
Compatibility	Device is compatible with coaxial needle standardized sizes as per ISO 9626. Compatible with AprioMed Gangi-SoftGuard and Gangi-HydroGuard.	Conformity has been demonstrated.
Qualification metal tubing/needle component	Stainless-steel tubing fulfills the requirement in ISO 9626.	Conformity has been demonstrated.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes bench testing, not a clinical study with a "test set" in the context of diagnostic accuracy. Therefore, information about human subject sample size, data provenance, retrospective/prospective nature, or country of origin is not applicable. The "test set" refers to the physical devices and materials used in the bench tests. The specific number of devices or test repetitions for each bench test is not explicitly stated in the summary, though it notes that testing confirms the device meets design requirements.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the document describes bench testing for a physical medical device, not a diagnostic device requiring expert interpretation or ground truth establishment by clinical experts for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as the document describes bench testing for a physical medical device, not a diagnostic study requiring adjudication of expert readings.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a physical biopsy needle, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical biopsy needle, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the bench tests, the "ground truth" or reference for comparison was primarily the predicate device performance and recognized consensus standards (e.g., ISO 9626, ISO 10993). For example:

Activation force, Penetration force, Loading force, Specimen size: Comparison was directly against the predicate device.
Sterilization, Biocompatibility, Metal tubing: Compliance with international standards (ISO 11607-1, ISO 10993, ISO 9626).
Visibility, Depth projection, Mechanical durability, Tissue sample extraction, Compatibility: Demonstrated functional success against predefined requirements, likely derived from engineering specifications and predicate device characteristics.

8. The sample size for the training set

This is not applicable. The device is a physical medical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable. The device is a physical medical device, not an AI algorithm.

Summary

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Image /page/0/Picture/0 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 in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.

February 27, 2020

AprioMed AB Katrin Svensson Director, Quality and Regulatory Affairs Virdings Alle 28 Uppsala, Sweden 754 50

Re: K193268

Trade/Device Name: APrioCore plus Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: January 20, 2020 Received: January 22, 2020

Dear Katrin Svensson:

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

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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 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 (OS) 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,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193268

Device Name AprioCore plus

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X 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

As Required by 21 CFR 807.92(c) 510(k) Summary

5.1 Submitter/510(k) Holder

AprioMed AB Virdings Allé 28 Uppsala, SWEDEN 754 50

Contact Person: Katrin Svensson, Director Quality & Regulatory Affairs Telephone: +46 (0) 73- 345 14 40

Date Prepared: November 22, 2019

5.2 Device

Proprietary Name:	AprioCore plus
Common/Usual Names:	Instrument, Biopsy
Classification Names:	Instrument, Biopsy
Regulation number:	876.1075, Gastroenterology-Urology Biopsy Instrument
Product Code:	KNW
510(k) number:	TBD

5.3 Predicate Devices identification

Proprietary Name:	Quick-Core Biopsy Needle
Common/Usual Names:	Instrument, Biopsy
Classification Names:	Instrument, Biopsy
Regulation number:	876.1075, Gastroenterology-Urology Biopsy Instrument
Product Code:	KNW
510(k) number:	K973565

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5.4 Device Description

ર્સ્ડ Technological Characteristics

AprioCore plus is a spring-loaded semi-automatic biopsy needle that is visible in CT (computed tomography) and fluoroscopy. The device is equipped with a beveled needle with centimeter markings and an echogenic distal tip for visualization during ultrasound imaging.

During use, the position of the device is monitored using technique. The inner stylet is equipped with a slot (specimen notch) to collect a biopsy specimen. Compared to predicate device, AprioCore plus has a shorter tip, thereby making it possible to take a biopsy specimen closer to nearby sensitive anatomy/structure. The housing of the device has been designed to facilitate different hand positioning options during use.

The materials used for construction of AprioCore plus needles are typical for this type of medical device. The only material in direct patient contact is the stainless steel AISI 304 and stainless steel AISI 302.

5.6 Indications for Use

Substantial Equivalence 5.7

AprioMed AB has determined that AprioCore plus are substantially equivalent to the predicate device based on the indications for use, compliance with internationally recognized design and performance standards, material specifications, use environments, and performance. The differences between subject devices and the predicate device used for the same indications for use do not raise new issues of safety and effectiveness.

A substantial equivalence comparison table of subject devices. AprioCore plus and the predicate device, Quick-Core Biopsy Needle (K973565) is provided in Table 5-1.

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Parameter	Subject Devices	Predicate Device
Proprietary Name	AprioCore plus	Quick-Core Biopsy Needle
510(k)	This 510(k) application	K973565
Device ClassificationName	Biopsy needle	Biopsy needle
Product Code	KNW	KNW
Regulationdescription	Gastroenterology-Urology BiopsyInstrument	Gastroenterology-Urology BiopsyInstrument
Regulation Number	21 CFR 876.1075	21 CFR 876.1075
Intended/useIndications for Use	AprioCore plus is intended for use inobtaining core biopsy specimens from softtissue such as breast, kidney, liver, lung,thyroid, lymph nodes and various softtissue masses performed under imageguidance techniques for soft tissue biopsy.	Quick-Core Biopsy Needles are intendedfor soft tissue biopsy. The product isintended for use by physicians trained andexperienced in diagnostic andinterventional techniques. Standardtechnique for soft tissue biopsy should beemployed.
Anatomical sites	Specimens from soft tissue such asbreast, kidney, liver, lung, thyroid, lymphnodes and various soft tissue masses	Soft tissue biopsy
Device type	Semi-automatic biopsy gun, spring-operated	Semi-automatic biopsy gun, spring-operated
Visualizationtechnique	Conventional imaging guidance equipmentexcluding MRI	Conventional imaging guidance equipmentexcluding MRI
Single Use	Yes	Yes
Sterile	Yes, Ethylene Oxide	Yes, Ethylene Oxide
Needle material	Stainless Steel	Stainless Steel
Needle diameter(Gauge)	16G and 18G	14G, 16G, 18G and 20G
Needle length	8.5, 9.5, 13.5, 14.5, 18.5 and 19.5 cm	6, 9, 15 and 20 cm
Specimen notch size	10 mm and 20 mm	10 mm and 20 mm

Table 5-1: Substantial equivalence table

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5.7.1 Indication for Use

AprioMed has determined that the intended use of AprioCore plus are substantially equivalent to the predicate device.

5.7.2 Materials

AprioCore plus and the predicate device is constructed with medical grade stainless steel and the needle material fulfill the, by FDA, recognized consensus standard, ISO 9626 Stainless Steel Needle Tubing for the Manufacture of Medical Devices. AprioMed has concluded that the subject device is substantial equivalent to the predicate device.

5.7.3 Use Environment

AprioCore plus and the predicate device are used in the same clinical setting using conventional imaging guidance equipment excluding MRI. The users are physicians trained in percutaneous image-guided biopsy sampling of soft tissue. AprioMed has concluded that the subject device is substantial equivalent to the predicate device.

5.7.4 Size

AprioCore plus needle gauge size fulfill the, by FDA, recognized consensus standard, ISO 9626 Stainless Steel Needle Tubing for the Manufacture of Medical Devices. AprioMed has determined that the gauge, length and specimen notch size of AprioCore plus is substantially equivalent to the predicate device.

5.7.5 Activation force

Subject and predicate device was tested side-by-side to compare activation force. The activation force shall be equivalent or higher compared to the predicate device to prevent accidentally activation. AprioMed concluded that the subject device is substantial equivalent to the predicate device.

5.7.6 Penetration force

Subject and predicate device was tested side-by-side to compare penetration force. AprioCore plus shall have a penetration force that is equal or lower than corresponding penetration force of the predicate device, in order to cut through tissue easily. AprioMed concluded that the subject device is substantial equivalent to the predicate device.

5.7.7 Specimen size

Subject and predicate device was tested side-by-side to compare specimen extraction size by weight. AprioMed concluded that the subject device is substantial equivalent to the predicate device.

Summary of non-clinical and performance testing 5.8

Bench testing was performed to evaluate the performance and functionality of the subject device against requirement specification. The subject device has been subjected to compliance testing according to, by FDA, recognized consensus standards ISO 9626, ISO 10993-7, ISO 10993-1, ISO 11607-1. Results from testing performed confirms that the design requirement specification and user needs have been met. The subject device is confirmed to be safe and effective for the intended use.

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5.8.1 Sterilization and shelf life

AprioCore plus is delivered sterile and have successfully been tested according to ISO 11607-1. The label shelf life is 3 years.

5.8.2 Biocompatibility testing

AprioCore plus has successfully been tested for cytotoxicity, sensitization, intracutaneously irritation, acute systemic toxicity and material medicated pyrogenicity. The test results verify that the biocompatibility criteria given in ISO 10993 are fulfilled. AprioMed concludes that AprioCore plus is non-toxic and biocompatible.

5.8.3 Performance testing - Bench

The performance of AprioCore plus has been verified. Tests as described in table 5-2 have been completed.

Test:	Description:
Depth projection	To confirm that subject device will not extend over the stylet tip (over-throw) during use. Conformity has been demonstrated.
Penetration force	To confirm that the penetration force of the subject device is equivalent to predicate device. Conformity has been demonstrated.
Loading force	To confirm that the loading force of the subject device is equivalent to predicate device and that the user is able to load the subject device (force required to compress the spring). Conformity has been demonstrated.
Activation force	To confirm that the force to activate the subject device (release the spring) is not too low, resulting in unintentional activation during use. Conformity has been demonstrated.
Mechanical durability	To confirm that subject device withstands the forces applied to the subject device during normal use. Conformity has been demonstrated.
Tissue sample extraction test	To confirm that the subject device can successfully retrieve biopsy specimen multiple times. Conformity has been demonstrated.
Tip configuration	To confirm that it is possible to take a biopsy specimen closer to nearby sensitive anatomy/structure compared to predicate device. Subject device shall have a tip dead-space that is shorter compared to predicate device. Conformity has been demonstrated.
Visibility	To confirm that the invasive part of subject device is visible in CT, Fluoroscopy and Ultrasound. Conformity has been demonstrated.
Compatibility	To confirm that the device is compatible with coaxial needle standardized sizes as per ISO 9626 has been applied. AprioCore plus has been demonstrated to be compatible with AprioMed Gangi-SoftGuard and Gangi-HydroGuard.
Qualification metal tubing/needle component	The stainless-steel tubing fulfills the requirement in ISO 9626 Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods. Conformity has been demonstrated.

Table 5-2: Performance testing summary

5.9 Summary and Conclusion

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Conclusion drawn from testing completed is that AprioCore plus is equivalent to the predicate. AprioCore plus is as safe, as effective, and performs as well as or better than the predicate device.

Regulation Number and Section

§ 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.