The Semi-Automatic Biopsy Instrument and associated Co-Axial Introducer Needle are used to obtain samples from soft tissue such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, pancreas, and other masses.

Device Description

The Semi-Automatic Biopsy Instrument is used to obtain soft tissue biopsies. It is composed of a spring-loaded biopsy needle fitted into a plastic handle permitting single handed specimen collection. The position of the needle may be visualized by x-ray, CT, or ultrasound. The needle has numerically ordered centimeter markings to facilitate precise depth placement. The adjustable instrument allows for a specimen notch size of 10mm or 20mm, providing clinical flexibility. The device has an adjustable co-axial adapter built into the device for either the 10mm or 20mm notch settings. The stylet travels up to 27mm from when the device is in a fully charged position (prepared for a collection with the 20 mm notch size) to when the stylet is fully extended. The needle has an echogenic tip. The semi-automatic biopsy instrument is available in several needle gauge sizes and lengths. The plunger is color coded according to the various gauge sizes, e.g., green=14-gauge, purple=16-gauge, pink=18-gauge, and yellow=20-gauge.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Semi-Automatic Biopsy Instrument). It lacks the specific details required to answer your request about acceptance criteria and a study proving that an AI/ML-based device meets those criteria.

The document describes a traditional medical device (biopsy instrument) and its performance testing, which are primarily engineering and material tests, not clinical studies involving AI performance, human readers, or ground truth establishment relevant to AI.

Therefore, I cannot provide the requested information based on the provided text. The document does not contain:

A table of acceptance criteria and reported device performance related to AI/ML.
Sample sizes for test sets in an AI context.
Data provenance for AI/ML training/test sets.
Number of experts and their qualifications for ground truth in an AI context.
Adjudication method for AI test sets.
MRMC comparative effectiveness study details.
Standalone AI performance (algorithm only).
Type of ground truth (expert consensus, pathology, outcomes data) for AI/ML.
Sample size for training set for AI/ML.
How ground truth for the training set was established for AI/ML.

The "Performance Testing" section in the document refers to physical and material tests for the biopsy instrument itself (e.g., Dimensional, Peak Tensile Strength, Simulated Use, Radiopacity, Echogenicity, Corrosion Resistance). This is entirely different from the kind of performance testing relevant to AI/ML medical devices.

Summary

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July 1, 2022

Argon Medical Devices Daniel Lanois Senior Regulatory Affairs Specialist 1445 Flat Creek Road Athens. Texas 75751

Re: K213232

Trade/Device Name: Semi-Automatic Biopsy Instrument Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: June 15, 2022 Received: June 16, 2022

Dear Daniel Lanois:

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

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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 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,

for

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) K213232

Device Name Semi-Automatic Biopsy Intrument

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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Date Prepared:	June 30, 2022
Company:	Argon Medical Devices, Inc.1445 Flat Creek RoadAthens, Texas 75751 USAFacility Registration number: 1625425
Contact:	Scott BishopDirector Regulatory AffairsPhone: 469-731-1413Fax: 903-677-9396Email: scott.bishop@argonmedical.com
Device Trade Name(Subject Device):	Semi-Automatic Biopsy Instrument
Device CommonName:	Biopsy Instrument
Device Classification:	Instrument, BiopsyProduct code: KNW21 CFR 876.1075Class IIReview Panel: Gastroenterology/Urology
Predicate Device(s):	K974814 Argon Medical SuperCore™ Biopsy Instrument
Description of theDevice:	The Semi-Automatic Biopsy Instrument is used to obtain softtissue biopsies. It is composed of a spring-loaded biopsyneedle fitted into a plastic handle permitting single handedspecimen collection. The position of the needle may bevisualized by x-ray, CT, or ultrasound.The needle has numerically ordered centimeter markings tofacilitate precise depth placement. The adjustable instrumentallows for a specimen notch size of 10mm or 20mm, providingclinical flexibility. The device has an adjustable co-axialadapter built into the device for either the 10mm or 20mmnotch settings. The stylet travels up to 27mm from when thedevice is in a fully charged position (prepared for a collectionwith the 20 mm notch size) to when the stylet is fully extended.The needle has an echogenic tip. The semi-automatic biopsyinstrument is available in several needle gauge sizes and

510(k) Summary

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			K213232
		lengths. The plunger is color coded according to the variousgauge sizes, e.g., green=14-gauge, purple=16-gauge,pink=18-gauge, and yellow=20-gauge.
Indication for Use:	The Semi-Automatic Biopsy Instrument and associated Co-Axial Introducer Needle are used to obtain samples from softtissue such as lung, liver, spleen, kidney, prostate, lymph nodes,breast, thyroid, pancreas, and other masses.
TechnologicalCharacteristics:	A comparison of the technological characteristics of theSubject device and the Predicate device demonstrates theSubject device to be substantially equivalent to the currentmarketed Predicate device.
		The Subject device and the Predicate device are based on thefollowing same technological elements:
	● Use of an adjustable specimen notch size● Use of a semi-automatic spring-loaded biopsy needlepermitting the stylet to advance prior to firing thecannula● Use of an echogenic needle tip● Numerically ordered centimeter markings to facilitateprecise depth placement of the needle
	The following technological differences exist between theSubject device and the Predicate device:● Use of a co-axial adapter built into the Subject Deviceand is not built into the Predicate Device.

		SUBJECT DEVICE	PREDICATE DEVICE
		Semi-AutomaticBiopsy Instrument	SuperCore™ BiopsyInstrument
	Manufacturer	Argon Medical Devices,Inc - TX	SAME
	Gauge Size	14ga, 16ga, 18ga, 20ga	14ga, 16ga, 18ga,20ga
	Lengths	6cm, 10cm, 16cm,20cm, 25cm (18ga only)	6cm, 9cm, 15cm,20cm
	Notch Size	10mm and 20mm	9.5mm and 19mm
	Tip Geometry(Stylet andCannula)	Bevel	SAME
Echogenicity(Tip)	Yes	SAME
NeedleManufacturer	Argon Medical Devices,Inc. - IL	SAME
PatientContactingMaterials	Stylet: 304 SSCannula: 304 SS	SAME
Function Type	Semi-Automatic	SAME
Disposable	Yes	SAME
PerformanceTesting	• Dimensional• Peak Tensile Strength• Simulated Use(Charging Force,Firing Force, MinimumFiring Force, DryFiring, SampleCollection)• Shipping Qualification(Product andPackaging Integrity)• Radiopacity• Echogenicity• Corrosion Resistance• Resistance toBreakage / NeedleBending• Accelerated and Real-Time Aging• Penetration Force• Tissue Sampling	• Dimensional• Peak TensileStrength• Durability ofInstrument• Charging Force• Firing Force• Dry Firing (minimumfiring force)• Sample Collection• ShippingQualification
BiologicalComparison	Complies to ISO 10993-1:2018• Cytotoxicity (ISO10993-5)• Sensitization (ISO10993-10)• Irritation or -IntracutaneousReactivity (ISO 10993-10)• Acute SystemicToxicity (ISO 10993-11)• Material MediatedPyrogenicity (ISO10993-11)	Complies to ISO10993-1:2009• Cytotoxicity (ISO10993-5)• Sensitization (ISO10993-10)• Irritation -IntracutaneousReactivity (ISO10993-10)
IntendedShelf-Life	6 months	5 years
Packaging /Shipping	Biopsy InstrumentOnly	Biopsy InstrumentOnly

17mm, 27mm

12mm, 22mm

Throw

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• One biopsy devicepackaged in a TyvekPouch	• One biopsy devicepackaged in a TyvekPouch
Co-packaged Kit• One biopsy device,corresponding coaxialintroducer needle in aholder packaged in aTyvek pouch (18gaand 20ga coaxialintroducer needles areprovided with anadditional blunt stylet)10 pouches and one IFUin each labeled shippingcarton	Co-packaged Kit• One biopsy devicewith correspondingcoaxial introducerneedle, and adaptorpackaged in a Tyvekpouch10 pouches and oneIFU in one labeled shelfcarton

Equivalence is based upon the product performance, design and intended use. The Subject device and the Predicate device have similar materials of construction, dimensional specifications, design, and sterilization process. This demonstrates that the Subiect device is as safe and effective as the Predicate device, and it does not raise different questions of safety and effectiveness than the Predicate device.

Performance Tests No performance standards have been established under (Non-Clinical): section 514, performance standards, of the Food, Drug and Cosmetic Act for these devices. A series of testing was conducted in accordance with protocols based on requirements outlined in guidance and industry standards and the testing below was shown to meet the acceptance criteria that was determined to demonstrate substantial equivalence.

The following tests were performed under the specified testing parameters to support the Subject device substantial equivalence.

Performance Testing, including:

Dimensional ●
Peak Tensile Strength
Simulated Use (Charging Force, Firing Force, Minimum ● Firing Force, Dry Firing, Sample Collection)
Shipping Qualification (Product and Packaging Integrity) ●
Radiopacity
Echogenicity ●

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Corrosion Resistance ●
Resistance to Breakage / Needle Bending ●
Accelerated and Real-Time Aging ●
Penetration Force ●
Tissue Sampling o

Biocompatibility Testing, including:

Cytotoxicity (ISO 10993-5) .
Sensitization (ISO 10993-10) ●
Irritation or Intracutaneous Reactivity (ISO 10993-10) ●
. Acute Systemic Toxicity (ISO 10993-11)
Material Mediated Pyrogenicity (ISO 10993-11) ●

SubstantialEquivalence:	Based on the Indication for Use, design, and safety andperformance testing, the Subject device meets therequirements for its intended use and is substantiallyequivalent to the Predicate device.
Conclusion:	The results of all testing demonstrate that the Subject device issubstantially equivalent to 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.