Remington Medical, Inc. Automatic Cutting Needle (NAC) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

Device Description

The Remington Medical Inc. Automatic Cutting Needle (NAC) is a device used for obtaining biopsies from soft tissues such as liver, kidnev, prostate, spleen, lymph nodes and various soft tissue tumors in combination with compatible commercial biopsy instrument(s)/gun(s) which are FDA cleared and distributed in the US Market. The Automatic Cutting Needles (NAC) are available in five qauges (differentiated by color) and seven needle lengths. The Automatic Cutting Needle (NAC) is advanced via the compatible commercial biopsy instrument/gun into the desired tissue to obtain a sample for histological examination. The Automatic Cutting Needle (NAC) is a sterile, single patient use and non-pyrogenic device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Remington Medical, Inc. Automatic Cutting Needle (NAC). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance acceptance criteria through a clinical study or AI model evaluation.

Therefore, many of the requested details, such as those related to AI algorithm performance, training/test set data, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable to this type of regulatory submission. This is a traditional medical device, not an AI/ML enabled device.

Based on the provided information, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

There isn't a table of specific performance acceptance criteria in the sense of accuracy, sensitivity, or specificity metrics typical for AI/ML devices. Instead, the "acceptance criteria" are implied by the non-clinical testing performed to establish substantial equivalence. The "reported device performance" are the results of these non-clinical tests demonstrating the device's physical and functional properties are comparable to the predicate.

Acceptance Criteria (Implied by Study Type)	Reported Device Performance (Summary)
Dimensional Requirements	Met (results demonstrated equivalence to predicate)
Stylet / Cannula to Hub Tensile Strength	Met (results demonstrated equivalence to predicate)
Equipment Interface	Met (results demonstrated equivalence to predicate)
Integrity of the Sterile Barrier	Met (results demonstrated equivalence to predicate)
Biocompatibility	Met (results demonstrated equivalence to predicate)
Pyrogenicity	Met (results demonstrated equivalence to predicate)
Sterility Assurance	Met (results demonstrated equivalence to predicate)
Distribution Simulation	Met (results demonstrated equivalence to predicate)
Simulated Use Soft Tissue Sampling (Ex Vivo)	Met (results demonstrated equivalence to predicate for obtaining biopsies)

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated as a numerical sample size of "cases" like in an AI study. The tests listed are non-clinical (e.g., mechanical, material, engineering tests) performed on samples of the device itself.
Data Provenance: The tests are ex-vivo (meaning, performed outside of a living organism, likely in a lab setting using tissue phantoms or excised animal tissue for the "Simulated Use Soft Tissue Sampling"). The document does not specify a country of origin for the data beyond being conducted by Remington Medical, Inc. for their 510(k) submission. It is by definition "prospective" testing of manufactured devices for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth in the context of clinical or AI studies (e.g., disease presence) is not relevant here. The "ground truth" for these engineering tests would be the established specifications and performance of the predicate device, against which the subject device's non-clinical performance is compared. This is a comparison of physical device characteristics.

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

Not applicable. Adjudication methods are for resolving discrepancies in expert interpretations of medical data (e.g., radiologist reads), which is not part of this 510(k) submission's non-clinical testing.

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:

No. An MRMC study was not done, as this is for a traditional biopsy needle, not an AI-enabled device.

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

No. This is not an algorithm, but a physical medical device.

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

Not applicable in the AI/clinical sense. The "ground truth" for the non-clinical tests is based on engineering specifications, material properties, and the established performance characteristics of the predicate device. For the "Simulated Use Soft Tissue Sampling," the ground truth would be the ability to successfully obtain a biopsy sample comparable to that obtained by the predicate.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set" or "ground truth" for it in the context of an AI/ML device.

Summary

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July 12, 2019

Remington Medical, Inc. Caitlin Senter Regulatory Affairs Manager 6830 Meadowridge Court Alpharetta, Georgia 30005

Re: K191315

Trade/Device Name: Remington Medical, Inc. Automatic Cutting Needle (NAC) Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: May 14, 2019 Received: May 15, 2019

Dear Caitlin Senter:

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

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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 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.

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 Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K191315

Device Name

Remington Medical Inc. Automatic Cutting Needle (NAC)

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/1 description: The image contains the logo for Remington Medical. The logo consists of a blue geometric shape on the left and the words "Remington MEDICAL" on the right. The word "Remington" is in a larger, bold font, while the word "MEDICAL" is in a smaller font below it. The geometric shape is a stylized cross or plus sign with radiating lines.

Traditional 510(k) Notification Remington Medical Inc. Automatic Cutting Needle (NAC)

Section 5 - 510(k) Summary

Preparation Date	May 14, 2019
Applicant	Remington Medical, Inc.6830 Meadowridge Court,Alpharetta, GA, USA 30005
	Registration Number: 1056553Owner/Operator Number: 9006473
Contact Person	Caitlin Senter, MS, RACRegulatory Affairs Manager470-719-1105caitlins@remmed.com
Trade ProprietaryName(s)	Remington Medical, Inc. Automatic Cutting Needle (NAC)
Common Name (s)	Instrument, Biopsy
Classification Name	21 CFR 876.1075 Gastroenterology-urology biopsy instrumentProduct Code: KNW
Device Class:	II

Predicate Device:

Bard® Biopty-Cut® Biopsy Needle (K962077)

Description of the Device:

Intended Use/Indications for Use

Comparison to Predicate Device:

The technological characteristics (design, specifications, materials and performance) of the subject device and the predicate device are substantially equivalent.

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Image /page/4/Picture/0 description: The image contains the logo for Remington Medical. The logo consists of a blue, stylized cross-like symbol on the left, followed by the text "Remington" in bold, dark blue letters. Below "Remington" is the word "MEDICAL" in smaller, lighter blue letters. The overall design is clean and professional, suggesting a healthcare or medical services company.

Traditional 510(k) Notification Remington Medical Inc. Automatic Cutting Needle (NAC)

		Subject Device:		Predicate Device:
	Remington Medical, Inc. Automatic Cutting		Bard® Biopty-Cut® Biopsy Needle
	Needle (NAC)			(K962077).
Device Class	Class II			Class II
FDA Product Code	KNW			KNW
Requlation	21 CFR 876.1075 (Instrument, Biopsy)			21 CFR 876.1075 (Instrument, Biopsy)
Indications for Use	Remington Medical, Inc. Automatic Cutting			The device is intended for use in obtaining
Statement	Needle (NAC) is intended for use in obtaining			biopsies from soft tissues such as liver,
		biopsies from soft tissues such as liver, kidney,		kidney, prostate, spleen, lymph nodes and
	prostate, spleen, lymph nodes and various soft			various soft tissue tumors. It is not intended
	tissue tumors. It is not intended for use in bone.			for use in bone.
Type of Use	Prescription Use			Prescription Use
Cannula Material	Metal, Stainless Steel			Metal, Stainless Steel
Cannula DepthMarking	Wide Band, Centimeter Gradations			Wide Band, Centimeter Gradations(Optional)
Etched Tip	Standard			Optional
Cannula HubMaterial	Color-coded Plastic (Polycarbonate) orColor-coded Plastic (Acrylonitrile butadienestyrene (ABS))			Color-coded Plastic (Polycarbonate)
Stylet Material	Metal, Stainless Steel			Metal, Stainless Steel
Stylet Hub Material	Color-coded Plastic (Polycarbonate) orColor-coded Plastic (Acrylonitrile butadienestyrene (ABS))			Color-coded Plastic (Polycarbonate)
	12 GA	10, 13, 16, 20	Pale Blue*	12 GA	10, 16, 20	Blue*
Gauge/Length	14 GA	10, 12, 13, 16, 20	Pale Green*	14 GA	10, 16, 20	Green
(centimeters)/Color	16 GA	10, 13, 16, 20, 25	White*	16 GA	10, 16, 20, 25, 30	Purple
Depiction	18 GA	10, 13, 16, 20, 25, 30	Pink*	18 GA	10, 16, 20, 25, 30	Pink
	20 GA	10, 13, 16, 20	Yellow*	20 GA	10, 16, 20	Yellow
	*Per ISO 6009:2016(E)			*Assumption per ISO 6009:2016(E)
Mechanism ofAction	Single puncture and sample			Single puncture and sample
Principle ofOperation	Cutting			Cutting
Final NeedleAssemblyProtection	Sheath			Sheath
Sterilization Method	ETO			ETO

Performance Data:

To demonstrate that the subject device Remington Medical Inc. Automatic Cutting Needle (NAC) is as safe and as effective as the predicate device Bard® Biopty-Cut® Biopsy Needle, materials, technological characteristics and performance criteria were evaluated. The following tests were performed on the subject device

Dimensional Requirements ●

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Image /page/5/Picture/2 description: The image contains the logo for Remington Medical. The logo consists of a blue symbol on the left and the words "Remington MEDICAL" on the right. The symbol is a stylized blue shape with lines radiating outward from the center. The word "Remington" is in a bold, sans-serif font, and the word "MEDICAL" is in a smaller font below it.

Traditional 510(k) Notification Remington Medical Inc. Automatic Cutting Needle (NAC)

Stylet / Cannula to Hub Tensile Strength ●
Equipment Interface o
Integrity of the Sterile Barrier ●
Biocompatibility ●
Pyrogenicity
Sterility Assurance ●
Distribution Simulation

In addition, the following ex vivo tests were performed on the subject device and predicate device:

Simulated Use Soft Tissue Sampling ●

Clinical testing:

No clinical testing was required.

Conclusion:

The results of the non-clinical testing demonstrated that the subject device, Remington Medical Inc. Automatic Cutting Needle (NAC), is substantially equivalent to the predicate device, Bard® Biopty-Cut® Biopsy Needle, with respect to intended use, materials, design, and technological characteristics.

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.