The Remington Medical (RMI) CentreFire 22 Biopsy Instrument is a semi-automatic, reusable, spring-loaded mechanical device that is designed to be used with Remington Medical NAC Biopsy Needles to obtain core biopsy samples from the prostate.

AI/ML Overview

1. Table of acceptance criteria and reported device performance:

The document describes non-clinical performance studies for the Remington Medical CentreFire 22 Biopsy Instrument, focusing on its substantial equivalence to a predicate device, the Medical Device Technologies, Inc. Ultra (K962969). The acceptance criteria for the subject device are implicitly met if its performance is equivalent to the predicate device and meets established requirements for consistent performance and reprocessing.

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from study description)	Reported Device Performance
Device Performance: Needle Excursion	Equivalent penetration depth to predicate device; meets established requirements for consistent performance.	The study results demonstrate that the device meets established requirements necessary for consistent performance during its intended use and performs equivalent to the predicate device.
Device Performance: Biopsy Sampling	Equivalent quality/consistency of biopsy samples to predicate device; meets established requirements for consistent performance.	The study results demonstrate that the device meets established requirements necessary for consistent performance during its intended use and performs equivalent to the predicate device.
Reprocessing Validation: Cleaning	Ensures appropriate cleaning methods for the end user and meets established requirements for consistent reprocessing.	The device meets the established requirements necessary for consistent reprocessing.
Reprocessing Validation: Sterilization	Ensures appropriate sterilization methods for the end user (Gravity Displacement Steam Sterilization (Autoclave)) and meets established requirements for consistent reprocessing.	The device meets the established requirements necessary for consistent reprocessing.

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

The document does not specify the exact sample sizes used for the non-clinical performance studies (Needle Excursion and Biopsy Sampling) or the reprocessing validations.
The data provenance is from internal non-clinical testing performed by Remington Medical, Inc. (prospective, as it was performed for this 510(k) submission). The geographical origin of the data is not explicitly stated, but it would be assumed to be conducted in the USA where Remington Medical Inc. is based.

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

Not applicable. The study involved non-clinical performance testing and reuse/reprocessing validations, not human-read interpretations requiring expert consensus for ground truth.

4. Adjudication method for the test set:

Not applicable. The study involved non-clinical performance testing and reuse/reprocessing validations, not human-read interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical testing was required." The evaluation was based on non-clinical performance studies demonstrating equivalence to a predicate device.

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

Not applicable. This is a medical device (biopsy instrument), not an AI algorithm. The performance testing was for the physical instrument.

7. The type of ground truth used:

For the non-clinical performance studies (Needle Excursion and Biopsy Sampling), the ground truth was established through measurement and observation of physical characteristics and outcomes based on predefined test protocols and acceptance criteria. This would involve objective metrics such as actual penetration depth, visual assessment of sample quality and consistency, etc.

For the reuse/reprocessing validations, the ground truth was established by testing the efficacy of cleaning and sterilization protocols to ensure the instrument consistently met accepted standards for reprocessing (e.g., absence of biological residues, sterility assurance levels).

8. The sample size for the training set:

Not applicable. This is a medical device, not an AI algorithm requiring a training set.

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

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

Summary

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Traditional 510(k) Notification Remington Medical Inc. CentreFire 22 Biopsy Instrument

MAY 1 3 2013

Preparation Date	March 4, 2013
Applicant	Remington Medical, Inc.6830 Meadowridge Court,Alpharetta, GA, USA 30005Registration Number: 1056553Owner/Operator Number: 9006473
Contact Person	Caitlin Senter, MS, RACRegulatory Affairs Manager770-888-8520, extension 207caitlins@remmed.com
Trade ProprietaryName(s)	Remington Medical CentreFire 22 Biopsy Instrument
Common Name (s)	Biopsy Instrument
Classification Name	21 CFR 876.1075 (Instrument, Biopsy); Product Code: KNW
Device Class:	Class II

510(k) Summary

Legally Marketed Device to Which Substantial Equivalence is Claimed:

Medical Device Technologies, Inc. Ultra (K962969)

Description of the Device:

Intended Use/Indications for Use

The Remington Medical CentreFire 22 Biopsy Instrument is used to obtain multiple core samples from the prostate. It is not intended for bone.

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Image /page/1/Picture/0 description: The image shows the logo for Remington Medical, Inc. The logo consists of a stylized black square with the letters "RM" inside, followed by the words "Remington" and "Medical, Inc." in a bold, sans-serif font. The logo is simple and professional, and it is likely used to represent the company's brand.

Traditional 510(k) Notification Remington Medical Inc. CentreFire 22 Biopsy Instrument

Technological Characteristics:

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

	Subject Device:Remington Medical CentreFire 22Biopsy Instrument	Predicate Device:Medical Device Technologies Ultra,a.k.a. MANAN PRO-MAG™ ULTRA(K962969)
Device Class	Class II	Class II
FDA Product Code	KNW	KNW
Regulation	21 CFR 876.1075 (Instrument, Biopsy)	21 CFR 876.1075 (Instrument, Biopsy)
Indications for UseStatement	The Remington Medical CentreFire 22Biopsy Instrument is used to obtain multiplecore samples from the prostate. It is notintended for bone.	The Ultra™ Biopsy Device is used toobtain multiple core samples from softtissue such as the liver, kidney, prostate,breast, and various soft tissue lesions. Itis not intended for bone.
Configuration	Reusable Biopsy Instrument for use withdisposable biopsy needle assembly	Reusable Biopsy Instrument for use withdisposable biopsy needle assembly
Needle MountingMethod /CompatibleNeedles	Proximal and Distal Carriages grooved toallow insertion of Biopsy Needles	Proximal and Distal Carriages grooved toallow insertion of Biopsy Needles
Cocking Method	Two-handed sequential operation	Two-handed sequential operation
Needle Sled(Carriage) Material	Plastic with stainless steel pins	Plastic with stainless steel pins
Needle Sled(Carriage)Propulsion	Stainless steel spring, one per sled/carriage	Stainless steel spring, one per sled
Cocked Sled(Carriage)Retention Method	Mechanical latch mechanism in instrument(Distal and Proximal)	Mechanical latch mechanism ininstrument
Body Material	Aluminum (anodized)	Aluminum (anodized)
Guards/Safety	Automatic Safety	Automatic Safety
ReprocessingMethod(s)	Manual CleaningGravity Displacement Steam Sterilization(Autoclave)	Manual CleaningGravity Displacement Steam Sterilization(Autoclave)*

Additional reprocessing methods were provided in the IFU for the predicate device but were not included in the subject device IFU

Performance Data:

The Remington Medical CentreFire 22 Biopsy Instrument was evaluated in the following nonclinical performance studies: Needle Excursion (Penetration Depth) and Biopsy Sampling (Quality/Consistency).

Results of the performance testing demonstrates that the materials chosen, the manufacturing process and the design of the Remington Medical CentreFire 22 Biopsy Instrument meet the established requirements necessary for consistent performance during its intended use. The performance data also demonstrates that the Remington Medical CentreFire 22 Biopsy Instrument performs equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for Remington Medical, Inc. The logo consists of a black square with the letters "RMI" in white, and the words "Remington Medical, Inc." in black text to the right of the square. The text is in a bold, sans-serif font.

Traditional 510(k) Notification Remington Medical Inc. CentreFire 22 Biopsy Instrument

Reuse/Reprocessing validations were performed on the Remington Medical CentreFire 22 Biopsy Instrument to ensure appropriate cleaning and sterilization methods for the end user.

Results of the reuse/reprocessing validations demonstrates that the Remington Medical CentreFire 22 Biopsy Instrument meets the established requirements necessary for consistent reprocessing.

Clinical testing:

No clinical testing was required.

Conclusion:

The results of the non-clinical testing demonstrated that the subject device, Remington Medical CentreFire 22 Biopsy Instrument, is substantially equivalent to the predicate device, Medical Device Technologies, Inc. Ultra, with respect to intended use, materials, design, and technological characteristics.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 13, 2013

Remington Medical, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313

Re: K130282

Trade/Device Name: Remington Medical CentreFire 22 Biopsy Instrument Regulation Number: 21 CFR§ 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: May 1, 2013 Received: May 7, 2013

Dear Mr. Job:

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. 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.

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Page 2 - Mr. Mark Job

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _ K130282

Device Name: Remington Medical CentreFire 22 Biopsy Instrument

Indications for Use:

The Remington Medical CentreFire 22 Biopsy Instrument is used to obtain multiple core samples from the prostate. It is not intended for bone.

Prescription Use X

AND/OR

(Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) . .

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner -S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number_ K130282

Page 1 of _1

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.