The RP Cutting Needle is intended to be used by medical professionals with the Bard® Magnum® reusable biopsy instrument for biopsies of soft tissues, such as the liver, lung, kidney or prostate. The RP Cutting Needle is not intended for use in bone. The RP Cutting Needle is provided sterile as a single use device.

Device Description

The RP Cutting Needle is a sterile, disposable biopsy instrument composed of a stainless steel cannula with a molded plastic hub, and a stainless steel stylet with a notch removed for specimen collection and a molded plastic hub. The cannula and stylet hubs are provided with a spacer attached which is designed to allow for easy insertion of both hubs into a Bard® Magnum® reusable biopsy instrument. The needle is covered with a LDPE sheath for safety. Needles are available in 14-20 gauge, with lengths between 10 and 25 cm. The predicate devices listed contain identical or substantially equivalent materials and characteristics as described above.

AI/ML Overview

The provided text details the submission of a 510(k) premarket notification for the "RP Cutting Needle" and states its substantial equivalence to predicate devices. However, it does not contain the specific information requested regarding acceptance criteria, a study proving device performance against those criteria, sample sizes, expert involvement, adjudication methods, or MRMC/standalone study results.

Here's an analysis of what can be extracted and what is missing based on your request:

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

Missing. The document states: "The RP Cutting needle is designed and manufactured to be substantially equivalent to the predicate devices listed below for safety and effectiveness." and "Dimensional and quality verifications, along with material certification has confirmed that the RP Cutting Needle is substantially equivalent to the predicate devices in size, shape, and function."
This indicates that the acceptance criteria are based on substantial equivalence to predicate devices regarding general shape, size, method of function, and material properties. However, specific numerical acceptance criteria (e.g., minimum tensile strength, maximum bend angle, biopsy core length) and the reported performance against those numerical criteria are not provided.

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

Missing. No information on sample sizes for any testing (e.g., dimensional, quality verifications) is provided.
Missing. No information on data provenance is provided.

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)

Missing. No information about experts or ground truth establishment for a test set is provided, as no clinical or comparative performance study is detailed. The device is deemed substantially equivalent based on engineering/material comparisons to predicate devices.

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

Missing. Not applicable, as no test set requiring ground truth adjudication is described.

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

Missing. Not applicable. This document is for a biopsy needle, not an AI-powered diagnostic device, so an MRMC study with human readers and AI assistance would not be relevant.

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

Missing. Not applicable. This is a physical medical device (biopsy needle), not an algorithm.

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

Missing. Not applicable. The "ground truth" here seems to be engineering specifications and material properties of existing predicate devices for establishing substantial equivalence, rather than clinical outcomes or diagnostic accuracy.

8. The sample size for the training set

Missing. Not applicable. This is not an AI/machine learning device that would have a training set.

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

Missing. Not applicable.

Summary of available relevant information from the document related to substantial equivalence:

Device Description: "The RP Cutting Needle is a sterile, disposable biopsy instrument composed of a stainless steel cannula with a molded plastic hub, and a stainless steel stylet with a notch removed for specimen collection and a molded plastic hub. The cannula and stylet hubs are provided with a spacer attached which is designed to allow for easy insertion of both hubs into a Bard® Magnum® reusable biopsy instrument. The needle is covered with a LDPE sheath for safety. Needles are available in 14-20 gauge, with lengths between 10 and 25 cm."
Equivalence Claim: "The RP Cutting needle is designed and manufactured to be substantially equivalent to the predicate devices listed below for safety and effectiveness."
Evidence for Equivalence: "All materials used were selected based on known biocompatibility and established histories of use in the medical device industry for non-implantable devices, and are identical or substantially equivalent to the materials used in the predicate devices listed. The RP Cutting Needle has been designed to have the same general shape, size and method of function as the predicate devices. Dimensional and quality verifications, along with material certification has confirmed that the RP Cutting Needle is substantially equivalent to the predicate devices in size, shape, and function."
Predicate Devices:
- C.R. Bard®: Biopty-Cut® Needle; Magnum® Needle
- Remington Medical: MLL Needle; M-Needle
- Cook® Medical: Cook Biopsy Needle

Based on the provided text, the device's acceptance criteria are implicit in its claim of "substantial equivalence" to existing predicate devices regarding materials, general shape, size, and method of function. The "study" proving this substantial equivalence consists of "dimensional and quality verifications, along with material certification." Specific quantitative results or detailed study protocols are not included in this 510(k) summary.

Summary

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Image /page/0/Picture/0 description: The image shows a logo with the letters 'rp' stacked on top of each other. The top of each letter 'r' is stylized into a circle. Below the logo, the word 'riverpoint' is written in lowercase letters. The logo appears to be for a company or organization named Riverpoint.

SEP 24 2009

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510(k) Summary

Submitter Information

Submitter's Name:

Address:

825 NE 25th Ave. Portland, OR 97232

(503) 517-8001 or 866 445-4923

Riverpoint Medical

Phone Number:

Fax Number:

Registration Number:

Contact Person:

Douglas Rowley

3006981798

(503) 517-8002

Date of Preparation:

(503) 517-8001

July 1st, 2009

Device Name

RP Cutting Needle Trade Name: Biopsy Needle (Disposable) Common Name: Instrument, Biopsy Classification Name:

Device Classification

FDA Class:

Product Classification:

Code:

876.1075(a) Gastroenterology-Urology-Urology Instrument, Needle KNW

Classification Panel:

Gastroenterology-Urology

Predicate Devices

C.R. Bard®: Remington Medical: Cook® Medical:

Biopty-Cut® Needle; Magnum® Needle MLL Needle; M-Needle Cook Biopsy Needle

510(k) Summary - RP Cutting Needle

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K092059
Page 2 of 2

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Special Controls

Not applicable for this device

Device Description

Intended Use

Safety and Effectiveness

The RP Cutting needle is designed and manufactured to be substantially equivalent to the predicate devices listed below for safety and effectiveness. All materials used were selected based on known biocompatibility and established histories of use in the medical device industry for non-implantable devices, and are identical or substantially equivalent to the materials used in the predicate devices listed.

The RP Cutting Needle has been designed to have the same general shape, size and method of function as the predicate devices. Dimensional and quality verifications. along with material certification has confirmed that the RP Cutting Needle is substantially equivalent to the predicate devices in size, shape, and function.

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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services - USA. The logo features a stylized eagle emblem on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the emblem.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

SEP 2 4 2009

Mr. Doug Rowley RA/QA Manager Riverpoint Medical 825 NE 25th Avenue PORTLAND OR 97232

Re: K092059

Trade/Device Name: RP Cutting Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II · Product Code: KNW Dated: July 1, 2009 Received: July 7, 2009

Dear Mr. Rowley:

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.

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 (reporting of medical

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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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K092059

Device Name:

RP Cutting Needle

Indications for Use:

Prescription Use · X (Part 21 CFR 801 Subpart D)

AND/OR

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)

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(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

Labels	Values
510(k) Number	K092059

510(k) Indications for Use Statement - RP Cutting Needle

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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.