(79 days)
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Not Found
No
The document describes a mechanical biopsy needle and does not mention any computational or analytical capabilities, let alone AI/ML.
No
The device is a biopsy needle used to collect tissue samples, not to treat a condition or disease.
No
The device is a cutting needle used to obtain tissue samples for biopsy, which is a diagnostic procedure. However, the needle itself does not perform the diagnostic analysis. It is a tool for specimen collection, not a diagnostic device.
No
The device description clearly outlines physical components like a stainless steel cannula, stylet, plastic hubs, and an LDPE sheath, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for obtaining tissue samples (biopsies) from soft tissues within the body. This is a procedure performed on the patient, not on a sample from the patient in a laboratory setting.
- Device Description: The device is a needle designed for physical tissue collection. It does not involve reagents, assays, or analysis of biological samples in vitro.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting markers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a person's health. This device is used inside the body to collect the specimen.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KNW
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
soft tissues, such as the liver, lung, kidney or prostate.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
C.R. Bard®: Biopty-Cut® Needle; Remington Medical: Magnum® Needle; Cook® Medical: MLL Needle; Cook Biopsy Needle
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
Page 1-11
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:
2
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
1
Image /page/1/Picture/0 description: The image shows a logo with the word "riverpoint" in lowercase letters at the bottom. Above the word, there are two stylized "r" letters, each with a circle at the top. The "r" on the left is lighter in color, while the "r" on the right is darker, creating a contrasting effect.
K092059
Page 2 of 2
Page 1-12
Special Controls
Not applicable for this 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.
Intended Use
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.
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.
2
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
3
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:
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.
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)
Page 1 of 1
(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
Page 1-10