(90 days)
The device is intended for use in obtaining biopsies from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes and various soft tissue tumors.
The Revolution™ Full Core Blopsy Device is a sterile, disposable device which features a stainless steel cutting cannula with spoon, rotating coring cannula and stylet. The device is comprised of a plastic housing that contains the mechanically actuated components. The key performance attribute of the Revolution™ Full Core Biopsy Device is the capability of obtaining a full core specimen. A variable throw feature allows the user to choose a throw setting ranging from 10 to 25 mm.
The provided text describes a medical device, the Revolution™ Full Core Biopsy Device, and its 510(k) summary for FDA clearance. However, it does not contain specific acceptance criteria, detailed study designs, or performance metrics beyond a general statement of equivalency.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as this information is not present in the provided document.
The document states:
- "Performance testing confirms that the quality of samples obtained with the Revolution™ Full Core Biopsy Device is equivalent to that of the predicate device." This is a high-level statement indicating a study occurred, but without details on how "quality" was measured or the specific criteria for "equivalency."
To answer your questions, the following information would be needed:
- A section detailing the specific performance tests conducted.
- The acceptance criteria for each test (e.g., in terms of specimen length, integrity, diagnostic yield, etc.).
- The results of those tests compared to the predicate device or a defined threshold.
- Details about the methodology of sample quality assessment (e.g., histological review, pathological assessment).
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SECTION 5: 510(k) SUMMARY
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pg 1 of
JUN - 4 2009
March 4, 2009
Contact Information
Melissa Lalomia Director of Quality & Regulatory Affairs Phone: 616-301-7800, ext. 102 616-301-7799 Fax: E-mail: mlalomia@inrad-inc.com
Company Information
Inrad, Inc 4375 Donker Court SE Kentwood, MI 49512 616-301-7800 Phone: 616-301-7799 Fax:
Device Name(s)
Revolution™ Full Core Biopsy Device Revolution™ Full Core Biopsy Device w/HiLiter®
Device Summary
Trade or Proprietary Name: Revolution™ Full Core Biopsy Device Revolution™ Full Core Biopsy Device w/HiLiter® Common or Usual Name: Biopsy Instrument Gastroenterology-urology biopsy instrument Classification Name: (21 CFR 876.1075, Product code KNW)
Name of Predicate(s) or Legally Marketed Device(s)
K904987 - Vibronics Auto Core Biopsy Device
Also known as:
-
BioPince® Full Core Biopsy Instrument (currently sold by InterV/Angiotech)
- Inrad Express™ Core Biopsy Device (formerly manufactured for Inrad by Amedic)
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SECTION 5: 510(k) SUMMARY
2090611
Device Description
The Revolution™ Full Core Blopsy Device is a sterile, disposable device which features a stainless steel cutting cannula with spoon, rotating coring cannula and stylet. The device is comprised of a plastic housing that contains the mechanically actuated components. The key performance attribute of the Revolution™ Full Core Biopsy Device is the capability of obtaining a full core specimen. A variable throw feature allows the user to choose a throw setting ranging from 10 to 25 mm.
Indications for Use
The device is intended for use in obtaining biopsies from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes and various soft tissue turnors.
Substantial Equivalence
The Revolution™ Full Core Biopsy Device has the same intended use as the BioPince® Full Core Biopsy Instrument. The device and the predicate device have the same technological characteristics in terms of design and materials.
Performance Testing Summary
Performance testing confirms that the quality of samples obtained with the Revolution™ Full Core Biopsy Device is equivalent to that of the predicate device.
Section 5 - 2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 4 2009
Ms. Melissa Lalomia Director of RA/QA Inrad. Inc. 4375 Donker Court SE KENTWOOD MI 49512
Re: K090611
Trade/Device Name: Revolution™ Full Core Biopsy Device and Revolution™ Full Core Biopsy Device w/HiLiter® Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: KNW Dated: March 4, 2009 Received: March 6, 2009
Dear Ms. Lalomia:
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 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 device-related adverse events) (21 CPR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
21 CFR 876.xxx 21 CFR 884.xxx 21 CFR 892.xxx Other
(Gastroenterology/Renal/Urology) (Obstetrics/Gynecology) (Radiology)
(240) 276-0115 (240) 276-0115 (240) 276-0120 (240) 276-0100
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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ravine M. Murry
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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Indications for Use
Ko90611
510(k) Number (if known):
Device Name:
Revolution™ Full Core Biopsy Device Revolution™ Full Core Biopsy Device w/HiLiter®
Indications for Use:
The device is intended for use in obtaining biopsies from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes and various soft tissue tumors.
Prescription Use × (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)
ula Rema
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
Section 4 - 1
INRAD, INC. - CONFIDENTIAL
§ 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.