(155 days)
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No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on a biopsy instrument.
No
The device is described as a biopsy instrument used for obtaining tissue samples, which is a diagnostic procedure, not a therapeutic one.
No
Explanation: The device is used for obtaining biopsies, which is a process of collecting tissue samples. While these samples are then used for diagnostic purposes, the device itself is a tool for sample collection, not for making a diagnosis or interpreting medical images.
No
The device description "Remington CentreFire Biopsy Instrument" and the intended use "obtaining biopsies from soft tissue" strongly suggest a physical instrument, not a software-only device.
Based on the provided information, the Remington CenterFire is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for obtaining biopsies from soft tissue. This is a procedure performed on the patient to collect a sample, not a test performed on a sample outside the body to diagnose a condition.
- Device Description: It's described as a "Biopsy Instrument," which aligns with a device used for sample collection from a living organism.
- Lack of IVD Characteristics: The description doesn't mention any components or processes related to analyzing biological samples in vitro (in a lab setting). IVDs typically involve reagents, analyzers, or other tools for testing blood, urine, tissue samples, etc., outside the body.
Therefore, the Remington CenterFire is a medical device used for a surgical or interventional procedure (biopsy), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Remington CenterFire is Intended for use in obtaining biopsies from soft tissue such as liver, kidney, prostate, breast, spleen and various soft tissue turnors. It is not intended for use in the bone.
Product codes
78 KNW
Device Description
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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 tissue such as liver, kidney, prostate, breast, spleen
Indicated Patient Age Range
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Intended User / Care Setting
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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)
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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.
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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
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§ 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/1 description: The image shows a circular seal with text around the perimeter and a stylized bird in the center. The text around the perimeter appears to be in all capital letters, but it is difficult to read due to the image quality. The bird in the center is composed of three curved lines that suggest wings and a body, giving it a sense of motion. The seal has a simple, graphic design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 9 2004
Ms. Maria P. Granito VP Operations Remington Medical, Inc. 6830 Meadowridge Court ALPHARETTA GA 30005
Re: K040266
Trade/Device Name: Remington CentreFire Biopsy Instrument Regulation Number: 21 CFR §876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: 78 KNW Dated: May 24, 2004 Received: June 8, 2004
Dear Ms. Granito:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosate) to regard) the enactment date of the Medical Device Amendments, or to connine.co phor to may 20, 1978) in accordance with the provisions of the Federal Food, Drug, devices that have occh roomssing in avere approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dicioloro, mance and act include requirements for annual registration, listing of general controls provisions or ractice, 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 your acvice is classified (500 acove) and existing major regulations affecting your device can be n may be subject to address againtions, 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 I Tease of advised that I Dr. or beautes a your device complies with other requirements of the Act that I Dri has made a seconneced by other Federal agencies. You must or any I ederal statutes and regarants, including, but not limited to: registration and listing Compry with an the roc requirently Part 801); good manufacturing practice requirements as set (21 CFR Part 007), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quanty by trems (sections 531-542 of the Act); 21 CFR 1000-1050.
1
This letter will allow you to begin marketing your devec as described in your Scetion 510(k)
This letter will and the first of the success of your device to a logally This letter will allow you to begin marketing of substantial equivalence of your device to a legally premarket notification - The PITA momy, or saisines by our device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Park (1), please
r the regulation If you desire spectic advice for your device on our lassing on good on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, Tor questions of the promotion and the regulation entitled, "Masbranding
Office of Compliance at (301) 594-4639. Othios of Compliance at (301) 574-1857. Fax) 807.97) you may obtain. Other general
by reference to premarket notification" (21CFR Part 807.97) you may obtained from the Divi by reference to premarket notification (21 of It's are a be obtained from the Division of Small
information on your responsibilities under the Act may be its the sumber (800) information on your responsibilities uncer at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-fremanain http:// Manufacturers, International and Coulsumor rusicience and Courselv/dsma/dsmamain.html.
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsmaldsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K040266
Device Name: Remington CentreFire Biopsy Instrument
Indications For Use:
The Remington CenterFire is Intended for use in obtaining biopsies from soft tissue such as liver, kidney, prostate, breast, spleen and various soft tissue turnors. It is not intended for use in the bone.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| ------------------------------------------------- | --- |
· AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sammy Morris for NCB
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number J
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