(29 days)
The Bio-Cut Soft Tissue Biopsy Needle is intended for harvesting soft tissue biopsy specimens.
The biopsy instrument is a sterile disposable device which features a stainless steel cannula with an echogenic tip, and a stainless steel stylet which is spring loaded and fitted into a plastic handle permitting single handed specimen collection. Sizes are available in 14 - 20 gauge needles. The length of the needles ranges between 9 and 20 cm. The needle is used by advancing the entire device to the site of soft tissue sampling. The needle is advanced with gentle but firm pressure. Once the needle is in position, the sample is taken and the device is removed from the sampling site. The sample can then be expelled from the stylet notch.
The provided text describes a Special 510(k) Premarket Notification for the Manan Bio-Cut Soft Tissue Biopsy Needle. However, it does not contain the detailed information necessary to answer all the questions about specific acceptance criteria and a study proving the device meets them. The document focuses on establishing substantial equivalence to predicate devices and outlines the device's description and intended use.
Here's an attempt to answer the questions based on the available information and, where information is missing, to explicitly state that it is not provided in the text.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not specify quantifiable acceptance criteria or reported device performance metrics from a study. It focuses on the device's description, intended use, and substantial equivalence to legally marketed predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided document | Not specified in the provided document |
2. Sample size used for the test set and the data provenance
The document does not describe a specific test set, its sample size, or its data provenance. This type of information would typically be found in a detailed study report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention any experts used to establish ground truth or their qualifications. This is because no specific performance study with a test set is detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
As no specific test set or ground truth establishment method is described, there is no information on an adjudication method.
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
The device described is a physical medical instrument (a biopsy needle), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and not mentioned in the document.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical biopsy needle, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Since no specific performance study is detailed, the document does not describe the type of ground truth used. For a biopsy needle, performance might be evaluated by factors like sample adequacy (confirmed by pathology), ease of use, or mechanical properties, but these are not specified here.
8. The sample size for the training set
The document does not mention a training set. This is irrelevant for a physical medical device that is not an AI/machine learning product.
9. How the ground truth for the training set was established
This question is not applicable as no training set is mentioned for this physical device.
Summary of Study Information in the Document:
The provided 510(k) summary for the Manan Bio-Cut Soft Tissue Biopsy Needle, K052802, is a regulatory submission focused on demonstrating substantial equivalence to predicate devices (Manan Super-Core Biopsy Needle K950732 and Medical Device Technologies Super-Core Biopsy Needle K974814). It describes the device, its intended use, and technological characteristics. The document does not include details about specific performance studies, clinical trials, acceptance criteria, or expert evaluations related to device performance in the way often associated with AI/software devices or more complex diagnostic tools. The FDA's letter confirms that the device is substantially equivalent, allowing it to be marketed under general controls.
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Manan Medical Products, Inc. Special 510(k) Manan Bio-Cut Soft Tissue Biopsy Needle
NOV - 1 2005 TAB 4
PREMARKET NOTIFICATION [510(K)] SUMMARY
| Trade Name: | Manan Bio-Cut Soft Tissue Biopsy Needle |
|---|---|
| Common Name: | Biopsy needle |
| Classification Name: | Instrument, biopsy (per 21 CFR section 876.1075) |
| Manufacturer's Name: | Manan Medical Products, Inc.241 W. Palatine RoadWheeling, IL 60090 |
| Corresponding Official: | Nicohl WildingManager Regulatory Affairs241 W. Palatine RoadWheeling, IL 60090Phone: (800) 424-6779 ext, 331Fax: (847) 637-3334 |
| Predicate Device(s): | Manan Super-Core Biopsy Needle K950732.Medical Device Technologies Super-Core Biopsy NeedleK974814 |
| Device Description: | The biopsy instrument is a sterile disposable device whichfeatures a stainless steel cannula with an echogenic tip, and astainless steel stylet which is spring loaded and fitted into aplastic handle permitting single handed specimen collection.Sizes are available in 14 - 20 gauge needles. The length ofthe needles ranges between 9 and 20 cm.The needle is used by advancing the entire device to the siteof soft tissue sampling. The needle is advanced with gentlebut firm pressure. Once the needle is in position, the sampleis taken and the device is removed from the sampling site.The sample can then be expelled from the stylet notch. |
| Intended Use: | For harvesting soft tissue biopsy specimens. |
| TechnologicalCharacteristics: | The biopsy needles are available in 14 - 20 gauge sizes andlengths from 9 to 20 centimeters. |
4-1
CONFIDENTIAL
This document and the information contained herein may not be reproduced, used or disclosed without written permission from Manan Medical Products, Inc.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized representation of the human form. The human form is depicted with three abstract figures, symbolizing the department's focus on health and well-being. The seal is in black and white.
Public Health Service
NOV - 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nicohl Wilding Manager Regulatory Affairs Manan Medical Products, Inc. 241 West Palatine Road Wheeling, Illinois 60090
Re: K052802
Trade/Device Name: Manan Bio-Cut Soft Tissue Biopsy Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: KNW Dated: October 26, 2005 Received: October 27, 2005
Dear Ms. Wilding:
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 such 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); 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.
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Page 2- Nicohl Wilding
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your 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 Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Barbara Bruckner
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number:
Device Name: Manan Bio-Cut Soft Tissue Biopsy Needle
Indications for Use:
The Bio-Cut Soft Tissue Biopsy Needle is intended for harvesting soft tissue biopsy specimens.
× Prescription Use (per 21 CFR 801.109) and/or
] Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buchup
(Division Sign-Off)
Division of General, Restora and Neurological Devices
510(k) Number K052802
§ 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.