(17 days)
The Manan™ Super-Core Biopsy Needle is used for obtaining soft tissue biopsies such as from the liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung.
The Manan™ Super-Core Biopsy Needle is used for obtaining soft tissue biopsies such as from the liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung. It is composed of a echogenic spring loaded biopsy needle fitted into a plastic handle permitting single handed specimen collection. The placement position of the needle may be visualized by either x-ray or ultrasonography.
This submission, K974814, is for the Manan™ Super-Core Biopsy Needle. It is a traditional 510(k) submission, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with acceptance criteria and performance data in the same way a software AI/ML device would.
Therefore, the requested information cannot be fully provided in the typical format for AI/ML device studies because this submission refers to a hardware medical device.
Here's an explanation based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Performance:
- Not Applicable in the AI/ML context. This device is a manual, spring-loaded biopsy needle. The "performance" is demonstrated through substantial equivalence to a legally marketed predicate device (Manan Medical Products Super-Core Biopsy Needle, K950732) and through adherence to general controls and good manufacturing practices. There are no "acceptance criteria" or "reported device performance" in the sense of accuracy, sensitivity, or specificity metrics derived from a clinical study for an AI/ML algorithm.
- The FDA letter confirms the device is substantially equivalent for its stated indications for use, which implies its performance is considered comparable to the predicate device for obtaining soft tissue biopsies.
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. The document does not describe a clinical performance study with a test set of data (images, etc.) that would typically be used for an AI/ML device. The "test" for this device would relate to its physical attributes, such as needle sharpness, deployment mechanism reliability, echogenicity, etc., usually assessed through engineering tests and comparison to standards, not a clinical data set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. There is no "ground truth" establishment in the context of an AI/ML diagnostic or prognostic study. The function of the device is to collect tissue samples, not to interpret them. The "truth" in this context would be the successful collection of a viable tissue sample, which is a functional outcome achieved by the clinician using the device.
4. Adjudication Method for the Test Set:
- Not Applicable. As there is no "test set" in the AI/ML sense, there is no adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not Applicable. This is not an AI/ML device designed to assist human readers in interpretation. It is a physical instrument for biopsy collection. Therefore, an MRMC study is irrelevant.
7. Type of Ground Truth Used:
- Not Applicable/Implied Functional Equivalence. For a physical biopsy device, the "ground truth" related to its primary function is its ability to reliably obtain a tissue sample suitable for pathological examination. This is implicitly demonstrated by substantial equivalence to a predicate device that has already established this functional capability. The "truth" about the tissue itself (e.g., presence of disease) is determined by subsequent pathology, which is enabled by the device but not part of the device's diagnostic function.
8. Sample Size for the Training Set:
- Not Applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
In summary, the provided 510(k) summary for the Manan™ Super-Core Biopsy Needle is for a physical medical device, not an AI/ML software device. Therefore, the questions related to AI/ML device performance studies (acceptance criteria, test/training sets, ground truth, expert adjudication, MRMC studies) are not applicable to this document. The safety and effectiveness of this device are established through substantial equivalence to a predicate device and compliance with general controls.
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Gainesville, Florida 320 TEL: 352/338-0440 FAX: 352/338-0662
97 4814
510(k) SUMMARY
| APPLICANT: | Medical Device Technologies, Inc.4445-310 SW 35th TerraceGainesville, FL 32608 |
|---|---|
| CONTACT: | Karl SwartzQuality Assurance Manager |
| TELEPHONE: | (352)338-0440fax (352)338-0662 |
| TRADE NAMES: | Manan™ Super-Core Biopsy Needle |
| COMMON NAME: | Spring loaded biopsy needle |
| CLASSIFICATION NAME: | §878.4800 - Needle, biopsy (Manual surgical instrument forgeneral use) |
SUBSTANTIAL EQUIVALENCE:
| Company Name | Product Name | 510(k) No. |
|---|---|---|
| Manan Medical Products | Super-Core Biopsy Needle | K950732 |
DESCRIPTION OF DEVICE:
The Manan™ Super-Core Biopsy Needle is used for obtaining soft tissue biopsies such as from the liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung. It is composed of a echogenic spring loaded biopsy needle fitted into a plastic handle permitting single handed specimen collection. The placement position of the needle may be visualized by either x-ray or ultrasonography.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Karl Swartz Quality Assurance Manager Medical Device Technologies, Incorporated 4445 S.W. 35th Terrace, Suite 310 Gainsville, Florida 32608
JAN - 8 1998
Re: K974814
Trade Name: Manan™ Super-Core Biopsy Needle Regulatory Class: II Product Code: KNW Dated: December 18, 1997 Received: December 23, 1997
Dear Mr. Swartz:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compirance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for
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Page 2 - Mr. Swartz
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celta M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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145-310 S.W. 35th Gainesville, Florida 3260 TEL: 352/338-0440 FAX: 352/338-0662
Page_1_of_1_
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Manan™ Super-Core Biopsy Needle.
Indications for Use:
The Manan™ Super-Core Biopsy Needle is used for obtaining soft tissue biopsies such as from the liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Rach
510(k) Number K974814
Prescription Use
(Per 21 CFR 801(109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96.)
§ 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.