(128 days)
The Ultra™ Biopsy Device is used to obtain multiple core samples from soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.
Our company is presently authorized by the Food and Drug Administration to manufacture disposable soft tissue biopsy needles, K921418. This device is to be the reusable handle gun that will compete with the products that currently use the biopsy needles covered by this 510 (k) .
Here's an analysis of the provided text regarding acceptance criteria and study details for the Ultra™ Biopsy Device. However, it's immediately apparent that the provided document does not contain the information requested for acceptance criteria and the specifics of a study proving device performance as outlined in your prompt. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than reporting detailed performance studies against specific acceptance criteria.
Therefore, I will populate the table and answer the questions indicating that the information is "Not provided in the document."
Acceptance Criteria and Device Performance Study
The provided 510(k) summary for the Ultra™ Biopsy Device does not detail specific acceptance criteria or report a study proving the device meets such criteria. The document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for market clearance.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. | Not provided in the document. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not provided in the document.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not provided in the document.
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:
Not applicable. The device described is a reusable biopsy handle gun, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance would not be relevant. The document does not describe any such study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The device is a physical medical instrument (a biopsy handle gun), not an algorithm. Therefore, a standalone algorithm performance study is not relevant. The document does not describe any such study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not provided in the document.
8. The sample size for the training set:
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or algorithms. The document does not describe any training data for an algorithm.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for a physical device.
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Image /page/0/Picture/1 description: The image shows a logo for MDTech Medical Device Technologies Inc. The logo is in a rectangular shape with a black background and white text. The text is in a bold, sans-serif font. The logo is simple and modern.
45 S.W. 35th Terrace Suite 310 Jainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662 DEC - 6 1996
510 (k) SUMMARY
- Medical Device Technologies, Inc. APPLICANT : 4445-310 SW 35th Terrace Gainesville, FL 32608
- CONTACT : Karl Swartz Quality Assurance Manager
- TELEPHONE : (352)338-0440 fax (352)338-0662
- Medical Device Technoloqies, Inc. Ultra™ TRADE NAMES :
- Reusable handle gun for use with COMMON NAME :
- CLASSIFICATION NAME: Instrument, Biopsy, No. 78KNW
SUBSTANTIAL EQUIVALENCE:
| Company Name | Product Name | 510(k) No |
|---|---|---|
| Manan Medical Products | Pro Mag 2.2 | K914874 |
| C R Bard | Biopty Biopsy System | K871390 |
DESCRIPTION OF DEVICE:
Our company is presently authorized by the Food and Drug Administration to manufacture disposable soft tissue biopsy needles, This device is to be the reusable handle gun that will K921418. compete with the products that currently use the biopsy needles covered by this 510 (k) .
The Ultra™ Biopsy Device is used to obtain multiple core samples from soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.
§ 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.