(37 days)
This device is intended to be used to take high quality histological core samples from soft tissue, including (but not limited to) liver, kidney, prostate.
The device is a spring loaded, disposable biopsy needle.
This document is a 510(k) summary for the "TZ®" Biopsy Needle, dated January 3, 1997. It describes a spring-loaded, disposable biopsy needle intended for taking histological core samples from soft tissues. The summary states that the device is identical in technological characteristics to its predicate device, the ProMedical Ltd. - PRO-B Biopsy Needle (K824598).
The document does not contain any information regarding acceptance criteria related to device performance in terms of diagnostic accuracy or clinical outcomes. The "tests" mentioned (Firing Test, Pyrogen Test, Biocompatibility) appear to be related to manufacturing quality, sterility, and material safety, not diagnostic performance. Therefore, I cannot construct a table of acceptance criteria and reported device performance as requested in point 1, nor can I answer points 2 through 9, as they pertain to a study proving diagnostic performance, which is not present in this document.
Here's a breakdown of what is and is not in the provided text:
- 1. A table of acceptance criteria and the reported device performance: Not provided in the context of diagnostic accuracy. The tests listed are "Firing Test," "Pyrogen Test (LAL)," and "Biocompatibility," all of which "Passed." These relate to manufacturing and material safety, not how well the device performs its intended diagnostic function in terms of tissue quality or diagnostic yield.
- 2. Sample size used for the test set and the data provenance: Not applicable, as there's no diagnostic performance study described.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 4. Adjudication method for the test set: Not applicable.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not mentioned.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical biopsy needle, not an algorithm.
- 7. The type of ground truth used: Not applicable.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
The document primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and basic safety/manufacturing tests. It does not provide any clinical study data for diagnostic performance.
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K9647777
Jan 3, 1997
Medical Products and Services
510(K) SUMMARY
OWNER:
Gallini s.r.I. 88/90 Via S. Faustino 41037-Mirandola (MO) Italy
CONTACT PERSON: Paul L. Hawthorne U.S. Representative
November 22, 1996 SUBMISSION DATE:
"TZ®" Biopsy Needle DEVICE NAME:
ProMedical Ltd. - PRO-B Biopsy Needle PREDICATE DEVICE: 240(K)# - K824598
DESCRIPTION OF DEVICE FUNCTION:
The device is a spring loaded, disposable biopsy needle.
This device is intended to be used to take high INTENDED USE: quality histological core samples from soft tissue, including (but not limited to) liver, kidney, prostate.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The "TZ®" Biopsy needle is identical to the predicate devices in terms of technological characteristics.
The following tests were performed to demonstrate the safety and efficacy of the device.
TEST Firing Test Pyrogen Test (LAL) Biocompatibility
RESULT Passed Passed All tests are performed by the raw material suppliers.
§ 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.