(83 days)
The Accucore Biopsy Needle can be used for obtaining core and/or aspiration biopsies of various tissues (prostate, lung, liver, spleen, thyroid, adrenals, abdominal soft tissue masses, breast). For breast biopsy this product is for diagnosis only - not for therapeutic use.
The design of the Inrad Accucore Biopsy Needle as well as the predicate device is referenced in the Comparison Information Section. The products are identically manufactured using the identical manufacturing systems, design and materials. Both needles are manufactured by Manan Medical products, Inc. The primary difference is packaging and sterilization which will be performed by Inrad. The device is manufactured from plastic(ABS) and stainless steel. The stainless steel is the only thing that has direct patient contact.
The provided text is a 510(k) summary for the Inrad Accucore Biopsy Needle. It asserts substantial equivalence to a predicate device rather than presenting a study demonstrating its performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and study details for the device's performance cannot be extracted directly from this document.
The document focuses on demonstrating that the Inrad Accucore Biopsy Needle is substantially equivalent to the Manan Medical Products, Inc. Automatic Cutting Needle (K 974446)/(K895897). The argument for safety and effectiveness is based on the predicate device's established use and the identical manufacturing process.
Here's a breakdown of what can be inferred or explicitly stated from the provided text, and where information is missing:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated. The document does not define specific performance metrics or acceptance criteria for the Inrad Accucore Biopsy Needle. | Not Explicitly Stated. The document does not present quantitative performance data for the Inrad Accucore Biopsy Needle against any metrics. |
| Implicit Acceptance Criteria: Substantial equivalence to the predicate device (Manan Medical Products, Inc. Automatic Cutting Needle). This essentially means the device performs at least as well as the predicate for its intended use. | Implicit Reported Performance: The Inrad Accucore Biopsy Needle is "identically manufactured using the identical manufacturing systems, design and materials" as the predicate device, which has been "sold ... in the market place since 1989 and has proven to be safe and effective." The primary differences are packaging and sterilization. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable/Not provided. No specific test set or study data is presented for the Inrad Accucore Biopsy Needle.
- Data Provenance: Not applicable/Not provided in the context of a new study for this device. The claim of safety and effectiveness relies on the historical performance of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. No new ground truth establishment is described for the Inrad Accucore Biopsy Needle.
4. Adjudication method for the test set:
- Not applicable/Not provided.
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. This device is a biopsy needle, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used:
- Implicit Ground Truth: The established safety and effectiveness of the predicate device (Manan Medical Products, Inc. Automatic Cutting Needle) through its long-term use in the market since 1989. The regulatory body (FDA) accepted this as sufficient evidence for the predicate's performance.
8. The sample size for the training set:
- Not applicable. This device is a physical medical instrument, not a learning algorithm or AI.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of the Study (as described in the 510(k) summary):
The "study" presented here is based on the principle of substantial equivalence. The manufacturer (Inrad Incorporated) argues that its Accucore Biopsy Needle is fundamentally the same as its predicate device, the Manan Medical Products, Inc. Automatic Cutting Needle.
The key arguments for this equivalence are:
- Identical Indications for Use: Both devices are for obtaining soft tissue biopsies.
- Identical Design, Manufacturing Systems, and Materials: Both needles are manufactured by Manan Medical Products Inc. using the same processes and components (plastic (ABS) and stainless steel).
- Established Safety and Effectiveness of Predicate: The predicate device has been on the market since 1989 and is stated to have "proven to be safe and effective."
- Minimal Differences: The only stated differences are packaging and sterilization, which Inrad will perform on the bulk, non-sterile product purchased from Manan.
Therefore, the "proof" that the Inrad Accucore Biopsy Needle meets acceptance criteria (implicitly, the safety and effectiveness standards of a biopsy needle) is the demonstration of its identical nature to a legally marketed and established predicate device. No new performance study on the Inrad Accucore Biopsy Needle itself is described or required for this 510(k) submission.
§ 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.