(243 days)
The SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices are intended for diagnostic sampling of soft tissue during soft tissue biopsy procedures. They are to be used for diagnostic purposes only and are not intended for therapeutic uses.
The SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices are indicated to provide soft tissue samples for diagnostic sampling of soft tissue abnormalities, including breast, liver, kidney, prostate, spleen, lymph nodes, and various other soft tissue abnormalities. They are designed to provide soft tissue for histologic examination, with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from imaging appearance (ultrasound, radiographic, e.g., mammographic) of a soft tissue abnormality. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
SpeedBird Model SB38 Soft Tissue Biopsy Device Description: The SpeedBird Model SB38 Soft Tissue Biopsy Device is a sterile, single-use, percutaneous electro-mechanical vacuum-assisted biopsy device used to provide soft tissue samples for histological examination with partial or complete removal of the imaged abnormality. The handle contains controls, a laser pointer, a specimen collection tube, a drive mechanism, a vacuum pump, a DC motor, a power indicator light, and batteries. The working end includes a stainless steel coring cannula with twin opposed cutter blades.
SpeedBird Model SBU Soft Tissue Biopsy Device Description: The SpeedBird Model SBU Soft Tissue Biopsy Device is a sterile, single-use percutaneous electro-mechanical vacuum-assisted biopsy device used to provide soft tissue samples for histological examination with partial or complete removal of the imaged abnormality. The handle contains controls, a trigger, a vacuum pump or tubing for external vacuum, a DC motor, a power indicator light, a current rectifier, resistors, an accessory attachment rail, and a receptacle for electrical current input. The working end includes a stainless steel coring cannula with twin opposed cutter blades.
SpeedBird Model SBU99 Soft Tissue Biopsy Device Description: The SpeedBird Model SBU99 Soft Tissue Biopsy Device is a two-component biopsy device comprising a sterile, single-use percutaneous biopsy needle cassette for use within a reusable biopsy needle handle (driver). The Biopsy Needle Cassette contains a stainless steel coring cannula with twin opposed cutter blades, a detachable coaxial outer tube, and fluid transport tubing. The Biopsy Needle Handle (driver) contains controls, a trigger, a vacuum pump or tubing for external vacuum, a DC motor, a power indicator light, a current rectifier, resistors, an accessory attachment rail, and a receptacle for electrical current input.
Here's an analysis of the acceptance criteria and study information for the SpeedBird Soft Tissue Biopsy Devices, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not explicitly state formal "acceptance criteria" in a quantitative sense (e.g., minimum sensitivity/specificity). Instead, the performance testing focuses on demonstrating the device's functional equivalence to predicate devices and its ability to effectively perform its intended use. The criteria are indirectly inferred from the study endpoints.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Effectiveness of tissue penetration, tissue sample part-off, and tissue transport across various tissue densities. | The SpeedBird devices effectively penetrated, cored, and severed all surrogate tissue types in both single and multiple sample modes. |
| Ability to obtain adequate tissue samples for histopathological evaluation. | All coring passes obtained consistent, predictable, undistorted (by unmagnified visual inspection) composite samples. Samples were full-diameter and ranged in length from 19mm to 46mm, producing corresponding volume measurements. |
| Effectiveness of tissue transport mechanisms (vacuum, fluid flush, transport pathway) for successful core collection. | Tissue transport via vacuum and the specimen collection tube was effective, leading to successful collection of tissue sample cores. |
| Condition of the needle tip after each sampling pass. | SpeedBird needle tips continued to rotate throughout all powered passes in all tissue types and remained undistorted following all portions of the testing. |
| Proper functioning of driving motor, gear power train, motor controls, and power source. | Motor torque and battery power remained adequate throughout the procedures, with no requirement to exchange batteries. No significant change in needle rotation speed observed. |
| Force of tissue penetration comparable to predicate devices. | Forces required to penetrate surrogate tissues remained low, with no significant change observed. SpeedBird devices performed substantially equivalently to predicate devices for force of penetration. |
| Absence of tissue sampling bias. | No tissue sampling bias was noted with either SB38 or SBU. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of "samples" in the traditional sense of patients or cases. The test set involved "surrogate tissues" representing a wide variety of tissue densities. The testing involved multiple passes and samples taken from these surrogates.
- Data Provenance: The data is from "bench testing" using "surrogate tissues." This indicates it's an in-vitro (laboratory) study and does not involve human or animal data. The country of origin is not specified, but the submission is to the U.S. FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For bench testing with surrogate tissues, the "ground truth" is typically the physical measurement of the device's performance against predefined objectives (e.g., sample size, penetration force, integrity of the device). There's no mention of human expert consensus for "ground truth" in this context.
4. Adjudication Method for the Test Set
This information is not provided and is generally not applicable to this type of bench testing. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving multiple human readers to resolve discrepancies in diagnoses or interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study described is bench testing, not a clinical study involving human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the SpeedBird device is a physical biopsy instrument, not an AI algorithm. If the question implies "device only" performance, then the bench testing effectively serves as a standalone performance evaluation of the device's mechanical and functional capabilities.
7. The Type of Ground Truth Used
For the bench testing, the "ground truth" was established through physical measurements and visual inspection of the device's performance on surrogate tissues, including:
- Physical dimensions and integrity of the acquired tissue samples.
- Measured forces of penetration.
- Observed condition of the needle tip.
- Verification of motor function and power.
This is distinct from pathology, expert consensus, or outcomes data, which are typically used for clinical diagnostic devices.
8. The Sample Size for the Training Set
This information is not applicable. The SpeedBird devices are mechanical medical devices, not AI/ML algorithms that require a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for a mechanical device.
§ 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.