(215 days)
The TeesuVac Breast Biopsy Device Mark 1 is indicated to obtain percutaneous core biopsy specimens from soft tissue, and tumors of the breast. This product is intended for diagnostic use only, NOT therapy. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removing 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.
TeesuVac Breast Biopsy Device Mark 1 is a sterile, tetherless vacuum-assisted handheld biopsy device intended to obtain percutaneous core biopsy specimens from soft tissue and tumors of the breast with ultrasound guidance. TeesuVac Breast Biopsy Device Mark 1 is intended for biopsy and diagnosis only. The device is battery-driven and for single-patient use. An unsterilized Battery Pack that comes with the biopsy device is applied using the sterile Battery Clip, stored in the tray containing the biopsy device. The device is fitted with a 14G needle set to obtain specimens from soft tissue and tumors. The device is for professional users only. The tissue harvested by TeesuVac Breast Biopsy Device Mark 1 is intended for diagnostic use only.
The cannula needle consists of two hollow cannulas, an inner cannula with a specimen chamber, and a sharp outer cutting cannula that extends at high speeds over the aperture to acquire targeted tissue specimens. During the shot, a vacuum pulls the tissue into the chamber, followed by moving the outer cutting cannula forward over the specimen chamber to cut the tissue and collect the specimen in the specimen chamber. The TeesuVac Breast Biopsy Device Mark 1 has two buttons: the Slider for loading and the Sampling button to perform the biopsy procedure.
The information provided describes a medical device, the TeesuVac Breast Biopsy Device Mark 1, and its substantial equivalence to a predicate device (Bard Max-Core Disposable Core Biopsy Instrument) based on non-clinical testing. It does not contain information about clinical studies with human participants, AI performance, or ground truth established by experts.
Therefore, many of the requested sections about acceptance criteria, efficacy studies, and ground truth cannot be filled from the provided text.
Here's the available information based on the document:
1. A table of acceptance criteria and the reported device performance
The document presents a comparison of attributes between the subject device (TeesuVac Breast Biopsy Device Mark 1) and the predicate device (Bard Max-Core, K133948). The "Evaluation" column in the table suggests that the subject device's performance is considered "Similar" or "Same as" the predicate device for most attributes, indicating that meeting these comparable performance characteristics serves as the de facto acceptance criteria for "substantial equivalence."
| Attribute | Acceptance Criteria (Implicit: Similar to/Same as Predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| Device Type | Biopsy Instrument | Biopsy Instrument |
| Regulation Number | 21 CFR 876.1075 | 21 CFR 876.1075 |
| Product Code | KNW | KNW |
| Indication for Use | Similar to Bard Max-Core (broader for predicate) | To obtain percutaneous core biopsy specimens from soft tissue and tumors of the breast (diagnostic use only) |
| Patient Population | Similar to Bard Max-Core | Any patient population requiring the harvest of cellular material |
| Disposable | Single-use | Single-use |
| SAL level | SAL > 10^-6 | SAL > 10^-6 |
| Sterilization method | Similar to Bard Max-Core | Gamma |
| Visualization Techniques | Similar to Bard Max-Core (predicate has more options) | Ultrasound Imaging |
| Principle of Operation | Similar to Bard Max-Core | Make a small incision or puncture the skin with a scalpel. Using ultrasound guidance, insert the needle through the incision, and position the tip to the appropriate depth. |
| Materials | A single-use device composed primarily of plastics and stainless steel | A single-use device composed primarily of plastics and stainless steel |
| Patient contacting materials | Stainless steel needle (and rarely the plastic handle) | Stainless steel needle (and rarely the plastic handle) |
| Mechanical principle | Similar to Max-Core (predicate is not electromechanical) | Self-contained handheld electromechanical vacuum-assisted biopsy device |
| Number of tissue samples | Single sample per puncture | Single sample per puncture |
| Mechanism of action | Similar to Bard Max-Core | Outer tube retracts, then moves forward |
| Mode of action | Fast-moving outer tube | Fast-moving outer tube |
| Needle Design | Separated Coaxial Cannula, Hollow outer cutting cannula, Notched inner needle/trocar tipped, no transport of tissue, Aspiration via inner needle | Separated Coaxial Cannula, Hollow outer cutting cannula, Notched inner needle/trocar tipped, no transport of tissue, Aspiration via inner needle |
| Needle diameter/gauge | 14G | 14G |
| Number of samples | Single sample per puncture | Single sample per puncture |
| Sample weight | ~10 mg (Pig breast) | 14 mg (Pig Breast) |
| Sample Length | ~8.35 mm (Pig breast) | 9.04 mm (Pig breast) |
| Number of segments in samples | Minimum 1.2, Maximum 2.1 segments | Minimum 1 segment, Maximum 2.1 segments |
| Sample Quality score | 4.86 | 7.71 |
| Durability | ≥ 5 shots, Intact needle tip | ≥ 5 shots, Intact needle tip |
| Duration of the sample cut |
§ 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.