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510(k) Data Aggregation
(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 | < 1 second | < 1 second |
| Firing Distance (Needle Advancement) | 22mm (piercing) | 21.5 mm (Steady cut) |
| Power source | NA (Mechanical only for predicate) | Low Voltage VDC motor |
| Energy Used/Delivered | NA (Mechanical, delivered by manual operation for predicate) | Direct Current from Battery |
| Stroke/Travel length outer tube | 22 mm | 21.5 mm |
| Penetration (Initial Penetration Force) | 1.0 N | 0.8 N |
| Penetration Force - Pear (depth of 12.5 mm) | 5.6 N | 6.1 N |
| Bending load (Deflection at 40 N < 0.4 mm) | 0.19 mm | 0.29 mm |
| Probe tip welding strength | Resistance to 100N: Yes | Resistance to 100N: Yes |
| Operated by either hand | Right or left | Right or left |
| Packaging materials | PET, and Tyvek | PET, Tyvek, and LDPE |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "in-vitro device performance," "electrical & product safety," "sterilization," "biocompatibility," "predicate device comparison," and "simulated use testing." The specific sample sizes for these non-clinical tests are not provided. The data provenance is also not specified (country of origin, retrospective/prospective). The sample weight, length, and number of segments are reported for "Pig breast," indicating animal tissue was used for some performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The document discusses device performance and comparison to a predicate, not diagnostic accuracy based on expert interpretation. No ground truth established by experts is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or adjudication.
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 document describes a medical device for obtaining biopsy specimens, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance metrics like sample weight, length, number of segments, and quality score, the "ground truth" would be the objective measurements obtained from the biopsy samples taken from "Pig breast." This is a form of objective measurement/laboratory data from a biological model, not expert consensus or pathology on human samples in the context of diagnostic accuracy.
8. The sample size for the training set
Not applicable. This is a physical device, and the testing described is non-clinical performance evaluation, not machine learning model training.
9. How the ground truth for the training set was established
Not applicable. (See #8).
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