(471 days)
HS NOTA is an automatic biopsy needle and can be used in Fluoroscopic, CT and Mammographic procedures to obtain biopsies of soft tissue including those from prostate, kidney, breast and liver.
The device is for prescription use, to be used by physicians in hospitals and clinics.
Both the HS NOTA and the predicate device consist of a 304 stainless steel cannula and stylet. In both the devices the cannula and stylet inner handles are moved by springs that must be loaded, toward a charging lever positioned on the external housing of the needle, before firing the needle.
Both PRECISA and HS NOTA are single patient use, disposable, sterile and non-pyroqenic products.
The external plastic handle of HS NOTA has a different shape relative to the predicate device. This difference does not affect the performance or safety of the device as it does not affect the advancement and penetration of the needle inside the tissues, yet it just implies a different way for the user to handle the device.
The charging lever for PRECISA needle is straight, it means operator must pull-it for charging, while the NOTA one is designed to be rotated for loading the springs. This difference is a consequence of the specific external plastic handles of HS NOTA relative to the predicate device and does not impact in safety and effectiveness of the needles.
HS NOTA needle performs a biopsy of 2.5 cm of length inside the soft tissue. PRECISA needle can be adjusted to advance 1 cm or 2 cm of length. When considering PRECISA needle in 2 cm advancing configuration there is a total equivalence between the two devices. Indeed the additional run of 0.5 cm characterizing HS NOTA, is only due to the different inner mechanism of the HS NOTA compared to PRECISA and it does not affect safety and effectiveness: final outcomes in terms of quality and length of the bioptic samples depend on the notch realized on the stylet (shape of stylet tip) which is exactly the same for both HS NOTA and PRECISA.
The sample notch size is 20 mm. So maximum length for core collected is 20 mm.
The shape of cannula and stylet tips are exactly the same for HS NOTA and PRECISA. It means that the HS NOTA and PRECISA are substantially equivalent as capacity to cut the soft tissue.
The Spring used inside the two devices are exactly the same, it means that the force moving the cannula and stylet of both the needle is exactly the same.
Needles diameter characterizing both HS NOTA and PRECISA are 14G, 16G, 18G, and 20G. Furthermore both the devices are provided with needles characterizing by a length within the range 7 cm-25 cm.
HS NOTA is provided with a safety element that is automatically activated as the spring has been loaded. The safety feature must be removed by the physician to fire the device. This mechanism allows to avoid accidental firing of the needle. The predicate device has been manufactured with an identical safety element.
Inner mechanism: The inner mechanism for an automatic biopsy device is responsible for the automatic movements of both stylet and cannula composing the needle. The inner mechanism of HS NOTA is composed by:
- 2 plastic handles, each plastic handle is attached to stylet and cannula distal part, both these handles slide inside the external plastic housing of the product, each plastic handle is provided with hooking means capable to retain the handle in charged position once the spring has been charged
- Inner spring that must charged, they are responsible for the automatic advancing of the inner plastic handles.
- A firing lever which is capable to pull back the inner plastic handles (loading the sprinq) during the charging phase and which is capable to act on the hooking means (which are part of the inner plastic handles) realising them and making possible the inner handles advancing.
PRECISA inner mechanism is composed by the same functional elements.
During the functioning of the product no mechanical damages on these parts must occur.
Materials:
The only part of HS NOTA coming in contact with the patient is represented by the cannula and stylet that are made of biocompatible AISI 304 material, identically to the predicate device. The external part of the device representing the plastic handle is made of nylon while PRECISA's plastic handle is made of ABS. This difference does not affect effectiveness and safety of the device since both nylon and ABS have equivalent characteristics: they are thermoplastic materials allowing the needle to move properly and providing adequate resistance to the force exerted by the spring on the device.
The provided document is a 510(k) summary for the medical device HS NOTA, an automatic biopsy needle. The summary focuses on establishing substantial equivalence to a predicate device (HS Hospital Service S.p.A. "PRECISA" biopsy needle, K002944) and does not contain detailed acceptance criteria and a study proving those criteria are met in the way typically found in performance studies for AI/ML devices.
However, based on the closest information available, here's an attempt to answer the request, highlighting what is implicitly or explicitly stated.
Interpretation: The "acceptance criteria" here are functional performance requirements for a biopsy needle, primarily related to its ability to fire, penetrate tissue, and obtain adequate biopsy samples without mechanical failure. The "study" refers to the performance tests conducted on the HS NOTA device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Performance Tests) | Reported Device Performance (HS NOTA) |
|---|---|
| A. Mechanical Integrity & Functionality: | |
| 1. Good needle advancement and penetration. | Demonstrated good needle advancement and penetration in bovine liver (low density), bovine scrotum (high density), pork lard, and bovine fat. |
| 2. Able to be fired (multiple times as claimed) without damage to the interior mechanism. | Able to obtain the claimed (20) amount of samples without damage to the interior mechanism in both "worst-case" (bovine liver, bovine scrotum) and intermediate tissue types (pork lard, bovine fat). |
| B. Biopsy Sample Quality: | |
| 1. Ability to obtain the claimed amount of samples per firing. | Device was able to obtain the claimed (20) amount of samples. |
| 2. Quality and size of biopsy sample taken with later shots are equivalent to earlier shots. | Quality and length of the bioptic samples for later shots (up to 20) are equivalent for the tested tissue types. |
| 3. Achieves the specified sample notch size (20mm) and maximum core length (20mm). | The sample notch size is 20mm, and the maximum length for collected core is 20mm. Core lengths obtained were in line with those from bovine liver and scrotum tests, with fat samples yielding values between those of the high-density (scrotum) and low-density (liver) tissues, thus corroborating effectiveness within design parameters. The shape of cannula and stylet tips are identical to the predicate device, implying equivalent cutting capacity. |
| C. Biocompatibility & Material Performance: | |
| 1. Parts in contact with patient are biocompatible. | Cannula and stylet are made of biocompatible AISI 304 material, identical to the predicate device. |
| 2. External plastic handle material provides adequate resistance and allows proper needle movement. | Nylon handle (current device) and ABS handle (predicate device) are thermoplastic materials with equivalent characteristics, allowing proper needle movement and providing adequate resistance. |
| 3. Spring force moving cannula and stylet is consistent and adequate. | The springs used inside both the HS NOTA and PRECISA are exactly the same, implying the force moving the cannula and stylet is identical. |
| D. Safety Features: | |
| 1. Safety element prevents accidental firing. | HS NOTA includes a safety element automatically activated upon spring loading, requiring physician removal to fire, avoiding accidental discharge. An identical safety element was used in the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions that the device was able to obtain the claimed 20 samples. This likely refers to the number of firings or samples taken per device tested, rather than the number of devices or tissue blocks. The exact number of devices or tissue blocks tested is not specified, but the tests involved "different samples" of bovine liver, bovine scrotum, pork lard, and bovine fat.
- Data Provenance: The document does not explicitly state the country of origin for the data or tissue samples used. The study was conducted as a performance test to support a 510(k) submission, implying it's a prospective internal test conducted by the manufacturer (H.S. Hospital Service S.p.A., Italy).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This type of study (performance testing for a biopsy needle's mechanical and sample retrieval capabilities) does not typically involve human experts establishing a "ground truth" in the way an AI/ML diagnostic device study would. The "ground truth" here is the physical performance of the device (e.g., successful firing, no damage, measured core length, visual inspection of sample quality). There is no mention of experts, such as radiologists or pathologists, being involved in establishing ground truth for these specific performance tests.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is a physical performance test, not a subjective assessment requiring expert adjudication. The "ground truth" is measured or observed directly by the testing personnel.
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 is not an AI-assisted device. The document describes a physical medical device (an automatic biopsy needle) and its mechanical and functional performance, not a diagnostic algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for these performance tests is based on direct physical measurement and observation of device functionality and retrieved samples. This includes:
- Observation of "good needle advancement and penetration."
- Confirmation of no "damage to the interior mechanism" after multiple firings.
- Measurement of "core length" of biopsy samples (expected 20mm maximum).
- Assessment of "quality" and "size" of biopsy samples.
- Verification of safety mechanism activation.
- Biocompatibility of materials.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for a physical 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.