(337 days)
The medical devices object of this 510K are all needles for biopsy. The products could be classified in 3 families that are:
- the needles for bone-marrow biopsy (In this family of needles for bone-marrow biopsy there is also a little group of devices intended for bone-marrow explants). In particular the indications for use for each different model are the followings:
OSTEOBELL 'T': Needle for bone-marrow biopsy
ORION: Needle for bone-marrow biopsy
ILIAC-MARROW: Needle for bone-marrow biopsy
OBSTERN: Needle for bone-marrow biopsy
STERNOBELL: Needle for bone-marrow biopsy
TOTALLY REMOVE: Needle for bone-marrow biopsy
UNLUX SYSTEM: Needle for bone-marrow biopsy
OSTEOBELL EXPLANT: Needle for bone-marrow explant
ORION EXPLANT: Needle for bone-marrow explant
ILIAC-MARROW EXPLANT: Needle for bone-marrow explant
OBSTERN EXPLANT: Needle for bone-marrow explant
STERNOBELL EXPLANT: Needle for bone-marrow explants
- the semiautomatic quillotine needles for soft-tissue biopsy (breast, kidney, liver, prostate):
SPEEDYBELL: semiautomatic guillotine needle for soft-tissue biopsy (breast, kidney, liver, prostate)
SPEEDYBELL DOPPIA CORSA: semiautomatic guillotine needle for soft-tissue biopsy (breast, kidney, liver, prostate)
SPEEDYBELL & INTRODUTTORE: semiautomatic guillotine needle for soft-tissue biopsy (breast, kidney, liver, prostate)
SPEEDYBELL DOPPIA CORSA & INTRODUTTORE: semiautomatic guillotine needle for soft-tissue biopsy (breast, kidney, liver, prostate)
- the automatic guillotine needles for soft-tissues biopsy (liver):
ESTER: automatic quillotine needle for soft-tissue biopsy (liver)
ESTER & INTRODUTTORE: automatic guillotine needle for soft-tissue biopsy (liver)
The medical devices object of this 510K are all needles for biopsy, used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination (biopsy). The devices could be classified in 3 families that are:
- the needles for bone-marrow biopsy,
- the semiautomatic guillotine needles for soft-tissue biopsy and
- the automatic quillotine needles for soft-tissue biopsy.
All the needles are single use and sterile (ETO sterilization).
All the needles are composed with an external cannula (tube) and an internal stylet (mandrel) both in AISI 304 stainless steel. The grip of the needles is in plastic (different depending from the model).
The provided document describes the acceptance criteria and the studies conducted to demonstrate the safety and effectiveness of Biopsybell S.R.L.'s biopsy needles. The studies are non-clinical bench tests performed on three families of biopsy needles: needles for bone-marrow biopsy, semiautomatic guillotine needles for soft-tissue biopsy, and automatic guillotine needles for soft-tissue biopsy.
Here's an organized summary of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Family 1: Needles for Bone-Marrow Biopsy (Test Report n°59/10 dated 08/11/2010)
| Acceptance Criteria (Purpose of Testing) | Reported Device Performance |
|---|---|
| 1) Stylet perforation capacity in the bone | Insertion was optimal and conducted effortlessly and without any difficulty whatsoever. (Visual test) |
| 2) Cannula perforation capacity in the bone tissue | The specially sharpened cannula tip allows easy and trouble-free insertion. Stylet was easily withdrawn to allow full needle penetration into the medullary cavity for at least 2 cm, flawlessly and without obstruction. Collection of an intact sample further supported this, indicating no clogging or obstruction. (Manual observation for ease of insertion, sample integrity) |
| 3) Handle grip during bone insertion procedures | The handle never became detached or deformed; it did not rotate on the cannula, or break under compression, twisting, or traction. In-vise trials showed the cannula broke only under excess force, while the handle remained intact. (Stress tests on animal tissues and in-vise) |
| 4) Adequacy of the Luer-lock connection | Fully compliant with ISO594-1 gauges testing and three-syringe trials. No loss of liquid, no disruptions, and easy/trouble-free needle-to-syringe connection in all cases. (ISO 594-1 buffer test, three-syringe aspiration/injection tests) |
| 5) Quantity of the collected sample | Each sample was abundant and with a length greater than 1.5 cm. (Acceptance criteria threshold was at least 0.5 cm). Each fragment was cylindrical and minimum 1.5 cm. (Measurement of collected samples) |
| 6) Integrity of the collected sample | Each collected sample, whether from animal, apples, or expanded polyurethane, was intact and abundant. Each sample was cylindrical, well preserved, intact, and free of frays. (Video-microscope examination) |
Family 2: Semiautomatic Guillotine Needles for Soft-Tissue Biopsy (Test Report n°67 dated 08/11/2010)
| Acceptance Criteria (Purpose of Testing) | Reported Device Performance |
|---|---|
| 1) Needle perforation capacity (penetration) | Insertion was optimal and conducted effortlessly and without any difficulty whatsoever. (Visual test) |
| 2) Shot of the needle (cannula covering the notch) | The shot was always complete, and the cannula always covered completely the notch of the stylet. The shot was perfect for both 1cm and 2cm race. (Observation of release mechanism in air and tissues) |
| 3) Quantity of the collected sample | For the 1cm notch, samples were abundant and greater than 0.7 cm (acceptance threshold: at least 0.5 cm). For the 2cm notch, samples were abundant and greater than 1.3 cm (acceptance threshold: at least 1 cm). Each collected fragment was cylindrical. (Measurement of collected samples from liver, muscle, polyurethane, apple) |
| 4) Integrity/quality of the collected sample | Each collected sample (from animal, apples, or expanded polyurethane) was intact and abundant, cylindrical in shape, well preserved, intact, and free of frays. (Video-microscope examination) |
Family 3: Automatic Guillotine Needles for Soft-Tissue Biopsy (Test Report n°68 dated 30/04/2012)
| Acceptance Criteria (Purpose of Testing) | Reported Device Performance |
|---|---|
| 1) Needle perforation capacity (penetration) | Insertion was optimal and conducted effortlessly and without any difficulty whatsoever. (Visual test) |
| 2) Correct loading of the needle | Loading of the cannula and the stylet resulted as good in all cases. The two components remained loaded, and loading was realized with the first try. (Observation of loading mechanism) |
| 3) Shot of the needle (cannula covering the notch) | The shot was always complete, and the cannula always covered completely the notch of the stylet. The shot was perfect with both lateral and side buttons. (Observation of release mechanism) |
| 4) Quantity of the collected sample | Each sample was abundant and with a length greater than 1 cm for all samples. Each collected fragment was cylindrical. (Measurement of collected samples) |
| 5) Integrity/quality of the collected sample | Each collected sample (from animal, apples, or expanded polyurethane) was intact and abundant, cylindrical in shape, well preserved, intact, and free of frays. (Video-microscope examination) |
2. Sample Size Used for the Test Set and Data Provenance
The studies are non-clinical bench tests. The document does not specify exact numerical sample sizes for each test in terms of "n=". Instead, it states that:
- Family 1 (Bone-Marrow): "2 model of products that are the worst case of all the other models" (ILIAC MARROW and TOTALLY REMOVE) were used. The "sterile devices have been utilized for each code in the test samples." The tests included "repeatedly tested" for handle grip and "three different trials" for Luer-lock.
- Family 2 (Semiautomatic Soft-Tissue): "Five samples" of 'Speedybell doppia corsa' (worst case model) were used, manufactured in "four different lots, having 14G, 16G and 18G diameters and lengths ranging from 70mm, 100 mm." Tests were conducted both at 1cm and 2cm shots.
- Family 3 (Automatic Soft-Tissue): 'Ester' devices of different diameters and lengths (16G and 18G diameters, 100 mm and 150 mm lengths) from "different lots" were used.
Data Provenance:
The data provenance is retrospective, as these were bench tests performed by the manufacturer (Biopsybell S.R.L.) as part of their 510(k) submission. The tests involved the use of animal tissues (calf femur, liver, muscle), and artificial tissues (expanded polyurethane, apples). The country of origin for the studies is implied to be Italy, where Biopsybell S.R.L. is located.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The ground truth in these bench tests was established through direct observation and measurement of the physical properties and performance of the devices by the testing personnel. The document does not specify the "number of experts" or their "qualifications" in the sense of clinical experts (like radiologists). The "ground truth" was based on objective physical testing, visual inspection, and measurement by technical personnel responsible for conducting the bench tests. For example, "visually tested" and "carefully reviewed and measured."
4. Adjudication Method for the Test Set
No formal adjudication method (like 2+1, 3+1 consensus) is described, as the "ground truth" for these bench tests was based on direct physical observations, measurements, and functional assessments performed by the testing team. The results were reported directly from these tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The studies are non-clinical bench tests evaluating the physical and functional performance of the biopsy needles, not diagnostic accuracy or human reader performance.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a physical medical device (biopsy needles), not an AI algorithm.
7. Type of Ground Truth Used
The ground truth used was based on objective physical measurements, functional assessments, and visual inspection of the device's performance in different tissue types (animal and artificial). This included:
- Ease of penetration (visual/manual assessment)
- Integrity and quantity of collected samples (measurement, video-microscope examination)
- Mechanical function (Luer-lock compliance, shot completion, handle integrity)
8. Sample Size for the Training Set
Not applicable. These are non-clinical bench tests of a physical device, not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI model.
§ 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.