(79 days)
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No
The device description focuses solely on the mechanical design and function of the biopsy system components. There is no mention of software, algorithms, data processing, or any terms related to AI or ML.
No.
The device is indicated for use for biopsy of bone lesions, which is a diagnostic procedure, not a therapeutic one.
No
The device is indicated for biopsy of bone lesions, which is a procedure to collect tissue for diagnosis, but the device itself is a tool for tissue collection, not a diagnostic device that interprets data or provides a diagnosis.
No
The device description clearly details physical components like cannulas, drill bits, stylets, and depth gauges, indicating it is a hardware-based medical device. There is no mention of software as a component or the primary function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Bonopty™ Coaxial Bone Biopsy System with Eccentric Drill is a surgical instrument used to physically obtain a sample of bone tissue from a lesion. It is a tool for sample collection, not for analyzing the sample itself.
- Intended Use: The intended use is "for biopsy of bone lesions," which is the act of taking a tissue sample.
- Device Description: The description details the physical components and how they are used to penetrate bone and collect a sample. There is no mention of analyzing biological samples or providing diagnostic information based on the sample itself.
Therefore, this device is a medical device used for a surgical procedure (biopsy), but it does not perform in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Bonopty™ Coaxial Bone Biopsy System with Eccentric Drill is indicated for use for biopsy of bone lesions.
Product codes
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Device Description
The Bonopty Coaxial Bone Biopsy System with Eccentric Drill consists of a cannula with a sharp cutting edge and a drill bit (drill) that fits into the cannula. When the biopsy system is assembled, the tip of the drill protrudes beyond the cutting edge of the cannula. The distal tip of the drill has two cutters which do not align with the center line of the drill, as would a conventional drill. During drilling, the eccentric drill tip functions like a guide and forces the drill to wobble in the hole, with the drill tip as a center of rotation. Therefore, the hole created is larger than the outer diameter of the cannula of the needle assembly thus making it easy to advance the cannula over the drill until the cannula is anchored in the bone. Then the drill can be removed and the cannula left in the bone, mounted as a fixed guiding path to facilitate sampling with different biopsy needles or to allow further treatment, without the need to obtain localizing CT scans for each biopsy.
The Bonopty™ Coaxial Bone Biopsy System with Eccentric Drill consists of a Penetration Set, a Biopsy Set and an optional Extended Drill.
The Penetration Set consists of one Penetration Cannula with stylet (OD 14G, ID 15G, Length 95mm), one Drill (OD 15G, Length 122mm), one Depth Gauge (adjustable length) and one Reference Guide.
The Biopsy Set consists of one Biopsy Cannula with Stylet (OD 15G. ID 18G. Length 160mm), one Ejector Pin, one Depth Gauge (adjustable length) and one Reference Guide.
The Extended Drill (OD 15G, ID 18G, Length 160mm) is optional.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
bone
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Angiomed Osty-Cut Bone Biopsy Needle
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/0 description: The image shows a handwritten sequence of numbers and letters. The sequence starts with the letter 'K', followed by the numbers 9, 6, 2, 4, and 5. The handwriting style is casual and slightly rounded, with varying stroke thicknesses.
B.
C.
SECTION VI
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
- Submitter's Information: A.
SEP 1 1 1996
| Submitter's Name: | Radi Medical Systems AB |
|---|---|
| Address: | Palmbladsgatan 10 |
| S-754 50 Uppsala, Sweden | |
| Phone: | 46-18-69-40-20 |
| Fax: | 46-18-69-61-36 |
| Contact Person: | Per Egnelöv |
| Date of Preparation: | June 11, 1996 |
| Device Name: | |
| Trade Name: | BonoptyTM Coaxial Bone Biopsy Syswith Eccentric Drill |
| Common Name: | Bone biopsy system |
| Classification Names: | Set, biopsy needle and needle, gastro-urology |
| Predicate Device Names: | |
| Trade Names: | Angiomed Osty-Cut Bone Biopsy Needle |
- D. Device Description:
The Bonopty Coaxial Bone Biopsy System with Eccentric Drill consists of a cannula with a sharp cutting edge and a drill bit (drill) that fits into the cannula. When the biopsy system is assembled, the tip of the drill protrudes beyond the cutting edge of the cannula. The distal tip of the drill has two cutters which do not align with the center line of the drill, as would a conventional drill. During drilling, the eccentric drill tip functions like a guide and forces the drill to wobble in the hole, with the drill tip as a center of rotation. Therefore, the hole created is larger than the outer diameter of the cannula of the needle assembly thus making it easy to advance the cannula over the drill until the cannula is anchored in the bone. Then the drill can be removed and the cannula left in the bone, mounted as a fixed guiding path to facilitate sampling with different biopsy needles or to allow further treatment, without the need to obtain localizing CT scans for each biopsy.
1
The Bonopty Coaxial Bone Biopsy System with Eccentric Drill consists of a Penetration Set, a Biopsy Set and an optional Extended Drill.
The Penetration Set consists of one Penetration Cannula with stylet (OD 14G, ID 15G, Length 95mm), one Drill (OD 15G, Length 122mm), one Depth Gauge (adjustable length) and one Reference Guide.
The Biopsy Set consists of one Biopsy Cannula with Stylet (OD 15G. ID 18G. Length 160mm), one Ejector Pin, one Depth Gauge (adjustable length) and one Reference Guide.
The Extended Drill (OD 15G, ID 18G, Length 160mm) is optional.
- E. Intended Use:
I MEDICAL SYSTEMS
The Bonopty™ Coaxial Bone Biopsy System with Eccentric Drill is indicated for use for biopsy of bone lesions.
- F. Technical Characteristics:
The Bonopty™ Coaxial Bone Biopsy System with Eccentric Drill itructed of biocompatible materials. Most of the materials used in the construction are typical for similar accessories. These include brass and solder.