(224 days)
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No
The summary describes a mechanical biopsy instrument with no mention of AI/ML, image processing, or data-driven performance metrics.
No
This device is designed to take core samples (biopsies) for diagnostic purposes, not to treat a disease or condition.
No
This device is designed to take samples (biopsy) from tissues, which are then typically sent for laboratory analysis to diagnose a condition. The device itself is for sample collection, not for performing the diagnosis.
No
The device description explicitly states it is a "disposable biopsy instrument," which is a physical hardware device. The performance studies also focus on physical tests like "Firing Test" and biocompatibility tests.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "take core samples from a variety of soft tissues". This describes a device used in vivo (within the body) to collect tissue for later analysis.
- Device Description: The description of an "automatic spring loaded, depth programmable, disposable biopsy instrument" further supports its use for collecting tissue samples directly from a patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve reagents, analyzers, or other components used to test biological samples like blood, urine, or tissue after they have been collected.
This device is a surgical instrument used for tissue collection, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
An automatic biopsy system designed to take core samples from a variety of soft tissues, including (but not limited to) liver, prostate, kidney.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Speed-Cut® is an automatic spring loaded, depth programmable, disposable biopsy instrument.
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
soft tissues, including (but not limited to) liver, prostate, kidney.
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
The following tests were performed to verity the safety and efficacy of the instrument.
TEST | RESULTS
Firing Test* | Passed
Intracutaneous Reactivity | Passed
Acute Systemic Activity | Passed
Pyrogen Test | Passed
Cytotoxicity | Passed
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- Gallini exhaustive test procedures (firing until failure) indicate the Speed-Cut® biopsy instruments may be fired on average fifty (50) times before failling. The manufacturer feels a ten to one (fire to fail/max.pl. use)ratio provides adequate safety margin.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ACECUT Automatic Biopsy System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
NOV 21 1996
K961407
.
ll
ll
PI 12
510K SUMMARY
Owner:
Gallni s.r.l. 88/90 Via S. Faustino 41037-Mirandola-Italy
Contact:
Paul L. Hawthorne U.S. Representative C/O Coeurage Enterprises 3106 Bretton Court Glen Allen, VA 23060
April, 1996 Submission Date:
Speed-Cut® - Automatic Biopsy System Device Name:
ACECUT Automatic Biopsy System Predicate Device: Meadox Medical, Inc.
Description of The Speed-Cut® is an automatic spring loaded, Device Function depth programmable, disposable biopsy instrument.
Intended Use: An automatic biopsy system designed to take core samples from a variety of soft tissues, including (but not limited to) liver, prostate, kidney.
TECHNOLOGICAL CHARACTERISTICS
The SPEED-CUT® Automatic Biopsy System is equivalent to the predicate device in terms of technological characteristics.
Due to the variety of sizes available for this device, it may be used in laparascopic procedures. The small size and longer needles facilitate placement through one of the incisions while the surgeon "views" the tlssue to be blopsied using fiber optics or ultra-sound.
1
P2012
2
510K SUMMARY
The following tests were performed to verity the safety and efficacy of the instrument.
| TEST | RESULTS |
|---|---|
| Firing Test* | Passed |
| Intracutaneous Reactivity | Passed |
| Acute Systemic Activity | Passed |
| Pyrogen Test | Passed |
| Cytotoxicity | Passed |
-
- Gallini exhaustive test procedures (firing until failure) indicate the Speed-Cut® biopsy instruments may be fired on average fifty (50) times before failling. The manufacturer feels a ten to one (fire to fail/max.pl. use)ratio provides adequate safety margin.