(128 days)
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No
The summary describes a reusable handle for a biopsy needle and makes no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
This device is used to obtain tissue samples for diagnostic purposes (biopsy), not for treating a disease or condition.
No
The device is described as a "reusable handle gun" used to "obtain multiple core samples from soft tissue", which are then likely sent for analysis rather than being analyzed by the device itself. This indicates it is a tool for sample collection, not for diagnosis.
No
The device description explicitly states it is a "reusable handle gun" and references disposable biopsy needles, indicating it is a hardware device.
Based on the provided information, the Ultra™ Biopsy Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to obtain tissue samples from the body. IVD devices are used to examine specimens (like tissue samples, blood, urine, etc.) outside of the body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device is described as a reusable handle gun for biopsy needles. This is a tool for collecting samples, not for analyzing them.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological specimens, such as reagents, assays, or analytical instruments.
The Ultra™ Biopsy Device is a surgical instrument used for tissue collection. The collected tissue samples could then be used with IVD devices for analysis, but the biopsy device itself is not an IVD.
N/A
Intended Use / Indications for Use
The Ultra™ Biopsy Device is used to obtain multiple core samples from soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.
Product codes
78KNW
Device Description
Our company is presently authorized by the Food and Drug Administration to manufacture disposable soft tissue biopsy needles, This device is to be the reusable handle gun that will K921418. compete with the products that currently use the biopsy needles covered by this 510 (k) .
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 tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions
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
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
K962969/S1
Image /page/0/Picture/1 description: The image shows a logo for MDTech Medical Device Technologies Inc. The logo is in a rectangular shape with a black background and white text. The text is in a bold, sans-serif font. The logo is simple and modern.
45 S.W. 35th Terrace Suite 310 Jainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662 DEC - 6 1996
510 (k) SUMMARY
- Medical Device Technologies, Inc. APPLICANT : 4445-310 SW 35th Terrace Gainesville, FL 32608
- CONTACT : Karl Swartz Quality Assurance Manager
- TELEPHONE : (352)338-0440 fax (352)338-0662
- Medical Device Technoloqies, Inc. Ultra™ TRADE NAMES :
- Reusable handle gun for use with COMMON NAME :
- CLASSIFICATION NAME: Instrument, Biopsy, No. 78KNW
SUBSTANTIAL EQUIVALENCE:
| Company Name | Product Name | 510(k) No |
|---|---|---|
| Manan Medical Products | Pro Mag 2.2 | K914874 |
| C R Bard | Biopty Biopsy System | K871390 |
DESCRIPTION OF DEVICE:
Our company is presently authorized by the Food and Drug Administration to manufacture disposable soft tissue biopsy needles, This device is to be the reusable handle gun that will K921418. compete with the products that currently use the biopsy needles covered by this 510 (k) .
The Ultra™ Biopsy Device is used to obtain multiple core samples from soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.