(60 days)
No
The device description focuses on mechanical and negative pressure mechanisms for specimen harvesting, with no mention of AI or ML technologies.
No.
The device is strictly for harvesting bone and/or bone marrow specimens and does not provide any therapeutic benefit or treatment. Its function is diagnostic.
No
This device is used to harvest bone and/or bone marrow specimens. The retrieved specimens would then presumably be sent for analysis, but the device itself is for collection, not diagnosis.
No
The device description clearly describes a physical needle and cannula used for mechanical harvesting of bone and bone marrow specimens, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "harvesting bone and/or bone marrow specimens." This describes a procedure to obtain a sample from the patient's body.
- Device Description: The description details a mechanical device used for percutaneous insertion and specimen collection. It does not describe a device used to examine specimens in vitro (outside the body) to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing the collected specimens, reagents, calibrators, controls, or any other components typically associated with IVD devices. The focus is solely on the collection of the sample.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro to provide information for diagnostic, monitoring, or screening purposes. This device's function is to obtain the specimen, not to analyze it for diagnostic purposes.
N/A
Intended Use / Indications for Use
The MD Tech Biopsy-Set is intended for the purpose of harvesting bone and/or bone marrow specimens.
Product codes
19DWO
Device Description
Our company is presently authorized by the Food and Drug Administration to manufacture soft tissue biopsy needles, K944837 The bone biopsy needle is a variation of this needle.
The MD Tech Biopsy-Set is intended for the purpose of harvesting bone and/or bone marrow specimens.
The MD Tech Biopsy-Set Bone and Bone marrow is inserted percutaneously, adjacent to the biopsy site. Access to the bone and/or bone marrow specimen(s) is achieved mechanically via cutting surfaces on the device. Harvesting of bone and/or bone marrow specimen(s) is accomplished both by mechanical and negative pressure (aspiration), which is created by attaching a syringe to a fitting on the outer cannula of the device. Specimen(s) are contained within the outer cannula during withdrawal from the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone and/or bone marrow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K890925, K930732, K940025, K945109
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
The 1 9 1996
510(k) SUMMARY
APPLICANT : Medical Device Technologies, Inc. 4445-310 SW 35th Terrace Gainesville, FL 32608
CONTACT : Karl Swartz Quality Assurance Manager
TELEPHONE : (352)338-0440 fax (352)338-0662
- TRADE NAMES: Medical Device Technologies, Inc. and/or MD TECH Biopsy Set For Bone and Bone Marrow
COMMON NAME: Bone and/or bone marrow aspiration/biopsy needles.
CLASSIFICATION NAME: Needle, Biopsy, Cardiovascular, No. 19DWO
SUBSTANTIAL EQUIVALENCE:
| Company Name
www.assens.com/sports and and with the became of the became
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Product Name
and and the many of the more of the commend them and commend of the first from the first for the first for the first for the first for the first for the first for | 510(k) No.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
| Mannan Medical Products | Bone Marrow Biopsy Needle | K890925 |
| Mannan Medical Products | Super Core Biopsy Needle | K930732 |
| Mannan Medical Products | Bone Marrow Harvest Needle | K940025 |
| Sherwood Medical | Monoject Bone Marrow Needle | K945109 |
DESCRIPTION OF DEVICE:
Our company is presently authorized by the Food and Drug Administration to manufacture soft tissue biopsy needles, K944837 The bone biopsy needle is a variation of this needle.
The MD Tech Biopsy-Set is intended for the purpose of harvesting bone and/or bone marrow specimens.
The MD Tech Biopsy-Set Bone and Bone marrow is inserted percutaneously, adjacent to the biopsy site. Access to the bone and/or bone marrow specimen(s) is achieved mechanically via cutting surfaces on the device. Harvesting of bone and/or bone marrow specimen(s) is accomplished both by mechanical and negative pressure (aspiration), which is created by attaching a syringe to a fitting on the outer cannula of the device. Specimen(s) are contained within the outer cannula during withdrawal from the patient.