(84 days)
Not Found
No
The device description and performance studies indicate a standard mechanical bone biopsy needle with no mention of AI/ML components or capabilities.
No
This device is a bone marrow biopsy needle used for diagnostic procedures to obtain tissue samples, not for treating a disease or condition.
Yes
The device is described as a biopsy system, which is used to collect tissue samples. Biopsies are diagnostic procedures because the collected samples are analyzed to diagnose diseases or conditions.
No
The device description clearly outlines physical components (cannula, stylet, hub, handle) which are hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "physicians performing bone marrow biopsy procedures." This describes a procedure performed on the patient's body to obtain a sample.
- Device Description: The device is a "standard bone marrow biopsy needle." This is a tool used to physically extract a sample from the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens in vitro (outside the body) to provide information about a patient's health. This device is used in vivo (inside the body) to collect the specimen.
The device is a tool for collecting a sample, not for analyzing it. Therefore, it falls under the category of a surgical or procedural device, not an IVD.
N/A
Intended Use / Indications for Use
The Mathis Vertebral and Bone Biopsy Systems are intended for use by physicians performing bone marrow biopsy procedures.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
The Mathis Vertebral and Bone Biopsy System is a standard bone marrow biopsy needle consisting of a cannula with a sharpened distal end and a stylet received coaxially in the cannula and having a sharpened distal end protruding from the distal end of the cannula. The cannula is insert molded to a hub with standard threadable lug tabs. The stylet is insert molded to a standard hub. When the stylet assembly is placed into the cannula assembly, the entire cannula/stylet unit can be threaded into a removable gripable handle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone marrow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians
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): 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.
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.
Not Found
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).
Not Found
§ 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
IMS
International Medical Systems
PO Box 4936 Annapolis, Maryland 21403
×990515
510(k) Summary
Submitted by: Charles Simonelli 28 Spring Lane Farmington, CT 06032 Phone: 860-676-0770 Fax:860-676-0871
Date Submitted: February 2, 1999
Classification, Common or Usual Name, Device Name:
| Trade Name: | Mathis Vertebral and Bone Biopsy System |
|---|---|
| Common Name: | Bone Marrow Biopsy Needle |
| Classification Name: | Needle, Biopsy, Cardiovascular |
| General and Plastic Surgury-878 | |
| Classification Number-79DWO | |
| Regulation Number-878.4800 | |
| Class I |
Predicate Device:
Manan Bone Marrow Aspiration / Biopsy Needle (K890925). The device is available in the following sizes:
8 ga x 4" 8 ga x 6" 11 ga x 4" 11 ga x 6" 13 ga x 4" 13 ga x 2-1/2"
Device Description:
The Mathis Vertebral and Bone Biopsy System is a standard bone marrow biopsy needle consisting of a cannula with a sharpened distal end and a stylet received coaxially in the cannula and having a sharpened distal end protruding from the distal end of the cannula. The cannula is insert molded to a hub with standard threadable lug tabs. The stylet is insert molded to a standard hub. When the stylet assembly is placed into the cannula assembly, the entire cannula/stylet unit can be threaded into a removable gripable handle.
Indications For Use:
The Mathis Vertebral and Bone Biopsy Systems are intended for use by physicians performing bone marrow biopsy procedures.
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Technological Characteristics:
The key technological characteristic involved in bone marrow biopsy procedures is the effect of the point geometry of the cannula and protruding stylet on the units ability to penetrate the outer layer of the bone in a controllable manner. Stylets and cannula presently in the market have been designed with various sharpened distal ends to facilitate bone penetration. The Mathis Vertebral and Bone Biopsy System will not substantially differ its stylet and cannula point geometry from product currently available in the market.
Non-Clinical Data:
Part specification and prints for the Mathis Vertebral and Bone Biopsy System show it to be substantially equivalent to the Manan Bone Marrow Aspiration/Biopsy Needle.
Clinical Performance Data:
None available at this time.
Conclusions:
It is the conclusion of International Medical Systems that the Mathis Vertebral and Bone Biopsy System is substantially equivalent, relative to its key technical performance characteristics, to product already available in the market.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 1999
Mr. Charles Simonelli Quality Assurance Manager International Medical Systems P.O. Box 4936 Annapolis, Maryland 21403
Re: K990515 Trade Name: Mathis Vertebral and Bone Biopsy System Regulatory Class: II Product Code: KNW Dated: February 9, 1999 Received: February 18, 1999
Dear Mr. Simonelli:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Charles Simonelli
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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International Medical Systems PO Box 4936 Annapolis, Maryland 21403
Statement For Indications For Use:
K 940215 510(k) Number (if known):_
Device Name: Mathis Vertebral and Bone Biopsy System
Indications For Use:
The Mathis Vertebral and Bone Biopsy Systems are intended for use by physicians performing bone marrow biopsy procedures.
Prescription Use
(Per 21 CFR 801.109)
Dooelo
(Division Sign-Off Division of General Restorative Dev 9905 510(k) Number