(90 days)
Not Found
Not Found
No
The summary describes a mechanical biopsy instrument and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
Explanation: A therapeutic device is used to treat or cure a disease or condition. This device is described as a biopsy instrument used for drawing osteomedullary substance or explantation of bone marrow, which are diagnostic or procedural actions rather than therapeutic.
No
The device is used for drawing or explantation of substances (osteomedullary substance, bone marrow), which are procedures typically performed for therapeutic or interventional purposes, or to obtain samples for subsequent diagnostic analysis, rather than performing the diagnosis itself.
No
The device is described as a "biopsy instrument," which strongly implies a physical, hardware-based device used for drawing osteomedullary substance and bone marrow. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "drawing of osteomedullary substance and or for explantation of bone marrow." This describes a procedure performed on the patient to obtain a sample.
- IVD Definition: In vitro diagnostics are tests performed outside the body on samples such as blood, urine, or tissue to detect diseases, conditions, or infections.
This device is a tool used to collect the sample, not to analyze it in vitro.
N/A
Intended Use / Indications for Use
This biopsy instrument is used for drawing of osteomedullary substance and or for explantation of bone marrow
Product codes
FCG, KNW
Device Description
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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
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows a logo with the letters "HG" in a bold, stylized font. The letters are interconnected and have a textured, pixelated appearance, giving them a retro or digital feel. There are also horizontal lines below the letters, adding to the design's visual interest.
PREMARKET NOTIFICATION SUBMISSION - 510 (k)
Data: 09-03-2001
JAMSHIDI™
Pag. 28 di 28
KO 130 70
DEC 1 2 2001
510 (k) SUMMARY
: H.S. Hospital Service S.p.A. > Applicant Via Naro, 81 - 00040 Pomezia (Rome) Italy : MMC International, LLC > Contact Person Mr. Lucio Improta 10147 Umberland Place - Boca Raton, FL 33428 Tel. (561)477-1671 - Fax. (561)477-0863 e-mail : mmcintern@aol.com : September 03, 2001 > Submission Date : Jamshidi Bone Marrow Biopsy Needle > Trade Name : Bone Marrow Biopsy Needle > Common Name : 876.1075 - Biopsy instrument > Classification Name
-
- Indication for use :
This biopsy instrument is used for drawing of osteomedullary substance and or for explantation of bone marrow
- Indication for use :
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 2 2001
H.S. Hospital Service S.p.A. c/o Mr. Lucio Improta MMC International, LLC 10147 Umberland Place Boca Raton, Florida 33428
Re: K013070
Korsovo
Trade/Device Name: Jamshidi Bone Marrow Biopsy Needle Regulation Number: 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: FCG, KNW Dated: September 3, 2001 Received: September 13, 2001
Dear Mr. Improta:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premainer is substantially equivalent (for the indications ferenced above and nave decemblied the arrest are devices marketed in interstate for use stated in the encrosule) to regally the Medical Device Amendments, or to commerce prior to May 28, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been recassified in accerative while approval application (PMA).).
and Cosmetic Act (Act) that do not require approval of a pressions of the Act . The and Cosmelle Act (Act) that do not require approval controls provisions of the Act. The Act. The You may, therefore, market the devices, boyser to the manages and michaeling and general controls provisions of the 110 libeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Scc above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA may be subject to such additional bentrelist - Entrologie Parts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In be found in the Ood of Pouchar Ing your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 3 issualled of a backed on a bevice complies with other requirements of the Act that FDA has made a decormination administered by other Federal agencies. You must or any Federal statutes and regulations annuding, but not limited to: registration and listing (21 comply with an the Act s requirements, mort 801); good manufacturing practice requirements as set CFK Part 807); labeling (21 CFR Part 800); good if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electroni forul in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Lucio Improta
This letter will allow you to begin marketing your device as described in your Section 510(k)
The success of the first of a first of a lot stick as well as worldevice of your This letter will anow you to begin marksmig your any as a vour device of your device to a legally premarket notification. The FDA Inding of substantial equal not of the same of 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 If you desire specific advice lot your do vites diagnostic devices), please contact the Office of
additionally 21 CFR Part 809.10 for in vitro diagnostic devices, please cont additionally 21 CFR Part 809.10 think to unestions on the promotion and advertising of
Compliance at (301) 594-4659. Additionally, for questions on the promotion and adverti Compliance at (301) 394-4659. Additionally, to: quest (301) 594-4639. Also, please note the your device, prease comact the Orited of concerner to premarket notification' (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to the Ast may be obtained f regulation entitled, "Misoranuing of references in and the Act may be obtained from the Other general miormation on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Walker, MD
Celia M. Witten, Ph.D., M.D. . Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
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PREMARKET NOTIFICATION SUBMISSION - 510 (k)
JAMSHIDI™
210 (k) # KO130 70
DEVICE NAME
Jamshidi Biopsy Needle
INDICATION FOR USE
This biopsy instrument is used for drawing of osteomedullary substance and or for explantation of bone marrow
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Walk
(Division Sign-Off) (Division of General Restorative Division ological Devices
013090 510(k) Number ..
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use