(90 days)
No
The summary describes a mechanical biopsy needle and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is used to obtain biopsies, which is a diagnostic procedure, not a therapeutic one.
No
The device is a biopsy needle used to obtain tissue samples, which are then typically sent for laboratory analysis to make a diagnosis. It does not perform the diagnostic function itself.
No
The device description explicitly states it is an "automated, disposable biopsy needle," which is a physical 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 to "obtain biopsies of various tissues". This is a procedure performed on the patient to collect a sample.
- Device Description: It's described as a "biopsy needle". This is a tool used for a surgical or interventional procedure.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body (like blood, urine, tissue) outside of the body to provide information about a person's health.
This device is used to collect the sample, not to test it. The testing of the collected tissue sample would likely be performed using IVD devices and procedures in a laboratory setting.
N/A
Intended Use / Indications for Use
This biopsy device can be used in Fluoroscopic, CT, Mammographic and Laparoscopic procedures to obtain biopsies of various tissues including those from Breast, Kidney, Liver, Prostate.
Product codes
FCG
Device Description
This device is an automated, disposable biopsy needle and can be used in Fluoroscopic, CT and Mammographic procedures to obtain biopsies of various tissues including those from Prostate Kidney, Breast and Liver.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic, CT, Mammographic and Laparoscopic procedures
Anatomical Site
Breast, Kidney, Liver, Prostate
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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 black and have a textured appearance, possibly due to the image being a scan or photocopy. There are horizontal lines below the letters, adding to the overall design.
PREMARKET NOTIFICATION SUBMISSION - 510 (k)
BIOSPEED ™
Owner Operator # 8010312
KO13069 DEC 1 2 2001 510 (k) SUMMARY
| Applicant | : H.S. Hospital Service S.p.A.
Via Naro, 81 – 00040 Pomezia (Roma) Italy |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | : MMC International, LLC
Mr. Lucio Improta
10147 Umberland Place – Boca Raton, FL 33428
Tel. (561) 477-1671 - Fax. (561) 477-0863
e-mail : mmcintern@aol.com |
| Submission Date | : September 03, 2001 |
| Trade Name | : BIOSPEED™ Spring Loaded Biopsy Needle |
| Common Name | : Spring Loaded Biopsy Needle |
| Classification Name | : 876.1075 - Biopsy instrument |
Substantial Equivalence :
| Company Name | Product Name | 510(k) # |
|---|---|---|
| Promedical Ltd | PRO-B Biopsy Needle | K951598 |
Indication for use :
This biopsy device can be used in Fluoroscopic, CT, Mammographic and Laparoscopic procedures to obtain biopsies of various tissues including those from Breast, Kidney, Liver, Prostate.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
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: K013069
K015009
Trade/Device Name: BIOSPEED™ Spring Loaded Biopsy Needle Regulation Number: 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: FCG 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 nave reviewed your becaon. 910(s) pecifically equivalent (for the indications felerenced above and nave determined in asketed predicate devices marketed in interstate for use stated in the encrosuly to regars neatment date of the Medical Device Ameral Food France commerce prior to May 26, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been recalised in acceracy was a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applicati and Cosmelle Act (Act) that do not require approval controls provisions of the Act. The 1 ou may, dierelore, market the act include requirements for annual registration, listing of general controls provisions of the 110 labeling, 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 classifica (sec above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations ED may be subject to such additional controller Entisting and to 898. In addition, FDA may be found in the Ood of Pouchas concerning 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 s issuation of a basedianted on the requirements of the Act that TDA has made a dolorimiation administered by other Federal agencies. You must in and ligit or any Federal statutes and regulations annuting, but not limited to: registration and listing (21 comply with an the Act 3 requirements, merceing, and manufacturing practice requirements as set CFR Part 607), adomig (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QD) regulations (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) I mis letter will and w you to ough and and equivalence of your device to a legally premailed.com "The 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 11 you decline specific and 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of 11 and 1659. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-1697 office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). I cigulation childred, "Thiorians" responsibilities under the Act may be obtained from the Other general mistmances, International 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 Walk, is
Image /page/2/Picture/5 description: The image shows a handwritten symbol or character. It appears to be a cursive letter or a stylized design. The symbol has a loop at the top and a curved line extending downwards, with a small stroke or mark at the bottom left.
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
Image /page/3/Picture/0 description: The image shows a logo with a bold, stylized design. Below the logo, the text "Owner Operator # 8010312" is printed in a simple, sans-serif font. The logo itself appears to be a stylized representation of letters or symbols, with a thick, horizontal line pattern filling the shapes. The overall impression is a combination of a graphic element and identifying text, likely for a business or individual operating under that number.
PREMARKET NOTIFICATION SUBMISSION - 510 (k)
Data: 09-03-2001
BIOSPEED ™
510 (k) # KO13069
DEVICE NAME
BIOSPEED™ Biopsy Needle
INDICATION FOR USE
This device is an automated, disposable biopsy needle and can be used in Fluoroscopic, CT and Mammographic procedures to obtain biopsies of various tissues including those from Prostate Kidney, Breast and Liver.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED LLEASE DO NOT MIGTE DEDO 4 THIS EXTE SOULD -----------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Wale
(Division Sign-Of! (Division Sign-Of.)
Division of Geners | Restorative
Division of General | Aces Division of Gener
and Neurological Levices
510(k) Number K013067
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use