(63 days)
Not Found
Not Found
No
The summary describes a disposable biopsy needle and does not mention any software, algorithms, or capabilities related to AI or ML.
No
This device is a biopsy needle used to obtain tissue samples for diagnostic purposes, not for treating a disease or condition.
No
The device is a biopsy needle used to obtain tissue samples, not to analyze them for diagnostic purposes. While the samples collected might be used for diagnosis, the needle itself is a collection tool.
No
The device description explicitly states it is a "disposable biopsy needle," which is a physical hardware component.
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 from the body using a needle. This is an in vivo procedure (performed within a living organism).
- Device Description: It's described as a disposable biopsy needle, which is a surgical instrument used for tissue collection from the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens outside of the body (in vitro) to provide information about a patient's health. This device's function is to collect the specimen, not to analyze it.
Therefore, this device falls under the category of a surgical instrument used for tissue collection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Indication for use :
Indicanon for use :
This biopsy device can be used in, CT, Manmographic and Echographic and Echographic I his blopsy device can be used in, Cry neasonaling those from Prostate, Kidney, Breast and Liver using an automatic device.
This device is a disposable biopsy needle and can be used in , CT, Mammographic Radiographic and Echographic procedures to obtain biopsies of various tissues including those from Prostate, Kidney, Breast and Liver using an automatic device.
Product codes (comma separated list FDA assigned to the subject device)
78 FCG
Device Description
TOPCUT™ Cutting Biopsy Needle
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
CT, Manmographic, Echographic, Mammographic Radiographic
Anatomical Site
Prostate, Kidney, Breast and Liver
Indicated Patient Age Range
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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.
Not Found
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
JUL 1 2 2002
| Owner Operator # | 8010312 |
|---|---|
| ------------------ | --------- |
PREMARKET NOTIFICATION
SUBMISSION – 510 (k)
TOPCUT
510 (k) K021525
| Data: | 05-10-2002 |
|---|---|
| Pag. | 30 di 33 |
Page 1 of 1
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 | : May 10-, 2002 | |
| Trade Name | : TOPCUT™ Cutting Biopsy Needle | |
| Common Name | : Cutting Biopsy Needle | |
| Classification Name | : 876.1075 - Biopsy instrument | |
| Substantial Equivalence | : This product is identical to the following predicate device: | |
| Company Name | Product Name | 510(k) # |
| MANAN Medical Products | Automatic Cutting Needle | |
Indication for use :
Indicanon for use :
This biopsy device can be used in, CT, Manmographic and Echographic and Echographic I his blopsy device can be used in, Cry neasonaling those from Prostate, Kidney, Breast and Liver using an automatic device.
1
Image /page/1/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads, each head facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
H.S. Hospital Service, S.p.A. % Mr. Lucio Improta President & CEO MMC International, LLC 10147 Umberland Place BOCA RATON FL 33428
JUL 1 2 2002
Re: K021525
Trade/Device Name: TOPCUT™ Biopsy Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II
Product Code: 78 FCG Dated: May 10, 2002 Received: May 10, 2002
Dear Mr. Improta:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Ilisting 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
2
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows a logo with a series of horizontal lines underneath. Below the logo, the text "Owner Operator # 8010312" is visible. The logo itself appears to be a stylized design, possibly representing a company or organization.
PREMARKET NOTIFICATION SUBMISSION - 510 (k)
TOPCUT™ 510 (k) K021525 Data: 05-10-2002
Pag. 14 di 33
510 (k) # K021525
DEVICE NAME
TOPCUT™ Biopsy Needle
INDICATION FOR USE
This device is a disposable biopsy needle and can be used in , CT, Mammographic Radiographic and Echographic procedures to obtain biopsies of various tissues including those from Prostate, Kidney, Breast and Liver using an automatic device.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) OR Over-The-Counter Use
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K021525