(21 days)
Not Found
No
The description focuses on the mechanical function of a biopsy device and does not mention any AI/ML components or capabilities.
No
The device is described as a biopsy device used for retrieving tissue samples for histological analysis, which is a diagnostic procedure, not a therapeutic one.
Yes
The device is used to retrieve tissue samples for histological analysis, which is a diagnostic procedure to identify diseases or conditions.
No
The device description explicitly details physical components such as a handle, thumb tab, fire buttons, and a cannula with a needle tip, indicating it is a hardware device for tissue sampling.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "retrieve tissue sampling of soft organs, tumors or masses for histological analysis." This describes a device used to obtain a sample from the body.
- Device Description: The description details a mechanical device designed to physically extract tissue.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device's function is to collect the sample, not to analyze it.
- Histological Analysis: The tissue sample is intended for histological analysis, which is a separate process performed after the sample is obtained, typically in a laboratory setting using other devices and techniques.
This device is a biopsy device, which is used to collect tissue samples for subsequent in vitro analysis. It is not the IVD itself.
N/A
Intended Use / Indications for Use
The proposed device is indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes but not limited to organs such as breast, liver, kidney and prostate.
Product codes
78 FCG
Device Description
The proposed device is designed to simultaneously fire a stylet followed by a cannula to capture a biopsy sample of soft organs, tumor or masses for histological analysis. The design includes a handle with a thumb tab activated drive mechanism, a side fire button, a rear fire button, and a cannula with a needle tip. The cannula may have marker bands spaced at 1 cm (10 mm) intervals starting from the stylet tip and extending various lengths depending upon the needle. When the device is fully loaded, the yellow indicator is visible when looking at the top of the handle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft organs, tumors or masses (e.g., breast, liver, kidney and 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
Performance standards have not been established by FDA under Section514 of the Food, Drug and Cosmetic Act.
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
Special 510(k) Premarket Notification EasyCore Biopsy System II January 14, 2004
510 (k) SUMMARY
| SPONSOR: | Boston Scientific Corporation
One Boston Scientific Place
Natick, MA 01760 |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Michelle M. Berry
Regulatory Affairs Specialist |
| | Or |
| | Lorraine M. Hanley
Director Regulatory Affairs |
| DEVICE:
Trade Name:
Common Name:
Classification: | To Be Determined
Biopsy Instrument
Class II, per 21 CFR Part 876.1075 |
| PREDICATE DEVICE: | Easy Core Biopsy System (K040893) |
| DESCRIPTION: | The proposed device is designed to simultaneously fire a stylet
followed by a cannula to capture a biopsy sample of soft organs,
tumor or masses for histological analysis. The design includes a
handle with a thumb tab activated drive mechanism, a side fire
button, a rear fire button, and a cannula with a needle tip. The
cannula may have marker bands spaced at 1 cm (10 mm)
intervals starting from the stylet tip and extending various
lengths depending upon the needle. When the device is fully
loaded, the yellow indicator is visible when looking at the top of
the handle. |
| INTENDED USE: | The proposed device is indicated for use endoscopically or
percutaneously to retrieve tissue sampling of soft organs, tumors
or masses for histological analysis. Soft tissue sampling includes
but not limited to organs such as breast, liver, kidney and
prostate. |
| TECHNOLOGICAL
CHARACTERISTICS: | The intended use, design, operating principles and materials are
similar to devices previously cleared via the 510(k) process. |
| PERFORMANCE DATA: | Performance standards have not been established by FDA under
Section514 of the Food, Drug and Cosmetic Act. |
Proprietary and Confidential Information of Boston Scientific Corporation
1
Image /page/1/Picture/1 description: The image shows the seal of 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.
Public Health Service
FEB - 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific Corporation c/o Ms Michelle M. Berry One Boston Scientific Place NATICK, MA 01760 1537
RE: K050120
Trade/Device Name: Easy Core Biopsy System Regulation Number: 21 CFR & 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument
Regulatory Class: II Product Code: 78 FCG Dated: January 14, 2005 Received: January 18, 2005
Dear Ms Berry:
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, 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 (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
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), 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
3
Boston Scientific Corporation
INDICATIONS FOR USE STATEMENT
| 510(k)
| Number | To be determined |
|---|---|
| Device Name | To be determined (Biopsy Instrument) |
| Indications | |
| For Use | The proposed device is indicated for use endoscopically or |
| percutaneously to retrieve tissue sampling of soft organs, tumors or | |
| masses for histological analysis. Soft tissue sampling includes but | |
| not limited to organs such as breast, liver, kidney and prostate. |
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)