(30 days)
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Not Found
No
The summary describes a mechanical biopsy needle and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is used to retrieve tissue samples for analysis, which is a diagnostic procedure, not a therapeutic one.
Yes
Explanation: The device is used to retrieve tissue samples for histological analysis, which is a diagnostic process to determine the nature of diseases (e.g., distinguishing between benign and malignant tumors).
No
The device description explicitly states it is a "sterile, single-use biopsy needle," which is a physical hardware component.
Based on the provided information, the Easy Core Biopsy System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens outside the body. They analyze samples like blood, urine, tissue, etc., to provide information about a person's health status.
- The Easy Core Biopsy System is a device used to retrieve the tissue sample from the body. Its function is the collection of the specimen, not the analysis of it.
- The intended use clearly states it's for "retrieving tissue sampling... for histological analysis." Histological analysis is the examination of tissue under a microscope, which is a separate process performed after the sample is collected.
Therefore, the Easy Core Biopsy System is a medical device used for tissue collection, which is a step that precedes the in vitro diagnostic process (histological analysis).
N/A
Intended Use / Indications for Use
The Easy Core Biopsy System 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 (comma separated list FDA assigned to the subject device)
78 FCG
Device Description
The Easy Core Biopsy System is a sterile, single-use biopsy needle.
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
Soft organs/tumors or masses including 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Easy Core Biopsy System has been tested and compared to the predicate device. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
ASAP Biopsy System (Formally referred to as Stamey Sampler Spring Loaded Needle), ASAP 14g Biopsy System.
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
MAY - 6 2004
Image /page/0/Picture/2 description: The image contains handwritten text. The first line reads 'K040893'. The second line reads 'Prze i vf i'.
Summary of Safety and Effectiveness
| General
| Provisions | Trade Name: Easy Core™ |
|---|---|
| Classification Name: Biopsy System, Gastroenterology-urology | |
| Name of | |
| Predicate | |
| Devices | ASAP Biopsy System (Formally referred to as Stamey Sampler Spring |
| Loaded Needle), ASAP 14g Biopsy System. | |
| Classification | Class II |
| Performance | |
| Standards | Performance Standards have not been established by FDA under Section 514 |
| of the Food, Drug and Cosmetic Act | |
| Intended Use | |
| and Device | |
| Description | The Easy Core Biopsy System 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. The Easy Core Biopsy System is a | |
| sterile, single-use biopsy needle. | |
| Biocompatibility | The Easy Core Biopsy System has been tested for biocompatibility per ISO |
- All data demonstrate this device is biocompatable for its intended use. |
| Summary of
Substantial
Equivalence | The Easy Core Biopsy System has been tested and compared to the predicate
device. All data gathered demonstrate this device as substantially equivalent.
No new issues of safety or efficacy have been raised. |
1
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 caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 6 2004
RE: K040893
Ms. Christine Cameron Regulatory Specialist II Boston Scientific Corporation One Boston Scientific Place NATICK MA 01760
Trade/Device Name: Easy Core Biopsy System Regulation Number: 21 CFR§ 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instruments
Regulatory Class: II Product Code: 78 FCG Dated: April 5, 2004 Received: April 6, 2004
Dear Ms. Cameron:
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
K040893
Page 1 of 1
Indications For Use
| 510(k) Number (if known) | Unknown K040893 |
|---|---|
| Device Name: | Easy Core™ Biopsy System |
| Indications for Use | The Easy Core Biopsy System 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. |
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 040843 510(k) Number.