(22 days)
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No
The summary describes a mechanical biopsy needle and does not mention any AI or ML components or functions.
No
The device is used for retrieving tissue samples for diagnostic analysis (histological analysis), not for treating or rehabilitating a condition.
Yes
Explanation: The device is used to retrieve tissue samples for histological analysis, which is a diagnostic procedure to identify and characterize diseases.
No
The device description explicitly states it is a "sterile, single-use biopsy needle," which is a physical hardware component, not software.
Based on the provided information, the Easy Core Detachable Biopsy System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or treatment. This typically involves tests performed outside the body (in vitro) on samples like blood, urine, or tissue.
- The Easy Core Detachable Biopsy System is a device used to obtain the tissue sample. Its function is to retrieve the tissue, which is then sent for histological analysis. The analysis itself, which is performed on the tissue sample, would be considered an in vitro diagnostic procedure, but the biopsy needle itself is the tool for collection, not the diagnostic test.
The description clearly states its purpose is to "retrieve tissue sampling... for histological analysis." This indicates it's a device for sample collection, not for performing the diagnostic analysis on the sample.
N/A
Intended Use / Indications for Use
The Easy Core Detachable 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 is not limited to organs such as breast, liver, kidney and prostate.
Product codes
KNW, 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, breast, liver, kidney and prostate
Indicated Patient Age Range
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Intended User / Care Setting
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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
The Easy Core Detachable Biopsy System has been tested and compared to the predicate device. All data gathered demonstrate this device as substantially equivalent.
Key Metrics
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Predicate Device(s)
Easy Core™ Biopsy System, Easy Core Biopsy System II, ASAP Biopsy System (Formerly referred to as Stamey Sampler Spring Loaded Needle), ASAP 14g Biopsy System.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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K051361 Summary of Safety and Effectiveness
| General
| Provisions | Trade Name: Easy Core™ Detachable Biopsy System |
|---|---|
| Classification Name: Biopsy System, Gastroenterology-urology | |
| Name of | |
| Predicate | |
| Devices | Easy Core™ Biopsy System, Easy Core Biopsy System II, ASAP Biopsy |
| System (Formerly 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 Detachable 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 is 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 Detachable Biopsy System has been tested for |
| biocompatibility per ISO 10993. All data demonstrate this device is | |
| biocompatible for its intended use. | |
| Summary of | |
| Substantial | |
| Equivalence | The Easy Core Detachable 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. |
Boston Scientific Corporation CONFIDENTIAL
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Image /page/1/Picture/2 description: The image shows a logo with a stylized bird figure on the right and text on the left. The bird figure is composed of three curved lines that suggest the shape of a bird in flight. The text on the left is arranged in a circular fashion, following the curve of the logo. The text is not fully legible, but it appears to be part of a government agency or organization's name.
JUN 1 6 2005
ﺎ ﺍﻟﻤﺮﺍﺟﻊ
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Christine M. Cameron Regulatory Specialist Boston Scientific Corporation Oncology Division 100 Fairbanks Blvd. MARLBOROUGH MA 01752-1242
Re: K051361
Trade/Device Name: Easy Core™ Detachable Biopsy System Regulation Number: 21 CFR §876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW and FCG Dated: May 24, 2005 Received: May 25, 2005
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 (Premarket Approval), it may be subject to such 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 Section 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:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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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Indications For Use
| 510(k) Number (if known) | Unknown |
|---|---|
| K051361 | |
| Device Name: | Easy Core™ Detachable Biopsy System |
| Indications for Use | The Easy Core Detachable 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 is 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)
Nancy C. Burgdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number .
Boston Scientific Corporation CONFIDENTIAL