(22 days)
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.
The provided text is a K051361 Summary of Safety and Effectiveness for the Easy Core™ Detachable Biopsy System. It focuses on establishing substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving device performance against such criteria. The document primarily addresses regulatory aspects, intended use, biocompatibility, and the FDA's clearance.
Therefore, I cannot provide the requested information as it is not present in the given text.
Here's a breakdown of why each point cannot be answered:
- A table of acceptance criteria and the reported device performance: This information is not present. The document states a "Summary of Substantial Equivalence" declaring that "All data gathered demonstrate this device as substantially equivalent." However, it does not specify what "data gathered" refers to in terms of performance metrics or acceptance criteria.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable and not mentioned. This device is a biopsy system, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable and not mentioned. This device is a biopsy system, not an algorithm.
- The type of ground truth used: Not mentioned, as no specific performance study against a ground truth is described.
- The sample size for the training set: Not applicable and not mentioned. As this is not an AI/ML device, a "training set" in that context is not relevant.
- How the ground truth for the training set was established: Not applicable and not mentioned.
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K051361 Summary of Safety and Effectiveness
| GeneralProvisions | Trade Name: Easy Core™ Detachable Biopsy System |
|---|---|
| Classification Name: Biopsy System, Gastroenterology-urology | |
| Name ofPredicateDevices | Easy Core™ Biopsy System, Easy Core Biopsy System II, ASAP BiopsySystem (Formerly referred to as Stamey Sampler Spring Loaded Needle),ASAP 14g Biopsy System. |
| Classification | Class II |
| PerformanceStandards | Performance Standards have not been established by FDA under Section 514of the Food, Drug and Cosmetic Act |
| Intended Useand DeviceDescription | The Easy Core Detachable Biopsy System is indicated for use endoscopicallyor percutaneously to retrieve tissue sampling of soft organs/tumors or massesfor histological analysis. Soft tissue sampling includes but is not limited toorgans such as breast, liver, kidney and prostate. The Easy Core BiopsySystem is a sterile, single-use biopsy needle. |
| Biocompatibility | The Easy Core Detachable Biopsy System has been tested forbiocompatibility per ISO 10993. All data demonstrate this device isbiocompatible for its intended use. |
| Summary ofSubstantialEquivalence | The Easy Core Detachable Biopsy System has been tested and compared tothe predicate device. All data gathered demonstrate this device assubstantially equivalent. No new issues of safety or efficacy have beenraised. |
Boston Scientific Corporation CONFIDENTIAL
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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.
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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
§ 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.