(21 days)
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.
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.
The provided text is a 510(k) Premarket Notification for the EasyCore Biopsy System II. This document focuses on establishing substantial equivalence to a predicate device, not on demonstrating performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria and study details is not present in this document.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in this document. 510(k) submissions for Class II devices often rely on demonstrating substantial equivalence to a legally marketed predicate device rather than setting new, quantitative performance acceptance criteria that require extensive clinical trials for de novo devices.
- Reported Device Performance: The document states, "The intended use, design, operating principles and materials are similar to devices previously cleared via the 510(k) process." This implies that the device is expected to perform comparably to its predicate device (Easy Core Biopsy System, K040893). No specific performance metrics (e.g., successful biopsy rate, tissue quality, adverse event rates) are reported.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable/not provided. This document does not describe a test set or a clinical study with human subjects for performance evaluation.
- Data Provenance: Not applicable/not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/not provided, as no test set or ground truth establishment process is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/not provided.
5. 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. This is a biopsy system, not an AI-powered diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a medical device (biopsy system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/not provided. The document focuses on the physical characteristics and intended use of the device, not its diagnostic accuracy requiring ground truth. The purpose of the biopsy system is to retrieve tissue for histological analysis, where pathology would establish the ground truth of the sample.
8. The sample size for the training set:
- Not applicable/not provided, as no machine learning algorithm development is described.
9. How the ground truth for the training set was established:
- Not applicable/not provided.
In summary, the provided 510(k) document for the EasyCore Biopsy System II primarily asserts substantial equivalence to a predicate device (Easy Core Biopsy System K040893) based on similar intended use, design, operating principles, and materials. It does not contain details of a clinical study with acceptance criteria, ground truth establishment, or performance metrics specific to the new device.
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Special 510(k) Premarket Notification EasyCore Biopsy System II January 14, 2004
510 (k) SUMMARY
| SPONSOR: | Boston Scientific CorporationOne Boston Scientific PlaceNatick, MA 01760 |
|---|---|
| CONTACT PERSON: | Michelle M. BerryRegulatory Affairs Specialist |
| Or | |
| Lorraine M. HanleyDirector Regulatory Affairs | |
| DEVICE:Trade Name:Common Name:Classification: | To Be DeterminedBiopsy InstrumentClass II, per 21 CFR Part 876.1075 |
| PREDICATE DEVICE: | Easy Core Biopsy System (K040893) |
| DESCRIPTION: | The proposed device is designed to simultaneously fire a styletfollowed by a cannula to capture a biopsy sample of soft organs,tumor or masses for histological analysis. The design includes ahandle with a thumb tab activated drive mechanism, a side firebutton, a rear fire button, and a cannula with a needle tip. Thecannula may have marker bands spaced at 1 cm (10 mm)intervals starting from the stylet tip and extending variouslengths depending upon the needle. When the device is fullyloaded, the yellow indicator is visible when looking at the top ofthe handle. |
| INTENDED USE: | The proposed device is indicated for use endoscopically orpercutaneously to retrieve tissue sampling of soft organs, tumorsor masses for histological analysis. Soft tissue sampling includesbut not limited to organs such as breast, liver, kidney andprostate. |
| TECHNOLOGICALCHARACTERISTICS: | The intended use, design, operating principles and materials aresimilar to devices previously cleared via the 510(k) process. |
| PERFORMANCE DATA: | Performance standards have not been established by FDA underSection514 of the Food, Drug and Cosmetic Act. |
Proprietary and Confidential Information of Boston Scientific Corporation
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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.
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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
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Boston Scientific Corporation
INDICATIONS FOR USE STATEMENT
| 510(k)Number | To be determined |
|---|---|
| Device Name | To be determined (Biopsy Instrument) |
| IndicationsFor Use | The proposed device is indicated for use endoscopically orpercutaneously to retrieve tissue sampling of soft organs, tumors ormasses for histological analysis. Soft tissue sampling includes butnot 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)
§ 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.