(30 days)
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.
The provided document describes a 510(k) premarket notification for the "Easy Core™ Biopsy System." It highlights the device's intended use and substantial equivalence to predicate devices but does not contain information regarding specific acceptance criteria, performance metrics, or a study that would demonstrate the device meets those criteria.
Therefore, most of the requested information cannot be extracted from the given text. The document is primarily a regulatory approval letter and a summary of the device's classification, intended use, and substantial equivalence, not a detailed study report.
Here's what can be inferred or explicitly stated from the provided text:
1. A table of acceptance criteria and the reported device performance:
This information is not available in the provided document. The document states "All data gathered demonstrate this device as substantially equivalent" to predicate devices, but it does not specify what performance metrics were measured or what success criteria were set.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document (only a general statement of "substantially equivalent" is provided) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not available in the provided document. The document refers to "data gathered" but does not detail the specifics of any test set, sample size, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not available in the provided document. As no specific test set or ground truth establishment process is described, this detail cannot be provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not available in the provided document.
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:
This information is not available in the provided document. The device is a biopsy system, not an AI-assisted diagnostic tool, so an MRMC study in this context is unlikely and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not available in the provided document. The device is a physical biopsy system, not an algorithm, so "standalone performance" in that context is not relevant or described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not available in the provided document. While the device is used for "histological analysis," the method for establishing ground truth for any potential comparative study is not discussed.
8. The sample size for the training set:
This information is not available in the provided document. The document does not describe a training set for an algorithmic device.
9. How the ground truth for the training set was established:
This information is not available in the provided document.
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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
| GeneralProvisions | Trade Name: Easy Core™ |
|---|---|
| Classification Name: Biopsy System, Gastroenterology-urology | |
| Name ofPredicateDevices | ASAP Biopsy System (Formally referred to as Stamey Sampler SpringLoaded 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 Biopsy System is indicated for use endoscopically orpercutaneously to retrieve tissue sampling of soft organs/tumors or masses forhistological analysis. Soft tissue sampling includes but not limited to organssuch as breast, liver, kidney and prostate. The Easy Core Biopsy System is asterile, single-use biopsy needle. |
| Biocompatibility | The Easy Core Biopsy System has been tested for biocompatibility per ISO10993. All data demonstrate this device is biocompatable for its intended use. |
| Summary ofSubstantialEquivalence | The Easy Core Biopsy System has been tested and compared to the predicatedevice. All data gathered demonstrate this device as substantially equivalent.No new issues of safety or efficacy have been raised. |
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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.
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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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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.
§ 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.