(41 days)
The FINESSE™ Ultra Breast Biopsy System is intended to obtain soft tissue samples for diagnostic and histological analysis of breast abnormalities.
The FINESSE™ Ultra Breast Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
The subject device, the FINESSE™ Ultra Breast Biopsy System, is a handheld, self-contained, vacuum assisted breast biopsy system for use with ultrasound imaging guidance. The system is comprised of (1) a reusable hand piece (driver) that contains all electronics and components to generate a vacuum without the need to be connected to any external power supply or vacuum source and (2) a disposable biopsy probe capable of excising and storing multiple tissue samples without the need for the probe to be removed from the patient between samples.
The provided text describes the FINESSE™ Ultra Breast Biopsy System and states that "[t]he FINESSE™ Ultra Breast Biopsy System met all acceptance criteria for design verification and validation, as specified by applicable standards, guidance, test protocols and/or customer inputs." However, the document does not provide specific details about the acceptance criteria or the study that proves the device meets those criteria.
Therefore, I cannot provide the requested information in a table or answer the specific questions about sample size, ground truth, expert qualifications, or study types like MRMC comparative effectiveness or standalone performance.
The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed study reports with specific performance metrics and methodologies.
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FINESSE™ Ultra Breast Biopsy System 510(k) Summary of Safety and Effectiveness 21 CFR 807.92
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a summary of the safety and effectiveness information upon which substantial equivalence determination is based as follows:
Submitter Information:
| Applicant: | Bard Peripheral Vascular, Inc1415 West 3rd StreetP.O. Box 1740Tempe, Arizona 85281 |
|---|---|
| Phone: | 480-379-2836 |
| Fax: | 480-449-2546 |
| Contact: | Cindy Moss, Project Manager, Regulatory Affairs |
Date September 8, 2009
Subject Device Name:
| Device Trade Name: | FINESSE™ Ultra Breast Biopsy System |
|---|---|
| Common or Usual Name: | Biopsy Instrument (21 CFR 876.1075, ProductCode KNW) |
| Classification: | Class II |
| Classification Panel: | Gastroenterology/Urology |
Predicate Devices:
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- · Vacora® Vacuum Assisted Breast Biopsy System (K082681, cleared October 15, 2008), manufactured by Bard Peripheral Vascular, Inc (hereafter referred to as Vacora).
- · Mammotome® Hand Held 8G Probe (K003297, cleared January 18, 2001), manufactured by Ethicon Endo-Surgery, Inc. (hereafter referred to as Mammotome).
- · Vacuum Assisted Spring Loaded Core Biopsy Device (K034021, cleared September 8, 2004), manufactured by Suros Surgical Systems (hereafter referred to as Celero 114 Vacuum Assisted Core Biopsy Device or Celero)
Device Description:
The subject device, the FINESSE™ Ultra Breast Biopsy System, is a handheld, self-contained, vacuum assisted breast biopsy system for use with ultrasound imaging guidance. The system is comprised of (1) a reusable hand piece (driver) that contains all electronics and components to generate a vacuum without the need to be connected to any external power supply or vacuum source and (2) a disposable biopsy probe capable of excising and storing multiple tissue samples without the need for the probe to be removed from the patient between samples.
Intended Use of Device:
The FINESSE™ Ultra Breast Biopsy System is intended to obtain soft tissue samples for diagnostic and histological analysis of breast abnormalities.
Indications for Use of Device:
The FINESSE™ Ultra Breast Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the
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sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
Technological Comparison to Predicate Devices:
The FINESSE™ Ultra Breast Biopsy System has the following similarities to the predicate devices:
- Similar intended use
, `··········································································································································································· . :
.
- · Similar indications for use
- Same target population
- · Similar fundamental scientific technology
- · Similar operating principle
- · Similar packaging materials
- · Same sterility assurance level and method of sterilization
Conclusions:
The FINESSE™ Ultra Breast Biopsy System met all acceptance criteria for design verification and validation, as specified by applicable standards, guidance, test protocols and/or customer inputs. The FINESSE™ Ultra Breast Biopsy System is substantially equivalent to the legally marketed predicate devices, the Vacora, Mammotome, and the Celero.
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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation. The seal is simple and monochromatic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
NOV 1 0 2009
C.R. Bard, Inc. % Citech Mr. Robert Mosenkis President 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298
Re: K093068
Trade/Device Name: FINESSE™ Ultra Breast Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: October 23, 2009 Received: October 27, 2009
Dear Mr. Mosenkis:
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
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Page 2 - Mr. Robert Mosenkis
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Mark A. Mckesson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
11093068 510(k) Number (if known):
Device Name: FINESSE™ Ultra Breast Biopsy System
Indications for Use: The FINESSE™ Ultra Breast Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
| Prescription Use | X |
|---|---|
| Use | |
| (Part21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter | |
| (21CFR 801 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 Surgical, Orthopedic, and Restorative Devices
| 510(k) Number | K093068 |
|---|---|
| --------------- | --------- |
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Bard Peripheral Vascular, Inc. TRADE SECRET/CONFIDENTIAL INFORMATION Notify CR Bard Before Releasing this Document.
BARD
§ 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.