(57 days)
Not Found
No
The summary describes a mechanical vacuum-assisted biopsy system with a control module, vacuum system, and touch screen display. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is used for diagnostic sampling of breast abnormalities, not for treatment or therapy.
Yes
The device is indicated to provide breast tissue samples for diagnostic sampling and histologic examination of breast abnormalities, which are diagnostic purposes. While it also performs partial removal of abnormalities, its primary stated purpose involves obtaining samples for diagnosis.
No
The device description clearly outlines hardware components such as a control module, vacuum system, and touch screen display, indicating it is not solely software.
Based on the provided information, the EnCor Enspire™ Breast Biopsy System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to obtain breast tissue samples for diagnostic sampling and histologic examination. It is a tool for tissue acquisition, not for performing the diagnostic test itself.
- Device Description: The device description details a system for controlling a biopsy probe and applying vacuum to collect tissue. It does not describe any components or functions related to analyzing biological samples or providing diagnostic information based on those samples.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device's primary function is to collect the specimen, not to analyze it.
The tissue collected by the EnCor Enspire™ Breast Biopsy System is then sent for histologic examination, which is the actual diagnostic process performed by a pathologist using other IVD devices and procedures.
N/A
Intended Use / Indications for Use
The EnCor Enspire™ Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities.
- . It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
- lt is intended to provide breast tissue for histologic examination . with partial removal of a palpable abnormality. The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or 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.
In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the EnCor Enspire™Breast Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. 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.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
The subject device is the EnCor Enspire™ Breast Biopsy System, an automated directional vacuum-assisted biopsy device consisting of an integrated control module and vacuum system with a detachable touch screen display. The key functional components of the EnCor Enspire™ Breast Biopsy System are integrated into a single console.
Control Module - The control module is designed to provide control operations and serve as an interface for drivers, probes and foot pedals.
- Inputs are delivered to the control module via either a driver or foot pedal. o
- Based on the input received, the control module adjusts the motor speed of o drivers and probes.
- System status is provided to the physician via an integrated LCD screen. o
Vacuum System - During a breast biopsy procedure, the vacuum system draws the target tissue into the biopsy probe tissue acquisition chamber by creating a negative pressure differential at the tip of the probe being used. A disposable vacuum canister and disposable vacuum tubing cassette (with or without optional rinse tubing) is installed in the vacuum system at the time of each breast biopsy procedure.
Touch Screen Display – The touch Screen Display provides an intuitive user interface for the EnCor Enspire™ Breast Biopsy System. The display provides the system status and initiates operation of the installed driver and probe based on information and options entered or selected by the user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were performed:
- . Vacuum Level
- Joint Tensile Strength .
- . Cassette Functionality
- ◆ Rinse Volume
- . Cassette and Vacuum Reliability
- . Packaging Validation
- User Validation .
- . Software Verification and Validation
The results from these tests demonstrate that the technological characteristics and performance criteria of the EnCor Enspire™ Breast Biopsy System are comparable to the predicate device and that it can perform in a manner equivalent to devices currently on the market for the same intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
EnCor Enspire™ Breast Biopsy System JUN 16 2011
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 510(k) summary upon which substantial equivalence determination is based is as follows:
Submitter Information:
Applicant: SenoRx, Inc. A Business Unit of Bard Peripheral Vascular, Inc. 3 Morgan Irvine, CA 92618
Phone: 1-480-638-2915
1-480-449-2546 Fax:
Contact: Justin Lovelace, Regulatory Affairs Specialist
Date: April 18, 2011
Subject Device Name:
| Device Trade Name: | EnCor Enspire TM Breast Biopsy System |
|---|---|
| Common or Usual Name: | Biopsy Instrument |
| Classification: | Class II (21 CFR 876.1075) |
| Classification Panel: | Gastroenterology & Urology |
| Product Code: | KNW |
| Predicate Device: | EnCor ® Breast Biopsy System (K093512; Clearance November 20, 2009) |
Bard Peripheral Vascular, Inc.
Image /page/0/Picture/15 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, with a white fill. The word is slightly distorted, with the letters appearing to be stretched horizontally. The background is white.
(1 of 5)
1
Device Description:
The subject device is the EnCor Enspire™ Breast Biopsy System, an automated directional vacuum-assisted biopsy device consisting of an integrated control module and vacuum system with a detachable touch screen display. The key functional components of the EnCor Enspire™ Breast Biopsy System are integrated into a single console.
Control Module - The control module is designed to provide control operations and serve as an interface for drivers, probes and foot pedals.
- Inputs are delivered to the control module via either a driver or foot pedal. o
- Based on the input received, the control module adjusts the motor speed of o drivers and probes.
- System status is provided to the physician via an integrated LCD screen. o
Vacuum System - During a breast biopsy procedure, the vacuum system draws the target tissue into the biopsy probe tissue acquisition chamber by creating a negative pressure differential at the tip of the probe being used. A disposable vacuum canister and disposable vacuum tubing cassette (with or without optional rinse tubing) is installed in the vacuum system at the time of each breast biopsy procedure.
Touch Screen Display – The touch Screen Display provides an intuitive user interface for the EnCor Enspire™ Breast Biopsy System. The display provides the system status and initiates operation of the installed driver and probe based on information and options entered or selected by the user.
Indications for Use of Device:
The EnCor Enspire™ Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities.
It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
It is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy.
Bard Peripheral Vascular, Inc.
BARD
2
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.
In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g. fibroadenoma, fibrocystic lesion), the EnCor Enspire™ Breast Biopsy Systems may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. 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.
Technological Comparison to Predicate Devices:
The predicate device is the EnCor® Breast Biopsy System (K093512, cleared on November 20, 2009). It is referenced as the predicate device for the EnCor Enspire™ Breast Biopsy System because the two are substantially equivalent in terms of:
Intended Use Indications for Use Contraindications Patient Population Mechanics of Action Mode of Action Electrical Compatibility Patient Contacting Materials Available Accessories and Disposable Components
The subject device and the predicate device are different in the following manner:
The subject device integrates the major components of the predicate device (control module, vacuum system and cart) into a single assembly.
The subject device adds a large touch screen display with integrated graphical user interface software which replaces the small LCD screen display with integrated into the control module of the predicate device.
The subject device adds an adjustable tray to the body of the console.
Bard Peripheral Vascular, Inc.
Image /page/2/Picture/12 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, with a white fill. The word is horizontally oriented and appears to be a logo or brand name.
3
The design of the single-use vacuum and rinse tubing sets has been changes to contain them in an ABS plastic housing.
Performance Testing Summary:
To demonstrate substantial equivalence of the subject device, the EnCor Enspire™ Breast Biopsy System to the predicate device, the technological characteristics and performance criterion were evaluated. Using the FDA draft guidance document, "Design Control Guidance for Medica! Device Manufacturers" dated March 11, 1997, FDA guidance document "General Principles of Software Validation: Final Guidance for Industry and FDA Staff," issued January 11, 2002 and internal Risk Assessment procedures, the following non-clinical tests were performed:
- . Vacuum Level
- Joint Tensile Strength .
- . Cassette Functionality
- ◆ Rinse Volume
- . Cassette and Vacuum Reliability
- . Packaging Validation
- User Validation .
- . Software Verification and Validation
The results from these tests demonstrate that the technological characteristics and performance criteria of the EnCor Enspire™ Breast Biopsy System are comparable to the predicate device and that it can perform in a manner equivalent to devices currently on the market for the same intended use.
Conclusions:
The outcome of the risk management activities demonstrate the EnCor Enspire™ Breast Biopsy System presents an acceptable level of risk when used within its intended use. The RA, DFMEA, and design verification and validation activities demonstrate the design outputs of the subject device meet the device inputs and user need requirements.
In summary, the subject devise, the EnCor Enspire™ Breast Biopsy System, is substantially equivalent to the legally marketed predicate device, the EnCor® Breast
Bard Peripheral Vascular, Inc.
Image /page/3/Picture/17 description: The image shows the word "BARD" in a bold, outlined font. The letters are all capitalized and evenly spaced. The font style gives the word a blocky, geometric appearance.
Page 23
4
Biopsy System (K093512).
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
C. R. Bard, Inc. % Bard Peripheral Vascular, Inc. Mr. Justin Lovelace 1415 West Third Street Tempe, Arizona 85281-1740
JUN 1 6 2011
Re: K111100
Trade/Device Name: EnCor Enspire™ Breast Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: May 18, 2011 Received: May 19, 2011
Dear Mr. Lovelace:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
6
Page 2 - Mr. Justin Lovelace
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); 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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Eric Keith
or Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use Statement
EnCor Enspire™ Breast Biopsy System
K111100 510(k) Number (if known):
Device Name:
Indications for Use:
The EnCor Enspire™ Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities.
- . It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
- lt is intended to provide breast tissue for histologic examination . with partial removal of a palpable abnormality. The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or 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.
In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the EnCor Enspire™Breast Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. 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 (Part 21 CFR 801 Subpart D)
:AND/OR
Over the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)