(23 days)
Not Found
No
The description focuses on the mechanical and operational aspects of a vacuum-assisted biopsy device and does not mention any AI/ML capabilities or image processing beyond ultrasound guidance. The performance studies listed are also related to mechanical and software validation, not AI/ML performance metrics.
No.
The device is used to obtain tissue samples for diagnostic analysis, not for treating a condition.
Yes
The device is indicated to "obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis for breast abnormalities," and the components are designed for "diagnostic sampling during a breast biopsy procedure."
No
The device description explicitly states it is a "handheld, self-contained, single insertion, multiple sample vacuum-assisted biopsy device" with a "battery-powered, reusable driver and a disposable probe." This indicates it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to analyze these samples.
- Device Function: The EleVation Breast Biopsy System is a device used to obtain tissue samples from the breast or axillary lymph nodes. It is a tool for collecting the sample, not for analyzing it.
- Intended Use: The intended use is to "obtain tissue samples... for diagnostic analysis." This clearly indicates that the device's role is the collection of the sample, which is then sent for separate diagnostic analysis (likely histological examination).
- Device Description: The description focuses on the mechanical aspects of the device for sample collection (handheld, vacuum-assisted, single insertion, multiple sample).
The diagnostic analysis itself (histological examination) would be performed using other methods and potentially other IVD devices, but the EleVation Breast Biopsy System is the instrument used to acquire the sample for that analysis.
N/A
Intended Use / Indications for Use
The EleVation Breast Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis for breast abnormalities. The 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 essue margins be examined for completeness of removal using standard surgical procedures.
Product codes
KNW
Device Description
The ELEVATION™ Breast Biopsy System is a handheld, self-contained, single insertion, multiple sample vacuum-assisted biopsy device and is intended to be used with ultrasound guidance. The device can obtain and store multiple samples with a single insertion probe. The components of the system are designed to operate safely when used together for diagnostic sampling during a breast biopsy procedure. The device consists of a battery-powered, reusable driver and a disposable probe with a sample container.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound guidance
Anatomical Site
breast or axillary lymph nodes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies
To demonstrate substantial equivalence of the subject device to the predicate device, the technological characteristics and performance criteria were evaluated. Using the FDA Guidance document, "Design Control Guidance for Medical Device Manufacturers," dated March 11, 1997, and internal risk assessments procedures, the following non-clinical tests were performed:
- Software Validation
- Penetration Force Testing
- Tensile Testing
- Prime/Pierce Testing
- Reliability Testing
- Sample Mass Testing
The results demonstrate that the technological characteristics and performance criteria of the modified ELEVATION™ Breast Biopsy System is comparable to the predicate device and that it performs as safely and as effectively as the legally marketed predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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July 15, 2021
Bard Peripheral Vascular, Inc. Meghan Mckelvev Senior Regulatory Affairs Specialist 1625 W. 3rd Street Tempe, Arizona 85281
Re: K211933
Trade/Device Name: EleVation Breast Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: June 21, 2021 Received: June 22, 2021
Dear Meghan Mckelvey:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pmn.cfm identifies.combination product submissions. 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.
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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): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211933
Device Name EleVation Breast Biopsy System
Indications for Use (Describe)
The EleVation Breast Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis for breast abnormalities. The 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 essue margins be examined for completeness of removal using standard surgical procedures.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary (K211933) 21 CFR 807.92
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (()(3)(A) of the Food, Drug and Cosmetic Act, a summary of the information upon which substantial equivalence determination is based is as follows:
1. Submitter Information:
| Applicant: | Bard Peripheral Vascular, Inc.
1625 West 3rd Street
Tempe, Arizona 85281 |
|------------|--------------------------------------------------------------------------------|
| Phone: | 602-830-5063 |
| Fax: | 312-949-0436 |
| Contact: | Meghan McKelvey, Senior Regulatory Affairs Specialist |
| Date: | July 14, 2021 |
2. Subject Device:
| Device Trade Name: | ELEVATIONTM Breast Biopsy System |
|---|---|
| Classification Name: | Instrument, Biopsy (Product Code KNW) |
| Review Panel: | Gastroenterology/Urology |
| Regulation Number: | 21 CFR 876.1075 |
3. Predicate Device:
ELEVATION™ Breast Biopsy System (K192948; cleared November 7, 2019)
4. Device Description:
The ELEVATION™ Breast Biopsy System is a handheld, self-contained, single insertion, multiple sample vacuum-assisted biopsy device and is intended to be used with ultrasound guidance. The device can obtain and store multiple samples with a single insertion probe. The components of the system are designed to operate safely when used together for diagnostic sampling during a breast biopsy procedure. The device consists of a battery-powered, reusable driver and a disposable probe with a sample container.
Image /page/3/Picture/13 description: The image shows the word "BARD" in a stylized, outlined font. The letters are bold and connected, giving the word a unified appearance. The overall design is simple and modern.
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5. Indications for Use of Device:
The ELEVATION™ Breast Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis for 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.
6. Technological Comparison to Predicate Devices:
The technological characteristics of the subject device are substantially equivalent to those of the predicate device, in terms of following:
- Intended Use
- . Indications for Use
- Performance Characteristics .
- . Target Population
- . Fundamental Scientific Technology
- . Operating Principle (Mechanism of Action)
- . Patient Contacting Materials
- . Sterility Assurance Level and Method of Sterilization
- . Shelf-Life
- Packaging Configuration
The subject device and the predicate device are different in the following manner:
- . Software Modifications (Transportation Indicator and Enhanced Logging Capabilities)
- . Needle Tip Modification (Needle Tip Dimensional Improvement and Venting Hole Change)
- . Addition of Optional Accessories (Introducer Stylet, Half-Notch Support Cannula, Additional Sample Container)
Image /page/4/Picture/22 description: The image shows the word "BARD" in a stylized, bold font. Each letter is outlined in black, giving it a distinct and modern appearance. The letters are closely spaced, creating a compact and unified design.
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7. Performance Testing Summary:
To demonstrate substantial equivalence of the subject device to the predicate device, the technological characteristics and performance criteria were evaluated. Using the FDA Guidance document, "Design Control Guidance for Medical Device Manufacturers," dated March 11, 1997, and internal risk assessments procedures, the following non-clinical tests were performed:
- . Software Validation
- . Penetration Force Testing
- . Tensile Testing
- Prime/Pierce Testing
- Reliability Testing
- . Sample Mass Testing
The results demonstrate that the technological characteristics and performance criteria of the modified ELEVATION™ Breast Biopsy System is comparable to the predicate device and that it performs as safely and as effectively as the legally marketed predicate device.
8. Conclusion:
The modified ELEVATION™ Breast Biopsy System is substantially equivalent to the legally marketed predicate device, the ELEVATION™ Breast Biopsy System (K192948).
Image /page/5/Picture/14 description: The image shows the word "BARD" in a stylized, outlined font. Each letter is bold and geometric, with sharp angles and thick lines. The letters are evenly spaced and aligned horizontally, creating a clear and legible wordmark.