(20 days)
No
The document describes a mechanical, vacuum-assisted biopsy device and its performance testing, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a biopsy system used for diagnostic purposes, not for treating or rehabilitating a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities." This directly indicates its use in diagnosis.
No
The device description explicitly states it is a "handheld, self-contained, single insertion, multiple sample vacuum-assisted biopsy device" with physical components like a "battery-powered, reusable driver and a disposable probe with a sample container." This indicates it is a hardware device, not software-only.
Based on the provided information, the EleVation™ Breast Biopsy System 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 provide information for diagnosis.
- 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 the collection of the sample, not for the analysis of the sample itself.
- Intended Use: The intended use clearly states it is "to obtain tissue samples... for diagnostic analysis." The diagnostic analysis happens after the tissue is obtained using this device.
- Device Description: The description focuses on the mechanical aspects of the device for tissue collection (handheld, vacuum-assisted, single insertion, multiple sample).
The diagnostic analysis of the tissue samples obtained by this device would be performed using IVD methods (e.g., histology, pathology), but the EleVation™ system itself is a surgical/biopsy device, not an IVD.
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 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.
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 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
Prescription Use
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)
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:
- Sampling Reliability
- Prime/Pierce Reliability
- System Lifetime Reliability
- Driver Components Reliability
- Needle Requirements
- -Gauge size and length
- -Penetration Force
- -Sample Notch Length
- -Penetration Force
- Probe Torque
- Probe Bending
- Tissue Sample Quality
- Tensile
- Driver Reprocessing
- Driver Packaging Validation
- Software Validation
The results demonstrate that the technological characteristics and performance criteria of the 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 (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
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November 7, 2019
Bard Peripheral Vascular, Inc. Meghan Mckelvey Regulatory Affairs Specialist 1625 West 3rd Street Tempe, Arizona 85281
Re: K192948
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: October 17, 2019 Received: October 18, 2019
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/cfpmn/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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192948
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 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.
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 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 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: | 480-350-6153 |
| Fax: | 480-449-2546 |
| Contact: | Meghan McKelvey, Regulatory Affairs Specialist |
| Date: | October 18, 2019 |
2. Subject Device:
| Device Trade Name: | ELEVATION™ Breast Biopsy System |
|---|---|
| Classification Name: | Instrument, Biopsy (Product Code KNW) |
| Review Panel: | Gastroenterology/Urology |
| Regulation Number: | 21 CFR 876.1075 |
3. Predicate Device:
FINESSE® Ultra Breast Biopsy System (K103359; cleared December 27, 2010)
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 a breast biopsy procedure. The device consists of a battery-powered, reusable driver and a disposable probe with a sample container.
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
Image /page/3/Picture/15 description: The image shows the word "BARD" in a stylized, bold font. Each letter is outlined in black, giving it a distinct and modern look. The letters are closely spaced, creating a compact and unified design.
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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.q. 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 ●
The subject device and the predicate device are different in the following manner:
- . Optimized Tissue Cutting and Transport Method
- . Echogenic Markings on Needle
- . TriConcave™ Needle Tip
- . Driver Packaging Configuration
- . Software Modifications
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:
Image /page/4/Picture/23 description: The image shows the word "BARD" in a stylized, outlined font. Each letter is bold and constructed from thick lines, giving it a geometric and modern appearance. The letters are evenly spaced and aligned horizontally, creating a balanced and visually appealing logo or wordmark.
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- . Sampling Reliability
- . Prime/Pierce Reliability
- System Lifetime Reliability
- Driver Components Reliability .
- . Needle Requirements
- -Gauge size and length
- -Penetration Force
- -Sample Notch Length
- -Penetration Force
- Probe Torque
- . Probe Bending
- Tissue Sample Quality ●
- Tensile .
- . Driver Reprocessing
- . Driver Packaging Validation
- Software Validation ●
The results demonstrate that the technological characteristics and performance criteria of the 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 ELEVATION™ Breast Biopsy System is substantially equivalent to the legally marketed predicate device, the FINESSE® Ultra Breast Biopsy System (K103359).
Image /page/5/Picture/21 description: The image shows the word "BARD" in a stylized, outlined font. Each letter is bold and constructed from thick lines, giving it a geometric and modern appearance. The letters are tightly spaced, creating a compact and unified design. The overall effect is clean and impactful, making the word easily recognizable.