(27 days)
No
The device description and performance studies focus on mechanical and functional aspects of a biopsy probe, with no mention of AI/ML for image analysis, diagnosis, or any other function.
No.
The device is used for diagnostic sampling of breast abnormalities to acquire tissue for histologic examination, not for treating a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "indicated to acquire tissue for diagnostic sampling of breast abnormalities." This tissue is then used for "histologic examination," which is a diagnostic process.
No
The device description clearly outlines physical components such as a cutter/cannula, housing, sample container, tubing, and a rinse subcassette, indicating it is a hardware device.
Based on the provided information, the EnCor™ Breast Biopsy Probe with Rinse Tube is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Function: The EnCor™ Breast Biopsy Probe is a tool used during a medical procedure (breast biopsy) to acquire tissue samples from the body. It is used in vivo (within the body) to collect the specimen.
- Intended Use: The intended use is to "acquire tissue for diagnostic sampling" and "provide breast tissue for histologic examination." This means the device's purpose is to obtain the sample that will then be used for diagnostic testing (histologic examination), which is typically performed using IVD methods.
- Lack of Diagnostic Function: The device itself does not perform any diagnostic analysis on the tissue. It is a sample collection tool.
Therefore, while the tissue collected by this device is intended for in vitro diagnostic testing, the device itself is a surgical/biopsy instrument, not an IVD.
N/A
Intended Use / Indications for Use
The EnCor™ Breast Biopsy Probe with Rinse Tube is indicated to acquire tissue for diagnostic sampling of breast abnormalities and saline rinse the tissue samples collected within the tissue chamber during a biopsy procedure. It 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 EnCor™ Breast Biopsy Probe with Rinse Tube is a handheld, single use, sterile (irradiation) biopsy probe used as part of a vacuum-assisted biopsy system (EnCor™ or EnCor Enspire™) and is intended to be used with ultrasound or stereotactic guidance. The probe is used for diagnostic sampling during a breast biopsy procedure. The device consists of a cutter/cannula with a sharp trocar tip, housing, sample container, vacuum and rinse tubing, and a rinse sub-cassette. A stainless steel cutter acquires the tissue samples, which are transported by vacuum to the probe's sample container, where they may be rinsed with saline. The EnCor™ Breast Biopsy Probe with Rinse Tube is available in 7 gauge, and 12 gauge, in both standard and vertical orientations for each gauge size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound or stereotactic guidance
Anatomical Site
Breast
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
Not Found
Summary of Performance Studies
Non-clinical tests were performed:
- Cassette functionality and switch activation
- Vacuum testing
- Rinse testing
- Tensile testing
- Sub-cassette reliability
- Packaging validation
The results demonstrate that the technological characteristics and performance criteria of the EnCor™ Breast Biopsy Probe with Rinse Tube are 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)
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 31, 2021
SenoRx, Inc. Jessica Myer Regulatory Affairs Specialist 1625 West 3rd Street Tempe, Arizona 85251
Re: K210654
Trade/Device Name: EnCor Breast Biopsy Probe with Rinse Tube Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: March 4, 2021 Received: March 4, 2021
Dear Jessica Myer:
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 approv al 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.
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
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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 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210654
Device Name EnCor Breast Biopsy Probe with Rinse Tube
Indications for Use (Describe)
The EnCor™ Breast Biopsy Probe with Rinse Tube is indicated to acquire tissue for diagnostic sampling of breast abnormalities and saline rinse the tissue samples collected within the tissue chamber during a biopsy procedure. It 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 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 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: | SenoRx, Inc.
1625 West 3rd Street
Tempe, Arizona 85281 |
|------------|---------------------------------------------------------------|
| Phone: | 480-597-8420 |
| Fax: | 312-949-0436 |
| Contact: | Jessica Meyer, Regulatory Affairs Specialist |
| Date: | March 3, 2021 |
2. Subject Device:
| Device Trade Name: | EnCorTM Breast Biopsy Probe with Rinse Tube |
|---|---|
| Common or Usual Name: | Breast Biopsy Probe |
| Classification Name: | Instrument, Biopsy (Product Code KNW) |
| Review Panel: | Gastroenterology/Urology |
| Regulation Number: | 21 CFR 876.1075 |
3. Predicate Device:
EnCor™ Breast Biopsy Probe (K051158; May 16, 2005)
Reference Device: EnCor Enspire™ Breast Biopsy System Vacuum and Rinse Tubing Cassette (K111100; June 16, 2011)
4. Device Description:
The EnCor™ Breast Biopsy Probe with Rinse Tube is a handheld, single use, sterile (irradiation) biopsy probe used as part of a vacuum-assisted biopsy system (EnCor™ or EnCor Enspire™) and is intended to be used with ultrasound or stereotactic guidance. The probe is used for diagnostic sampling during a breast biopsy procedure. The device consists of a cutter/cannula
SenoRx, Inc.
Image /page/3/Picture/14 description: The image contains a logo with two distinct elements. On the left, there is a circular symbol resembling a stylized sun or starburst, with multiple rays emanating from a central point. To the right of this symbol, the letters 'BD' are displayed in a bold, sans-serif typeface. The overall design is simple and monochromatic, with a focus on clarity and recognizability.
Image /page/3/Picture/15 description: The image contains the word "BARD" in a bold, sans-serif font. Below the word "BARD" are the words "has joined BD" in a smaller font. The text is black and the background is white.
4
with a sharp trocar tip, housing, sample container, vacuum and rinse tubing, and a rinse subcassette. A stainless steel cutter acquires the tissue samples, which are transported by vacuum to the probe's sample container, where they may be rinsed with saline. The EnCor™ Breast Biopsy Probe with Rinse Tube is available in 7 gauge, and 12 gauge, in both standard and vertical orientations for each qauge size.
5. Indications for Use of Device:
The EnCor™ Breast Biopsy Probe with Rinse Tube is indicated to acquire tissue for diagnostic sampling of breast abnormalities and saline rinse the tissue samples collected within the tissue chamber during a biopsy procedure. It 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 the same as those of the predicate device, in terms of following:
- . Intended Use
- . Performance Characteristics
- . Target Population
- Fundamental Scientific Technology
- . Operating Principle (Mechanism of Action)
- . Patient Contacting Materials
- . Sterility Assurance Level and Method of Sterilization
- Packaging Configuration .
The subject device and the predicate device are different in the following manner:
Image /page/4/Picture/17 description: The image shows the BD logo. The logo consists of a stylized sun-like symbol on the left and the letters "BD" in bold, sans-serif font on the right. The logo is black and white.
Image /page/4/Picture/18 description: The image shows the word "BARD" in a bold, sans-serif font. Below the word "BARD" are the words "has joined BD" in a smaller, lighter font. The text is all in black and white. The image appears to be a logo or announcement.
SenoRx, Inc.
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- . Directions for Use
- Precautions
.
- Integrated rinse tubing and sub-cassette assembly .
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:
does not affect its safety and effectiveness as compared to the predicate.
- . Cassette functionality and switch activation
- . Vacuum testing
- . Rinse testing
- Tensile testing
- . Sub-cassette reliability
- . Packaging validation
The results demonstrate that the technological characteristics and performance criteria of the EnCor™ Breast Biopsy Probe with Rinse Tube are comparable to the predicate device and that it performs as safely and as effectively as the legally marketed predicate device.
8. Conclusion:
The EnCor™ Breast Biopsy Probe with Rinse Tube is substantially equivalent to the legally marketed predicate device, the EnCor™ Breast Biopsy Probe (K051158).
Image /page/5/Picture/16 description: The image shows the text "SenoRx, Inc." in a bold, sans-serif font. The text is arranged on a single line, with "SenoRx" followed by a comma and then "Inc." The text appears to be a company name or logo.
Image /page/5/Picture/17 description: The image shows the BD logo. The logo consists of a circular symbol on the left and the letters "BD" on the right. The circular symbol appears to be a stylized sun or starburst. The letters "BD" are in a bold, sans-serif font.
Image /page/5/Picture/18 description: The image shows the logo for Bard, a company that has joined BD. The logo is in black and white and features a stylized font. The text "has joined BD" is in a smaller font size and is located below the main logo.