(18 days)
Not Found
No
The summary describes a mechanical introducer set for breast biopsy and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is used to facilitate a diagnostic biopsy, which is a diagnostic procedure, not a therapeutic one. It provides a passageway for a biopsy probe and allows for subsequent marking of the biopsy site.
No
The EnCor Introducer is a device that provides a passageway for a biopsy probe and biopsy site marker, which is used for diagnostic purposes. However, the Introducer itself does not perform the diagnosis; it facilitates the process by creating access for another device (the biopsy probe) that acquires the tissue for diagnosis.
No
The device description clearly outlines physical components (Trocar, Obturator, Cannula, Needle Guide Block, Introducer, Adapter) and describes their physical interaction and use in a biopsy procedure. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "penetrate the breast under image guidance and provide a passageway through which a diagnostic biopsy of a breast may be performed." This describes a surgical/interventional device used to obtain a tissue sample from the body.
- Device Description: The description details components like a Trocar, Obturator, Cannula, and Needle Guide Block, which are instruments used for accessing and creating a pathway within the body.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnostic purposes. This device is used in vivo (within the body) to obtain the specimen.
The device is a tool used to facilitate the collection of a sample, which would then likely be sent to a laboratory for in vitro diagnostic testing. The device itself is not performing the diagnostic test.
N/A
Intended Use / Indications for Use
The EnCor® Introducer is used with the EnCor® biopsy probe to penetrate the breast under image guidance and provide a passageway through which a diagnostic biopsy of a breast may be performed.
Product codes
KNW
Device Description
The ENCOR® MRI Introducer Set consists of a Trocar, Obturator, Cannula and Needle Guide Block. The Trocar, Obturator, and ENCOR® MRI probes can be used co-axially with the Cannula. When inserted in the cannula, the tip of the Obturator approximates the center of the sample aperture of the ENCOR® MRI Probe. Markings on the Cannula indicate the distance to the center of the ENCOR® MRI probe sample aperture.
The ENCOR® Probe Introducer is sterile, disposable and consists of an Introducer and Adapter. The ENCOR® Probe Introducer is used co-axially with the ENCOR® biopsy probe. The same Introducer allows for both tissue acquisition with an ENCOR® probe and subsequent marking of the biopsy site with GEL MARK ULTRACOR® Biopsy site marker.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Image 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
To verify that the device design met its functional and performance requirements, representative samples of each device underwent testing. Results of this testing demonstrate that the design outputs continue to meet the design inputs and user need requirements. Using the FDA guidance document, "Design Control Guidance for Medical Device Manufacturers," dated March 11, 1997, and internal risk assessment procedures, the following non-clinical tests were performed:
- . Biocompatibility testing of ink used on cannulas (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Pyrogen Testing)
- . Functional testing after Accelerated Shelf Life and T=0 (Ink adhesion and ink adhesion IPA wiping)
The results demonstrate that the technological characteristics and performance criteria of the EɴCοዩ® Introducers 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)
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 19, 2016
SenoRx Incorporated Ms. Sarah McCartney Senior Regulatory Affairs Specialist 1625 West 3rd Street Tempe, Arizona 85281
Re: K161805
Trade/Device Name: EnCor MRI Introducer Set, EnCor Probe Introducer Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: June 30, 2016 Received: July 1, 2016
Dear Ms. McCartney:
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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Christopher J. Ronk -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161805
Device Name EnCor® MRI Introducer Set EnCor® Probe Introducer
Indications for Use (Describe)
The EnCor® Introducer is used with the EnCor® biopsy probe to penetrate the breast under image guidance and provide a passageway through which a diagnostic biopsy of a breast may be performed.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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:
- SenoRx, Inc. Applicant: 1625 West 3rd Street Tempe, Arizona 85281 Sarah McCartney, B.S. Contact: Senior Regulatory Affairs Specialist sarah.mccartney@crbard.com Phone: 480-638-2954 Fax: 480-449-2546 Date: June 30, 2016
2. Subject Device:
| Device Trade Name: | ENCOR® MRI Introducer Set
ENCOR® Probe Introducer |
|-----------------------|-----------------------------------------------------------------|
| Common or Usual Name: | Biopsy Guide, Trocar/Introducer |
| Classification: | Class II |
| Classification Name: | Instrument, Biopsy (Product Code KNW) |
| Review Panel: | Gastroenterology/Urology |
| Regulation Number: | 21 CFR 876.1075 (Gastroenterology-urology biopsy
instrument) |
3. Predicate Device:
The predicate device is the SenoRx, Inc. Introducers (K042098, cleared on August 19, 2004).
4. Summary of Change:
This submission details a change in the printing ink material used on the outer cannula of the subject device.
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5. Device Description:
ENCOR® MRI Introducer Set
The ENCOR® MRI Introducer Set consists of a Trocar, Obturator, Cannula and Needle Guide Block. The Trocar, Obturator, and ENCOR® MRI probes can be used co-axially with the Cannula. When inserted in the cannula, the tip of the Obturator approximates the center of the sample aperture of the ENCOR® MRI Probe. Markings on the Cannula indicate the distance to the center of the ENCOR® MRI probe sample aperture.
ENCOR® Probe Introducer
The ENCOR® Probe Introducer is sterile, disposable and consists of an Introducer and Adapter. The ENCOR® Probe Introducer is used co-axially with the ENCOR® biopsy probe. The same Introducer allows for both tissue acquisition with an ENCOR® probe and subsequent marking of the biopsy site with GEL MARK ULTRACOR® Biopsy site marker.
6. Indications for Use of Device:
The ENCOR® Introducer is used with the ENCOR® biopsy probe to penetrate the breast under image guidance and provide a passageway through which a diagnostic biopsy of the breast may be performed.
7. 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:
- . Same intended use
- Same operating principal and method of action .
- Same fundamental scientific technology .
- Same design .
- . Same target population
- . Same performance specifications
- . Same packaging configuration
- Same sterility assurance level and method of sterilization .
The subject devices and the predicate device are different in the following manner:
- Modifications to ink used in printing depth markings on cannula .
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8. Performance Testing Summary:
To verify that the device design met its functional and performance requirements, representative samples of each device underwent testing. Results of this testing demonstrate that the design outputs continue to meet the design inputs and user need requirements. Using the FDA guidance document, "Design Control Guidance for Medical Device Manufacturers," dated March 11, 1997, and internal risk assessment procedures, the following non-clinical tests were performed:
- . Biocompatibility testing of ink used on cannulas (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Pyrogen Testing)
- . Functional testing after Accelerated Shelf Life and T=0 (Ink adhesion and ink adhesion IPA wiping)
The results demonstrate that the technological characteristics and performance criteria of the EɴCοዩ® Introducers are comparable to the predicate device and that it performs as safely and as effectively as the legally marketed predicate device.
9. Conclusion:
The results of performance testing demonstrated the subject device is substantially equivalent to the legally marketed predicate device (K042098).
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