Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices
Applicant
Transmed7, LLC
Product Code
KNW · Gastroenterology, Urology
Decision Date
Aug 7, 2020
Decision
SESE
Submission Type
Special
Regulation
21 CFR 876.1075
Device Class
Class 2
Indications for Use
The Concorde Models Concorde ST Soft Tissue Biopsy Devices are intended for diagnostic sampling of soft tissue during soft tissue biopsy procedures. They are to be used for diagnostic purposes only and are not intended for therapeutic uses. The Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices are indicated to provide soft tissue samples for diagnostic sampling of soft tissue abnormalities, including brostate, spleen, lymph nodes, and various other soft tissue abnormalities. They are designed to provide soft tissologic examination, with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from imaging appearance (ultrasound, radiographic, e.g., mammographic) of a soft tissue abnormality. 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.
Device Story
Concorde US and Concorde ST are soft tissue biopsy devices; used for diagnostic sampling of soft tissue abnormalities; intended for partial or complete removal of imaged abnormalities for histologic examination; operated by clinicians in clinical settings; provides tissue samples for pathology; does not provide therapeutic treatment; requires standard surgical follow-up for margin assessment if malignancy is suspected.
Indications for Use
Indicated for diagnostic sampling of soft tissue abnormalities in patients requiring histologic examination of tissue, including prostate, spleen, lymph nodes, and other soft tissue sites.
Regulatory Classification
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.
Submission Summary (Full Text)
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August 7, 2020
TransMed7, LLC James Vetter Chairman, TransMed7, LLC 117 Solana Road Portola Valley, CA 94028
Re: K201244
Trade/Device Name: Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: July 2, 2020 Received: July 9, 2020
# Dear James Vetter:
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.
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
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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,
for Shani P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology 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) K201244
#### Device Name
Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices
Indications for Use (Describe)
The Concorde Models Concorde ST Soft Tissue Biopsy Devices are intended for diagnostic sampling of soft tissue during soft tissue biopsy procedures. They are to be used for diagnostic purposes only and are not intended for therapeutic uses.
The Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices are indicated to provide soft tissue samples for diagnostic sampling of soft tissue abnormalities, including brostate, spleen, lymph nodes, and various other soft tissue abnormalities. They are designed to provide soft tissologic examination, with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from imaging appearance (ultrasound, radiographic, e.g., mammographic) of a soft tissue abnormality. 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.
Type of Use (Select one or both, as applicable)
| <span style="display:inline-block; width:15px;"></span> <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
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| <span style="display:inline-block; width:15px;"></span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |
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