(13 days)
KNW
No
The description focuses on the electrosurgical and vacuum-assisted mechanical aspects of the device, with no mention of AI, ML, image processing, or data-driven algorithms.
No.
The device is clearly stated to be "intended for diagnostic sampling of breast tissue during a breast biopsy procedure," which is a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" states that the device "is intended for diagnostic sampling of breast tissue during a breast biopsy procedure."
No
The device description explicitly details hardware components such as a hand-held biopsy handle, a single-use biopsy probe with electrodes, a stainless steel cannula, an outer plastic sleeve, and a control unit. This indicates it is a physical medical device with integrated hardware, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to analyze these samples.
- Device Function: The description clearly states that the en-bloc Biopsy System is used for the sampling of breast tissue during a breast biopsy procedure. It is a tool used to obtain the tissue sample from the patient's body.
- Intended Use: The intended use is "diagnostic sampling of breast tissue during a breast biopsy procedure." This refers to the process of collecting the tissue, not the analysis of the tissue itself.
While the tissue sample obtained by this device will likely be used for in vitro diagnostic testing (e.g., pathology analysis), the device itself is a surgical/biopsy instrument used in vivo (within the body) to acquire the sample.
N/A
Intended Use / Indications for Use
The en-bloc Biopsy System is intended for diagnostic sampling of breast tissue during a breast biopsy procedure.
Product codes
KNW
Device Description
The en-bloc is a percutaneous high frequency, automated, vacuum-assisted electrosurgical device used to remove tissue by automated electrosurgical cutting and simultaneous capture of an incised tissue volume. The Neothermia en-bloc ™ consists of a hand-held biopsy handle, upon which the single-use en-bloc Biopsy Probe is attached, with an integral cable to connect the handle to the control unit. The Probe™ contains two sets of active electrodes at its distal end - a precursor electrode and cutting/capture electrodes. The shaft of the Probe™ is encased in a stainless steel cannula. An outer plastic sleeve surrounds this stainless steel cannula and an annular gap between the sleeve and the cannula provides a conduit for vacuum-assisted removal of the gaseous products of electrosurgical cutting and any liquids (e.g., blood) that may accumulate at the distal end of the Probe during the biopsy procedure. The vacuum also helps maintain the required cutting arc during automated tissue capture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Neothermia Corp.'s en-bloc Biopsy System™
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
Ko 33 427
NOV 1 0 2003
510(k) SUMMARY
Neothermia Corporation's en-bloc Biopsy System™
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Sherrie Coval-Goldsmith VP. RA/QA Neothermia Corporation One Apple Hill, Suite 316 Natick, Massachusetts 01760 Phone: (508) 655-7820 Facsimile: (508) 655-7822
Date Prepared: October 21, 2003
Name of Device and Name/Address of Sponsor
| Common or Usual Name: | Electrosurgical Generator |
|---|---|
| Trade or Proprietary Name: | en-bloc Biopsy System™ |
| Classification Name: | Electrosurgical Cutting & Coagulation Device & |
| Accessories (21 C.F.R. § 878.4400) | |
| Biopsy Instrument (21 C.F.R. § 876.1075) |
Neothermia Corporation One Apple Hill, Suite 316 Natick, Massachusetts 01760 Phone: (508) 655-7820 Facsimile: (508) 655-6239
Predicate Devices
Neothermia Corp.'s en-bloc Biopsy System™
Intended Use
The en-bloc Biopsy System is intended for diagnostic sampling of breast tissue during a breast biopsy procedure.
Technological Characteristics
The en-bloc is a percutaneous high frequency, automated, vacuum-assisted electrosurgical device used to remove tissue by automated electrosurgical cutting and
1
simultaneous capture of an incised tissue volume. The Neothermia en-bloc ™ consists of a hand-held biopsy handle, upon which the single-use en-bloc Biopsy Probe is attached, with an integral cable to connect the handle to the control unit. The Probe™ contains two sets of active electrodes at its distal end - a precursor electrode and cutting/capture electrodes. The shaft of the Probe™ is encased in a stainless steel cannula. An outer plastic sleeve surrounds this stainless steel cannula and an annular gap between the sleeve and the cannula provides a conduit for vacuum-assisted removal of the gaseous products of electrosurgical cutting and any liquids (e.g., blood) that may accumulate at the distal end of the Probe during the biopsy procedure. The vacuum also helps maintain the required cutting arc during automated tissue capture.
Substantial Equivalence
The modified cradle has the same intended use, principles of operation, and technological characteristics as the previously cleared predicate devices. The modified device and its predicate devices are both electrosurgical devices used to biopsy breast tissue. The change does not raise new questions of safety or efficacy. The modified cradle is substantially equivalent to Neothermia's cleared en-bloc cradles.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 2003
Ms. Sherrie Coval-Goldsmith Vice President, Regulatory Affairs Neothermia Corporation One Apple Hill, Suite 316 Natick, Massachusetts 01760
Re: K033427
Trade/Device Name: en-bloc Biopsy System™ Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: October 27, 2003 Received: October 31, 2003
Dear Ms. Coval-Goldsmith:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Sherrie Coval-Goldsmith
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: en-bloc Biopsy System™
Indications for Use:
The en-bloc Biopsy System is intended for diagnostic sampling of breast tissue during a breast biopsy procedure.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
CDRH, Office of Device Evaluation (ODE)
. ____________________________________________________________________________________________________________________________________________________________________________
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use_ (Per 21 C.F.R. 801.109)
(Optional Format 1-2-96)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K033427