(28 days)
Not Found
Not Found
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 strictly for diagnostic sampling of breast tissue.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The en-bloc Biopsy System is intended for diagnostic sampling of breast tissue during a breast biopsy procedure." Diagnostic sampling is a direct indication of a diagnostic device.
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
GEI, 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 tissue
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
K 0234 13
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 (508) 655-7822 Facsimile:
8 2002 NOV
September 26, 2002 Date Prepared:
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
9
6
1
0
0
0
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 probe 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 probe is substantially equivalent to Neothermia's cleared en-bloc probes.
000170
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized bird or a human figure with outstretched arms. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 2002 NOV
Neothermia Corporation Sherrie Coval-Goldsmith Vice President, Regulatory Affairs One Apple Hill. Suite 316 Natick, Massachusetts 01760
Re: K023413
Trade/Device Name: en-bloc Biopsy System™ Regulation Number: 878.4400; 876.1075 Regulation Name: Electrosurgical cutting and coagulation device and accessories; Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: GEI; KNW Dated: October 7, 2002 Received: October 11, 2002
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
uriam C. Provost
fed 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)
Concurrence of
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 iive
510(k) Number K023413
000:72