(82 days)
Not Found
No
The summary describes a mechanical and electrosurgical device for tissue sampling and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is intended for diagnostic sampling of breast tissue, not for treatment or therapy.
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 clearly outlines hardware components including a hand-held biopsy handle, a disposable probe with electrodes, a stainless steel cannula, a plastic sleeve, and an electrosurgical generator. This is not a software-only device.
Based on the provided information, 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 to provide information for diagnosis, monitoring, or screening.
- Device Function: The en-bloc Biopsy System is a device used to obtain a tissue sample (biopsy). It is a surgical tool for tissue removal.
- Intended Use: The intended use is "diagnostic sampling of breast tissue during a breast biopsy procedure." This describes the process of obtaining the sample for subsequent diagnostic analysis, not the diagnostic analysis itself.
- Device Description: The description details the electrosurgical mechanism for cutting and capturing tissue. It does not describe any components or processes for analyzing the tissue sample itself.
- Performance Studies: The performance studies focus on the device's ability to obtain an intact and suitable tissue sample for post-biopsy pathology evaluation. This further reinforces that the device's role is in sample acquisition, not the diagnostic evaluation of the sample.
The diagnostic evaluation of the tissue sample obtained by this device would be performed in vitro (outside the body) by a separate process, such as histopathology, which would be considered an IVD procedure. However, the en-bloc Biopsy System itself is a device used in vivo (within the body) to facilitate that diagnostic process by providing 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 (comma separated list FDA assigned to the subject device)
GEI, KNW
Device Description
The en-bloc is a high frequency, vacuum-assisted electrosurgical device used to remove and perform simultaneous capture of an incised tissue volume. The Neothermia en-bloc TM consists of a hand-held biopsy handle, upon which the single-use disposable Probe is attached, with an integral cable to connect the handle to the en-bloc Biopsy System™ 11000 console. 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 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.
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)
Testing of the device was conducted on porcine tissue to evaluate the ability of the 20mm probe to cut and capture a predictable volume of tissue and to assess its suitability for post-biopsy pathology evaluation. It was determined that the 20mm probe is capable of obtaining intact, unfragmented biopsy specimens having a predictable diameter and length and suitable for post-biopsy histopathologic examination.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
020031 1/2
MAR 2 7 2002
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 (508) 655-7820 Phone: (508) 655-6239 Facsimile:
Date Prepared:January 3, 2002
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™ (K003190) and the 20mm Auto Suture ABBI Breast Biopsy System (K983296).
Intended Use
The en-bloc Biopsy System is intended for diagnostic sampling of breast tissue during a breast biopsy procedure.
000129
1
020031 2/2
Technological Characteristics
The en-bloc is a high frequency, vacuum-assisted electrosurgical device used to remove The on bloc is a might no quating and simultaneous capture of an incised tissue volume. The Neothermia en-bloc TM consists of a hand-held biopsy handle, upon which the singler the roomering on orobe is attached, with an integral cable to connect the handle to the use chool Droppy 11000 is antains two sets of active electrodes at its distal end - a precursor electrode and cutting/capture electrodes. The shaft of the Probe™ is encased in provinsity clostrode and canning the plastic sleeve surrounds this stainless steel cannula and an annular gap between the sleeve and the cannula provides a conduit for vacuumassisted removal of the gaseous products of electrosurgical cutting and any liquids (e.g., abood) that may accumulate at the distal end of the Probe during the biopsy procedure.
Performance Data
Testing of the device was conducted on porcine tissue to evaluate the ability of the 20mm probe to cut and capture a predictable volume of tissue and to assess its suitability for proble to our pathology evaluation. It was determined that the 20mm probe is capable of obtaining intact, unfragmented biopsy specimens having a predictable diameter and length and suitable for post-biopsy histopathologic examination.
Substantial Equivalence
The Company's en-bloc Biopsy System™ with a 20mm probe covered by this submission is substantially equivalent to its en-bloc Biopsy System™ with a 10mm probe ( K003190). Additionally, it is substantially equivalent to United States Surgical Corp.'s 20mm Auto Suture (ABBI) Breast Biopsy System (K9963825).
The modified en-bloc Biopsy System™ with a 20mm probe is identical to the cleared enbloc Biopsy System™ with a 10mm probe except that the former is available with a 20mm disposable probe, as well as the cleared 10mm disposable probe.
With respect to the predicate device (en-bloc Biopsy System™ with a 10mm probe), the en-bloc Biopsy System™ with a 20mm probe has the same intended use, principles of operation, and technological characteristics.
With respect to the predicate device (20mm ABBI Breast Biopsy System), the en-bloc Biopsy System™ with a 20mm probe has similar intended use, both devices remove breast tissue for diagnostic biopsies. Both devices have similar principles of operation, and similar technological characteristics. Both devices remove a 20mm specimen.
Although there are minor differences in the characteristics of the 20mm en-bloc Biopsy System™ and its predicate devices, those differences do not raise new questions of safety or efficacy.
000130
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with only the outlines of the faces visible.
7 2002 JUN
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sherrie Coval-Goldsmith Vice President, Regulatory Affairs and Quality Assurance Neothermia Corporation One Apple Hill, Suite216 Natick, MA 01760
Re: K020031
Trade/Device Name: En-Bloc Biopsy System™ Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI and KNW Dated: January 3, 2002 Received: January 4, 2002
Dear Ms. Coval-Goldsmith:
This letter corrects our substantially equivalent letter of March 27, 2002 regarding the product code.
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). 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 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
3
Page 2 - Ms. Sherrie Coval-Goldsmith
This letter will allow you to continue 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 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. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Miriam C. Provost
(W 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
4
510(k) Number (if known): _ КО 2 ОО 3/
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
ion Sion-Off Division of General, Restorative and Neurological Devices
510(k) Number K020031