(10 days)
No
The device description focuses on the mechanical and electrical aspects of tissue cutting and removal, with no mention of AI or ML technologies for analysis, control, or image processing.
No
The device is described as being for "diagnostic sampling of breast tissue," which indicates a diagnostic rather than therapeutic purpose.
Yes
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 purpose.
No
The device description clearly outlines hardware components including 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 is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "diagnostic sampling of breast tissue during a breast biopsy procedure." This describes a procedure to obtain a tissue sample from the body.
- Device Description: The device is a "percutaneous high frequency, automated, vacuum-assisted electrosurgical device used to remove tissue." This describes a surgical tool used to physically remove tissue from a patient.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections. They are used to analyze the sample outside of the body.
This device is used to obtain the tissue sample, which is then likely sent to a lab for in vitro analysis (which would be an IVD process). However, the device itself is a surgical instrument for tissue removal, not a test performed on a sample outside the body.
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
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)
Reference Device(s)
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
MAR 3 ] 2005
P 1 of 2
510(k) SUMMARY
Neothermia Corporation's en-bloc Biopsy System™
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
David Jacobs VP. Engineering and Operations Neothermia Corporation One Apple Hill, Suite 316 Natick, Massachusetts 01760 (508) 655-7820 Phone: (508) 655-7822 Facsimile:
March 10, 2005 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) 655-7822
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
KOSO737
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 probe with this manufacturing modification has the same intended use, principles of operation, and technological characteristics as the previously cleared predicate devices. The en-bloc probe with the manufacturing modification and its predicate devices are both electrosurgical devices used to biopsy breast tissue. The en-bloc probe with the manufacturing modification is substantially equivalent to Neothermia's cleared 10mm, 12mm, 15mm and 20mm en-bloc probes.
2
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. In the center of the seal is a stylized symbol that resembles a caduceus, a symbol often associated with medicine and healthcare.
MAR 3 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David Jacobs V.P. Engineering Neothermia Corporation One Apple Hill, Suite 316 Natick, Massachusetts 01760
Re: K050737
Trade/Device Name: en-bloc Biopsy System™ Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 18, 2005 Received: March 21, 2005
Dear Mr. Jacobs:
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 -- Mr. David Jacobs
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in your be only finding of substantial equivalence of your device to a legally premative notification ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific acrive 101 7 216-0120 . 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 other generers, 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/industry/support/index.html.
Sincerely yours.
A
Miriam C. Provost, Ph.D.
n C. Provost, Ph.D. Mi Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: en-bloc Biopsy SystemTm
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
Indications For Use: The en-bloc Biopsy System is intented for diagnostic sampling of breast tissue during a breast biopsy procedure.
Prescription Use
AND/OR
Over-The-Counter Use
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ・・・
்படுகின்றன.
இந்து இருக்கு இருக்கு இருக்கு இருக்கும் இருக்கும் இருக்கும் இருக்கும் இருக்கும் இருக்கும் இருக்கும் இருக்கும் இருக்கும் இருக்கும் இருக்கும் இருக்கும் இருக்கும் இ
(Part 21 CFR 801 Subcart D)
(21 CFR 807 Subpart C)
(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Stypt Rhodes
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(1) ATarshage K050737