(27 days)
Not Found
No
The description focuses on electrosurgical cutting, vacuum assistance, and mechanical components, with no mention of AI or ML terms or functionalities.
No.
The device is clearly stated as "intended for diagnostic sampling of breast tissue during a breast biopsy procedure," which is a diagnostic purpose, not therapeutic.
Yes
The "Intended Use / Indications for Use" states that the system "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 cable, a control unit, a stainless steel cannula, and an outer plastic sleeve. This indicates it is a physical medical device with integrated hardware, 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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to analyze these samples.
- Device Function: The en-bloc Biopsy System is a device used during a medical procedure (breast biopsy) to obtain a tissue sample from the body. It is a surgical tool for tissue acquisition, not a test performed on a sample after it has been removed.
- Intended Use: The intended use is "diagnostic sampling of breast tissue during a breast biopsy procedure." This clearly describes a procedure to collect a sample, not a test performed on a collected sample.
Therefore, the en-bloc Biopsy System is a medical device used for tissue acquisition, which is a step that precedes any potential in vitro diagnostic testing that might be performed on the collected tissue 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
Device Description
The en-bloc is a percutaneous high frequency, automated, vacuum-assisted electrosurgical device that removes 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, and a cable from 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 sheath of the Probe™ is encased in a stainless steel cannula. An outer plastic sleeve surrounds and an annular gap between the sleeve and the cannula provides a conduit for vacuum-assisted removal of the gaseous products and any liquids (e.g., blood) that may accumulate at the distal tip or surrounding 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
042170 1/2
SEP - 7 2004
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) 655-7822 Facsimile:
August 5, 2004 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 The on broe is a perculance as remove tissue by automated electrosurgical cutting and
1
K042170 2/2
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, a nand note bropey manase, mandle to the control unit. The Probe™ contains two with an micegrar castors at its distal end - a precursor electrode and cutting/capture sees of active crocalers of the Probe™ is encased in a stainless steel cannula. An outer electrodes. The bhair of any stainless steel cannula and an annular gap between the sleeve plastic slove surrounds and suduit for vacuum-assisted removal of the gaseous products and the cannula provides and any liquids (e.g., blood) that may accumulate at the distal or crectroomgrounding the biopsy procedure. The vacuum also helps maintain the required cutting arc during automated tissue capture.
Substantial Equivalence
The 12mm en-bloc probe has the same intended use, principles of operation, and The Izimir on oroo probo has the earleviously cleared predicate devices. The 12mm entechnological Character.itles as the pressurgical devices used to biopsy breast bloc proble and to progreate as rioss aifference in the technological characteristics of the 12 mm probe and its predicate devices (e.g., size of basket) this difference does not raise 12 min probo and to promotion acy. The 12mm en-bloc probe is substantially equivalent to Neothermia's 10mm, 15mm and 20mm en-bloc probes.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 7 2004
Ms. Sherrie Coval-Goldsmith Vice President, Regulatory Affairs Neothermia Corporation One Apple Hill, Suite 316 Natick, Massachusetts 01760
Re: K042170
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: August 9, 2004 Received: August 11, 2004
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)
This and the supportunity of all confeence of your device of your device to a le This letter will allow you to begin marketing your actives of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your devi premarket notification. The FDA finding of substantal equivaliso or your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs the regulation and 1901 - 1601 - Algo, please note the regulation entitl If you desire specific advice for your device on our nacemits (a mease not the regulation entitled, and the regulation entitled, and the regulation contact the Office of Compliance at (301) 594-407. The Pat 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Patt 807.97). You may obtain "Misbranding by reference to premarks nouthcapon" (17 er er t er trom the Division of Small
other general information on your responsibilities under the Act from the Division other general information on your responsibilities uner are a more (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-fire mumbin.html Manufacturers, International and Consumer Assistance and Carlineral Constitutional dismamain.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
Indications for Use
510(k) Number (if known):
Device Name: en-bloc Biopsy System™
Indications For Use: The en-bloc Biopsy System is intented for diagnostic
Children For Use: The en-blocationsy procedure Indications For Ose. The en bloodstopsy of any of any of any procedure.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(21 CFR 807 Subpart C)
Over-The-Counter Use
(Part 21 CFR 801 Subcart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
iriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_K 04 3/70