(30 days)
K0062832
Not Found
No
The summary describes an electro-mechanical biopsy system for tissue collection and does not mention any AI or ML components for analysis or guidance.
No.
The device is used to collect breast tissue samples for diagnostic purposes, not to treat a disease or condition.
Yes
This device is used to collect tissue samples for "diagnostic sampling of breast abnormalities" and "diagnostic analysis of breast abnormalities." This indicates its role in the diagnostic process.
No
The device description explicitly states it is an "electro-mechanical medical device" comprised of hardware components like a driver module, biopsy needle probes, and cannulae.
No, 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.
- Vacora® Biopsy System Function: The Vacora® Biopsy System is a device used to collect tissue samples from the breast. It is a surgical/interventional device used on the patient's body to obtain the sample.
- Purpose of the Sample: The tissue samples collected by the Vacora® system are then sent for histologic examination. This examination is the diagnostic process, and it is performed in vitro on the collected tissue. The Vacora® system is the tool for obtaining the sample, not the diagnostic test itself.
The description clearly states the device is used to "provide breast tissue samples for diagnostic sampling" and that the tissue is for "histologic examination." This confirms its role as a sample collection device, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Vacora® Biopsy System is intended for diagnostic sampling of breast tissue during a biopsy procedure.
The Vacora® Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
Product codes
KNW
Device Description
The Vacora® Biopsy System is a self-contained, electro-mechanical medical device used to collect breast tissue samples for diagnostic analysis of breast abnormalities. The system is comprised of the non-sterile reusable driver module, and biopsy needle probes, coaxial cannulae/cannula sets and various accessories needed to accomplish a breast tissue biopsy. Most of the accessories are sterile, single use, disposable components of the system.
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
The modified Vacora® Biopsy System met all predetermined acceptance criteria of the design verification and validation testing performed under design controls, and are substantially equivalent to the unmodified, currently marketed Vacora® Biopsy System.
Key Metrics
Not Found
Predicate Device(s)
K0062832
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
Vacora® 14G Probe Improvements 510(k) Summary of Safety and Effectiveness 21 CFR 807.92.
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a summary of the safety and effectiveness information upon which substantial equivalence determination is based as follows:
1. Submitter Information:
| Applicant: | Bard Peripheral Vascular, Inc |
|---|---|
| 1625 West 3rd Street | |
| P.O. Box 1740 | |
| Tempe, Arizona 85280 |
Phone: 480-379-2836
Fax: 480-449-2546
Contact: Cindy Moss
2. Subject Device Name:
| Device Trade Name: | Vacora® Vacuum Assisted Biopsy System |
|---|---|
| Common or Usual Name: | Instrument, Biopsy |
| Classification: | Class II |
| Classification Panel: | Gastroenterology/Urology |
3. Predicate Device:
Bard® Vacora® Vacuum Assisted Biopsy System (K0062832, clearance date October 20, 2006)
4. Summary of Change:
The modification from the predicate to the subject Vacora® Vacuum Assisted Biopsy System include design improvements to the driver, probe and coaxial; packaging configuration changes, a change in method of sterilization for sterile accessories, and added performance characteristics.
Image /page/0/Picture/18 description: The image shows the word "BARD" in a stylized, outlined font. Each letter is capitalized and has a distinct geometric design. The letters are bold and stand out against the white background.
1
5. Device Description:
The Vacora® Biopsy System is a self-contained, electro-mechanical medical device used to collect breast tissue samples for diagnostic analysis of breast abnormalities. The system is comprised of the non-sterile reusable driver module, and biopsy needle probes, coaxial cannulae/cannula sets and various accessories needed to accomplish a breast tissue biopsy. Most of the accessories are sterile, single use, disposable components of the system.
6. Intended Use of Device:
The Vacora® Biopsy System is intended for diagnostic sampling of breast tissue during a biopsy procedure.
7. Technological Comparison to Predicate Device:
The technological characteristics of the subject device are identical to those of the predicate device in terms of intended use, indications for use, fundamental scientific technology, operating principle, user population, and sterilization level.
8. Conclusions:
The modified Vacora® Biopsy System met all predetermined acceptance criteria of the design verification and validation testing performed under design controls, and are substantially equivalent to the unmodified, currently marketed Vacora® Biopsy System.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.
OCT 1 5 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
C.R. Bard, Inc. % Ms. Cindy Moss Associate Project Manager, Regulatory Affairs 1625 West 3rd Street P.O. Box 1740 Tempe, Arizona 85280-1740
Re: K082681
Trade/Device Name: Vacora® Vacuum Assisted Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: September 12, 2008 Received: September 15, 2008
Dear Ms. Moss:
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
3
Page 2 - Ms. Cindy Moss
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Mullens
Mark N. Melkerson 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): | K082681 |
|---|---|
| Device Name: | Vacora® Vacuum Assisted Biopsy System |
| Indications For Use: | The Vacora® Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures. |
INDICATIONS FOR USE STATEMENT
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dolores
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K0826
Image /page/4/Picture/14 description: The image shows the word "BARD" in a bold, outlined font. The letters are capitalized and evenly spaced. The font style gives the word a blocky, geometric appearance.