(77 days)
No
The summary describes a mechanical biopsy device and does not mention any AI or ML components or functionalities.
No
The 'Intended Use / Indications for Use' explicitly states that the device 'is not intended for therapeutic purposes' but 'for diagnostic purposes only'.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is used for "incisional breast biopsy procedures for diagnostic purposes only".
No
The device description explicitly states it is comprised of a biopsy needle probe, a probe driver, and a control module vacuum source, which are all hardware components.
Based on the provided information, the Auto Suture* MIBB** System 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 to examine these samples outside of the body.
- Device Description: The MIBB system is described as a device that "pierces, cut and collect tissue during a biopsy procedure." This is a device used within the body to obtain a tissue sample.
- Intended Use: The intended use is for "incisional breast biopsy procedures for diagnostic purposes only." This refers to the procedure of obtaining the tissue sample, not the analysis of the sample itself.
While the tissue collected by the MIBB system will likely be used for in vitro diagnostic testing (e.g., pathology analysis), the MIBB system itself is the tool used to obtain the sample, not to perform the diagnostic test on the sample.
Therefore, the Auto Suture* MIBB** System is a surgical/biopsy device, not an IVD.
N/A
Intended Use / Indications for Use
The Auto Suture* MIBB** System has indication in incisional breast biopsy procedures for diagnostic purposes only and is not intended for therapeutic purposes.
Product codes
KNW
Device Description
The MIBB** system is comprised of a biopsy needle probe, a probe driver and a control module vacuum source. The MIBB** system is a minimally invasive biopsy device designed to pierce, cut and collect tissue during a biopsy procedure.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Mammotome® (K970565)
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
K973496
Auto Suture* Minimally Invasive Breast Biopsy (MIBB**) System
| IX. 510(k) Summary of Safety and Effectiveness | DEC - 1 1997 |
|---|---|
| SUBMITTER: | United States Surgical Corporation |
| 150 Glover Avenue | |
| Norwalk, CT 06856 | |
| CONTACT PERSON: | Victor M. Clavelli |
| DATE PREPARED: | September 8, 1997 |
| CLASSIFICATION NAME: | Biopsy Instrument |
| COMMON NAME: | Biopsy Needle |
| PROPRIETARY NAME: | Not Yet Determined |
| PREDICATE DEVICES: | Mammotome® (K970565) |
| DEVICE DESCRIPTION: | The MIBB** system is comprised of a biopsy needle probe, |
| a probe driver and a control module vacuum source. The | |
| MIBB** system is a minimally invasive biopsy device | |
| designed to pierce, cut and collect tissue during a biopsy | |
| procedure. | |
| INTENDED USE: | The Auto Suture* MIBB** System has indication in |
| incisional breast biopsy procedures for diagnostic purposes | |
| only and is not intended for therapeutic purposes. | |
| MATERIALS: | The AUTO SUTURE* MIBB** system is composed |
| entirely of biosafe materials which have passed | |
| biocompatibility testing appropriate for their intended | |
| patient contact profile in accordance with ISO 10993-1. |
- *Trademark name not yet determined
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - I 1997
Mr. Victor M. Clavelli Sr. Associate, Regulatory Affairs United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856
Re: K973496
Trade Name: Auto Suture Minimally Invasive Breast Biopsy (MIBB) System Regulatory Class: II Product Code: KNW Dated: September 9, 1997 Received: September 15, 1997
Dear Mr. Clavelli:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that. through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Victor M. Clavelli
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A cooley
ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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R402
Auto Suturc* Minimally Invasive Breast Biopsy (MIBB**) System
IV. Indications For Use:
510(k) Number (if known):
AUTO SUTURE* MIBB** System Device Name:
Indications For Use:
The Auto Suture* MIBB** System has indication in incisional breast biopsy procedures for diagnostic purposes only and is not intended for therapeutic purposes.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRII, Office of Device Evaluation (ODE)
| Prescription Use: | X | OR Over-The-Counter Use: | |
|---|---|---|---|
| (Per 21 CFR §801.109) |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K973476 |
|---|---|
| --------------- | --------- |
UNITED STATES SURCICAL CORPORATION
· Trademark of United States Surgical Corporation * * Trademark name not you determined