(77 days)
The Auto Suture* MIBB** System has indication in incisional breast biopsy procedures for diagnostic purposes only and is not intended for therapeutic purposes.
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.
This K973496 premarket notification describes the Auto Suture Minimally Invasive Breast Biopsy (MIBB) System. However, this document is a 510(k) summary and does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and a study proving device performance. The 510(k) summary primarily focuses on establishing substantial equivalence to a predicate device, not on presenting a detailed clinical study with performance metrics.
Based only on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The provided document does not contain acceptance criteria or reported device performance in terms of clinical outcomes or diagnostic accuracy. It focuses on device description, intended use, and materials.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the provided 510(k) summary. A 510(k) summary typically doesn't detail the test set for performance studies in this manner; such information would be in the full 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not present in the provided 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided 510(k) summary.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This document describes a biopsy device (a physical instrument), not an AI-powered diagnostic system. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
As this is a physical biopsy device and not a diagnostic algorithm, a standalone algorithm performance study is not applicable and not mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present. For a biopsy device, the ground truth for diagnostic accuracy would typically be pathology results from the obtained tissue samples. However, no data related to this is provided in the summary.
8. The sample size for the training set
This information is not present in the provided 510(k) summary. As it's a physical device and not an algorithm, a "training set" in the context of machine learning isn't directly relevant.
9. How the ground truth for the training set was established
This information is not present.
Summary of what can be extracted, based on the provided text:
This document is a 510(k) summary (K973496) from December 1, 1997, for the Auto Suture Minimally Invasive Breast Biopsy (MIBB) System.
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.
Predicate Device: Mammotome® (K970565)
The 510(k) notification states the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. However, it does not provide details of clinical studies, performance metrics, or study design (like sample sizes, ground truth establishment, or expert qualifications) that would typically be found in a full submission with supporting data. The focus of this summary is regulatory clearance through substantial equivalence, not detailed performance reporting.
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K973496
Auto Suture* Minimally Invasive Breast Biopsy (MIBB**) System
| IX. 510(k) Summary of Safety and Effectiveness | DEC - 1 1997 |
|---|---|
| SUBMITTER: | United States Surgical Corporation150 Glover AvenueNorwalk, 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. TheMIBB** system is a minimally invasive biopsy devicedesigned to pierce, cut and collect tissue during a biopsyprocedure. |
| INTENDED USE: | The Auto Suture* MIBB** System has indication inincisional breast biopsy procedures for diagnostic purposesonly and is not intended for therapeutic purposes. |
| MATERIALS: | The AUTO SUTURE* MIBB** system is composedentirely of biosafe materials which have passedbiocompatibility testing appropriate for their intendedpatient contact profile in accordance with ISO 10993-1. |
- *Trademark name not yet determined
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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.
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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
§ 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.