The Easy Guide™ is indicated for use in diagnostic breast biopsy procedures to penetrate the breast under ultrasound guidance and provide a passageway through which a diagnostic biopsy of a breast may be performed.

Device Description

The SenoRx Easy Guide™ Electrosurgical Access Device consists of a monopolar electrosurgical trocar used to penetrate the breast, and a cannula to provide a passageway through which a breast biopsy instrument may be placed.

AI/ML Overview

This device, SenoRx Easy Guide™ Electrosurgical Access Device, is a Class II electrosurgical cutting and coagulation device. The provided text is a 510(k) summary and associated FDA correspondence, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting the results of a comprehensive study with acceptance criteria and detailed device performance metrics. Therefore, it does not contain the specific information required to complete all sections of your request.

Here's an analysis based on the provided text for the aspects that can be addressed:

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific acceptance criteria in terms of quantitative performance metrics, nor does it report detailed device performance data from a clinical or technical study. The submission focuses on demonstrating substantial equivalence to predicate devices based on intended use, design, construction, materials, and technology.

Acceptance Criteria	Reported Device Performance
Not specified in the document. The 510(k) submission relies on demonstrating substantial equivalence to predicate devices rather than presenting specific quantitative performance criteria for the new device.	Not explicitly reported in the document. The document states that the new device's "intended use, design, construction, materials and technology are comparable to the predicate devices," implying similar performance without providing specific metrics.

Study Details (Based on available information)

The provided document is a 510(k) premarket notification and an FDA clearance letter. Such submissions primarily focus on establishing "substantial equivalence" to legally marketed predicate devices, rather than comprehensive clinical trials with detailed performance metrics and statistical analyses as might be found in a PMA submission or a detailed clinical study report.

Therefore, many of the requested details about a "study that proves the device meets the acceptance criteria" are not present in this type of regulatory document.

Here's what can be gathered, or explicitly stated as "not applicable" or "not provided":

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. The document does not describe a specific clinical test set for performance evaluation. The substantial equivalence argument typically relies on bench testing, materials testing, and a comparison of technical specifications to predicate devices, rather than a prospective clinical study with a "test set" in the sense of patient data.
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):
- Not applicable / Not provided. Since no clinical test set for diagnostic accuracy or similar performance is described, there's no mention of experts establishing a ground truth for such a set.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. As no clinical test set requiring adjudication is described, this information is not relevant to the content.
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:
- No. This device is an electrosurgical access device, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a hardware device; no algorithm-only performance study would be relevant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided. Given that the device is an electrosurgical access tool rather than a diagnostic device requiring truth determination for disease, this concept is not discussed. The "ground truth" for this type of device would relate more to its mechanical and electrical safety, and its ability to create a passageway, which would typically be assessed through engineering and bench testing, not expert consensus on pathology.
The sample size for the training set:
- Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."
How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI model, this question is not relevant.

In summary, the provided 510(k) documentation focuses on demonstrating substantial equivalence to pre-existing devices based on design, materials, and intended use, rather than presenting detailed clinical study data with specific acceptance criteria and performance metrics for a new, innovative technology.

Summary

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June 26, 2001

SEP 2 5 2001

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92

SUBMITTER INFORMATION 1.

a. Company Name:	SenoRx Inc.
b. Company Address:	11 Columbia, Suite A
c. Telephone:Facsimile:	(949) 362-4800(949) 362-3519
d. Contact Person:	Amy BouclyDirector, Regulatory Affairsand Quality Assurance
e. Date Summary Prepared:	June 26, 2001
DEVICE IDENTIFICATION
a. Trade/Proprietary Name:	Easy Guide™ Electrosurgical AccessDevice
b. Classification Name:	Electrosurgical cutting and coagulationdevice and accessories, 21 CFR

878.4400

IDENTIFICATION OF PREDICATE DEVICES 3.

Sure Core Biopsy Electrode

Interventional Concepts, Inc. K963813

Accucise Electrosurgical Trocar

Applied Medical Resources K925984

Bovie Hand Control

Sybron Corporation K790187

ਟ I

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DESCRIPTION OF THE DEVICE 4.

STATEMENT OF INTENDED USE ડ.

COMPARISON WITH PREDICATE DEVICES 6.

The intended use, design, construction, materials and technology are comparable to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized caduceus or a human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 5 2001

Ms. Amy Boucly Director, Regulatory Affairs And Quality Assurance SenoRx, Inc. 11 Columbia Suite A Aliso Viejo, California 92656

Re: K012004

Trade/Device Name: SenoRx EasyGuide™ Electrosurgical Access Device Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 26, 2001 Received: July 27, 2001

Dear Ms. Boucly:

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.

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Page 2 -- Ms. Amy Boucly,

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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/dsma/dsmamain.html

Sincerely yours,

Mark N. Mikkelson

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

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2 FDA Indications for Use Page

510(k) number (if known)

510(k) number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Easy Guide™ Electrosurgical Access Device

Indications for Us

Indications for Use: The Easy Guide™ Electrosurgical Access Device is indicated for use to penetrate the breast under ultrasound guidance and provide a passageway through which a diagnostic biopsy of a breast may be performed.

for Mark N. Mellkuan

ision Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number .

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.