The SenoRx Anchor Guide™ Localization Device is a single use electrosurgical localization device which is used to localize and fixate a target lesion in the breast. Accessories are available separately.

AI/ML Overview

This document is a 510(k) summary for the SenoRx Anchor Guide™ Localization Device, dated June 27, 2001, and approved on September 12, 2001. It is a premarket notification to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria based on performance data. Therefore, many of the requested sections (e.g., specific acceptance criteria, reported performance, sample sizes, expert ground truth, MRMC study, standalone performance) cannot be filled from the provided text.

Here's an analysis based on the available information:

Analysis of Device Acceptance and Study Information:

This document is a 510(k) Premarket Notification for the SenoRx Anchor Guide™ Localization Device. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device and does not require premarket approval (PMA). The primary goal of a 510(k) is to establish "substantial equivalence," not necessarily to provide detailed clinical study data with acceptance criteria and performance metrics described in the way a clinical trial report would.

Therefore, the provided text does not contain information about specific acceptance criteria or a study that demonstrably "proves" the device meets these criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating equivalence to predicate devices.

Missing Information:

Specific Acceptance Criteria and Reported Device Performance: This type of information is generally not detailed in a 510(k) summary as it focuses on equivalence rather than de novo performance.
Sample Size for Test Set and Data Provenance: Not applicable in this context as no new clinical performance study is described.
Number of Experts/Qualifications for Ground Truth: Not applicable.
Adjudication Method: Not applicable.
MRMC Comparative Effectiveness Study: Not mentioned, as the focus is on equivalence.
Standalone Performance: Not addressed.
Type of Ground Truth Used: Not applicable.
Sample Size for Training Set: Not applicable.
How Ground Truth for Training Set was Established: Not applicable.

What the document does provide:

Device Identification: Anchor Guide™ Localization Device
Intended Use: Localization of breast lesions.
Comparison to Predicate Devices: The document explicitly states: "The intended use, design, construction, materials and technology are comparable to the predicate devices." This is the core of their "proof" of safety and effectiveness for a 510(k) pathway – not through a new performance study, but by demonstrating similarity to already approved devices.
Predicate Devices Listed: Kopans Breast Lesion Localization Needle (Cook, Milex), Biopsy Assistant (Surgimedics), PrecisionGuide Breast Lesion Localization Needle (Becton-Dickinson), Bovie Hand Control (Sybron), Sure Core Biopsy Electrode (Interventional Concepts, Inc.).
Regulatory Decision: The FDA determined the device is "substantially equivalent" to legally marketed predicate devices.

Summary Table (with placeholders for missing information):

Feature	Acceptance Criteria (from document)	Reported Device Performance (from document)	Notes
Overall Device Performance	Explicit acceptance criteria are not provided in this 510(k) summary.	No quantitative performance metrics are reported.	The 510(k) process relies on demonstrating substantial equivalence to predicate devices rather than meeting new, specific performance criteria through a dedicated study. The "acceptance" by FDA is based on this demonstration of equivalence in intended use, design, construction, materials, and technology.
Primary Performance Metric (e.g., accuracy, precision)	N/A (Not defined for this 510(k) submission)	N/A
Safety	Implicitly, device should be as safe as predicate devices.	No specific safety data is reported in this summary.	The substantial equivalence determination ensures that the device does not raise new questions of safety or effectiveness. General controls provisions (annual registration, GMP, labeling, etc.) would apply.
Effectiveness	Implicitly, device should be as effective as predicate devices for its intended use.	No specific effectiveness data is reported in this summary.	The claim is that "The intended use, design, construction, materials and technology are comparable to the predicate devices," implying comparable effectiveness for breast lesion localization.

Detailed Breakdown of Requested Information (based on provided text):

A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantitative metrics in this 510(k) summary. The implicit acceptance criteria are that the device is "substantially equivalent" to legally marketed predicate devices in terms of intended use, design, construction, materials, and technology.
- Reported Device Performance: No specific quantitative performance metrics (e.g., accuracy, success rate, mean localization error) are reported in this document. The "performance" is considered equivalent to the predicate devices.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No test set for performance evaluation is described in this 510(k) summary. This document is not a clinical study report.
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; no test set or ground truth establishment process is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable; no test set is described.
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 MRMC or AI-assisted study is mentioned. This device is a physical localization device, not an AI-driven image analysis tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable; this is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable; no specific study with ground truth is described.
The sample size for the training set
- Not applicable; no training set for an algorithm is mentioned.
How the ground truth for the training set was established
- Not applicable; no training set or ground truth establishment is mentioned.

In conclusion, the provided 510(k) summary demonstrates substantial equivalence to predicate devices, which is the basis for its market clearance. It does not provide the details of a clinical performance study with acceptance criteria and measured device performance that would traditionally be found in a study report.

Summary

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012023 1/2

SenoRx Inc. Premarket Notification Anchor Guide™ Localization Device

June 27, 2001

SEP 1 2 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

1. SUBMITTER INFORMATION

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 27, 2001

DEVICE IDENTIFICATION 2.

Anchor Guide™ Localization Device a. Trade/Proprietary Name:

Electrosugical cutting and coagulation b. Classification Name: device and accessories, 21 CFR 878.4400

IDENTIFICATION OF PREDICATE DEVICES 3.

Kopans Breast LesionLocalization Needle	Cook (K# unknown)Milex (K900903)
Biopsy Assistant	Surgimedics (K# unknown)
PrecisionGuide BreastLesion Localization Needle	Becton-Dickinson (K881687/C)
Bovie Hand Control	Sybron (K790187)
Sure Core BiopsyElectrode	Interventional Concepts, Inc.(K963813)

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K012023 2/2

SenoRx Inc. Premarket Notification Anchor Guide™ Localization Device

June 27, 2001

DESCRIPTION OF THE DEVICE 4.

STATEMENT OF INTENDED USE ડ.

The Anchor Guide™ Localization Device is indicated for localization of breast lesions.

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

SEP 1 2 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K012023

Trade/Device Name: Anchor Guide™ Localization Device Regulation Number: 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: June 27, 2001 Received: June 28, 2001

Dear Ms. Boucly:

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 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). 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 - Ms. Amy Boucly

This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will anow your of substantial equivalence of your device to a legally marketed nouticate 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 If you desire specific activer diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in This craguestions on the promotion and advertising of your device, (201) 594-4639. Nathlendry, sopiance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or 1301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Susan Walker, MD

Image /page/3/Picture/5 description: The image contains a handwritten symbol or character. It appears to be a cursive letter, possibly a lowercase 'f' or a similar character with a loop at the top and a curved line extending to the right. The character is drawn with a thin line and has a slightly irregular shape.

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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FDA Indications for Use Page 2

510(k) number (if known): K012023

Device Name:

Anchor Guide™ Localization Device

Indications for Use: The Anchor Guide™ Localization Device is indicated for localization of breast lesions.

(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)	✓
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	OR
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Over-The-Counter Use
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	Susan Walke
	(Division Sign-Off)
	Division of General, Restorativeand Neurological Devices

510(k) Number	K012023
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Regulation Number and Section

§ 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.