The Mammotome AutoCore™ Single Insertion Core Biopsy System is indicated to obtain tissue samples from the breast or lymph nodes for diagnostic analysis of breast abnormalities. This instrument is for diagnostic use only and is not indicated for therapeutic use.

The extent of a histologic abnormality cannot always be reliably determined from the palpation or imaged appearance. Therefore, the extent of removal of the palpated or 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 benian, it is essential that the tissue marqins be examined for completeness of removal using standard surgical procedures.

Device Description

The Mammotome AutoCore™ Single Insertion Core Biopsy System is an automated core needle biopsy system. It is a single insertion, multiple sample device that includes automated arming and automated sample collection. It is available in two gauge sizes (12G and 14G) and acquires soft tissue samples using a spring-loaded inner piercing stylet and outer cutting cannula in the probe needle.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or extensive study results that prove the device meets specific performance metrics. It primarily discusses the regulatory submission for the Mammotome AutoCore™ Single Insertion Core Biopsy System.

However, based on the limited information regarding performance testing, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance:

The document mentions several performance tests were conducted. While specific acceptance criteria values are not provided, the table below lists the characteristics tested, which implies that the device met the internal acceptance criteria for each test to achieve substantial equivalence.

Characteristic	Acceptance Criteria (Not Explicitly Stated, but implied to be met for SE)	Reported Device Performance (Implied to meet criteria)
Static force to penetrate	Not provided	Comparison performed, substantial equivalence confirmed
Lesion displacement	Not provided	Comparison performed, substantial equivalence confirmed
Overmold bond strength	Not provided	Comparison performed, substantial equivalence confirmed
Bend load	Not provided	Comparison performed, substantial equivalence confirmed
Sample weight	Not provided	Appropriate sample weight achieved
Sample acquisition	Not provided	Appropriate sample acquisition achieved
Sample quality	Not provided	Appropriate sample quality achieved

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Bench Testing: The document does not specify sample sizes for the bench tests (static force, lesion displacement, overmold bond strength, bend load). It also does not specify data provenance or if it was retrospective or prospective.
Animal Testing: The document does not specify sample sizes for the animal testing. It also does not specify data provenance or if it was retrospective or prospective.

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):

The document does not describe any human expert involvement in establishing ground truth for the performance tests mentioned. The tests appear to be primarily engineering and animal model assessments.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

No information is provided about adjudication methods for the test sets, as the studies described are not clinical or interpretative in nature where adjudication would typically be relevant.

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:

Not applicable. The Mammotome AutoCore™ is a physical biopsy system, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance would not be conducted for this device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable, as this is a physical medical device and not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Bench Performance: For bench tests, the ground truth would be based on engineering specifications and physical measurements, rather than clinical or pathological ground truth as defined in diagnostic studies.
Animal Performance: For animal testing, the ground truth for "appropriate sample weight, acquisition, and quality" would likely be determined by veterinary pathologists or other trained personnel assessing the biopsy samples obtained from the animal models, comparing them against established criteria for diagnostic-quality tissue samples.

8. The sample size for the training set:

Not applicable. This document describes the regulatory submission for a physical medical device, not an AI or machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this device.

Summary

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October 29, 2024

Devicor Medical Products, Inc. % Prithul Bom Most Responsible person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K243095

Trade/Device Name: Mammotome AutoCore™ Single Insertion Core Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: September 27, 2024 Received: September 30, 2024

Dear Prithul Bom:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jessica Carr -S

Jessica Carr, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

Device Name

Mammotome AutoCore™ Single Insertion Core Biopsy System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

scription Use (Part 21 CFR 801 Subpart D)

he-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
SUBMITTER INFORMATION
Name	Devicor Medical Products, Inc.
Address	300 E. Business Way, Fifth Floor, Cincinnati, OH 45241U.S.A
Establishment RegistrationNumber	3008492462
Name of contact person	Jamie Edenborg
Date prepared	23-JUL-2024
PRODUCT
Mammotome AutoCore™ Single Insertion Core Biopsy System
PRODUCT COMPONENTS
PRODUCT	DESCRIPTION
Mammotome AutoCore® Holster and ChargingBase	Holster and Charging Base
Mammotome AutoCore® Probe 12 Gauge	Probe 12g x 10cm
Mammotome AutoCore® Probe 14 Gauge	Probe 14g x 10cm
Mammotome AutoCore® Introducer 12 Gauge	Introducer 12g x 10cm
Mammotome AutoCore® Introducer 14 Gauge	Introducer 14g x 10cm
DESCRIPTION OF DEVICE
Trade or proprietary name	Mammotome AutoCore™ Single Insertion CoreBiopsy System
Common or usual name	Core Biopsy System, Single Insertion
Classification name	Instrument, biopsy
Classification panel	Gastroenterology/Urology
Regulation	21 CFR §876.1075
Product code(s)	KNW
Legally marketed device(s) to whichequivalence is claimed	K141552 Achieve® Programmable AutomaticBiopsy System
Submission Type	Traditional 510(k) Premarket Notification
Device description	The Mammotome AutoCore™ Single InsertionCore Biopsy System is an automated coreneedle biopsy system. It is a single insertion,multiple sample device that includesautomated arming and automated samplecollection. It is available in two gauge sizes(12G and 14G) and acquires soft tissuesamples using a spring-loaded inner piercingstylet and outer cutting cannula in the probeneedle.
Intended use of the device	The Mammotome AutoCore™ Single InsertionCore Biopsy System is intended to obtaintissue samples from the breast or lymph nodesfor diagnostic analysis of breast abnormalities

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This instrument is for diagnostic use only and is not indicated for therapeutic use. The extent of a histologic abnormality cannot always be reliably determined from the palpation or imaged appearance. Therefore, the extent of removal of the palpated or 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.

SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

Characteristic	New Device	Predicate
Mode of Action	Single Puncture and MultipleSamples	Single Puncture and MultipleSamples
Firing Modes	Automatic	Automatic and Delay
Anatomical Sites	Breast tissue and lymphnodes	Breast tissue, lymph nodes,kidney, liver, prostate, spleenand various soft tissuemasses

CONCLUSION OF DEVICE COMPARISON

A comparison of the technological characteristics of the proposed device and predicate device supports a determination of substantial equivalence.

PERFORMANCE DATA

SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE Performance Test Summary

Characteristic	Standard/Test/FDA Guidance
Performance- Bench	Functional testing was performed forcomparison of static force to penetrate, lesiondisplacement, overmold bond strength andbend load to prove substantial equivalence.
Performance- Animal	Animal testing was performed to verifyappropriate sample weight, acquisition, andquality.
Software and Electrical Test Summaries
Characteristic	Standard/Test/FDA Guidance

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Software	IEC 62304 Edition 1.1 2015-06 Medical DeviceSoftware
Electrical	IEC 60601-1-6 Edition 3.1 2013-10 Medicalelectrical equipment - Part 1-6: Generalrequirements for basic safety and essentialperformance.
Biocompatibility Data
Characteristic	Standard/Test/FDA Guidance
Biocompatibility	ISO 10993-1:2018-Biological Evaluation ofMedical Devices - Part 1: Evaluation andTesting Within a Risk Management Process
Biocompatibility- Cytotoxicity	ISO 10993-5:2009-Biological Evaluation ofMedical Devices – Part 5: Tests for In VitroCytotoxicity
Biocompatibility- Sensitization	ISO 10993-10:2010-Biological Evaluation ofMedical Devices – Part 10: Tests for Irritationand Skin Sensitization
Biocompatibility- Pyrogenicity/Acute SystemToxicity	ISO 10993-11:2017-Biological Evaluation ofMedical Devices - Part 11: Tests for SystemicToxicity
Biocompatibility- Irritation/IntracutaneousReactivity	ISO 10993-23:2021 Biological Evaluation ofMedical Devices – Part 23: Tests for Irritation
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIALEQUIVALENCE AND/OR OF CLINICAL INFORMATION [Per 807.92(b)(1)(2)(3)]
N/A - Clinical testing was not required for subject device
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The verification results and a side-by-side comparison of the technological characteristics of design, indication for use / intended use, components, and materials of construction, supports a determination that the Devicor Medical Products, Inc. Mammotome AutoCore™ Single Insertion Core Biopsy System [subject device] is substantially equivalent to the Achieve® Programmable Automatic Biopsy System (K141552) [predicate device].

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.