It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
It is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
The extent of a histologic abnormality cannot always be readily determined from 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. In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g. fibroadenoma, fibrocystic lesion), the BEXCORE Vacuum Assisted Breast Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. 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.

Device Description

BEXCORE Vacuum-Assisted Breast Biopsy (hereinafter referred to as VABB) system is 'a set of equipment used for biopsy' composed of a sterilized disposable needle probe unit (hereafter Probe) and an electronic system unit. The electronic system unit consists of a driver and a main controller box (hereafter Main Body for main controller box). A biopsy needle-BXC135, BXC140, BXC145 are the Probes approved separately-is mounted on a driver, and then inserted into a breast. The inserted biopsy needle, powered by the motor in the Main Body of BXS100F, could be rotated or moved forward/backward to cut affected tissue of the breast. The cut tissues are pulled out by vacuum pressure to a filter mesh of Probe connected to the vacuum suction unit of BXS100F's Main Body. At the moment of completing tissue cut, the air supplied from a Main Body to the front part of the biopsy needle makes easy to discharge the cut tissue smoothly.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the BEXCORE Breast Biopsy System. It outlines the device's intended use, comparison to a predicate device, and performance testing. However, it does not contain explicit acceptance criteria or detailed results of a study proving the device meets those criteria.

The document discusses performance testing, but the results are summarized as "All of these performance tests demonstrate the device performs according to its intended use and meets the performance specifications," without providing specific numerical acceptance criteria or the reported performance values. It also doesn't detail clinical studies with human participants for effectiveness or safety beyond bench testing.

Therefore, I cannot fully complete the requested table and answer all questions based solely on the provided text. I will fill in what can be inferred or explicitly stated.

Here's an analysis based on the given information:

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

The document states, "All of these performance tests demonstrate the device performs according to its intended use and meets the performance specifications." However, it does not explicitly list numerical acceptance criteria or reported performance values for each test. The listed tests are primarily bench tests comparing the subject device to a predicate device, rather than specific quantitative readouts against pre-defined thresholds.

Acceptance Criteria (Inferred from tests performed)	Reported Device Performance (Inferred/Stated)
Ability to extract a biopsy tissue sample	Demonstrates ability to extract tissue
Average Tissue Length	Meets performance specifications
Edge of Cut Sample Evaluation	Meets performance specifications
Average Tissue Weight	Meets performance specifications
Multiple Sample Operation of the BEXCORE Biopsy Needle	Operates successfully for multiple samples
Vacuum Pressure (operates within specified range)	Operates within specified range (LOW: -15kPa ~ -35kPa; MID: -35kPa ~ -55kPa; HIGH: -55kPa ~ -80kPa)
Safety Feature (Cover) of the BEXCORE Biopsy Needle	Functions as intended for safety
Force to Arm the BEXCORE Biopsy Needle	Meets performance specifications
Force to Advance the BEXCORE Biopsy Needle	Meets performance specifications
BEXCORE Biopsy Needle Obstruction Test	Passes obstruction test
Tissue sample dimensions, firmness for combinations of jaw size, vacuum settings	Performs according to intended use

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

The text describes "non-clinical bench tests" and does not specify a sample size for these tests. It also does not mention the country of origin of the data or whether the tests were retrospective or prospective. These are typically simulated environments or direct measurements on the device itself, not human subject data.

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 mention the use of experts to establish "ground truth" for the a test set in the context of diagnostic accuracy, as this is a device for tissue extraction, not a diagnostic AI algorithm. The performance tests are largely engineering/bench tests.

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

Not applicable, as this is for bench testing of a physical device, not a diagnostic study requiring human expert assessment and adjudication.

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. This is a biopsy system, not an AI-assisted diagnostic tool. No MRMC study was mentioned or implied.

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

Not applicable. This is a physical medical device (biopsy system), not an algorithm. Bench tests were performed on the device's physical and functional characteristics.

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

For the performance tests described, the "ground truth" would likely be engineering specifications, physical measurements, and comparison to the predicate device's known performance characteristics. For instance, for "Average Tissue Length" or "Average Tissue Weight," the ground truth would be the direct measurement of the extracted tissue. No mention of expert consensus, pathology, or outcomes data for performance testing of the device itself. The extracted tissue would then undergo histological examination, which is the standard of care, but that's a downstream process, not the "ground truth" for the device's performance.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable (as above).

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 20, 2018

Medical Park CO., LTD % Mr. Dave Kim, MBA Medical Device Regulatory Affairs 8310 Buffalo Speedway Houston, Texas 77025

Re: K171890

Trade/Device Name: BEXCORE Breast Biopsy System, Biopsy Needle BXC135, BXC140, BXC145 Biopsy Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW, FCG Dated: July 16, 2018 Received: July 23, 2018

Dear Mr. Kim:

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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/ofpmn.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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entiled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jennifer R. Stevenson -

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171890

Device Name

BEXCORE Vacuum Assisted Breast Biopsy System; BXC135, BXC140, BXC145 Biopsy Needle

Indications for Use (Describe)

The BEXCORE Vacuum Assisted Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities.

It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
It is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

The extent of a histologic abnormality cannot always be readily determined from 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. In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g. fibroadenoma, fibrocystic lesion), the BEXCORE Vacuum Assisted Breast Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. 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.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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K171890

510(k) Summary

Date 510k summary prepared: August 16, 2018

I. SUBMITTER

Submitter's Name	Medical Park Co., Ltd.
Submitter's Address	#601/623/624/901, Knowledge-IndustryCenter,BundangSuji U-Tower, 767, Sinsu-ro, Suji-gu
	Yongin-si, Gyeonggi-do, Korea
Submitter's Telephone	+82 (070) 4800-6532
Contact person	Ms. Hye-Yeon Park, / RA Manager
	hypark @ medicalpark.co.kr
Official Correspondent	Mtech GroupDave Kim, MBA, Presidentdavekim@mtech-inc.net
Address	8310 Buffalo Speedway, Houston, TX 77025
Telephone	+713-467-2607

DEVICE II.

Trade/proprietary Name	BEXCORE Vacuum Assisted Breast Biopsy SystemBXC135, BXC140, BXC145 Biopsy Needles
Common or Usual Name	Vacuum Assisted Breast Biopsy System & Needle
Regulation Name	Gastroenterology-urology biopsy instrument
Regulation Number	21 CFR 876.1075 (Product Code: KNW, FCG)
Regulatory Class	Class II

III. PREDICATE DEVICE

Primary Manufacturer	SenoRx, Inc
Device Name	EnCor Breast Biopsy System
510(k) Number	K093512(Decision Date - Nov 20, 2009)
Regulation Name	Gastroenterology-urology biopsy instrument
Regulation Number	21 CFR 876.1075 (Product Code: KNW)
Regulatory Class	Class II

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IV. REFERENCE DEVICE

Primary Manufacturer	PFM Medical, Inc
Device Name	Safety Biopsy Needle SystemSafety Biopsy Needle and Safety Coaxial Needle
510(k) Number	K140137(Decision Date – March 25, 2014)
Regulation Name	Gastroenterology-urology biopsy instrument
Regulation Number	21 CFR 876.1075 (Product Code: FCG)
Regulatory Class	Class II

V. DEVICE DESCRIPTION

VI. INDICATIONS FOR USE:

The BEXCORE Vacuum-Assisted Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities.

It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
It is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

The extent of a histologic abnormality cannot always be readily determined from 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. In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g. fibroadenoma, fibrocystic lesion), the BEXCORE Vacuum-Assisted Breast Biops v System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed. histological evaluation of the standard of care. 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.

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Substantial Equivalence VII.

BEXCORE Vacuum Assisted Breast Biopsy System is substantially equivalent to EnCor (K093512). The following comparison table is presented to demonstrate substantial equivalence.

	SUBJECT DEVICE	Predicate 1	Remarks
510(k) Number	K171890	K093512	-
DeviceTrade(Brand) Name	BEXCORE Vacuum-AssistedBreast Biopsy SystemBXC135, BXC140, BXC145 BiopsyNeedles	EnCor Breast Biopsy System	-
Common Name	Biopsy System	Biopsy System	-
Manufacturer	MEDICAL PARK CO., Ltd..	SenoRx, Inc.	-
Intended Use	The BEXCORE Vacuum-AssistedBreast Biopsy System is indicatedto provide breast tissue samplesfor diagnostic sampling of breastabnormalities.- It is intended to provide breasttissue for histologic examinationwith partial or complete removalof the imaged abnormality.- It is intended to provide breasttissue for histologic examinationwith partial removal of apalpable abnormality.The extent of a histologicabnormality cannot always bereadily determined frompalpation or imaged appearance.Therefore, the extent of removalof the palpated or imagedevidence of an abnormality doesnot predict the extent of removalof a histologic abnormality, e.g.,malignancy. When the sampledabnormality is not histologicallybenign, it is essential that thetissue margins be examined forcompleteness of removal usingstandard surgical procedures. Ininstances when a patientpresents with a palpableabnormality that has beenclassified as benign throughclinical and/or radiologicalcriteria (e.g. fibroadenoma,fibrocystic lesion), the BEXCORE	The EnCor Breast Biopsy Systemis indicated to provide breasttissue samples for diagnosticsampling of breastabnormalities.- It is intended to provide breasttissue for histologic examinationwith partial or complete removalof the imaged abnormality.- It is intended to provide breasttissue for histologic examinationwith partial removal of apalpable abnormality.The extent of a histologicabnormality cannot always bereadily determined frompalpation or imaged appearance.Therefore, the extent of removalof the palpated or imagedevidence of an abnormality doesnot predict the extent of removalof a histologic abnormality, e.g.,malignancy. When the sampledabnormality is not histologicallybenign, it is essential that thetissue margins be examined forcompleteness of removal usingstandard surgical procedures. Ininstances when a patientpresents with a palpableabnormality that has beenclassified as benign throughclinical and/or radiologicalcriteria (e.g. fibroadenoma,fibrocystic lesion), the EnCor	Same

	be used to partially remove suchpalpable lesions. Wheneverbreast tissue is removed,histological evaluation of thetissue is the standard of care.When the sampled abnormalityis not histologically benign, it isessential that the tissue marginsbe examined for completenessof removal using standardsurgical procedures	be used to partially remove suchpalpable lesions. Wheneverbreast tissue is removed,histological evaluation of thetissue is the standard of care.When the sampled abnormalityis not histologically benign, it isessential that the tissue marginsbe examined for completenessof removal using standardsurgical procedures
needle,cannula(s),	8G, 10G and 12G	7G, 10G and 12G	Same
jaw size	5mm, 10mm, 15mm, 20mm	10mm, 20mm	Different
mode of action	Vacuum-assisted device toremove breast tissue, singlepuncture and multiple samples,brush rotation, suction scraping,for use with ultrasound	Vacuum-assisted device toremove breast tissue, singlepuncture and multiple samples,brush rotation, suction, scraping,for use with ultrasound	Same
electrica	100~120VAC 6A, 50/60Hz,460VA	110-120V~, 10A, 50/60Hz220-240V~, 10A, 50/60Hz	Similar
Material comeinto patientcontact : Needle	Needle: stainless steel	Needle: stainless steel	Same
vacuum pressure	-LOW: -15kPa ~ -35kPa-MID: -35kPa ~ -55kPa-HIGH: -55kPa ~ -80kPa	-82.4kPa	Different
method ofplacement; andother relatedinformation	A biopsy of breast tissue mustbe taken only at the positiondiagnosed and determinedbased on the ultrasound image.Device operate with footswitches and driver(holster).	A biopsy of breast tissue mustbe taken only at the positiondiagnosed and determinedbased on the ultrasound image.Device operate with footswitches and driver(holster).	Same
Single UseComponent	Vacuum- Assisted Breast BiopsyNeedle	Vacuum- Assisted Breast BiopsyNeedle	Same
ReusableComponent	Suction canister, Hand driver,Foot switch	Suction canister, Hand driver,Foot switch	Same
Electrical	120V, 60Hz, 5A, 460VA	Free voltage	Same

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VIII. DESCRIPTION THE DIFFERENCES OF SUBJECT DEVICE AND PREDICATE DEVICE

BEXCORE Vacuum Assisted Breast Biopsy System has the same indications for use. It shows equivalent specifications with the predicate devices in most of parameters. The main difference is that the subject device offers different Jaw size and has a lower vacuum pressure range than the predicate devices.

Despite the differences above, the performance test results submitted in this 510k shows that the subject device is substantially equivalent to the predicate devices in safety and effectiveness.

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Performance Testing IX.

Performance testing of the Bexcore Vacuum Assisted Biopsy Needle System was conducted in accordance with the following international standards:

"Guidance on Premarket Notification [51 0(k)] for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA. 03/01/1995

"Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology"

"AAMI/ANSI/ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified Safety & ISO 10993 Test Profile

AAMI/ANSI/ISO 1 0993-7:-2008, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Results
AAMI/ANSI/ISO 11135:2007, Sterilization of Healthcare Products Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 14971:2007, Medical Devices - Risk Management for Medical Devices.

Pyrogen Test and Endotoxin Test were conducted based on "ISO 10993-11: 2006, Information on material mediated pyrogens which is FDA recognized standard (recognition no: 2-176).

The EMC and Electrical safety tests are conducted based on the currently FDA-recognized version of standards.

IEC 60601-1-2: 2007 is FDA recognized IEC standard (Recognition No: 19-1).

IEC 60601-1 Electrical Safety Test report contains the US National Differences – Differences according to US National standard ANSI/AAMI ES6060-1-: 2005 / A2: 2010.

Furthermore, the following non-dinical bench tests were performed on the BEXCORE Biopsy Needle System and compared to the predicate device.

- Ability to extract a biopsy tissue sample
- Average Tissue Length
- Edge of Cut Sample Evaluation
- Average Tissue Weight
- Multiple Sample Operation of the BEXCORE Biopsy Needle
- Vacuum Pressure
- Safety Feature (Cover) of the BEXCORE Biopsy Needle
- Force to Arm the BEXCORE Biopsy Needle
- Force to Advance the BEXCORE Biopsy Needle
- BEXCORE Biopsy Needle Obstruction Test

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Tissue sample dimensions, firmness for combinations of jaw size, vacuum settings

All of these performance tests demonstrate the device performs according to its intended use and meets the performance specifications.

Summary X.

Based on the indications for use and safety and performance testing, the BEXCORE Vacuum Assisted Biopsy Needle System meets the requirements that are considered for its intended use and is substantially equivalent in design materials, sterilization, and indications for use. The conclusions drawn from the nonclinical tests demonstrate that the device is as safe and effective as the legally marketed 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.