The Biopsy Needle is intended for use in obtaining core biopsy samples from soft tissue such as kidney, liver, prostrate, spleen, lymph nodes, and various soft tissue masses. Not intended for use in bone.

The Biopsy Needle is also indicated to provide breast tissue sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the 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.

Device Description

The Biopsy Needle are used to remove, by cutting, a specimen of tissue for microscopic evaluation. The organs in which the device may be used include but are not limited to breast, kidney, liver, prostate, spleen and lymph nodes plus various soft tissue masses. As the device is single use device, which is individually packaged sterile devices. In the package, there is a whole device with the structure shown in the picture above without any accessories. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified bacterial film to maintain the sterilization condition of the device.

AI/ML Overview

This document describes the Ushare Medical Inc. Biopsy Needle (K191472) and its substantial equivalence to a predicate device. It primarily focuses on comparing technical characteristics and performance testing. However, it does not contain information about the device's diagnostic performance or any studies related to human-in-the-loop performance, as it is a medical instrument (biopsy needle) and not a diagnostic AI/ML device.

Here's a breakdown of the requested information based on the provided text, with clear indications where the information is not available for this type of device submission:

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

The document does not specify formal "acceptance criteria" for diagnostic performance, as the device is a biopsy needle and not a diagnostic tool. Instead, it outlines performance testing to demonstrate substantial equivalence to the predicate device in terms of mechanical, biological, and sterilization characteristics.

Characteristic	Acceptance Criteria (Implied by testing to standards/predicate)	Reported Device Performance (Summary from text)
Biocompatibility	Meet ISO 10993 requirements	Met ISO10993-1, ISO10993-4, ISO10993-5, ISO10993-10, ISO10993-11
Sterilization	Meet ISO 11135, ISO 11138, ASTM F1980, ISO 11737-1, ISO 10993-7, ISO 11607 requirements	Met ISO11135, ISO11138, ASTM F1980, ISO11737-1, ISO10993-7, ISO11607
Device Shelf-life (5 years simulated)	Maintain seal strength, dye penetration, vacuum leak, bacterial performance after accelerated aging	Aged subject devices (60°C, 162 days, <50% RH) tested for seal Strength, Dye Penetration, Vacuum Leak, and Packaging resistance Bacterial performance (implied to have met requirements as supporting substantial equivalence)
Performance (Mechanical/Operational)	Equivalent to predicate device for specific tests	Performance tests conducted on "Pressing parts, Pressing parts firing force, Cannula firing force, Safety switch, Sampling switch, Scale marks firmness, Total heavy metal content, Scale mark identification, Sampling structure, Sampling method, Penetration force." Comparison of results between proposed and predicate devices to prove equivalency.
Biopsy Sample Quality	Equivalent to predicate device	Biopsy Sample Testing – Comparison of samples obtained by predicate and proposed devices to prove equivalency.
Ultrasound Visibility	Ensure safety and effectiveness	Ultrasound Visibility Testing - Verification of the proposed device ultrasound visibility to ensure safety and effectiveness.
Pyrogenicity	Non-pyrogenic	Results from device testing indicate that subject devices are non-pyrogenic.

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 available in the provided text. The document refers to "Performance Testing" which includes comparison testing with a predicate device and specific tests for biocompatibility, sterility, shelf-life, and mechanical function. However, details about the sample sizes of devices tested, the origin of the samples (e.g., if tissue samples were used), or whether the data was retrospective or prospective are not provided.

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 applicable/available. As a biopsy needle, the device itself does not establish a "ground truth" in a diagnostic sense (e.g., identifying disease from an image). Its function is to obtain tissue samples. The "ground truth" for the effectiveness of the biopsy sample, once acquired, would typically be established by a pathologist examining the tissue. This document does not detail any studies involving expert interpretation of collected biopsy samples.

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

This information is not applicable/available. Adjudication methods are typically relevant for diagnostic studies where expert consensus is needed to establish a ground truth for imaging or other diagnostic interpretations. For a physical device like a biopsy needle, this concept does not directly apply to the reported performance testing.

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 information is not applicable. This device is a biopsy needle, an instrument used for tissue sampling, not an AI/ML-driven diagnostic tool. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is not relevant to this submission.

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

This information is not applicable. This is a medical instrument (biopsy needle), not an algorithm or AI system.

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

This information is partially applicable but not explicitly detailed for the performance testing.

For Biopsy Sample Testing, the "ground truth" would implicitly be the histological examination of the tissue samples. The text states "Comparison of samples obtained by predicate and proposed devices to prove equivalency." This suggests that the quality or characteristics of the obtained tissue (which would be assessed via pathology) were compared. However, details on how this comparison was quantified or what specific metrics were used are not provided.
For other tests (biocompatibility, sterility, mechanical performance), the "ground truth" is adherence to established international standards and comparable performance to the predicate device.

8. The sample size for the training set

This information is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable. As above, this device does not utilize a training set.

Summary

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January 29, 2020

Ushare Medical Inc. % Raymond Luo Technical Manager Shanghai Sungo Management Consulting Co., Ltd. 13th F, 1500# Century Avenue Shanghai, China 200122

Re: K191472

Trade/Device Name: Biopsy Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: December 2, 2019 Received: December 2, 2019

Dear Raymond Luo:

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/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.

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/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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "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 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-regulatoryassistance/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.

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

Enclosure

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Indications for Use

510(k) Number (if known) K191472

Device Name Biospy Needle

Indications for Use (Describe)

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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510(K) Summary

Date of preparation: 2020-1-28

1. Applicant:

Company Name: Ushare Medical Inc. Company Address: 445 An Ji Zhong Road, San Zao Town, Zhuhai, Guangdong, P. R. China Contact Person Name: Amy Wang (Ms.) Title: Quality Manager Tel: 0086-756-7516888 Mail: qm(@usharemedical.com

Official Contact Person Information

Company Name: Shanghai Sungo Management Consulting Company Limited Contact Person Name: Raymond Luo (Mr.) Title: Technical Manager Tel: 0086-21-68828050 Mail: fda.sungo@gmail.com

2. Current Device:

The proprietary name of the new device: Biopsy Needle The generic name of the device: Instrument, Biopsy Classification regulation: 21 CFR 876.1075 Classification: Class II. Regulation Medical Specialty: Gastroenterology/Urology Product code: KNW

3. Predicate device:

K number: K141552 Company: CareFusion Address: 75 North Fairway Drive, Vernon Hills, IL 60061 USA Predicate Device: Achieve Programmable Automatic Biopsy Systems

4. Intended use of the device:

The Biopsy Needle is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

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benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

5. Device Description:

The sketch of the product structure and the dimension is shown in the figure below.

6. Current Device and Predicate Device Technical Characteristics

The proposed Biopsy Needle is substantially equivalent to the predicate Achieve Programmable Automatic Biopsy Systems with regards to claims, design, technology, and intended use. Refer to the Side by Side Comparison Table below.

6.1 Device Format

The subject disposable biopsy devices share format as the predicate devices for sterile, single use, and EO compatible packaging. Results from device testing indicate that subject devices are non-pyrogenic.

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Predicate
Device
	A Fully AutomaticD-Stylet OnlyACHIEVE™Programmable Automatic Biopsy System

6.2 Technical Characteristics

Device	Current Device	Predicate Device
Manufacturer	Ushare Medical Inc. K191472	CareFusion K141552
Model Name	MBN Series Biopsy Needle	Achieve Programmable Automatic Biopsy Systems
Classification	Class II Device, KNW	Class II Device, KNW,
Intend use	The Biopsy Needle is intended for use in obtaining core biopsy samples from soft tissue such as kidney, liver, prostrate, spleen, lymph nodes, and various soft tissue masses. Not intended for use in bone.The Biopsy Needle is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the 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.	The Achieve Programmable Automatic Biopsy Systems is intended for use in obtaining core biopsy samples from soft tissue such as kidney, liver, prostrate, spleen, lymph nodes, and various soft tissue masses. Not intended for use in bone.The Achieve Programmable Automatic Biopsy Systems is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the 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.
Designatedmetric size	14G, 16G, 18G, 20G	12G, 14G, 16G, 18G, 20G
Length L(mm)	100mm, 150mm, 200mm	60mm, 90mm, 110mm, 150mm, 200mm, 250mm
Slot size	10mm, 15mm, 20mm	20mm
Cannula andStylet	The cannula is designed with an outer cutting cannula having a sharpened tip and an inner	The cannula is designed with an outer cutting cannula having a sharpened tip and an inner

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	stylet with sample slot.	stylet with sample slot.
NeedleAdvancementand TissueAccess	Biopsy Needle with guillotine coring and thepredicate device with guillotine coring providethe clinician with the same single or two-stage(sequential) automatic advancement for fixedsample length for tissue penetration and cutting.	Same as current device
Mechanism ofAction	single-hand automatic activation	Same as current device
Usability andConvenience	Provide design features that facilitate clinicianuse during biopsies: cannula centimeter marks,echogenic radiographic visibility, color codedneedle hubs, and adjustable depth stops.	Same as current device
Standard	Biocompatibility: ISO10993-1 (ISO10993-4,ISO10993-5, ISO10993-10, ISO10993-11)Sterilization: ISO11135, ISO11138, ASTMF1980, ISO11737-1, ISO10993-7, ISO11607Performance: ISO9626	Biocompatibility: ISO10993-1Sterilization: ISO11135, ISO11138, ASTMF1980, ISO11737-1, ISO10993-7, ISO11607Performance: ISO9626
Comparisontesting	Pressing parts, Pressing parts firing force,Cannula firing force, Safety switch, Samplingswitch, Scale marks firmness, Total heavy metalcontent, Scale mark identification, Samplingstructure, Sampling method, Penetration force,Biopsy Sample Testing, Ultrasound VisibilityTesting	Pressing parts, Pressing parts firing force,Cannula firing force, Safety switch, Samplingswitch, Scale marks firmness, Total heavy metalcontent, Scale mark identification, Samplingstructure, Sampling method, Penetration force,Biopsy Sample Testing, Ultrasound VisibilityTesting

The technological characteristics of the subject device are identical to those of predicate device. The subject device has the same basic design as the predicate device. The comparison between the subject and predicate devices is based on the following:

Same intended use
Same indications for use
· Similar material types that meet ISO 10993 biocompatibility requirements
· Same sterilization methods
· Same fundamental technology/principal of operation/user interface

The disposable biopsy device needle designs display minor differences between the subject device and the predicate devices for gauge and needle length. The Max and Min size of the current device were covered by the predicate device. There is no significant risk raised by the difference.

Characteristic	Standard	Content
Biocompatibility	AAMI/ANSI/ISO10993-1	Biological evaluation of Medical Devices Part 1: Evaluationand Testing
Biocompatibility	ISO 10993-4	Biological evaluation of medical devices--Part 4: Selection of tests for

7. Performance Testing

7.1 Biocompatibility and Sterility

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		interactions with blood
Biocompatibility	ISO 10993-5	Biological evaluation of medical devices - Part 5: Tests for in vitrocytotoxicity
Biocompatibility	ISO 10993-10	Biological evaluation of medical devices - Part 10: Tests for irritation and skinsensitization
Biocompatibility	ISO 10993-11	Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
Sterilization	ISO11135	Medical Device, Validation and Routine Control of Ethylene OxideSterilization
Residuals	ISO10993-7	Biological evaluation of Medical Devices Part 7: EthyleneOxide Sterilization Residuals
Sterilization	ANSI/AAMI/ISO11607	Packaging for Terminally Sterilized Medical Devices
Sterilization	ASTM F1980-07	Accelerated Aging of Sterile Barrier Systems

7.2 Device Shelf-life

The subject devices in their packaging were subjected to accelerated aging to simulate a 5 year shelf life (Treatment: 60°C, 162 days, <50% RH). The aged subject devices were tested for seal Strength, Dye Penetration, Vacuum Leak and Packaging resistance Bacterial performance.

Characteristic	Standard	Content
Performance	ISO 9626:2016	Stainless Steel Needle Tubing for the Manufacture of Medical Devices.
Performance	The test wasconducted to thepredicate deviceand currentdevice tocompare theirperformance.	Pressing parts, Pressing parts firing force, Cannula firing force, Safety switch,Sampling switch, Scale marks firmness, Total heavy metal content, Scale markidentification, Sampling structure, Sampling method, Penetration force-Comparison of testing result of predicate and proposed devices to proveequivalency.
Performance		Biopsy Sample Testing – Comparison of samples obtained by predicate andproposed devices to prove equivalency.
Performance		Ultrasound Visibility Testing - Verification of the proposed device ultrasoundvisibility to ensure safety and effectiveness

7.3 Performance Testing

8. Conclusion

The analysis of the Current Biopsy Devices by intended use, indications, anatomical locations, and mechanism of action supports that the subject devices are the same as those of the predicate devices.

Needle advancement for the subject device provides a single or two-stage (sequential) automatic advancement for fixed sample length for tissue penetration and cutting same as the predicate device. Materials of construction are those commonly used in medical devices and met biocompatibility requirements for medical devices. The sterile disposable devices also met the requirements for sterility per ISO and USP standards. There are no new questions concerning the safety and effectiveness of these devices.

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.