Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle

Q: Who is the manufacturer of Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle?

Guangzhou Shengwei Medical Devices Co., Ltd. filed the 510(k) submission for Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle (K214063).

Q: What is the FDA product code for Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle?

KNW. It is classified under 21 CFR 876.1075 as a Class 2 device in the Gastroenterology, Urology panel.

Q: What is the regulatory pathway for Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle?

ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES (K853312); BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT (K133948); Biopsy Devices and Accessories (K160316).

Q: Who can help prepare an FDA 510(k) submission like Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K214063 · Guangzhou Shengwei Medical Devices Co., Ltd. · KNW · Jun 3, 2022 · Gastroenterology, Urology

Device Facts

Record ID	K214063
Device Name	Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle
Applicant	Guangzhou Shengwei Medical Devices Co., Ltd.
Product Code	KNW · Gastroenterology, Urology
Decision Date	Jun 3, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1075
Device Class	Class 2

Intended Use

Model 121 Biopsy Needle is intended for obtaining percutaneous or surgical histological core samples from soft tissues such as breast, kidney, liver, lung and various soft tissue masses. The device is not intended for use in bone. Model 111/112 Biopsy Needle is intended for obtaining core biopsy from samples soft tissues such as kidney, liver, prostate and various soft tissue masses. The device is not intended for use in bone. Model 111/112 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 abnormality. Model 131 Disposable Coaxial Biopsy Needle is intended for use with biopsy needle during soft tissue core biopsy procedures. The device is not intended for use in bone. The extent of histological abnormality cannot be reliably determined from it mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality (e.g. malignancy). When the sampled abnormality is not histologically benign, it is essue margins be examined for completeness of removal using standard surgical procedures.

Device Story

Disposable semi-automatic and automatic spring-powered biopsy needles; used to obtain histological core samples from soft tissues. Input: manual operation by clinician; device transforms mechanical spring energy into rapid needle advancement (guillotine style) to capture tissue. Output: tissue core sample for histologic examination. Used in clinical settings for diagnostic sampling of abnormalities. Model 131 acts as a coaxial introducer for biopsy needles. Benefits: enables minimally invasive tissue acquisition for diagnosis; aids in determining malignancy or benign status of soft tissue abnormalities.

Clinical Evidence

No clinical data. Bench testing only. Performance evaluated via mechanical testing (depth projection, penetration force, activation force, mechanical durability, sample extraction) compared to predicate devices. Biocompatibility testing per ISO 10993-1:2018 (cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis). Sterilization validated per ISO 11135.

Technological Characteristics

Materials: 304 stainless steel (X5CrNi18-9). Design: Disposable, spring-powered, semi-automatic/automatic biopsy needles. Gauge: 14G-20G (biopsy), 15G-19G (coaxial). Length: 47mm-250mm. Energy: Mechanical spring. Sterilization: Ethylene Oxide (EO). Connectivity: None. Standards: ISO 9626 (needle performance), ISO 10993 (biocompatibility), ASTM F3014 (penetration force).

Indications for Use

Indicated for individuals requiring percutaneous or surgical histological core biopsy of soft tissue masses (breast, kidney, liver, lung, prostate, spleen, lymph nodes). Not for use in bone.

Regulatory Classification

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.

Predicate Devices

ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES (K853312)
BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT (K133948)
Biopsy Devices and Accessories (K160316)

Related Devices

K201166 — Temno Elite Biopsy System · Merit Medical Systems, Inc. · Aug 28, 2020
K191472 — Biopsy Needle · Ushare Medical, Inc. · Jan 29, 2020
K964777 — TZ · Gallini Intl., Inc. · Jan 3, 1997
K160316 — SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles · M.D.L. S.R.L. · Oct 27, 2016
K241793 — Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle · Zhejiang Curaway Medical Technology Co., Ltd. · Jan 24, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 3, 2022 Guangzhou Shengwei Medical Devices Co., Ltd Xiaoiun Cai Marketing Manager No. 126. Guangshao Road, Aotou Town Conghua city, Guangdong 510900 China Re: K214063 Trade/Device Name: Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW, FCG Dated: December 24, 2021 Received: December 27, 2021 Dear Xiaojun Cai: 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. {1}------------------------------------------------ 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 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use ### 510(k) Number (if known) K214063 ### Device Name Model 121 Biopsy Needle, Model 111/112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle Indications for Use (Describe) The Shengwei Biopsy needle consist of Model 121 Biopsy Needle, Model 111/112 Biopsy Needle, and Model 13 1 Disposable Coaxial Biopsy Needle. These devices are indicated for use as follows: Model 121 Biopsy Needle is intended for obtaining percutaneous or surgical histological core samples from soft tissues such as breast, kidney, liver, lung and various soft tissue masses. The device is not intended for use in bone. Model 111/112 Biopsy Needle is intended for obtaining core biopsy from samples soft tissues such as kidney, liver, prostate and various soft tissue masses. The device is not intended for use in bone. Model 111/112 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 abnormality. Model 131 Disposable Coaxial Biopsy Needle is intended for use with biopsy needle during soft tissue core biopsy procedures. The device is not intended for use in bone. The extent of histological abnormality cannot be reliably determined from it mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality (e.g. malignancy). When the sampled abnormality is not histologically benign, it is essue margins be examined for completeness of removal using standard surgical procedures. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <svg height="16" width="16"> <polygon points="1 0, 16 0, 16 15, 1 15" style="fill:green;stroke:purple;stroke-width:1"></polygon> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <svg height="16" width="16"> <polygon points="1 0, 16 0, 16 15, 1 15" style="fill:white;stroke:purple;stroke-width:1"></polygon> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: ### 1. SUBMITTER Guangzhou Shengwei Medical Devices Co., Ltd No. 126, Guangshao Road, Aotou Town, Conghua city, Guangzhou, China . Phone: +86-13660308085 Fax: +86-020-87886883 | Primary Contact | Xiaojun Cai | |-----------------|---------------------------------------------| | Person: | Marketing Manager | | | Guangzhou Shengwei Medical Devices Co., Ltd | | | Tel: (+86) -13660308085 | | | Fax: (+86) - 020-87886883 | December 24, 2021 Date prepared - 2. DEVICE | Device Name: | Biopsy Needle | |-------------------|-----------------| | Common name: | Biopsy Needle | | Regulation number | 21 CFR 876.1075 | | Regulation Class: | Class II | | Product Code: | KNW FCG | ### 3. PREDICATE DEVICE K853312 ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES K133948 BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT K160316, Biopsy Devices and Accessories The predicate devices K133948 and K160316 had been subject to a non-design related recall. ### DEVICE DESCRIPTION 4. The Shengwei Biopsy needle include semi-automatic and automatic spring powered guns (disposable). Cannula accessory is provided in a variety of sizes, designed to work with the manufacturer's semi-automatic and automatic guns to obtain and deliver a soft tissue core sample, facilitate skin and tissue penetration, sample retention and / or expulsion depending on the sample sites. The following biopsy devices are included {4}------------------------------------------------ in this submission for Shengwei Biopsy needle [Table 1]. ## Table 1 Soft Tissue Biopsy Devices and Accessories | Product Name | Product Description | |-------------------------------------------------------------|---------------------------------------------------------------------------------------| | Biopsy Devices | | | Model 111 | Disposable, automatic device for core biopsy of soft tissue | | Model 112 | Disposable, automatic device for core biopsy of soft tissue with locking function. | | Model 121 | Disposable, semi-automatic device for core biopsy of soft tissue | | Biopsy Device Accessories: Disposable Coaxial Biopsy Needle | | | Model 131 | Disposable needles for introduction of cannula, or biopsy devices | ## 4.1 Device Format The device format consists of two configurations: individually packaged sterile devices, co-packaged with various sterile compatible introducer needles in disposable packaging materials in various sized medical grade plastic blister pouches. These devices includes automatic guns (disposable design) packaged individually, or provided with compatible needles. The packaging is compatible with the product's EO sterilization method. ### 5. INDICATIONS FOR USE The Shengwei Biopsy needle consist of Model 121 Biopsy Needle, Model 111/112 Disposable Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle. These devices are indicated for use as follows: - . Model 121 Biopsy Needle is intended for obtaining percutaneous or surgical histological core samples from soft tissues such as breast, kidney, liver, lung and various soft tissue masses. The device is not intended for use in bone. - Model 111/112 Biopsy Needle is intended for obtaining core biopsy from ● samples soft tissues such as kidney, liver, prostate and various soft tissue masses. The device is not intended for use in bone. Model 111/112 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 abnormality. - Model 131 Disposable Coaxial Biopsy Needle is intended for use with biopsy needle during soft tissue core biopsy procedures. The device is not intended for use in bone. The extent of histological abnormality cannot be reliably determined {5}------------------------------------------------ from it mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological 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. #### 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The subject device is the same as the predicate device in the intended use, material, biocompatibility, and similar in product style, design feature and dimension. So the subject device is similar to the predicate device. | | Subject Device | Predicate Device (K160316) | Predicate Device (K133948) | | |-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------| | Trade Name | Model 111 Biopsy Needle | Themy Automatic Disposable Biopsy Device | BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT | Comments | | Manufacturer | Guangzhou Shengwei Medical Devices Co., Ltd | M.D.L. S.r.l. | BARD PERIPHERAL VASCULAR, INC | | | Device Class | Class II | Class II | Class II | Same | | Product Code | KNW,FCG | KNW,FCG | KNW | Same | | Regulation number | 876.1075 | 876.1075 | 876.1075 | Same | | Regulation Name | Gastroenterology- Urology Biopsy Instrument | Gastroenterology- Urology Biopsy Instrument | Gastroenterology- Urology Biopsy Instrument | Same | | Device Description | Disposable programmable automatic spring- loaded guillotine style biopsy system for histological biopsy on soft tissue. | Disposable programmable automatic spring- loaded guillotine style biopsy system for histological biopsy on soft tissue. | Disposable programmable automatic spring- loaded guillotine style biopsy system for histological biopsy on soft tissue. | Same | | Intended Use/ Indications for Use | Model 111 Biopsy Needle is intended for obtaining core biopsy samples from soft tissues such as kidney, liver, prostate and various soft tissue masses. The device is not intended for use in bone. | Themy Automatic Biopsy Needle is intended for obtaining core biopsy samples from soft tissues such as kidney, liver, prostate and various soft tissue masses. The device is not intended for use in bone. | The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue masses. It is not intended for use in bone. | Same | | Use/ Indications for Use | Model 111 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 | Themy Automatic 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 | | | Table 2: Comparison of the Model 111 Biopsy Needle to the predicate device. {6}------------------------------------------------ | | or complete removal of the abnormality. | complete removal of the abnormality. | | | |-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|------| | Target Population | Individuals requiring biopsy for sampling of soft tissue abnormalities | Individuals requiring biopsy for sampling of soft tissue abnormalities | Individuals requiring biopsy for sampling of soft tissue abnormalities | Same | | Mechanics of Operation | Single hand automatic activation | Single hand automatic activation | Single hand automatic activation | Same | | Gauge | 14G-20G | 14G-20G | 14G-20G | Same | | Needle Length | 100mm-250mm | 100 mm to 300 mm | 100 mm to 250 mm | Same | | Patient/ Tissue Contact Material | Inner needle and outer needle are made out of 304 stainless steel (X5CrNi18-9).Only Stainless steel is in direct surgical contact with all soft tissues of the patient. | Cannula and mandrel are made out of AISI 304 stainless steel. Only Stainless steel is in direct surgical contact with all soft tissues of the patient. | Cannula and mandrel are made out of AISI 304 stainless steel. Only Stainless steel is in direct surgical contact with all soft tissues of the patient. | Same | | Performance | Complied with ISO 9626 | Complied with ISO 9626 | Complied with ISO 9626 | Same | | Sterilization | EO Sterilization | EO Sterilization | EO Sterilization | Same | | Single use | Yes | Yes | Yes | Same | | Biocompatibili ty | Biocompatible according to ISO 10993 applicable parts | Biocompatible according to ISO 10993 applicable parts | Biocompatible according to ISO 10993 applicable parts | Same | ## Table 3: Comparison of the Model 112 Biopsy Needle to the predicate device. | | Subject Device | Predicate Device (K160316) | Predicate Device (K133948) | | |---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | Trade Name | Model 112 Biopsy Needle | Themy Automatic Disposable Biopsy Device | BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT | Comments | | Manufacturer | Guangzhou Shengwei Medical Devices Co., Ltd | M.D.L. S.r.l. | BARD PERIPHERAL VASCULAR, INC | | | Device Class | Class II | Class II | Class II | Same | | Product Code | KNW,FCG | KNW,FCG | KNW | Same | | Regulation number | 876.1075 | 876.1075 | 876.1075 | Same | | Regulation Name | Gastroenterology- Urology Biopsy Instrument | Gastroenterology- Urology Biopsy Instrument | Gastroenterology- Urology Biopsy Instrument | Same | | Device Description | Disposable programmable automatic spring- loaded guillotine style biopsy system for histological biopsy on soft tissue. | Disposable programmable automatic spring- loaded guillotine style biopsy system for histological biopsy on soft tissue. | Disposable programmable automatic spring- loaded guillotine style biopsy system for histological biopsy on soft tissue. | Similar It has an insurance mechanism to prevent accidental activation before | | | | | | puncture | | Intended Use/ Indications for Use Use/ Indications for Use | Model 112 Biopsy Needle is intended for obtaining core biopsy samples from soft tissues such as kidney, liver, prostate and various soft tissue masses. The device is not intended for use in bone. Model 112 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 abnormality. | Themy Automatic Biopsy Needle is intended for obtaining core biopsy samples from soft tissues such as kidney, liver, prostate and various soft tissue masses. The device is not intended for use in bone. Themy Automatic 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 abnormality. | The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue masses. It is not intended for use in bone. | Same | | Target Population | Individuals requiring biopsy for sampling of soft tissue abnormalities | Individuals requiring biopsy for sampling of soft tissue abnormalities | Individuals requiring biopsy for sampling of soft tissue abnormalities | Same | | Mechanics of Operation | Single hand automatic activation | Single hand automatic activation | Single hand automatic activation | Same | | Gauge | 14G-20G | 14G-20G | 14G-20G | Same | | Needle Length | 100mm-250mm | 100 mm to 300 mm | 100 mm to 250 mm | Same | | Patient/Tissu e Contact Material | Inner needle and outer needle are made out of 304 stainless steel (X5CrNi18-9). Only Stainless steel is in direct surgical contact with all soft tissues of the patient. | Cannula and mandrel are made out of AISI 304 stainless steel. Only Stainless steel is in direct surgical contact with all soft tissues of the patient. | Cannula and mandrel are made out of AISI 304 stainless steel. Only Stainless steel is in direct surgical contact with all soft tissues of the patient. | Same | | Performance | Complied with ISO 9626 | Complied with ISO 9626 | Complied with ISO 9626 | Same | | Sterilization | EO Sterilization | EO Sterilization | EO Sterilization | Same | | Single use | Yes | Yes | Yes | Same | | Biocompatibili ty | Biocompatible according to ISO 10993 applicable parts | Biocompatible according to ISO 10993 applicable parts | Biocompatible according to ISO 10993 applicable parts | Same | | | Subject Device | Predicate Device (K160316) | Predicate Device (K853312) | | | Trade Name | Model 121 Biopsy Needle | SemiCut Semi-Automatic Biopsy Needle | ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES | Comment | | Manufacturer | Guangzhou Shengwei Medical Devices Co., Ltd | M.D.L. S.r.l. | ARGON MEDICAL CORP | | | Device Class | Class II | Class II | Class II | Same | | Product Code | KNW,FCG | KNW,FCG | DWO | Same | | Regulation number | 876.1075 | 876.1075 | 478.4800 | Same | | Regulation Name | Gastroenterology- Urology Biopsy Instrument | Gastroenterology- Urology Biopsy Instrument | Gastroenterology- Urology Biopsy Instrument | Same | | Device Description | Disposable semi- automatic spring loaded guillotine style biopsy system with adjustable penetration depth for histological biopsy on soft tissue. | Disposable semi- automatic spring loaded guillotine style biopsy system with adjustable penetration depth for histological biopsy on soft tissue. | Disposable semi- automatic spring loaded guillotine style biopsy system with adjustable penetration depth for histological biopsy on soft tissue. | Same | | Intended Use/ Indications for Use Use/ Indications for Use | intended for obtaining percutaneous or surgical histological core samples from soft tissues such as breast, kidney, liver, lung and various soft tissue masses. The device is not intended for use in bone. | intended for obtaining percutaneous or surgical histological core samples from soft tissues such as breast, kidney, liver, lung and various soft tissue masses. The device is not intended for use in bone. | intended for obtaining percutaneous or surgical histological core samples from soft tissues such as breast, kidney, liver, lung and various soft tissue masses. The device is not intended for use in bone. | Same | | Target Population | Individuals requiring biopsy for sampling of soft tissue abnormalities | Individuals requiring biopsy for sampling of soft tissue abnormalities | Individuals requiring biopsy for sampling of soft tissue abnormalities | Same | | Mechanics of Operation | Single hand automatic activation | Single hand automatic activation | Single hand automatic activation | Same | | Gauge | 14G-20G | 14G-20G | 14G-20G | Same | | Needle Length | 100mm-250mm | 70 mm to 300 mm | 90 mm to 200 mm | Similar, the difference does not cause any safety and effectiveness concern. | | Patient/Tissu e Contact Material | Inner needle and outer needle are made out of 304 stainless steel (X5CrNi18-9). | Cannula and mandrel are made out of AISI 304 stainless steel. | Cannula and mandrel are made out of AISI 304 stainless steel. | Same | | | Only Stainless steel is in direct surgical contact with all soft tissues of the patient. | Only Stainless steel is in direct surgical contact with all soft tissues of the patient. | Only Stainless steel is in direct surgical contact with all soft tissues of the patient. | | | | | | patient. | | |…