(158 days)
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.
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 provided document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Shengwei Biopsy Needles (Model 121, Model 111/112, and Model 131 Disposable Coaxial Biopsy Needle).
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance (Shengwei Biopsy Needle) |
|---|---|
| Biocompatibility | |
| Cytotoxicity (ISO 10993-5:2009) | Meets |
| Sensitization (ISO 10993-10:2010) | Meets |
| Skin Irritation (ISO 10993-10:2010) | Meets |
| Acute Systemic Toxicity (ISO 10993-11:2017) | Meets |
| Hemolysis (ISO 10993-4:2017) | Meets |
| Non-pyrogenicity (USP <151>) | Meets |
| Bacterial Endotoxins (USP <85>) | Meets |
| Sterilization (ISO 11135) | Meets |
| ETO, EG, ECH Residuals (ISO 10993-7) | Below limit of quantitation (1 mg/device) |
| Device Shelf-life (5 years simulated) | |
| Visual Appearance (Metal Oxidation, Plastic Coloration, Plastic Integrity) | No aesthetic or design changes for aged devices |
| Mechanical Durability (Aged vs. Non-aged) | Unchanged compared to non-aged device |
| Depth Projection (Aged vs. Non-aged) | Unchanged compared to non-aged device |
| Device Needle Penetration (Aged vs. Non-aged) | Unchanged compared to non-aged device |
| Activation Force (Spring Force) (Aged vs. Non-aged) | Unchanged compared to non-aged device |
| Extraction (Aged vs. Non-aged) | Unchanged compared to non-aged device |
| Mechanism Performance | |
| Depth Projection (Cannula Advancement > 20 mm) | Subject devices (Model 111, Model 121) were comparable to predicate devices over 50 shots per use and met criteria (Needle Advancement > 20 mm). N/A for Model 112 as design is different. |
| Mechanical Durability (Breakage Force (SHENGWEI) > FPredicate; Detachment of Components Does Not Occur) | Subject devices were comparable to predicate devices and met criteria (Breakage Force (SHENGWEI) > FPredicate and Detachment of Components: Does Not Occur). |
| Penetration Force (Penetration Force (SHENGWEI) < FPredicate) | Subject devices (Model 112, Model 121; Model 111 uses same needle as Model 121) required less force compared to predicate devices and met criteria (Penetration Force (SHENGWEI) < FPredicate). |
| Activation Force (Spring) (Activation Force (Shengwei) < FPredicate) | Subject devices were comparable to predicate devices over 50 shots per use and met criteria (Spring Force (Shengwei) > F Predicate). (Note: There is a discrepancy in the table criteria vs. text description for Activation Force). |
| Extraction (Shengwei Non-statistically Significant Different to Predicate) | Subject devices (Model 111/112/121) were comparable over 50 shots per use and produced slightly larger samples by weight compared to predicate devices. This is described as "Statistically Sig. Diff. (Shengwei Sample Wt. > Predicate Sample Wt.)" in the summary table. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: For performance testing (Depth Projection, Penetration Force, Activation Force, Mechanical Durability, Extraction), "Samples of each device product family (subject device) were selected at the extremes of device design for needle length and gauge sizes." For Depth Projection, Activation Force, and Extraction, testing was performed "over 50 shots per use." For Penetration Force, "Each tested subject and predicate device was activated 50 times." For Shelf-life, "Three lots of aged and non-aged subject devices were tested in triplicate."
- Data Provenance: The document does not explicitly state the country of origin of the data for these performance tests. It also does not explicitly state whether the tests were retrospective or prospective, but given they are laboratory performance tests, they are inherently prospective for the purpose of this submission.
- Clinical Data: No clinical data was included in this submission.
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 as the studies described are laboratory performance tests focusing on mechanical and biological properties of the device, not clinical performance requiring expert interpretation or ground truth establishment in a medical context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not applicable as the studies described are laboratory performance tests measuring quantifiable physical properties of the device, not clinical studies involving interpretation or 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
- No MRMC study was done. This document is for a medical device (biopsy needle), not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone (algorithm only) performance study was done. This document is for a physical medical device (biopsy needle), not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For biocompatibility, the ground truth is established by recognized international standards (ISO 10993 series and USP tests) which define acceptable biological responses.
- For performance testing, the ground truth is established by specific criteria outlined in the testing protocols (e.g., "Needle Advancement > 20 mm," "Breakage Force (SHENGWEI) > FPredicate") and comparison to legally marketed predicate devices. Quantitative measurements are taken against these predefined standards or predicates.
8. The sample size for the training set
- This information is not applicable as the document describes laboratory performance and biocompatibility testing for a physical medical device, not a machine learning model that would require a training set.
9. How the ground truth for the training set was established
- This information is not applicable for the same reason as point 8.
{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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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
-
- 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 biopsyof soft tissue |
| Model 112 | Disposable, automatic device for core biopsy ofsoft tissue with locking function. |
| Model 121 | Disposable, semi-automatic device for corebiopsy of soft tissue |
| Biopsy Device Accessories: Disposable Coaxial Biopsy Needle | |
| Model 131 | Disposable needles for introduction ofcannula, 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 DisposableBiopsy Device | BARD(R) MAX-CORE(R)DISPOSABLE COREINSTRUMENT | Comments |
| Manufacturer | Guangzhou ShengweiMedical Devices Co., Ltd | M.D.L. S.r.l. | BARD PERIPHERALVASCULAR, INC | |
| Device Class | Class II | Class II | Class II | Same |
| Product Code | KNW,FCG | KNW,FCG | KNW | Same |
| Regulationnumber | 876.1075 | 876.1075 | 876.1075 | Same |
| RegulationName | Gastroenterology-Urology BiopsyInstrument | Gastroenterology-Urology BiopsyInstrument | Gastroenterology-Urology BiopsyInstrument | Same |
| DeviceDescription | Disposable programmableautomatic spring- loadedguillotine style biopsysystem for histologicalbiopsy on soft tissue. | Disposable programmableautomatic spring- loadedguillotine style biopsy systemfor histological biopsy on softtissue. | Disposable programmableautomatic spring- loadedguillotine style biopsysystem for histologicalbiopsy on soft tissue. | Same |
| IntendedUse/IndicationsforUse | Model 111 Biopsy Needleis intended for obtainingcore biopsy samples fromsoft tissues such askidney, liver, prostateand various soft tissuemasses. The device is notintended for use in bone. | Themy Automatic BiopsyNeedle is intended forobtaining core biopsy samplesfrom soft tissues such askidney, liver, prostate andvarious soft tissue masses. Thedevice is not intended for usein bone. | The core needle biopsydevice is intended for usein obtaining biopsies fromsoft tissues such as liver,kidney, prostate, spleen,lymph nodes and varioussoft tissue masses. It is notintended for use in bone. | Same |
| Use/Indicationsfor Use | Model 111 Biopsy Needle isalso indicated to providebreast tissue samples fordiagnostic sampling ofbreast abnormalities. It isdesigned to provide breasttissue for histologicexamination with partial | Themy Automatic BiopsyNeedle is also indicated toprovide breast tissue samplesfor diagnostic sampling ofbreast abnormalities. It isdesigned to provide breasttissue for histologicexamination 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. | |||
|---|---|---|---|---|
| TargetPopulation | 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 ofOperation | 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/TissueContactMaterial | 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 |
| Biocompatibility | 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 BiopsyNeedle | Themy AutomaticDisposable BiopsyDevice | BARD(R) MAX-CORE(R)DISPOSABLE COREINSTRUMENT | Comments |
| Manufacturer | Guangzhou ShengweiMedical Devices Co., Ltd | M.D.L. S.r.l. | BARD PERIPHERALVASCULAR, INC | |
| Device Class | Class II | Class II | Class II | Same |
| Product Code | KNW,FCG | KNW,FCG | KNW | Same |
| Regulationnumber | 876.1075 | 876.1075 | 876.1075 | Same |
| RegulationName | Gastroenterology- UrologyBiopsy Instrument | Gastroenterology- UrologyBiopsy Instrument | Gastroenterology-Urology BiopsyInstrument | Same |
| DeviceDescription | Disposable programmableautomatic spring- loadedguillotine style biopsysystem for histologicalbiopsy on soft tissue. | Disposable programmableautomatic spring- loadedguillotine style biopsysystem for histologicalbiopsy on soft tissue. | Disposable programmableautomatic spring- loadedguillotine style biopsysystem for histologicalbiopsy on soft tissue. | SimilarIt has aninsurancemechanismto preventaccidentalactivationbefore |
| puncture | ||||
| IntendedUse/IndicationsforUseUse/Indicationsfor Use | Model 112 Biopsy Needleis intended for obtainingcore biopsy samples fromsoft tissues such askidney, liver, prostateand various soft tissuemasses. The device is notintended for use in bone.Model 112 Biopsy Needle isalso indicated to providebreast tissue samples fordiagnostic sampling ofbreast abnormalities. It isdesigned to provide breasttissue for histologicexamination with partialor complete removal ofthe abnormality. | Themy Automatic BiopsyNeedle is intended forobtaining core biopsy samplesfrom soft tissues such askidney, liver, prostate andvarious soft tissue masses.The device is not intended foruse in bone.Themy Automatic BiopsyNeedle is also indicated toprovide breast tissue samplesfor diagnostic sampling ofbreast abnormalities. It isdesigned to provide breasttissue for histologicexamination with partial orcomplete removal of theabnormality. | The core needle biopsydevice is intended for usein obtaining biopsiesfrom soft tissues such asliver, kidney, prostate,spleen, lymph nodes andvarious soft tissuemasses. It is not intendedfor use in bone. | Same |
| TargetPopulation | Individuals requiringbiopsy for sampling ofsoft tissue abnormalities | Individuals requiring biopsyfor sampling of soft tissueabnormalities | Individuals requiringbiopsy for sampling ofsoft tissueabnormalities | Same |
| Mechanics ofOperation | Single hand automaticactivation | Single hand automaticactivation | Single hand automaticactivation | 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 ContactMaterial | Inner needle and outerneedle are made out of304 stainless steel(X5CrNi18-9).Only Stainless steel is indirect surgical contactwith all soft tissues ofthe patient. | Cannula and mandrel aremade out of AISI 304stainless steel.Only Stainless steel is indirect surgical contact withall soft tissues of thepatient. | Cannula and mandrel aremade out of AISI 304stainless steel.Only Stainless steel is indirect surgical contactwith all soft tissues of thepatient. | 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 |
| Biocompatibility | Biocompatible accordingto ISO 10993 applicableparts | Biocompatible according toISO 10993 applicable parts | Biocompatible accordingto ISO 10993 applicableparts | Same |
| Subject Device | Predicate Device(K160316) | Predicate Device(K853312) | ||
| Trade Name | Model 121 BiopsyNeedle | SemiCut Semi-AutomaticBiopsy Needle | ARGON CUT BIOPSYNEEDLES, VARIOUS SIZES | Comment |
| Manufacturer | Guangzhou Shengwei MedicalDevices 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 |
| Regulationnumber | 876.1075 | 876.1075 | 478.4800 | Same |
| RegulationName | Gastroenterology- UrologyBiopsy Instrument | Gastroenterology- UrologyBiopsy Instrument | Gastroenterology-Urology BiopsyInstrument | Same |
| DeviceDescription | Disposable semi- automaticspring loaded guillotinestyle biopsy system withadjustable penetrationdepth for histologicalbiopsy on soft tissue. | Disposable semi- automaticspring loaded guillotine stylebiopsy system withadjustable penetration depthfor histological biopsy on softtissue. | Disposable semi-automatic springloaded guillotinestyle biopsy systemwith adjustablepenetration depth forhistological biopsy onsoft tissue. | Same |
| IntendedUse/IndicationsforUseUse/Indicationsfor Use | intended for obtainingpercutaneous or surgicalhistological core samplesfrom soft tissues such asbreast, kidney, liver, lungand various soft tissuemasses. The device is notintended for use in bone. | intended for obtainingpercutaneous or surgicalhistological core samplesfrom soft tissues such asbreast, kidney, liver, lungand various soft tissuemasses. The device is notintended for use in bone. | intended forobtainingpercutaneous orsurgical histologicalcore samples fromsoft tissues such asbreast, kidney, liver,lung and various softtissue masses. Thedevice is not intendedfor use in bone. | Same |
| TargetPopulation | Individuals requiring biopsyfor sampling of soft tissueabnormalities | Individuals requiring biopsyfor sampling of soft tissueabnormalities | Individuals requiringbiopsy for samplingof soft tissueabnormalities | Same |
| Mechanics ofOperation | Single hand automaticactivation | Single hand automaticactivation | Single handautomatic 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, thedifference doesnot cause anysafety andeffectivenessconcern. |
| Patient/Tissue ContactMaterial | Inner needle and outerneedle are made out of 304stainless steel (X5CrNi18-9). | Cannula and mandrel aremade out of AISI 304stainless steel. | Cannula and mandrelare made out of AISI304 stainless steel. | Same |
| Only Stainless steel is indirect surgical contactwith all soft tissues of thepatient. | Only Stainless steel is indirect surgical contact withall soft tissues of the patient. | Only Stainless steel isin direct surgicalcontact with all softtissues of thepatient. | ||
| patient. | ||||
| 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 |
| Biocompatibility | Biocompatible according toISO 10993 applicable parts | Biocompatible according toISO 10993 applicable parts | Biocompatibleaccording to ISO10993 applicable parts | Same |
{7}------------------------------------------------
{8}------------------------------------------------
Table 4: Comparison of the Model 121 Biopsy Needle to the predicate device.
{9}------------------------------------------------
Table 5: Comparison of the Model 131 Disposable Coaxial Biopsy Needle to the predicate device.
| Subject Device | Predicate Device(K160316) | Predicate Device(K853312) | ||
|---|---|---|---|---|
| Trade Name | Model 131 DisposableCoaxial Biopsy Needle | INTRO CoaxialIntroducer Needles | ARGON CUT BIOPSYNEEDLES, VARIOUS SIZES | Comments |
| Manufacturer | Guangzhou ShengweiMedical 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 |
| Regulationnumber | 876.1075 | 876.1075 | 478.4800 | Same |
| RegulationName | Gastroenterology-Urology BiopsyInstrument | Gastroenterology-Urology BiopsyInstrument | Gastroenterology-Urology BiopsyInstrument | Same |
| Intended Use/Indications forUse | Intended for use with biopsydevices cannula during softtissue core biopsyprocedures. The device isnot intended for use inbone. | Intended for use with biopsydevices cannula during softtissue core biopsyprocedures. The device isnot intended for use inbone. | Intended for use withbiopsy devices cannuladuring soft tissue corebiopsy procedures. Thedevice is not intendedfor use in bone. | Same |
| TargetPopulation | Individuals requiring biopsyfor sampling of soft tissueabnormalities | Individuals requiringbiopsy for sampling ofsoft tissueabnormalities | Individuals requiringbiopsy for sampling ofsoft tissueabnormalities | Same |
| Gauge | 15G-19G | 13G-19G | 13G-19G | Same |
| Needle Length | 47mm-198mm | 44 mm to 244 mm | 35 mm to 151 mm | Similar, thedifferencedoes notcause anysafety andeffectivenessconcern. |
| Device Type | Trocar tip stylet | Trocar tip stylet | Trocar tip stylet | Same |
| VisualizationTechnique | Conventional imagingguidance equipmentexcluding MRI | Conventional imagingguidance equipmentexcluding MRI | Conventional imagingguidance equipmentexcluding MRI | Same |
| NeedleMaterial | Stainless steel | Stainless steel | Stainless steel | 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 |
| Biocompatibility | Biocompatibleaccording to ISO 10993applicable parts | Biocompatibleaccording to ISO 10993applicable parts | Biocompatibleaccording to ISO 10993applicable parts | Same |
{10}------------------------------------------------
7. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the medical face mask was conducted in accordance with the International Standard ISO 10993-1:2018, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing included the following tests:
- Cytotoxicity - (ISO 10993-5: 2009)
- Sensitization - (ISO 10993-10:2010)
- Skin Irritation - (ISO 10993-10:2010)
- Acute Systemic Toxicity-(ISO 10993-11:2017)
- Hemolysis-(ISO 10993-4:2017).
The devices met the requirements for non-pyrogenicity per Pyrogen Test USP<151>, Bacterial Endotoxins Test USP<85>. Sterilization was validated per ISO11135, and residuals for ETO, EG and ECH met ISO10993-7.
Device Shelf-life
The subject devices in their packaging were subjected to accelerated aging to simulate a 5 year shelf life (Treatment: 60°C, 28 days, <50% RH). Three lots of aged and non-aged subject devices were tested in triplicate for Mechanical Durability, Depth Projection, Device Needle Penetration, Activation Force (Spring Force) and Extraction to assess the impact of simulated aging on the device performance. Visual Appearance inspection for Metal Oxidation, Plastic Coloration, Plastic Integrity (cracks, damage) indicated that there no aesthetic, or design changes for the aged devices. Performance testing results of the aged devices was unchanged compared to untreated (non-aged) device.
{11}------------------------------------------------
Performance testing
Samples of each device product family (subject device) were selected at the extremes of device design for needle length and gauge sizes for comparative testing to predicate devices for device performance.
Depth Projection: Subject devices vs. predicate devices testing for Depth Projection measured the needle advancement during activation. Cannula needle advancement must meet a distance of ≥ 20mm compared to the notch. The results showed that subject devices tested side-by-side with predicate devices were comparable over 50 shots per use and met criteria: Needle Advancement > 20 mm.
Penetration Force: Subject devices vs. predicate devices for Penetration Force was assessed using ASTM F3014 guidance. Simulation of biological tissues using a certified testing foil was used in the Dynamometer setup. Each tested subject and predicate device was activated 50 times to replicate the maximum number of biopsy shots performed during a medical procedure. The results showed that the subject devices required less force compared to the predicate devices and met the criteria: Penetration Force (Shengwei) < F (Predicate).
Activation Force: Subject and predicate device testing for Spring Force was measured during device activation. The results showed the subject devices tested side-by-side with predicate devices were comparable over 50 shots per use and met criteria: Spring Force (Shengwei) > F Predicate.
Mechanical Durability: Subject and predicate device testing for Mechanical Durability was performed in two parts: breaking force and detachment force. Device cannulas subjected to progressive force determined the breaking force. The detachment force test determined the point at which the plastic components sever from the device point of attachment. Results showed that subject devices in comparison to the predicate device met the criteria, Breakage Force (Shengwei) > F (Predicate), and Detachment of Components: Does Not Occur.
Extraction Testing: Subject and predicate devices testing for Sample Extraction quantitatively evaluated extraction capacity of subject devices compared with predicate devices. The results showed that the subject devices tested side-by-side with predicate devices were comparable over 50 shots per use compared to the predicate device. Model 111/112/121 devices produced slightly larger samples by weight compared to predicate device at 50 shots per use.
{12}------------------------------------------------
| Performance Testing | Device Name | ||
|---|---|---|---|
| Model 111 | Model 112 | Model 121 | |
| Biocompatibility per ISO10993 | Meets | Meets | Meets |
| Pyrogen Test USP per <151> | Meets | Meets | Meets |
| Bacterial Endotoxins Test USP per <85> | Meets | Meets | Meets |
| Residual ETO, ECH§, EG§ per ISO10993-7 | Meets | Meets | Meets |
| Sterile per ISO 11135 | Meets | Meets | Meets |
| Mechanism Performance | |||
| ● Depth Projection (1) | Similar** | N/A | Similar |
| ● Mechanical - Durability (2) | Similar | Similar | Similar |
| ● Penetration (3) | (a) | Pass | Pass |
| ● Activation Force (Spring) (4) | Pass** | Pass | Pass |
| ● Extraction (5) | *** | *** | *** |
Table 6 Performance Testing Summary
** 20 mm Slot, ***Statistically Sig. Diff. (Shengwei Sample Wt. > Predicate Sample Wt.)
ട് Below limit of quantitation (1 mg/device)
N/A/ not applicable (design), (a) Same Needle as Model 121.
Criteria: (1) Cannula Advancement > 20 mm = Pass; (2) Breakage Force (SHENGWEI) > FPredicate and Detachment of Components does not occur; (3) Penetration Force (SHENGWEI) < FPredicate; (4) Activation Force (Shengwei) < FPredicate; (5) Shengwei Non-statistically Significant Different to Predicate
8. CLINICAL DATA
No clinical data was included in this submission.
9. CONCLUSION
The indications for use statement for the subject device is similar to that of the predicate. The differences between the biopsy needle and its predicate device do not raise new issues of safety and effectiveness. The non-clinical data support the safety of the device and the performance testing report demonstrate that the medical face mask should perform as intended in the specified use conditions.
From the results of non-clinical data including the performance testing described, Guangzhou Shengwei Medical Devices Co., Ltd concludes that the biopsy needle is as safe, as effective, and performs as well as or better than the legally marketed as the predicate devices (K853312, K133948, K160316).
§ 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.