(158 days)
Not Found
No
The summary describes a mechanical biopsy needle and its performance characteristics. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is intended for obtaining tissue samples for diagnostic purposes (e.g., histological examination), not for treating a disease or condition.
Yes
Explanation: The device, a biopsy needle, is used to obtain tissue samples for "histologic examination" and "diagnostic sampling of breast abnormalities." This indicates its purpose is to aid in the diagnosis of conditions, which makes it a diagnostic device.
No
The device description clearly states it is a physical biopsy needle with mechanical components (spring-powered guns, cannula accessory) used for obtaining tissue samples. It does not describe any software functionality as the primary medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Shengwei Biopsy needle is a tool used to obtain the tissue sample from the body. It is a surgical instrument used in vivo (within the living body).
- Intended Use: The intended use clearly states it's for "obtaining percutaneous or surgical histological core samples from soft tissues." This is the act of collecting the sample, not analyzing it.
- Performance Studies: The performance studies focus on the mechanical aspects of the device (depth projection, penetration force, durability, etc.) and biocompatibility. They do not evaluate the diagnostic accuracy of the device itself in analyzing a sample.
While the tissue samples obtained by this device will likely be used for in vitro diagnostic testing (histological examination), the biopsy needle itself is not the IVD. It's a device used in the process of obtaining the sample for subsequent IVD testing.
N/A
Intended Use / Indications for Use
The Shengwei Biopsy needle consist of Model 121 Biopsy Needle, Model 111/112 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 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.
Product codes (comma separated list FDA assigned to the subject device)
KNW, FCG
Device Description
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.
Table 1 Soft Tissue Biopsy Devices and Accessories
Product Name: 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
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Conventional imaging guidance equipment excluding MRI
Anatomical Site
Breast, kidney, liver, lung, prostate, spleen, lymph nodes and various soft tissue masses.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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, Bacterial Endotoxins Test USP. 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, = 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.
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.
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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) |
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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 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. | |
| 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 |
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 Disposable
Coaxial Biopsy Needle | INTRO Coaxial
Introducer Needles | ARGON CUT BIOPSY
NEEDLES, VARIOUS SIZES | Comments |
| 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 |
| Intended Use/
Indications for
Use | Intended for use with biopsy
devices cannula during soft
tissue core biopsy
procedures. The device is
not intended for use in
bone. | Intended for use with biopsy
devices cannula during soft
tissue core biopsy
procedures. The device is
not intended for use in
bone. | Intended for use with
biopsy devices cannula
during soft tissue core
biopsy procedures. 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 |
| Gauge | 15G-19G | 13G-19G | 13G-19G | Same |
| Needle Length | 47mm-198mm | 44 mm to 244 mm | 35 mm to 151 mm | Similar, the
difference
does not
cause any
safety and
effectiveness
concern. |
| Device Type | Trocar tip stylet | Trocar tip stylet | Trocar tip stylet | Same |
| Visualization
Technique | Conventional imaging
guidance equipment
excluding MRI | Conventional imaging
guidance equipment
excluding MRI | Conventional imaging
guidance equipment
excluding MRI | Same |
| Needle
Material | 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 | Biocompatible
according to ISO 10993
applicable parts | Biocompatible
according to ISO 10993
applicable parts | Biocompatible
according to ISO 10993
applicable 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, Bacterial Endotoxins Test USP. 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, 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.
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 | Meets | Meets | Meets |
| Bacterial Endotoxins Test USP per | 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)