(217 days)
Not Found
No
The device description and performance studies focus on the mechanical aspects and material properties of the biopsy instruments and needles. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The "Automatic" and "Semi-Automatic" descriptions refer to the firing mechanisms, not intelligent automation.
No
This device is for obtaining biopsies, which is a diagnostic procedure, not a therapeutic treatment.
No
The devices (Automatic Core Biopsy Instrument, Semi-Automatic Core Biopsy Instrument, and Disposable Coaxial Biopsy Needle) are intended for obtaining tissue samples (biopsies), which are then typically used for diagnosis by other means (e.g., pathology). The devices themselves are instruments for sample collection, not for performing the diagnosis.
No
The device description clearly outlines physical components like needles, handles, and cannulas, indicating it is a hardware device used for obtaining biopsies. There is no mention of software as the primary or sole component.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health.
- Device Function: The described devices (Automatic Core Biopsy Instrument, Semi-Automatic Core Biopsy Instrument, and Disposable Coaxial Biopsy Needle) are used to obtain tissue samples from within the body. They are tools for collecting the specimen, not for analyzing it.
- Intended Use: The intended use clearly states they are for "obtaining biopsies from soft tissues." This is a procedure performed on the patient to collect a sample.
- Device Description: The description focuses on the mechanical aspects of the instruments used for tissue collection (needles, handles, firing mechanisms).
- Performance Studies: The performance studies described are related to the safety and functionality of the device in collecting the sample (biological testing, sterilization, mechanical properties), not the analysis of the collected sample.
While the collected tissue sample will likely be used for in vitro diagnostic testing later (e.g., pathology analysis), the devices themselves are not IVDs. They are considered surgical or procedural instruments used for tissue acquisition.
N/A
Intended Use / Indications for Use
Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as breast, liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
Semi-Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and various soft tissue tumors. It is not intended for use in bone.
Disposable Coaxial Biopsy Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid and various soft tissue tumors. It is designed for use with CuraWay Automatic Core Biopsy Instrument and CuraWay Semi-Automatic Core Biopsy Instrument. It is not intended for use in bone.
Product codes
KNW
Device Description
Automatic Core Biopsy Instrument
Automatic Core Biopsy Instrument has seven models: BN-OCR-1, BN-OCR-2, BN-OCR-3, BN-OCR-6, BN-OCR-7, BN-OCR-8 and BN-OCR-9.
BN-OCR-1, BN-OCR-2 and BN-OCR-3 of Automatic Core Biopsy Instrument is automatic firing, and the structure is consisted of Inner Stylet, Cutting Cannula, Operating Handle, Actuation button, Depth stopper, Slide block and Protective sheath.
BN-OCR-6, BN-OCR-7, BN-OCR-8 and BN-OCR-9 of Automatic Core Biopsy Instrument has both automatic firing and delay firing options, the automatic firing mode releases the cannula and stylet in rapid sequence and captures a tissue sample with the push of a button. The delay firing method is used to verify the position of the sample notch in the target area prior to depressing the actuation button "A", which activates the cutting cannula, capturing the tissue sample. The structure is consisted of Inner Stylet, Cutting Cannula, Adjustable Knob (only for BN-OCR-7 and BN-OCR-9), Charging handle, Operating Handle, Security Lock (only for BN-OCR-8 and BN-OCR-9) and Protective Sheath.
Each model has various specifications depending on different sizes such as needle lengths, needle diameters, etc.
The cutting cannula has centimeter scales on it to provide reference for depth placement. In the distal area of the cutting cannula, an ultrasound enhancement is available to promote accurate placement under ultrasound or X-ray guidance, excluding MRI.
The Automatic Core Biopsy Instrument is single-use device, supplied in a sterile state sterilized by EO gas. A re-sterilization by users is not allowed. The shelf life is defined for 3 years, which is verified.
Semi-Automatic Core Biopsy Instrument
The Semi-Automatic Core Biopsy Instrument has two models (BN-OCR-4, BN-OCR-5) according to whether there is a Safety limit slot.
The Semi-Automatic Core Biopsy Instrument consists of Inner stylet, Cutting cannula, Fixed handle, Windows, Safety switch, Plunger and Protective sheath. The needle is protected in a protective sheath.
Each model has various specifications depending on different sizes such as needle lengths, needle diameters, etc. The plunger is color-coded, which indicates gauge size of the needle.
The Cutting cannula has centimeter scales on it to provide reference for depth placement. In the distal area of the Cutting cannula, an ultrasound enhancement is available to promote accurate placement under ultrasound or X-ray guidance, excluding MRI.
The Semi-Automatic Core Biopsy Instrument is single-use device, supplied in a sterile state sterilized by EO gas. A re-sterilization by users is not allowed. The shelf life is defined for 3 years, which is verified.
Disposable Coaxial Biopsy Needle
Disposable Coaxial Biopsy Needle has two models: BN-MAR-5, BN-MAR-6.
The Disposable Coaxial Biopsy Needle consists of Inner Stylet, Cutting cannula, Operating handle of Cutting cannula. Operating handle of Inner stylet, Depth stopper, Protective Sheath, Adaptor (optional) and Blunt needle (optional).
An adjustable depth stopper allows the user to restrict forward movement, localizing the needle tip to the biopsy site. The Depth Stopper is color-coded, which indicates gauge size of the needle. It is available in several needle gauge sizes and lengths.
Disposable Coaxial Biopsy Needle is intended for soft-tissue biopsy and designed as guiding needle for use with CuraWay disposable Biopsy Instruments/Needles such as CuraWay's Automatic Core Biopsy Instrument and CuraWay's Semi-Automatic Core Biopsy Instrument. The outer cannula is one gauge-size less than the compatible Biopsy Instrument/Needle, e.g., 19-gauge CuraWay Coaxial Biopsy Needle for a 20 gauge CuraWay Disposable Biopsy Needle or CuraWay Disposable biopsy instrument.
The Cutting cannula has numerical scales on it to provide reference for depth placement. In the distal area of the cutting cannula, an ultrasound enhancement is available to promote accurate placement under ultrasound or X-ray guidance excluding MRI.
The Disposable Coaxial Biopsy Needle is single-use device, supplied in a sterile state sterilized by EO gas. A re-sterilization by users is not allowed. The shelf life is defined for 3 years, which is verified.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound, X-Ray, CT
Anatomical Site
Breast, liver, kidney, prostate, spleen, lymph nodes, lung, thyroid, and various soft tissue tumors.
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)
Summary of Non-Clinical Testing
CuraWay performed the following bench testing so as to demonstrate the intended use of the products.
Biological Testing
- In Vitro Cytotoxicity Test (ISO 10993-5: 2009)
- Intracutaneous Reactivity Test (ISO 10993-23: 2021)
- Skin Sensitization test (ISO 10993-10: 2021)
- Irritation or Intracutaneous Reactivity (ISO 10993-10)
- Acute Systemic Toxicity Test (ISO 10993-11: 2017)
- Pyrogen Test (ISO 10993-11: 2017).
Sterilization validation
Sterilization validation is performed according to ISO 11135: 2014, EO and ECH are validated according to ISO 10993-7: 2008. SAL=10-6.
The sterility test is carried out according to ISO 11737-2: 2019.
Packaging and shelf-life testing
The primary package of the proposed device is intended to maintain the sterility and performances of the product during its claimed shelf life. The testing is carried out in accordance with ASTM F1980: 2016.
Performance comparison with predicate devices
Comparison test was conducted between the subject devices and predicate devices to compare their performances, including appearance, dimensions, sampling performance, connection firmness, stiffness, toughness, resistance to corrosion, puncture force, chemical properties, etc.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
BARD® MAX-CORE®Disposable Core Biopsy Instrument (K133948), Achieve Programmable Automatic Biopsy System (K141552), Bard® Mission® Disposable Core Biopsy Instrument (K171953), Bard® TruGuide® Disposable Coaxial Biopsy Needle (K171953)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
January 24, 2025
Image /page/0/Picture/1 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Zhejiang CuraWay Medical Technology Co., Ltd. Li Yin Regulatory affairs specialist Room 106, Building 1, No. 600, 21st Avenue, Baiyang Sub-district, Qiantang New District Hangzhou, Zhejiang 310018 China
Re: K241793
Trade/Device Name: Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: December 27, 2024 Received: December 27, 2024
Dear Li Yin:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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-regulatory
2
assistance/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,
Jessica Carr -S
Jessica Carr 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
3
Indications for Use
Submission Number (if known)
Device Name
Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle
Indications for Use (Describe)
Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as breast, liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
Semi-Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and various soft tissue tumors. It is not intended for use in bone.
Disposable Coaxial Biopsy Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid and various soft tissue tumors. It is designed for use with CuraWay Automatic Core Biopsy Instrument and CuraWay Semi-Automatic Core Biopsy Instrument. It is not intended for use in bone.
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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4
510(K) Summary K241793
| Company Name/Owner | Zhejiang CuraWay Medical Technology Co., Ltd. |
|---|---|
| Contact person/Author | Yin Li |
| Date prepared | January 24, 2025 |
| Contact details Address | Room 106, Building 1, No. 600, 21st Avenue, Baiyang |
| Sub-district, Qiantang New District, 310018 Hangzhou | |
| City, Zhejiang Province, China | |
| Contact phone number | 86-571-87016876 |
| Trade name | Automatic Core Biopsy Instrument |
| Semi-Automatic Core Biopsy Instrument | |
| Disposable Coaxial Biopsy Needle | |
| Common name | Core Biopsy Instrument, Biopsy Needle |
| Classification name | Instrument, biopsy |
| Review panel | Gastroenterology/Urology |
| Regulation number | 21 CFR 876.1075 |
| Product code | KNW |
| Predicate device | BARD® MAX-CORE®Disposable Core Biopsy |
| Instrument (K133948) | |
| Achieve Programmable Automatic Biopsy System | |
| (K141552) | |
| Bard® Mission® Disposable Core Biopsy Instrument | |
| (K171953) | |
| Bard® TruGuide® Disposable Coaxial Biopsy Needle | |
| (K171953) |
5
1. Device Description
● Automatic Core Biopsy Instrument
Automatic Core Biopsy Instrument has seven models: BN-OCR-1, BN-OCR-2, BN-OCR-3, BN-OCR-6, BN-OCR-7, BN-OCR-8 and BN-OCR-9.
BN-OCR-1, BN-OCR-2 and BN-OCR-3 of Automatic Core Biopsy Instrument is automatic firing, and the structure is consisted of Inner Stylet, Cutting Cannula, Operating Handle, Actuation button, Depth stopper, Slide block and Protective sheath.
BN-OCR-6, BN-OCR-7, BN-OCR-8 and BN-OCR-9 of Automatic Core Biopsy Instrument has both automatic firing and delay firing options, the automatic firing mode releases the cannula and stylet in rapid sequence and captures a tissue sample with the push of a button. The delay firing method is used to verify the position of the sample notch in the target area prior to depressing the actuation button "A", which activates the cutting cannula, capturing the tissue sample. The structure is consisted of Inner Stylet, Cutting Cannula, Adjustable Knob (only for BN-OCR-7 and BN-OCR-9), Charging handle, Operating Handle, Security Lock (only for BN-OCR-8 and BN-OCR-9) and Protective Sheath.
Each model has various specifications depending on different sizes such as needle lengths, needle diameters, etc.
The cutting cannula has centimeter scales on it to provide reference for depth placement. In the distal area of the cutting cannula, an ultrasound enhancement is available to promote accurate placement under ultrasound or X-ray guidance, excluding MRI.
The Automatic Core Biopsy Instrument is single-use device, supplied in a sterile state sterilized by EO gas. A re-sterilization by users is not allowed. The shelf life is defined for 3 years, which is verified.
● Semi-Automatic Core Biopsy Instrument
The Semi-Automatic Core Biopsy Instrument has two models (BN-OCR-4, BN-OCR-5) according to whether there is a Safety limit slot.
The Semi-Automatic Core Biopsy Instrument consists of Inner stylet, Cutting cannula, Fixed handle, Windows, Safety switch, Plunger and Protective sheath. The needle is protected in a protective sheath.
6
Each model has various specifications depending on different sizes such as needle lengths, needle diameters, etc. The plunger is color-coded, which indicates gauge size of the needle.
The Cutting cannula has centimeter scales on it to provide reference for depth placement. In the distal area of the Cutting cannula, an ultrasound enhancement is available to promote accurate placement under ultrasound or X-ray guidance, excluding MRI.
The Semi-Automatic Core Biopsy Instrument is single-use device, supplied in a sterile state sterilized by EO gas. A re-sterilization by users is not allowed. The shelf life is defined for 3 years, which is verified.
● Disposable Coaxial Biopsy Needle
Disposable Coaxial Biopsy Needle has two models: BN-MAR-5, BN-MAR-6.
The Disposable Coaxial Biopsy Needle consists of Inner Stylet, Cutting cannula, Operating handle of Cutting cannula. Operating handle of Inner stylet, Depth stopper, Protective Sheath, Adaptor (optional) and Blunt needle (optional).
An adjustable depth stopper allows the user to restrict forward movement, localizing the needle tip to the biopsy site. The Depth Stopper is color-coded, which indicates gauge size of the needle. It is available in several needle gauge sizes and lengths.
Disposable Coaxial Biopsy Needle is intended for soft-tissue biopsy and designed as guiding needle for use with CuraWay disposable Biopsy Instruments/Needles such as CuraWay's Automatic Core Biopsy Instrument and CuraWay's Semi-Automatic Core Biopsy Instrument. The outer cannula is one gauge-size less than the compatible Biopsy Instrument/Needle, e.g., 19-gauge CuraWay Coaxial Biopsy Needle for a 20 gauge CuraWay Disposable Biopsy Needle or CuraWay Disposable biopsy instrument.
The Cutting cannula has numerical scales on it to provide reference for depth placement. In the distal area of the cutting cannula, an ultrasound enhancement is available to promote accurate placement under ultrasound or X-ray guidance excluding MRI.
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The Disposable Coaxial Biopsy Needle is single-use device, supplied in a sterile state sterilized by EO gas. A re-sterilization by users is not allowed. The shelf life is defined for 3 years, which is verified.
2. Indications for use
Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as breast, liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
Semi-Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and various soft tissue tumors. It is not intended for use in bone.
Disposable Coaxial Biopsy Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid and various soft tissue tumors. It is designed for use with CuraWay Automatic Core Biopsy Instrument and CuraWay Semi-Automatic Core Biopsy Instrument. It is not intended for use in bone.
3. Substantial equivalence comparison with predicate device
Detailed substantial comparison was made between subject device and predicate
| Subject device | Predicate device 1 | Predicate device 2 | Comparison | |
|---|---|---|---|---|
| Automatic Core | ||||
| Biopsy | ||||
| Instrument | BARD® | |||
| MAX-CORE®Disposable | ||||
| Core Biopsy Instrument | ||||
| (K133948) | Achieve | |||
| Programmable | ||||
| Automatic Biopsy | ||||
| System (K141552) | Refer to Table | |||
| 1 below | ||||
| Semi-Automatic | ||||
| Core Biopsy | ||||
| Instrument | Bard® Mission® | |||
| Disposable Core Biopsy | ||||
| Instrument (K171953) | / | Refer to Table | ||
| 2 below | ||||
| Disposable | ||||
| Coaxial Biopsy | ||||
| Needle | BARD® TRUGUIDE® | |||
| Disposable Coaxial | ||||
| Biopsy Needle | ||||
| (K171953) | / | Refer to Table | ||
| 3 below | ||||
| Subject Device | Predicate Device 1 | Predicate Device 2 | ||
| Comparison | ||||
| Elements | Automatic Core Biopsy | |||
| Instrument | BARD® MAX-CORE® | |||
| Disposable Core Biopsy | ||||
| Instrument | Achieve Programmable | |||
| Automatic Biopsy System | Comment | |||
| Classification | ||||
| Regulation | 876.1075 | 876.1075 | 876.1075 | Same |
| Product Code | KNW | KNW | KNW | Same |
| 510(k) Number | - | K133948 | K141552 | / |
| Indications for | ||||
| use | The Automatic Core Biopsy | |||
| Instrument is intended for use | ||||
| in obtaining biopsies from soft | ||||
| tissues such as breast, liver, | ||||
| kidney, prostate, spleen, lymph | ||||
| nodes and various soft tissue | ||||
| tumors. It 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 tumors. It is not intended | ||||
| for use in bone. | The Achieve Programmable | |||
| Automatic Biopsy System is | ||||
| intended for use in obtaining | ||||
| core biopsy samples from soft | ||||
| tissue such as kidney, liver, | ||||
| prostate, spleen, lymph nodes, | ||||
| and various soft tissue masses. | ||||
| Not intended for use in bone. |
The Achieve Programmable
Automatic Biopsy System 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 | Same |
| | | | | partial or complete removal of
the imaged abnormality. |
| Operation
mechanics | Automatic activation and
Automatic mode and delay
mode | Automatic activation | Automatic mode and delay mode | Same |
| Material of
patient contact
component | Stainless steel | Stainless steel | Stainless steel | Same |
| Body contact
site | Breast, liver, kidney, prostate,
spleen, lymph nodes and
various soft tissue tumors | Liver, kidney, prostate, spleen,
lymph nodes and various soft
tissue tumors | Kidney, liver, prostate, spleen,
lymph nodes, various soft tissue
masses and breast | Same |
| Structure | The Automatic Core Biopsy
Instrument contains automatic
activation type (BN-OCR-1,
BN-OCR-2 and BN-OCR-3)
and automatic and delay type
(BN-OCR-6, BN-OCR-7,
BN-OCR-8 and BN-OCR-9).
Automatic activation type is
consisted of inner stylet, cutting
cannula, operating handle, slide
block, actuation button, depth
stopper and protective sheath.
Automatic and delay type is | The device is consisted of handle
and biopsy instrument. The
biopsy instrument is composed of
inner stylet and cutting cannula.
Each needle has numerically
ordered centimeter markings on
the outer cannula to provide
reference for depth placement.
Needles feature an adjustable
needle stop which allows the user
to restrict forward movement,
localizing the needle tip to the
biopsy site. | The device is consisted of
notched stylet, cutting cannula,
firing buttons and charging
handle. | Difference
1 |
| | consisted of inner stylet, cutting
cannula, adjustable knob,
charging handle, operating
handle, security lock and
protective sheath. | Color coded stylet hubs indicate
gauge size of needles available in
a variety of gauge sizes and
centimeter lengths. | | |
| | The cutting cannula has
numerically ordered centimeter
markings on it to provide
reference for depth placement. | | | |
| | An adjustable depth stopper
allows the user to restrict
forward movement, localizing
the needle tip to the biopsy site.
The operating handle is
color-coded, which indicates
gauge size of the needle. | | | |
| Visualization
technique | The introduction of the needle
into the body should be carried
out under imaging guidance
(ultrasound, X-Ray, CT, etc.) | The introduction of the needle
into the body should be carried
out under imaging control
(ultrasound, X-Ray, CT, etc.). | Echogenic markings on both
stylet tip and cannula help
confirm the placement of the
sample notch for precise
ultrasound positioning. | Same |
| Nominal length
of Cutting
Cannula (mm) | 80, 90, 100, 130, 150, 160,180,
200, 250 | 100, 160, 200, 250 | 60, 90, 110, 150, 200, 250 | Difference
2 |
device.
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Table 1: Substantial equivalence comparison of Automatic Core Biopsy Instrument
9
10
11
| Needle size | 14G, 16G, 18G, 20G | 14G, 16G, 18G, 20G | 14G, 16G, 18G, 20G | Same |
|---|---|---|---|---|
| Length of | ||||
| sample notch | ||||
| (mm) | 18.5 mm | 18mm, 19mm | 20mm | Difference |
| 3 | ||||
| Biocompatibility | ISO 10993 series standards | ISO 10993-1, ISO 10993-5 and | ||
| ISO 10993-10 | ISO 10993-1, ISO 10993-5 and | |||
| ISO 10993-10 | Same | |||
| Sterilization | ||||
| method | EO sterilization | EO sterilization | EO sterilization | Same |
| Single use | Yes | Yes | Yes | Same |
● Difference 1: Structure
The structure and working principle of subject devices are basically the same. The components of subject device and predicate devices both include inner stylet, cutting cannula, operating handle, actuation button, and depth stopper, but they are named differently. The function of components of subject devices are the same. The differences in design do not affect the safety and effectiveness of product. In sum, subject device and predicate devices have similar structure.
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Difference 2: Nominal length of Cutting Cannula
It can be seen from the table above that subject device provides more selections on the nominal length of Cutting Cannula, namely 80mm, 130mm and 180mm. Considering the different shape of patients and the distance between needle insertion point and lesion, 80mm. 130mm and 180mm are provided by subject device. Besides, 80mm and 180mm are within the length range (60mm to 250mm) of predicate devices. So this difference does not affect the safety and effectiveness of device. -
Difference 3: Length of sample notch
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The length of subject device is 18.5 mm, and the length of sample notch of predicate devices are 18mm, 19mm and 20mm. Although the lengths are not the same, the length of within the length range of predicate devices. So this difference does not affect the safety and effectiveness of device.
Conclusion
Comparison of the device in question with the predicate devices K141552 is performed, and comparison items include indications for use, operation mechanics, material of paient, component, body contact site, structure, visualization technique, nominal length of Cutting Cannula, needle size, length of sample notch, biocompatibility, sterilization method and single we. It can be concluded that subject device and predicate device perform the same clinical conditions. The differences between the subject device and predicate devices do not affect the safety and effectiveness. Therefore, they can be considered as equivalent devices.
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| Comparison
| Elements | Subject Device | Predicate Device | Comment |
|---|---|---|---|
| Proprietary Name | Semi-Automatic Core Biopsy Instrument | Bard® Mission® Disposable Core Biopsy | |
| Instrument | - | ||
| Classification | |||
| Regulation | 876.1075 | 876.1075 | Same |
| Product Code | KNW | KNW | Same |
| 510(k) Number | - | K171953 | - |
| Indications for use | Semi-Automatic Core Biopsy Instrument is | ||
| intended for use in obtaining biopsies from soft | |||
| tissues such as lung, liver, spleen, kidney, prostate, | |||
| lymph nodes, breast, thyroid, and various soft | |||
| tissue tumors. It is not intended for use in bone. | The BARD® MISSION® Disposable Core Biopsy | ||
| Instrument is intended for use in obtaining biopsy | |||
| samples from soft tissues such as from the lung, | |||
| liver, spleen, kidney, prostate, lymph nodes, breast, | |||
| thyroid, and various soft tissue tumors. It is not | |||
| intended for use in bone. | Same | ||
| Operation | |||
| mechanics | Semi-Automatic | Semi-Automatic | Same |
| Comparison | |||
| Elements | Subject Device | Predicate Device | Comment |
| Material of patient | |||
| content component | Stainless Steel | Stainless Steel | Same |
| Body contact site | Lung, liver, spleen, kidney, prostate, lymph nodes, | ||
| breast, thyroid, and various soft tissue tumors. | Lung, liver, spleen, kidney, prostate, lymph | ||
| nodes, breast, thyroid, and various soft tissue | |||
| tumors. | Same | ||
| Structure | Component/ Design features: Inner stylet, Cutting | ||
| cannula, Fixed handle, Windows, Safety switch, | |||
| Plunger and Protective sheath, Centimeter marking, | |||
| fixed handle, windows, ultrasound enhancement | |||
| (offers enhanced ultrasound visibility of the Inner | |||
| stylet and Cutting cannula). The plunger is | |||
| color-coded, which indicates gauge size of the | |||
| needle. | Component/Design features: Trocar stylet, Coaxial | ||
| cannula, Depth stop, centimeter marks, Ergonomic | |||
| grip design, Fire Ready Indicator, Penetration | |||
| depth indicator, Echogenic technology (offers | |||
| enhanced ultrasound visibility of the stylet needle | |||
| and cutting cannula needle), Protective needle | |||
| sheath. The plunger (is color coded according to | |||
| the various gauge sizes. | Difference 1 | ||
| Visualization | |||
| technique | The introduction of the needle into the body should | ||
| be carried out under imaging guidance (ultrasound, | The introduction of the needle into the body | ||
| should be carried out under imaging guidance | Same | ||
| Comparison | |||
| Elements | Subject Device | Predicate Device | Comment |
| X-Ray, CT, etc.). excluding MRI. | (ultrasound, X-Ray, CT, etc.). excluding MRI. | ||
| Nominal length of | |||
| Cutting Cannula | 8cm, 9cm, 10cm, 13cm, 15cm, 16cm, 18cm, | ||
| 20cm, 25 cm | 10cm, 16cm, 20cm, 25cm | Difference 2 | |
| Needle size | 14G, 16G, 18G, 20G | 14G, 16G, 18G, 20G | Same |
| Penetration depth | 10mm and 20mm | 10mm and 20mm | Same |
| Biocompatibility | ISO 10993 series standards | ISO 10993 series standards | Same |
| Sterilization method | EO sterilization | EO sterilization | Same |
| Single use | YES | YES | Same |
Table 2: Substantial equivalence comparison of Semi-Automatic Core Biopsy Instrument
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Difference 1: Structure ●
The structure and working principle of Subject device are basically the same. The components are both including the Inner stylet, Cutting cannula, fixed handle, Plunger, and Protective sheath with identical appearances, but named differently. Both products are designed with two firing positions and support single-handed operation.
Major differences in structure Compared to Predicate device:
- Fixed Handle: Fixed handle of Subject device adopts a structure of a rectangular cover shell and a base shell. Two complete circular a. rings are designed on the base shell to facilitate effective gripping during operation. In contrast, Predicate device features a symmetrical cover and base shell design, forming open semi-circular rings on both sides when combined, allowing effective gripping.
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- Safety Switch: Subject device includes a safety switch at the end of the fixed handle to prevent accidental firing during the puncture b. process, ensuring safe usage.
- Window Design: The window of Subject device is marked with "10" and "20" indicator lines (with numbers) on both sides. When the C. plunger is pulled, a indicator line appears to show the firing length. Predicate device displays numbers ("(0", "10") directly within the window without using indicator lines.
Above all, The subject device and predicate device have fundamental Scientific Technology, including Mechanism/Mode of Action, and Energy Used/Delivered. These differences changes of structure are ergonomically designed and do not affect the safety and effectiveness of the product.
- Difference 2: Nominal length of Cutting Cannula ●
Due to the different body shapes of patients and the different distances between different lesions and the needle entry point, clinical and market demand, subject product has increased 5 kinds of needle length of 8cm, 15cm and 18cm compared with the predicate product, this will not raise any safety issue.
The above mentioned differences do not raise new questions of safety and effectiveness.
Conclusion
Comparison of the device in question with the predicate devices K171953 is performed, and comparison for use, operation mechanics, material of patient component, body contact site, structure, visualization technique, nominal length of Cutting Cannula, needle size, penetration depths, biocompatibility, sterlization method and single that subject device and predicate device perform the same finical conditions. The differences between the subject device and predicate devices do not affect the safety and effectiveness. Therefore, subject device can be considered as equivalent devices.
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| Comparison Elements | Subject Device | Predicate Device | Comment |
|---|---|---|---|
| Proprietary Name | Disposable Coaxial Biopsy Needle | BARD® TRUGUIDE® Disposable | |
| Coaxial Biopsy Needle | - | ||
| Classification Regulation | 876.1075 | 876.1075 | Same |
| Product Code | KNW | KNW | Same |
| 510(k) Number | - | K171953 | - |
| Indications for use | Intended for use as a guiding needle in | ||
| obtaining core biopsy samples from soft | |||
| tissue such as lung, liver, spleen, kidney, | |||
| prostate, lymph nodes, breast, thyroid and | |||
| various soft tissue tumors. It is designed for | |||
| use with CuraWay Automatic Core Biopsy | |||
| Instrument and CuraWay Semi-Automatic | |||
| Core Biopsy Instrument. It is not intended | |||
| for use in bone. | Intended for use in obtaining biopsy | ||
| samples from soft tissues such as from the | |||
| lung, liver, spleen, kidney, prostate, lymph | |||
| nodes, breast, thyroid, and various soft | |||
| tissue tumors. It is not intended for use in | |||
| bone. | Same | ||
| Material of patient content | |||
| component | Stainless Steel, TPE | Stainless Steel | Difference 1 |
| Body contact site | Soft tissue such as lung, liver, spleen, | ||
| kidney, prostate, lymph nodes, breast, | |||
| thyroid and various soft tissue tumors | lung, liver, spleen, kidney, prostate, lymph | ||
| nodes, breast, thyroid, and various soft | |||
| tissue tumors. | Same | ||
| Structure | ● The Disposable Coaxial Biopsy | ||
| Needle consists of Inner stylet, Cutting | ● The BARD® TRUGUIDE® | ||
| Disposable Coaxial Biopsy Needle is a | Difference 2 | ||
| Comparison Elements | Subject Device | Predicate Device | Comment |
| cannula, Operating handle of cutting cannula, Operating handle of Inner stylet, Blunt needle (optional), Depth stopper, Adapter (optional) and Protective sheath. | |||
| • Design features: Centimeter marks, Color Coding, Ultrasound enhancement. | three part device consisting of an outer cannula with an attached female luer-style lock hub, an inner stylet with an attached male luer-style lock hub, and a flexible slip ring style depth stop. | ||
| • Design features: Centimeter marks, Color Coding, Echogenic Enhancement | |||
| Visualization | |||
| technique | The introduction of the needle into the | ||
| body should be carried out under imaging | |||
| guidance (ultrasound, X-Ray, CT, etc.) | |||
| excluding MRI | The introduction of the needle into the body | ||
| should be carried out under imaging | |||
| guidance (ultrasound, X-Ray, CT, etc.) | |||
| excluding MRI | Same | ||
| Blunt needle | An optional blunt tip stylet is included with | ||
| all gauge size Disposable Coaxial Biopsy | |||
| Needles. | An optional blunt tip stylet is included with | ||
| all 18- and 20-gauge BARD® | |||
| TRUGUIDE® Coaxial Biopsy Needles. | Difference 3 | ||
| Nominal length of Cutting | |||
| Cannula | various sizes, min. 3cm to max. 21.6cm | 7.0-17.8 cm | Difference 4 |
| Needle size | 13G, 15G, 17G, 19G | 11G, 13G, 15G, 17G, 19G | Same |
| Connection type | Luer connection | Luer connection | Same |
| Biocompatibility | ISO 10993 series standards | ISO 10993 series standards | Same |
| Sterilization method | Yes, Ethylene Oxide sterilization | Yes, Ethylene Oxide sterilization | Same |
| Comparison Elements | Subject Device | Predicate Device | Comment |
| Single use | YES | YES | Same |
Table 3: Substantial equivalence comparison of Disposable Coaxial Biopsy Needle
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- Difference 1: Material of patient content component ●
The material used in Disposable Coaxial Biopsy Needle has been tested for biocompatibility in accordance with ISO 1093 for externally communicating devices in contact with tissue for 24 hours or less. The materials in direct patient include the Cutting camula, Inner stylet, and Blunt needle made of stainless steel SUS304, as well as the Depth stopper made of TPE.
Disposable Coaxial Biopsy Needle have successfully been tested for:
- Cytotoxicity
- Sensitization
- Intracutaneously irritation
- Acute Systemic Toxicity
- Pyrogenicity
- Difference 2: Structure ●
The structure and working principle of Subject device are basically the same, but the components named differently. The devices have same fundamental scientific technology, including design, mechanism/mode of action. The only major difference of design is the depth stopper Depth stopper of Subject device is cylinder is narrow at the cylinder is narrow at the top and wide at the bottom), which integrates the function of installing protective sheath. The Predicate device is cylindrical structure with the same diameter of the cylinder.
These changes are ergonomically designed and do not affectiveness of the product. So, similar structure and design concept.
- Difference 3: Blunt needle ●
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The blunt tip stylet may be used to manipulate through soft tissue around vasculature or other organs to minimize the risk of unintentional damage to these areas. The company offers a more comprehensive selection of blunt needle types to reduce injury in clinical applications.
- Difference 4: Nominal length of Cutting Cannula ●
Due to the different body shapes of patients and the different different lesions and the needle entry point, clinical and market demand, subject product has increased more needle lengths compared with the predicate product.
The above mentioned differences do not raise new questions of safety and effectiveness.
Conclusion
Comparison of the device in question with the predicate devices K171953 is performed, and comparison its mass, material of patient contact component, body contact site, structure, blunt needle, nominal length of Cutting Cannula, needle size, comection type, biocompatibility, sterilization method and single use. It can be concluded that subject device perform the same function under the same clinical conditions. The differences between the subject devices do not affect the safety and effectiveness. Therefore, the subject device can be considered as equivalent devices.
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4. Summary of Non-Clinical Testing
CuraWay performed the following bench testing so as to demonstrate the intended use of the products.
4.1 Biological Testing
- In Vitro Cytotoxicity Test (ISO 10993-5: 2009) ●
- Intracutaneous Reactivity Test (ISO 10993-23: 2021)
- Skin Sensitization test (ISO 10993-10: 2021) ●
- Irritation or Intracutaneous Reactivity (ISO 10993-10) ●
- Acute Systemic Toxicity Test (ISO 10993-11: 2017)
- Pyrogen Test (ISO 10993-11: 2017) ●
4.2 Sterilization validation
Sterilization validation is performed according to ISO 11135: 2014, EO and ECH are validated according to ISO 10993-7: 2008. SAL=10-6.
The sterility test is carried out according to ISO 11737-2: 2019.
4.3 Packaging and shelf-life testing
The primary package of the proposed device is intended to maintain the sterility and performances of the product during its claimed shelf life. The testing is carried out in accordance with ASTM F1980: 2016.
4.4 Performance comparison with predicate devices
Comparison test was conducted between the subject devices and predicate devices to compare their performances, including appearance, dimensions, sampling performance, connection firmness, stiffness, toughness, resistance to corrosion, puncture force, chemical properties, etc.
5. Clinical data
No clinical data was provided.
6. Conclusion
The indications for use, design and nonclinical performance testing indicate that the technological characteristics of subject device are equivalent to that of predicate devices. In conclusion, it can be determined that subject device is substantially equivalent to predicate devices.