M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle

Q: Who is the manufacturer of M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle?

Canyon Medical, Inc. filed the 510(k) submission for M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle (K233031).

Q: What is the FDA product code for M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle?

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

Q: What is the regulatory pathway for M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle?

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

Q: What are the predicate devices for M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle?

Automatic Disposable Biopsy Needle (K222865); Semi-automatic Disposable Biopsy Needle (K222865); Coaxial Biopsy Needle (K222865).

Q: Who can help prepare an FDA 510(k) submission like M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle?

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

K233031 · Canyon Medical, Inc. · KNW · Jan 17, 2024 · Gastroenterology, Urology

Device Facts

Record ID	K233031
Device Name	M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle
Applicant	Canyon Medical, Inc.
Product Code	KNW · Gastroenterology, Urology
Decision Date	Jan 17, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1075
Device Class	Class 2

Intended Use

Automatic Disposable Biopsy Needle: Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone. Semi-automatic Disposable Biopsy Needle: Semi-Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone. Coaxial Biopsy Needle: Coaxial Biopsy Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone.

Device Story

Hand-operated, non-electronic surgical instruments for soft tissue biopsy. Automatic and semi-automatic needles extract tissue samples via spring-loaded firing mechanisms; coaxial needles guide biopsy needle insertion under imaging (ultrasound, X-ray, CT). Used in clinical settings by physicians. Automatic needle: inner rod enters lesion, outer tube fires to cut and capture sample in groove. Semi-automatic needle: manual advancement of inner needle, spring-loaded outer cannula fires to cut. Optional swab component assists in specimen removal. Single-use, sterile. Output is a tissue core sample for pathological examination. Benefits include minimal surrounding tissue damage during extraction.

Clinical Evidence

No human clinical trials. Evidence consists of in vivo animal biopsy sampling performance comparison against predicate devices (K133948 and K171953) to validate expanded indications, and bench testing for the new swab component (functionality, sterility, shelf-life, EO/ECH residuals).

Technological Characteristics

Hand-operated, non-electronic, single-use, sterile (EO) biopsy needles. Materials meet ISO 10993 biocompatibility standards. Coaxial needles include trocar tip stylets. Swab component added for specimen handling. Standards: ISO 11607-1/2 (packaging), ASTM F 1980 (accelerated aging), ISO 10993-7 (EO/ECH residuals).

Indications for Use

Indicated for obtaining core biopsy samples from soft tissues (liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast, muscle) in patients requiring biopsy for soft tissue abnormalities. Not indicated for use in bone.

Regulatory Classification

Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Predicate Devices

Automatic Disposable Biopsy Needle (K222865)
Semi-automatic Disposable Biopsy Needle (K222865)
Coaxial Biopsy Needle (K222865)

Reference Devices

Biopsy needle (K133948)
Biopsy needle (K171953)

Related Devices

K222865 — M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle · Canyon Medical, Inc. · Apr 3, 2023
K210946 — Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles · Promisemed Hangzhou Meditech Co., Ltd. · Aug 12, 2021
K241793 — Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle · Zhejiang Curaway Medical Technology Co., Ltd. · Jan 24, 2025
K162588 — Möller Medical Biopsy Needles and Systems · Moller Medical GmbH · Jun 19, 2017
K171953 — Bard Mission Disposable Core Biopsy Instrument · Bard Peripheral Vascular, Inc. · Sep 14, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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. January 17, 2024 Canyon Medical Inc. Mingzhi Jin, RA Building 3, Phase 2 Accelerator, No. 11 Yaogu Avenue, Jiangbei New Area. Jiangsu Province Nanjing, 210032 China Re: K233031 Trade/Device Name: M Biopsy /SureCore Automatic Disposable Biopsy Needle. M Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: September 25, 2023 Received: September 25, 2023 Dear Mingzhi Jin: 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. 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" {1}------------------------------------------------ (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 OS 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. 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-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, Jessica Carr -S Jessica Carr, PhD 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 {2}------------------------------------------------ # Indications for Use #### 510(k) Number (if known) K233031 #### Device Name M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle Indications for Use (Describe) Automatic Disposable Biopsy Needle: Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone. Semi-automatic Disposable Biopsy Needle: Semi-Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone. Coaxial Biopsy Needle: Coaxial Biopsy Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X 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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows a logo for Canyon. The logo features two intertwined shapes resembling hearts or stylized letter 'C's. One shape is colored in blue, while the other is in yellow. Below the intertwined shapes, the word 'CANYON' is written in a stylized font, with the 'Y' colored in yellow to match the upper shape. # 1. 510(k) Owner Canyon Medical Inc. # 2. Submission Correspondent Submitter: Ms. Mingzhi Jin, RA E-mail: imz@canyonmedical.com.cn Telephone number: +86 13275719503 Address: Building 3, Phase 2 Accelerator, No. 11 Yaogu Avenue, Jiangbei New Area, 210032, Nanjing, Jiangsu Province People's Republic of China # 3. Date of Preparation: January 13, 2024 ## 4. Subject Device(s) Information | Common Name: | Automatic Disposable Biopsy Needle Semi-automatic Disposable Biopsy Needle Coaxial Biopsy Needle | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name: | M·Biopsy /SureCore Automatic Disposable Biopsy Needle M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle M·Biopsy /SureAim Coaxial Biopsy Needle | | Regulation Number: | 21 CFR 876.1075 | | Classification Name: | Instrument, Biopsy | | Device Class: | II | | Product Code: | KNW | | Review Panel: | Gastroenterology/Urology | #### 5. Predicate Device(s) Information | Subject device | Predicate device - K222865 | |-----------------------------------------|-----------------------------------------| | Automatic Disposable Biopsy Needle | Automatic Disposable Biopsy Needle | | Semi-automatic Disposable Biopsy Needle | Semi-automatic Disposable Biopsy Needle | | Coaxial Biopsy Needle | Coaxial Biopsy Needle | # 6. Device Description Automatic Disposable Biopsy Needle, Semi-automatic Disposable Biopsy Needle and Coaxial Biopsy Needle are hand-operated, non-electronic, surgical instruments. Automatic Disposable Biopsy Needle is designed for the automatic extraction of a specimen from soft tissues, while causing minimal surrounding tissue damage, for {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows a logo with the word "CANYON" in bold, sans-serif font. The "C" and "Y" are in yellow, while the "A", "N", "O", and "N" are in blue. Above the word "CANYON" is a stylized heart shape, with the left side in blue and the right side in yellow. The logo appears to be for an organization or company named Canyon. tissue pathological examination/ testing. Automatic Disposable Biopsy Needle is first loaded and then inserted into the edge of the target tissue. Then, the inner needle rod is threaded into the target lesion (automatic firing), then, the outer needle tube is fired to push forward, and the tissue sample is cut through the relative movement of the outer needle tube and the inner needle rod of the biopsy needle, later, the tissue sample is cut off and stored in the sampling groove. Finally, specimen was removed after withdrawing the biopsy needle. Semi-automatic Disposable Biopsy Needle is designed for the extraction of a specimen from soft tissues, while causing minimal surrounding tissue damage, for tissue pathological examination/testing. The semi-automated biopsy needle requires manual advancement of the inner needle to expose the specimen notch. With pressure on its plunger, a spring action rapidly advances the outer needle (cutting cannula) over the specimen notch of the inner needle. Coaxial Biopsy Needle is used with biopsy needles to guide the insertion of biopsy needle into the soft tissue under imaging control (ultrasound, X-ray, CT, etc.). It is supplied with trocar tip stylet with or without blunt tip needle. All of these devices are sterile with a Sterility Assurance Level (SAL) of 10-6, nonpyrogenic and single-use devices. The ultrasound, X-ray, CT and other equipments are used to guide the puncture and sampling. These devices cannot be used under MRI. #### 7. Indications for Use Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone. Semi-Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone. Coaxial Biopsy Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone. #### 8. Purpose of Submission The purpose of this submission is to introduce some modifications to the products {5}------------------------------------------------ Image /page/5/Picture/1 description: The image is a logo with a stylized heart shape. The top left portion of the heart is blue, while the top right portion is yellow. Below the heart shape, the word "CANYON" is written in blue, with the "Y" in yellow. The logo is simple and modern, with a focus on color and shape. base on K222865. 1) Extend indications; 2) Add a component (swab) which can be used optionally to help take the biopsy specimen for further diagnosis preparation to the Automatic and Semi-automatic Disposable Biopsy Needle; 3) Add some models within previous specifications (K222865). The specifications of the new models are within the previously approved specification range (Automatic Disposable Biopsy Needle are available in specification range from 12G to 20G; Semiautomatic Disposable Biopsy Needle are available in specification range from 14G to 20G; Coaxial Biopsy Needle are available in specification range from 13G to 19G). ## 9. Technical Characteristics The subject devices are substantially equivalent to the predicate devices in terms of intended use and technological characteristics. The differences between the subject devices and predicate devices do not affect the basic design principle, usage, effectiveness and safety of the subject device. The technological characteristics of the subject devices are identical to those of predicate devices, with the exception of the following design changes: 1) More soft tissues types for indication - breast and muscle 2) A new component swab which can be used optionally to help take the biopsy specimen for further diagnosis preparation 3) Add some models within previous specifications (K222865) Equivalence has been identified as follows: | Subject device | Predicate device - K222865 | |-----------------------------------------|-----------------------------------------| | Automatic Disposable Biopsy Needle | Automatic Disposable Biopsy Needle | | Semi-automatic Disposable Biopsy Needle | Semi-automatic Disposable Biopsy Needle | | Coaxial Biopsy Needle | Coaxial Biopsy Needle | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a logo for Canyon. The logo features two stylized shapes resembling intertwined hearts or loops, one in blue and the other in yellow. Below the shapes, the word "CANYON" is written in a sans-serif font, with the "Y" colored in yellow to match the loop above it. The overall design is simple and modern. # Table 1. Comparison of the Automatic Disposable Biopsy Needle to the predicate device. | Item | Subject Device-Canyon | Predicate Device-Canyon | | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device | Automatic Disposable Biopsy Needle | K222865 Automatic Disposable Biopsy Needle | Comments | | Classification | Class II | Class II | Same | | Product Code | KNW | KNW | Same | | Regulation Number | 21 CFR 876.1075 | 21 CFR 876.1075 | Same | | Regulation Name | Gastroenterology- Urology Biopsy Instrument | Gastroenterology- Urology Biopsy Instrument | Same | | Indications for Use | Intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone. | Intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid and lymph nodes. It is not intended for use in bone. | This change is to add new indications (breast and muscle). As for new indications, Canyon conducted sampling performance comparison with previously chosen predicate in K222865 to ensure the biopsy needles can be used on the new types of soft tissues. | | Target Population | Individuals requiring biopsy for sampling of soft tissue abnormalities | Individuals requiring biopsy for sampling of soft tissue abnormalities | Same | | Operation Mechanics | Single hand automatic activation | Single hand automatic activation | Same | | Gauge | 12G, 14G, 16G, 18G, 20G | 12G, 14G, 16G, 18G, 20G | Same | | Length (mm) | 100, 130, 160, 200, 250 | 100, 130, 160, 200, 250 | Same | | Penetration Depth (mm) | 11, 22 | 11, 22 | Same | | Slot Size (mm) | 18 | 18 | Same | | Sterilization | EO Sterilization | EO Sterilization | Same | | Single Use | Yes | Yes | Same | | Patient- contacting Information | Externally communicating device, in contact with the patient for a limited duration (no more than 24 hours) | Externally communicating device, in contact with the patient for a limited duration (no more than 24 hours) | Same | | Biocompatibility | Biocompatible according to ISO 10993 applicable parts | Biocompatible according to ISO 10993 applicable parts | Same | | Item | Subject Device-Canyon | Predicate Device-Canyon | Comments | | Device | Semi-automatic Disposable Biopsy Needle | K222865 Semi-automatic Disposable Biopsy Needle | | | Classification | Class II | Class II | Same | | Product Code | KNW | KNW | Same | | Regulation Name | Gastroenterology-Urology Biopsy Instrument | Gastroenterology-Urology Biopsy Instrument | Same | | Regulation Number | 21 CFR 876.1075 | 21 CFR 876.1075 | Same | | Indications for Use | Intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid, lymph nodes, breast and muscle. It is not intended for use in bone. | Intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid and lymph nodes. It is not intended for use in bone. | This change is to add new indications (breast and muscle). As for new indications, Canyon conducted sampling performance comparison with previously chosen predicate in K222865 to ensure the biopsy needles can be used on the new types of soft tissues. | | Target Population | Individuals requiring biopsy for sampling of soft tissue abnormalities | Individuals requiring biopsy for sampling of soft tissue abnormalities | Same | | Operation Mechanics | Single hand semi-automatic activation | Single hand semi-automatic activation | Same | | Gauge | 14G, 16G, 18G, 20G | 14G, 16G, 18G, 20G | Same | | Length (mm) | 60, 100, 130, 160, 200, 250, 300 | 60, 100, 130, 160, 200, 250, 300 | Same | | Penetration Depth (mm) | 10, 20 | 10, 20 | Same | | Sterilization | EO Sterilization | EO Sterilization | Same | | Single Use | Yes | Yes | Same | | Patient- contacting Information | Externally communicating device, in contact with the patient for a limited duration (no more than 24 hours) | Externally communicating device, in contact with the patient for a limited duration (no more than 24 hours) | Same | | Biocompatibility | Biocompatible according to ISO 10993 applicable parts | Biocompatible according to ISO 10993 applicable parts | Same | | Item | Subject Device-Canyon | Predicate Device-Canyon | | | Device | Coaxial Biopsy Needle | K222865 Coaxial Biopsy Needle | Comments | | Classification | Class II | Class II | Same | | Product Code | KNW | KNW | Same | | Regulation Number | 21 CFR 876.1075 | 21 CFR 876.1075 | Same | | Regulation Name | Gastroenterology- Urology Biopsy Instrument | Gastroenterology- Urology Biopsy Instrument | Same | | Indications for Use | Intended for use as a guiding needle in obtaining core biopsy samples from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid and lymph nodes, breast and muscle. It is not intended for use in bone | Intended for use as a guiding needle in obtaining core biopsy samples from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid and lymph nodes. It is not intended for use in bone. | This change is to add new indications (breast and muscle). As for new indications, Canyon conducted sampling performance comparison with previously chosen predicate in K222865 to ensure the biopsy needles can be used on the new types of soft tissues. | | Operation Mechanics | Single hand automatic activation | Single hand automatic activation | Same | | Target Population | Individuals requiring biopsy for sampling of soft tissue abnormalities | Individuals requiring biopsy for sampling of soft tissue abnormalities | Same | | Gauge | 13G, 14G, 15G, 16G, 17G, 18G, 19G | 13G, 15G, 17G, 19G | This change is to add new gauges, the gauges to be added are all within the previous cleared specifications of K222865. | | Sterilization | EO Sterilization | EO Sterilization | Same | | Single use | Yes | Yes | Same | | Patient contacting | Externally communicating device, in contact with the patient for a limited duration (no more than 24 hours) | Externally communicating device, in contact with the patient for a limited duration (no more than 24 hours) | Same | | Biocompatibility | Biocompatible according to ISO 10993 applicable parts | Biocompatible according to ISO 10993 applicable parts | Same | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows a logo for Canyon. The logo features two intertwined shapes resembling hearts or stylized letter 'C's. One shape is colored blue, and the other is yellow. Below the shapes, the word 'CANYON' is written in a sans-serif font, with the 'Y' in yellow to match the color of the shape above it. 510(k) Summary (K233031) # Table 2. Comparison of the Semi-automatic Disposable Biopsy Needle to the predicate device. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows a logo for Canyon. The logo consists of two intertwined shapes, one in blue and one in yellow, forming a heart-like design. Below the shapes, the word "CANYON" is written, with the "Y" in yellow to match the color of the shape above it. The overall design is simple and modern. Table 3. Comparison of the Coaxial Biopsy Needle to the predicate device. The technological characteristics of the subject device are identical to those of predicate device. The subject device has the same basic design as the predicate device. The comparison between the subject and predicate devices is based on the following: - Similar indications for use - Same material types that meet ISO 10993 biocompatibility requirements - · Same sterilization methods - · Same fundamental technology There is no significant risk raised by the difference. {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows a logo for Canyon. The logo features two intertwined shapes resembling hearts or stylized letter 'C's. One shape is blue, and the other is yellow. Below the shapes, the word "CANYON" is written in a sans-serif font, with the 'O' in yellow, matching the color of the heart shape above it. # 10. Summary of Non-Clinical Testing Based on the purpose of this submission and as for the targeted design changes, we explicate and support with following: ## 10.1 As for indication extension We conducted in vivo biopsy sampling from animal to compare the sampling performance of the subject devices and comparator devices (K133948 and K171953) , and the results indicated no substantial difference. ## 10.2 As for the addition of swab Summary of non-clinical and performance bench testing was performed to evaluate the performance and functionality of the subject device against requirement specification. The subject device has been subjected to compliance testing according to, by FDA, recognized consensus standards ISO 11607-1, ISO 11607-2, ASTM F 1980 etc. ## 1) Biocompatibility Since this component does not contact with the patient, therefore, biocompatibility test is unnecessary. # 2) Package Validation and Transport The swab is packaged in the previous package of Automatic Disposable Biopsy Needle and Semi-automatic Disposable Biopsy Needle without any other modification, therefore, no more test is carried out. #### 3) Sterility test In order to ensure the sterility, the sterility test is carried out and the result meets the requirement. ## 4) Swab performance and shelf life Overall requirement: the swab shall can help take the soft tissue Performance 1: the tissue strip should be successfully removed from the sampling tank, and there should be no impurities such as dander (exfoliation of the swab) in the tissue strip. Performance 2: after helping take soft tissue, the swab head should be complete, no broken, and no residual tissue strip on the swab head. Performance 3: shelf life: 5 years Accelerated aging was used to simulate the storage of 5 years, then the physical performance tests and chemical performance tests were performed on the accelerated aged samples. The test results demonstrate that the aged samples complied with the pre-determined acceptance criteria. {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows a logo for Canyon. The logo features two interlocking shapes, one in blue and one in yellow, that resemble stylized hearts or loops. Below the shapes, the word "CANYON" is written in a sans-serif font, with the "Y" colored yellow to match the yellow shape above. The overall design is simple and modern, with a focus on the interlocking shapes and the contrasting colors. #### EO/ECH Residual 5) Examination of the EO and ECH residuals have been conducted in accordance with ISO 10993-7:2008+Amd.1:2019 to evaluate whether the sterilized proposed device comply with the above selected allowable limits, and the results meet the requirements. EO/ECH residual testing is based on the whole product of biopsy needle and the swab. # 10.3 As for the addition of product models Since the models to be added are all within the previous cleared specifications of K222865. Therefore, as this change, no more tests are needed. ## 11. Conclusion The conclusions drawn from the comparison and analysis above demonstrate that the proposed subject devices are as safe, as effective, and performs as well as the legally marketed predicate devices and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.