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.

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 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.

AI/ML Overview

The provided text is a 510(k) premarket notification for M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, and M Biopsy /SureAim Coaxial Biopsy Needle. It primarily focuses on demonstrating substantial equivalence to a predicate device (K222865) based on design modifications. These modifications include extending indications to breast and muscle tissues, adding a swab component, and introducing new models within existing specifications.

Crucially, this document does not contain the acceptance criteria or a detailed study proving the device meets those criteria in the way typically expected for a software-based AI/ML medical device submission (e.g., performance metrics like sensitivity, specificity, AUC). The tests described are primarily related to the physical performance, biocompatibility, and sterility of the biopsy needles themselves, and their ability to obtain tissue samples. The "study" mentioned for the indication extension is an in vivo biopsy sampling from animal to compare the sampling performance.

Therefore, I cannot provide a detailed answer to your request in the format you've specified because the provided document does not contain the information about acceptance criteria and a study proving the device meets them in the context of an AI/ML device per your typical requirements.

Here's what can be extracted and inferred based on the provided document, addressing the points you requested, but with the caveat that it does not fit the typical AI/ML device study format:

Acceptance Criteria and Study for M Biopsy /SureCore and /SureAim Biopsy Needles

The provided document describes the safety and performance testing for a medical device (biopsy needles) which is not an AI/ML device. The "acceptance criteria" and "study" are therefore presented in terms of device functionality, material compatibility, and intended use as a physical instrument, rather than diagnostic performance metrics (e.g., sensitivity, specificity, AUC) typically associated with AI/ML systems.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implied/Stated)	Reported Device Performance/Findings
For Indication Extension (Breast & Muscle)	Biopsy needles can be used on new types of soft tissues (breast and muscle) with comparable sampling performance to the predicate device.	"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." (This implicitly indicates the performance was acceptable for the new indications, in comparison to an already cleared device).
For Addition of Swab - Performance	Performance 1: Tissue strip should be successfully removed from the sampling tank, with no impurities (e.g., dander/exfoliation) 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.	"The test results demonstrate that the aged samples complied with the pre-determined acceptance criteria." (This general statement applies to the swab performance specifications after accelerated aging).
For Addition of Swab - Shelf Life	Shelf life: 5 years (maintained physical and chemical performance after simulated aging).	"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."
Biocompatibility	All patient-contacting components must be biocompatible according to ISO 10993 applicable parts. (Note: Swab is not patient-contacting, so no biocompatibility test required).	"Biocompatible according to ISO 10993 applicable parts" (Stated as a characteristic, implying it meets this criterion). "Since this component [swab] does not contact with the patient, therefore, biocompatibility test is unnecessary."
Sterility	SAL of 10-6. The swab component should also be sterile.	"All of these devices are sterile with a Sterility Assurance Level (SAL) of 10-6..." "In order to ensure the sterility, the sterility test is carried out and the result meets the requirement."
Package Validation and Transport	Packaging integrity and maintenance of sterility.	"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." (Implies prior validation of the packaging covers the new component).
EO/ECH Residuals	Residuals must be within allowable limits according to ISO 10993-7:2008+Amd.1:2019.	"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."
Addition of Product Models	New models must be within previously cleared specifications and not raise new questions of safety or effectiveness.	"Since the models to be added are all within the previous cleared specifications of K222865. Therefore, as this change, no more tests are needed." (Implies compliance by bounding the previously cleared range).
General Equivalence	Device is as safe, as effective, and performs as well as legally marketed predicate devices, raising no new questions of safety or effectiveness.	"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."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated as a number of "cases" or "patients" in the context of a diagnostic test. For the in vivo animal study, the sample size is not specified. For the swab performance testing, "aged samples" are mentioned, but the quantity is not detailed.
Data Provenance: The in vivo animal study data provenance is not specified (e.g., country of origin). The studies are "non-clinical testing" conducted by Canyon Medical Inc. (China). The data for physical/chemical tests (shelflife, EO/ECH residuals) would be from in-house lab testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This is not applicable to this submission. The "ground truth" for these physical medical devices is established through engineering and biological testing (e.g., successful tissue sample retrieval, material integrity, sterility, biocompatibility), not through expert clinical consensus on diagnostic images.

4. Adjudication Method for the Test Set

This is not applicable as there is no diagnostic test performance being adjudicated by multiple experts for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not conducted because this is a physical biopsy needle, not a software-based AI/ML device that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone performance evaluation was not done. This is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

Physical Performance Bench Testing: Verification that the device can successfully obtain tissue samples, the swab functions as intended (tissue removal, no residue), and the dimensions/mechanics are within specifications.
Material Testing: Biocompatibility testing (per ISO 10993), sterility testing (per SAL 10-6 requirements), EO/ECH residual testing (per ISO 10993-7).
Animal Studies: For the extended indications (breast and muscle), performing in vivo biopsy sampling in animals to compare performance with predicate devices.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set was Established

This is not applicable.

Summary

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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"

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(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

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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:

Semi-automatic Disposable Biopsy Needle:

Coaxial Biopsy Needle:

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)

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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 NeedleSemi-automatic Disposable Biopsy NeedleCoaxial Biopsy Needle
Trade Name:	M·Biopsy /SureCore Automatic Disposable Biopsy NeedleM·Biopsy /SureCore Semi-automatic Disposable Biopsy NeedleM·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

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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.

7. Indications for Use

8. Purpose of Submission

The purpose of this submission is to introduce some modifications to the products

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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.

Extend indications;
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;
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:

More soft tissues types for indication - breast and muscle
A new component swab which can be used optionally to help take the biopsy specimen for further diagnosis preparation
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

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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 DisposableBiopsy Needle	K222865 AutomaticDisposable 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 forUse	Intended for use inobtaining biopsies from softtissues such as liver,kidney, prostate, spleen,lung, thyroid, lymph nodes,breast and muscle. It is notintended for use in bone.	Intended for use in obtainingbiopsies from soft tissuessuch as liver, kidney,prostate, spleen, lung,thyroid and lymph nodes. Itis not intended for use inbone.	This change is to add newindications (breast andmuscle). As for newindications, Canyonconducted samplingperformance comparisonwith previously chosenpredicate in K222865 toensure the biopsy needlescan be used on the newtypes of soft tissues.
TargetPopulation	Individuals requiringbiopsy for sampling ofsoft tissue abnormalities	Individuals requiringbiopsy for sampling ofsoft tissue abnormalities	Same
OperationMechanics	Single hand automaticactivation	Single hand automaticactivation	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
PenetrationDepth (mm)	11, 22	11, 22	Same
Slot Size (mm)	18	18	Same
Sterilization	EO Sterilization	EO Sterilization	Same
Single Use	Yes	Yes	Same
Patient-contactingInformation	Externally communicatingdevice, in contact with thepatient for a limitedduration (no more than 24hours)	Externally communicatingdevice, in contact with thepatient for a limited duration(no more than 24 hours)	Same
Biocompatibility	Biocompatible according toISO 10993 applicable parts	Biocompatible according toISO 10993 applicable parts	Same
Item	Subject Device-Canyon	Predicate Device-Canyon	Comments
Device	Semi-automatic DisposableBiopsy Needle	K222865 Semi-automaticDisposable 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 forUse	Intended for use in obtainingbiopsies from soft tissuessuch as liver, kidney,prostate, spleen, lung,thyroid, lymph nodes, breastand muscle. It is notintended for use in bone.	Intended for use in obtainingbiopsies from soft tissuessuch as liver, kidney,prostate, spleen, lung,thyroid and lymph nodes. Itis not intended for use in bone.	This change is to add newindications (breast andmuscle). As for newindications, Canyonconducted samplingperformance comparisonwith previously chosenpredicate in K222865 toensure the biopsy needlescan be used on the newtypes of soft tissues.
TargetPopulation	Individuals requiringbiopsy for sampling ofsoft tissue abnormalities	Individuals requiringbiopsy for sampling ofsoft tissue abnormalities	Same
OperationMechanics	Single hand semi-automaticactivation	Single hand semi-automaticactivation	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
PenetrationDepth (mm)	10, 20	10, 20	Same
Sterilization	EO Sterilization	EO Sterilization	Same
Single Use	Yes	Yes	Same
Patient-contactingInformation	Externally communicatingdevice, in contact with thepatient for a limited duration(no more than 24 hours)	Externally communicatingdevice, in contact with thepatient for a limited duration(no more than 24 hours)	Same
Biocompatibility	Biocompatible according toISO 10993 applicable parts	Biocompatible according toISO 10993 applicable parts	Same
Item	Subject Device-Canyon	Predicate Device-Canyon
Device	Coaxial Biopsy Needle	K222865 Coaxial BiopsyNeedle	Comments
Classification	Class II	Class II	Same
Product Code	KNW	KNW	Same
RegulationNumber	21 CFR 876.1075	21 CFR 876.1075	Same
RegulationName	Gastroenterology-Urology Biopsy Instrument	Gastroenterology-Urology Biopsy Instrument	Same
Indications forUse	Intended for use as aguiding needle in obtainingcore biopsy samples fromsoft tissues such as liver,kidney, prostate, spleen,lung, thyroid and lymphnodes, breast and muscle. Itis not intended for use inbone	Intended for use as aguiding needle in obtainingcore biopsy samples fromsoft tissues such as liver,kidney, prostate, spleen,lung, thyroid and lymphnodes. It is not intended foruse in bone.	This change is to add newindications (breast andmuscle). As for newindications, Canyonconducted samplingperformance comparisonwith previously chosenpredicate in K222865 toensure the biopsy needlescan be used on the newtypes of soft tissues.
OperationMechanics	Single hand automaticactivation	Single hand automaticactivation	Same
TargetPopulation	Individuals requiringbiopsy for sampling ofsoft tissue abnormalities	Individuals requiringbiopsy for sampling ofsoft tissue abnormalities	Same
Gauge	13G, 14G, 15G, 16G, 17G,18G, 19G	13G, 15G, 17G, 19G	This change is to add newgauges, the gauges to beadded are all within theprevious clearedspecifications of K222865.
Sterilization	EO Sterilization	EO Sterilization	Same
Single use	Yes	Yes	Same
Patientcontacting	Externally communicatingdevice, in contact with thepatient for a limited duration(no more than 24 hours)	Externally communicatingdevice, in contact with thepatient for a limited duration(no more than 24 hours)	Same
Biocompatibility	Biocompatible according toISO 10993 applicable parts	Biocompatible according toISO 10993 applicable parts	Same

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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.

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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.

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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.

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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.

Regulation Number and Section

§ 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.