(193 days)
Not Found
No
The device description explicitly states that the devices are "hand-operated, non-electronic, surgical instruments" and there is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a biopsy needle, used for obtaining tissue samples for pathological examination/testing. This process is diagnostic, not therapeutic, as it does not treat a disease.
Yes
Explanation: The device is used to obtain biopsies from soft tissues, and biopsies are samples taken to diagnose diseases or conditions. The "Intended Use" explicitly states that the device is for "obtaining biopsies," and the "Device Description" states it is for "tissue pathological examination/testing," which is a diagnostic process.
No
The device description explicitly states that the devices are "hand-operated, non-electronic, surgical instruments" and describes their mechanical operation for obtaining tissue samples. There is no mention of software as a component or function of these devices.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment. The devices described here are used to obtain the specimens (tissue samples) from the body.
- The intended use clearly states they are for "obtaining biopsies from soft tissues". This is a surgical procedure to collect a sample, not a test performed on a sample.
- The device descriptions detail the mechanical process of collecting the tissue sample. They do not describe any analytical or diagnostic function performed on the sample itself.
- There is no mention of analyzing or testing the collected tissue by the device. The tissue is collected for "tissue pathological examination/ testing," which would be performed separately in a laboratory using IVD devices.
These devices are surgical instruments used for tissue collection, which is a step prior to in vitro diagnostic testing.
N/A
Intended Use / 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 and lymph nodes. 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 and lymph nodes. 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 and lymph nodes. It is not intended for use in bone.
Product codes (comma separated list FDA assigned to the subject device)
KNW
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 can't be used under MRI.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound, X-ray, CT
Anatomical Site
liver, kidney, prostate, spleen, lung, thyroid and lymph nodes. It is not intended for use in bone.
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 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 9626, ISO 10993 series standards, ISO 11607-1, ISO 11607-2, ASTM F 1980 etc. Results from testing performed confirm the design requirement.
-
- Biocompatibility
The subject devices are externally communicating medical devices with tissue less than 24h which means limited duration. Therefore, as per "Table A.1: Biocompatibility Evaluation Endpoints" of FDA guidance, following items shall be carried out.
- Biocompatibility
Test Items: Cytotoxicity, Maximization Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen Test, Hemolysis.
-
- Package Validation
The primary package of the proposed device is intended to maintain the sterility of the product during its claimed shelf life. The integrity performance as per ISO 11607-1:2019 and ISO 11607-2:2019 is carried out.
- Package Validation
-
- Transport
Subject devices are processed by compression, first vibration, shock and second vibration, and then check. The result indicates that packaging is not damaged.
- Transport
-
- Shelf Life
Accelerated aging was used to simulate the storage of 5 years, then the physical performance tests, chemical performance tests as well as the package integrity tests were performed on the accelerated aged samples. The test results demonstrate that the aged samples complied with the pre-determined acceptance criteria.
- Shelf Life
-
- Comparative Claims/Performance Comparison with predicate devices
The test was conducted to the predicate device and subject device to compare their performance, including scale mark identification, puncture force, biopsy sample testing, stiffness, resistance to breakage, resistance to corrosion, joint strength, total heavy metal content.
- Comparative Claims/Performance Comparison with predicate devices
-
- EO/ECH Residual
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
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.
K133948 BARD® MAX-CORE® Disposable Core Biopsy Instrument, K171953 BARD® MISSION® Disposable Core Biopsy Instrument, K171953 BARD® TRUGUIDE® Disposable Coaxial Biopsy Needle
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
April 3, 2023
Canyon Medical Inc. Huiqi Jiang RA Building 3, Phase 2 Accelerator, No. 11 Yaogu Avenue Jiangbei New Area Nanjing, Jiangsu Province 210032 China
Re: K222865
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: March 3, 2023 Received: March 3, 2023
Dear Huiqi Jiang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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.
| Mark | Digitally signed by |
|---|---|
| Trumbore | Mark Trumbore -S |
| -S | Date: 2023.04.03 |
| 11:20:56-04'00' |
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K222865
Device Name
Automatic Disposable Biopsy Needle Semi-automatic Disposable Biopsy Needle 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 and lymph nodes. 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 and lymph nodes. 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 and lymph nodes. 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
510(k) Summary
4
1. 510(k) Submitter Information:
Submitter Name: Canyon Medical Inc.
Address: Building 3, Phase 2 Accelerator, No. 11 Yaogu Avenue, Jiangbei New Area, 210032, Nanjing, Jiangsu Province, People's Republic of China
Submission Correspondent: Ms. Huiqi Jiang, RA
E-mail: jhq@canyonmedical.com.cn
Telephone: +86-13241196637
2. Date of Preparation: January 24, 2023
| 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 |
3. Subject Device(s) Information:
4. Predicate Device(s) Information:
| Subject device | Predicate device |
|---|---|
| Automatic Disposable | |
| Biopsy Needle | K133948 BARD® MAX-CORE® Disposable Core Biopsy |
| Instrument | |
| Semi-automatic Disposable | |
| Biopsy Needle | K171953 BARD® MISSION® Disposable Core Biopsy |
| Instrument | |
| Coaxial Biopsy Needle | K171953 BARD® TRUGUIDE® Disposable Coaxial Biopsy |
| Needle |
5. 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
5
510(K) Summarv
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 quide 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 can't be used under MRI.
6. 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 and lymph nodes. lt 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 and lymph nodes. 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 and lymph nodes. It is not intended for use in bone.
7. 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
6
devices and predicate devices do not affect the basic design principle, usage, effectiveness and safety of the subject device. Equivalence has been identified as
follows:
| Subject device | Predicate device |
|---|---|
| Automatic Disposable | |
| Biopsy Needle | K133948 BARD® MAX-CORE® Disposable Core Biopsy |
| Instrument | |
| Semi-automatic Disposable | |
| Biopsy Needle | K171953 BARD® MISSION® Disposable Core Biopsy |
| Instrument | |
| Coaxial Biopsy Needle | K171953 BARD® TRUGUIDE® Disposable Coaxial Biopsy |
| Needle |
7
| Item | Subject Device-Canyon | Predicate Device-Bard |
|---|---|---|
| Device | Automatic Disposable Biopsy | |
| Needle | K133948 BARD® MAX-CORE® | |
| Disposable Core Biopsy | ||
| Instrument | ||
| Classification | Class II | Same as subject device |
| Product Code | KNW | Same as subject device |
| Regulation Number | 21 CFR 876.1075 | Same as subject device |
| Regulation Name | Gastroenterology- | |
| Urology Biopsy Instrument | Same as subject device | |
| Indications for Use | 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. | Same as subject device | |
| Target Population | Individuals requiring | |
| biopsy for sampling of | ||
| soft tissue abnormalities | Same as subject device | |
| Operation Mechanics | Single hand automatic activation | Same as subject device |
| Gauge | 12G, 14G, 16G, 18G, 20G | 14G, 16G, 18G, 20G |
| Length (mm) | 100, 130, 160, 200, 250 | 100, 160, 200, 250 |
| Penetration | ||
| Depth | ||
| (mm) | 11, 22 | Same as subject device |
| Slot Size (mm) | 18 | 18, 19 |
| Sterilization | EO Sterilization | Same as subject device |
| Single Use | Yes | Yes |
| Patient-contacting | ||
| Infomarion | Externally communicating device, | |
| in contact with the patient for a | ||
| limited duration (no more than 24 | ||
| hours) | Same as subject device | |
| Biocompatibility | Biocompatible according to ISO | |
| 10993 applicable parts | Biocompatible according to ISO | |
| 10993 applicable parts | ||
| Item | Subject Device-Canyon | Predicate Device-Bard |
| Device | Semi-automatic Disposable Biopsy | |
| Needle | K171953 BARD® MISSION® | |
| Disposable Core Biopsy | ||
| Instrument | ||
| Classification | Class II | Same as subject device |
| Product Code | KNW | Same as subject device |
| Regulation | ||
| Number | 21 CFR 876.1075 | Same as subject device |
| Regulation Name | Gastroenterology- | |
| Urology Biopsy Instrument | Same as subject device | |
| Indications for | ||
| Use | 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. | Same as subject device | |
| Target Population | Individuals requiring | |
| biopsy for sampling of | ||
| soft tissue abnormalities | Same as subject device | |
| Operation | ||
| Mechanics | Single hand semi-automatic activation | Same as subject device |
| Gauge | 14G, 16G, 18G, 20G | 14G, 16G, 18G, 20G |
| Length (mm) | 60, 100, 130, 160, 200, 250, 300 | 60, 100, 160, 200, 250 |
| Penetration Depth | ||
| (mm) | 10, 20 | Same as subject device |
| Sterilization | EO Sterilization | Same as subject device |
| Single Use | Yes | Yes |
| Patient-contacting | ||
| Information | Externally communicating device, in | |
| contact with the patient for a limited | ||
| duration (no more than 24 hours) | Same as subject device | |
| Biocompatibility | Biocompatible according to ISO 10993 | |
| applicable parts | Biocompatible according to | |
| ISO 10993 applicable parts |
Table 1. Comparison of the Automatic Disposable Biopsy Needle to the predicate device.
8
Table 2. Comparison of the Semi-automatic Disposable Biopsy Needle to the predicate device.
9
| Item | Subject Device-Canyon | Predicate Device-Bard |
|---|---|---|
| Device | Coaxial Biopsy Needle | K171953 BARD® TRUGUIDE® |
| Disposable Coaxial Biopsy Needle | ||
| Classification | Class II | Same as subject device |
| Product Code | KNW | Same as subject device |
| Regulation Number | 21 CFR 876.1075 | Same as subject device |
| Regulation Name | Gastroenterology- | |
| Urology Biopsy Instrument | Same as subject device | |
| 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. It is not intended for use | ||
| in bone | Same as subject device | |
| Operation Mechanics | Single hand automatic activation | Same as subject device |
| Target Population | Individuals requiring | |
| biopsy for sampling of | ||
| soft tissue abnormalities | Same as subject device | |
| Gauge | 13G, 15G, 17G, 19G | 11G, 13G, 15G, 17G, 19G |
| Sterilization | EO Sterilization | Same as subject device |
| Single use | Yes | Yes |
| Patient contacting | Externally communicating device, in | |
| contact with the patient for a limited | ||
| duration (no more than 24 hours) | Same as subject device | |
| Biocompatibility | Biocompatible according to ISO | |
| 10993 applicable parts | Biocompatible according to ISO | |
| 10993 applicable parts |
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:
- · Same 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.
10
8. Summary of Non-Clinical Testing
Summary of non-clinical and performance bench testing was performed to evaluate the performance and functionality of the subject device aqainst requirement specification. The subject device has been subjected to compliance testing according to, by FDA, recognized consensus standards ISO 9626, ISO 10993 series standards, ISO 11607-1, ISO 11607-2, ASTM F 1980 etc. Results from testing performed confirm the design requirement.
-
- Biocompatibility
The subject devices are externally communicating medical devices with tissue less than 24h which means limited duration. Therefore, as per "Table A.1: Biocompatibility Evaluation Endpoints" of FDA quidance, following items shall be carried out.
- Biocompatibility
| No. | Test Item | Standard |
|---|---|---|
| 1 | Cytotoxicity | ISO10993-5:2009 |
| 2 | Maximization Sensitization | ISO10993-10:2010 |
| 3 | Intracutaneous Reactivity | ISO10993-10:2010 |
| 4 | Acute Systemic Toxicity | ISO10993-11:2017 |
| 5 | Pyrogen Test | ISO10993-11:2017/ USP General Chapter |
| 6 | Hemolysis | ISO 10993-4:2017 |
-
- Package Validation
The primary package of the proposed device is intended to maintain the sterility of the product during its claimed shelf life. The integrity performance as per ISO 11607-1:2019 and ISO 11607-2:2019 is carried out.
- Package Validation
-
- Transport
Subject devices are processed by compression, first vibration, shock and second vibration, and then check. The result indicates that packaging is not damaged.
- Transport
-
- Shelf Life
Accelerated aging was used to simulate the storage of 5 years, then the physical performance tests, chemical performance tests as well as the package integrity tests were performed on the accelerated aged samples. The test results demonstrate that the aged samples complied with the pre-determined acceptance criteria.
- Shelf Life
-
- Comparative Claims/Performance Comparison with predicate devices
The test was conducted to the predicate device and subject device to compare their performance, including scale mark identification, puncture force, biopsy sample testing, stiffness, resistance to breakage, resistance to corrosion, joint strength, total heavy metal content.
- Comparative Claims/Performance Comparison with predicate devices
11
6) EO/ECH Resudial
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.
9. Preclinical (Animal) Studies
Bench testing is sufficient to demonstrate performance of the device. No preclinical testing of the subject device is necessary.
10. Clinical Test
No. Use of biopsy needle is proven technology and is well accepted by the medical community. Performance Test is sufficient to demonstrate safety and effectiveness of the subject devices with the predicate devices.
11. Conclusion
The differences between both devices are insignificant in terms of safety and effectiveness. The conclusions drawn from information above demonstrate that the proposed devices are as safe, as effective, and performs as well as the legally marketed predicate devices and raises no new risks of safety or effectiveness.