(257 days)
It is used for percutaneous puncture to the renal pelvis, establishing a percutaneous approach and providing access for endoscopes and surgical instruments.
The product consists of a needle tube, a needle hub, a rear end, equipment channel interface E, fiber image channel interface F, irrigation channel interface I, an obturator, a needle-free joint and a two-way water valve, and that primary package of the product contains a protective sleeve which is only used for product protection. The product is sterilized by ethylene oxide and is single use.
The provided text is a 510(k) summary for an "Introducer Needle" device. It outlines the device's comparison to a predicate device and the performance data submitted to demonstrate substantial equivalence. However, it does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
The performance data section (9. Performance Data) details physical and chemical performance testing, biocompatibility testing, and packaging/shelf-life testing, which are standard for medical devices like introducer needles. These tests are to demonstrate the device meets design requirements and performs as intended, but they do not involve acceptance criteria related to algorithmic performance, expert image interpretation, or human reader improvement with AI assistance.
Therefore, I cannot provide the requested information about acceptance criteria, a study proving device meets acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment in the context of an AI/ML device, as this document pertains to a physical medical device.
Here's what I can extract from the provided text regarding the physical device's "acceptance criteria" and "performance data" if interpreted broadly:
Acceptance Criteria and Reported Device Performance (Physical Device)
The document doesn't explicitly list "acceptance criteria" in a table format with specific quantitative thresholds that need to be met for each test for the "Introducer Needle." Instead, it states that "Performance testing was performed in accordance with applicable clauses in ISO 9626-2016 and ISO 7864-2016" and that the testing was "to demonstrate that the Introducer Needle met applicable design requirements." The conclusion then states, "The results of these tests provide reasonable assurance that the Introducer Needle will perform as intended."
However, based on the performance tests listed, we can infer the "acceptance criteria" are implied by meeting the standards of ISO 9626-2016 (presumably for stainless steel needle tubing for the manufacture of medical devices) and ISO 7864-2016 (likely for sterile hypodermic needles for single use).
Here's a representation of the implied acceptance criteria based on the testing performed, and the "reported performance" is that the device met these criteria.
| Acceptance Criteria (Implied from testing) | Reported Device Performance (Implied) |
|---|---|
| Biocompatibility: | |
| No Skin Sensitization (ISO 10993-1) | Met (passed testing) |
| No Intracutaneous Reactivity (ISO 10993-1) | Met (passed testing) |
| No Acute Systemic Toxicity (ISO 10993-1) | Met (passed testing) |
| Apyrogenicity (ISO 10993-1) | Met (passed testing) |
| Physical & Chemical Performance (ISO 9626-2016, ISO 7864-2016): | |
| Adequate Flow Rate | Met (passed flow test) |
| Appropriate Penetration Force | Met (passed penetration force test) |
| Sufficient Stiffness | Met (passed stiffness test) |
| Resistance to Breakage | Met (passed resistance to breakage test) |
| Secure Bond between Hub and Needle Tube | Met (passed bond test) |
| Ultrasound Detectability (if specified) | Met (passed ultrasound detection test) |
| Resistance to Corrosion | Met (passed corrosion test) |
| Packaging & Shelf-life: | |
| Maintenance of Sterility | Met (passed sterilization packaging test) |
| Maintenance of Performance over Shelf-life (2 years) | Met (passed shelf-life test for 2 years) |
Other Requested Information (Not Applicable to this Document as it's not an AI/ML Device)
The following points are not applicable to the provided document, as it describes a physical medical device (introducer needle) and not an AI/Machine Learning device. Therefore, information regarding AI/ML-specific testing is absent.
- Sample sizes used for the test set and the data provenance: Not applicable to a physical device performance study of this nature. The "test set" here refers to physical units subjected to tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device refers to engineering specifications and performance standards.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of AI/ML. For this physical device, the ground truth is established by the specified engineering standards (ISO 9626-2016, ISO 7864-2016) and biocompatibility standards (ISO 10993 series).
- The sample size for the training set: Not applicable (no ML training).
- How the ground truth for the training set was established: Not applicable (no ML training).
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 22, 2023
YouCare Technology Co., Ltd. (Wuhan) Bing Hu Manager Great Wall Science and Technology Park East Lake Development Zone, Wuhan Wuhan. China
Re: K222705
Trade/Device Name: Introducer Needle Regulatory Class: Unclassified Product Code: LJE Dated: May 9, 2023 Received: May 10, 2023
Dear Bing Hu:
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.
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
{1}------------------------------------------------
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.05.22 11:37:24 -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}------------------------------------------------
Indications for Use
510(k) Number (if known)
Device Name Introducer Needle
Indications for Use (Describe)
It is used for percutaneous puncture to the renal pelvis, establishing a percutaneous approach and providing access for endoscopes and surgical instruments.
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}------------------------------------------------
Section 5 - 510(k) Summary
Date of Summary Preparation: 08/29/2022 1. Submitter's Identifications
Submitter's Name: YouCare Technology Co., Ltd.(Wuhan). Address: Great Wall Science and Technology Park, East Lake Development Zone Wuhan.
Contact Person: Bing Hu Contact Email: hb@youcaretech.com Telephone: 86-027-87926396-830
2. Correspondent's Identifications
Correspondent's Name: YouCare Technology Co., Ltd.(Wuhan). Address: Great Wall Science and Technology Park, East Lake Development Zone Wuhan. Contact Person: Bing Hu Contact Email: hb@youcaretech.com Telephone: 86-027-87926396-830
3. Name of the Device
Product Name: Introducer Needle Trade Name: Introducer Needle Model: YC-Jianxing-needleperc-A YC-Jianxing-needleperc-B YC-Jianxing-needleperc-C. (Other places in the document are abbreviated as Model A, Model B, Model C) Classification Panel: Gastroenterology/Urology Product Code: LJE Device Classification: Unclassified
4. The Predicate Devices
K183035
Percutaneous Entry Set
This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
5. Device Description
The product consists of a needle tube, a needle hub, a rear end, equipment channel interface E, fiber image channel interface F, irrigation channel interface I, an obturator, a needle-free joint and a two-way water valve, and that primary package of the product
{4}------------------------------------------------
contains a protective sleeve which is only used for product protection. The product is sterilized by ethylene oxide and is single use.
6. Intended Use
It is used for percutaneous puncture to the renal pelvis, establishing a percutaneous approach and providing working access for endoscopes and surgical instruments.
7. Comparison to Predicate Device
| New device | Predicate device | Comparison | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| “K”NUMBERS | / | K183035 | / | ||||||||||||||||||||
| Manufacturer | YouCare Technology Co.,Ltd.(Wuhan). | Cook Incorporated | / | ||||||||||||||||||||
| Product Code | LJE | LJE | Same | ||||||||||||||||||||
| Classification name | Gastroenterology/Urology | Gastroenterology/Urology | Same | ||||||||||||||||||||
| Intended Use | It is used for percutaneous puncture to the renal pelvis, establishing a percutaneous approach and providing working access for endoscopes and surgical instruments. | The Percutaneous Entry Set is used to establish percutaneous tract into the renal pelvis for catheter placement or stone manipulation. | Same | ||||||||||||||||||||
| Regulatory Class | Unclassified | Unclassified | / | ||||||||||||||||||||
| Sterility | Yes | Yes | Same | ||||||||||||||||||||
| Sterilization Method | EO | EO | Same | ||||||||||||||||||||
| Single Use | Yes | Yes | Same | ||||||||||||||||||||
| Lengths/Sizes | Model A Model B Model C Needle Gauge 17 Ga 17 Ga 14 Ga Diameter 4.2 Fr 4.5 Fr 6.0 Fr Needle Length/Introducer length 152mm±7mm Total length 263mm±7mm | Needle Gauge: 18Needle Length: 15-20cm | Different 1 |
{5}------------------------------------------------
| Primarystructure | Image: Needle tube and rear end with three channels | The PercutaneousEntry Set is comprisedof a Skinny Needle®with Chiba Tip, aDisposable Two-PartTrocar Needle, 8dilators and a wireguide. | Different 2 | |
|---|---|---|---|---|
| Materials | Needle tube | 304 Stainless Steel | Needle: 304 StainlessSteel | Different 3 |
| needle hub | ABS | |||
| rear end | ||||
| equipmentchannelinterface Efiber imagechannelinterface Firrigationchannelinterface I | polycarbonate (PC) | |||
| needle-freejoint | polycarbonate (PC) 、 silicagel | |||
| obturatortwo-waywater valve | polycarbonate (PC) 、Polyoxymethylene | |||
| ModeofOperation | Manual Insertion | Manual Insertion | Same | |
| usage method | Needle tube as instrumental channel | Needle tube asinstrumental channel | Same | |
| Requirements | flow testpenetration forceStiffnessResistance to breakageBond between hub and needle tubeultrasound detectionCorrosion Test | flow testpenetration forceStiffnessResistance to breakageBond between hub andneedle tubeultrasound detectionCorrosion Test | Same | |
| Biocompatible | Yes | Yes | Same | |
| Shelf Life | 2 years | 3 years | Different 4 |
8. Substantial equivalence discussion:
Different 1 - Lengths/Sizes
This difference is in diameter and length. Different diameter device will be selected by physician per patient's condition. Moreover, a small diameter difference has little effect on the product safety performance; For different length, B-ultrasonic and endoscopic double positioning was used at the time of surgery, the length difference did not affect the safety and efficacy of the product.
{6}------------------------------------------------
Different 2 - Primary structure
The Percutaneous Entry Set is comprised of a Skinny Needle® with Chiba Tip, a Disposable Two-Part Trocar Needle, 8 dilators and a wire guide. The function and structure of new device is similar to Disposable Two-Part Trocar Needle of Percutaneous Entry Set. The reasons are:
-
Disposable Two Part Trocar Needle has a trocar tip, which is used for free flow of urine indicators proper positioning. Our product can be used in conjunction with a fiber optic endoscope during puncture to achieve visual puncture and directly see whether the puncture has reached the expected position. it does not raise different questions of safety and effectiveness for patient, it only increases the operation requirements for doctors
-
New device does not have a trocar tip, but we have conducted Stiffness and Resistance to breakage tests to ensure that the needle tube will not break without a trocar tip, so it will not be affected by safety and effectiveness.
Different 3 - Materials
The materials of direct contacting component puncture body are different. The new device is 304 Stainless Steel, materials of predicate device are 304 Stainless Steel and Low-Density Polyethylene; The materials of indirect tissue-contacting components are different, but the whole device passed the biological test.
Different 4 - Shelf Life
The difference in shelf life does not affect the product.
Substantial Equivalence discussion:
The subject devices have similar indications for use, methods of operation, and fundamental technological characteristics as the predicate device. Differences between the subject devices and the predicate device include design specifications, dimensions, and materials. Characteristics of the subject devices that differ from the predicate device are supported by testing.
9. Performance Data:
The following performance data were provided in support of the substantial equivalence determination.
9.1 Biocompatibility testing
The biocompatibility evaluation for the Introducer Needle was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
Skin Sensitization Intracutaneous Reactivity Acute Systemic Toxicity
{7}------------------------------------------------
Pyrogen
9.2 Physical and chemical performance testing. Performance testing was performed in accordance with applicable clauses in ISO 9626-2016 and ISO 7864-2016,The following testing was performed to demonstrate that the Introducer Needle met applicable design requirements.
- flow test penetration force Stiffness Resistance to breakage Bond between hub and needle tube ultrasound detection Corrosion Test
9.3 Packaging and shelf-life testing
Sterilization Packaging Shelf-life
10. Conclusion:
The results of these tests provide reasonable assurance that the Introducer Needle will perform as intended. The new devices do not raise new questions of safety or effectiveness as compared to the predicate device. In conclusion, the results of these tests support a determination of substantial equivalence to the predicate device.
--- End of this section ---
N/A