(257 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the physical and material properties of a surgical instrument, with no mention of software, image processing, or AI/ML algorithms.
No
The device is described as an "Introducer Needle" used for percutaneous puncture to the renal pelvis to establish access for other instruments, not to directly treat a medical condition.
No
This device is described as an introducer for percutaneous puncture to the renal pelvis, facilitating access for endoscopes and surgical instruments. Its function is to create a pathway, not to diagnose a condition. The performance studies focus on physical, chemical, and biocompatibility aspects, not diagnostic accuracy.
No
The device description explicitly lists physical components such as a needle tube, needle hub, obturator, etc., indicating it is a hardware device. The performance studies also focus on physical and chemical properties, further confirming it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for percutaneous puncture to the renal pelvis to establish an access route for surgical instruments. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical instrument (needle, obturator, etc.) used for a surgical intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVDs are typically used to perform tests on samples taken from the body, such as blood tests, urine tests, or tissue biopsies. This device is a surgical tool used for direct access to an anatomical site within the body.
N/A
Intended Use / Indications for Use
It is used for percutaneous puncture to the renal pelvis, establishing a percutaneous approach and providing access for endoscopes and surgical instruments.
Product codes (comma separated list FDA assigned to the subject device)
LJE
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 contains a protective sleeve which is only used for product protection. The product is sterilized by ethylene oxide and is single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
renal pelvis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
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 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.
The results of these tests provide reasonable assurance that the Introducer Needle will perform as intended.
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.
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.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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)
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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: 18 | |||||||||||||||||||||
| Needle Length: 15-20cm | Different 1 |
5
| Primary
structure | Image: Needle tube and rear end with three channels | | 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. | Different 2 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Materials | Needle tube | 304 Stainless Steel | Needle: 304 Stainless
Steel | Different 3 |
| | needle hub | ABS | | |
| | rear end | | | |
| | equipment
channel
interface E
fiber image
channel
interface F
irrigation
channel
interface I | polycarbonate (PC) | | |
| | needle-free
joint | polycarbonate (PC) 、 silica
gel | | |
| | obturator
two-way
water valve | polycarbonate (PC) 、
Polyoxymethylene | | |
| Mode
of
Operation | Manual Insertion | | Manual Insertion | Same |
| usage method | | Needle tube as instrumental channel | Needle tube as
instrumental channel | Same |
| Requirements | flow test
penetration force
Stiffness
Resistance to breakage
Bond between hub and needle tube
ultrasound detection
Corrosion Test | | flow test
penetration force
Stiffness
Resistance to breakage
Bond between hub and
needle tube
ultrasound detection
Corrosion Test | Same |
| Biocompatibl
e | 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.
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