K210917 · Anrei Medical (Hangzhou) Co., Ltd. · FBK · May 28, 2021 · Gastroenterology, Urology
Device Facts
Record ID
K210917
Device Name
Single Use Injection Needle
Applicant
Anrei Medical (Hangzhou) Co., Ltd.
Product Code
FBK · Gastroenterology, Urology
Decision Date
May 28, 2021
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Single use injection needle is to be used in conjunction with an endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.
Device Story
Sterile, single-use injection needle; designed for passage through endoscope forceps channel (minimum 2.8 mm). Device consists of needle, connecting tube, inner tube, sheath, handle, and luer connector. Operated by trained physicians or technicians during endoscopic procedures; needle advanced through endoscope to target site in digestive tract; therapeutic or diagnostic agents injected via luer connection. Enables targeted delivery of substances for variceal treatment or tissue marking; facilitates minimally invasive GI interventions.
Clinical Evidence
No clinical data. Bench testing only. Performance testing included insertion/withdrawal, tube advancement/retraction, needle puncturing, lumen patency, and luer lock integrity. Biocompatibility testing per ISO 10993 (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity). Sterilization validation per ISO 11135 (SAL 10^-6). Shelf-life validated via accelerated aging per ASTM F1980-16.
Technological Characteristics
Sterile, single-use endoscopic injection needle. Available in 21G, 23G, 25G; lengths 1800mm, 2000mm, 2300mm. Compatible with endoscopes having ≥2.8mm working channel. Materials evaluated per ISO 10993. Sterilization via Ethylene Oxide (ISO 11135). Packaging tested per ASTM F88, F1929, D4169.
Indications for Use
Indicated for patients requiring endoscopic injections for the treatment of esophageal and gastric varices or for submucosal dye marking in the GI tract. To be used by trained doctors or technicians.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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May 28, 2021
Anrei Medical (Hangzhou) Co., Ltd. Huibing Yang Director, Regulatory Affairs No.3 Ave.8. HEDA Hangzhou, Zhejiang 310018 CHINA
Re: K210917
> Trade/Device Name: Single Use Injection Needle Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FBK Dated: March 25, 2021 Received: March 29, 2021
Dear Huibing Yang:
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
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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 (OS) 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,
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K210917
Device Name Single Use Injection Needle
Indications for Use (Describe)
Single use injection needle is to be used in conjunction with an endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.
| 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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510(k) Summary
### Tab #5 510(k) Summary
#### Submitter: 1.
Anrei Medical (Hangzhou) Co., Ltd. No. 3, Ave 8 Hangzhou Economic Development Area, 310018 Hangzhou, P.R.China
| Contact Person: | Huibing Yang |
|-----------------|------------------------------|
| Contact Title: | Director, Regulatory Affairs |
| Tel: | +86-571-8691333 ext. 8658 |
| Fax: | +86-571-87603502 |
| Email: | huibing.yang@anrei.com.cn |
| Date Prepared: | 3/25/2021 |
#### Proposed Device: 2.
| Trade Name: | Single Use Injection Needle |
|--------------------|-----------------------------|
| Regulation Name: | Endoscope and Accessories |
| Regulation Number: | 21 CFR 876.1500 |
| Product Code: | FBK |
| Regulation Class: | II |
#### 3. Predicate Device(s):
| Primary Predicate Device: | |
|---------------------------|-------------------------------|
| Trade Name: | Injection Needle |
| 510(k) Number: | K150434 |
| Regulation Name: | Endoscope and Accessories |
| Regulation Number: | 21 CFR 876.1500 |
| Product Code: | FBK |
| Regulation Class: | II |
| Manufacturer: | Micro-Tech (Nanjing) CO., Ltd |
#### Proposed Device Description 4.
The Single Use Injection Needles are sterile, single-use devices. The Single Use Injection Needles can is expected to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.
The Single Use Injection Needle is designed to pass through the endoscope's forceps to mark the lesions of the digestive tract and use it for injection. Compatibility with endoscopes, working lengths are 1800mm, 2000mm, 2300mm, and the minimum working clamp channel is φ 2.8 mm.
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## 5. Indication for use
Single use injection needle is to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.
#### Technological Characteristics: 6.
The Single use injection needle is available in three needle sizes, two needle size and three working length. The two Characteristics: sizes relate to the needle gauge. The sizes are 21 gauges 23 gauge and 25 gauge. The needle sizes are 4mm, and 6 mm. Working lengths includes 1800mm, 2000mm and 2300mm. There are eighteen (18) models injection needles. Anrei Medical (Hangzhou) believes that the proposed Single use Injection Needle is substantially equivalent to the currently cleared Injection Needle (K150434) in device function and overall design.
#### Summary of non-clinical testing: 7.
Performance testing was conducted to demonstrate the essential performance of the proposed device and confirmed that the proposed device works as intended with the compatible devices. Additionally, the results of the tests below were evaluated as substantially equivalent to the cited predicate devices.
· The following bench testing were performed on the proposed Single Use Injection Needle .
- A 1. Inserting into endoscope
- 2. Withdrawing from endoscope A
- A 3. Advance of tube
- 4. Retraction of tube >
- A 5. Smooth puncturing of the needle
- > 6. Normal reaction force to needle puncturing.
- > 7. Patency of lumen
- > 8. Needle retraction propriety
- > 9. Luer lock connector
- > 10. Dimension
· Shelf-Life testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16, the standard guide for accelerated aging of sterile barrier systems for medical devices. Three-year aging will be performed to demonstrate longer stability and support the results of the accelerated aging test.
· Sterilization validation was conducted in accordance with ISO 11135:2014 using the overkill validation methods to demonstrate the ability to achieve a
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510(k) Summary
sterility assurance level of less than 10-6.
· Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process"
The following standards have been applied to the proposed Single Use Injection Needle .
- ISO 10993-1:2009 Biological evaluation of medical devices Part 1: A Evaluation testing within a risk management process
- A ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity
- A ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene Oxide Sterilization Residuals
- ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test A for irritation and delayed-type hypersensitivity
- A ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- A ANSI/AAMI/ISO11135:2014 Sterilization of health-care products - Ethylene oxide - Requirement for the development, validation and routine control of a sterilization process for medical devices
- ASTM F88/F88M-15 standard method for seal strength of flexible barrier A materials
- ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier A Systems for Medical Devices
- ASTM F1929-15 Standard test method for detecting seal leaks in porous A medical packaging by dye penetration.
- ASTM D4169-16 Standard Practice for Performance Testing of Shipping A Containers and Systems
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## 8. Clinical Test Conclusion
No clinical study is included in this submission.
# 9. Substantially Equivalent (SE) Comparison
| | Table 1 Comparison of Technology Characteristics<br>) |
|--|-------------------------------------------------------|
|--|-------------------------------------------------------|
| Item | Proposed Device | Predicate Device K150434 | Substantial Equivalence |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | Single Use Injection Needle | Injection Needle | Predicate Device is single used,<br>Same |
| Product Code | FBK | FBK | Same |
| Regulation Number | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| User qualification | This device must be used by trained doctors or technicians. | This device must be used by trained doctors or technicians. | Same |
| Class | II | II | Same |
| Supplied Sterile | Yes | Yes | Same |
| Configuration | Needle, Connecting Tube, Inner Tube, Sheath, Protect Tube, Metal Tube, handle, Luer Connector | Needle, inner sheath, outer shell, outer sheath and luer lock | Similar, Tests including biocompatibility, bench performance were performed. The results show the device is substantially equivalent to the currently marketed Micro-Tech (Nanjing) predicate devices. |
| Outer Sheath diameter | 2.4mm | 2.3 mm | Similar, the slight difference does not affect the device compatibility with the endoscope of the minimum working cannel size of 2.8 mm. |
| Working length | 1800mm, 2000mm, 2300mm | 1800mm, 2000mm, 2300mm | Same |
| Needle size | 21G, 23G, 25G | 19G, 22G, 25G | Similar, Within the range of the predicate Needle size. |
| Needle Length | 4mm, 6mm | 4mm, 5mm, 6mm | Similar, Within the range of the predicate Needle Length. |
| Minimum required working channel | φ2.8mm | φ2.8mm | Same |
| Indication for Use | The injection needle is to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract. | The injection needle is to be used in conjunction with an endoscope to perform endoscopic injections treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract. | Same |
| Single Use | Single Use | Single Use | Same |
| Labeling | Comply with 21 CFR Part 801 | Comply with 21 CFR Part 801 | Same |
| Cytotoxicity | No cytotoxicity | Comply with ISO 10993 standards | Same |
| Skin Sensitization | No skin sensitization | Comply with ISO 10993 standards | Same |
| Irritation | No irritation | | Same |
| Acute Systemic | No acute toxicity | | Same |
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| Toxicity | | | |
|-----------------|----------------|----------------|------|
| Pyrogen | No pyrogen | Same | |
| Method | Ethylene oxide | Ethylene oxide | Same |
| SAL | $10^{-6}$ | $10^{-6}$ | Same |
| Endotoxin Limit | 20EU | 20EU | Same |
| Shelf life | 3 years | 3 years | Same |
### 10. Conclusion:
Anrei Medical (Hangzhou) Co., Ltd has demonstrated that the proposed Single Use Injection Needle is substantially equivalent to the currently marketed Micro-Tech (Nanjing) predicate devices and can be safely and effectively used for its proposed indications.
