(60 days)
Not Found
No
The summary describes a mechanical injection needle and does not mention any AI or ML components or functionalities.
No.
The device is an accessory (injection needle) used in conjunction with an endoscope for various procedures, but it does not intrinsically provide a therapeutic effect on its own. It's a tool for delivering treatment, not the treatment itself.
No
The device is an injection needle used for treatment and marking in the GI tract, not for diagnostic purposes.
No
The device description clearly describes a physical, sterile, single-use injection needle, which is a hardware component. The performance studies also focus on bench testing of physical attributes and sterilization, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a "Single use injection needle" used in conjunction with an endoscope for procedures like treating esophageal and gastric varices and submucosal dye marking. These are interventional procedures performed directly on the patient's body, not tests performed on samples outside the body.
- Intended Use: The intended use is for endoscopic injections within the GI tract, which is a therapeutic or diagnostic procedure performed in vivo, not an in vitro test.
The device is a medical device used for direct intervention and marking within the body, not for analyzing samples taken from the body.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
FBK
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI tract (Gastrointestinal tract), esophageal, gastric
Indicated Patient Age Range
Not Found
Intended User / Care Setting
This device must be used by trained doctors or technicians.
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)
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:
- Inserting into endoscope
- Withdrawing from endoscope A
- Advance of tube
- Retraction of tube
- Smooth puncturing of the needle
- Normal reaction force to needle puncturing.
- Patency of lumen
- Needle retraction propriety
- Luer lock connector
- 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 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".
No clinical study is included in this submission.
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.
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
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.
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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
1
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
2
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
-
- Withdrawing from endoscope A
- A 3. Advance of tube
-
- Retraction of tube >
- A 5. Smooth puncturing of the needle
-
- Normal reaction force to needle puncturing.
-
- Patency of lumen
-
- Needle retraction propriety
-
- Luer lock connector
-
- 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
5
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
) |
| -- | ------------------------------------------------------- |
|---|
| Item | Proposed Device | Predicate Device K150434 | Substantial Equivalence |
|---|---|---|---|
| Device name | Single Use Injection Needle | Injection Needle | Predicate Device is single used, |
| 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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8
| 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.