(177 days)
No
The description focuses on a mechanical injection needle accessory for endoscopes and does not mention any AI/ML capabilities or image processing.
No.
The device is used to deliver a therapeutic agent or dye, but it is an accessory for an endoscope and is not
a therapeutic agent itself. Its function is primarily mechanical for delivery, not inherent therapy.
No
The device is described as an accessory for endoscopic injections used for treatment (e.g., esophageal and gastric varices) and marking (e.g., submucosal dye marking), indicating a therapeutic or procedural function rather than a diagnostic one. It is explicitly stated that "Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.) Not applicable (device is an accessory, not a diagnostic tool)".
No
The device is a physical, sterile, single-use injection needle intended for use with an endoscope, clearly indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for performing endoscopic injections for therapeutic purposes (treating esophageal and gastric varices) and for marking tissue (submucosal dye marking). These are interventional procedures, not diagnostic tests performed on samples outside the body.
- Device Description: The device is described as an accessory for digestive endoscopy used to inject substances into the body. This aligns with a therapeutic or procedural device, not a diagnostic one.
- Lack of Diagnostic Function: The device itself does not analyze biological samples or provide diagnostic information. It is a tool for delivering substances during a procedure.
- Performance Studies: The performance studies focus on non-clinical testing related to the device's physical properties, safety, and equivalence to a predicate device, not on diagnostic accuracy metrics like sensitivity, specificity, or AUC.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Disposable Injection Needle is intended 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
FBK
Device Description
The Disposable Injection Needle is a sterile, single-use device as a kind of accessories for digestive endoscopy. The Disposable Injection Needle is intended 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 Disposable Injection Needle is designed to insert through the suitable endoscope's forceps to inject harden agent to target lesion in treatment for bleeding of esopha-gastric varix or to mark the lesions of the digestive tract.
The Disposable Injection Needle has different model specifications depending on different working length and the needle size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI tract (esophageal and gastric)
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
Non-clinical testing:
- Biocompatibility: MTT Cytotoxicity Test (ISO 10993-5:2009), Skin Sensitization Test, Skin Irritation Test (ISO 10993-10:2010), Acute Systemic Toxicity Test, Subacute Systemic Toxicity Test and Pyrogen Test (ISO 10993-11:2017).
- Sterilization Validation: ISO11135:2014+A1:2018, ISO 11737-2, ISO 10993-7:2008, USP .
- Shelf Life and Sterile Barrier System: ASTM F1980-16, ISO11607-1:2019, ISO11607-2:2019, ASTM F 1929-15, ASTM D 3078-02(2013), DIN 58593-6: 2016, ASTM F88/F88M-15, ASTM D4169-16.
- Performance Data - Bench: Tests were implemented on both the subject device (Alton Disposable Injection Needle) and the predicate device (Anrei Single Use Injection Needle) with the following test items: Appearance, Dimension, Bond Strength, Operational performance, Puncture Performance, Liquid leakage, Injection connector (Luer connector), Patency of lumen, Corrosion Property, Chemical performance.
- Animal studies: N/A.
- Clinical studies: N/A.
Key results: Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended. From the results of nonclinical testing described, it can be concluded that the subject device is substantially equivalent to the legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image contains 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.
September 27, 2023
Alton (Shanghai) Medical Instruments Co. Ltd Wei Song Project Engineer No.24 Building Jinshao Rd. 1688.Baoshan District. Shanghai. 200949 China
Re: K230925
Trade/Device Name: Disposable Injection Needle AF series Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FBK Dated: August 28, 2023 Received: August 28, 2023
Dear Wei Song:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 -S
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
2
Indications for Use
Submission Number (if known)
Device Name
Disposable Injection Needle (AF series)
Indications for Use (Describe)
The Disposable Injection Needle is intended 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K230925
Page 1 of 10
SECTION 2
510(k) Summary
4
510(k) Summary
I. SUBMITTER
Name: Alton (Shanghai) Medical Instruments Co. Ltd.
Address: No.24 Building, JinShao Rd. 1688, Baoshan District, 200949 Shanghai, P. R.
China
Name of contact person: Vivian Li
Position: Director of Quality Department
Tel: +86 21 56771811
Fax: +86 21 66307823
Mail: vivian@alton.com.cn
Date prepared: 2023-09-25
II. Identification of Subjective Device
Device trade name: Disposable Injection Needle Regulation Name: Endoscope and accessories Regulation number: 21CFR 876.1500 Regulation class: 2 Review Panel: Gastroenterology/Urology Product Code Description: Endoscopic Injection Needle, Gastroenterology-Urology Product code: FBK
III. Identification of Predicate device
Predicate Submission Number: K210917 Trade/Device Name: Single Use Injection Needle Regulation Name: Endoscope and accessories Regulation Number: 21 CFR 876.1500 Regulatory Class: 2 Review Panel: Gastroenterology/Urology Product Code Description: Endoscopic Injection Needle, Gastroenterology-Urology Product Code: FBK
5
IV. Device description
The Disposable Injection Needle is a sterile, single-use device as a kind of accessories for digestive endoscopy. The Disposable Injection Needle is intended 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 Disposable Injection Needle is designed to insert through the suitable endoscope's forceps to inject harden agent to target lesion in treatment for bleeding of esopha-gastric varix or to mark the lesions of the digestive tract.
The Disposable Injection Needle has different model specifications depending on different working length and the needle size. Details of the models and specifications refer to below table:
| No. | Specification No. | Needle
Gauge | Needle
Length | Outer Tube
Diameter | Working
length | Min. endoscopic
working channel |
|-----|-------------------|-----------------|------------------|------------------------|-------------------|------------------------------------|
| 1 | AF-D1818NJ2104 | 21G | 4 mm | Ф1.8 mm | 1800 mm | Ф2.0 mm |
| 2 | AF-D1818NJ2105 | | 5 mm | | | |
| 3 | AF-D1818NJ2106 | | 6 mm | | | |
| 4 | AF-D1821NJ2104 | 21G | 4 mm | Ф1.8 mm | 2100 mm | Ф2.0 mm |
| 5 | AF-D1821NJ2105 | | 5 mm | | | |
| 6 | AF-D1821NJ2106 | | 6 mm | | | |
| 7 | AF-D1823NJ2104 | 21G | 4 mm | Ф1.8 mm | 2300 mm | Ф2.0 mm |
| 8 | AF-D1823NJ2105 | | 5 mm | | | |
| 9 | AF-D1823NJ2106 | | 6 mm | | | |
| 10 | AF-D2418NJ2104 | 21G | 4 mm | Ф2.4 mm | 1800 mm | Ф2.8 mm |
| 11 | AF-D2418NJ2105 | | 5 mm | | | |
| 12 | AF-D2418NJ2106 | | 6 mm | | | |
| 13 | AF-D2421NJ2104 | 21G | 4 mm | Ф2.4 mm | 2100 mm | Ф2.8 mm |
| 14 | AF-D2421NJ2105 | | 5 mm | | | |
| 15 | AF-D2421NJ2106 | | 6 mm | | | |
| 16 | AF-D2423NJ2104 | 21G | 4 mm | Ф2.4 mm | 2300 mm | Ф2.8 mm |
| 17 | AF-D2423NJ2105 | | 5 mm | | | |
| 18 | AF-D2423NJ2106 | | 6 mm | | | |
| 19 | AF-D1818NJ2304 | 23G | 4 mm | Ф1.8 mm | 1800 mm | Ф2.0 mm |
| 20 | AF-D1818NJ2305 | | 5 mm | | | |
| 21 | AF-D1818NJ2306 | | 6 mm | | | |
| 22 | AF-D1821NJ2304 | 23G | 4 mm | Ф1.8 mm | 2100 mm | Ф2.0 mm |
| 23 | AF-D1821NJ2305 | | 5 mm | | | |
6
| 24 | AF-D1821NJ2306 | 6 mm | ||||
|---|---|---|---|---|---|---|
| 25 | AF-D1823NJ2304 | 23G | 4 mm | Ф1.8 mm | 2300 mm | Ф2.0 mm |
| 26 | AF-D1823NJ2305 | 5 mm | ||||
| 27 | AF-D1823NJ2306 | 6 mm | ||||
| 28 | AF-D2418NJ2304 | 23G | 4 mm | Ф2.4 mm | 1800 mm | Ф2.8 mm |
| 29 | AF-D2418NJ2305 | 5 mm | ||||
| 30 | AF-D2418NJ2306 | 6 mm | ||||
| 31 | AF-D2421NJ2304 | 23G | 4 mm | Ф2.4 mm | 2100 mm | Ф2.8 mm |
| 32 | AF-D2421NJ2305 | 5 mm | ||||
| 33 | AF-D2421NJ2306 | 6 mm | ||||
| 34 | AF-D2423NJ2304 | 23G | 4 mm | Ф2.4 mm | 2300 mm | Ф2.8 mm |
| 35 | AF-D2423NJ2305 | 5 mm | ||||
| 36 | AF-D2423NJ2306 | 6 mm |
V. Indication for use
Disposable 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.
| Attribute | Subject device | Predicative d17evice (K210917) | Discussion/
Conclusion |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Manufacturer | Alton (Shanghai) Medical
Instruments Co. Ltd | Anrei Medical (Hangzhou) Co.,
Ltd. | / |
| Trade name | Disposable Injection Needle | Single Use Injection Needle | / |
| Regulation name | Endoscope and accessories | Endoscope and accessories | Same |
| Regulatory Class | II | II | Same |
| Product code | FBK | FBK | Same |
| Clinical characteristics | | | |
| Indications for use | Disposable 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. | 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. | Same |
| General technological characteristics | | | |
| Device
composition | Needle, bushing, outer tube,
infusion inner tube, protective
tube, handle and pusher (with
Luer connector on top part) | Needle, Connecting Tube, Inner
Tube, Sheath, Protect Tube, Metal
Tube, handle, Luer Connector | Difference,
see
Discussion 1 |
| Principle of | The catheter sheath of the product | The catheter sheath of the product | Same |
| Attribute | Subject device | Predicative d17evice (K210917) | Discussion/Conclusion |
| Operation | is inserted into the endoscope channel. When the front part of the catheter sheath is placed on the lesion site, push the Luer connector for injection, the needle is exposed to the catheter sheath, and the needle is inserted into the lesion site, then drug injection. | is inserted into the endoscope channel. When the front part of the catheter sheath is placed on the lesion site, push the Luer connector for injection, the needle is exposed to the catheter sheath, and the needle is inserted into the lesion site, then drug injection. | |
| Outer Tube diameter | 1.8 mm; 2.4 mm | 2.4 mm | Difference, see Discussion 2 |
| Minimum endoscopic working channel | $Φ$ 2.0 mm; $Φ$ 2.8 mm | $Φ$ 2.8 mm | Difference, see Discussion 3 |
| Working length | 1800 mm; 2100 mm; 2300 mm | 1800mm, 2000mm, 2300mm | Same |
| Needle size | 21G; 23G | 21G, 23G, 25G | Difference, see Discussion 4 |
| Needle Length | 4 mm; 5 mm; 6 mm | 4mm, 6mm | Difference, see Discussion 5 |
| Components material | Needle: SUS304
Outer tube: PTFE | Needle: SUS304
Outer tube: PTFE | Same |
| Sterilization | Method: Ethylene Oxide sterilization
SAL: 10-6 | Method: Ethylene Oxide sterilization
SAL: 10-6 | Same |
| Endotoxin Limit | 20EU | 20EU | Same |
| Single use/reuse | For single use | For single use | Same |
| Shelf life | 3 years | 3 years | Same |
| Mechanical performance | Appearance/ Dimension/ Bond Strength/ Operational performance/ Puncture Performance/ Liquid leakage/ Injection connector (Luer connector)/ Patency of lumen/ Corrosion Property | Inserting into endoscope/Withdrawing from endoscope/Advance tube/Retraction of tube/Smooth puncturing of the needle/Normal reaction force to needle puncturing/Patency of lumen/Needle retraction propriety/Luer connector/Dimension | Difference, See Discussion 6 |
| Chemical performance | Appearance (turbidity, color)/pH value/Total dissolved heavy metal | Not publicly available | Difference, See |
| Attribute | Subject device | Predicative d17evice (K210917) | Discussion/Conclusion |
| | content/Potassium permanganate
reducing substance/Evaporated residue | | Discussion 6 |
| Biocompatibility | Cytotoxicity
Skin Sensitization
Skin Irritation Test
Acute Systemic Toxicity Test,
Pyrogen Test
Comply with ISO 10993 standards | Cytotoxicity
Skin Sensitization
Skin Irritation Test
Acute Systemic Toxicity Test,
Pyrogen Test
Comply with ISO 10993 standards | Same |
VI. Comparison of technological characteristics with the predicate device
7
8
Discussion on differences between the subject device and the predicate device
Discussion 1: Both devices share the same structure except an additional bushing is used in the subjective device to protect the needle, and such difference will not change the intended use and clinical performance of the subjective device. in addition, all mechanical performances an chemical performances between the subject device and the predicate device have been performed to demonstrate substantial equivalence between subject device and predicate device, such difference will not affect the clinical performance and safety of the subjective device.
Discussion 2: There are two specifications (1.8mm; 2.4mm) related to Outer Tube diameter of the needle for the subject device. 2.4mm specification is same as the predicate device. 1.8mm specification is applicable for smaller endoscopic working channel, different from the predicate device. As the size of the outer diameter is designed to be compatible with the smaller size of the endoscopic working channel during the surgical procedure, in addition, the 1.8mm specification has been available on the other marketed device (K212668). Therefore, such differences will not affect clinical performance and safety of the subject device.
Discussion 3: There are two specifications (Φ2.0mm; Φ2.8mm) related to minimum endoscopic working channel for the subject device. Φ2.8mm specification is applicable for types of the subject device with outer tube diameter of the needle (2.4mm) and this @2.8mm specification of the subject device is same as the predicate device. Φ2.0mm specification is applicable for types of the subjective device with
9
smaller outer tube diameter of the needle (1.8mm), different from the predicate device. As the size of the minimum endoscopic working channel is only used to ensure the appropriate size of the injection needle applied during the surgical procedure, and such differences will not affect clinical performance and safety of the subject device. Discussion 4: there is less optional needle size specifications of the subject device than ones of the predicate device, therefore, such differences will not affect clinical performance and safety of the subject device.
Discussion 5: the needle length specification of the subject device are more than ones of the predicate device, as different needle length is to meet different requirement for different lesion injection or marking, such differences will not affect clinical performance and safety of the subject device.
Discussion 6: The bench performance tests, including mechanical performance and chemical performance, were carried out on both the subject device and the predicate device according to specific product technical specification and the test results demonstrate substantial equivalence between subject device and predicate device. therefore, such difference will not affect effectiveness and safety of the subject device.
VII. Summary of substantial equivalence discussion
Based on the above comparison table as well as discussion on differences, the subject device and the predicate device have similar design features and performance specifications. Although there are some differences on size specification parameters (e.g. outer tube diameter, applicable endoscopic working channel, working length, needle size and needle length) on the subject device and predicate device, such differences will not affect the effectiveness and safety of the subject device. In addition, a performance comparison testing between the subject device and the predicate device is implemented and all performances including mechanical property and chemical property are verified to confirm the performance of the subject device is substantially equivalent to the predicate device. These technological differences between the subject device and the predicate device do not affect the safety and effectiveness of the subject device when used as labeled.
VIII. Summary of Non-clinical Data
10
Non-clinical testing for Disposable Injection Needle was conducted to verify that the subject device met all design specifications, demonstrated safety and essential performance based on current applicable standards, and to demonstrate substantial equivalence to the predicate. The following tests were performed.
-
A Biocompatibility
The biocompatibility evaluation for the Disposable Injection Needle was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" September 4, 2020, 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. -
MTT Cytotoxicity Test: ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity
-
Skin Sensitization Test, Skin Irritation Test: ISO 10993-10:2010, Biological ● evaluation of medical devices -- Part 10: Tests for irritation and sensitization
-
. Acute Systemic Toxicity Test, Subacute Systemic Toxicity Test and Pyrogen Test: ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
-
A Sterilization Validation
The EO sterilization of the Disposable Injection Needle has been validated according to the following applicable standards:
- ISO11135:2014+A1:2018 Sterilization of medical device- validation and . routine control of ethylene oxide sterilization
- ISO . methods-part 2: Tests of sterility performed in the validation of a sterilization process
- ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- USP Bacterial endotoxins test ●
- Shelf Life and Sterile Barrier System A page 8 of 10
11
Shelf Life and Sterile Barrier System of the Disposable Injection Needle has been validated according to the following applicable standards:
- . ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ISO11607-1:2019 Packaging for terminally sterilized Medical Device Part 1: ● Requirement for materials, sterile barrier systems and packaging systems
- . ISO11607-2:2019 Packaging for terminally sterilized Medical Device Part 2: Validation Requirement for forming, sealing and assembly process
- ASTM F 1929-15: Standard Test Method for Detecting Seal Leaks in Porous ● Medical Packaging by Dye Penetration
- ASTM D 3078-02(2013): Standard Test Method for Determination of Leaks ● in Flexible Packaging by Bubble Emission
- DIN 58593-6: 2016 Sterilization Sterile Supply Part 6: Microbial Barrier . Testing of Packaging Materials for Medical Devices Which Are to Be Sterilized
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible ● Barrier Materials
- ASTM D4169-16 Standard practice for performance testing of shipping . containers and systems (DC-13, Level II)
- A Performance Data - Bench
The performance tests were implemented on both the subject device (Alton Disposable Injection Needle) and the predicate device (Anrei Single Use Injection Needle) to demonstrate substantial equivalence according to the specific product specification with the following test items:
- Appearance
- . Dimension
- . Bond Strength
- . Operational performance
- . Puncture Performance
- Liquid leakage
12
- Injection connector (Luer connector)
- Patency of lumen
- . Corrosion Property
- . Chemical performance
- A Performance Data - Animal
N/A, no animal studies are available for the subject device.
IX. Summary of Clinical Data
N/A, no clinical studies are available for the subject device.
X. Conclusions
In conclusion, the technological characteristics, features, specifications, materials, principle of operation, and intended use of the subject device substantially equivalent to the predicate devices quoted above. The differences between the subjective device and its predicate devices do not introduce a new intended use and do not raise new issues of safety and effectiveness. Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended. From the results of nonclinical testing described, it can be concluded that the subject device is substantially equivalent to the legally marketed predicate devices.