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.

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.

AI/ML Overview

This document is a 510(k) summary for a Disposable Injection Needle. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria for a complex AI/software-driven medical device. Therefore, the requested information, which pertains to such a study (sample sizes, expert adjudication, MRMC studies, ground truth establishment for AI/ML models), is not present in the provided text.

The document discusses non-clinical bench testing to demonstrate that the Disposable Injection Needle meets design specifications and performs comparably to a predicate device. This is a physical device, not an AI/ML-driven one.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide a direct "acceptance criteria" table in the sense of performance metrics for an AI/ML model (e.g., sensitivity, specificity, AUC). Instead, it lists various physical and chemical performance tests for the medical device. The "acceptance criteria" for these tests would be meeting the specified thresholds or demonstrating equivalence to the predicate device. The "reported device performance" is that the tests were carried out and demonstrated substantial equivalence.

Non-Clinical Performance Tests Performed:

Test Category	Specific Tests Performed	Reported Performance
Material/Device Safety	Biocompatibility (Cytotoxicity, Skin Sensitization, Skin Irritation, Acute/Subacute Systemic Toxicity, Pyrogen Test)	Complies with ISO 10993 standards and FDA guidance.
Sterilization	EO sterilization validation (ISO 11135, ISO 11737-2, ISO 10993-7, USP <85>)	Validated according to applicable standards.
Shelf Life & Packaging	Accelerated Aging (ASTM F1980), Packaging Requirements (ISO11607-1, ISO11607-2), Seal Leaks (ASTM F 1929, ASTM D 3078), Microbial Barrier (DIN 58593-6), Seal Strength (ASTM F88/F88M), Shipping Performance (ASTM D4169)	Validated according to applicable standards.
Bench Performance	Appearance, Dimension, Bond Strength, Operational performance, Puncture Performance, Liquid leakage, Injection connector (Luer connector), Patency of lumen, Corrosion Property, Chemical performance	Tests carried out, demonstrated substantial equivalence to predicate.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated for specific tests. The document mentions tests were performed on "both the subject device (Alton Disposable Injection Needle) and the predicate device (Anrei Single Use Injection Needle)." It doesn't specify the number of units tested for each.
Data Provenance: Not applicable in the context of clinical or image data. The "data" here refers to the results of bench testing. There is no mention of country of origin of data, nor whether it's retrospective or prospective, as these terms apply to clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. This device is a physical medical instrument, not an AI/ML system that requires expert annotation for ground truth. The "ground truth" for these tests would be established by validated test methods and reference standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is not a study involving human readers or interpretation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI-assisted device. The document explicitly states: "N/A, no clinical studies are available for the subject device."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The ground truth for this device's performance is based on established engineering and materials testing standards (e.g., ISO, ASTM, USP) and the performance of the legally marketed predicate device. For example, for biocompatibility, the ground truth is compliance with ISO 10993. For mechanical performance, it's demonstrating equivalence to the predicate and meeting specified functional requirements.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

In summary: The provided FDA 510(k) summary is for a physical medical device (Disposable Injection Needle) and demonstrates substantial equivalence through non-clinical bench testing against a predicate device and adherence to recognized standards. It does not contain the information requested regarding AI/ML device performance studies, as those types of studies (MRMC, standalone algorithm performance, expert adjudication, ground truth for training/test sets) are not relevant to this specific device submission.

Summary

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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).

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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

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Indications for Use

Submission Number (if known)

K230925

Device Name

Disposable Injection Needle (AF series)

Indications for Use (Describe)

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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K230925
Page 1 of 10

SECTION 2 510(k) Summary

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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

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IV. Device description

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.	NeedleGauge	NeedleLength	Outer TubeDiameter	Workinglength	Min. endoscopicworking 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

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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) MedicalInstruments 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 tobe used in conjunction with anendoscope to perform endoscopicinjections, such as for thetreatment of esophageal andgastric varies and for submucosaldye marking in the GI tract.	Single use injection needle is to beused in conjunction with anendoscope to perform endoscopicinjections, such as for the treatmentof esophageal and gastric varies andfor submucosal dye marking in theGI tract.	Same
General technological characteristics
Devicecomposition	Needle, bushing, outer tube,infusion inner tube, protectivetube, handle and pusher (withLuer connector on top part)	Needle, Connecting Tube, InnerTube, Sheath, Protect Tube, MetalTube, handle, Luer Connector	Difference,seeDiscussion 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: SUS304Outer tube: PTFE	Needle: SUS304Outer tube: PTFE	Same
Sterilization	Method: Ethylene Oxide sterilizationSAL: 10-6	Method: Ethylene Oxide sterilizationSAL: 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 permanganatereducing substance/Evaporated residue		Discussion 6
Biocompatibility	CytotoxicitySkin SensitizationSkin Irritation TestAcute Systemic Toxicity Test,Pyrogen TestComply with ISO 10993 standards	CytotoxicitySkin SensitizationSkin Irritation TestAcute Systemic Toxicity Test,Pyrogen TestComply with ISO 10993 standards	Same

VI. Comparison of technological characteristics with the predicate device

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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

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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

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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 <85> Bacterial endotoxins test ●
Shelf Life and Sterile Barrier System A page 8 of 10

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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

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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.

Regulation Number and Section

§ 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.