It is to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varices and for submucosal dye marking in the GI tract.

Device Description

It is a flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform needle functions (e.g., injection) during endoscopy. It is designed with appropriate shape, materials and gauge to function through the working channel of an endoscope. This is a single-use device.

AI/ML Overview

The provided document is a 510(k) summary for the "Endoscopic Injection Needles" (K240675) from Promisemed Hangzhou Meditech Co., Ltd. It focuses on demonstrating substantial equivalence to a predicate device (Single Use Injection Needle, K210917) through non-clinical performance testing.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of acceptance criteria with specific numerical targets and results in the format requested. Instead, it lists the performance items tested and concludes that the testing "successfully demonstrated essential performance" and that the device "is at least equivalent to the predicate device."

Here's a breakdown of the tested performance items:

Acceptance Criterion (implicitly met)	Device Performance (reported)
Appearance	Tested, results met essential performance.
Cleanliness	Tested, results met essential performance.
Leakage	Tested, results met essential performance.
Puncture force	Tested, results met essential performance.
Stiffness	Tested, results met essential performance.
Resistance of needle tube to breakage	Tested, results met essential performance.
Corrosion resistance of needle tube	Tested, results met essential performance.
Particle contamination	Tested, results met essential performance.
Flexible properties	Tested, results met essential performance.
Flow	Tested, results met essential performance.
Compatibility and performance with endoscopes	Tested, results met essential performance.
Luer lock hub	Tested, results met essential performance.
EO residual	Measured to meet criteria defined in ISO 11135 and AAMI/ANSI/ISO 10993-7:2008(R)2012.
ECH residual	Measured to meet criteria defined in ISO 11135 and AAMI/ANSI/ISO 10993-7:2008(R)2012.
Shelf-life (3 years)	Validated in accelerated testing per ASTM F1980-16 (2016). Packaging requirements per ISO 11607-1 and ISO 11607-2 were also met.
Biocompatibility	Tested by a GLP laboratory following ISO 10993-1:2018; results are qualified (implying compliance with ISO 10993-4, -5, -10, -11, -23, and USP <151>).

2. Sample Size Used for the Test Set and Data Provenance:

The document
does not specify the sample sizes
used for each individual non-clinical performance test. It only states that "Performance testing was conducted."

Regarding data provenance, the document indicates that Promisemed Hangzhou Meditech Co., Ltd. is the manufacturer, located in Hangzhou City, China. The biocompatibility testing was conducted by a "third GLP laboratory," but its location is not specified. All tests described are retrospective in the sense that they were conducted for the purpose of this 510(k) submission, likely in a controlled laboratory environment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not applicable as the provided document details non-clinical, benchtop performance testing, not studies involving human subjects or expert assessment of clinical data to establish a "ground truth" as might be done for diagnostic devices. The acceptance criteria for these tests are based on established engineering standards and specifications rather than expert consensus on medical conditions.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. Benchtop performance tests typically involve objective measurements against predefined specifications, not subjective assessments requiring adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical test is included in this submission." and "No reference devices were used in this submission." This type of study is relevant for diagnostic imaging devices where human interpretation is involved.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone algorithm performance study was not done. This device is an Endoscopic Injection Needle, a physical medical instrument, not a software algorithm. Therefore, the concept of "standalone algorithm performance" (without human intervention) is not applicable.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical tests described is based on:

Engineering specifications and design requirements for the device.
Established national and international standards for medical device testing (e.g., ISO 11135, AAMI/ANSI/ISO 10993-7, ASTM F1980-16, ISO 11607-1, ISO 11607-2, ISO 10993 series, USP <151>).
Comparison to the predicate device's performance characteristics to establish substantial equivalence.

8. The Sample Size for the Training Set:

This information is not applicable. As this is a physical medical device and not a machine learning or AI-driven system, there is no "training set." The device's design is based on engineering principles and prior knowledge.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

October 4, 2024

Promisemed Hangzhou Meditech Co., Ltd. Yang Zearou Regulatory Affairs Manager No. 1388 Cangxing Street Cangqian Community, Yuhang District Hangzhou City, 311121 China

Re: K240675

Trade/Device Name: Endoscopic Injection Needles Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FBK Dated: September 6, 2024 Received: September 6, 2024

Dear Yang Zearou:

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"

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(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).

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 OS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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).

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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

Enclosure

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Indications for Use

Submission Number (if known)

K240675

Device Name

Endoscopic Injection Needles

Indications for Use (Describe)

It is to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varices 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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Image /page/4/Picture/0 description: The image shows the logo for Promisemed. The word "Promise" is in blue, except for the "P" which is in green. Above the "om" in "Promise" is a green circle connected to a blue circle by a blue line. To the right of the word "Promisemed" is the registered trademark symbol.

510(k) Summary

Date prepared: 2024-03-08

K240675

1. Manufacturer[21 CFR 807.92 (a) (1)]
Name	Promisemed Hangzhou Meditech Co., Ltd.
Address	No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, China.
Contact Person	Zearou Yang
Phone	+86 571 88772985
Fax	+86 571 88772985
Email	zearou.yang@promisemed.ca
2. Device [21 CFR 807.92 (a) (2)]
Name	Endoscopic Injection Needles
Common Name	Endoscopic Injection Needles
Classification Name	Endoscope and accessories
Regulation Number	876.1500
Class	Class II
Product Code	FBK
3. Legally Marketed Predicate Device[21 CFR 807.92 (a) (3)]
Predicate Name	Single Use Injection Needle
510(k) Number	K210917
Product Code	FBK
Reference Devices	No reference devices were used in this submission.
4. Device Description [21 CFR 807.92 (a) (4)]
It is a flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform needle functions (e.g., injection) during endoscopy. It is designed with appropriate shape, materials and gauge to function through the working channel of an endoscope.This is a single-use device.
5. Indication for use [21 CFR 807.92 (a) (5)]
It is to be used in conjunction with an endoscope to perform endoscopic injections, such as for the

treatment of esophageal and gastric varices and for submucosal dye marking in the GI tract.

Indications for Use Comparison [21 CFR 807.92 (a) (5)] 6.

No difference.

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No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, P. R. China.

Comparison of Technological Characteristic [21 CFR 807.92 (a) (6)] 7.

Compared with the predicate device, the subject device is identical in mechanism of action, materials, dimension, sterilization method and biocompatibility. The subject device has the same performance specifications except for Outer sheath diameter, Minimal working channel and working length. Through performance bench testing, the subject device and the predicate device demonstrated to be substantially equivalent. At a high level, the subject and predicate devices are based on the following same technological elements:

Specification	Subject Device	Predicate Device(K210917)	Discussion of difference
Trade Name	Endoscopic InjectionNeedles	Single Use Injection Needle	Discussion of difference
Manufacturer	Promisemed HangzhouMeditech Co., Ltd.	Anrei Medical (Hangzhou)Co., Ltd.
Device Class	Class II	Class II	No difference
Product Code	FBK	FBK	No difference
Regulation number	21 CFR 876.1500	21 CFR 876.1500	No difference
Prescription/over-the-counter use	Prescription	Prescription	No difference
Indications for Use	It is to be used in conjunctionwith an endoscope toperform endoscopicinjections, such as for thetreatment of esophageal andgastric varices and forsubmucosal dye marking inthe GI tract.	It is to be used in conjunctionwith an endoscope toperform endoscopicinjections, such as for thetreatment of esophageal andgastric varices and forsubmucosal dye marking inthe GI tract.	No difference
Environment of use	Healthcare facility/hospital	Healthcare facility/hospital	No difference
Single Use	Yes	Yes	No difference
Performance
Needle tube size	21G, 23G, 25G	21G, 23G, 25G	No difference
Needle tube length	4mm, 6mm	4mm, 6mm	No difference
Outer sheathdiameter	1.8mm, 2.4mm	2.4mm	Difference.Within the range.It does not introduceany new concerns forsafety or efficacy whichhas been confirmedperformance testing.
Minimal workingchannel	$Φ2.0mm$ or $Φ2.8mm$	$Φ2.8mm$	Difference.Within the range.It does not introduce anynew concerns for safetyor efficacy whichhas been confirmedperformance testing.
Working length	1200mm, 1800mm, 2000mm,2300mm, 2700mm.	1800mm, 2000mm, 2300mm.	Difference.More specifications.It does not introduce anynew concerns for safetyor efficacy which hasbeen confirmedperformance testing.
Patient-contactpotential(Durationand type ofcontact)	Externally communicatingmedical devices in contactwith tissue. The contactduration is limited exposure(i.e. contact is up to 24hours).	Externally communicatingmedical devices in contactwith tissue. The contactduration is limited exposure(i.e. contact is up to 24hours).	No difference
Sterility (SAL of 10-6)	Yes	Yes	No difference
Sterilizationmethod	Ethylene Oxide	Ethylene Oxide	No difference
Biocompatibility	ISO 10993-4:2017,ISO 10993-5:2009,ISO 10993-10:2021,ISO 10993-11:2017,ISO 10993-23:2021,USP <151>, 2017	Comply with ISO 10993standards	The biocompatibilitytesting for subject devicehas been tested inaccordance with the ISO10993-1: 2018, andresults are qualified.

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Image /page/6/Picture/1 description: The image shows the logo for "Promisemed". The word "Promise" is in green, and the word "med" is in blue. There is a blue molecular structure above the "o" in "Promise", and a registered trademark symbol in the upper right corner of the image.

No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, P. R. China.

Nonclinical test [21 CFR 807.92 (b) (1)] 8.

Performance testing was conducted on the following items to support the marketing claims and to confirm that the safety and effectiveness of the subject device is at least equivalent to the predicate device.

Appearance —
Cleanliness ー
-Leakage
Puncture force -
-Stiffness
-Resistance of needle tube to breakage
Corrosion resistance of needle tube
-Particle contamination
Flexible properties
-Flow
-Compatibility and performance with endoscopes
-Luer lock hub
Etc. —

The EO residual and ECH residual were measured after sterilization of the device to meet the criteria defined in ISO 11135 Second edition 2014 and AAMI/ANSI/ISO 10993-7:2008(R)2012.

The shelf-life for three years had been validated in accelerated testing according to ASTM F1980-16 (2016) and the requirements on packaging for terminally sterilized medical device per ISO 11607-1 and ISO 11607-2 are also met. The testing successfully demonstrated essential performance is achieved before and after the shelf life test.

Biocompatibility was tested by the third GLP laboratory following ISO 10993-1:2018;

Clinical test [21 CFR 807.92 (b) (2)] 9.

No clinical test is included in this submission.

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Image /page/7/Picture/1 description: The image shows the logo for "Promisemed". The word "Promise" is in green and blue, with a green atom-like structure above the "o". The word "med" is in blue, and there is a registered trademark symbol to the right of the word.

No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, P. R. China.

Conclusion [21 CFR 807.92 (b) (3)]

Based on the information provided within this 510(k) submission, the subject device is substantially equivalent to the predicate device and is as safe, as effective and performs as well as the legally marketed predicate device.

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.