(87 days)
None
No
The document describes a purely mechanical device (injection needle) and explicitly states that AI, DNN, or ML were not found in the description.
No
The device is used to perform endoscopic vascular or submucosal injection, which is a therapeutic procedure, but the device itself is an injection needle, an instrument used for the procedure rather than a device that directly provides therapy.
No
Explanation: The device is used for injection purposes (therapeutic or diagnostic), not for diagnosing a condition or disease. It performs an action within the GI tract following an endoscopic procedure.
No
The device description clearly lists physical components such as a handle, sheath, tubes, and tip, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "endoscopic vascular or submucosal injection in the GI tract." This is a therapeutic or procedural use, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a mechanical device for delivering injections, not a system for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any other components typically associated with IVD devices.
Therefore, the Disposable Endoscope Injection Needles are a medical device used for a procedural intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Disposable Endoscope Injection Needles are used with endoscope to perform endoscopic vascular or submucosal injection in the GI tract.
Product codes
FBK
Device Description
The Disposable Endoscope Injection Needles consist of a Sliding handle, Handle, Cap, Sheath, Inner Tube, Guide Tube, Connecting tube, and Tip (only Type B). It is available in a variety of configurations with varying needle lengths, gauges and working lengths. Type A and Type B are included in this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI tract (Gastrointestinal tract)
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
The following bench tests were performed on Disposable Endoscope Injection Needles: Appearance, Physical properties. The results of all testing were passing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
November 9, 2023
Zhejiang Soudon Medical Technology Co.,Ltd % Nick Wang RA Specialist Shanghai Vanhe Consulting Co., Ltd 2F, Building No.1, 3938 Huqingping Road, Qingpu District Shanghai, 201703 China
Re: K232442
Trade/Device Name: Disposable Endoscope Injection Needles Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FBK Dated: August 11, 2023 Received: August 14, 2023
Dear Nick Wang:
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.
1
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).
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.
2
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,
Sivakami Venkatachalam -S
for
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
3
Indications for Use
510(k) Number (if known) K232442
Device Name Disposable Endoscope Injection Needles
Indications for Use (Describe) Disposable Endoscope Injection Needles are used with endoscope to perform endoscopic vascular or submucosal injection 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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Image /page/4/Picture/0 description: The image shows a logo for Soudan Medical. The logo is blue and features a stylized design with the words "soudan medical" written in a smaller font below the main design. The main design consists of two vertical bars connected by a horizontal bar, with a flame-like symbol above it.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
1. Submitter
| Submitted by: | Zhejiang Soudon Medical Technology Co.,Ltd
Address:Room 302-1,Floor 3, Building 4, No.1 Nangonghe
Road, Donghu Street, Linping District, Hangzhou 311100
Zhejiang, China |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact
Person: | Nick Wang
RA Specialist
Shanghai Vanhe Consulting Co., Ltd
Address: 2F, Building No.1, 3938 Huqingping Road, Qingpu
District, Shanghai, China.
Phone: 0086-13585860297
Email: vanheconsulting@126.com |
| Date
Prepared: | August 11, 2023 |
Device
| Device Name: | Disposable Endoscope Injection Needles |
|---|---|
| Classification Name: | Endoscopic Injection Needle, Gastroenterology-Urology |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 876.1500 |
| Regulation Name: | Endoscope and Accessories |
| Product Code: | FBK |
Predicate Device
| Device Name: | Disposable Sclerotherapy Needle, K190032 |
|---|---|
| Manufacturer: | Hangzhou AGS MedTech CO., Ltd |
| Classification Name: | Endoscopic Injection Needle, |
| Gastroenterology-Urology | |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 876.1500 |
| Regulation Name: | Endoscope and Accessories |
| Product Code: | FBK |
2. Device Description
The Disposable Endoscope Injection Needles consist of a Sliding handle, Handle, Cap,
5
Image /page/5/Picture/0 description: The image shows a logo for Soudon Medical. The logo is primarily blue and features a stylized design. The top part of the logo includes a symbol that resembles a flame or a stylized bird in flight. Below this symbol, there is a geometric shape that looks like two pillars connected by a horizontal bar. Underneath the geometric shape, the words "soudon medical" are written in a smaller, sans-serif font.
Sheath, Inner Tube, Guide Tube, Connecting tube, and Tip (only Type B). It is available in a variety of configurations with varying needle lengths, gauges and working lengths. Type A and Type B are included in this submission.
3. Indication for Use:
Disposable Endoscope Injection Needles are used with endoscope to perform endoscopic vascular or submucosal injection in the GI tract.
4. Comparison of Technological Characteristics
The Disposable Endoscope Injection Needles has substantially equivalent device design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device Hangzhou AGS MedTech CO., Ltd 's Disposable Sclerotherapy Needle, K190032. The differences between the proposed device and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below.
| Item | Disposable Endoscope
Injection Needles(Proposed
Device) | Disposable
Sclerotherapy Needle,
K190032 | Discussion |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|------------|
| Indication for
Use | Disposable Endoscope
Injection Needles are used
with endoscope to perform
endoscopic vascular or
submucosal injection in the
GI tract. | The Disposable
Sclerotherapy Needle is
intended for endoscopic
injection into the
gastrointestinal mucosa. | Same |
| Outer Diameter | 2.3mm | 2.4mm | Same |
| Needle Gauge | 21G, 23G, 25G | 21G, 22G, 23G, 24G,
25G | Similar |
| Working Length | 1800mm, 2300mm | 1600mm, 2000mm,
2300mm | Similar |
| SAL | 10-6 | 10-6 | Same |
| Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | |
| Sterilization
Method | EO Sterilization | EO Sterilization | Same |
5. Non-clinical Performance Data
The proposed device meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing", ISO 11135-1 "Sterilization of Health Care products Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and
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Image /page/6/Picture/0 description: The image features a logo for "Soudon Medical". The logo is predominantly blue and consists of two distinct parts. The upper part of the logo contains a stylized image that resembles a flame or a stylized letter 'S'. The lower part of the logo features the text "soudon medical" in a smaller, sans-serif font, positioned beneath a larger, more abstract design that could be interpreted as stylized letters.
ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals" .
The following bench tests were performed on Disposable Endoscope Injection Needles: Appearance, Physical properties. The results of all testing were passing.
6. Clinical Test Data
No Clinical Study is included in this submission.
7. Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Zhejiang Soudon Medical Technology Co.,Ltd has demonstrated that proposed device Disposable Endoscope Injection Needles is substantially equivalent to Hangzhou AGS MedTech CO., Ltd 's currently marketed Disposable Sclerotherapy Needle, K190032.