(184 days)
Not Found
No
The description focuses on a mechanical device for injection and does not mention any computational or analytical capabilities.
Yes.
The device is used to inject substances to control bleeding lesions in the digestive system, which is a therapeutic intervention.
No
The device is described as an Sclerotherapy Needle used for endoscopic injection to control bleeding lesions or mark lesions. Its function is interventional (therapeutic/procedural), not diagnostic.
No
The device description clearly outlines physical components (Luer connector, handle, sheath, infusion tube, fixed button connection tube, needle) and mentions bench tests for physical properties, indicating it is a hardware 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 endoscopic injection into gastrointestinal mucosa or to introduce a sclerosing agent to control bleeding. 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 physical device designed for injection and marking lesions within the digestive tract. It does not mention any components or functions related to analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, tissue, or other bodily fluids, which is characteristic of IVDs.
- Performance Studies: The performance studies mentioned are bench tests related to physical properties and appearance, not analytical performance on biological samples.
Therefore, this device is a medical device used for endoscopic procedures, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is used for endoscopic injection into gastrointestinal mucosa, or to endoscopically introduce a sclerosing agent into selected sites to control actual or potential bleeding lesions in the digestive system.
Product codes (comma separated list FDA assigned to the subject device)
FBK
Device Description
The Sclerotherapy Needle device consists of Luer connector, handle, sheath, infusion tube, fixed button connection tube and needle. EO sterilization and use for single use only.
The Sclerotherapy Needle device is designed to pass through the channel of endoscope to mark the lesions of the digestive tract and use it for injection. Compatibility with endoscopes, working lengths are 1200mm,1800mm, 2000mm, 2300mm, and the minimum working channel is ф 2.8 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal mucosa, digestive system
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed device meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing", ISO 11135:2014 "Sterilization of Health Care products Ethylene Oxide - Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals"
The following bench tests were performed on Sclerotherapy Needle: Appearance, Physical properties. The results of all testing were passing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
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.
February 23, 2022
Zhejiang Chuangxiang Medical Technology Co., LTD. Lucius Long, RA Manager Building 50, No. 650 Hongfeng Road Donghu Street Yuhang District, Hangzhou, 311100 CHINA
Re: K212668
Trade/Device Name: Sclerotherapy Needle Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FBK Dated: August 24, 2021 Received: January 27, 2022
Dear Lucius Long:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212668
Device Name Sclerotherapy Needle
Indications for Use (Describe)
The device is used for endoscopic into gastrointestinal mucosa, or to endoscopically introduce a sclerosing agent into selected sites to control actual or potential bleeding lesions in the digestive system.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K212668 Page 1 of 5
Image /page/3/Picture/1 description: The image contains a logo with a geometric shape on the left, resembling a stylized hexagon with a gradient from green to blue. To the right of the shape, there are Chinese characters in blue, followed by the word "MEDNOVA" in a combination of blue and green. The overall design appears to represent a company or organization, possibly in the medical or technological field, given the name and the clean, modern aesthetic.
g Medical Technology Co., LTD.
Page: 1 / 5
510(k) Summary( 21CFR 807.92)
1. Submitter's information
Name: Zhejiang Chuangxiang Medical Technology Co., LTD.
Address: Room 101,201,301,401,501, Building 50, No.650 Hongfeng Road Donghu Street, Yuhang District, Hangzhou City, Zhejiang Province, 311100, P.R. China
Contact person: Lucius.Long Email: lucius.long@med-nova.com Telephone: 86-571-89167088 Fax: 86-571-89167086
2. Date of Submission
09-Aug- 2021
3. Device
Trade/Device Name: Sclerotherapy Needle Regulation name: Endoscope and accessories Regulation class: II Regulation number:876.1500 Panel: Gastroenterology/Urology Product code: FBK
4. Predicative device
4.1) 510(k) Number: K190032 Device Name: Disposable Sclerotherapy Needle
5. Device description
The Sclerotherapy Needle device consists of Luer connector, handle, sheath, infusion tube, fixed button connection tube and needle. EO sterilization and use for single use only.
The Sclerotherapy Needle device is designed to pass through the channel of endoscope to mark the lesions of the digestive tract and use it for injection. Compatibility with endoscopes, working lengths are 1200mm,1800mm, 2000mm, 2300mm, and the minimum working channel is ф 2.8 mm.
6. Indications for use
The device is used for endoscopic injection into gastrointestinal mucosa, or to endoscopically introduce a sclerosing agent into selected sites to control actual or potential bleeding lesions in the digestive system.
4
Image /page/4/Picture/1 description: The image contains a logo with a geometric shape on the left, transitioning from green to blue. To the right of the logo, there is text in blue, followed by the word "MEDNOVA" in a smaller font size, with the letters transitioning from green to blue. The text appears to be a company or organization name, with the logo serving as its visual identifier.
Zhejiang Chuangxiang Medical Technology Co., LTD.
Page:
7. Comparison of Technological Characteristics:
The Sclerotherapy Needle has substantially equivalent device design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device Hangzhou AGS'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 | Proposed device | Predicate device | Comparison to
Predicate Devices |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Device name | Sclerotherapy Needle | Disposable Sclerotherapy Needle | / |
| Indications
for Use | The device is used for
endoscopic injection into
gastrointestinal mucosa, or to
endoscopically introduce a
sclerosing agent into selected
sites to control actual or
potential bleeding lesions in
the digestive system. | The Disposable Sclerotherapy
Needle is intended for endoscopic
injection into the
gastrointestinal mucosa. | Substantial
Equivalence |
| Configuration | Luer connector,Handle,
Infusion tube,Sheath,Fixed
button,Connection tube,Needle | Luer connector, handle, molding
metal tube, Inner sheath
connection limit tube, Fixing
sleeve, Outer sheath, Inner
sheath, connection tube, metal
cap, needle | Similar |
| Photographs | Sclerotherapy Needle:
Image: [Sclerotherapy Needle A Standard type]
- Luer connector 2. Handle 3. Drive Pipe 4. Sheath
Image: [Sclerotherapy Needle B simple type]
- Luer connector 2. Handle 3. Drive Pipe 4. Sheath | Disposable Sclerotherapy Needle:
Image: [Disposable Sclerotherapy Needle]
5311 Series ( with tip forming ) : | Similar |
| Zhejiang Chuangxiang Medical Technology Co., LTD. | | | Page: 3 / 5 |
| | Image: Diagram of tip structure with labels "Infusion tube", "connection tube Needle", and "Fixed button".
The tip structure
With fixed button:
Image: Syringe with fixed button
Image: Syringe with fixed button in packaging | Image: Syringe with metal cap
5311 Series (with metal cap):
Image: Syringe with metal cap | |
| | Without fixed button:
Image: Syringe without fixed button
Image: Syringe without fixed button | Image: Green syringe with metal cap
5313 Series (with metal cap):
Image: Green syringe with metal cap | |
| Sheath diameter | 1.8mm,2.4mm | 2.4mm | Similar |
| Needle size: | 19G,21G, 23G,25G | 21G, 22G, 23G, 24G, 25G | Similar |
| Outer tubing | PTFE | For 5311 series: PP;
For 5313 series: SUS 304 covered by PE. | Similar: We conducted a Biocompatibility |
| | | | Page: 4 / 5 |
| | | | evaluation of the
device. The results
show the device is
safe in the aspect of
biocompatibility
evaluation |
| Working
Length | 1200mm,1800mm, 2000mm,
2300mm | 1600mm, 2000mm, 2300mm | Similar |
| Packaging | Single-use EO sterilized
paper-plastic pouch with one
device per pouch. | Single-use EO sterilized Tyvek
pouch with one device per pouch. | Similar |
| Materials | Luer connector: ABS
Handle: ABS
Infusion tube: PP
Sheath: PTFE
Fixed button: Y12Cr18Ni9Cu3
Connection tube:
SUS304(06Cr19Ni10 )
Needle:X5CrNi18-9 | Luer connector: PC;
Handle: PC;
Molding metal tube: SUS304;
Inner sheath connection limit
tube: PTFE;
Fixing sleeve: ABS;
Outer sheath: PP( 5311series);
SUS 304 and PE (5313 series);
Inner sheath: PP;
Connection tube: SUS 304;
Metal cap: SUS303;
Needle: SUS304.
The material expected to come
into contact with the patient is
SUS304, SUS303 and PP, or
SUS304、SUS303 and PE. | Similar |
| Principle of
operation | The catheter sheath of the
product 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. | The outer sheath of the product is
inserted into the endoscope
clamp. When the front part of the
outer sheath tube is placed on the
lesion site, push the Luer
connector, the needle tube is
exposed to the outer sheath, and
the needle is inserted into the
lesion site, then normal saline
injection. | Similar |
5
Image /page/5/Picture/1 description: The image contains a logo with a geometric shape on the left, followed by text. The geometric shape is a hexagon with a gradient fill, transitioning from green at the bottom to blue at the top. To the right of the shape, there are Chinese characters in blue, followed by the word "MEDNOVA" in blue and green. The word "MED" is in blue, while "NOVA" is in green.
Zhejiang Chuangxiang Medical Technology Co., LTD.
6
Image /page/6/Picture/1 description: The image contains a logo with a geometric shape on the left and text on the right. The geometric shape is a hexagon with a smaller hexagon inside, and it is colored with a gradient from green to blue. To the right of the shape, there are Chinese characters in blue, followed by the word "MEDNOVA" in blue and green. The logo appears to represent a company or organization, possibly in the medical or technology field.
Zhejiang Chuangxiang Medical Technology Co., LTD.
7
K212668 Page 5 of 5
Image /page/7/Picture/1 description: The image contains a logo for Zhejiang Chuangxiang Medical Technology Co., LTD. The logo features a geometric shape in shades of green and blue, along with the text "MEDNOVA" in green. The company name is written below the logo in black text.
5 / 5 Page: Page
8. Applicable Guidance Document
NA
9. Performance Data
The proposed device meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing", ISO 11135:2014 "Sterilization of Health Care products Ethylene Oxide - Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals"
The following bench tests were performed on Sclerotherapy Needle: Appearance, Physical properties. The results of all testing were passing.
10. Clinical Test Conclusion
No clinical study is included in this submission.
11. Conclusions
Chuangxiang medical has demonstrated that the proposed device Sclerotherapy Needle is substantially equivalent to Hangzhou AGS MedTech CO., Ltd. currently marketed Disposable Sclerotherapy Needle (K190032).