(416 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterilization of a disposable needle, with no mention of AI or ML technologies.
No
The Disposable Sclerotherapy Needle is intended for endoscopic injection into the gastrointestinal mucosa, which suggests a procedural or delivery function rather than actively providing therapy itself.
No
The device is described as an "injection" device and "intended for endoscopic injection into the gastrointestinal mucosa." Its function is to deliver substances, not to diagnose conditions.
No
The device description explicitly lists physical components such as a Luer connector, handle, tubes, sheaths, and a needle, 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 "endoscopic injection into the gastrointestinal mucosa." This describes a procedure performed directly on a patient's tissue within the body.
- Device Description: The description details a needle and associated components for delivering a substance (likely a sclerosing agent) into tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not to directly treat or interact with tissue inside the body in the way this sclerotherapy needle does.
N/A
Intended Use / Indications for Use
The Disposable Sclerotherapy Needle is intended for endoscopic injection into the gastrointestinal mucosa.
Product codes (comma separated list FDA assigned to the subject device)
FBK
Device Description
The Disposable Sclerotherapy Needle device consists of: Luer connector, handle, molding metal tube, Inner sheath connection limit tube, Fixing sleeve, Outer sheath, Inner sheath, connection tube, metal cap, needle. EO Sterilization and use for single use only. The material expected to come into contact with the patient is SUS304 、SUS303、PP/PE.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal mucosa
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 11135-1 "Sterilization of Health Care products Ethylene Oxide - Part 1: 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 Disposable Sclerotherapy Needle: Appearance, Physical properties. The results of all testing were passing.
No Clinical test is included in this submission.
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.
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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 and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
February 27, 2020
Hangzhou AGS MedTech CO., Ltd Yangping Fu RA Specialist Building 5, Building 6, Kangxin Road No.597 Yuhang District 311106 Hangzhou, Zhejiang CHINA
Re: K190032
Trade/Device Name: Disposable Sclerotherapy Needle Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBK Dated: February 20, 2020 Received: February 26, 2020
Dear Yangping Fu:
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
1
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 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 (QS) 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 medical devices and radiation-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. Acting 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K190032
Device Name
Disposable Sclerotherapy Needle
Indications for Use (Describe)
The Disposable Sclerotherapy Needle is intended for endoscopic injection into the gastrointestinal mucosa.
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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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
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Image /page/3/Picture/0 description: The image contains a logo for AGS Medtech. The logo consists of a circular design with three blue curved shapes forming a triangle around a green center. To the right of the circular design, the text "AGS MEDTECH" is written in a simple, sans-serif font. Below that, there are Chinese characters, likely representing the company's name in Chinese.
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.
5.1 Submitter
| Submitted by: | Hangzhou AGS MedTech CO., Ltd.
Building 5, Building 6, No.597 Kangxin Road,
Yuhang District, 311106 Hangzhou, Zhejiang, China |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration Number: | 3010288205 |
| Owner/Operator Number: | 10052959 |
| Contact Person: | Yanping Fu
Phone: +86-571--87671223
Fax: +86-571--87671225
Email:fuyp@bioags.com |
| Date Prepared: | Jan 3, 2019 |
5.2 Proposed Device
Trade Name: | Disposable Sclerotherapy Needle |
---|---|
Common Name: | Disposable Sclerotherapy Needle |
Classification: | Class II |
Regulation Number: | 876.1500 |
Regulation Name: | Endoscope and accessories |
Product Code: | FBK |
Product Code Name: | Endoscopic Injection Needle, Gastroenterology-Urology |
5.3 Predicate Device
Trade Name: | Injection Therapy Needle Catheter |
---|---|
Common Name: | Injection Therapy Needle Catheter |
Manufacturer: | Boston Scientific Corporation |
510(k) Number: | K171454 |
Classification: | Class II |
Regulation Number: | 876.1500 |
Regulation Name: | Endoscope and accessories |
Product Code: | FBK |
Product Code Name: | Endoscopic Injection Needle, Gastroenterology-Urology |
5.4 Device Description
The Disposable Sclerotherapy Needle device consists of: Luer connector, handle, molding metal tube, Inner sheath connection limit tube, Fixing sleeve, Outer sheath, Inner sheath, connection tube, metal cap, needle. EO Sterilization and use for single use only. The material expected to come into contact with the patient is SUS304 、
4
Image /page/4/Picture/0 description: The image contains a logo for AGS Medtech. The logo consists of a circular design with three blue curved shapes forming a triangle, with a green shape in the center. To the right of the circular design, the text "AGS MEDTECH" is written in English, followed by Chinese characters below it.
SUS303、PP/PE.
5.5 Indication for Use:
The Disposable Sclerotherapy Needle is intended for endoscopic injection into the gastrointestinal mucosa.
5.6 Comparison of Technology Characteristics
The Disposable Sclerotherapy Needle has substantially equivalent device design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device Boston Scientific Corporation's Injection Therapy Needle Catheter, K171454. 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.
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Image /page/5/Picture/0 description: The image contains a logo for AGS Medtech. The logo consists of a circular design with three curved shapes in blue and green. To the right of the logo, the text "AGS MEDTECH" is written in English, followed by the same name written in Chinese characters. The text is in a smaller font size compared to the logo.
Item | Proposed Device | Predicate device(K171454) | Comment |
---|---|---|---|
Indication | |||
for Use | The Disposable Sclerotherapy Needle | ||
is intended for endoscopic injection | |||
into the gastrointestinal mucosa. | The InterjectTM Injection Therapy Needle | ||
Catheter is used for endoscopic injection | |||
into gastrointestinal mucosa and submucosa | |||
to: | |||
introduce a sclerosing agent, | |||
vasoconstrictor, or other solutions | |||
into selected sites to control actual or | |||
potential bleeding lesions in the | |||
digestive system aid in Endoscopic Mucosal Resection | |||
(EMR), Endoscopic Submucosal | |||
Dissection (ESD), or polypectomy | |||
procedures control non-variceal hemorrhage | Similar: | ||
Both can | |||
be used | |||
for | |||
gastrointes | |||
tinal | |||
mucosal | |||
injection. | |||
Configurat | |||
ion | Luer connector, handle, molding metal | ||
tube, Inner sheath connection limit | |||
tube, Fixing sleeve, Outer sheath, Inner | |||
sheath, connection tube, metal cap, | |||
needle | The InterjectTM Injection Therapy Needle | ||
Catheter is a catheter that consists of a | |||
handle | |||
with a hub for injection, a catheter sheath, | |||
and a needle. | Similar | ||
Photograp | |||
hs | Disposable Sclerotherapy Needle: | ||
Image: Disposable Sclerotherapy Needle diagram | |||
Image: Disposable Sclerotherapy Needle close up | |||
5311 Series ( with tip forming ) : | |||
Image: Disposable Sclerotherapy Needle with tip forming | Interject Clear Single-Use Injection | ||
Therapy Needle Catheters: | |||
Image: Interject Clear Single-Use Injection Therapy Needle Catheters | |||
Interject Contrast Single-Use Injection | |||
Therapy Needle Catheters: | |||
Image: Interject Contrast Single-Use Injection Therapy Needle Catheters | Similar | ||
Item | Proposed Device | Predicate device(K171454) | Comment |
5311 Series (with metal cap): | |||
Image: [5311 Series (with metal cap)] |
5313 Series (with metal cap):
Image: [5313 Series (with metal cap)] | Image: [Predicate device(K171454)] | |
| Sheath
diameter | 2.4mm | 1.8mm,2.3mm | Similar |
| Needle
size: | 21G, 22G, 23G, 24G, 25G | 23G, 25G | Similar |
| Outer
tubing | For 5311 series: PP;
For 5313 series: SUS 304 covered by PE. | For clear sheath design: unknown;
For contrast sheath design: unknown. | May be
different
: We
conducted
a
biocompat
ibility
evaluation
of the
device.
The
results
show the
device is
safe in the
aspect of
biocompat
ibility
evaluation |
| Working
Length | 1600mm, 2000mm, 2300mm | 2000mm ,2400mm | Similar |
| Packaging | Single-use EO sterilized Tyvek pouch | Single-use EO sterilized | Similar |
| Item | Proposed Device | Predicate device(K171454) | Comment |
| | with one device per pouch. | | |
| Materials | 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. | Unknown | Different:
This
difference
does not
alter the
suitability
of the
proposed
device for
its
intended
use. We
conducted
a
biocompat
ibility
evaluation
of the
device.
The
results
show the
device is
safe in the
aspect of
biocompat
ibility
evaluation |
| Principle
of
operation | 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, | The catheter sheath of the product is
inserted into the endoscope clamp. When
the front part of the catheter sheath is
placed on the lesion site, push the handle
with a hub for injection, the needle is
exposed to the catheter sheath, and the
needle is inserted into the lesion site, then | Similar |
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Image /page/6/Picture/0 description: The image shows the logo for AGS Medtech. The logo consists of a circular design with three blue curved shapes forming a triangle, with a green triangle in the center. To the right of the logo, the text "AGS MEDTECH" is written in English, followed by Chinese characters below it. The logo appears to be for a medical technology company.
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Image /page/7/Picture/0 description: The image contains a logo with the text "AGS MEDTECH" and "安杰思医学". The logo consists of a circular design with three curved shapes in blue, forming a triangle in the center. The central triangle is filled with green color. The text "AGS MEDTECH" is written in English, while "安杰思医学" is written in Chinese.
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Image /page/8/Picture/0 description: The image contains a logo for AGS Medtech. The logo consists of a circular design with three curved shapes in blue and green. To the right of the logo, the text "AGS MEDTECH" is written in English, followed by Chinese characters below it. The overall design is clean and professional, suggesting a company in the medical technology field.
5.7 Applicable Guidance Document
NA
5.8 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 ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals"
The following bench tests were performed on Disposable Sclerotherapy Needle: Appearance, Physical properties. The results of all testing were passing.
5.9 Clinical Test
No Clinical test is included in this submission.
5.10 Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Hangzhou AGS Medtech Co., Ltd has demonstrated that proposed device Disposable Sclerotherapy Needle is substantially equivalent to Boston Scientific Corporation's Injection Therapy Needle Catheter, K171454.