(103 days)
Not Found
No
The device description and intended use are purely mechanical, and there are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML development.
Yes
The device is used for the "treatment of esophageal and gastric varices" and "submucosal dye marking in the GI tract," which are therapeutic applications.
No
Explanation: The device is an injection needle used for therapeutic purposes (injecting materials for treatment or marking), not for diagnosing conditions.
No
The device description clearly outlines a physical medical device consisting of a stainless steel needle, plastic tubing, and a luer lock hub. It also mentions sterilization and physical testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for performing endoscopic injections directly into tissue (esophageal and gastric varices, submucosal dye marking). This is a therapeutic and procedural use, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a needle designed for delivering substances into tissue, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting specific analytes, or providing diagnostic information based on the analysis of such samples.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used for direct intervention and treatment within the body.
N/A
Intended Use / Indications for Use
The 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.
Product codes (comma separated list FDA assigned to the subject device)
FBK
Device Description
The injection needle consists of a stainless steel needle attached to plastic tubing and luer lock hub where a standard syringe can be attached for injection of materials through the lumen of the needle into tissue. The minimum required working channel for this proposed product is 2.8mm.
The proposed products are intended for single use, an individual device is packed in a sealed pouch following ETO sterilization. The device is used for local injection via endoscope, with the average contact time of the product and the mucosa of the human digestive tract of less than 1 hour.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI tract, esophageal and gastric
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)
Biocompatibility, accelerated aging, performance, and sterilization validation testing was performed on the injection needle that demonstrated that this device is safe and effective for use. Testing was based on a formal risk analysis.
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/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract design featuring three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 2, 2015
Micro-Tech (Nanjing) CO., Ltd. Becky Li Manager of Quality Department No. 10. Gaoke Third Road High-New Tech Industry Development Dist. Nanjing, Jiangsu, 210032 China
Re: K150434 Trade/Device Name: Injection Needle Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FBK Dated: April 14, 2015 Received: April 20, 2015
Dear Becky Li.
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. 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 requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation 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)
Device Name Injection Needle
Indications for Use (Describe)
The injection needle is to be used in conjunction with an endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.
| 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."
Type of Use (Select one or both, as applicable)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
Image /page/3/Picture/1 description: The image contains a logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, three-dimensional font on the left side. To the right of the letters is the text "MICRO-TECH" in a sans-serif font, with a line underneath it. Below the line are two Chinese characters.
Tab7
510K Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: __
1. Date of Preparation: 01/16/2015
2. Sponsor Identification
Micro-Tech (Nanjing) Co., Ltd.
No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone, Nanjing, Jiangsu Province, PRC Establishment Registration Number: 3004837686 Contact Person: Becky Li Position: Manager of Quality Department Tel: +86-25-58646378
Fax: +86-25-58744269
Email: In@micro-tech.com.cn
3. Identification of Proposed Device
Product Name: Injection Needle Common Name: Endoscopic Needle Regulatory Information Classification Name: Endoscopy and accessories Classification: 2 Product Code: FBK Regulation Number: 876.1500 Review Panel: Gastroenterology/Urology
4. Indications for Use
The 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.
4
Image /page/4/Picture/1 description: The image contains the logo for MICRO-TECH. The logo consists of a stylized blue "MT" on the left, followed by the text "MICRO-TECH" in blue. Below the text is a thin blue line, and below that are two Chinese characters, also in blue.
5. Device Description
The injection needle consists of a stainless steel needle attached to plastic tubing and luer lock hub where a standard syringe can be attached for injection of materials through the lumen of the needle into tissue. The minimum required working channel for this proposed product is 2.8mm.
The proposed products are intended for single use, an individual device is packed in a sealed pouch following ETO sterilization. The device is used for local injection via endoscope, with the average contact time of the product and the mucosa of the human digestive tract of less than 1 hour.
6. Identification of Predicate Device
510(k) Number: K061222 Product Name: Injectra Injection Needle
7. Technological Characteristics:
The injection needle is available in three needle sizes, three needle size and three working length. The two Characteristics: sizes relate to the needle gauge. The sizes are 19 gauges 22 gauge and 25 gauge. The needle sizes are 4mm, 5mm and 6 mm. Working lengths includes 1800mm, 2000mm and 2300mm. There are twenty-seven (27) models injection needles. Micro-Tech (Nanjing) believes that the proposed Injection Needle is substantially equivalent to the currently cleared Injection Needle (K061222) in device function and overall design.
8. Testing Performed:
Biocompatibility, accelerated aging, performance, and sterilization validation testing was performed on the injection needle that demonstrated that this device is safe and effective for use. Testing was based on a formal risk analysis.
The following table shows a summary substantial equivalence of the Injection Needle and the chosen predicate, indicating no additional safety risks arise in the new device based on similarities in materials, intended use, and function of the Injection Needle in comparison to the predicate device.
5
Image /page/5/Picture/0 description: The image shows the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, three-dimensional font on the left. To the right of the letters is the text "MICRO-TECH" in a simple font, with a line underneath it. Below the line are two Chinese characters.
510K Summary
| ltem | Proposed Device | Predicate Device 2 | Substantial Equivalence |
|---|---|---|---|
| Injection Needle | Injectra Injection Needle | ||
| (K061222) | |||
| Product Code | FBK | FBK | Same |
| Regulation No. | 876.1500 | 876.1500 | Same |
| Class | വ | 2 | Same |
| Supplied Sterile | Yes | Yes | Same |
| Outer Sheath diameter | 2.3 mm | 2.3 mm | Same |
| Needle size | 19gauge, 22gauge, 25 gauge | 19gauge, 22gauge, 25 gauge | Same |
| Outer Sheath Material | Thermoplastic-PTFE Polymer | Thermoplastic-PTFE Polymer | Same |
| Working Length | 1800mm, 2000mm, 2300mm | 1200mm,1600mm,1800mm, | |
| 2300mm | Similar | ||
| Needle Length | 4mm, 5mm, 6mm | 4mm,6mm | Similar |
| Indications for Use | The injection needle is to be used in conjunction | The Injectra Injection Needle | Similar |
| with an endoscope to perform endoscopic | is a complete one-piece | ||
| injections, such as for the treatment of esophageal | injection needle intended for | ||
| Item | Proposed Device | Predicate Device 2 | Substantial Equivalence |
| Injection Needle | |||
| and gastric varies and for submucosal dye marking | |||
| in the GI tract. | Injectra Injection Needle | ||
| (K061222) | |||
| endoscopic injection of | |||
| solutions such as sclerosing | |||
| agents into tissues of the | |||
| digestive system to control | |||
| bleeding and for injection of | |||
| saline as a procedural aid in | |||
| endoscopic Polypectomy | |||
| procedures. The Injectra | |||
| Injection Needle is a | |||
| disposable device and is | |||
| intended for single patient use | |||
| only. | |||
| Configuration | Needle, inner sheath, outer shell, outer sheath and | ||
| luer lock | Needle, inner sheath, outer | ||
| shell, outer sheath and luer | |||
| lock | Similar | ||
| Single Use | Yes | Yes | Same |
Table 1 Comparison of Technology Characteristics
6
Image /page/6/Picture/0 description: The image contains the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, blue, three-dimensional font on the left. To the right of the letters is the text "MICRO-TECH" in a simple font, with a line underneath it, and the Chinese characters "微 创" below the line.
7
Image /page/7/Picture/0 description: The image shows the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, blue font on the left side of the image. To the right of the letters is the company name, "MICRO-TECH", in a sans-serif font, also in blue. Below the company name are two Chinese characters.
| Item | Proposed Device | Predicate Device 2 | Substantial Equivalence |
|---|---|---|---|
| Injection Needle | Injectra Injection Needle | ||
| (K061222) | |||
| Packaging | Single-use EO sterilized pouch with one device per pouch | Single-use EO sterilized pouch with one device per pouch | Similar |
9. Substantially Equivalent (SE) Conclusion
Based on the technological characteristics and overall performance of the devices, Micro-Tech (Nanjing) CO., Ltd. believes that the Injection Needle and the predicate device selected are substantially equivalent. While the intended uses are slightly different, both devices are intended to be used in the same body regions during endoscopic procedures for injection of fluids. Therefore, this difference is minor, and does not raise new issues of safety or effectiveness.