(60 days)
No
The device description and performance studies focus on the mechanical aspects of a biopsy needle and do not mention any computational or analytical capabilities.
No.
The device is designed for sampling and aspiration for diagnostic purposes, not for treating a disease or condition.
Yes
The device is designed to "sample targeted submucosal and extraluminal gastrointestinal lesions," which implies collecting biological material (biopsy) for pathological examination to determine the nature of the lesions. This sampling process is a key step in diagnosing diseases.
No
The device description clearly outlines physical components (needle, syringe, stopcock) and mentions performance testing related to physical properties (Dimension Testing, Tensile Strength Testing, Needle Puncture Force Testing). There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to sample targeted lesions. This is a device used to collect a sample from the body.
- Device Description: The device is a needle designed for aspiration. It's a tool for obtaining a biological specimen.
- No mention of in vitro analysis: There is no indication that this device is used to perform tests on the collected sample outside of the body (in vitro). IVD devices are specifically designed for testing biological specimens in a laboratory or other in vitro setting to provide information about a patient's health.
This device is a medical device used for biopsy or aspiration, which is a procedure to obtain a sample for subsequent analysis, which might be done using an IVD device, but this needle itself is not the IVD.
N/A
Intended Use / Indications for Use
The Endoscopic Ultrasound Aspiration Needle is designed to sample targeted submucosal and extraluminal gastrointestinal lesions through the accessory channel of suitable ultrasound videoendoscope in adult patients only.
Product codes
ODG, FCG
Device Description
The proposed Endoscopic Ultrasound Aspiration Needle is a sterile single-use device, designed to sample targeted submucosal and extraluminal gastrointestinal lesions through the accessory channel of suitable ultrasound videoendoscope.
It consists of three parts, Aspiration Needle, Syringe and Stopcock. The aspiration needle is offered with multiple types with different dimension, needle tip design and needle material. Syringe and stopcock are accessories to provide and control the vacuum suction to aspirate the sample.
There are 12 specifications, the difference is the diameter, material and tip design of needle.
The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10t and placed in a sterility maintenance package to ensure a shelf life of 2 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
submucosal and extraluminal gastrointestinal lesions
Indicated Patient Age Range
adult patients only
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)
Performance testing such as Dimension Testing, Tensile Strength Testing, Needle Puncture Force Testing and etc, were performed.
The testing performed demonstrated that the proposed device meets the same performance requirements and is Substantially Equivalent (SE) to the currently cleared predicate devices (K070129, K083802, K160845).
Clinical Test is not applicable for the proposed device. No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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Image /page/0/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The address is printed in a standard font and is left-aligned.
September 29, 2017
Micro-Tech (Nanjing) CO.,Ltd. Becky Li Quality and Regulatory Affairs Director No. 10 Gaoke Third Road Nanjing, Jiangsu 210032 China
Re: K172309
Trade/Device Name: Endoscopic Ultrasound Aspiration Needle Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: ODG, FCG Dated: July 28, 2017 Received: July 31, 2017
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.
1
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 (reporting of medical device-related 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 (DICE) 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 (DICE) 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,
Charles Viviano -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
Endoscopic Ultrasound Aspiration Needle
Indications for Use (Describe)
The Endoscopic Ultrasound Aspiration Needle is designed to sample targeted submucosal and extraluminal gastrointestinal lesions through the accessory channel of suitable ultrasound videoendoscope in adult patients only.
| 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/3/Picture/1 description: The image shows the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, three-dimensional blue font on the left. To the right of the letters, the words "MICRO-TECH" are written in blue, with a line underneath. Below the line, there are two Chinese characters, also in blue.
Tab 7
510K Summary
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: 2017-09-29
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: Quality and Regulatory Affairs Director Tel: +86-25-58646378
Fax: +86-25-58350006
Email: ln@micro-tech.com.cn
3. Identification of Proposed Device
Trade Name: Endoscopic Ultrasound Aspiration Needle Common Name: Endoscopic ultrasound Needle Regulatory Information Classification Name: Endoscopes and Accessories Classification: 2 Product Code: ODG & FCG Regulation Number: 876.1500 & 876.1075
Review Panel: Gastroenterology/Urology
Intended Use Statement:
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Image /page/4/Picture/1 description: The image shows the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, three-dimensional font, with the words "MICRO-TECH" to the right of the letters. Below the words "MICRO-TECH" are two Chinese characters. The logo is blue and white.
510K Summary
The Endoscopic Ultrasound Aspiration Needle is designed to sample targeted submucosal and extraluminal gastrointestinal lesions through the accessory channel of suitable ultrasound videoendoscope in adult patients only..
| Item | Predicate Device
1 | Predicate Device
2 | Predicate Device
3 |
|---------------|---------------------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------------------------|
| 510(k) Number | K070129 | K083802 | K160845 |
| Product Name | Medi-Globe
SonoTip II
Ultrasound
Needle System | Medi-Globe
SonoTip II
25-gauge
Ultrasound
Needle System | AcquireTM
Endoscopic
Ultrasound Fine
Needle Biopsy
(FNB) Device |
| Manufacturer | Medi-Globe
Corporation | Medi-Globe
Corporation | Boston Scientific
Corporation |
4. Identification of Predicate Device
5. Indications for Use
The Endoscopic Ultrasound Aspiration Needle is designed to sample targeted submucosal and extraluminal gastrointestinal lesions through the accessory channel of suitable ultrasound videoendoscope in adult patients only..
6. Device Description
The proposed Endoscopic Ultrasound Aspiration Needle is a sterile single-use device, designed to sample targeted submucosal and extraluminal gastrointestinal lesions through the accessory channel of suitable ultrasound videoendoscope.
It consists of three parts, Aspiration Needle, Syringe and Stopcock. The aspiration needle is offered with multiple types with different dimension, needle tip design and needle material. Syringe and stopcock are accessories to provide and control the vacuum suction to aspirate the sample.
5
Image /page/5/Picture/1 description: The image shows the logo for Micro-Tech. The logo consists of a blue, three-dimensional "MT" symbol on the left, followed by the text "MICRO-TECH" in blue, sans-serif font. Below the text "MICRO-TECH" are two Chinese characters, also in blue.
510K Summary
There are 12 specifications, the difference is the diameter, material and tip design of needle.
The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10t and placed in a sterility maintenance package to ensure a shelf life of 2 years.
7. Comparison of Technological Characteristics
The Endoscopic Ultrasound Aspiration Needle of Micro-Tech (Nanjing) CO., Ltd. incorporates substantially equivalent materials, design, configuration, packaging fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate devices (K070129, K083802, K160845).
8. Performance Data
The proposed device Endoscopic Ultrasound Aspiration Needle meets the requirements of ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within A Risk Management Process", ISO 11135 "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 device specific guidance document was consulted in preparing this premarket submission, . Performance testing such as Dimension Testing, Tensile Strength Testing, Needle Puncture Force Testing and etc, were performed.
The testing performed demonstrated that the proposed device meets the same performance requirements and is Substantially Equivalent (SE) to the currently cleared predicate devices (K070129, K083802, K160845).
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Image /page/6/Picture/1 description: The image shows the logo for MICRO-TECH. The logo consists of a blue stylized "MT" symbol on the left, followed by the text "MICRO-TECH" in blue. Below the text "MICRO-TECH" are two Chinese characters, also in blue.
9. Clinical Test Conclusion
Clinical Test is not applicable for the proposed device. No clinical study is included in this submission.
10. Substantially Equivalent (SE) Conclusion
Based on the indications for use, technological characteristics, and safety and performance testing, the Endoscopic Ultrasound Aspiration Needle has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared: