(90 days)
Not Found
No
The summary describes a mechanical aspiration needle and suction device, with no mention of AI/ML capabilities, image processing, or data-driven performance metrics.
No
The device is designed to sample gastrointestinal lesions, indicating a diagnostic rather than a therapeutic (treatment) purpose.
Yes
The device is described as an "Endoscopic Ultrasound Aspiration Needle" designed to "sample targeted submucosal and extraluminal gastrointestinal lesions." Taking samples (biopsies) of lesions is a diagnostic procedure to determine the nature of the lesions.
No
The device description explicitly states it is a sterile single-use device consisting of an Aspiration Needle and negative suction device, which are physical hardware components. The performance studies also focus on physical characteristics like puncture force, stiffness, and tensile strength.
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 procedure to obtain a sample, not to perform a diagnostic test on the sample itself.
- Device Description: The device is an aspiration needle and a negative suction device. These are tools for collecting a sample, not for analyzing it.
- Lack of Diagnostic Function: There is no mention of the device performing any analysis, measurement, or determination of a physiological state or disease. IVDs are designed to be used in vitro (outside the body) to examine specimens derived from the human body for diagnostic purposes.
- Performance Studies: The performance studies focus on the physical and functional aspects of the needle (actuation, leakage, puncture force, etc.), not on the accuracy or reliability of any diagnostic results.
This device is a medical device used for obtaining a sample for potential subsequent diagnostic testing (which would likely be an IVD).
N/A
Intended Use / Indications for Use
The device is designed to sample targeted submucosal and extraluminal gastrointestinal lesions through the accessory channel of suitable ultrasound videoendoscope in adult patients only.
Product codes (comma separated list FDA assigned to the subject device)
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.
The Endoscopic Ultrasound Aspiration Needle consists of an Aspiration Needle and negative suction device. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 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 image
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 was conducted to demonstrate the essential performance of the proposed device Adapt Endoscopic Ultrasound Aspiration Needle and confirmed that the proposed device works as intended with the compatible devices.
The bench tests below were tested and evaluated as substantially equivalent to the predicate device.
- Smooth Actuation of Handle
- Leakage
- Ultrasound Visibility
- Puncture Force
- Stiffness
- Durability
- Stylet Removal Force
- Locking Force of Handle
- Tensile Strength
Shelf-life testing and packaging integrity testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices and ISO 11607-1:2019: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2019: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes. Two-years aging test will be performed to demonstrate longer stability and support the results of the accelerated aging test.
Sterilization validation was carried out in accordance with ISO 11135:2014+A1:2018 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices".
The biocompatibility evaluation for the Adapt Endoscopic Ultrasound Aspiration Needle was conducted in accordance with ISO 10993-1: 2009 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" and FDA's biocompatibility guidance, Use of International Standard ISO-10993-1. "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process (issued on September 4, 2020,) the following tests were conducted:
- Cytotoxicity Test
- Sensitization Test
- Irritation Test
- Acute Systemic Toxicity Test
- Material Mediated Pyrogenicity Test
- Hemolysis Test
The results of all the performance testing demonstrated that the proposed device met the acceptance criteria and support substantial equivalence to the predicate device the predicate device Endoscopic Ultrasound Aspiration Needle cleared under K172309.
No animal study is included in this submission.
No clinical study 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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 6, 2021
Micro-Tech(Nanjing) Co., Ltd. Cecilia Sun RA Engineer No.10 Gaoke Third Road, Nanjing National Hi-tech Industrial Development Zone Nanjing, Jiangsu Province 210032 CHINA
Re: K212852
Trade/Device Name: Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODG, FCG Dated: September 3, 2021 Received: September 7, 2021
Dear Cecilia Sun:
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.
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 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. 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) K212852
Device Name
Adapt Endoscopic Ultrasound Aspiration Needle
Indications for Use (Describe)
The device 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)|X 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 a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be leaning slightly to the right, creating a sense of depth. A small registered trademark symbol is visible in the upper right corner of the logo.
510(k) 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: 2021-08-31
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: Cecilia Sun
Position: RA Engineer
Tel: +86-25-58646395
Fax: +86-25-58350006
Email: RA.Micro-Tech@outlook.com
3. Identification of Proposed Device
Trade Name: Adapt Endoscopic Ultrasound Aspiration Needle
Common Name: Endoscopic Ultrasound Aspiration Needle
Regulatory Information
Classification Name: Endoscopic Ultrasound System, Gastroenterology-Urology & Biopsy
Needle
Classification: II
Product Code: ODG, FCG
Regulation Number: 21 CFR§ 876.1500
Review Panel: Endoscope and Accessories
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Image /page/4/Picture/1 description: The image shows a logo with the letters "MT" in a stylized, three-dimensional font. The letters are a deep blue color, and the logo has a slightly angled perspective, giving it a sense of depth. A small registration mark (®) is visible in the upper right corner of the logo.
Section 5 510(k) Summary
4. Identification of Predicate Device
Predicate Device
510(k) Number: K172309 Product Name: Endoscopic Ultrasound Aspiration Needle Manufacturer: Micro-Tech (Nanjing) Co., Ltd.
5. Indications for Use
The device 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.
The Endoscopic Ultrasound Aspiration Needle consists of an Aspiration Needle and negative suction device. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10 ° and placed in a sterility maintenance package to ensure a shelf life of 2 years.
7. Comparison of Technological Characteristics
The Adapt Endoscopic Ultrasound Aspiration Needle incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate device Endoscopic Ultrasound Aspiration Needle cleared under K172309.
| Item | Proposed Device
Adapt Endoscopic Ultrasound
Aspiration Needle | Predicate Device (K172309)
Endoscopic Ultrasound Aspiration
Needle | Remark |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Product Code | ODG, FCG | ODG, FCG | Same |
| Regulation No. | 876.1500 | 876.1500 | Same |
| | Proposed Device | Predicate Device (K172309) | |
| Item | Adapt Endoscopic Ultrasound | Endoscopic Ultrasound Aspiration | Remark |
| | Aspiration Needle | Needle | |
| Class | 2 | 2 | Same |
| Intended
Use/Indications | The device is designed to sample
targeted submucosal and
extraluminal gastrointestinal lesions
through the accessory channel of
suitable ultrasound videoendoscope
in adult patients only. | The device is designed to sample
targeted submucosal and
extraluminal gastrointestinal lesions
through the accessory channel of
suitable ultrasound videoendoscope
in adult patients only. | Same |
| Single Use | Yes | Yes | Same |
| Configuration | Aspiration Needle and Negative
suction device (including Stopcock
and Syringe) | Aspiration Needle, Vacuum Syringe
and Stopcock | Same |
| Compatible
Endoscope Working
Channel (mm) | ≥2.8 | ≥2.8 | Same |
| Needle Diameter | 19G, 22G | 19G, 22G, 25G | Similar |
| Needle Length out of
Sheath (mm) | 080 | 080 | Same |
| Working Length
(mm) | 13751415 | 13751415 | Same |
| Operation Principle | The device goes through the
ultrasound endoscope to reach the
target area, then the needle is pierced
into the targeted lesions in the
ultrasound image. The needle moves
back and forth by operating the
handle to sample tissue or cells by
applying suction. | The device goes through the
ultrasound endoscope to reach the
target area, then the needle is pierced
into the targeted lesions in the
ultrasound image. The needle moves
back and forth by operating the
handle to sample tissue or cells by
applying suction. | Same |
| Packaging | Single-use EO sterilized pouch with
one device per pouch | Single-use EO sterilized pouch with
one device per pouch | Same |
| Shelf Life | Two years | Two years | Same |
| Item | Proposed Device
Adapt Endoscopic Ultrasound
Aspiration Needle | Predicate Device (K172309)
Endoscopic Ultrasound Aspiration
Needle | Remark |
| Biocompatibility | Conform to ISO 10993-1 | Conform to ISO 10993-1 | Same |
| Sterilization | EO Sterilized, SAL:10-6 | EO Sterilized, SAL:10-6 | Same |
| Labeling | Conform to 21 CFR part 801 | Conform to 21 CFR part 801 | Same |
Table 7.1 Comparison to Predicate Devices
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Image /page/5/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are bold and appear to be angled slightly, giving the logo a sense of depth. There is a small circle with a registered trademark symbol in the upper right corner of the logo.
Section 5 510(k) Summary
6
Section 5 510(k) Summary
Image /page/6/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, blocky font. The letters are connected and appear to be three-dimensional, with a shadow effect that gives them depth. In the upper right corner of the logo, there is a small circle with the letter "R" inside, indicating a registered trademark symbol.
8. Performance Data
Performance testing was conducted to demonstrate the essential performance of the proposed device Adapt Endoscopic Ultrasound Aspiration Needle and confirmed that the proposed device works as intended with the compatible devices.
The bench tests below were tested and evaluated as substantially equivalent to the predicate device.
-
Smooth Actuation of Handle
-
Leakage
-
Ultrasound Visibility
-
Puncture Force
-
Stiffness
-
Durability
- Stylet Removal Force >
-
Locking Force of Handle
-
Tensile Strength
Shelf-life testing and packaging integrity testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices and ISO 11607-1:2019: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2019: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes. Two-years aging test will be performed to demonstrate longer stability and support the results of the accelerated aging
7
Image /page/7/Picture/1 description: The image shows a blue and white logo with the letters "MT" in a stylized, three-dimensional font. The letters are large and bold, with a shadow effect that gives them depth. The logo is simple and modern, and the colors are bright and eye-catching. There is a registered trademark symbol in the upper right corner of the image.
test.
Section 5 510(k) Summary
Sterilization validation was carried out in accordance with ISO 11135:2014+A1:2018 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices".
The biocompatibility evaluation for the Adapt Endoscopic Ultrasound Aspiration Needle was conducted in accordance with ISO 10993-1: 2009 "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing within a Risk Management Process" and FDA's biocompatibility guidance, Use of International Standard ISO-10993-1. "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process (issued on September 4, 2020,) the following tests were conducted:
The biocompatibility evaluation for the was conducted in accordance with ISO 10993-1: 2009 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" and FDA's biocompatibility guidance, Use of International Standard ISO-10993-1. "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process (issued on September 4, 2020,) the following tests were conducted:
-
Cytotoxicity Test
-
Sensitization Test
-
Irritation Test
-
Acute Systemic Toxicity Test
-
Material Mediated Pyrogenicity Test
-
Hemolysis Test
The results of all the performance testing demonstrated that the proposed device met the acceptance criteria and support substantial equivalence to the predicate device the predicate device Endoscopic Ultrasound Aspiration Needle cleared under K172309
8
Image /page/8/Picture/1 description: The image shows a blue logo with the letters 'MT' in a stylized, blocky font. The letters are connected and appear to be three-dimensional, with the 'M' on the left and the 'T' on the right. A small circle with an 'R' inside, indicating a registered trademark symbol, is located in the upper right corner of the image.
9. Animal Study Conclusion
No animal study is included in this submission.
10. Clinical Test Conclusion
No clinical study is included in this submission.
11. Substantially Equivalent (SE) Conclusion
Based on the indications for use, technological characteristics, and safety and performance testing, the Adapt 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 predicate device Endoscopic Ultrasound Aspiration Needle cleared under K172309.