(60 days)
No
The device description and performance studies focus on mechanical properties and usability, with no mention of AI/ML algorithms or data processing.
Yes
The device is described as assisting in "tissue resection, exposure, and removal of tissue" and is designed to "provide retraction" within the stomach and colon, which are therapeutic actions.
No
The device is described as an Elastic Traction System used for retraction to assist in tissue resection, exposure, and removal of tissue during flexible endoscopy. Its function is to manipulate tissue for therapeutic purposes, not to diagnose a condition.
No
The device description clearly outlines physical components (Elastic Traction Device and Clipping Device) made of materials like silicone, and the performance studies focus on physical properties and interactions (dimension, release force, clamping strength, tensile strength, etc.), 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 to provide retraction to assist in tissue resection, exposure, and removal of tissue within the stomach and colon during flexible endoscopy. This is a surgical/interventional procedure performed directly on the patient's body.
- Device Description: The device is a mechanical system consisting of clips and an elastic band used for physical manipulation of tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. It does not analyze biological samples like blood, urine, or tissue biopsies in a laboratory setting.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is used in vivo (within the body) to facilitate a medical procedure.
N/A
Intended Use / Indications for Use
The Elastic Traction System is indicated for adult only for use in flexible Endoscopy to provide retraction to assist in tissus resection, exposure, and removal of tissue within the stomach and colon.
Product codes
QSW
Device Description
The proposed device, Elastic Traction System, consists of 2 components, an Elastic Traction Device, and a clipping device (Fig. 1). Two components are single use device.
The Elastic Traction Device is a single use tissue traction device. It is consisting of clip assembly, silicone band and delivery system. The silicone band is consisting of three rings. Ring A is preloaded with the clip.
The Clipping Device is a single use device, and its purpose is to use it as a second clip. The second clip is used to engage the silicone band of the previously anchored clip of Elastic Traction Device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
stomach and colon
Indicated Patient Age Range
adult only
Intended User / Care Setting
Endoscopy suite, used with a compatible Endoscope
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 Elastic Traction System and confirmed that the proposed device works as intended.
The bench tests below were tested and evaluated as substantially equivalent to the predicate device.
- Dimension
- Release Force
- Clamping Strength
- Tensile strength
- Elastic Performance
- Rotation Performance
- Repeated Opening and Closing Performance
- Clip Opening and Closing Forces A
- Endoscope Compatibility
- A Endoscope Damage
Usability assessment was performed to demonstrate that the intended user can safely and correctly use the proposed device.
Shelf-life 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. Two-years aging test was 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+A1:2019 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices".
Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
The results of performance testing demonstrate that the proposed device Elastic Traction System is considered safe and effective for its intended use.
Animal Study: The proposed device Elastic Traction System has conducted animal test according to 21 CFR §58 (GLP Regulations) to demonstrate the safety and effectiveness.
Clinical Study: 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
N/A
0
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October 3, 2022
Micro-Tech (Nanjing) Co., Ltd. Sally He. RA Engineer No.10 Gaoke Third Road, Nanjing National Hi-Tech Industrial Development Zone Nanjing, Jiangsu 210032 CHINA
K222354 Re: Trade/Device Name: Elastic Traction System Regulation Number: 21 CFR 876.4410 Regulation Name: Endoscopic traction device Regulatory Class: Class II Product Code: QSW Dated: July 29, 2022 Received: August 4, 2022
Dear Sally He:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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)
Device Name Elastic Traction System
Indications for Use (Describe)
The Elastic Traction System is indicated for adult only for use in flexible Endoscopy to provide retraction to assist in tissus resection, exposure, and removal of tissue within the stomach and colon.
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------- | ------------------------------------------------------------ |
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Type of Use (Select one or both, as applicable)
3
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 angled slightly, giving the logo a sense of depth. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.
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: K222354
1. Date of Preparation: 2022-09-30
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: Sally He
Position: RA Engineer
Tel: +86-25-58646395
Fax: +86-25-58350006
Email: ra.micro-tech@outlook.com
3. Identification of Proposed Device
Trade Name: Elastic Traction System
Common Name: Endoscopic Traction Device
Regulatory Information
Device Classification Name: Endoscopic Traction Device
Classification: 2
Product Code: OSW
Regulation Number: 21 CFR 876.4410
Review Panel: Gastroenterology/Urology
4
K222354 Page 2 of 6
Image /page/4/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 angled slightly to the right, creating a sense of depth. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.
4. Identification of Predicate Device
De Novo Number: DEN220006 Product Name: ProdiGI Traction Wire Manufacturer: Covidien LLC.
5. Indications for Use
The Elastic Traction System is indicated for adult only for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the stomach and colon.
Device Description 6.
The proposed device, Elastic Traction System, consists of 2 components, an Elastic Traction Device, and a clipping device (Fig. 1). Two components are single use device.
The Elastic Traction Device is a single use tissue traction device. It is consisting of clip assembly, silicone band and delivery system. The silicone band is consisting of three rings. Ring A is preloaded with the clip.
The Clipping Device is a single use device, and its purpose is to use it as a second clip. The second clip is used to engage the silicone band of the previously anchored clip of Elastic Traction Device.
7. Comparison of Technological Characteristics
The Elastic Traction System substantially equivalent device materials, design, configuration, packaging, sterilization process and intended use as those featured in the predicate device ProdiGI Traction Wire
(DEN220006).
| Characteristics | Proposed Device
Elastic Traction System | Predicated Device
ProdiGI Traction Wire
(DEN220006) | Remark |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | QSW | QSW | Same |
| Class | II | II | Same |
| Regulation | Endoscopic Traction Device | Endoscopic Traction Device | Same |
| Characteristics | Proposed Device
Elastic Traction System | Predicated Device
ProdiGI Traction Wire
(DEN220006) | Remark |
| Description | | | |
| Regulation
number | 876.4410 | 876.4410 | Same |
| Indications for
Use | The Elastic Traction System is
indicated for adult only for use in
flexible Endoscopy to provide
retraction to assist in tissue resection,
exposure, and removal of tissue within
the stomach and colon. | The Medtronic ProdiGI Traction
Wire is indicated to grasp tissue
within the esophagus, stomach, and
colon of adults during an
Endoscopic Submucosal Dissection
(ESD) procedure. | Similar |
| Target population | Adults | Adults | Same |
| Use Condition | Endoscopy suite, used with a
compatible Endoscope | Endoscopy suite, used with a
compatible Endoscope | Same |
| Mechanics of
Action | Manual | Manual | Same |
| Operation Principle | Anchor the edge of tissue on the
silicone band with endoscopic clips
and retract the tissue through own
elastic force of the silicone band. | Anchor the edge of tissue on the
wire with endoscopic clips and
retract the tissue through restoring
force of the wire . | Similar |
| General
Configuration | 2 Clips
Silicone band | 2 Clips
Metal Wire band | Similar |
| Compatible
endoscopy working
channel | 2.8 mm
or larger | 2.8 mm
or larger | Same |
| Working length | 1650 mm, 2350 mm | 2300 mm | Similar |
| Silicone
band/Traction wire
length | The longest distance of the rings center
is 7.1 mm | 20 mm, 35mm | Similar |
| Main Patient-
contact Material | Silicone rubber | Metal | Different |
| Single Use | Yes | Yes | Same |
| Supplied in Sterile | Yes | Yes | Same |
| Characteristics | Proposed Device
Elastic Traction System | Predicated Device
ProdiGI Traction Wire
(DEN220006) | Remark |
| Rx-only | Yes | Yes | Same |
| Non-clinical
Performance | Performs as intended under
anticipated conditions of use | Performs as intended under
anticipated conditions of use | SE |
| Usability | The intended user can safely and
correctly use the proposed device. | The intended user can safely and
correctly use the proposed device. | SE |
| In vivo study | Animal study performs as intended
under anticipated conditions of use | In vivo performance testing
performs as intended under
anticipated conditions of use | SE |
| Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | SE |
| Shelf Life | Comply with ASTM F1980 | Comply with ASTM F1980 | SE |
| Labeling | Conforms to 21 CFR part 801 | Conforms to 21 CFR part 801 | SE |
Comparison to predicate Devices:
5
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 connected and appear to be leaning slightly to the right. A small registered trademark symbol is located in the upper right corner of the logo.
6
Image /page/6/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are bold and connected, with the "M" slightly overlapping the "T". A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo. The logo has a simple, modern design.
The proposed device and the predicate device both used the two clips to anchor the edge of the tissue and lift the mucosal to provide the visualization with a connecting band during the ESD procedure. The main difference between the two devices is the material of the connecting band, the proposed device used the silicon rubber which provides retraction with elastic force of deforming, while the predicate device used the metal wire with restoring force of memory function.
8. Performance Data
Performance testing was conducted to demonstrate the essential performance of the proposed device Elastic Traction System and confirmed that the proposed device works as intended.
The bench tests below were tested and evaluated as substantially equivalent to the predicate device.
-
Dimension
-
Release Force
-
Clamping Strength
-
Tensile strength
-
Elastic Performance
-
Rotation Performance
-
Repeated Opening and Closing Performance
7
Image /page/7/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 made of solid blocks. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.
- Clip Opening and Closing Forces A
-
Endoscope Compatibility
- A Endoscope Damage
Usability assessment was performed to demonstrate that the intended user can safely and correctly use the proposed device.
Shelf-life 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. Two-years aging test was 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+A1:2019 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices".
Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
The results of performance testing demonstrate that the proposed device Elastic Traction System is considered safe and effective for its intended use.
9. Animal Study
The proposed device Elastic Traction System has conducted animal test according to 21 CFR §58 (GLP Regulations) to demonstrate the safety and effectiveness.
10. Clinical Study
No clinical study is included in this submission.
8
Image /page/8/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 made of solid blocks. A small registered trademark symbol is located in the upper right corner of the logo.
11. Substantially Equivalent (SE) Conclusion
Based on the indications for use, technological characteristics, and safety and performance testing, the Elastic Traction System has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate device the ProdiGI approved under DEN220006.