(226 days)
Not Found
No
The description focuses on a mechanical injection needle and its components, with no mention of AI/ML terms or image processing capabilities.
Yes
The device is used to perform endoscopic vascular or submucosal injection in the GI tract, which involves delivering a substance for therapeutic purposes (e.g., stopping bleeding, lifting polyps).
No
The device is an injection needle used with an endoscope to perform endoscopic vascular or submucosal injection, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly lists multiple physical components (needle, connector tube, outer tube, handles, etc.) and describes its function as a physical instrument used with an endoscope for injection.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to perform endoscopic vascular or submucosal injection in the GI tract. This is a procedure performed in vivo (within a living organism).
- Device Description: The device is a physical instrument used for injection during an endoscopic procedure. It does not involve testing samples of bodily fluids or tissues in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical/procedural tool used directly on the patient.
N/A
Intended Use / Indications for Use
The device is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract.
Product codes
FBK
Device Description
The injection needle is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract, which consists of needle, connector tube, outer tube, outer tube, outer tube, protective sleeve, front handle, injection handle, front handle cover and boosting tube. The proposed device is used to puncture the target tissue where guided by the endoscope. The fluid is injected to the target through the proposed device by an injector which is connected the proposed device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The device must be used by trained doctors or technicians.
Hospital
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
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device with the following standards:
- ISO 10993-5:2009 Biological evaluation of medical Devices-Part 5: Tests for in Vitro Cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and skin sensitization.
- ISO 10993-11:2017 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
- ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
- ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
- ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility)
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
- ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems(DL-13, Level II)
- ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications-Part 7: Connectors for intravascular or hypodermic applications
- ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals
- USP Bacterial Endotoxins Test
- USP Pyrogen Test
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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July 29, 2022
Jiangsu Vedkang Medical Science and Technology Co.,Ltd % Diana Hong General Manager Mid-Link Consulting Co.,Ltd. P.O.box 120-119 Shanghai. 200120 CHINA
Re: K213914
Trade/Device Name: Injection Needle Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBK Dated: June 27, 2022 Received: June 29, 2022
Dear Diana Hong:
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. 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) K213914
Device Name Injection Needle
Indications for Use (Describe)
The device is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract.
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K213914
-
- Date of Preparation: 01/24/2022
-
- Sponsor Identification
Jiangsu Vedkang Medical Science & Technology Co., Ltd.
No.52, Guoxiang Road, Wujin Economic Development Zone, Changzhou 213149, Jiangsu, P.R. China
Establishment Registration Number: 3013526170
Contact Person: Ting Tang Position: Int'l RA Tel: +86-519-69877791-8147 Email: tangting@vedkang.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
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4. Identification of Proposed Device
Trade Name: Injection Needle Common Name: Endoscopic Injection Needle
Regulatory Information Classification Name: Endoscope and accessories Classification: II; Product Code: FBK Regulation Number: 21 CFR 876.1500 Review Panel: Gastroenterology/Urology
Indication for use:
The device is intended to be used with an endoscopic vascular or submucosal injection in the GI tract.
Device Description
The injection needle is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract, which consists of needle, connector tube, outer tube, outer tube, outer tube, protective sleeve, front handle, injection handle, front handle cover and boosting tube. The proposed device is used to puncture the target tissue where guided by the endoscope. The fluid is injected to the target through the proposed device by an injector which is connected the proposed device.
- Identification of Predicate Device న్.
510(k) Number: K153625 Product Name: Single Use Injector NM600/610
Non-Clinical Test Conclusion 6.
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device with the following standards:
-
ISO 10993-5:2009 Biological evaluation of medical Devices-Part 5: Tests for in Vitro Cytotoxicity
- A ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and skin sensitization.
- A ISO 10993-11:2017 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
-
ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
- A ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
5
| K213914 | |
|---|---|
| Page 3 of 6 | |
| 510(k) Summary | Ref.: M31272021 |
-
ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility)
-
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
-
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems(DL-13, Level II)
-
ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications-Part 7: Connectors for intravascular or hypodermic applications
-
ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals
-
USP Bacterial Endotoxins Test
-
USP Pyrogen Test
-
- Clinical Test Conclusion
No clinical study is included in this submission.
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Substantially Equivalent (SE) Comparison 8.
| ITEM | Proposed Device | Predicate Device
K153625 | Remark |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product | Injection Needle | Single Use Injector NM600/610 / | |
| Product Code | FBK | FBK | Same |
| Regulation
Number | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Class | Class II | Class II | Same |
| Indication for Use | The device is intended to be used
with an endoscope to perform
endoscopic vascular or submucosal
injection in the GI tract. | This instrument has been
designed to be used with an
Olympus endoscope to perform
endoscopic vascular or
submucosal injection in the GI
tract. | Same |
| Configuration | needle, connector tube, guiding
head, inner tube, outer tube,
protective sleeve, front handle,
injection handle, front handle
cover, boosting tube | Handle section, needle section,
sheath section | Different |
| Environment of
use | Hospital | Hospital | Same |
| Intended users | The device must be used by trained
doctors or technicians. | The device must be used by
trained doctors or technicians. | Same |
| Single Use | Single Use | Single Use | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part
801 | Same |
| Specifications | | | |
| Working Length | 1200mm, 1800mm, 2300mm,
3000mm | 1650mm, 2300mm | Different |
| Minimum working
channel | 2.0mm, 2.8mm | 2.8mm | Different |
| Needle Size | 19G, 20G, 21G, 22G, 23G, 25G | 21G, 23G, 25G 26G | Different |
| Needle Length | 3mm, 4mm, 5mm, 6mm, 8mm | 3mm, 4mm, 5mm, 6mm,
1.8mm | Different |
| Patient
contact
material | Needle: S30400
Guiding Head: S30300
Inner Tube: PTFE or PP
Outer Tube: PTFE or PP | Stainless steel
PTFE | Different |
| Injection Handle: ABS | | | |
| Boosting Tube: S30400 | | | |
| Biocompatibility | | | |
| Cytotoxicity | No cytotoxicity | Comply with the ISO 10993 | Same |
| Irritation | No intracutaneous reactivity | Standards | |
| Sensitization | No skin sensitization | | |
| Systemic Toxicity | No systemic toxicity | | |
| Pyrogen | No Pyrogen | | |
| Hemolysis | No Hemolysis | | |
| Properties | | | |
| Sterilization | | | |
| Method | EO Sterilized | EO Sterilized | Same |
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
Table 1 Comparison of Technology Characteristics for Injection Needle
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Different - Configuration
The configuration for proposed device is different from the predicate device K153625. The proposed injection needle has the same main components as the predicate device, but the injection needle is configured in more detail than the predicate device. In addition, the performance tests were conducted on proposed device, and the test result does not show any significant difference, the difference in configuration will not affect the safect the safety and effectiveness of the proposed device.
Different - Working Length
The working length for proposed device is different from the predicate device K153625. The proposed 2300mm specification is also included by the predicate device, and the proposed 1800mm specification can be covered in the working length range of predicate device. While the proposed 1200mm specification is shorter than the predicate device and 3000mm specification is longer than the predicate device. The different length will be selected by physician per patient's condition and this difference does not affect intended use. In addition, the performance tests were conducted on proposed device and predicate device, and the test result does not significant difference. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
Different-Minimum Working Channel
The minimum working channel for proposed device is different from the predicate device K153625. The proposed 2.8mm working channel is same as the prodicate device, while the proposed 2.0mm working channel is not covered by the predicate device. The reason for this difference is that the device outer diameter for the proposed device and predicate device are not same. The different size will be selected by physician per patient's condition and this difference does not affect intended use. Therefore, this difference will not affectiveness of the proposed device.
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Different – Needle Size
The needle size for proposed device is different from the predicate device K153625. For proposed needle size 20G to 25G. these specifications can be covered in the gauge ranges of predicate device. In addition to these specifications, the proposed device is available in 19G, which beyond the predicate device range. The different size will be selected by physician per patient's condition and this difference does not affect intended use. In addition, the performance tests were conducted on proposed device and predicate device, and the test result does not significant difference. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
Different – Needle Length
The needle length for proposed device is different from the predicate device K153625. For proposed needle length 3mm to 6mm, these specifications are same as predicate device. In addition to these specifications, the proposed device is available in 8mm, which beyond the predicate device range. The different needle length will be selected by physician per patient's condition and this difference does not affect intended use. In addition, the performance tests were conducted on proposed device and predicate device, and the test result does not significant difference. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
Different-Material
The patient contact material for the proposed device is different from the predicate device. However, biocompatibility test has been conducted on the proposed device and the test result does not show any adverse effect. Therefore, this difference will not raise any safety issues.
Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed device, is determined to be Substantially Equivalent (SE) to the predicate device K153625.