(245 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a physical injection needle, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is used for "treatment of esophageal and gastric varices," which is a therapeutic application.
No
The device is an injection needle used for therapeutic purposes, specifically for treating esophageal and gastric varices and for submucosal dye marking. Its function is to deliver substances, not to gather information for diagnosis.
No
The device description clearly outlines multiple physical components (Handle, Rod, Needle, etc.) and specifies various sizes and lengths, indicating it is a hardware medical device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The description details a physical device used for delivering substances into tissue during an endoscopic procedure. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a tool for performing a medical procedure.
N/A
Intended Use / Indications for Use
Single use 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
FBK
Device Description
Endoscopic Injection Needle consists of Handle, Rod, Needle, Needle holder, Sheath, Catheter, Adapter, Sheath holder, Sheath protection pipe, Tube cap.
The Endoscopic Injection Needle is available in three needle sizes (20 gauges 22 gauge and 25 gauge), five needle lengths (4mm,5mm,8mm and 10mm),five working length(1200mm,1600mm, 1950mm,2000mm, 2300mm). There are 5 series (SN18-05 series, SN18-07 series, SN18-09 series, SN19-05 series and SN19-07 series) total ninety (90) specification injection needles.
The Endoscopic Injection Needle is sterile, single-use device. It is expected to be used in conjunction with an endoscope to perform endoscopic injections into tissue in the GI tract during an endoscopic procedure.
The Endoscopic Injection Needle is designed to pass through the endoscope's forceps to mark the lesions of the digestive tract and use it for injection. Compatibility with endoscopes, working lengths are 1600mm, 1950mm,2000mm, 2300mm, and the minimum working clamp channel is φ 2.8 mm.
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
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)
Summary of non-clinical and performance testing- Bench testing was performed to evaluate the performance and functionality of the subject device against requirement specification. The subject device has been subjected to compliance testing according to, by FDA, recognized consensus standards ISO 7864, ISO 9626, ISO 10993-7, ISO 10993-1, ISO 11607-1, and Technical Requirements of "Endoscopic Injection Needle" provided by Beijing ZKSK Technology Co., Ltd. Results from testing performed confirms that the design requirement specification and user needs have been met. The subject device is confirmed to be safe and effective for the intended use.
7.1 Sterilization and shelf life of Endoscopic Injection Needle is delivered sterile and have successfully been tested according to ISO 11607- 1. The label shelf life is 2 years.
7.2 Biocompatibility testing of Endoscopic Injection Needle has successfully been tested for hemolysis, cytotoxicity, sensitization, intracutaneously irritation, acute systemic toxicity and material medicated pyrogenicity. The test results verify that the biocompatibility criteria given in ISO 10993 are fulfilled. Endoscopic Injection Needle is non-toxic and biocompatible.
7.3 Performance testing - Bench: The performance of Endoscopic Injection Needle has been verified. Tests as described in table 1 have been completed.
Table 1: Performance testing summary - Bench
- Appearance: To confirm that subject device is integrity and cleanliness and hygiene.
- Dimension: To confirm that the dimensions of the subject device complied with the company's requirements.
- Leakage: There shall be no gas leakage.
- Needle protection: Needle shall not be exposed when pulling rod back.
- Resistance to corrosion: No corrosive marks should be found in the immersed part of the needle.
- Stiffness: To confirm the needle tube is not easy to deform
- Resistance to breakage: To confirm the needle tube is not broken during use
- Penetrating force: Make sure the needle tip is sharp
- Connection strength: To confirm all joints of the subject device is rigid connect.
- Basic functional testing: To confirm the device can be successfully inserted and withdrawn into and out of an endoscope, and the stylet can pass through the syringe successfully.
- Luer lock connectors: To confirm the performance of the luer lock connectors of the device meets the requirement of ISO 80369-7
- Chemical properties: To confirm that pH, Total content of heavy metals, Potassium permanganate reductive substance, Evaporative residues and Ultraviolet Absorbance meet the related requirements.
- Sterility: This device is sterilized by ethylene oxide. The device shall be sterile.
- EO residue: EO residue shall be ≤10 μg/g.
- Pyrogen: Shall be no pyrogen
No clinical study is included in this submission.
Key Results: The conclusions drawn from the comparison and analysis above demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicated device in K210917 and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
June 2, 2022
Beijing ZKSK Technology Co.,Ltd % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lujiazui Rd.,Pudong Shanghai, Shanghai 200120 CHINA
Re: K213239
Trade/Device Name: Endoscopic Injection Needle Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: II Product Code: FBK Dated: April 25, 2022 Received: April 29, 2022
Dear Boyle Wang:
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 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) K213239
Device Name Endoscopic Injection Needle
Indications for Use (Describe)
Single use 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.
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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3
510(k) Summary K213239
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's Information
Name: Beijing ZKSK Technology Co., Ltd Address: Building 9, 6 & No.6 Yuan Hengye North 7th Street, Yongle Economic Development Zone, Tongzhou District,Beijing 101105, China Tel: +86 -13811778090 Contact: Ma Li
Designated Submission Correspondent
Contact: Mr. Boyle Wang Name: Shanghai Truthful Information Technology Co., Ltd. Address: Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
Date of Preparation: Apr.22, 2022
2.0 Device Information
Trade name: Endoscopic Injection Needle Common name: Endoscopic Injection Needle, Gastroenterology-Urology Classification name: Endoscope and accessories Production code: FBK Regulation number: 21 CFR 876.1500 Classification: Class II Gastroenterology/Urology Panel:
3.0 Predicate Device Information
Manufacturer: Anrei Medical (Hangzhou) Co., Ltd. Trade/Device Name: Single Use Injection Needle 510(k) number: K210917
4.0 Device Description
4
Endoscopic Injection Needle consists of Handle, Rod, Needle, Needle holder, Sheath, Catheter, Adapter, Sheath holder, Sheath protection pipe, Tube cap.
The Endoscopic Injection Needle is available in three needle sizes (20 gauges 22 gauge and 25 gauge), five needle lengths (4mm,5mm,8mm and 10mm),five working length(1200mm,1600mm, 1950mm,2000mm, 2300mm). There are 5 series (SN18-05 series, SN18-07 series, SN18-09 series, SN19-05 series and SN19-07 series) total ninety (90) specification injection needles.
The Endoscopic Injection Needle is sterile, single-use device. It is expected to be used in conjunction with an endoscope to perform endoscopic injections into tissue in the GI tract during an endoscopic procedure.
The Endoscopic Injection Needle is designed to pass through the endoscope's forceps to mark the lesions of the digestive tract and use it for injection. Compatibility with endoscopes, working lengths are 1600mm, 1950mm,2000mm, 2300mm, and the minimum working clamp channel is φ 2.8 mm.
5.0 Indication for Use Statement
Single use 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.
6.0 Summary of Non-Clinical Testing
Summary of non-clinical and performance testing- Bench testing was performed to evaluate the performance and functionality of the subject device against requirement specification. The subject device has been subjected to compliance testing according to, by FDA, recognized consensus standards ISO 7864, ISO 9626,ISO 10993-7, ISO 10993-1, ISO 11607-1,and Technical Requirements of "Endoscopic Injection Needle" provided by Beijing ZKSK Technology Co., Ltd. Results from testing performed confirms that the design requirement specification and user needs have been met. The subject device is confirmed to be safe and effective for the intended use.
7.1 Sterilization and shelf life of Endoscopic Injection Needle is delivered sterile and have successfully been tested according to ISO 11607- 1. The label shelf life is 2 years.
7.2 Biocompatibility testing of Endoscopic Injection Needle has successfully been tested for hemolysis, cytotoxicity, sensitization, intracutaneously irritation, acute systemic toxicity and material medicated pyrogenicity. The test results verify that the biocompatibility criteria given in ISO 10993 are fulfilled. Endoscopic Injection Needle
5
is non-toxic and biocompatible.
7.3 Performance testing - Bench: The performance of Endoscopic Injection Needle has been verified. Tests as described in table 1 have been completed.
| Test Item | Description |
|---|---|
| Appearance | To confirm that subject device is integrity and cleanliness and hygiene. |
| Dimension | To confirm that the dimensions of the subject device complied with the company's requirements. |
| Leakage | There shall be no gas leakage. |
| Needle protection | Needle shall not be exposed when pulling rod back. |
| Resistance to corrosion | No corrosive marks should be found in the immersed part of the needle. |
| Stiffness | To confirm the needle tube is not easy to deform |
| Resistance to breakage | To confirm the needle tube is not broken during use |
| Penetrating force | Make sure the needle tip is sharp |
| Connection strength | To confirm all joints of the subject device is rigid connect. |
| Basic functional testing | To confirm the device can be successfully inserted and withdrawn into and out of an endoscope, and the stylet can pass through the syringe successfully. |
| Luer lock connectors | To confirm the performance of the luer lock connectors of the device meets the requirement of ISO 80369-7 |
| Chemical properties | To confirm that pH, Total content of heavy metals, Potassium permanganate reductive substance, Evaporative residues and Ultraviolet Absorbance meet the related requirements. |
| Sterility | This device is sterilized by ethylene oxide. The device shall be sterile. |
| EO residue | EO residue shall be ≤10 $ μ $ g/g. |
| Pyrogen | Shall be no pyrogen |
| Table 1: Performance testing summary - Bench | |
|---|---|
| ---------------------------------------------- | -- |
7.0 Summary of Clinical Testing
No clinical study is included in this submission.
8.0 Technological Characteristic Comparison Table
| ltem | Subject Device | Predicate Device |
|---|---|---|
| 510(k) No. | K213239 | K210917 |
| Product Name | Endoscopic Injection Needle | Single Use Injection Needle |
Table 2- Comparison of Technology Characteristics
6
| Product Code | FBK | FBK |
|---|---|---|
| Regulation No. | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Class | II | II |
| Indication for Use | Single use 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. | Single use 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. | ||
| Configuration | Endoscopic Injection | |
| Needle | ||
| consists of Handle, Rod, Needle, | ||
| Needle holder, Sheath, Catheter, | ||
| Adapter, Sheath holder, Sheath | ||
| protection pipe, Tube cap. | Needle, Connecting Tube, Inner | |
| Tube, Sheath, Protect Tube, Metal | ||
| Tube, handle, Luer Connector | ||
| Minimal required | ||
| working channel | 2.8mm | 2.8mm |
| Outer Sheath | ||
| diameter | 1.8mm,2.4mm | 2.4mm |
| Needle size | 20G, 22G, 25G | 21G, 23G, 25G |
| Working | ||
| Length | 1200mm,1600mm, | |
| 1950mm,2000mm, 2300mm | 1800mm, 2000mm, 2300mm | |
| Needle Length | 4mm, 5mm,6mm,8mm,10mm | 4mm, 6mm |
| Patient Contact | ||
| Material | Sheath: PTEF | |
| Catheter: | ||
| SN18 series: | ||
| Polypropylene(PP)/ | ||
| SN19 series: Nylon (PA) | ||
| Needle/ Needle holder: Stainless | ||
| steel | ||
| Rod: | ||
| Acrylonitrile/butadiene/styrene | ||
| copolymer (ABS) | Not publicly Available | |
| Sterile | Ethylene Oxide, SAL: 10-6 | Ethylene Oxide, SAL: 10-6 |
| Shelf Life | 2 years | 3 years |
| Single Use | Single Use | Single Use |
| Biocompatibility | Conform with ISO10993-1 | |
| (ISO | ||
| 10993-4,ISO10993-5, | ||
| ISO10993-10, ISO10993-11) | Conform with ISO 10993 | |
| standards |
The technological characteristics of the subject device are identical to those of predicate device. The subject device has the same basic design as the predicate device. The comparison between the subject and predicate devices is based on the
7
following:
- Same intended use
- Same indications for use
- · Similar material types that meet ISO 10993 biocompatibility requirements
- · Same sterilization methods
- · Same fundamental technology/principal of operation/user interface
The outer sheath diameter of the subject device is different with that of the predicate device, but it does not affect the device compatibility with the endoscope of the minimum working cannel size of 2.8 mm.
The Needle size, working length and Needle Length of the subject device are larger than those of the predicate device, bench performance and Comparison testing including Stiffness testing, breakage testing, Penetration testing and Connection strength testing on the subject device and the predicate device shown the difference does not affect the device's safety and effectiveness, the subject device is substantially equivalent to the predicate device.
9.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicated device in K210917 and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.