(163 days)
Not Found
No
The summary describes a mechanical device (disposable injection needle) and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is used to perform therapies such as endoscopic sclerotherapy, hemostasis, and submucosal injection, which are therapeutic interventions.
No
This device is an injection needle used for therapeutic procedures like sclerotherapy and hemostasis, not for diagnosing conditions.
No
The device description explicitly states it is primarily constituted of hardware components (handle, tube, and needle) and is used in conjunction with an endoscope, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a therapeutic procedure (endoscopic injection for sclerotherapy, hemostasis, and submucosal injection) performed directly on the patient's internal tissues.
- Device Description: The device is a physical tool (needle, tube, handle) used to deliver substances into the body during an endoscopic procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for treatment.
N/A
Intended Use / Indications for Use
Wilson disposable injection needle has been designed to be used with an endoscope to perform following therapy:
-
- Endoscopic sclerotherapy within the esophagus, stomach, duodenum, small intestine, large intestine.
-
- Endoscopic hemostasis within the esophagus, stomach, duodenum, small intestine, large intestine.
-
- Endoscopic submucosal injection within esophagus, stomach, small intestine, large intestine.
Product codes
FBK
Device Description
The subjected Disposable Injection Needle is operated together with an endoscope to conduct an endoscopic injection for the treatment of esophageal and gastric varices and submucosal injection in the digestive tract, such as esophagus, stomach, duodenum, small intestine, large intestine.
The subjected device is primarily constituted of handle, tube and needle. The models include PN series, PM series and PM(H) series.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus, stomach, duodenum, small intestine, large intestine
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)
The disposable injection needle of Wilson has taken the biocompatibility, sterility and performance testing into concern in accordance with Food and Drug Administration related guidance and recognized international standards. Test data and report information included in this submission demonstrate that the subjected device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with a flowing ribbon-like element connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 15, 2015
Wilson Instruments (Shanghai) Company Limited Lijuan Zhang Regulatory Manager Building 5. No. 258 Shuangbang Road Xujing Town, Qingpu District, Shanghai, 201702 China
K142144 Re:
Trade/Device Name: Disposable Injection Needle Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FBK Dated: December 9, 2014 Received: December 10, 2014
Dear Lijuan Zhang,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
Ben
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142144
Device Name
Disposable Injection Needle (PN series, PM series, PM (H) series)
Indications for Use (Describe)
- Wilson disposable injection needle has been designed to be used with an endoscope to perform following therapy:
-
- Endoscopic sclerotherapy within the esophagus, stomach, duodenum, small intestine, large intestine.
-
- Endoscopic hemostasis within the esophagus, stomach, duodenum, small intestine, large intestine.
-
- Endoscopic submucosal injection within esophagus, stomach, small intestine, large intestine.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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007_510(k) Summary
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510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
Nov 28th, 2014
2. Submitter's Information [21 CFR807.92 (a) (1)]
| Name of Sponsor: | Wilson Instruments (Shanghai) Company Limited |
|---|---|
| Address: | Building 5, No.258 Shuangbang Road, Xujing Town |
| Qingpu District Shanghai China | |
| Contact Name: | Lijuan Zhang |
| Telephone No.: | +86 (021) 39290005 |
| Fax No.: | +86 (021) 66311471 |
| Email Address: | wilson.ljzhang@gmail.com |
3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]
| Trade Name: | Disposable Injection Needle |
|---|---|
| Model Name: | PN series, PM series, PM(H) series |
| Common Name: | Endoscopic Injection Needle |
| Regulatory Classification: | 21 CFR 876.1500 Endoscope and accessories |
| Product Code: | FBK |
| Classification Panel: | Gastroenterology/Urology |
| Device Class: |
5
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicates within this submission are as follows:
Olympus Optical Co., Ltd., Olympus Injector NM-4-1, NM-6-1, NM-6-1, NM-7-1, NM-8-1, NM-7-1, NM-8-1, NM-9-1 has been cleared by FDA through 510(k) No. K011484 (Decision Date – Aug 10, 2001).
5. Description of the Device [21 CFR 807.92(a)(4)]
The subjected Disposable Injection Needle is operated together with an endoscope to conduct an endoscopic injection for the treatment of esophageal and gastric varices and submucosal injection in the digestive tract, such as esophagus, stomach, duodenum, small intestine, large intestine.
The subjected device is primarily constituted of handle, tube and needle. The models include PN series, PM series and PM(H) series.
6. Intended Use [21 CFR 807.92(a)(5)]
Wilson disposable injection needle has been designed to be used with an endoscope to perform following therapy:
-
Endoscopic sclerotherapy within the esophagus, stomach, duodenum, small intestine, large intestine.
-
Endoscopic hemostasis within the esophagus, stomach, duodenum, small intestine, large intestine.
-
Endoscopic submucosal injection within esophagus, stomach, duodenum, small intestine, large intestine.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
As the reason that the working situation and environment of Wilson's Disposable Injection Needle is the same as that of the similar Olympus Injector, the technological characteristics of this product series are designed to make same as that of the equivalence product, including product structure such as the scope of working length for the product series, the maximum insertion portion diameter, the minimum endoscope working channel size, etc., and such as the application of materials over different parts of the product series are also be designed to be equal respectively. It applies EO sterilization method, which is also same as that of predicate device.
8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
The disposable injection needle of Wilson has taken the biocompatibility, sterility and performance testing into concern in accordance with Food and Drug Administration related guidance and recognized international standards. Test data and report information included in this submission demonstrate that the subjected device is substantially equivalent to the predicate device.
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9. Conclusion [21 CFR 807.92(b) (3)]
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Wilson Instruments (Shanghai) Company Limited concludes that Disposable Injection Needle is substantially equivalent to predicate devices with regard to safety and effectiveness.