(163 days)
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.
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.
The provided document is a 510(k) premarket notification for a medical device: "Disposable Injection Needle" (PN series, PM series, PM (H) series) by Wilson Instruments (Shanghai) Company Limited. This type of document is a regulatory submission for medical devices, primarily demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a specific study proving the device meets those criteria, as one might find in a clinical trial report or a performance study for AI/software as a medical device (SaMD).
Here's an analysis based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of quantitative acceptance criteria for performance, nor does it present specific device performance results in a measurable, quantifiable way against such criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device through:
- Similar intended use.
- Similar technological characteristics (materials, design, sterilization method).
- Compliance with biocompatibility, sterility, and performance testing in accordance with FDA guidance and international standards.
For medical devices like injection needles, "performance" is often assessed through bench testing for things like needle sharpness, force of injection, material integrity, sterilization effectiveness, and biocompatibility, rather than diagnostic accuracy metrics. The document states that "Test data and report information included in this submission demonstrate that the subjected device is substantially equivalent to the predicate device," but these specific test results are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of data for an AI/SaMD product. It refers to "test data and report information" for biocompatibility, sterility, and performance, which would typically involve physical samples of the device undergoing laboratory testing. The sample sizes for these types of tests are not disclosed in this summary. Data provenance (country of origin, retrospective/prospective) is not applicable in the context of this device and type of submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable to a disposable injection needle. Ground truth, expert consensus, or clinical outcome data are typically relevant for diagnostic or AI devices where there's an interpretation or prediction being made that can be compared against a 'truth'. For an injection needle, the "ground truth" related to its function is derived from engineering specifications and objective physical/chemical tests.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies in expert interpretations in diagnostic studies.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done for this device. This type of study is relevant for diagnostic devices (especially those involving image interpretation by human readers) to assess the impact of AI assistance on human performance. The Disposable Injection Needle is a physical therapeutic/interventional device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone performance study (algorithm only) was not done. This is also specific to AI/SaMD products.
7. The Type of Ground Truth Used:
As noted, the concept of "ground truth" in the diagnostic/AI sense is not applicable. For this physical device, the "truth" is established by:
- Engineering specifications: Meeting defined physical dimensions, material properties, and functional performance (e.g., needle sharpness, strength).
- Biocompatibility testing: Adhering to standards (e.g., ISO 10993) to ensure no adverse biological reactions.
- Sterility testing: Confirming the absence of viable microorganisms per established standards.
- Material safety data: Ensuring components are safe for their intended use.
8. The Sample Size for the Training Set:
This information is not applicable. There is no "training set" for a physical medical device like an injection needle. Training sets are used in machine learning for AI algorithms.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set.
Summary of Acceptance Criteria and Evidence from the Document:
The document states that the device is "substantially equivalent" to the predicate device (Olympus Injector NM-4-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1 cleared via K011484). The "acceptance criteria" can be inferred as meeting the same performance, safety, and effectiveness profiles as the predicate device.
Inferred Acceptance Criteria (not explicitly quantitative in the document):
| Acceptance Criteria Category | Reported Device Performance (Inferred from "Substantial Equivalence") |
|---|---|
| Intended Use | Same as predicate: Endoscopic sclerotherapy, hemostasis, and submucosal injection in the digestive tract. |
| Technological Characteristics | Same as predicate: Product structure (working length, diameter, channel size), materials, EO sterilization method. |
| Biocompatibility | Compliant with FDA guidance and international standards (implied to be equivalent to predicate's compliance). |
| Sterility | Compliant with FDA guidance and international standards (EO sterilization, implied to be equivalent to predicate's compliance). |
| Performance | Compliant with FDA guidance and international standards (implies functional equivalence for injection tasks, such as needle sharpness, force, material integrity, etc., as demonstrated by "test data and report information" not detailed here). |
In conclusion, this 510(k) summary focuses on demonstrating substantial equivalence of a physical medical device (Disposable Injection Needle) to a legally marketed predicate. It does not contain the specific detail about acceptance criteria, study design, and performance metrics typically seen for AI/SaMD or clinical trial reports. The "study" proving the device met the criteria would consist of laboratory tests for biocompatibility, sterility, and various physical performance tests, the details of which are not included in this summary but would have been part of the full 510(k) submission.
{0}------------------------------------------------
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."
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the word "WILSON" in large, bold, purple letters. The letters are closely spaced together, creating a solid block of text. The font appears to be sans-serif, and the overall impression is one of strength and clarity.
007_510(k) Summary
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the word "WILSON" in large, bold, purple letters. The font is sans-serif and the letters are closely spaced together. The word is centered and takes up most of the frame. The background is plain white.
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 TownQingpu 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.
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows the word "WILSON" in large, bold, purple letters. The letters are sans-serif and appear to be a standard font. The word is centered and takes up most of the frame. The background is plain white.
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.
§ 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.