(304 days)
WellCare Anoscope is intended for transanal use to provide physicians access to the anal sphincter, anus, and rectum and to perform various diagnostic and therapeutic procedures using additional accessories.
WellCare Anoscope is composed of Anoscope, Introducer and Sleeve.The anoscopes are divided into the following models according to the way the components are configured and the differences in size : WellCare-ANO-Light Sterile . WellCare-ANO-Truncated Sterile.This is a single use, disposable device(s), provided sterile.
The provided text describes the regulatory clearance of the WellCare Anoscope by the FDA, primarily relying on non-clinical (bench) testing. There is no information about any study that proves the device meets specific performance criteria related to AI or human-in-the-loop performance. The device described is a physical medical instrument, an anoscope, not a software or AI-driven diagnostic tool. Therefore, many of the requested details, such as those pertaining to AI assistance, ground truth establishment, expert qualifications, adjudication methods, and training/test set sizes for AI, are not applicable to this submission.
Here's the relevant information based on the provided text, focusing on the acceptance criteria and the non-clinical study conducted for the WellCare Anoscope:
1. A table of acceptance criteria and the reported device performance
| ID# | Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| 1 | Appearance | Smooth surface of all parts, no sharp edges, no burrs. | Pass |
| 2.1 | Compatibility | The anal expander and the guide mirror opened and closed easily with the scope, without swing and jam. The end of the anal expander should be smooth and anastomosed with the endoscope, and the maximum gap should not be greater than 0.6mm. | Pass |
| 2.2 | Material strength | Any of the components (excluding the light source) should be able to withstand a 4 kg suspension without significant deformation. | Pass |
| 3.1 | Reducing substances (oxide prone) | The difference in the volume of potassium permanganate solution [ c(1/5KMnO4) = 0.01 mol/L ] consumed by the test solution and the blank control solution should not exceed 2.0 mL. | 0.4ml |
| 3.2 | pH | The difference between the pH of the test solution and that of the blank control solution should not exceed 1.5. | 1.01 |
| 3.3 | EO/ECH residues | Average daily dose to patient: EO < 4 mg, ECH < 9mg. | Pass |
| 3.4 | Sterile | WellCare Anoscope should be sterile. | Pass |
| 4.1 | In Vitro Cytotoxicity | Non-cytotoxic. | Pass |
| 4.2 | Skin Sensitization Test | Non-sensitizer. | Pass |
| 4.3 | Acute Systemic Toxicity Test | No systemic toxicity. | Pass |
| 4.4 | Pyrogen Test | Non-pyrogen. | Pass |
| 4.5 | Irritation Test | Non-Irritation. | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The text states "Take 1 set of samples" for compatibility and material strength testing. Specific numbers for other tests (Appearance, Chemical Testing, Biocompatibility) are not explicitly provided, but these are typically batch-based tests on representative samples.
- Data Provenance: Not specified, but generally, these are laboratory bench tests conducted by the manufacturer (Well Care (Wuhan) Medical Technology Co., Ltd. in Wuhan, Hubei, China). These are prospective tests during device development and verification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The performance testing described is for physical, chemical, and biological characteristics of a medical device, not for diagnostic accuracy requiring expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical anoscope, not an AI-assisted diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests is based on established engineering standards, material science properties, chemical analysis, and biological safety testing protocols. For example:
- Physical tests: Engineering specifications (e.g., gap tolerance, deformation under load).
- Chemical tests: Analytical chemistry principles (e.g., KMnO4 titration, pH measurement).
- Biocompatibility tests: Recognized international standards (ISO 10993 series) for evaluating biological responses to medical devices.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning product and does not involve training data.
9. How the ground truth for the training set was established
Not applicable.
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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".
December 22, 2023
Well Care (Wuhan) Medical Technology Co., Ltd Zhou Huimin Ouality Manager No. 11# The No.1 Road Fozuling of East Lake High-Tech Development Zone Wuhan, Hubei 430205 China
Re: K230439
Trade/Device Name: WellCare Anoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FER Dated: November 21, 2023 Received: November 21, 2023
Dear Zhou Huimin:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
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Sincerely,
Shanil P. Haugen -S
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
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Indications for Use
510(k) Number (if known) K230439
Device Name WellCare Anoscope
Indications for Use (Describe)
WellCare Anoscope is intended for transanal use to provide physicians access to the anal sphincter, anus, and rectum and to perform various diagnostic and therapeutic procedures using additional accessories.
|--|
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 3 510(k) Summary
l 510(k) Submitter
| Device Submitter: | Well care (Wuhan) medical technology Co., Ltd.. |
|---|---|
| No. 11# The No. 1 road | |
| Fozuling of East Lake High-Tech Development Zone Wuhan, Hubei |
Contact Person: ZhouHuimin Quality Manager Phone: +86-15626465068 E-mail: wec-qm@wellcare.onaliyun.com
II Device
| Trade Name of Device: | WellCare Anoscope |
|---|---|
| Regulation Number: | 21 CFR 876.1500 |
| Classification Name: | Endoscope and acccessories |
| Product Code: | FER |
| Regulation Number: | 21 CFR 876.1500 |
| Regulatory Class | II |
| Review Panel | GU - Gastroenterology-Urology |
III Predicate Devices
| 510k Number | K121135 |
|---|---|
| Trade Name of Device: | Family of disposable,sterile and not sterile THDAnoscope,Proctoscope , Rectoscope and Light-scope |
| Regulation Number: | 21 CFR 876.1500 |
| Regulation Name: | Endoscope and accessories |
| Regulatory Class | II |
| Product Code: | FER |
IV Device Description
WellCare Anoscope are intended for the examination of the anus,it also can be used as an auxiliary instrument for hemorrhoid surgery.WellCare Anoscope is composed of Anoscope, Introducer and Sleeve.The anoscopes are divided into the following models according to the way the components are configured and the differences in size : WellCare-ANO-Light Sterile . WellCare-ANO-Truncated Sterile.This is a single use, disposable device(s), provided sterile.
V Indications for use
WellCare Anoscope is intended for transanal use to provide physicians access to the anal sphincter, anus, and rectum and to perform various diagnostic and therapeutic procedures using additional accessories.
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VI Technological Characteristics Comparison
VI-1: Comparison of WellCare Anoscope
| DeviceCharacteristic | Subject Device | Predicate Device(K121135) | Discussion | ||||
|---|---|---|---|---|---|---|---|
| Indicationsfor Use | WellCare Anoscope is intended fortransanal use to provide physiciansaccess to the anal sphincter, anus,and rectum and to perform variousdiagnostic and therapeuticprocedures using additionalaccessories. | Family of disposable,sterile and not sterile THDAnoscope, Proctoscope,Rectoscope andLight-scope is a single-useanoscope with integratedLED lighting, suitable forperforming diagnostic andoperational anoscopes.. | Identical | ||||
| OperationPrinciple | WellCare Anoscope opens up theanal passage and then exits theanus, and the anal passage iscontinuously visualized by thespeculum, and Sleeve fixes theperianal tissue at a certain angleduring PPH and RPH hemorrhoidsurgery, leaving a space and anglesuitable for the operation. Thus, itcan be used as an auxiliaryinstrument for hemorrhoid surgery | Gently press the TheANOSCOPES into theanus and slowly enter, thenpull out the core, adjust thelight, and slowly exit fromdeep to shallow, Thecompact andasymmetricaldesign of theTHD Surgy MaxiLEDallows easy access to theanalcanal without sphinctertraumaensuring gooddilation and anexcellentview of the operatingfield | Identical | ||||
| Design | WellCare Anoscope is composed ofAnoscope, Introducer and Sleeve, adisposable illuminator and approvedlight source. | The LightScope LEDanoscope combines inasingle device a lightanoscope and LED lightsource. | DifferentComment1 | ||||
| Anoscopematerial | medical polymer material PC | medical polymer materialPC | Identical | ||||
| Size(Unit: mm) | Anoscope | Introducer | Sleeve | ||||
| BEVELLEDdiameter | length | TRUNCATEDdiameter | length | DifferentComment1 |
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| diameter | length | diameter | Height | diameter | er | h | er | h | ||
|---|---|---|---|---|---|---|---|---|---|---|
| 41.1±1 | 25 | 70 | 25 | 70 | ||||||
| 28.4±1 | 28±1 | / | / | 21.7 | 91 | 21.7 | 91 | |||
| 28.4±1 | 41.1±1 | 28±1 | 114±2 | 26±1 | 15 | 65 | 15 | 65 | ||
| 28.4±1 | 41.1±1 | / | 114±2 | 26±1 | 22 | 90 | 22 | 90 | ||
| 19.9±1 | 80.2±1 | 19.5±1 | / | / | 26 | 90 | 26 | 90 | ||
| AnoscopePackaging | sealed bag, Individually packaged | sealed bag, Individually packaged | Identical | |||||||
| Sterilizationmethod | Sterilized by Ethylene Oxide | Sterilized by Ethylene Oxide | Identical | |||||||
| Light | a disposable illuminator and approved light source. | Self-light, with an integrated light source | DifferentComment1 | |||||||
| Singe UseOnly | disposable | disposable | Identical | |||||||
| Shelf Life | 2 years | 2 years | Identical |
Comment 1
The Design of the two are only different ,For example, in terms of size, dimensions, and light source design,But the actual intended use is the same, which does not affect the safety and effectiveness of the product.
Comment 2
The light source of the two are different,But the function is the same Therefore, the safety and effectiveness of the product will not be affected.
VII Summary of Non-clinical Testing (Bench)
The non-clinical testing for WellCare Anoscope was performed to demonstrate verification testing in conformance with the acceptance criteria of test methods and recognized consensus standards shown below.
Table VII-1: Performance testing was conducted on the subject device
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| ID# | Test | Method | Acceptance Criteria | Conclusion |
|---|---|---|---|---|
| 1 | Appearance | The shapeshouldbesmoothandsymmetrical, with nosharp edgesand no burrs in all parts.Themirror tube should be rounded, witha smooth inner walland a roundededgeatthewithouth eadend,burrs. | Smooth surface of all parts no sharp edges,no burrs. | Pass |
| 2 | Physical Testing of Anoscope | |||
| 2.1 | compatibility | Take 1 set of samples and test them manually | The anal expander and the guide mirror opened and closed easily with the scope, without swing and jam. The end of the anal expander should be smooth and anastomosed with the endoscope, and the maximum gap should not be greater than 0.6mm. | Pass |
| 2.2 | Materialstrength | Take 1 set of samples, place the assembly horizontally and hang a 4 kg suspension in the middle of the assembly in accordance with the requirements | Any of the components (excluding the light source) should be able to withstand a 4 kg suspension without significant deformation | Pass |
| 3 | Chemical Testing of Anoscope | |||
| 3.1 | Reducingsubstances(oxideprone) | The sample was taken, configured at a ratio of 0.1g plus 1mL of water and then thermostated at 37°C ± 1°C for 8h, the sample was separated from the liquid and cooled to room temperature as the test solution. Take the same volume of water in a glass container and prepare a blank control solution by the | The difference in the volume of potassium permanganate solution [ c(1/5KMnO4) = 0.01 mol/L ] consumed by the test solution and the blank control solution should not exceed 2.0 mL | 0.4ml |
| 3.2 | pH | same methodTake the test solution of 3.1and the blank controlsolution and determine theirpH values respectively withan acidity meter | the difference between the pHof the test solution and that ofthe blank control solutionshould not exceed 1.5 | 1.01 |
| 3.3 | EO/ECHresidues | ISO 10993-7:2008 | average daily dose to patientEO < 4 mg, ECH < 9mg | Pass |
| 3.4 | Sterile | ISO 11135:2014 | WellCare Anoscope should besterile | Pass |
| 4 | Biocompatibility Testing | |||
| 4.1 | In VitroCytotoxicity | ISO 10995-5:2009 | Non-cytotoxic | Pass |
| 4.2 | SkinSensitizationTest | ISO 10993-10:2021 | Non-sensitizer | Pass |
| 4.3 | AcuteSystemicToxicity Test | ISO 10993-11:2017 | No systemic toxicity | Pass |
| 4.4 | PyrogenTest | ISO 10993-11:2017 | Non-pyrogen | Pass |
| 4.5 | Irritation Test | ISO 10993-23:2021 | Non-Irritation | Pass |
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VIII Clinical Test Conclusion
No clinical study is included in this submission.
IX Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the WellCare Anoscope is as safe as effective, and performs as well as or better than the legally marketed device.
§ 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.