(114 days)
The Single-Use Flexible Cystoscope is designed to be used with the Vathin Display Unit, endotherapy accessories and other auxiliary device for endoscopy and treatment of adult bladder.
The Digital Video Monitor is specially designed to be used with Vathin medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
The devices are for use in professional Healthcare Facility Environment.
The device consists of a Single-use Flexible Cystoscope and a Digital Video Monitor for endoscopic image processing and displaying. They are used in conjunction with other accessories for the endoscopy and treatment of adult bladder.
The provided document, a 510(k) summary for the Hunan Vathin Medical Instrument Co. Ltd's Single-use Flexible Cystoscope and Digital Video Monitor, describes non-clinical performance testing for device acceptance and claims substantial equivalence to a predicate device. However, it does not contain information related to a study proving the device meets acceptance criteria through clinical performance metrics, multi-reader multi-case (MRMC) studies, or AI-assisted diagnostic improvements. The document focuses on bench testing, biocompatibility, electrical safety, sterilization, software validation, and cybersecurity.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, including specifics on sample size, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or how training ground truth was established. This information is typically found in clinical validation studies, which are not detailed in this 510(k) summary.
The document primarily addresses the safety and fundamental performance of the device itself (e.g., optical properties, mechanical bending, material biocompatibility) rather than its diagnostic accuracy or impact on human reader performance, especially in relation to AI assistance.
Despite the lack of information to fully address your request, here's what can be extracted from the document regarding acceptance criteria for non-clinical performance:
1. A table of acceptance criteria and the reported device performance (based on non-clinical tests):
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance and Compliance |
|---|---|---|
| Biocompatibility | Meets ISO 10993-1:2018 for "Surface - Mucosal Membrane" (< 24 hrs) for: Cytotoxicity, Irritation, Sensitization, Pyrogenicity, Acute Systemic Toxicity. | "All evaluation acceptance criteria were met." (Implies compliance with ISO 10993-1:2018 and successful completion of all listed tests without adverse findings.) |
| Electrical Safety & EMC | Complies with IEC 60601-1, IEC 60601-2-18, IEC 60601-1-2, IEC 60601-4-2. | "Electrical safety and EMC testing were conducted on the device complies with the IEC 60601-1 and IEC60601-2-18 for safety and the IEC 60601-1-2, IEC 60601-4-2 for EMC." (Implies compliance with these standards.) |
| Sterilization Validation | Validated according to ISO 11135 (EO sterilization). | "EO sterilization of the Single-use Flexible Cystoscope has been validated according to ISO 11135." (Implies successful validation meeting the standard.) |
| Shelf Life & Packaging Testing | Packaging integrity and product performance maintained after accelerated aging (ASTM F1980-21) and simulated transport (ASTM D4169-22). | "Shelf Life and Sterile Barrier System of the Single-use Flexible Cystoscope have been validated. Packaging integrity testing and product performance testing were carried out following the accelerated aging of the final devices per ASTM F1980-21 and simulated transportation distribution according to ASTM D4169-22." (Implies successful validation meeting these standards, indicating acceptable shelf life and packaging integrity.) |
| Software V&V | Compliance with FDA Guidance: "Content of Premarket Submissions for Device Software Functions". | "Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions"." (Implies compliance with FDA guidance regarding software V&V.) |
| Cybersecurity Testing | Compliance with FDA Guidance: "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions". | "Cybersecurity testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions"." (Implies compliance with FDA guidance regarding cybersecurity.) |
| Bench Testing - Mechanical Performance | Meets design specifications and comparable to predicate device; in accordance with ISO 8600-1, ISO 8600-4. | "The mechanical performance testing was conducted in accordance with applicable parts of ISO 8600-1, ISO 8600-4." (Implies successful testing meeting these standards and demonstrating design specification compliance and substantial equivalence.) |
| Bench Testing - Optical Performance | Meets design specifications for: Field of view, Direction of view, Depth of field, Geometric distortion, Image intensity uniformity, Color performance, Signal-To-Noise Ratio, Dynamic Range. | "Bench testing - Optical Performance" was conducted for all listed parameters. (Implied successful completion and meeting of specifications, leading to the overall conclusion of substantial equivalence in performance.) |
| Bench Testing - Photobiological Safety | Complies with IEC 62471:2006. | "The subject device was tested according to FDA recognized standards IEC 62471:2006." (Implies successful testing and compliance with the standard.) |
2. Sample size used for the test set and the data provenance: Not applicable/Not provided. The document describes bench testing on the device itself, not a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth for clinical diagnostic performance is not discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.
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/Not provided. This device is a flexible cystoscope, not an AI-powered diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/Not provided. This device is an endoscope, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided. The "ground truth" for the non-clinical tests would be the established engineering and safety standards (e.g., ISO, IEC, ASTM) and the device's design specifications.
8. The sample size for the training set: Not applicable/Not provided. This is a hardware device, not an AI algorithm requiring a training set of data.
9. How the ground truth for the training set was established: Not applicable/Not provided.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box. To the right of the blue box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 18, 2024
Hunan Vathin Medical Instrument Co. Ltd Charlene Du RA Manager 1/F, Bldg 12, Innovation and Entrepreneurship Service Center No 9 Chuangi West Road, Jiuhua Economic Development Zone Xiangtan, Hunan 411100 CHINA
Re: K242535
Trade/Device Name: Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01. CY-E2F01R. CY-E2G01. CY-E2G01R. CY-S2E01. CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ Dated: November 25, 2024 Received: November 25, 2024
Dear Charlene Du:
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/ofdocs/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 (OS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
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 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
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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,
Mark R. Kreitz -S
for Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology, and Urology 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
Submission Number (if known)
Device Name
Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R);
Digital Video Monitor (DVM-D1, DVM-D2)
Indications for Use (Describe)
The Single-Use Flexible Cystoscope is designed to be used with the Vathin Display Unit, endotherapy accessories and other auxiliary device for endoscopy and treatment of adult bladder.
The Digital Video Monitor is specially designed to be used with Vathin medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
The devices are for use in professional Healthcare Facility Environment.
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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K242535 Page 1 of 7
Image /page/4/Picture/1 description: The image shows the word "VATHIN" in blue. The "VA" portion of the word is stylized with three parallel lines that form the shape of the letters. The "THIN" portion of the word is in a solid blue font, and there is a small blue circle above the "I".
Premarket Notification 510(k) Submission
510(k) Summary
I Submitter
| Device submitter: | Hunan Vathin Medical Instrument Co., Ltd. |
|---|---|
| Address: | 1/F, Building 12, Innovation and Entrepreneurship Service Center, No9 Chuanqi west road, Jiuhua Economic Development Zone, 411100Xiangtan, Hunan, China |
| Contact person: | Du JingTitle: Regulatory Affairs ManagerPhone: +86-731-5558558E-mail: charlene@vathin.com |
| Date of prepared: | December 18, 2024 |
II Device
| Trade Name of | Single-use Flexible Cystoscope |
|---|---|
| Device: | Digital Video Monitor |
| Common name: | Endoscope and Accessories |
| Classification name: | Cystoscope and Accessories, Flexible/rigid |
| Regulation number: | 21 CFR 876.1500 |
| Regulatory Class: | Class II |
| Product Code: | FAJ |
| Review Panel: | Gastroenterology/Urology |
III Predicate device and reference device
| Predicate device | Reference device | |
|---|---|---|
| Trade name: | Ambu AScope 4 Cysto | Ambu aView™ 2 Advance |
| Regulation number: | 21 CFR 876.1500 | 21 CFR 874.4680 |
| Regulation name: | Endoscope and accessories | Bronchoscope (Flexible Or Rigid) |
| Regulatory class: | Class II | Class II |
| Product code: | FAJ | EOQ |
| Submitter: | Ambu A/S | Ambu A/S |
| 510(k) number: | K193095 | K223299 |
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K242535 Page 2 of 7
Image /page/5/Picture/1 description: The image shows the logo for Vathin. The logo is blue and features the word "VATHIN" in a stylized font. The "VA" portion of the logo is made up of three lines, while the "THIN" portion is in a solid blue font. There is a blue dot above the "I" in "THIN".
Premarket Notification 510(k) Submission
IV Device description
The device consists of a Single-use Flexible Cystoscope and a Digital Video Monitor for endoscopic image processing and displaying. They are used in conjunction with other accessories for the endoscopy and treatment of adult bladder.
V Indications for use
The Single-Use Flexible Cystoscope is designed to be used with the Vathin Display Unit, endotherapy accessories and other auxiliary device for endoscopy and treatment of adult bladder.
The Digital Video Monitor is specially designed to be used with compatible Vathin endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
The device is for use in professional Healthcare Facility Environment.
VI Comparison of technological characteristics with the predicate devices
The device is similar to the predicate device in the following areas:
- Intended use (including intended use, intended user and patient population) ●
- Operation principle ●
- Design and performance specifications
- Digital video technology and illumination source
- It allows for irrigation
- It is single-use and delivered sterile
The device is different to the predicate device in the following areas:
- The field of view is slightly smaller than that of the predicate device
- The bending angle is larger than that of the predicate device
- There are 8 specifications while predicate device has 2 specification
- Working length is 400mm while working length of predicate device is 390mm
The differences between the device and predicate device do not alter suitability of the proposed device for its intended use.
| Device feature | Proposed Device | Predicate Device |
|---|---|---|
| Trade Name | Single-Use Flexible Cystoscope | Ambu AScope 4 Cysto (K193095) |
| ClassificationName | Cystoscope and Accessories,Flexible/rigid | Cystoscope and Accessories,Flexible/rigid |
| Product Code | FAJ | FAJ |
| Device feature | Proposed Device | Predicate Device |
| Trade Name | Single-Use Flexible Cystoscope | Ambu AScope 4 Cysto (K193095) |
| RegulationNumber | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Intended use | The Single-Use Flexible Cystoscope isdesigned to be used with the VathinDisplay Unit, endotherapy accessories andother auxiliary device for endoscopy andtreatment of adult bladder. | The aScope 4 Cysto is a sterile, single-use, flexible cystoscope intended to beused for endoscopic access to andexamination of the lower urinary tract.The aScope 4 Cysto is intended to providevisualisation via Ambu displaying unitsand can be used with endoscopicaccessories.The aScope 4 Cysto is intended for use ina hospital environment or medical officeenvironment.The aScope 4 Cysto is designed for use inadults. |
| The compatibleDisplay Unit | Device Name: Digital Video MonitorModels:DVM-D1, DVM-D2 | Ambu aView 2 Advance |
| Application field | The device is for use in a hospital orqualified medical institution. | The aScope 4 Cysto is intended for use ina hospital environment or medical officeenvironment. |
| Intended user | The device is only to be used by skilledmedical staff trained in clinicalendoscopic techniques and procedures. | Before initial use of the aScope 4 Cysto, itis essential for operators to have receivedsufficient training in clinical endoscopictechniques and to be familiar with theintended use, warnings and cautionsdescribed in these instructions. |
| Patient population | Adults | Adults |
| Scope type | Flexible | Flexible |
| Field of view | 110° | 120° |
| Bending angle | Up: 210°Down: 210° | Up: 210°Down: ≥120° |
| InstrumentChannel ID(mm) | CY-E2E01, CY-E2E01R,CY-S2E01, CY-S2E01R:2CY-E2F01, CY-E2F01R:2.2CY-E2G01, CY-E2G01R:2.4 | 2.2 |
| Device feature | Proposed Device | Predicate Device |
| Trade Name | Single-Use Flexible Cystoscope | Ambu AScope 4 Cysto (K193095) |
| Maximum outerdiameter ofinsertion part (mm) | CY-E2E01, CY-E2E01R,CY-S2E01, CY-S2E01R:5.25CY-E2F01, CY-E2F01R:5.45CY-E2G01, CY-E2G01R:5.65 | 6.0 |
| Outer diameter ofmain hose (mm) | CY-E2E01, CY-E2E01R,CY-S2E01, CY-S2E01R:4.9CY-E2F01, CY-E2F01R:5.1CY-E2G01, CY-E2G01R5.3 | 5.4 |
| Distal endOD(mm) | CY-E2E01, CY-E2E01R,CY-S2E01, CY-S2E01R:5.1CY-E2F01, CY-E2F01R:5.3CY-E2G01, CY-E2G01R:5.5 | 5.4 |
| Working length(mm) | 400 | 390 |
| Digital videotechnology | CMOS | CMOS |
| Illumination source | LED | LED |
| Single-use | Yes | Yes |
| Biocompatibility | No CytotoxicityNo Irritation to SkinNo significant evidence of sensitization | No CytotoxicityNo Irritation to SkinNo significant evidence of sensitization |
| Sterilization | EO | EO |
Table 1 Substantial Comparison (Single-use Flexible Cystoscope)
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Image /page/6/Picture/1 description: The image shows the word "VATHIN" in blue letters. The "VA" portion of the word is stylized with three parallel lines that are light blue. The rest of the word is in a darker blue color. There is a small light blue circle above the "I" in the word.
Premarket Notification 510(k) Submission
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K242535
Page 4 of 7
Image /page/7/Picture/1 description: The image shows the logo for Vathin. The logo is blue and white. The word "Vathin" is written in a stylized font, with the "V" and "A" being made up of three parallel lines. There is a blue dot above the "i" in "Vathin".
Premarket Notification 510(k) Submission
Table 2 Substantial Comparison (Digital Video Monitor)
| Device feature | Proposed Device | Reference Device |
|---|---|---|
| Trade Name | Digital Video Monitor | Ambu® aView™ 2 Advance (K223299) |
| Classification | Cystoscope and Accessories, | Bronchoscope (Flexible or Rigid) and |
| Name | Flexible/rigid | Accessories |
| Product Code | FAJ | EOQ |
| Regulation | 21 CFR 876.1500 | 21 CFR 874.4680 |
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K242535 Page 5 of 7
Image /page/8/Picture/1 description: The image shows the word "VATHIN" in blue font. The "VA" portion of the word is stylized with three parallel lines that are light blue. The rest of the word is in a darker blue font. There is a light blue circle above the "I" in the word.
Premarket Notification 510(k) Submission
| Device feature | Proposed Device | Reference Device |
|---|---|---|
| Number | ||
| Models | Digital Video Monitor:DVM-D1, DVM-D2 | Ambu® aView™ 2 Advance |
| Intended use | The Digital Video Monitor is speciallydesigned to be used with Vathin medicalendoscopes and other auxiliary equipmentfor the purposes of endoscopic diagnosis,treatment and video observation. | The Ambu® aView™ 2 Advance isintended to display live imaging data fromcompatible Ambu visualization devices. |
| Application field | The device is for use in a hospital orqualified medical institution. | For in-hospital use. |
| Intended user | For use by trained clinicians/physiciansonly. | For use by trained clinicians/physiciansonly. |
| Max. resolution | 1920 * 1080 | 1920 * 1080 |
| Display type | 15.6" touch screen | 12.8" colour TFT LCD |
| USB connection | A-type | Type A |
| Video output | HDMI, SDI | HDMI, 3G-SDI |
| Image/Videocapture | Yes | Yes |
VII Summary of Non-clinical performance tests:
Biocompatibility testing
Biocompatibility of the Single-Use Flexible Cystoscope was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "Surface - Mucosal Membrane" with a contact duration of "Limited (< 24 hours)". The following tests were performed, as recommended: Cytotoxicity, Irritation, Sensitization, Pyrogenicity and Acute systemic toxicity. All evaluation acceptance criteria were met.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the device complies with the IEC 60601-1 and IEC60601-2-18 for safety and the IEC 60601-1-2, IEC 60601-4-2 for EMC.
Sterilization validation
EO sterilization of the Single-use Flexible Cystoscope has been validated according to ISO 11135.
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K242535 Page 6 of 7
Image /page/9/Picture/1 description: The image shows the word "VATHIN" in blue. The "VA" portion of the word is a lighter blue and has three lines running through it. The "THIN" portion of the word is a darker blue. There is a light blue circle above the "I" in "THIN".
Premarket Notification 510(k) Submission
Shelf life and Packaging testing
Shelf Life and Sterile Barrier System of the Single-use Flexible Cystoscope have been validated. Packaging integrity testing and product performance testing were carried out following the accelerated aging of the final devices per ASTM F1980-21 and simulated transportation distribution according to ASTM D4169-22.
Software Verification and Validation
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions".
Cybersecurity testing
Cybersecurity testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions".
Bench performance testing
Bench testing was performed to ensure that the device met its design specifications and is substantially equivalent to the predicate device. The following performance testing was conducted.
Bench testing - Mechanical Performance
The mechanical performance testing was conducted in accordance with applicable parts of ISO 8600-1, ISO 8600-4.
Bench testing - Optical Performance
- Field of view ●
- Direction of view
- Depth of field
- Geometric distortion
- Image intensity uniformity
- Color performance
- Signal-To-Noise Ratio
- Dynamic Range
Bench testing - Photobiological Safety
The subject device was tested according to FDA recognized standards IEC 62471:2006.
VIII Conclusion
The device is substantially equivalent to predicate device. The non-clinical performance testing
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K242535 Page 7 of 7
Image /page/10/Picture/1 description: The image shows the word "VATHIN" in blue font. The "VA" portion of the word is stylized with three parallel lines, while the "THIN" portion is in a solid blue color. There is a light blue circle above the "I" in "THIN". The overall design is clean and modern.
Premarket Notification 510(k) Submission
demonstrates that the device is as safe, as effective and performs as well as the legally marketed predicate 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.