(260 days)
The Single-use Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract.
The Single-use Ureteral Access Sheath is a prescription device intended to provide physicians with access to the urinary tract and the capability to serve as a pathway for device exchanges. Similar to all ureteral access sheath sets, this device also safeguards the ureter during device exchanges, thus helping to minimize tissue trauma. The Single-use Ureteral Access Sheath consists of two components: the inner semi-rigid dilator assembly and the outer semi-rigid sheath assembly, both of which have a hydrophilic coating to allow for smooth and easy deployment into the upper tracts over a preplaced ureteral guidewire. The sheath has a locking mechanism that attaches to the luer lock hub of the inner dilator, allowing the sheath and dilator to move as a single unit. To ease the insertion of the Single-use Ureteral Access Sheath into the body orifice, the dilator is advanced over a 0.038 inch guidewire. Since both the sheath and dilator are radiopaque, they can be monitored using X-ray (fluoroscopy) to ensure their accurate positioning during the placement process. The Single-use Ureteral Access Sheath is designed to accommodate endoscopes and other urological instruments with an outer diameter (OD) that is compatible with the sheath's inner diameter (ID) of 10Fr, 11Fr, 13Fr, and 14Fr. The inner layer of the sheath is made of stainless steel to provide radial rigidity that remains patent and intact after the dilator is removed, allowing endoscopes and other urological instruments to pass easily along the lumen of the Access Sheath. The Single-use Ureteral Access Sheath is offered in five French size combinations: 10Fr/12Fr, 11Fr/13Fr, 12Fr/14Fr, 13Fr/15Fr, and 14Fr/16Fr, and two lengths: 35cm and 45cm. The device is constructed using biologically safe materials and is provided in a sterile condition, intended for single use only.
The device in question is the Single-use Ureteral Access Sheath (K240167). The provided document is a 510(k) summary, which outlines the device's characteristics and the studies performed to demonstrate its substantial equivalence to a legally marketed predicate device.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document details performance testing for various attributes. While it states "All evaluation acceptance criteria were met" for specific categories (e.g., Biocompatibility), it does not explicitly list numerical or qualitative acceptance criteria for each functional/mechanical test in a table form, nor does it provide the exact reported performance values. It only lists the tests conducted.
| Category | Acceptance Criteria (Stated/Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | In accordance with ISO 10993-1:2018 (no cytotoxicity, no irritation, no sensitization, met pyrogenicity and acute systemic toxicity requirements) | All evaluation acceptance criteria were met. |
| Sterility | Sterile barrier systems met ISO 11607; sterilization process validated per ISO 11135. | Validated in accordance with ISO 11135 and ISO 11607. |
| Functional/Mechanical Performance | Implicitly, met standards for safe and effective use comparable to the predicate device. | All tests listed below were conducted (see section VII for tests listed). The results supported substantial equivalence. |
| - Appearance | (Not explicitly stated, but implies acceptable visual quality) | Conducted |
| - Mark | (Not explicitly stated, but implies clear and correct marking) | Conducted |
| - Size | (Not explicitly stated, but implies dimensional accuracy) | Conducted |
| - Luer fitting | (Not explicitly stated, but implies proper fitting) | Conducted |
| - Patency | (Not explicitly stated, but implies open and unobstructed lumen) | Conducted |
| - Freedom from leakage | (Not explicitly stated, but implies no leaks) | Conducted |
| - Resistance to deformation | (Not explicitly stated, but implies maintaining structural integrity) | Conducted |
| - Breaking force | (Not explicitly stated, but implies adequate strength) | Conducted |
| - Connection firmness | (Not explicitly stated, but implies secure connections) | Conducted |
| - Toughness | (Not explicitly stated, but implies resistance to fracture) | Conducted |
| - Flexural properties | (Not explicitly stated, but implies appropriate flexibility) | Conducted |
| - Anti-twisting force | (Not explicitly stated, but implies resistance to twisting) | Conducted |
| - Compression Resistance | (Not explicitly stated, but implies resistance to compression) | Conducted |
| - Compatibility | (Not explicitly stated, but implies compatibility with other instruments) | Conducted |
| - Air pressure Regulation Function | (Not explicitly stated, but implies proper function) | Conducted |
| - Negative Pressure Suction Function | (Not explicitly stated, but implies proper function) | Conducted |
| - Bending Reliability | (Not explicitly stated, but implies reliable bending without failure) | Conducted |
| - Corrosion resistance | (Not explicitly stated, but implies resistance to corrosion) | Conducted |
| - Friction | (Not explicitly stated, but implies acceptable friction during use) | Conducted |
| - Coating Uniformity | (Not explicitly stated, but implies consistent coating application) | Conducted |
| - Firmness | (Not explicitly stated, but implies appropriate rigidity/stiffness) | Conducted |
| - Chemical Property | (Not explicitly stated, but implies appropriate chemical composition) | Conducted |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for any of the non-clinical performance tests (biocompatibility, sterility, functional/mechanical testing).
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data mentioned for the performance testing. However, the applicant is Hunan Vathin Medical Instrument Co., Ltd., located in China, suggesting the testing was likely conducted by or for the manufacturer.
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)
This device is a physical medical instrument (Ureteral Access Sheath), not an AI/Software as a Medical Device (SaMD) that requires expert consensus for ground truth establishment. Therefore, this information is not applicable. The "ground truth" for this device is based on objective measurements and compliance with recognized standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As this is not a clinical study involving human interpretation or subjective assessment necessitating adjudication, this information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical imaging or diagnostic studies.
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
No MRMC study was conducted. This device is a physical medical instrument and does not involve AI assistance or human reader interpretation in its intended use.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to AI/software performance. This device is a physical medical instrument, so this concept is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" used for this device's performance evaluation is based on objective measurements and tests against established engineering, material, and biocompatibility standards. For example:
- Biocompatibility: In vitro and in vivo tests according to ISO 10993-1, measured against scientific criteria (e.g., cell viability for cytotoxicity, skin reaction for irritation).
- Sterility: Measured by sterility assurance level (SAL) achieved through validated sterilization processes per ISO 11135.
- Functional/Mechanical: Measured by physical properties (e.g., dimensions, force resistance, patency, leakage) against pre-defined specifications derived from engineering principles and comparison to the predicate device.
8. The sample size for the training set
This device does not involve a "training set" in the context of machine learning or AI. It is a physical medical device.
9. How the ground truth for the training set was established
As there is no training set for this physical device, this question is not applicable.
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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, which consists of a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 2, 2024
Hunan Vathin Medical Instrument Co., Ltd. Jing Du RA Manager 1/F, Building 12, Innovation Entrepreneurship Service Center No.9 Chuanqi West Road, Jiuhua Economic Development Zone Xiangtan, Hunan 411100 CHINA
Re· K240167
Trade/Device Name: Single-use Ureteral Access Sheath Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED
Dear Jing Du:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 8, 2024. Specifically, FDA is updating this SE Letter (incorrect predicate device manufacturer name and subject device materials table in the 510(k) Summary) as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Mark J. Antonino, OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices, (240) 402-9980, Mark.Antonino@fda.hhs.gov.
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
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Image /page/1/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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 8, 2024
Hunan Vathin Medical Instrument Co., Ltd. Jing Du RA Manager 1/F, Building 12, Innovation Entrepreneurship Service Center No.9 Chuanqi West Road, Jiuhua Economic Development Zone Xiangtan, Hunan 411100 CHINA
Re· K240167
Trade/Device Name: Single-use Ureteral Access Sheath Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED Dated: September 3, 2024 Received: September 4, 2024
Dear Jing 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/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.
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"
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(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 820.70) 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 Rue"). 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-udi-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 Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
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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
510(k) Number (if known) K240167
Device Name Single-use Ureteral Access Sheath
Indications for Use (Describe)
The Single-use Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Production (Part 611 Subpart J) | □ Gas Storage (Part 611 Subpart G) |
|---|---|
| ----------------------------------------------------------------------------------- | ------------------------------------- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary – K240167 Single-use Ureteral Access Sheath Hunan Vathin Medical Instrument Co., Ltd.
I. SUBMITTER INFORMATION
| Applicant: | Hunan Vathin Medical Instrument Co., Ltd. |
|---|---|
| Address: | 1/F, Building 12, Innovation and Entrepreneurship ServiceCenter, No 9 Chuanqi west road, Jiuhua Economic DevelopmentZone, 411100 Xiangtan, Hunan, China |
| Contact Person: | Du JingRegulatory Affairs Manager+86-18915069265charlene@vathin.com |
| Date Prepared: | January 19, 2024 |
II. SUBJECT DEVICE
| Trade Name: | Single-use Ureteral Access Sheath |
|---|---|
| Common Name: | Ureteral Access Sheath |
| Classification Name: | Endoscopic Access Overtube, Gastroenterology-Urology |
| Regulatory Class: | II |
| Product Code: | FED |
| Regulation Number: | 21 CFR 876.1500 |
| Review Panel: | Gastroenterology/Urology |
III. PREDICATE DEVICE
| Trade Name: | Disposable Ureteral Access Sheath |
|---|---|
| 510(k) Number: | K203165 |
| Manufacturer: | Suzhou Beyo Medical Technology Co., Ltd. |
This predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The Single-use Ureteral Access Sheath is a prescription device intended to provide physicians with access to the urinary tract and the capability to serve as a pathway for device exchanges.
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Similar to all ureteral access sheath sets, this device also safeguards the ureter during device exchanges, thus helping to minimize tissue trauma.
The Single-use Ureteral Access Sheath consists of two components: the inner semi-rigid dilator assembly and the outer semi-rigid sheath assembly, both of which have a hydrophilic coating to allow for smooth and easy deployment into the upper tracts over a preplaced ureteral guidewire. The sheath has a locking mechanism that attaches to the luer lock hub of the inner dilator, allowing the sheath and dilator to move as a single unit.
To ease the insertion of the Single-use Ureteral Access Sheath into the body orifice, the dilator is advanced over a 0.038 inch guidewire. Since both the sheath and dilator are radiopaque, they can be monitored using X-ray (fluoroscopy) to ensure their accurate positioning during the placement process.
The Single-use Ureteral Access Sheath is designed to accommodate endoscopes and other urological instruments with an outer diameter (OD) that is compatible with the sheath's inner diameter (ID) of 10Fr, 11Fr, 13Fr, and 14Fr. The inner layer of the sheath is made of stainless steel to provide radial rigidity that remains patent and intact after the dilator is removed, allowing endoscopes and other urological instruments to pass easily along the lumen of the Access Sheath.
The Single-use Ureteral Access Sheath is offered in five French size combinations: 10Fr/12Fr, 11Fr/13Fr, 12Fr/14Fr, 13Fr/15Fr, and 14Fr/16Fr, and two lengths: 35cm and 45cm. The device is constructed using biologically safe materials and is provided in a sterile condition, intended for single use only.
The subject device components are made of the following materials:
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| Device Components | Contact Method | Material Full Name | |
|---|---|---|---|
| Inner Layer | Direct Contact | Austenitic stainless steel | |
| Sheath | Outer Layer | Low-density polyethylene (LDPE)+ Thermoplastic polyurethanes (TPU) | |
| Polyethylene terephthalate (PET) | |||
| Hub | Indirect Contact | Polycarbonate (PC) | |
| Sheath Hub | Suction Nozzle | Polycarbonate (PC) | |
| Sheath Cap | Indirect Contact | Polycarbonate (PC) | |
| Sealing Sleeve | Indirect Contact | Silicone | |
| Vent Push Button | Indirect Contact | Acrylonitrile–butadiene –styrene (ABS) | |
| Dilator | Direct Contact | Low-density polyethylene (LDPE) | |
| Dilator Hub | Hub | Indirect Contact | Polypropylene (PP) |
| Locking Clip | Polycarbonate (PC) | ||
| Hydrophilic Coatings | / | Urethane acrylate copolymer | |
| Direct Contact | Polyvinyl pyrrolidone (PVP) |
Table 1. Subject Device Materials
V. INDICATIONS FOR USE
The Single-use Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract.
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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Single-use Ureteral Access Sheath is like the predicate device in the following areas:
- · Intended use (including application field, intended user and patient population)
- Principal operation .
- · Design and performance specifications
- · With hydrophilic coatings
- · It is single-use and delivered sterile
The following technological differences exist between the subject and predicate devices:
- · The sheath hub structure
- · The distal segment of the sheath can be passively bent
- · It allows for suction operation
- · The sheath is available in five French sizes, compared to the predicate device's three sizes
- · There are two sheath lengths available, whereas the predicate device offers five lengths
The differences between the Single-use Ureteral Access Sheath and predicate device do not alter suitability of the subject device for its intended use.
| Description | Subject Device | Predicate Device (K203165) |
|---|---|---|
| Trade Name | Single-use Ureteral Access Sheath | Disposable Ureteral Access Sheath |
| Regulation Number | 876.1500 | 876.1500 |
| Regulatory Class | II | II |
| Product Code | FED | FED |
| Indications for Use | The Single-use Ureteral AccessSheath is used to establish a conduitduring endoscopic urologicalprocedures, facilitating the passageof endoscopes and other instrumentsinto the urinary tract. | The Ureteral Access Sheath isintended to use in urologicendoscopic procedures to facilitatethe passage of endoscopes. |
| Delivered Sterile | Yes | Yes |
| Sterilization Method | EO | EO |
| Single Use | Yes | Yes |
| Sheath ID | 10Fr, 11Fr, 12Fr, 13Fr, 14Fr | 10Fr, 12Fr, 14Fr |
| Sheath Length | 35cm, 45cm | 25cm, 35cm, 40cm, 45cm, 55cm |
| Guidewire Compatibility | 0.038" (0.97mm) guidewire cansmoothly enter and exit the innerlumen of the dilator. | 0.038" (0.97mm) guidewire cansmoothly enter and exit the innercavity of the dilator. |
Table 2. Comparison of Technological Characteristics
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| Description | Subject Device | Predicate Device (K203165) |
|---|---|---|
| Materials | Sheath: TPU, LDPE, PET, SUS304Dilator: LDPEHydrophilic coating: PVP | Sheath: PEBAX, SUS304, PTFEDilator: LDPEHydrophilic coating: PAM |
| Biocompatibility | No CytotoxicityNo Irritation to SkinNo significant evidence ofsensitization | No CytotoxicityNo Irritation to SkinNo significant evidence ofsensitization |
| Package | Single-use EO sterilized blister boxwith one device per box | Single-use EO sterilized pouch withone device perpouch |
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination:
Non-Clinical Performance Data
Biocompatibility Testing
Biocompatibility of the Single-use Ureteral Access Sheath was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "breached or compromised surface" 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.
Sterility Testing
Sterile barrier systems were evaluated in accordance with ISO 11607.
Sterilization Process has been validated accordance with ISO 11135.
Performance Testing
The following functional and mechanical performance testing were conducted on the Single-use Ureteral Access Sheath:
- Appearance .
- Mark .
- Size ●
- Luer fitting ●
- Patency ●
- Freedom from leakage ●
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- . Resistance to deformation
- . Breaking force
- . Connection firmness
- Toughness .
- . Flexural properties
- Anti-twisting force ●
- . Compression Resistance
- . Compatibility
- · Air pressure Regulation Function
- Negative Pressure Suction Function
- · Bending Reliability
- Corrosion resistance .
- Friction .
- Coating Uniformity .
- Firmness ●
- Chemical Property ●
VIII. CONCLUSION
The results of the performance testing described above demonstrate the Single-use Ureteral Access Sheath is as safe and effective as the predicate device and supports a determination of substantial equivalence.
§ 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.