(75 days)
The Disposable Endoscopic Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
The Fengh Medical Disposable Endoscopic Trocar has applications in abdominal, thoracic and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions. A Disposable Endoscopic Trocar is mainly composed of Obturator Handle, Outer Seal Release Lever. Trocar Stability Sleeve, Obturator Locking Button, Trocar Stability Sleeve, etc. Materials being used include Stainless 12Cr18Ni9, Stainless 06Cr19Ni10, ABS plastic, PC. All the components of Disposable Endoscopic Trocar are evaluated by cytotoxicity test, sensitization test, intracutaneous mucosa stimulation test, Systemic toxicity(acute) test and Pyrogenicity test. Therefore, it will not cause bad stimulations, allergic reactions or other harm to human tissue or mucosa. Furthermore, no toxic substances will be separated out during the use of Disposable Endoscopic Trocar. Endoscopic surgery is conducted through a cannula that extends across the abdominal wall and provides channels where instruments, such as scopes, retractors and staplers, can be inserted to perform surgery. As part of this procedure, the abdominal cavity is inflated with an insufflation gas, such carbon dioxide, to maintain the abdomen in a distended state and provide increased instrument maneuvering capability within the cavity. Valves are typically provided in the trocars to form seals around the instruments to prevent leakage of the insufflation gas.
The provided text describes the acceptance criteria and the results of a study for the Fengh Medical Disposable Endoscopic Trocar.
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists several "Testing" categories and provides specific criteria along with implied performance (meeting those criteria). However, the "Table 2" under "Substantial Equivalence" merges proposed device characteristics with general requirements. I've extracted the acceptance criteria from the "Testing" section and the detailed comparison table, and for performance, the document generally states that the device is "substantially equivalent" because "testing standards are identical" and "the differences between both devices are insignificant in terms of safety and effectiveness," implying the device met these criteria.
| Acceptance Criteria / Test Name | Criterion | Reported Device Performance (Implied) |
|---|---|---|
| Non-Clinical Testing | ||
| Sterility Test | (Implied: Device must be sterile) | Met (Included in tests) |
| Peel Strength | (Implied: Must meet strength requirements) | Met (Included in tests) |
| Flexibility | (Implied: Must meet flexibility requirements) | Met (Included in tests) |
| Fitness | (Implied: Components fit correctly) | Met (Included in tests) |
| Leakage | (Implied: No leakage or minimal leakage as specified) | Met (Included in tests, further detailed below) |
| Roughness | Obturator roughness Ra must not be bigger than 0.4μm. | Met (Included in tests) |
| Dimension | (Implied: Dimensions must be within specified tolerances) | Met (Included in tests) |
| Appearance | (Implied: Must meet visual inspection standards) | Met (Included in tests) |
| Insertion & Cannula Stability | When the obturator pulled out Trocar sleeve, the friction should not exceed 5N. | Met (Included in tests) |
| Trocar sleeve retention force | Apply a pressure of 5N ± 1N on both sides of the thread area, the pull-out force of the sleeve should not less than 10N. | Met (Included in tests) |
| Endoscope Visualization Quality | Accommodate an appropriately sided 0° endoscope. | Met (Included in tests) |
| Obturator & Cannula Compatibility | Sleeve and Obturator should fit well without any interference. Max clearance between sleeve and Obturator: D≤0.3mm. The tip of Obturator should be fully out of sleeve when fit. | Met (Included in tests) |
| Air Leakage as a whole device | There should be no leakage under 4kPa pressure between stopcock and sealing cap. | Met (Included in tests) |
| Air Leakage with obturator withdrawn | Choke valve should have good gas blocking performance. Bubbles should be less than 20 under 4KPa pressure. | Met (Included in tests) |
| Biocompatibility Testing | ||
| In Vitro Cytotoxicity Test | (Implied: Must not show cytotoxicity) | Met (Included in tests; document states "will not cause bad stimulations, allergic reactions or other harm") |
| Skin Sensitization Test | (Implied: Must not cause skin sensitization) | Met (Included in tests; document states "will not cause bad stimulations, allergic reactions or other harm") |
| Intracutaneous reactivity Test | (Implied: Must not cause intracutaneous reactivity) | Met (Included in tests; document states "will not cause bad stimulations, allergic reactions or other harm") |
| Acute Systemic Toxicity | (Implied: Must not cause acute systemic toxicity) | Met (Included in tests; document states "will not cause bad stimulations, allergic reactions or other harm") |
| Pyrogen Test | (Implied: Must be non-pyrogenic) | Met (Included in tests; document states "will not cause bad stimulations, allergic reactions or other harm") |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test mentioned (e.g., Sterility Test, Peel Strength, Biocompatibility tests). It only lists "Testing" categories and the methods.
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The document describes non-clinical and biocompatibility tests, which typically rely on standardized laboratory protocols and measurements rather than expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set:
This information is not provided. Given the nature of the tests (non-clinical, biocompatibility), adjudication methods common in diagnostic device studies (like 2+1 or 3+1) are not typically applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done or reported in this document. The document focuses on performance testing of the device itself against established criteria and comparison to a predicate device based on technological characteristics and intended use.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This question is not applicable as the device is a physical medical instrument (trocar) and not an algorithm or AI-based diagnostic tool.
7. Type of Ground Truth Used:
For the non-clinical and biocompatibility tests, the "ground truth" would be objective measurements and adherence to pre-defined physical, chemical, and biological standards (e.g., specific force measurements, absence of microbial growth, absence of toxic reactions). These are not expert consensus, pathology, or outcomes data in the typical sense for diagnostic devices.
8. Sample Size for the Training Set:
This question is not applicable as the device is a physical medical instrument and does not involve AI or machine learning models that require a training set.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 9, 2018
Fengh Medical Co., Ltd. Jun Zhou Regulatory Affairs Manager D3 No. 6 Dongsheng West Road, Jiangyin National High-tech Zone Jiangyin, 214437 Cn
Re: K180208
Trade/Device Name: Disposable Endoscopic Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: February 8, 2018 Received: February 12, 2018
Dear Jun Zhou:
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, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jennifer R. Stevenson -S3
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K180208
Device Name Disposable Endoscopic Trocar
Indications for Use (Describe)
The Disposable Endoscopic Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows a logo for FENG Medical. The logo is in blue and teal. The word "FENG" is in blue, and the word "Medical" is in a smaller font below the "G" in FENG.
Fengh Medical Co., Ltd. 510(k) Submission Trocar
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
(As Required by 21 CFR 807.92)
1. Date Prepared [21 CFR 807.92(a)(1)]
02/20/2018
2. Submitter's Information [21 CFR 807.92(a)(1)]
| Company Name: | Fengh Medical Co., Ltd. |
|---|---|
| Company Address: | D3 No.6 Dongsheng West Road, Jiangyin National Hightech Zone, 214437 Jiangsu, China |
| Contact Person: | Jun Zhou |
| Phone: | 86 - 15906171661 |
| Email: | zj_fenghmedical@163.com |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name: | Disposable Endoscopic Trocar |
|---|---|
| Common Name: | General & Plastic Surgery |
| Product Code: | GCJ |
| Regulation Number: | 21 CFR 876.1500 |
| Device Class: | II |
4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[
The identification of predicates within this submission is as follow:
| Predicate I | |
|---|---|
| Manufacturer: | Ethicon Endo-Surgery, Inc |
| Trade Name: | ENDOPATH III Bladeless TrocarsENDOPATH III Blunt Tip TrocarsENDOPATH III Dilating Tip Trocars |
| Common Name: | ENDOPATH III Trocar System |
| Product Code: | GCJ |
| Classification Name: | General& Plastic Surgery |
| Regulation Number: | 21 CFR 876.1500 |
| Classification: | Class II |
| FDA 510 (k) Number: | K032676 |
SECTION 6 - 2 of 7
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Image /page/4/Picture/0 description: The image shows the text 'K180208 p 3/7'. This appears to be an identifier or code, possibly a document or page number. The 'p' likely stands for 'page', indicating that this is page 3 of a 7-page document. The 'K180208' could be a unique identifier for the document itself.
Image /page/4/Picture/1 description: The image shows a logo for FENG Medical. The logo consists of the word "FENG" in blue, with a stylized "h" in a circle to the right. To the left of "FENG" are two Chinese characters in a similar blue color. Below the "h" is the word "Medical" in a smaller font.
Fengh Medical Co., Ltd. 510(k) Submission Trocar
5. Description of the Device [21 CFR 807.92(a)(4)]
The Fengh Medical Disposable Endoscopic Trocar has applications in abdominal, thoracic and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and econdary insertions.
A Disposable Endoscopic Trocar is mainly composed of Obturator Handle, Outer Seal Release Lever. Trocar Stability Sleeve, Obturator Locking Button, Trocar Stability Sleeve, etc. Materials being used include Stainless 12Cr18Ni9, Stainless 06Cr19Ni10, ABS plastic, PC. All the components of Disposable Endoscopic Trocar are evaluated by cytotoxicity test, sensitization test, intracutaneous mucosa stimulation test, Systemic toxicity(acute) test and Pyrogenicity test. Therefore, it will not cause bad stimulations, allergic reactions or other harm to human tissue or mucosa. Furthermore, no toxic substances will be separated out during the use of Disposable Endoscopic Trocar.
Endoscopic surgery is conducted through a cannula that extends across the abdominal wall and provides channels where instruments, such as scopes, retractors and staplers, can be inserted to perform surgery. As part of this procedure, the abdominal cavity is inflated with an insufflation gas, such carbon dioxide, to maintain the abdomen in a distended state and provide increased instrument maneuvering capability within the cavity. Valves are typically provided in the trocars to form seals around the instruments to prevent leakage of the insufflation gas.
6. Intended Use [21 CFR 807.92(a)(5)]
The Disposable Endoscopic Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
7. Technological Characteristic [21 CFR 807.92(a)(6)]
Optical Entry
- Visualization is optically guided by a 0° endoscope .
- . Enables visualization of tissue layers during insertion Durable Universal Seal
SECTION 6 - 3 of 7
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风和FE
Fengh Medical Co., Ltd. 510(k) Submission Trocar
- . No reducer caps needed
- Maintains insufflation ●
Camera Scope-Locking Tab
- Holds camera locked in place during visually guided entry ●
- Helps provide visual clarity and protects camera from scratching or falling out . Integrated Stability Thread Design
- Maximizes abdominal wall retention for minimal trocar slip-outs ●
Bladeless Optical Tip
- Separates, rather than cuts, along tissue fibers ●
- . Reduced risk of abdominal wall injuries
8. Testing
| Table 1 | Tests |
|---|---|
| Clinical | Not Applicable |
| Non-Clinical Testing: | Sterility Test |
| Peel Strength | |
| Flexibility | |
| Fitness | |
| Leakage | |
| Roughness | |
| Dimension | |
| Appearance | |
| Insertion & Cannula Stability | |
| Trocar sleeve retention force | |
| Endoscope Visualization Quality | |
| Biocompatibility Testing: | In Vitro Cytotoxicity Test |
| Skin Sensitization Test | |
| Intracutaneous reactivity Test | |
| Acute Systemic Toxicity | |
| Pyrogen Test |
9. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]
| Table 2 | Proposed Device | Predicate Device |
|---|---|---|
| Device Name | Disposable Endoscopic Trocar | ENDOPATH@ III BladelessTrocars |
| Trade Name | Disposable Endoscopic Trocar | ENDOPATH@ III BladelessTrocars |
| ENDOPATH@ III Blunt TipTrocarsENDOPATH@ III DilatingTip Trocars | ||
| DeviceClassification | II | II |
| RegulationNumber | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Product Code | GCJ | GCJ |
| Intended Use | The Disposable EndoscopicTrocar has applications inabdominal, thoracic, andgynecologic minimally invasivesurgical procedures to establisha path of entry for endoscopicinstruments. The trocar may beused with or withoutvisualization for primary andsecondary insertions. | The ENDOPATH III BladelessTrocar has applications inabdominal, thoracic, andgynecologic minimallyinvasive procedures toestablish a path of entry forendoscopic instruments. Thetrocar may be used with orwithout visualization forprimary and secondaryinsertions.The ENDOPATH III DilatingTip Trocar has applications inthoracic, gynecologiclaparoscopy and otherabdominal procedures toestablish a path of entry forendoscopic instruments.The ENDOPATH III Blunt TipTrocar has applications inthoracic, gynecologic,laparoscopic and otherabdominal procedures toestablish a path of entry forminimally invasiveinstruments. |
| Sizes (Diameter) | 5mm | 5mm |
| N/A | 8mm | |
| 10mm | N/A | |
| N/A | 11mm | |
| 12mm | 12mm | |
| N/A | 15mm | |
| Size (Length) | N/A | 75mm |
| 100mm | 100mm | |
| N/A | 150mm | |
| Principles ofDuring the operation, the trocar | During the operation, the | |
| operation | sleeve and the obturator areused together. The surgeon usesthe obturator to expand theincision of the abdomen andpenetrates the trocar sleevethrough the abdominal surfaceof the human body into theabdominal cavity, therebydelivering gas to the abdominalcavity and establishing a path ofentry for endoscopicinstruments. | trocar sleeve and the obturatorare used together. The surgeonuses the obturator to expandthe incision of the abdomenand penetrates the trocar sleevethrough the abdominal surfaceof the human body into theabdominal cavity, therebydelivering gas to the abdominalcavity and establishing a pathof entry for endoscopicinstruments. |
| MainComponents | ObturatorObturator HandleScope locking Cam (ExceptFLPC5, FLPC10, FLPC12)Obturator Locking Button(housed in obturator handle)Outer SealOuter Seal Release Lever(Except FLPC5,FLPC10,FLPC12)StopcockTrocar Smooth SleeveTrocar Stability SleeveOptical ElementBladeless TipN/AN/A | ObturatorObturator HandleScope locking Cam (housed inobturator handle)Obturator Locking Button(housed in obturator handle)Outer SealOuter Seal Release LeverStopcockTrocar Smooth SleeveTrocar Stability SleeveOptical ElementBladeless TipBladeless Tip SymbolPistol Handle |
| PatientContactingStructure | ObturatorTrocar Smooth SleeveTrocar Stability SleeveOptical ElementBladeless Tip | ObturatorTrocar Smooth SleeveTrocar Stability SleeveOptical ElementBladeless Tip |
| PatientContactingMaterial | ABS-1, MN, 095-30-16-15/PC/Stainless 12Cr18Ni9(Except FLPC5, FLPC10,FLPC12)/Stainless 06Cr19Ni10(Except FLPC5, FLPC10,FLPC12) | N/A |
| Sterilization | Sterilized using Irradiation | N/A |
| ApplicationSites | AbdominalThoracic | AbdominalThoracic |
| Number of Ports | 1 | 1 |
| Single Use | Yes | Yes |
| Obturator &CannulaCompatibility | Sleeve and Obturator should fitwell without any interference.Max clearance between sleeveand Obturator: D≤0.3mmThe tip of Obturator should befully out of sleeve when fit. | N/A |
| Insertion&CannulaStability | When the obturator pulled outTrocar sleeve, the frictionshould not exceed 5N. | N/A |
| Trocar SystemPuncturePerformance | Obturator roughness Ra mustnot be bigger than 0.4μm. | N/A |
| Trocar sleeveretention force | Apply a pressure of 5N ± 1Non both sides of the thread area,the pull-out force of the sleeveshould not less than 10N. | N/A |
| Air Leakage as awhole device | There should be no leakageunder 4kPa pressure betweenstopcock and sealing cap. | N/A |
| Air Leakagewith obturatorwithdrawed | Choke valve should have goodgas blocking performance.Bubbles should be less than 20under 4KPa pressure. | N/A |
| EndoscopeVisualizationQuality | Accommodate an appropriatelysided 0° endoscope. | N/A |
| Biocompatibility | In Vitro Cytotoxicity TestSkin Sensitization TestIntracutaneous reactivity TestAcute Systemic Toxicity | N/A |
SECTION 6 - 4 of 7
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Image /page/6/Picture/1 description: The image contains a logo with both Chinese characters and English text. The Chinese characters "风和" are displayed in a teal color, followed by the English word "FENG" in a darker blue. Below the "G" in "FENG", the word "Medical" is written in a smaller font size.
Fengh Medical Co., Ltd.
Trocar
SECTION 6 - 5 of 7
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Image /page/7/Picture/1 description: The image shows the logo for Fenghe Medical. The logo consists of two Chinese characters followed by the word "FENG" in blue, sans-serif font. To the right of "FENG" is a stylized image of a human figure in blue, with the word "Medical" in smaller font below it.
Fengh Medical Co., Ltd.
Trocar
SECTION 6 - 6 of 7
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Image /page/8/Picture/1 description: The image shows the logo for FENG Medical. The logo consists of the Chinese characters "风和" on the left, followed by the word "FENG" in blue, and then a stylized "h" inside a circle, also in blue. Below the "h" is the word "Medical" in a smaller font.
Fengh Medical Co., Ltd. 510(k) Submission Trocar
10. Conclusion [21 CFR 807.92(b)(3)]
The Disposable Endoscopic Trocar substantially equivalent to predicate device because both devices use identical technology and same intended use, also testing standards are identical with the predicates. The differences between both devices are insignificant in terms of safety and effectiveness.
SECTION 6 - 7 of 7
§ 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.