(53 days)
The YelloPort Elite port access system is indicated for use in laparoscopic procedures to give access to the abdominal cavity while maintaining pneumoperitoneum.
The YelloPort Elite port access system is also indicated for use in thoracoscopic procedures to give access to the thoracic cavity.
The YelloPort Elite Port Access System comprises a trocar, available with a range of tip styles, cannula. Universal Seal and Hasson (fascia) adaptor. The trocar, cannula and Hasson (fascia) adaptor elements of the device are fully reusable and can be sterilised in pressurised steam. The Universal seal is single use only.
In order to obtain access to the surgical site during laparoscopic surgery, the YelloPort Elite Trocar is introduced into the YelloPort Elite Cannula to accomplish cannula penetration of the abdominal wall. The cannula is connected to the YelloPort Elite Universal Seal at its proximal end and once the abdominal/thoracic wall is punctured, the trocar is removed. The cannula acts as a channel for the introduction of the endoscopes and instruments. Generically, trocars and cannulas are available in a range of lengths and diameters.
This document is a 510(k) premarket notification for the YelloPort Elite Port Access System. It demonstrates substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a study in the same way a new, innovative device might.
Therefore, the requested information elements related to performance studies, ground truth, expert adjudication, MRMC studies, and sample sizes for test and training sets are not applicable in this context. The provided text details non-clinical (bench) testing to show equivalence, not clinical performance against acceptance criteria for a novel functionality.
Here's a breakdown of the applicable and non-applicable information based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in the traditional sense of a clinical performance study with acceptance criteria for a novel claim.
- The document's purpose is to demonstrate substantial equivalence to existing predicate devices based on technological characteristics and non-clinical testing. The "acceptance criteria" here are implicitly related to meeting the performance characteristics of the predicate devices for safety and effectiveness through bench testing.
The document lists various non-clinical tests performed:
| Test | Purpose (Implied Acceptance Criteria) | Reported Performance |
|---|---|---|
| Sealing Performance | Ensure gas retention (pneumoperitoneum) | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Instrument Insertion Force (Universal Seal) | Ensure instruments can be inserted with appropriate force | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Seal Contamination Testing | Ensure seal does not contaminate the surgical field or instruments | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Instrument Compatibility Testing (Universal Seal) | Ensure compatibility with a range of instruments | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Port Insertion Force Testing | Ensure appropriate force for port insertion | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Insufflation Testing | Verify ability to maintain insufflation | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Seal Inversion Testing | Evaluate seal integrity under stress | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Trocar Knob Pull Testing | Assess trocar retention/security | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Stopcock Torque Lever Test | Evaluate function of the stopcock mechanism | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Universal Seal Attachment and Removal Test | Verify ease and security of seal handling | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Cannula Mechanical Testing | Assess structural integrity of the cannula | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Pressure Retention of Universal Seal (With Use of Locking Shielded Trocar) | Ensure seal maintains pressure during use with specific trocar type | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Trocar Peritoneum Insertion Simulation Test (Locking Shielded) | Simulate insertion to ensure safety and effectiveness | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Torque Force Test (Locking Shielded) | Evaluate torque limits of the locking shielded trocar | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Tensile Test (Locking Shielded) | Evaluate tensile strength of the locking shielded trocar | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Biocompatibility Testing in accordance with ISO 10993-1 | Ensure materials are safe for patient contact | Compliance with ISO 10993-1, implying successful completion of biocompatibility evaluations. |
| Shelf life and lifecycle studies | Determine product stability and usability over time and repeated use | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Transit studies | Ensure device integrity during shipping/transport | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Cleaning and sterilisation validation | Validate methods for proper cleaning and sterilization of reusable components | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance and that reusable components "can be sterilised in pressurised steam." |
| Clinical (Design) validations which include a simulated surgical evaluation by a consultant surgeon | Evaluate design in a simulated surgical environment by an expert | "Simulated surgical evaluation by a consultant surgeon" was performed. Conclusion states "shows no adverse indications or results" and "is safe, effective". |
| Usability assessments | Ensure ease of use for the intended user | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The submission is for a 510(k) premarket notification relying on substantial equivalence demonstrated through non-clinical (bench) testing, not a clinical study with test sets in the context of AI/diagnostic device performance. No sample sizes for "test sets" or data provenance (country, retrospective/prospective) are mentioned as no clinical data in that format was required or provided.
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. This information relates to clinical studies, particularly for diagnostic devices. For this 510(k), evidence of safety and effectiveness was established through non-clinical bench testing and comparison to predicate devices. A "consultant surgeon" conducted a "simulated surgical evaluation" as part of the "Clinical (Design) validations," but this is not establishing ground truth for a diagnostic test set. No number or specific qualifications beyond "consultant surgeon" are given, nor is "ground truth" established in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for clinical studies, particularly for diagnostic devices where disagreement among readers needs resolution for ground truth. This 510(k) focused on non-clinical engineering and performance testing.
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. An MRMC study is relevant for evaluating the impact of AI or new diagnostic methods on human reader performance. This device is a surgical access system, not a diagnostic AI system, and no clinical MRMC studies were conducted. The document explicitly states: "No clinical studies were conducted as part of submission to prove substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This refers to the performance of an AI algorithm. The YelloPort Elite Port Access System is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. Ground truth, in the context of clinical studies for diagnostic accuracy, is not relevant here. The "ground truth" for this device's performance is established by successfully meeting the engineering and performance specifications during the non-clinical bench tests and demonstrating equivalence to existing predicate devices.
8. The sample size for the training set
- Not Applicable. This refers to training data for AI algorithms. This device is a physical medical device, not an AI algorithm.
9. How the ground truth for the training set was established
- Not Applicable. This refers to the establishment of ground truth for training data for AI algorithms. This device is a physical medical device.
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April 29, 2019
Surgical Innovations Limited Ms. Shazia Chaudhry Quality Assurance and Regulatory Manager Clayton Wood House 6 Clayton Wood Bank Leeds, West Yorkshire, LS16 6QZ, United Kingdom
Re: K190592
Trade/Device Name: YelloPort Elite Port Access System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: February 28, 2019 Received: March 7, 2019
Dear Ms. Chaudhry:
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. 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 located 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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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 801and Part 809: medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or post marketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 4, Subpart A) for combination products; 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 comprehensive regulatory information about mediation-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.
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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Indications for Use
510(k) Number (if known) K190592
Device Name YelloPort Elite Port Access System
Indications for Use (Describe)
The YelloPort Elite port access system is indicated for use in laparoscopic procedures to give access to the abdominal cavity while maintaining pneumoperitoneum.
The YelloPort Elite port access system is also indicated for use in laparoscopic procedures to give access to the thoracic cavity.
| 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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For YelloPort Elite Port Access System 510(k) Summary - 510(k)190592
This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.
Submitter's Name:
Surgical Innovations Ltd.
Submitter's Address:
Clayton Wood House 6 Clayton Wood Bank Leeds LS16 6QZ United Kingdom
Telephone: +44(0)113 230 7597
Establishment Registration Number:
9680952
Contact Person:
Miss Shazia Chaudhry (BSc. M.Phil. MBA)
Clayton Wood House 6 Clayton Wood Bank Leeds LS16 6QZ United Kingdom
Telephone: +44(0)113 230 7597
E-Mail: shazia.chaudhry@surginno.co.uk
Date Prepared:
24 April 2019
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For YelloPort Elite Port Access System 510(k) Summary - 510(k)190592
The information below summarises the Device Classification Information regarding the YelloPort Elite Port Access System:
Primary Product Code:
| RegulationNumber | Device | Device Class | ProductCode | ClassificationPanel |
|---|---|---|---|---|
| 876.1500 | Laparoscope, General &Plastic Surgery | Class 2 | GCJ | General &Plastic Surgery |
Device Trade Name:
YelloPort Elite Port Access System
Device Common Name:
YelloPort Elite Port Access System
Intended/ Indications Use:
The YelloPort Elite port access system is indicated for use in laparoscopic procedures to give access to the abdominal cavity while maintaining pneumoperitoneum.
The YelloPort Elite port access system is also indicated for use in thoracoscopic procedures to give access to the thoracic cavity.
Summary of Substantial Equivalence:
The predicate devices which are used to claim equivalence of the YelloPort Elite Port Access System are detailed in the summary table below.
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For YelloPort Elite Port Access System 510(k) Summary – 510(k)190592
Summary of Comparison between Proposed Device and Predicate Device
| General Information | ||||
|---|---|---|---|---|
| Property | Proposed Device | Primary Predicate | Secondary Predicate | Secondary Predicate |
| YelloPort Elite PortAccess System | YelloPort Plus PortAccess System | YelloPort PortAccess System | ENDOPATH XCELBladeless TrocarUniversal Seal | |
| CommonName | Laparoscope,General & PlasticSurgery | Laparoscope,General & PlasticSurgery | Laparoscope,General & PlasticSurgery | Laparoscope, General& Plastic Surgery |
| DeviceManufacturer | Surgical Innovations | Surgical Innovations | Surgical Innovations | Ethicon Endo-Surgery,LLC |
| DeviceClassification | II | II | II | II |
| PrimaryProduct Code | GCJ | GCJ | GCJ | GCJ |
| 510(k)Number | N/A | K070712 | K070712 | K032676 |
| Environment | Hospital | Hospital | Hospital | Hospital |
| Intended Use/Indication forUse | The YelloPort ElitePort Access System isindicated for use inlaparoscopicprocedures to giveaccess to theabdominal cavity whilemaintainingpneumoperitoneum.The YelloPort ElitePort access system isalso indicated for usein thoracoscopicprocedures to giveaccess to the thoraciccavity. | The YelloPort PlusPort Access System isindicated for use inlaparoscopicprocedures to giveaccess to theabdominal cavitywhilst maintainingpneumoperitoneum.The YelloPort PlusPort Access System isalso indicated for usein laparoscopicprocedures to giveaccess to the thoraciccavity. | The YelloPort PortAccess System isindicated for use inlaparoscopicprocedures to giveaccess to theabdominal cavitywhilst maintaining thepneumoperitoneum.The YelloPort PortAccess System is alsoindicated for usein laparoscopicprocedures to giveaccess to the thoraciccavity. | The ENDOPATH XCELBladeless Trocar isintended for use inabdominal, thoracic andgynaecologic minimallyinvasive surgicalprocedures, to establisha path of entry forendoscopic instruments. |
| Trocar Types | BluntPencil point,PyramidalShielded (locking) | BluntPencil Point,PyramidalQuillShielded (locking andnon-locking). | BluntPencil Point,PyramidalShielded (locking andnon-locking). | N/A |
| Trocar /CannulaDiameter andLengths | Available in 10 and 12mm diameter; and in75, 105 and 150 mmworking lengths. | Available in 3, 5, 10,12 and 16 mmdiameter; and in 55,70, 75, 95, 105 and150 mm workinglengths. | Available in 3.5, 5.5,7.5, 10.5 and 12.5mmdiameter; and in 55,70, 95, 105 and 150mm working lengths. | N/A |
| Comparisonof Use: | Allows instrumentsfrom 5mm -12mm indiameter to be used. | Within the range,allows instrumentsfrom 5-12mm diameterto be used. | Within the range,allows instrumentsfrom 5-12mm diameterto be used. | Allows instruments from5mm-12mm in diameterto be used. |
| TrocarPatientContactingMaterial | Stainless Steel | Stainless Steel | Stainless Steel | N/A |
| TrocarSupplied: | Non-sterile(Reusable) | Non-sterile(Reusable) | Non-sterile(Reusable) | N/A |
| CannulaPatientContactingMaterials | PEEK plastic | PEEK plastic | PEEK plastic | N/A |
| CannulaSupplied: | Non-sterile(Reusable) | Non-sterile(Reusable) | Non- sterile(Reusable) | N/A |
| Seal | Consists of:Non-Return Valve &Instrument Seal | Consists of:Non-Return Valve &Instrument Seal | Consists of :Non-Return Valve &Instrument Seal | Consists of:Non-Return Valve &Instrument Seal |
| SealSupplied: | Sterile | Sterile | Sterile | Sterile |
| Hasson(Fascia)Adaptor | Available in both10mm and 12mmdiameter versions. | Available in both10mm and 12mmdiameter versions. | Available in both10mm and 12mmdiameter versions. | N/A |
| Hasson(Fascia)Adaptor | Fully reusable can besterilised inpressurised steam. | Fully reusable can besterilised inpressurised steam. | Fully reusable can besterilised inpressurised steam. | N/A |
| Hasson(FasciaAdaptor)ContactingMaterials | PEEK plastic | PEEK plastic | PEEK plastic | N/A |
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For YelloPort Elite Port Access System 510(k) Summary - 510(k)190592
Any technical differences have been justified, both scientifically and using performance testing. These do not affect the safety or effectiveness of the proposed device.
Device Description:
The YelloPort Elite Port Access System comprises a trocar, available with a range of tip styles, cannula. Universal Seal and Hasson (fascia) adaptor. The trocar, cannula and Hasson (fascia) adaptor elements of the device are fully reusable and can be sterilised in pressurised steam. The Universal seal is single use only.
In order to obtain access to the surgical site during laparoscopic surgery, the YelloPort Elite Trocar is introduced into the YelloPort Elite Cannula to accomplish cannula penetration of the abdominal wall. The cannula is connected to the YelloPort Elite Universal Seal at its proximal end and once the abdominal/thoracic wall is punctured, the trocar is removed. The cannula acts as a channel for the introduction of the endoscopes and instruments. Generically, trocars and cannulas are available in a range of lengths and diameters.
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For YelloPort Elite Port Access System 510(k) Summary - 510(k)190592
Technological Characteristics:
A comparative review of the YelloPort Elite Port Access System with the predicate devices found that the technology, mode of operation, and general principles for treatment with this device were substantially equivalent to the predicate devices.
Non-Clinical Tests (Performance/Physical Data):
The YelloPort Elite Port Access System was evaluated for its safety and effectiveness based on the following testing:
- Sealing Performance
- Instrument Insertion Force (Universal Seal)
- Seal Contamination Testing
- Instrument Compatibility Testing (Universal Seal)
- Port Insertion Force Testing
- . Insufflation Testing
- Seal Inversion Testing
- . Trocar Knob Pull Testing
- Stopcock Torque Lever Test
- Universal Seal Attachment and Removal Test
- Cannula Mechanical Testing
- Pressure Retention of Universal Seal (With Use of Locking Shielded Trocar) .
- Trocar Peritoneum Insertion Simulation Test (Locking Shielded)
- Torque Force Test (Locking Shielded)
- Tensile Test (Locking Shielded)
- . Biocompatibility Testing in accordance with ISO 10993-1
- . Shelf life and lifecycle studies
- . Transit studies
- . Cleaning and sterilisation validation
- Clinical (Design) validations which include a simulated surgical evaluation by a consultant surgeon
- . Usability assessments.
Clinical Studies
No clinical studies were conducted as part of submission to prove substantial equivalence. Non-Clinical Bench testing was sufficient to prove equivalence to the predicate device.
Safety and Effectiveness/Conclusion:
Based on the information presented in these 510(k) premarket notifications the YelloPort Elite Port Access System is considered substantially equivalent. The YelloPort Elite Port Access System is as safe and effective as the currently marketed predicate devices.
Based on testing and comparison with the predicate device. the YelloPort Elite Port Access System shows no adverse indications or results. It is our determination that the YelloPort Elite Port Access System is safe, effective and performs within its design specifications and is substantially equivalent to the predicate devices.
§ 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.