(270 days)
Sclerotherapy & Endoscopic Needles are endoscopic accessories intended to introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system or to inject liquid to aid in polypectomy procedures.
Sclerotherapy & Endoscopic Needles are endoscopic accessories intended to introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system or to inject liquid to aid in polypectomy procedures.
Sclerotherapy & Endoscopic Needles (see schematic representation in Figure 1) are made of a flexible catheter with an inner tube connected to the needle at the distal end and a handle with a piston and a luer-lock connection at the proximal end.
All devices of this family group are packed in a medical grade paper pouch and sterilized by ETO. The sterile devices are distributed in carton boxes along with an Instruction for Use.
There are 4 variations of the Sclerotherapy & Endoscopic Needles with different catheter lengths and diameters and different needle lengths and diameters (see Table 1).
The device is used through an endoscope to inject different types of sclerosing agents, vasoconstrictors, or other solutions into selected sites of the digestive system to control actual or potential bleeding. It can be also used to inject liquid into the mucosa to aid in polypectomy procedures.
These procedures can last from 15 minutes. Furthermore, this device comes in contact with the digestive system mucosa.
There are no accessories for this kind of devices.
This document describes the G-Flex Europe SPRL's Sclerotherapy & Endoscopic Needles, which are endoscopic accessories intended to introduce sclerosing agents or other solutions into the digestive system. The 510(k) submission, K222006, establishes substantial equivalence to the Boston Scientific Interject Injection Therapy Needle Catheter (K171454).
Here's an analysis of the acceptance criteria and supporting studies based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical targets for clinical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. The "acceptance criteria" are implied to be that the device performs comparably to the predicate and meets design specifications and relevant standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional / Mechanical Performance: Device meets design specifications for dimensions, mechanical integrity, controllability, permeability, and smoothness. | Bench testing (dimensions verification, visual inspection, mechanical evaluation, controllability, permeability, and smoothness) demonstrated that the device meets the design specifications. |
| Biocompatibility: Device is safe for intended contact with human tissue. | Biocompatibility tests were conducted in accordance with the ISO 10993 series. Test results confirmed the device is biocompatible for the stated intended use. |
| Sterility: Device reliably achieves a specified sterility assurance level (SAL). | Validation of ethylene oxide sterilization was conducted following the half-cycle method I, in accordance with ISO 11135-1:2014 and ISO 11138-2:2009, to meet a minimum SAL of 10^-6. |
| Shelf-life: Device maintains its performance and safety over its declared shelf-life. | 3-year accelerated and 2-year real-time aging validations were performed. These demonstrated that dimensions, mechanical resistance, controllability, permeability, thoroughness, bio-property, and sterility were not affected during the stated shelf-life. A 3-year real-time aging validation is ongoing. Packaging and shelf-life studies conform to ISO 11607-1:2019, ASTM F1980-16, and ASTM D4169-16. |
| Equivalence to Predicate Device: Device has similar technological characteristics and intended use to the predicate. | A detailed comparison table (Section 6) highlights similarities in regulatory information, clinical condition, intended use/indications for use, contraindications, site of use, duration of contact, patient population, design, conditions of use, environment of use, materials, and sterilization methods. Minor differences in dimensions and wording of indications/contraindications were assessed as not impacting clinical application. |
2. Sample sized used for the test set and the data provenance
The document explicitly states: "No clinical testing was performed to support the medical device as the indications for use are equivalent to the predicate device." Therefore, there is no clinical "test set" in the context of human data. The performance evaluations were based on non-clinical bench testing, biocompatibility testing, sterility validation, and shelf-life studies. The "sample sizes" for these non-clinical tests are not detailed in the summary, nor is the "data provenance" (country of origin), as it pertains to laboratory and manufacturing data rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Given that no clinical testing was performed and no "test set" of patient data was used, this information is not applicable.
4. Adjudication method for the test set
Not applicable, as no clinical test set was used.
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. The device is a physical endoscopic accessory, not an AI-assisted diagnostic or treatment system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical endoscopic accessory, not an algorithm.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" was established by:
- Design Specifications: For bench testing, comparing physical and mechanical characteristics to engineering and design requirements.
- International Standards: For biocompatibility (ISO 10993 series), sterility (ISO 11135-1:2014, ISO 11138-2:2009), packaging (ISO 11607-1:2019), and aging (ASTM F1980-16, ASTM D4169-16). Compliance with these standards serves as the ground truth for safety and performance in their respective domains.
- Predicate Device Characteristics: For the substantial equivalence comparison, the characteristics and established safety/effectiveness of the predicate device (Boston Scientific Interject Injection Therapy Needle Catheter, K171454) served as the "ground truth" baseline.
8. The sample size for the training set
Not applicable, as this device does not involve machine learning or AI models with a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services 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 3, 2023
G-Flex Europe SPRL Thierry Cremer OA & RA Manager 20, Rue de l'industrie Nivelles, Brabant Wallon 1400 BELGIUM
Re: K222006
Trade/Device Name: Sclerotherapy & Endoscopic Needles Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FBK Dated: February 22, 2023 Received: February 27, 2023
Dear Thierry Cremer:
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.
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
{1}------------------------------------------------
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/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,
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K222006
Device Name Sclerotherapy & Endoscopic Needles
Indications for Use (Describe)
Sclerotherapy & Endoscopic Needles are endoscopic accessories intended to introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system or to inject liquid to aid in polypectomy procedures.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
K222006 Page 1 of 5
Image /page/3/Picture/1 description: The image shows the logo for G-Flex. The logo is in blue and features a stylized letter "G" connected to the word "Flex". To the right of the word "Flex" are horizontal lines that give the impression of speed or movement.
Premarket Notification: Traditional 510(k) SCLEROTHERAPY & ENDOSCOPIC NEEDLES
510 (K) SUMMARY
Version: 3
Date: 10-AUG-2022
510(K) SUMMARY
1. SUBMITTER
| Submitter Name: | G-Flex Europe SPRL |
|---|---|
| Submitter Address: | 20, Rue de l'industrie1400 NivellesBelgium |
| Phone Number: | +32 67 88 36 65 |
| Fax Number: | +32 67 88 36 88 |
| Contact Person: | Thierry CREMER, QA & RA Manager |
| Email: | thierry@g-flex.com |
| Date Prepared: | March 10, 2022 |
2. DEVICE
| Device Trade Name: | Sclerotherapy & Endoscopic Needles |
|---|---|
| Common Name: | Endoscopic accessory |
| Classification Name: | Endoscope and Accessories |
| Requlation Number: | 876.1500 |
| Product Code: | FBK |
| Class: | 2 |
| Classification Panel: | Gastroenterology/Urology |
PREDICATE DEVICE 3.
Primary Predicate Device: Boston Scientific, Interject Injection Therapy Needle Catheter (K171454).
4. DEVICE DESCRIPTION
Sclerotherapy & Endoscopic Needles are endoscopic accessories intended to introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system or to inject liquid to aid in polypectomy procedures.
Sclerotherapy & Endoscopic Needles (see schematic representation in Figure 1) are made of a flexible catheter with an inner tube connected to the needle at the distal end and a handle with a piston and a luer-lock connection at the proximal end.
Image /page/3/Figure/16 description: The image shows a diagram of a tool with several labeled parts. Part 1 is on the right side of the tool, and part 7 is on the left side. The tool is labeled with measurements of 2300mm, 2.3mm, and 5mm.
Fiqure 1 - Schematic representation of Sclerotherapy & Endoscopic Needles. (1 Back handle, 2 Front handle, 3 Protective sleeve, 4 Outer tube, 6 Guiding head, 7 Needle.)
All devices of this family group are packed in a medical grade paper pouch and sterilized by ETO. The sterile devices are distributed in carton boxes along with an Instruction for Use.
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for G-Flex. The logo is in blue and features a stylized letter "G" followed by the word "Flex". To the right of the word "Flex" is a graphic that resembles a bullet or a fast-moving object, with lines suggesting speed or motion.
Premarket Notification: Traditional 510(k) SCLEROTHERAPY & ENDOSCOPIC NEEDLES 510 (K) SUMMARY
Version: 3
There are 4 variations of the Sclerotherapy & Endoscopic Needles with different catheter lengths and diameters and different needle lengths and diameters (see Table 1).
| Reference | Catheter dimensions | Needle dimensions | ||
|---|---|---|---|---|
| Length (cm) | Diameter (mm) | Length (mm) | Diameter (mm) | |
| GF252202 | 180 | 2.3 | 5 | 0.7 (22 GA) |
| GF252203 | 230 | 2.3 | 5 | 0.7 (22GA) |
| GF262302 | 180 | 2.3 | 5 | 1.0 (19 GA) |
| GF252203-25 | 230 | 2.3 | 5 | 0.5 (25 GA) |
Table 1 - Different models of Sclerotherapy & Endoscopic Needles.
The device is used through an endoscope to inject different types of sclerosing agents, vasoconstrictors, or other solutions into selected sites of the digestive system to control actual or potential bleeding. It can be also used to inject liquid into the mucosa to aid in polypectomy procedures.
These procedures can last from 15 minutes. Furthermore, this device comes in contact with the digestive system mucosa.
There are no accessories for this kind of devices.
5. INDICATIONS FOR USE
Sclerotherapy & Endoscopic Needles are endoscopic accessories intended to introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system or to inject liquid to aid in polypectomy procedures.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE
The comparison chart below provides evidence to facilitate the substantial equivalence determination between the Sclerotherapy & Endoscopic Needles to the predicate device (K171454) with respect to intended use, technological characteristics and principles of operation.
| Feature | Proposed Device | Primary Predicate Device | Assessment ofEquivalence |
|---|---|---|---|
| Device name | Sclerotherapy & EndoscopicNeedles | Interject Injection TherapyNeedle Catheter | NA |
| 510(k) Number | K222006 | K171454 | NA |
| Manufacturer | G-Flex SPRL | Boston Scientific | NA |
| RegulationNumber | 876.1500 | 876.1500 | Fully similar |
| DeviceClassificationName | Endoscopic Injection Needle,Gastroenterology-Urology | Endoscopic Injection Needle,Gastroenterology-Urology | Fully similar |
| Product Code | FBK | FBK | Fully similar |
| ClinicalCondition | Treatment of varices in thehuman digestive tract. | Treatment of varices in thehuman digestive tract. | Fully similar |
| Intended Use/Indications foruse | Sclerotherapy & EndoscopicNeedles are endoscopicaccessories intended tointroduce a sclerosing agent,vasoconstrictor, or othersolutions into selected sites tocontrol actual or potential | The Interject Injection TherapyNeedle Catheter is used forendoscopic injection intogastrointestinal mucosa andsubmucosa to:• Introduce a sclerosing agent,vasoconstrictor, or other | Similar |
| Feature | Proposed Device | Primary Predicate Device | Assessment ofEquivalence |
| bleeding lesions in thedigestive system or to injectliquid to aid in polypectomyprocedures. | solutions into selected sites tocontrol actual or potentialbleeding lesions in thedigestive system• Aid in Endoscopic MucosalResection (EMR), EndoscopicSubmucosal Dissection(ESD), or polypectomyprocedures• Control non-varicealhemorrhage | ||
| Contra-indications | Patients with lesionsinappropriate for injectiontherapy. | Contraindications for thisdevice are those applicable toinjection therapy and include,but may not be limited to,those patients allergic tosclerosing or vasoconstrictionagents and patients withlesions inappropriate forinjection therapy withsclerosing or vasoconstrictionagents. | Similar |
| Site of use | Gastrointestinal tract | Gastrointestinal tract | Fully similar |
| Duration ofcontact | Less than 60 minutes | Less than 60 minutes | Fully similar |
| Intendedpatientpopulation | Patients who have (potential)bleeding lesions in thedigestive system. | Patients who have (potential)bleeding lesions in thedigestive system. | Fully similar |
| Design | Needle + Catheter + Handle | Needle + Catheter + Handle | Fully similar |
| Conditions ofuse | Single Use | Single Use | Fully similar |
| Environmentof use | Hospitals or clinics | Hospitals or clinics | Fully similar |
| Catheterlength (cm) | 180230 | 200240 | Similar |
| Sheath outerdiameter (mm) | 2.3 | 1.82.3 | Similar |
| Needle length(mm) | 5 | 46 | Similar |
| Needlediameter (mm) | 0.5 (25 GA)0.7 (22GA)1.0 (19 GA) | 0.510.64 | Similar |
| Needlematerial | Stainless steel | Stainless steel | Fully similar |
| Sterilization | Ethylene oxideISO 11135 | Ethylene oxideISO 11135 | Fully similar |
| Biologicalevaluation | ISO 10993-1ISO 10993-7 | ISO 10993-1ISO 10993-7 | Fully similar |
{5}------------------------------------------------
K222006 Page 3 of 5
Image /page/5/Picture/1 description: The image shows the logo for G-Flex. The logo is in blue and features a stylized "G" followed by "-Flex". To the right of the word "Flex" is a symbol that resembles an arrow with lines trailing behind it, suggesting speed or flexibility. The logo has a modern and dynamic appearance.
Premarket Notification: Traditional 510(k) SCLEROTHERAPY & ENDOSCOPIC NEEDLES 510 (K) SUMMARY
Version: 3
Date: 10-AUG-2022
Equivalence:
{6}------------------------------------------------
K222006 Page 4 of 5
Image /page/6/Picture/1 description: The image shows the logo for G-Flex. The logo is in blue and features a stylized letter "G" followed by "-Flex". To the right of "Flex" are three horizontal lines that are stacked on top of each other and decrease in length from top to bottom. The lines are meant to represent speed.
Version: 3
The Sclerotherapy & Endoscopic Needles are comparable to the predicate device with similar technological characteristics and intended use, specifically to perform electrosurgical procedures through an endoscope. The Sclerotherapy & Endoscopic Needles thus meet the requirements for 510(k) substantial equivalence.
Differences that are demonstrated to be substantially equivalent:
As indicated in the table above, several differences were identified between the Sclerotherapy & Endoscopic Needles and the primary predicate, namely the general wording of the indications for use and of the contraindications and the dimensions of the devices. While the wording of the indications for use and of the contraindications differs slightly between the proposed and predicate devices, this does not reflect any difference in the intended use and clinical application of the Sclerotherapy & Endoscopic Needles which are strictly identical to the predicate. The differences in dimensions are minor and, once again, do not impact the clinical application of the proposed device compared to the predicate.
Performance testing was conducted to demonstrate substantial equivalence of the Sclerotherapy & Endoscopic Needles to the predicate device. The test results are summarized below.
7. NON-CLINICAL PERFORMANCE DATA
- Bench testing The Sclerotherapy & Endoscopic Needles were subjected to bench tests including dimensions verification, visual inspection, mechanical evaluation, controllability, permeability and smoothness. Results demonstrate that the device meets the design specifications
- Biocompatibility The Sclerotherapy & Endoscopic Needles were the subject of a range of biocompatibility tests in accordance with ISO 10993 series. Test results confirmed that the device is biocompatible for the stated intended use.
- Sterility The Sclerotherapy & Endoscopic Needles are provided sterile and are sterilized by ethylene oxide to meet a minimum sterility assurance level (SAL) of 10-6. Validation of the sterilization dose was conducted following the halfcycle method I, in accordance with ISO 11135-1:2014 and ISO 11138-2:2009.
- Shelf-life 3-year accelerated and 2-year real time ageing validations were performed to demonstrate that the dimensions, mechanical resistance, controllability, permeability, thoroughness, bio-property and sterility were not affected during the stated shelf-life of the device. A 3-year real time ageing validation is onqoing.
{7}------------------------------------------------
Image /page/7/Picture/1 description: The image shows the logo for G-Flex. The logo is in blue and features a stylized letter "G" connected to the word "Flex". To the right of the word "Flex" are three horizontal lines that are stacked on top of each other, which gives the impression of speed.
Version: 3
Validation studies for sterilization, packaging and shelf-life conform to the following standard:
| Standard reference | Standard title |
|---|---|
| ISO 11607-1:2019 | Packaging for terminally sterilized medical devices - Part 1:Requirements for materials, sterile barrier systems andpackaging systems |
| ISO 11135-1:2014 | Sterilization of healthcare products - Ethylene oxide - Part 1: Requirements fordevelopment, validation and routine control of a sterilizationprocess for medical devices |
| ASTM F1980-16 | Standard Guide for Accelerated Aging of Sterile BarrierSystems for Medical Devices |
| ASTM D4169-16 | Standard Practice for Performance Testing of ShippingContainers and Systems |
CLINICAL PERFORMANCE DATA 8.
No clinical testing was performed to support the medical device as the indications for use are equivalent to the predicate device. Additionally, endoscopic accessories such as the proposed and predicate devices have been on the market for many years and their use has been safe and effective.
9. CONCLUSION
The information discussed above and provided in this 510(k) submission demonstrates that the Sclerotherapy & Endoscopic Needles devices are substantially equivalent to the predicate device and that they are as safe and effective for the patients.
§ 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.