(700 days)
The Mediclose™ System is a single-use indicated for approximation of tissues and percutaneous suturing of port-site fascia wounds following laparoscopic surgery.
The Mediclose™ System is an Automatic Trocar Closure (ATC) device supplied with one or more Mediclose™ Adaptors, supplied sterile for single use. The combination of the Mediclose™ Device and one Mediclose™ Adaptor results in a minimally invasive surgical system which aids surgeons in closing trocar wounds following a laparoscopic procedure. In laparoscopic surgery, trocars are used to gain access to the body in a minimally invasive way. This means that these procedures are performed through incisions of approximately 12 mm, compared to traditional open surgery which needs a large wound across the abdomen. The Mediclose™ Device is available in one size and configuration, designed for single-handed use, to which each of three Mediclose™ Adaptors can be fitted, at the user's option, depending on the make/model of trocar being used. The Mediclose™ System is intended to pass a suture through the soft-tissue laver (fascia) of a trocar wound after laparoscopic surgery. This is done with the end-goal of closing the trocar-induced wound by pulling needles through the fascia and subsequently closing the wound. The Mediclose™ System has two items: The Mediclose™ Device, which incorporates the suture and needle set; The Mediclose™ Adaptor, three color-coded models are available separately from the Mediclose™ . Device which are compatible with a specific brand/model of 12 mm trocar sleeves that are legally cleared for marketing in the USA, viz: Ethicon EndoPath Covidien VersaOne Applied Medical Kii The Mediclose™ Device also contains a needle-suture set manufactured by Assut Europe composed of two straight cylindrical needles attached to Glicofil Lac, a braided, coated, violet PGLA absorbable suture. The suture and needles are mounted into the device at the time of manufacture, making it ready to use upon opening the packaging.
The provided FDA 510(k) summary for the Mediclose™ System focuses on non-clinical testing for substantial equivalence, rather than a study proving performance against clinical acceptance criteria. The device is a suturing device, and the evaluation is primarily based on mechanical and biocompatibility tests.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents extensive non-clinical testing with acceptance criteria. No clinical performance acceptance criteria are mentioned as no clinical studies were submitted. The table below summarizes the non-clinical acceptance criteria and reported results.
| Test Purpose | Acceptance Criteria | Result |
|---|---|---|
| Sterilization Validation | Sterile after half ETO cycle | Pass |
| Shelf Life Validation: | ||
| a) Transportation test | Packaging is fully functional and undamaged | Pass |
| b) Sterile pack seal integrity | No dye penetration | Pass |
| c) Sterile pack seal strength | >1.5 N/15mm | Pass |
| d) Suture needle/thread strength | Average >14.7 N; Single result >4.41 N | Pass |
| e) Suture knot pull strength | Average >38.2 N | Pass |
| Biocompatibility: | ||
| a) Cytotoxicity | ≥70% of the control mean % viability | Pass |
| b) Sensitization | Positive response in <10% of tests animals | Pass |
| c) Intracutaneous Reactivity | [Test article mean] - [Control mean] ≥ 1.0 | Pass |
| d) Acute systemic toxicity | Absence of toxic reaction after 72 hours | Pass |
| e) Material mediated Rabbit pyrogen | Temperature rise >0.5 degC | Pass |
| f) LAL bacterial endotoxicity | <0.5 EU/ml | Pass |
| Mechanical tests: | ||
| a) Mediclose joint tensile tests | >15 N | Pass |
| b) Mediclose folding part to handle tensile | >30 N | Pass |
| c) Mediclose folding part to handle compression | >30 N | Pass |
| d) Needle retention force | >15 N <30 N | Pass |
| e) Mediclose assembly tensile | >30 N | Pass |
| f) Adaptor security tensile | >30 N | Pass |
| g) Operating button spring resistance | <23.3 N | Pass |
| h) Device passage through trocar sleeve | Unrestricted passage | Pass |
| Performance tests in porcine model with pneumoperitoneum | No functional failures | Pass |
| Performance tests in human fascia model | No functional failures | Pass |
2. Sample size used for the test set and the data provenance
The sample sizes for these non-clinical tests are listed in the table above under the "Standard" column. They range from 1 sample to 44 Mediclose units, 35 guinea pigs, 3 white rabbits, or 10 male mice depending on the specific test.
The data provenance is not explicitly stated in terms of country of origin but is from internal test protocols and generally accepted international standards (ISO, ASTM, USP, EP). The tests are all described as non-clinical testing, implying a prospective testing approach conducted with the manufactured devices and biological models.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. For these non-clinical tests, the "ground truth" is established by the specified standards (e.g., ISO, ASTM) and measured quantitatively, rather than by expert consensus. There are no human "readers" or human expert interpretations involved in determining the outcome of these mechanical or biological tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, the tests are objective, quantitative measurements against predefined criteria from established standards or internal protocols, not subjective interpretations requiring adjudication.
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. This device is a surgical tool, not an AI-assisted diagnostic or imaging device. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual surgical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests is based on:
- Quantitative measurements: Mechanical strength, physical dimensions, chemical properties, and biological reactions as defined by international standards (ISO, ASTM, USP, EP) and internal test protocols.
- Absence of functional failures: Observed during performance tests in porcine and human fascia models.
8. The sample size for the training set
Not applicable. This device is a physical medical device, not a machine learning algorithm, so there is no training set in the typical sense. The device's design is likely based on iterative engineering and testing rather than data-driven machine learning training.
9. How the ground truth for the training set was established
Not applicable, for the same reasons as point 8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
August 31, 2023
Health Value Creation BV, trading as Corporis Medical % Roger Gray VP Quality and Regulatory Donawa Lifescience Consluting Srl Piazza Albania 10 Rome. 00153 Italy
Re: K213271
Trade/Device Name: MedicloseTM System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCW, GCJ, HCF Dated: June 15, 2023 Received: June 16, 2023
Dear Roger Gray:
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 Federal
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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-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 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-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 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,
David Krause -S
David Krause, Ph.D. Deputy Director OHT4, Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health U.S. Food and Drug Administration
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Mediclose™ System
Indications for Use (Describe)
The Mediclose114 System is a single-use indicated for approximation of tissues and percutaneous suturing of port-site fascia wounds following laparoscopic surgery.
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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510(k) Summary
| 510(k) Reference: | K213271 |
|---|---|
| Device Name: | Mediclose™ System |
| Type of 510(k) submission: | Traditional |
| Date of submission: | 26 August 2023 |
| 510(k) Owner and Submitter: | Health Value Creation BV, trading as Corporis MedicaOxfordlaan 556229 EV MaastrichtThe Netherlands |
| Owner/Operator Reg. Number: | Not yet registered |
| 510(k) Application Correspondent: | Mr Roger GrayVP Quality and RegulatoryDonawa Lifescience ConsultingPiazza Albania 1000153 Rome, Italy |
| Phone:Email: | +39 06 578 2665rgray@donawa.com |
| FDA Product Code: | OCW, GCJ, HCF |
| FDA Regulation Number: | 21 CFR 876.1500 |
| FDA Classification Name: | Endoscopic Tissue Approximation Device |
| Classification Panel: | Gastroenterology and Urology |
| Common Name: | Endoscopic Tissue Approximation Device |
| FDA Classification: | Class II |
| Submission Type: | 510(k) |
Predicate Device:
The predicate device selected for comparison with the Mediclose™ is:
| Predicate Device: | WECK EFX Endo Fascial Closure System |
|---|---|
| Sponsor: | Teleflex Medical, Inc. |
| 510(k) Number: | K132362 |
| Clearance Date: | 8 October 2013 |
| FDA Product Code: | OCW, GCJ, HCF |
| Classification Name: | Endoscopic tissue approximation device |
| Regulation No: | 21 CFR 876.1500 |
| Class: | II |
Device Description:
The Mediclose™ System is an Automatic Trocar Closure (ATC) device supplied with one or more Mediclose™ Adaptors, supplied sterile for single use. The combination of the Mediclose™ Device and one Mediclose™ Adaptor results in a minimally invasive surgical system which aids surgeons in closing trocar wounds following a laparoscopic procedure. In laparoscopic surgery, trocars are used to gain access to the body in a minimally invasive way. This means that these procedures are performed through incisions of approximately 12 mm, compared to traditional open surgery which needs a large wound across the abdomen. The Mediclose™ Device is available in one size and configuration, designed for single-handed use, to which each of three Mediclose™ Adaptors can be fitted, at the user's option, depending on the make/model of trocar being used.
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The Mediclose™ System is intended to pass a suture through the soft-tissue laver (fascia) of a trocar wound after laparoscopic surgery. This is done with the end-goal of closing the trocar-induced wound by pulling needles through the fascia and subsequently closing the wound.
The Mediclose™ System has two items:
- The Mediclose™ Device, which incorporates the suture and needle set; .
- The Mediclose™ Adaptor, three color-coded models are available separately from the Mediclose™ . Device which are compatible with a specific brand/model of 12 mm trocar sleeves that are legally cleared for marketing in the USA, viz:
- o Ethicon EndoPath
- Covidien VersaOne o
- Applied Medical Kii o
The Mediclose™ Device also contains a needle-suture set manufactured by Assut Europe composed of two straight cylindrical needles attached to Glicofil Lac, a braided, coated, violet PGLA absorbable suture. The suture and needles are mounted into the device at the time of manufacture, making it ready to use upon opening the packaging.
Indications for Use:
The Mediclose™ System is a single-use suturing device indicated for approximation of tissues and percutaneous suturing of port-site fascia wounds following laparoscopic surgery.
Comparison of Technological Characteristics Between the Subject Device and Predicate Device:
The following table provides a comparison of the technological characteristics of the subject device and selected predicate device.
| Comparison of Technological Characteristics | |||||
|---|---|---|---|---|---|
| Characteristic | Subject device | Predicate device | Similarity | ||
| Device name | Mediclose™ System | WECK EFX | N/A | ||
| 510(k) Sponsor | Health Value Creation BV, trading asCorporis Medical, Netherlands | Teleflex Medical, Inc., USA | N/A | ||
| 510(k) Reference | K213271 | K132362 | N/A | ||
| Clearance Date | This submission | 8 October 2016 | N/A | ||
| FDA ProductCode | OCW, GCJ, HCF | OCW, GCJ, HCF | Same | ||
| FDAClassificationName | Endoscopic tissue approximationdevice | Endoscopic tissue approximationdevice | Same | ||
| FDA RequlationNumber | 21 CFR 876.1500 | 21 CFR 876.1500 | Same | ||
| Devicedescription | A minimally invasive surgical device,which aids surgeons in closing trocarwounds following a laparoscopicprocedure. | Designed to facilitate placement andwithdrawal of suture loops to performrepair port entry punctures. | Same | ||
| Indications foruse | The Mediclose™ System is a single-use suturing device indicated forapproximation of tissues andpercutaneous suturing of port-sitefascia wounds following laparoscopicsurgery. | The WECK EFX Endo Fascial ClosureSystem has application in laparoscopicprocedures for approximation of tissuesand percutaneous suturing for closingincision sites. | Equivalent | ||
| Use environment | Operating room, sterile field | Operating room, sterile field | Same | ||
| Patientpopulation | Patients undergoing abdominallaparoscopic surgery | Patients undergoing abdominallaparoscopic surgery | Same | ||
| Sterile? | Yes, by ethylene oxide, SAL 10-6 | Yes, by radiation, SAL 10-6 | Different | ||
| Sterility Standard | ISO 11135: 2014/AMD 1:2018 | Unknown | N/A | ||
| Single use? | Yes | Yes | Same | ||
| Shelf Life | 12 months | Unknown | N/A |
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| Comparison of Technological Characteristics | |||
|---|---|---|---|
| Characteristic | Subject device | Predicate device | Similarity |
| Mechanism ofAction | Manual manipulation and energy fromspring release | Manual manipulation | Similar |
| Deployed throughTrocar Sleeve? | Yes | No, deployed through incision afterremoval of trocar sleeve | Different |
| Compatible withdifferent TrocarSleeves? | Yes, by means of mechanical adaptors | Unnecessary - device not deployedthrough trocar sleeve | Different |
| CompatibleWound Size | Wounds made by 12 mm trocars andmaintained by 12 mm trocar sleeves | Wounds made by 10/12 or 15 mmtrocars (2 x models available with 'pilotguides') | Different |
| Integral Needles? | Yes | Yes | Same |
| Suture Type/Size | PGLA Size 0 Braided Suture | PGLA Size 0 Braided Suture | Same |
| Suture pre-loaded? | Yes | No, suture must be loaded prior to use | Different |
| Separate suturepasser? | No - needles and suture are integral tothe device | Yes | Different |
| Prescriptiondevice? | Yes, Rx only | Yes, Rx only | Same |
| BiocompatibilityStandards | ISO 10993-5:2009ISO 10993-10:2010ISO 10993-11:2017 | Unknown | N/A |
| BacterialEndotoxin Test | LAL testEP 2018: 20614 | Unknown | N/A |
| Bench Tests | Mechanical test of critical itemsAssembly tensile integrity testsAdaptor tensile integrity testsSuture tensile strengthSuture knot pull strengthNeedle retention forceOperating button spring resistancePassage through trocar tubesTransportation test | Mechanical function testSuture retention testDestructive testing | Similar |
| Animal Tests | Porcine cadaver testsIn vivo porcine tests | Unknown | N/A |
| Other Pre-clinicalTests | Human tissue fascia tests | Unknown | N/A |
| UsabilityAssessment | Yes | Unknown | N/A |
The subject device and the predicate device have many identical or similar properties or features. The differences that exist and are identified in the above table include:
- Sterilization method .
- . Use with/without trocar sleeve
- . Compatibility with trocar systems
- Suture loading
- . Suture passer
None of the identified differences introduce new aspects of safety or effectiveness.
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Summary of non-clinical testing:
Non-clinical testing of the Mediclose™ System includes:
| Test Purpose | Standard | Acceptance criteria | Result | |
|---|---|---|---|---|
| Sterilization validation | ISO 11135:2020 1 | 5 samples | Sterile after half ETO cycle | Pass |
| Shelf life validation: | ISO 11607-2:2006 2See a) to e) below | |||
| a) Transportation test | ISTA 3A:2018 3 | 1 x sample | Packaging is fully functional andundamaged | Pass |
| b) Sterile pack sealintegrity | ASTM F1929-15 4 | 3 samples after ISTA3A test | No dye penetration | Pass |
| c) Sterile pack sealstrength | EN 868-5:2019 5 | 24 samples after ISTA3A test | >1.5 N/15mm | Pass |
| d) Sutureneedle/threadstrength | USP <881> 6 | 5 samples after ISTA3A test | Average >14.7 NSingle result >4.41 N | Pass |
| e) Suture knot pullstrength | USP <881> | 10 samples after ISTA3A test | Average >38.2 N | Pass |
| Biocompatibility: | See a) to f) below: | |||
| a) Cytotoxicity | ISO 10993-5:2009 7 | Optical density | ≥70% of the control mean %viability | Pass |
| b) Sensitization | ISO 10993-10:2010 8 | Kligman maximization35 guinea pigs | Positive response in <10% oftests animals | Pass |
| c) IntracutaneousReactivity | ISO 10993-10:2010 | 3 white rabbits | [Test article mean] - [Controlmean] ≥ 1.0 | Pass |
| d) Acute systemictoxicity | ISO 10993-11:2017 9 | 10 male mice | Absence of toxic reaction after72 hours | Pass |
| e) Material mediatedRabbit pyrogen | ISO 10993-11:2017 | 4 white rabbits | Temperature rise >0.5 degC | Pass |
| f) LAL bacterialendotoxicity | EP 01/2018:20614 10 | 3 samples | <0.5 EU/ml | Pass |
| Mechanical tests: | See a) to h) below | |||
| a) Mediclose jointtensile tests | Internal test protocol | 3 samples each, upperand lower joint | >15 N | Pass |
| b) Mediclose foldingpart to handle tensile | Internal test protocol | 2 samples | >30 N | Pass |
| c) Mediclose foldingpart to handlecompression | Internal test protocol | 3 samples | >30 N | Pass |
| d) Needle retentionforce | Internal test protocol | 5 samples average | >15 N <30 N | Pass |
| e) Medicloseassembly tensile | Internal test protocol | 3 samples | >30 N | Pass |
| f) Adaptor securitytensile | Internal test protocol | 3 samples per adaptortype | >30 N | Pass |
| g) Operating buttonspring resistance | Internal test protocol | 3 samples | <23.3 N | Pass |
| h) Device passagethrough trocar sleeve | Internal test protocol | 3 samples per adaptortype | Unrestricted passage | Pass |
| Performance tests inporcine model withpneumoperitoneum | Internal test protocol | 44 Mediclose units | No functional failures | Pass |
| Performance tests inhuman fascia model | Internal test protocol | 20 Mediclose units | No functional failures | Pass |
Summary of clinical information
No clinical testing was submitted, referenced, or relied on for the subject device.
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Conclusion:
The subject and predicate devices have very similar intended uses and fundamental technological characteristics. Any differences in technological characteristics between subject and predicate devices do not raise different questions of safety and effectiveness. The conclusions drawn from the non-clinical testing demonstrate that the subject device is as safe, as effective, and performs as well or better than the legally marketed predicate device K132362.
10 Bacterial endotoxins
¹ Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
2 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes 3 Packaged products for parcel delivery system shipment 70 kq or less
4 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
5 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
6 Tensile strength
7 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
8 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
9 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
§ 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.