The device is indicated for use in fixation of prosthetic material to soft tissue in minimally invasive ventral and minimally invasive groin hernia repair procedures.

Device Description

The MaxTack™ Motorized Fixation Device is a single-use, sterile device that contains 30 absorbable tacks, preloaded into a standard shaft. The device is designed for introduction and use through a 5 mm or larger cannula. The device's tacks are constructed of an absorbable synthetic polyester copolymer derived from lactic and glycolic acid. The first 25 tacks are dyed with D&C Violet No. 2. The last 5 tacks are dyed with D&C Green No. 6. to serve as an indicator of low tack count to the user. The distal end of the shaft has a mesh manipulation/grip feature that may be used to facilitate positioning of the mesh.

The device is intended for use in a sterile operating room environment in surgical procedures where fixation of prosthetic material, such as mesh, to soft tissues is indicated. This device is designed, tested, and manufactured for single patient use only. Intended users are healthcare professionals who have been trained in applicable surgical procedures and approaches involving fixation devices prior to employing this device.

AI/ML Overview

The MaxTack™ Motorized Fixation Device is a medical device for fixing prosthetic material to soft tissue in minimally invasive hernia repair. The FDA's 510(k) summary provides details on non-clinical performance data to demonstrate substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary for the MaxTack™ Motorized Fixation Device does not explicitly list quantitative acceptance criteria with specific thresholds alongside reported device performance. Instead, it indicates that "applicable design verification and validation activities... showed conformance to applicable technical design specifications and performance" and that the design differences from the predicate device "were found to have no impact on safety or effectiveness."

The "Summary of Studies" section outlines various performance tests conducted. While specific quantitative results are not provided in this summary document, the implication is that the device met the internal specifications and standards set for these tests to demonstrate substantial equivalence.

To illustrate, based on the document, here's a conceptual table of what acceptance criteria might have been inferred, along with the reported high-level outcome:

Acceptance Criteria Category	Implicit Acceptance Criteria Description	Reported Device Performance (Summary)
Functional Reliability of Tack Deployment	Successful and consistent deployment of all 30 tacks without malfunction, jamming, or partial deployment, across various firing angles (including perpendicular and non-perpendicular).	"Reliability study performed to confirm the reliability of tack deployment..." (Outcome: Confirmed reliability, implying successful deployment).
Fixation Strength (Perpendicular & Non-Perpendicular)	Maintenance or increase of current fixation strength compared to the predicate device, for both perpendicular and non-perpendicular tack firings.	"...to maintain/increase current fixation strength at both perpendicular and non-perpendicular tack firings." (Outcome: Achieved, implying satisfactory strength).
Mesh Manipulation/Grip Feature Integrity	The mesh manipulation/grip feature at the distal end of the device functions as intended for facilitating mesh positioning without failure or compromise.	"...functional integrity of the mesh manipulation grip feature at the distal end of the device." (Outcome: Confirmed integrity, implying proper function).
Material Strength of Tacks (In-vivo & In-vitro)	Tacks maintain adequate strength (force at break) for a defined period (e.g., during healing) and exhibit expected strength loss over time. Correlation between in-vitro and in-vivo strength.	"MaxTack™ in-vivo material strength study: MEDSD-2106 GLP Strength Loss Study of a Hernia Fixation Tack in a Rat Model"; "MaxTack™ in-vitro material strength correlation study"; "MaxTack™ in-vitro Mass Loss Study" (Outcome: Studies imply satisfactory material strength and degradation profile).
Biocompatibility	All device components (including green tacks) meet ISO 10993 series and FDA guidance for patient contact, with no unacceptable biological response. Safety of D&C Green No. 6 demonstrated.	"Biocompatibility testing of the green tacks and delivery system conducted in accordance with the FDA's 2020 guidance and ISO 10993-1..." (Outcome: Conformed to standards).
Software Verification & Validation	Software functions correctly and safely, ensuring proper motor control, tack deployment, and warning indicators (e.g., low tack count). Compliance with IEC 62304.	"Software verification & validation activities completed following the FDA's guidance documents and IEC 62304." (Outcome: Completed, implying satisfactory performance).
Electrical Safety & EMC	Device meets electrical safety standards (IEC 60601-1) and electromagnetic compatibility requirements (IEC 60601-1-2).	"Electrical safety testing per IEC 60601-1 and electromagnetic compatibility (EMC) testing per IEC 60601-1-2." (Outcome: Met standards).
Usability	Device design changes (e.g., motorized mechanism) do not introduce new use errors or significantly increase risk, ensuring safe and effective operation by trained users. Compliance with IEC 62366-1.	"Usability study performed to fulfil the primary objectives supporting design change following the FDA's quidance as well as IEC 62366-1." (Outcome: Met usability objectives).
Sterility & Packaging Integrity	Device achieves and maintains a minimum Sterility Assurance Level (SAL) of 10-6 through its shelf life, and packaging protects product integrity during shipping and storage.	"Ethylene oxide (EO) sterilization for the single use devices with a minimum Sterility Assurance Level (SAL) of 10-6"; "protection of the product during shipping and storage was evaluated using packaging & product integrity testing." (Outcome: Achieved sterility and packaging integrity).

2. Sample Size and Data Provenance for Test Set

The document does not specify the exact sample sizes for each of the non-clinical tests (benchtop, ex-vivo, reliability, in-vivo, in-vitro studies, usability testing). It also does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. However:

Non-clinical (benchtop, ex-vivo, in-vitro) studies: These are typically conducted in a controlled laboratory setting (prospective by nature of setting up experiments). The document mentions a "Rat Model" for the in-vivo strength study, which is a controlled animal study.
Usability study: These are prospective studies involving human users in a simulated or actual use environment.
Reliability study: Typically prospective testing under defined conditions.

3. Number of Experts used to establish Ground Truth and Qualifications:

The document does not describe the use of human experts to establish ground truth for this device in the way it would for an AI/CADe device. The MaxTack™ Motorized Fixation Device is a mechanical fixation device, not an image analysis or diagnostic AI device. Therefore, the "ground truth" is established through physical, chemical, and mechanical performance testing, as well as biological response studies (e.g., biocompatibility) against established engineering specifications and regulatory standards, rather than expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set:

Not applicable, as this is primarily a hardware/mechanical device with software control, not an AI diagnostic system requiring adjudication of interpretations. Performance is measured against physical and engineering metrics, not expert interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for AI-powered diagnostic or assistive devices, where the performance of human readers with and without AI assistance is evaluated. The MaxTack™ Motorized Fixation Device is a surgical tool, not an AI diagnostic assistant.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a motorized surgical tool, not a standalone algorithm. Its "performance" is inherently tied to its mechanical and software functions as a complete system.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance is established through empirical data from various non-clinical tests, including:

Pre-defined Engineering Specifications: Performance metrics (e.g., force required for tack deployment, fixation strength, battery life, dimensional tolerances) are compared against predetermined design and functional requirements.
Biocompatibility Standards: Adherence to ISO 10993 series and FDA guidance for biological safety.
Usability Metrics: Compliance with IEC 62366-1 regarding safety and effectiveness of use.
Electrical Safety and EMC Standards: Adherence to IEC 60601-1 and IEC 60601-1-2.
Sterilization and Packaging Standards: Compliance with SAL of 10-6 and packaging integrity standards (ASTM D4169, EN ISO 11607-1).
Benchtop and In-Vitro Measurements: Direct measurements of physical properties and performance in controlled environments.
In-Vivo (Animal Model) Outcomes: Biological responses and material degradation in a living system (rat model).

8. Sample Size for the Training Set:

Not applicable. This device is a mechanical/software system, not a machine learning model that requires a "training set" in the context of AI. The software within the device controls the motor and tack deployment, and its "training" or development would involve traditional software engineering and validation, not machine learning model training.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no "training set" in the machine learning sense for this device. The software's truth is established by its design specifications and validated through software verification and validation activities (e.g., unit testing, integration testing, system testing, compliance with IEC 62304) to ensure it correctly executes the intended functions (e.g., motor control for tack deployment, low tack count indication).

Summary

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October 25, 2023

Covidien Megha Patel Senior Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473

Re: K231240

Trade/Device Name: MaxTack™ Motorized Fixation Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCW, GDW, GDW

Dear Megha Patel:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated 09/08/2023. Specifically, FDA is updating this SE Letter to correct the main product code to OCW and the regulation to 21 CFR 876.1500 - Endoscope and accessories to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Mark Trumbore, OHT4: Office of Surgical and Infection Control Devices, 301-796-5436, Mark.Trumbore@FDA.HHS.GOV.

Sincerely,

MarkTrumbore -S	Digitally signed byMark Trumbore -SDate: 2023.10.2511:28:30 -04'00'
---------------------	---------------------------------------------------------------------------------

Mark Trumbore, Ph.D. Assistant Director, THT4A1: Robotically-Assisted Surgical Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Covidien Megha Patel Senior Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473

Re: K231240

Trade/Device Name: MaxTack™ Motorized Fixation Device Regulation Number: 21 CFR 876.1500 Regulation Name: Staple, Implantable Regulatory Class: Class II Product Code: OCW, GDW, GDW Dated: August 10, 2023 Received: August 10, 2023

Dear Megha Patel:

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 and Part 809); 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,

Francisco Delgado -S 2023.09.08 16:45:11 -04'00'

for Mark Trumbore, Ph.D. Assistant Director, THT4A1: Robotically-Assisted Surgical Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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	DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2023
	Indications for Use	See PRA Statement below.
510(k) Number (if known)
Device Name	MaxTack™ Motorized Fixation Device
Indications for Use (Describe)	The device is indicated for use in fixation of prosthetic material to soft tissue in minimally invasive ventral and minimally invasive groin hernia repair 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 ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork 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."
FORM FDA 3881 (6/20)	Page 1 of 1	PSC Publishing Services (300) 443-6740	EP
CONFIDENTIAL	MaxTack™ Motorized Fixation DeviceTraditional 510(k)Covidien		April 2023Page 22

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510(k) Summary

DATE PREPARED:

April 28, 2023

SUBMITTER:

Covidien 60 Middletown Avenue North Haven, CT 06473 USA

CONTACT PERSON:

Megha Patel, MS-RA Sr. Requlatory Affairs Specialist Telephone: (917) 664-9611

IDENTIFICATION OF DEVICE:

Proprietary/Trade Name:	MaxTack™ Motorized Fixation Device
Classification Name:	Endoscopic Tissue Approximation
	Device; Staple, implantable
Regulations Number:	21 CFR 876.1500; 21 CFR 878.4750
Device Class:	Class II
Product Codes:	OCW; GDW
Review Panel:	Gastroenterology/Urology; General and Plastic Surgery
Common Name:	Surgical Stapler

PREDICATE DEVICE:

	Predicate
510(k) Number	K090470
Proprietary/Trade Name	AbsorbaTack™ Absorbable Fixation Device (ABSTACK30)
Classification Name	Endoscopic Tissue Approximation Device and Staple,Implantable
Regulation Number	21 CFR 876.1500; 21 CFR 878.4750
Device Class	Class II
Product Code	OCW; GDW
Review Panel	Gastroenterology/Urology; General and Plastic Surgery
Common Name	Surgical Stapler

DEVICE DESCRIPTION:

INDICATIONS FOR USE:

The device is indicated for use in fixation of prosthetic material to soft tissue in minimally invasive ventral and minimally invasive groin hernia repair procedures.

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SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:

MaxTack™ Motorized Fixation Device, as implied by the product name, is a motorized hernia fixation technology that can deploy up to 30 absorbable tacks. The advantages of the device, such as push-button operations and in-line handle, offer an ergonomic advantage, allowing for each tack to be deployed with equivalent force.

Following changes to the technological characteristics have been made compared to the predicate -K090470, AbsorbaTack™ Absorbable Fixation Device (ABSTACK30):

. The tacks are delivered through a drive shaft assembly rotated by a motor that is controlled via software through a printed circuit board assembly (PCBA), housed in the handle. The device is powered bytwo 9V alkaline batteries in parallel.
Change in tack design as compared to predicate, to maintain/increase current fixation strength atboth ● perpendicular and non-perpendicular tack firings. Also, the last five tacks that will be fired by the subject device are dyed with a different colorant (D&C Green No. 6) as an indicator of low tack count to the user.
. The distal end of the shaft of the subject device will have a mesh manipulation/grip feature that may be used to facilitate positioning of the mesh.

The design differences were found to have no impact on safety or effectiveness. This was established through applicable design verification and validation activities that showed conformance to applicable technical design specifications and performance.

SUBSTANTIAL EQUIVALENCE:

The below table summarizes the similarities and differences between the subject and predicate devices.

Feature	Subject Device (MAXTACK30)	Predicate Device (ABSTACK30 - K090470)
Indications for Use	The device is indicated for fixation of prosthetic material to soft tissue in minimally invasive ventral and minimally invasive groin hernia repair procedures.	The device is intended for fixation of prosthetic material to soft tissue in minimally invasive and open surgical hernia repair procedures.
Target Anatomy	Abdominal wall (ventral & groin)	Abdominal wall (ventral & groin)
Surgical Procedures	Minimally Invasive hernia repair	Minimally Invasive and Open surgical hernia repair
Classification	OCW, 21 CFR 876.1500GDW, 21 CFR 878.4750	OCW, 21 CFR 876.1500GDW, 21 CFR 878.4750
Operating Principle	Push-button motorized firing mechanism to deploy tacks	Manual power grip squeeze to deploy tacks
Description	Straight configuration: stand-alone preloaded shaft with 30 tacks	Straight configuration: stand-alone preloaded shaft with 30 tacks
Sterilization	Ethylene Oxide (EO)	Ethylene Oxide (EO)
Biocompatibility	Evaluated per ISO 10993 series and FDA 2016 biocompatibility guidance	Evaluated per ISO 10993 series and FDA 2016 biocompatibility guidance
Tack Shape	Screw-like, with modified features	Screw-like
Tack Material	PGLA (Poly Glycolic and Lactic Acid)	PGLA (Poly Glycolic and Lactic Acid)
Tack Color	Violet & Green (25 tacks & 5 tacks respectively)	Violet (30 tacks)
Tack Length	7.0 mm	5.1 mm
Shaft Length	14 inches	14 inches
Shaft	304L Stainless Steel with laser etched logo and mesh manipulation/grip feature at distal end and	304L Stainless steel with laser etched logo and no mesh manipulation/grip feature

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SUMMARY OF STUDIES:

Non-clinical performance data - The following studies have been performed to demonstrate substantial equivalence to the predicate device. When possible, applicable FDA-recognized standards were considered:

Stability/Shelf-Life study for the single use devices
Performance testing that includes: ●
- Benchtop and ex-vivo testing o
- Reliability study performed to confirm the reliability of tack deployment and the functional O integrity of the mesh manipulation grip feature at the distal end of the device
- MaxTack™ in-vivo material strength study: MEDSD-2106 GLP Strength Loss Study of a O Hernia Fixation Tack in a Rat Model
- MaxTack™ in-vitro material strength correlation study o
- MaxTack™ in-vitro Mass Loss Study o
Usability study performed to fulfil the primary objectives supporting design change following the ● FDA's quidance as well as IEC 62366-1
Biocompatibility testing of the green tacks and delivery system conducted in accordance with the ● FDA's 2020 guidance and ISO 10993-1 for their intended patient contact profile and historical data on the safety of the green dye (D&C Green No. 6) has been reviewed and presented.
Software verification & validation activities completed following the FDA's guidance documents . and IEC 62304
Electrical safety testing per IEC 60601-1 and electromagnetic compatibility (EMC) testing per IEC ● 60601-1-2
Cybersecurity Assessment following FDA's Guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" issued October 2, 2014.
Following ASTM D4169 and EN ISO 11607-1, the protection of the product during shipping and ● storage was evaluated using packaging & product integrity testing.
Ethylene oxide (EO) sterilization for the single use devices with a minimum Sterility ● Assurance Level (SAL) of 10-6

Previously demonstrated compliance for the following aspects remain unimpacted:

Biocompatibility evaluation of the violet tacks conducted for Predicate Device in accordance with ● the FDA's guidance and ISO 10993-1 for their intended patient contact profile.
MR safety testing was performed on the Predicate device - K090470 and no change has been made to impact MR characteristics.
Packaging stability of sterile barrier material was evaluated for representative material of sterile barrier, and requirements are met per EN ISO 11607-1:2020.

Clinical performance data - No clinical study is deemed necessary since the substantial equivalence has been sufficiently demonstrated through non-clinical studies.

CONCLUSION:

Based upon the supporting data summarized above, we concluded that the MaxTack™ Motorized Fixation Device, is as safe and effective as the legally marketed predicate device and does not raise any additional questions of safety and effectiveness than the predicate device.

Regulation Number and Section

§ 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.