The MD™ MATTRESS Device is a nonpowered, hand-operated suture placement device that facilitates placement of a stitch, for example horizontal mattress stitches. Each sterile package contains one single-patient-use MD™ MATTRESS Device. The lavender device tip has an integrated tissue jaw incorporating a jaw width indicator that identifies the jaw when it is embedded in tissue. Two curved needles emerge from their protective compartments to advance across the tissue jaw, rotating about the circular needle axle indicator to engage needle caps with attached suture that are loaded into specialized needle cap compartments. An angulation indicator on the tip and the device shaft depicts the direction of the device tip angle, which is adjusted using the white angulation knob. The embossed arrow and word "IN" indicate the direction the device tip moves when the angulation knob is rotated clockwise; the device tip can be angled up to approximately 15° in either direction, as indicated by the 3 embossed radial lines in the angulation indicator The lavender rotational knob can be rotated to orient the device shaft and tip into one of six distinct positions. The rotational knob has an integrated eyelet, for stabilizing a suture tube with indwelling suture, and an indicator fin that is aligned with the device tip tissue jaw. Fully squeezing the lavender lever toward the white handle causes both curved needles in the device tip to advance across the tissue jaw toward the needle cap compartments. Fully releasing the lever causes both needles and their engaged needle caps with attached suture to retract back across the tissue gap, pulling both suture ends through the targeted tissue within the jaw. Fully squeezing the lever again causes the needles and engaged needle caps with attached suture to advance back into their corresponding needle cap compartments, and an internal mechanism alternates the device into its rearming mode. Fully releasing the lever again causes the needles to retract into their protective compartments, leaving the needle caps and attached suture ends in the needle cap compartments. Subsequently squeezing and releasing the lever will repeat the pickup and rearm cycle.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the MD™ MATTRESS Suture Placement Device.

Important Note: The provided document is a 510(k) Premarket Notification from the FDA. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving independent effectiveness from scratch. Therefore, the "study" described here is primarily a comparison and verification against the predicate device and established standards, not a de novo clinical trial to establish efficacy in humans.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" against specific numerical performance targets for the device's clinical operation (e.g., suture strength, success rate in tissue approximation). Instead, its acceptance criteria are primarily focused on:

Meeting Design Input Requirements: All aspects of the device design and functionality must perform as intended.
Equivalence to Predicate Device: The MD™ MATTRESS Device should perform comparably to the RD180® - THE RUNNING DEVICE®.
Safety and Biocompatibility: The device should not introduce new risks and must be safe for patient contact.
Sterility and Packaging Integrity: The device must maintain sterility and be appropriately packaged for its shelf life.

The reported device performance is largely qualitative and comparative, focusing on meeting these overarching criteria through various non-clinical tests.

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Functional Performance	Device must perform as intended (e.g., facilitate placement of a stitch, advance/retract needles, pick up suture, rearm).	"Functional Design Verification and Validation Testing to ensure the Design Input Requirements were met." (Result: Met)
Substantial Equivalence	Must demonstrate comparable intended use, indications for use, technological characteristics, target population, environment of use, and sterility/materials/packaging to the predicate device, without introducing new risks or negatively impacting safety/efficacy.	"Non-clinical performance data has demonstrated the subject device is substantially equivalent to the predicate device." "The MD™ MATTRESS Device and the predicate RD180® Device are substantially equivalent. The subject and predicate devices are comparable, and the differences do not introduce any new risks, and have no negative impact on the safety and efficacy of the MD™ MATTRESS Device."
Biocompatibility	Must conform to ISO 10993-1:2018 standards for externally communicating medical devices with limited contact (≤24 hours). Specific tests include chemical characterization, cytotoxicity, sensitization, irritation, material-mediated pyrogenicity, and acute systemic toxicity.	"Biocompatibility per ISO 10993-1:2018... The battery of testing included: Chemical characterization, Cytotoxicity, Sensitization, Irritation, Material-mediated pyrogenicity, Acute systemic toxicity." (Results met acceptance criteria)
Sterility	Must be sterilized with ethylene oxide to achieve a minimum lethality of 10⁻⁶.	"To be sterilized with ethylene oxide such that a minimum lethality of 10⁻⁶ is achieved." (Implicitly met through process, not a test result reported here for this specific device, but a manufacturing requirement.)
Packaging/Shelf-life	Must conform to ISO 11607-1:2019 and demonstrate a 2-year shelf life, ensuring packaging integrity and sterility maintenance.	"Packaging/Shelf-life Testing per ISO 11607-1:2019 demonstrating a 2 year shelf life." (Result: Met)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample sizes (number of devices or tests performed) for the "Functional Design Verification and Validation Testing," "Biocompatibility" tests, or "Packaging/Shelf-life Testing." The nature of these tests (e.g., material testing, functional checks) typically involves specific batch sizes or replicates determined by testing protocols, but these numbers are not disclosed in the summary.
Data Provenance: The tests are explicitly stated as "Bench top performance testing" and "non-clinical tests." This indicates the data is from laboratory (in-vitro) or simulated environments, not from human subjects. The country of origin for the data is not specified but implicitly would be from the manufacturer's testing facilities or contract labs. The data is prospective in the sense that these tests were specifically conducted for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable in the context of this 510(k) submission. The "ground truth" for the non-clinical tests (biocompatibility, functional design, packaging) is established by adherence to recognized international standards (e.g., ISO 10993, ISO 11607), engineering specifications, and comparison to the predicate device. There is no mention of "experts" in the sense of clinical reviewers establishing a diagnostic ground truth for a test set. The evaluation of the test results against the acceptance criteria would be performed by qualified engineers, toxicologists, and regulatory experts.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human observers or readers interpreting data (e.g., imaging studies) where there might be inter-reader variability. For bench-top and non-clinical engineering tests, the results are typically objectively measured and evaluated against predetermined specifications, not subject to subjective adjudication among multiple human readers.

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

This is not applicable. The MD™ MATTRESS Suture Placement Device is a mechanical, hand-operated surgical instrument, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance is entirely outside the scope of this device and submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. As stated above, this device is a mechanical surgical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For this device, the "ground truth" for the non-clinical tests is established by:

Engineering Specifications and Design Input Requirements: For functional performance, the device is tested against its own design specifications and expected performance characteristics.
International Standards: For biocompatibility (ISO 10993) and packaging/shelf-life (ISO 11607), the "ground truth" is adherence to the scientifically validated methodologies and acceptance limits defined by these standards.
Predicate Device Performance: For substantial equivalence, the "ground truth" is the established safety and effectiveness profile of the legally marketed predicate device (RD180® - THE RUNNING DEVICE®). The new device is evaluated to ensure it performs comparably and introduces no new risks.

There is no "pathology" or "outcomes data" directly from human patients contributing to the ground truth for this submission, as clinical testing was not performed or deemed necessary.

8. The Sample Size for the Training Set

This is not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for this type of device.

Summary

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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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

January 12, 2024

LSI Solutions, Inc. Christopher Miller Executive Director of Regulatory Affairs and Quality 7796 Victor-Mendon Rd Victor, New York 14564

Re: K222783

Trade/Device Name: MD Mattress Suture Placement Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Codes: GCJ, GAS Dated: June 21, 2023 Received: June 22, 2023

Dear Christopher Miller:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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, Tek N. v signed by Tek N Lamichhane -S Date: 2024.01.12 17:17:45 -05'00 Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive 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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Indications for Use

510(k) Number (if known) K222783

Device Name MD™ MATTRESS Suture Placement Device

Indications for Use (Describe)

The MD™ MATTRESS Suture Placement Device is indicated for use in the approximation of soft tissue and prosthetic materials.

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

Submitted By:	LSI SOLUTIONS, Inc.7796 Victor-Mendon RoadVictor, NY 14564
Contact Person:	Christopher B. MillerExecutive Director of Regulatory Affairs and QualityPhone: (585) 869-6665Fax: (585) 742-8086Email: cmiller@lsisolutions.com
Date Prepared:	10 JAN 2024
Trade Name:	MD™ MATTRESS Suture Placement Device
Common Name:	Needle Guide
Classification Name:	Endoscope and Accessories (per 21 CFR 876.1500)
Classification Regulation:	21 CFR 876.1500
Product Code:	GCJ (Primary Product Code)GAS (Secondary Product Code)

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Device Classification: Class II

Predicate Device:

RD180® - THE RUNNING DEVICE® (Cleared under Premarket Notification K100593)

Device Description

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attached suture to retract back across the tissue gap, pulling both suture ends through the targeted tissue within the jaw. Fully squeezing the lever again causes the needles and engaged needle caps with attached suture to advance back into their corresponding needle cap compartments, and an internal mechanism alternates the device into its rearming mode. Fully releasing the lever again causes the needles to retract into their protective compartments, leaving the needle caps and attached suture ends in the needle cap compartments. Subsequently squeezing and releasing the lever will repeat the pickup and rearm cycle.

While the MD™ MATTRESS Device is used for the placement of MD™ QUICK LOAD® SURGICAL SUTURES, this premarket submission does not include a request for clearance of suture materials since MD™ QUICK LOAD® SURGICAL SUTURE is listed on FDA's Establishment Registration and Device Listing database (K203081).

One (1) MD™ MATTRESS Device is provided per package, and the MD™ MATTRESS Device is intended to facilitate the placement of multiple sutures through tissue and prosthetic materials.

Intended Use

The MD™ MATTRESS Device is intended for use in the approximation of soft tissue and prosthetic materials.

Indications for Use

The MD™ MATTRESS Suture Placement Device is indicated for use in the approximation of soft tissue and prosthetic materials.

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Technological characteristics (comparison to Predicate Device)

Both the predicate RD180® Device and the subject MD™ MATTRESS Device have the same intended use: "Intended for use in the approximation of soft tissue and prosthetic materials." The predicate RD180® Device is "indicated for use in the approximation of soft tissue and prosthetic materials," and LSI recommends its use with 2-0 polyester suture, among other suture types. The subject MD™ MATTRESS Device has similar indications. The MD™ MATTRESS Device is "indicated for use in the approximation of soft tissue and prosthetic materials." The subject and predicate devices are both designed for sewing suture on similar technical principles. Both devices are single-patient-use, nonpowered, hand-operated devices that incorporate a leverdriven mechanism that pierces needles through tissue, picks up suture, and pulls the suture back through the tissue to facilitate placing a stitch.

Both the subject and predicate devices operate on the same principle to accomplish the tasks the devices are intended to perform. These tasks include: loading suture needle caps into the device tip; passing the device tip through the surgical access site (optionally through a cannula if appropriate); selecting the desired device tip position over a target site; firing needles through tissue and pulling the suture back through the tissue; rearming the device to allow for placement of additional tissue bites (as deemed appropriate by the surgeon); and removing the suture needle caps from the needles. Both the subject and predicate devices are provided sterile, after sterilization with ethylene oxide such that a minimum lethality of 10% is achieved. The predicate RD180® Device is a stainless steel and polymer suture delivery device. The MD™ MATTRESS Device is made from similar, often identical, materials. Both devices conform to the requirements of ISO 10993. The predicate device is packaged in a rigid thermoformed PETG

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blister tray with a Tyvek® cover. The subject device is packaged in the similar configuration with similar materials: a blue-tint PETG tray and retainer inserted into a Tyvek®/Nylon pouch.

The MD™ MATTRESS Device and the predicate RD180® Device are substantially equivalent. The subject and predicate devices are comparable, and the differences do not introduce any new risks, and have no negative impact on the safety and efficacy of the MD™ MATTRESS Device.

A summary of the comparison between the subject MD™ MATTRESS Device and predicate RD180® Device is provided in the table below.

Table 6: Substantial Equivalence Comparison
Subject Area	Predicate Device:RD180® - THE RUNNINGDEVICE®	Subject Device:MD™ MATTRESS Device
510(k) Number:	K100593	K222783
Device Class:	II	II
ClassificationRegulation:	21 CFR 876.1500	21 CFR 876.1500
Product Code:	GCJ	GCJ
Intended Use:	Intended for use in theapproximation of soft tissue andprosthetic materials.	Intended for use in theapproximation of soft tissue andprosthetic materials.
Indications for Use:	Indicated for use in theapproximation of soft tissue andprosthetic materials.	Indicated for use in theapproximation of soft tissue andprosthetic materials.

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Table 6: Substantial Equivalence Comparison
Subject Area	Predicate Device:RD180® - THE RUNNINGDEVICE®	Subject Device:MD™ MATTRESS Device
Single Use/Reusable:	Single Use	Single Use
Design:	Device tip (including a tissuejaw, single straight needle, and aneedle cap compartment)	Device tip (including a tissuejaw, jaw width indicator, dualcurved needles, needle axleindicator, needle capcompartments, and anangulation indicator)
	Device shaft	Device shaft (including anangulation knob, rotational knobwith an integrated eyelet andindicator fin)
	Pink lever	Lavender lever
	White handle	White handle
Table 6: Substantial Equivalence Comparison
Subject Area	Predicate Device:RD180® - THE RUNNINGDEVICE®	Subject Device:MD™ MATTRESS Device
TechnologicalCharacteristics:	Nonpowered, hand-operated; incorporating a lever-drivenmechanism utilizing needle-and-needle-cap technology to placesuture through tissue orprosthetic materials using asingle straight needle.The predicate device does notcontain any articulation orrotational knobs or functions.	Nonpowered, hand-operated; incorporating a lever-drivenmechanism utilizing needle-and-needle-cap technology to placesuture through tissue orprosthetic materials using dualcurved needles.COMPARABLEThe subject device contains anarticulation knob, which can beused to angulate the device tipinward or outward, and arotational knob, which enablesthe device shaft andcorrespondingly the device tipto rotate through six distinctpositions.
Target Population:	Any patient requiring theapproximation of soft tissue orprosthetic materials.	Any patient requiring theapproximation of soft tissue orprosthetic materials.SAME
Table 6: Substantial Equivalence Comparison
Subject Area	Predicate Device:RD180® - THE RUNNINGDEVICE®	Subject Device:MD™ MATTRESS Device
Environment ofUse:	Suitable for use in anyenvironment where surgicalprocedures occur under thesupervision of a physician.Compatible with open surgeries,smaller access/minimallyinvasive surgeries, and surgerythrough a cannula or otheraccess ports with seals tomaintain positive CO2 pressureat the surgical site.	Suitable for use in anyenvironment where surgicalprocedures occur under thesupervision of a physician.Compatible with open surgeries,smaller access/minimallyinvasive surgeries, and surgerythrough a cannula or otheraccess ports with seals tomaintain positive CO2 pressureat the surgical site.
Sterility	To be sterilized with ethyleneoxide such that a minimumlethality of 10-6 is achieved.	To be sterilized with ethyleneoxide such that a minimumlethality of 10-6 is achieved.
Materials andBiocompatibility	Comprising stainless steel andpolymers.Conforms to the requirements ofISO 10993-1:2009.	Comprising stainless steel andpolymers.Conforms to the requirements ofISO 10993-1:2018.
Packaging	Packaged in a rigidthermoformed PETG tray with aTyvek® cover.	Packaged in a PETG tray andretainer lid which are sealed in aTyvek®/Nylon pouch.

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Performance Testing Summary

Bench top performance testing was conducted to verify that the MD™ MATTRESS Device will perform as intended and to ensure the device will perform equivalently to the predicate device.

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The following non-clinical tests were conducted, and all results met the performance and riskbased acceptance criteria:

. Functional Design Verification and Validation Testing to ensure the Design Input Requirements were met.
Biocompatibility per ISO 10993-1:2018 and in accordance with FDA Guidance for . Industry Use of International Standard ISO 10993-1, "Biological evaluation of medical device – Part 1: Evaluation and testing within a risk management process, September 4, 2020. The MD™ MATTRESS Device can be classified as an externally communicating medical device that has limited contact (≤24 hours) with tissue. The battery of testing included:
- Chemical characterization O
- Cytotoxicity o
- Sensitization O
- Irritation o
- Material-mediated pyrogenicity o
- 0 Acute systemic toxicity
. Packaging/Shelf-life Testing per ISO 11607-1:2019 demonstrating a 2 year shelf life.

Clinical Testing

Not applicable. Neither the predicate nor the subject product require clinical testing. The substantial performance testing discussed above confirms the reliability and excellent performance of the MD™ MATTRESS Device. The performance testing included multiple experiments that do not require clinical testing in patients.

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Substantial Equivalence

The subject device and predicate device have the same intended use and technological characteristics. Non-clinical performance data has demonstrated the subject device is substantially equivalent to the predicate device.

Conclusion

The subject MD™ MATTRESS Device is substantially equivalent to the predicate RD180® Device, submitted under Premarket Notification K100593 and cleared in 2010. Extensive testing demonstrates that the proposed product consistently provides excellent suture placement and can be dependably manufactured. The MD™ MATTRESS Device will be safe and effective for the approximation of soft tissue and prosthetic materials.

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.