The AP50/30 Insufflator is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard/High Flow, Pediatric operating modes of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is specifically indicated for pediatric laparoscopic procedures. The Vessel Harvesting mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using CO2 gas during trans and minimal invasive surgery.

The Insuflow® Port (5 mm, 8 mm, 10mm and 12mm) devices have applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to heat, humidify, filter and introduce a CO2 gas stream for insufflation of the surgical cavity.

Device Description

The Lexion AP50/30 Insufflator is a microprocessor-controlled CO2 (carbon dioxide) insufflator with multiple operating modes. The insufflator instrumentation is intended for hospital use for Standard/High Flow, Pediatric, and Bariatric laparoscopic procedures used in conjunction with a laparoscope to fill and distend a peritoneal cavity with gas; for trans anal minimal invasive surgery (TAMIS) to fill and distend the rectum and colon using CO2 gas; and for Vessel Harvesting procedures used to create a cavity along the saphenous vein and/or the radial artery during an endoscopic vessel harvesting procedure.

The device incorporates the following major components and features: a metal housing, a world power supply, pressure reducers, a venting system, a gas heater control and a touch screen user interface with various settings and display elements. The software operation includes system checks, user interface, setting adjustments, warning/error messages and service info. The device is equipped with a continuous pressure measurement mode that controls the conformity of the actual pressure in the peritoneal or extraperitoneal cavity with the pre-set nominal pressure. The AP50/30 Insufflator is designed with several alarms/warnings to inform the operator in case of an overpressure or other malfunctions. The device is to be used with specially designed singleuse tubing sets, the Insuflow® Port, in order to utilize the full capabilities of continuous pressure measurement and gas heating and humidification. (The insufflator can also accept other tubing sets for gas deliver only.)

The Insuflow® Port (5, 8, 10, 12 mm) devices are gas conditioning/access port devices that attach to the outlet of the AP50/30 Insufflator and are designed to warm and humidify the CO2 gas stream prior to insufflation via an integral path of entry device during minimally invasive surgery. The Insuflow® Port consists of an ethylene oxide sterilized, disposable single use tubing set and a path of entry access port device which contains the pressure sensors, a filter, and gas heater/humidifier. The access port device materials are intended for patient contact of less than 24 hours. The Insuflow® Port is connected to the AP50/30 Insufflator via a plug connector cable, which controls the pressure sensing, gas heating and safety circuits for the system. Regulated CO2 gas from the AP50/30 Insufflator flows into the Insuflow® Port, through the in-line filter, continues along the tubing to enter the path of entry access device that contains the heating element and humidification media, and through the path of entry access device lumen for delivery into the patient's surgical cavity.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a medical device, the AP50/30 Insufflator with Insuflow® Port. It focuses on demonstrating substantial equivalence to predicate devices, particularly for a newly added operating mode (TAMIS).

Important Note: This document describes the acceptance criteria and study for a hardware medical device (insufflator), not an AI/ML-based device. Therefore, many of the requested fields related to AI/ML (e.g., ground truth establishment for training set, MRMC study, sample size for training set, number of experts for ground truth) are not applicable to this type of medical device submission. The study described is an engineering performance verification and validation.

Here's a breakdown based on the provided text, addressing the applicable criteria for this device:

Acceptance Criteria and Device Performance for AP50/30 Insufflator with Insuflow® Port (TAMIS Mode)

This submission focuses on demonstrating substantial equivalence of the modified AP50/30 Insufflator (with the addition of a TAMIS operating mode) to its predicate devices. The acceptance criteria are implicit in matching the performance specifications of the predicate devices for existing modes and ensuring the new TAMIS mode meets appropriate performance targets comparable to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by matching or demonstrating comparable performance to the predicate devices, particularly the PNEUMOCLEAR Insufflator (K170784) for the TAMIS mode. The tables provided in the document serve as the performance data compare to historical predicate performance.

Key Performance Specs	AP50/30 Insufflator with TAMIS (Reported Performance)	AP50/30 Insufflator K170799 (Primary Predicate)	PNEUMOCLEAR K170784 (Secondary Predicate - for TAMIS)	Acceptance Criteria (Implicit from Predicate)
Insufflator Indications for Use	Includes TAMIS mode to fill and distend rectum and colon using CO2 gas during trans anal minimal invasive surgery, in addition to existing modes.	Standard/High Flow, Pediatric, Bariatric, Vessel Harvesting.	Standard, High Flow/Bariatric, Pediatric, Advanced Flow, Vessel Harvest, and TAMIS mode for rectum and colon distention.	Device's TAMIS indication should match the secondary predicate. Other indications should match the primary predicate.
Operating Modes (New)	Standard/High Flow, Pediatric, Bariatric, Vessel Harvesting, and TAMIS	Standard/High Flow, Pediatric, Bariatric and Vessel Harvesting	Standard, High Flow/Bariatric, Pediatric, Advanced Flow, Vessel Harvesting, and TAMIS	New TAMIS mode should be consistent with the secondary predicate.
Max Gas Flow (TAMIS)	40 lpm (TAMIS)	N/A (No TAMIS mode)	40 lpm (TAMIS)	Max gas flow for TAMIS should be 40 lpm, matching secondary predicate.
Pressure Range (TAMIS)	1-20 mmHg (TAMIS)	N/A (No TAMIS mode)	1-20 mmHg (TAMIS)	Pressure range for TAMIS should be 1-20 mmHg, matching secondary predicate.
Intra-abdominal Max Pressure (TAMIS)	20 mmHg (TAMIS)	N/A (No TAMIS mode)	20 mmHg (TAMIS)	Max pressure for TAMIS should be 20 mmHg, matching secondary predicate.
Maximum Supply Pressure (TAMIS)	65 mmHg in TAMIS mode	N/A (No TAMIS mode)	65 mmHg in TAMIS mode	Max supply pressure for TAMIS should be 65 mmHg, matching secondary predicate.
Other Existing Modes (Flow, Pressure, Max Pressure, Supply Pressure, Adjustable Values, Pneumo Pressure Control, User Interface, Power, Error Warnings, Gas Conditioning, Tubing Sets)	Match previous AP50/30 performance.	Specified values for each mode.	Specified values for each mode.	Must remain consistent with the primary predicate.

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

Sample Size: The document refers to "comparative bench testing" and "design verification testing." It does not specify a numerical sample size in terms of "units tested" or "number of unique test scenarios." This type of engineering testing typically involves a set number of test runs or units to demonstrate specifications are met across operational ranges and conditions.
Data Provenance: The testing was "performed to demonstrate that the performance of the proposed AP50/30 Insufflator is substantially equivalent to that of the predicate devices." This implies that the data is prospective data generated from testing of the new device intended for submission. The location of testing is not specified, but it would have been conducted by the manufacturer (Lexion Medical LLC) or a contracted test facility.

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

N/A. For a hardware medical device like an insufflator, "ground truth" as it relates to expert consensus on images or clinical outcomes is not applicable. The device's performance is objectively measured against engineering specifications (e.g., flow rate, pressure accuracy, alarm function). Verification and validation testing is conducted by engineers and technicians against established specifications.

4. Adjudication Method for the Test Set

N/A. Adjudication methods (like 2+1, 3+1) are relevant for subjective assessments, typically in image interpretation or clinical trial endpoints that require expert consensus. For an insufflator, performance is measured against objective, quantifiable engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

N/A. MRMC studies are specific to evaluating the diagnostic performance of imaging devices or algorithms, usually involving human readers interpreting images. This is a hardware device for surgical procedures (insufflation), not an imaging or diagnostic AI/ML device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

N/A. This is not an AI/ML algorithm. The device has software that controls its functions, which was validated ("The software used in the AP50/30 Insufflator was determined to have a major level of concern, and was developed and successfully validated in accordance with the FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued May 11, 2005."). This software validation assesses the correct functioning of the control algorithms, which operates autonomously to maintain pressure and flow.

7. The Type of Ground Truth Used

Engineering Specifications / Predicate Device Performance: The "ground truth" for this device's performance is its ability to meet established engineering specifications (e.g., precise control of gas pressure and flow, accurate alarm triggers) and to perform comparably to its legally marketed predicate devices, particularly for the added TAMIS mode. The performance is quantified through direct physical measurements during bench testing.

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device; there is no "training set." The software is designed and programmed based on engineering principles and requirements, not trained on data.

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

N/A. As there is no training set for an AI/ML model, this question is not applicable. The software ground truth is derived from design requirements and engineering specifications documented during the device development process.

In summary, the provided document details the regulatory submission for a hardware medical device with specific performance characteristics. The "acceptance criteria" revolve around demonstrating that the modified device (with a new operating mode) performs comparably to its predicates and meets all relevant safety and performance standards. The "study" proving this involves comprehensive bench testing and software validation against objective engineering specifications. The concepts of AI/ML-specific evaluations (like training sets, data provenance for AI models, MRMC studies, or multi-expert adjudication for diagnostic ground truth) do not apply to this type of device submission.

Summary

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August 28, 2019

Lexion Medical LLC % Bernard Horwath Regulatory Consultant HRG 4486 Timberline Ct Vadnais Heights, MN 55127

Re: K191780

Trade/Device Name: AP50/30 Insufflator with Insuflow® Port Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF, OSV, GCJ Dated: July 1, 2019 Received: July 2, 2019

Dear Bernard Horwath:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (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-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,

Sharon Andrews Assistant Division Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191780

Device Name AP50/30 Insufflator with Insuflow® Port

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

AP50/30 Insufflator with Insuflow® Port

Date Prepared:	August 27, 2019
Submitter:	Lexion Medical, LLC545 Atwater CircleSt. Paul, MN 55103Telephone: 651-855-1447Fax: 651-636-1671
Contact:	Mr. Bernard HorwathRegulatory Affairs Consultant4486 Timberline CtVadnais Heights, MN 55127Telephone: 651- 231-1761

Device Name: AP50/30 Insufflator with Insuflow® Port

Common/Usual Name: Carbon dioxide insufflator for laparoscopic insufflation and endoscopic vessel harvesting (AP50/30), and gas conditioner path of entry device (Insuflow Port)

Classification Name/Code: Class II per regulations 884.1730, Laparoscopic Insufflator Product Code: HIF=Insufflator, laparoscopic Class II per regulations 884.1730, Laparoscopic Insufflator Product Code: OSV=Insufflator, endoscopic vessel harvesting Class II per regulations 876.1500, Endoscope and Accessories Product Code: GCJ=Laparoscope, general and plastic surgery

Predicate Devices:

LEXION Medical believes that the proposed AP50/30 Insufflator with Insuflow® Port devices is substantially equivalent to the following devices:

Primary Predicate: AP50/30 Insufflator with Insuflow Port, K170799
. Secondary Predicate: PNEUMOCLEAR Insufflator, K170784

None of the cited predicate devices have been subject to a design-related recall.

Description:

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Harvesting procedures used to create a cavity along the saphenous vein and/or the radial artery during an endoscopic vessel harvesting procedure.

Indications for Use:

The AP50/30 Insufflator is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard/High Flow. Pediatric and Bariatric operating modes of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is specifically indicated for pediatric laparoscopic procedures. The Vessel Harvesting operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using CO2 gas during trans anal minimal invasive surgery.

Technological characteristics, comparison to predicate devices.

AP50/30

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The proposed Lexion AP50/30 Insufflator is similar to the predicate devices in that they are all CO2 insufflators intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The proposed Lexion AP50/30 Insufflator is similar in technology to the primary predicate, the previously cleared Lexion AP50/30 Insufflator (K170799), in terms of operating mode, design, basic features, and custom tubing sets. The only change is the addition of the TAMIS mode of operation. As a result, the indications for use and the software design have been modified to incorporate the TAMIS mode. Concerning the TAMIS mode, the proposed Lexion AP50/30 Insufflator has the same indications for use as the secondary predicate, the PNEUMOCLEAR Insufflator (K170784), which is also indicated to fill and distend the rectum and colon using CO2 gas during trans rectal minimally invasive surgery.

The following table compares the key performance specifications for the proposed AP50/30 Insufflator and the current AP50/30 Insufflator, demonstrating that the only change from the primary predicate is the addition of the TAMIS mode with appropriate specs.

Primary Predicate Comparison Table: Kev Performance Specs

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Concerning the TAMIS mode the proposed Lexion AP50/30 Insufflator has similar technological characteristics to the PNEUMOCLEAR device, as shown in the table below.

KeyPerformanceSpecs	AP50/30 InsufflatorWith TAMIS	PNEUMOCLEARK170784	Comparison
InsufflatorIndications forUse	The AP50/30 Insufflator is aCO2 insufflator intended for useduring diagnostic and/ortherapeutic endoscopicprocedures to distend a cavity byfilling it with gas. TheStandard/High Flow, Pediatricand Bariatric operating modes ofthe device are indicated to filland distend a peritoneal cavitywith gas during a laparoscopicprocedure. The Pediatricoperating mode is specificallyindicated for pediatriclaparoscopic procedures. TheVessel Harvesting operatingmode is indicated for use duringendoscopic vessel harvestingprocedures to create a cavityalong the saphenous vein orradial artery. The TAMISoperating mode is indicated tofill and distend the rectumand colon using CO2 gasduring trans anal minimalinvasive surgery.	The devicePNEUMOCLEAR™ is ainsufflator intended for useduring diagnostic and/ortherapeutic endoscopicprocedures to distend a cavityby filling it with gas. TheStandard, High Flow/Bariatric,Pediatric and Advanced Flowoperating modes of the deviceare indicated to fill and distenda peritoneal cavity with gasduring a laparoscopicprocedure. The Pediatricoperating mode is indicated forpediatric laparoscopicprocedures. The Vessel Harvestoperating mode is indicated foruse during endoscopic vesselharvesting procedures to createa cavity along the saphenousvein or radial artery. TheTAMIS operating mode isindicated to fill and distend therectum and colon using CO2gas during trans anal minimallyinvasive surgery.	TAMIS indicationis the same
OperatingModes	Standard/High Flow,Pediatric, Bariatric, VesselHarvesting, and TAMIS	Standard/High Flow,Pediatric, Bariatric, VesselHarvesting, and TAMIS	TAMIS mode isthe same
Max Gas Flow	20 lpm (Pediatric)45 lpm (High Flow)50 lpm (Bariatric)10 lpm (Vessel Harvest)	20 lpm (Pediatric)45 lpm (High Flow)50 lpm (Bariatric)10 lpm (Vessel Harvest)	Same
KeyPerformanceSpecs	AP50/30 InsufflatorWith TAMIS	PNEUMOCLEARK170784	Comparison
Pressure Range	40 lpm (TAMIS)1-20mmHg (Pediatric/VesselHarvest)1-30mmHg (HighFlow/Bariatric)1-20 mmHg (TAMIS)	40 lpm (TAMIS)1-20mmHg (Pediatric/VesselHarvest)1-30mmHg (HighFlow/Bariatric)1-20 mmHg (TAMIS)	Same
Intra-abdominalMax Pressure	30 mmHg (HighFlow/Bariatric)20 mmHg (Pediatric/VesselHarvest)20 mmHg (TAMIS)	30 mmHg (HighFlow/Bariatric)20 mmHg (Pediatric/VesselHarvest)20 mmHg (TAMIS)	Same
MaximumSupply Pressure	65 mm Hg in Bariatric, HighFlow, Pediatric, VesselHarvest and TAMIS modesand 60 mm Hg in Veressmode	65 mm Hg in Bariatric, HighFlow, Pediatric, VesselHarvest and TAMIS modesand 60 mm Hg in Veressmode	Same

Secondary Predicate Comparison Table: Key TAMIS Mode Performance Specs

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Overall, the differences in technological characteristics between the subject device and the primary and secondary predicate devices do not raise different questions of safety and effectiveness.

Insuflow® Port

There are no changes in the Insuflow® Port (5 mm, 8 mm, 10 mm, and 12 mm) devices as compared to the predicate K170799.

Discussion of performance testing.

A risk analysis and resulting performance testing were conducted to assure that the proposed AP50/30 Insufflator with the Insuflow® Port devices perform in accordance with specifications and applicable standards. The AP50/30 hardware remains unchanged from the predicate. The addition of the TAMIS mode was via software changes, therefore, the design verification testing focused on software verification and insufflator performance testing. Design verification testing of the AP50/30 Insufflator demonstrated that the proposed device performs as intended, and that the performance of the device is comparable to that of the predicates.

The software used in the AP50/30 Insufflator was determined to have a major level of concern, and was developed and successfully validated in accordance with the FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued May 11, 2005.

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Comparative bench testing was performed to demonstrate that the performance of the proposed AP50/30 Insufflator is substantially equivalent to that of the predicate devices. The comparative bench test included the following tests: set pressure, flow, compensation of small and large leakages, overpressure, and pressure measurement/control. The test results demonstrate that the performance of the proposed AP50/30 device related to TAMIS mode operation, including attaining the set pressure, flow, compensation of small and large leakages, pressure measurement/control and overpressure are comparable to the performance of the predicate PNEUMOCLEAR Insufflator. In addition, the necessary changes to the software for TAMIS mode have not affected the AP50/30 Insufflator performance specifications for previously cleared operating modes.

All other testing, including electrical safety and electromagnetic compatibility testing per IEC 60601-1:2014 and IEC 60601-1-2:2014. that was successfully performed on the predicate K170799 AP50/30 Insufflator was leveraged to support the safety and effectiveness of the proposed AP50/30 Insufflator, as there were no associated changes in hardware with the addition of the TAMIS mode.

Conclusion:

The proposed AP50/30 Insufflator device has the same intended use as the cleared insufflator predicates. As identified above, the technological specifications are similar between the proposed device and predicate devices, and the differences in technological characteristics do not raise different questions of safety and effectiveness. Performance testing conducted on the proposed device demonstrates that the subject device is as safe and effective as the predicates. Therefore, the proposed AP50/30 Insufflator with Insuflow® Port is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 884.1730 Laparoscopic insufflator.

(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.