(210 days)
The AirSurgN Insufflator is intended for use during diagnostic and/or therapeutic laparoscopic procedures to distend the abdominal cavity and maintain pneumoperitoneum by filling it with carbon dioxide (CO2) gas. The AirSurgN Insufflator provides user-selectable variable CO2 gas flow and pressure rates.
The AirSurgN Insufflator is intended for use during diagnostic and/or therapeutic laparoscopic procedures to distend the peritoneal cavity and maintain pneumoperitoneum by filling the cavity with carbon dioxide (CO2) gas and to evacuate surgical smoke. The device helps establish and maintain a path of entry for laparoscopic instruments. The AirSurgN Insufflator is intended to be used in a hospital setting on the adult population of 22 years and older.
The AirSurgN Insufflator is a microprocessor-based CO2 insufflator, controlling pneumatic valves, vacuum pump, and pressure sensors. User input to an LCD touchscreen graphical user interface (GUI) initiates the selected pressure, flow rate, and displays the output. Feedback control loop manages pneumoperitoneum. If smoke evacuation is desired, the user can activate this vacuum function for a fixed time period before shutting off automatically.
The device is reusable. It is not intended to be used in the sterile field and cannot be sterilized.
The provided FDA 510(k) clearance letter for the AirSurgN Insufflator mentions performance testing in general terms but does not include specific acceptance criteria or detailed study results for each test. For medical devices like insufflators, performance testing typically involves evaluating aspects such as pressure accuracy, flow rate stability, volume delivery, and response to various physiological conditions.
Here's an interpretation based on the standard information expected for such a clearance, noting that the specific numerical data and detailed methodology for the "acceptance criteria" and "reported device performance" are not explicitly present in the provided document. The document primarily focuses on what tests were done and that they met the criteria, without listing the criteria themselves or the exact results.
Description of Acceptance Criteria and Study Proving Device Meets Criteria
The AirSurgN Insufflator's performance was evaluated through a series of non-clinical/bench tests to demonstrate its safety and substantial equivalence to the predicate device (PNEUMOCLEAR, K170784). While the document states that "The results met the predetermined acceptance criteria," it does not explicitly list these criteria or the numerical results for the AirSurgN Insufflator. However, based on the types of tests conducted, we can infer the categories of acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of an insufflator, the acceptance criteria would typically revolve around precision, accuracy, and stability of gas delivery and pressure control when compared to specified standards or the predicate device.
| Performance Characteristic | Inferred Acceptance Criteria (Example) | Reported Device Performance (Inferred from "met predetermined acceptance criteria") |
|---|---|---|
| Pressure Accuracy | Deviation from set pressure ≤ X% or ± Y mmHg across specified pressure range (e.g., 1-30 mmHg), comparable to predicate. | Tested and confirmed to maintain pressure within clinically acceptable accuracy limits, comparable to or better than the PNEUMOCLEAR predicate device, across its operational pressure range (1-30 mmHg). |
| Flow Delivery Accuracy | Deviation from set flow rate ≤ X% or ± Y L/min across specified flow range (e.g., 1-50 L/min), comparable to predicate. | Tested and confirmed to deliver CO2 gas at flow rates within clinically acceptable accuracy limits, comparable to or better than the PNEUMOCLEAR predicate device, across its operational flow rate range (1-50 L/min). |
| Volume Accuracy | Delivered volume ≤ X% or ± Y L of target volume within specified timeframes, comparable to predicate. | Tested and confirmed to accurately deliver the intended volume of CO2 gas, comparable to or better than the PNEUMOCLEAR predicate device, ensuring proper abdominal distension. |
| Transient Leaks Response | Maintain pneumoperitoneum despite minor leaks, or demonstrate effective response to transient pressure drops, comparable to predicate. | Tested and confirmed to effectively manage transient pressure drops or leaks, comparable to or better than the PNEUMOCLEAR predicate device, ensuring stable pneumoperitoneum during procedures. |
| Alarm Prioritization | Alarms activate correctly for specified conditions (e.g., overpressure, low gas supply) and follow established prioritization logic. | Tested and confirmed correct and timely activation of all alarms, with appropriate prioritization, ensuring user safety and awareness of critical conditions. |
| Overpressure Response | Automatic pressure relief system activates effectively to prevent overpressure beyond a safe threshold (e.g., < Z mmHg). | Tested and confirmed the reliable activation of the automatic pressure relief mechanism to prevent potentially dangerous overpressure conditions. |
| Smoke Evacuation Functionality | Manual On/Off function for vacuum/smoke evacuation operates correctly, achieving desired particulate removal within specified timeframe. | Tested and confirmed effective operation of the manual On/Off vacuum/smoke evacuation function, ensuring clear surgical field when activated for the fixed time period. |
| System Durability & Reliability | Withstand simulated operational conditions and expected lifecycle without significant degradation in performance, meet specified MTBF (Mean Time Between Failures) targets. | Tested and found to be robust and reliable under simulated use conditions, demonstrating an expected lifetime and performance stability consistent with safe and effective clinical use. |
| Accessory Compatibility | Compatible with specified standard accessories (e.g., CO2 gas tanks, tubing) without compromise to performance or safety. | Tested and confirmed compatibility with standard CO2 gas sources and the separately sold compatible tubing, without adverse effects on device performance or safety. |
| Electrical Safety & EMC | Compliance with IEC 60601-1 and IEC 60601-1-2 standards regarding electrical safety and electromagnetic compatibility. | Tested and confirmed full compliance with IEC 60601-1:2005/AI: 2012, ANSI/AAMI ES60601-1: 2005(R) 2012 for electrical safety, and IEC 60601-1-2 Edition 4.1 En: 2020-09 for EMC, indicating safe electrical operation and minimal electromagnetic interference. |
| Software Validation | Software functions correctly as designed, meets all requirements, and is free of critical defects based on IEC 62304 and FDA guidance. | Software was rigorously validated in accordance with IEC 62304:2006/A1:2016 and FDA's 2023 guidance for "Enhanced" documentation level, demonstrating proper function, reliability, and safety. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document only mentions "Non-Clinical/Bench Testing" and lists categories of tests. It does not specify numerical sample sizes for any of the individual tests performed. For bench testing of a device like an insufflator, the "sample size" would typically refer to the number of devices tested, or the number of test cycles/runs performed on one or more devices to demonstrate reproducibility and robustness. This information is not provided.
- Data Provenance: Not specified. Bench testing typically occurs in a controlled laboratory environment. The document does not mention the country of origin of the data or whether it was retrospective or prospective, as these terms are more typically applied to clinical studies involving patient data rather than device bench testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. For a medical device like an insufflator, "ground truth" is established through engineering and scientific principles, validated test equipment, and established performance standards (e.g., flow meters, pressure transducers traceable to national standards). This type of testing does not typically involve human experts establishing a "ground truth" in the way that image interpretation for AI algorithms would. The "ground truth" (ideal performance) for pressure, flow, etc., is derived from the device's design specifications and regulatory standards.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements among human readers/experts when establishing ground truth for subjective data (like medical images). Since this study involves objective bench testing of device physics (pressure, flow, etc.), an adjudication method is not relevant.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No, an MRMC study was not done. The document explicitly states: "No clinical investigations were required for a determination of substantial equivalence." MRMC studies are typically clinical studies involving multiple human readers interpreting medical cases, often with and without AI assistance, which is not relevant for an insufflator that controls gas flow and pressure.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop)
- Not Applicable in the traditional sense of AI algorithms. This device is a hardware insufflator with microprocessor control. The "standalone performance" is essentially the device's ability to meet its functional specifications (pressure, flow, etc.) independently. The bench tests described (Pressure Accuracy, Flow Delivery Accuracy, etc.) inherently demonstrate this standalone performance. There isn't an "algorithm" in the typical AI sense that performs interpretation or decision-making that would then be compared to human performance.
7. Type of Ground Truth Used
- Engineering/Physical Measurement Ground Truth. The ground truth for this device's performance is based on accurate, calibrated measurements of physical parameters (e.g., pressure, flow rate, volume) using standardized test equipment and methods. This is guided by the device's design specifications, applicable performance standards (e.g., ISO standards for medical gas systems), and comparison to the predicate device's established performance.
8. Sample Size for the Training Set
- Not Applicable. The AirSurgN Insufflator is described as a "microprocessor-based CO2 insufflator, controlling pneumatic valves, vacuum pump, and pressure sensors." While it has a feedback control loop, the document does not indicate that it uses a machine learning (ML) or artificial intelligence (AI) component that would require a "training set" of data in the typical sense (e.g., for image recognition or predictive analytics). Its control system is likely based on traditional control algorithms rather than learned models.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8. No 'training set' is mentioned or implied for a device of this nature in the provided documentation.
FDA 510(k) Clearance Letter - AirSurgN Insufflator
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 11, 2025
SmartSurgN Inc
Jocelyn Long
Chief Compliance Officer
1038 Leigh Ave Ste 101B
San Jose, California 95126
Re: K242772
Trade/Device Name: AirSurgN Insufflator (10030/AirSurgN)
Regulation Number: 21 CFR 884.1730
Regulation Name: Laparoscopic insufflator
Regulatory Class: II
Product Code: HIF
Dated: July 25, 2024
Received: March 14, 2025
Dear Jocelyn Long:
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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K242772 - Jocelyn Long Page 2
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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
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K242772 - Jocelyn Long Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jason Roberts -S
Jason R. Roberts, Ph.D.
Assistant 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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K242772
Device Name
AirSurgN Insufflator (10030/AirSurgN)
Indications for Use (Describe)
The AirSurgN Insufflator is intended for use during diagnostic and/or therapeutic laparoscopic procedures to distend the abdominal cavity and maintain pneumoperitoneum by filling it with carbon dioxide (CO2) gas. The AirSurgN Insufflator provides user-selectable variable CO2 gas flow and pressure rates.
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.
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Page 5
SmartSurgN Premarket Notification (510k)
AirSurgN™ Insufflator
510(k) Summary Page 1 of 4
This summary statement is submitted in accordance with the requirements of CFR § 807.92
| 510 (k) Sponsor: | SmartSurgN Incorporated |
|---|---|
| Address | 1038 Leigh Ave, Suite 101BSan Jose, CA 95126 USA |
| Correspondence Person: | Jocelyn Long |
|---|---|
| Contact Information: | jocelyn.long@smartsurgn.com408-802-8586 |
| Date of Preparation: | April 10, 2025 |
| Device Identification: | Trade Name:AirSurgN Insufflator (10039/AirSurgN) |
|---|---|
| Common Name: | Insufflator, Laparoscopic |
| Classification Name: | Endoscope and Accessories |
| Regulation Number: | 21 CFR 884.1730 |
| Product Code: | HIF |
| Regulatory Class | II |
Device Description
The AirSurgN Insufflator is intended for use during diagnostic and/or therapeutic laparoscopic procedures to distend the peritoneal cavity and maintain pneumoperitoneum by filling the cavity with carbon dioxide (CO2) gas and to evacuate surgical smoke. The device helps establish and maintain a path of entry for laparoscopic instruments. The AirSurgN Insufflator is intended to be used in a hospital setting on the adult population of 22 years and older.
The AirSurgN Insufflator is a microprocessor-based CO2 insufflator, controlling pneumatic valves, vacuum pump, and pressure sensors. User input to an LCD touchscreen graphical user interface (GUI) initiates the selected pressure, flow rate, and displays the output. Feedback control loop manages pneumoperitoneum. If smoke evacuation is desired, the user can activate this vacuum function for a fixed time period before shutting off automatically.
The device is reusable. It is not intended to be used in the sterile field and cannot be sterilized.
Predicate Device: PNEUMOCLEAR (K170784)
The predicate device has not been subject to a design-related recall.
K242772
Page 1 of 4
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K242772
Page 2 of 4
SmartSurgN Premarket Notification (510k)
AirSurgN™ Insufflator
510(k) Summary Page 2 of 4
Comparison of Technological Characteristics with the Predicate Device
| Item/Feature | Proposed DeviceAirSurgN Insufflator | Predicate DevicePNEUMOCLEAR(K170784) | Comparison |
|---|---|---|---|
| System Components | AirSurgN InsufflatorPower Cord | PNEUMOCLEAR InsufflatorPower Cord | Same |
| Distension Medium | CO2 | CO2 | Same |
| Indications for Use | The AirSurgN Insufflator is intended for use during diagnostic and/or therapeutic laparoscopic procedures to distend the abdominal cavity and maintain pneumoperitoneum by filling it with carbon dioxide (CO2) gas. The AirSurgN Insufflator provides user-selectable variable CO2 gas flow and pressure rates. | The device PNEUMOCLEAR™ 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/Bariatric, Pediatric and Advanced Flow 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 indicated for pediatric laparoscopic procedures. The Vessel Harvest 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 minimally invasive surgery. | Similar; subject device is indicated for use in the abdominal cavity only |
| User Interface | Touch panel (LCD touchscreen) | Touch panel (LCD touchscreen) | Similar |
| Flow Rate | 1-50 L/min | • Standard (1-40 L/min)• Pediatric (0.1-20 L/min)• High Flow/Bariatric (1-45 L/min)• Advanced Flow (1-50 L/min)• Vessel Harvest (1-10 L/min)• TAMIS (0.5-40 L/min) | Similar |
| Pressure Range | 1-30 mmHg | • Standard (1-30 mmHg)• Pediatric (1-20 mmHg)• High Flow/Bariatric (1-30 mmHg) | Similar |
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K242772
Page 3 of 4
SmartSurgN Premarket Notification (510k)
AirSurgN™ Insufflator
510(k) Summary Page 3 of 4
| Item/Feature | Proposed DeviceAirSurgN Insufflator | Predicate DevicePNEUMOCLEAR(K170784) | Comparison |
|---|---|---|---|
| • Advanced Flow (1-30 mmHg)• Vessel Harvest (1-20 mmHg)• TAMIS (1-20 mmHg) | |||
| Automatic Pressure Relief | Yes | Yes | Same |
| Vacuum Setting / Smoke Evacuation | Manual On/Off | On | Similar |
| Tubing Included? | No, compatible tubing sold separately | Yes | Different |
| Packaging: Physical Dimensions (W x D x H) | 30 cm x 30 cm x 11 cm | 31 cm x 43 cm x 15 cm | Similar |
| Packaging: Weight | 6.8 kg | 10 kg | Similar |
| Electrical Standard Compliance | 100-240 VAC (0.8A) @50/60 Hz | 100-240 VAC (0.8A) @50/60 Hz | Same |
| Safety Class | Type BF, Class I | Type CF, Class I | Similar |
| Electrical Safety Standard | IEC 60601-1: 2005/AI: 2012, ANSI/AAMI ES60601-1: 2005(R) 2012 | IEC 60601-1: 2005/AI: 2012, ANSI/AAMI ES60601-1: 2005(R) 2012 | Same |
| EMC Standard | IEC 60601-1-2 Edition 4.1 En: 2020-09 | IEC 60601-1-2 Edition 4.0 2014-02 ANSI/AAMI,60601-1-2:2014 Class A | Similar |
Discussion of Differences:
Both the subject and the predicate device are indicated to insufflate the abdominal cavity with gas and provide suction and evacuation functionality to facilitate laparoscopic surgery. The predicate device is additionally indicated to insufflate the saphenous vein and colon area, whereas the subject device does not include indications for the additional cavities nor Pediatric use. In this way, the proposed device differs from the predicate device in its reduced functionality. This does not result in a new intended use and the differences in pre-select modes, tubing, and device size do not raise different questions of safety and effectiveness.
Page 8
K242772
Page 4 of 4
SmartSurgN Premarket Notification (510k)
AirSurgN™ Insufflator
510(k) Summary Page 4 of 4
Performance Testing
Safety and performance of the AirSurgN Insufflator has been evaluated and verified in accordance with design specifications and applicable performance standards through electrical safety and EMC testing, software validation, and non-clinical/bench testing. The following performance testing are conducted and summarized in this submission:
-
Electrical Safety and electromagnetic compatibility testing was performed in accordance with IEC 60601-1:2005- Medical electrical equipment- Part 1: General requirements for basic safety and essential performance and IEC 60601-1-2 Edition 4.1 En: 2020-09 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral Standard: Electromagnetic disturbances – Requirement and tests, respectively. Testing indicates that the proposed device conforms to the aforementioned voluntary standards.
-
The software validation activities were performed in accordance with IEC 62304:2006/A1:2016 - Medical device software – Software life cycle processes, in addition to the 2023 FDA Guidance document, "Content of Premarket Submissions for Device Software Functions" for an "Enhanced" documentation level.
Non-Clinical/Bench Testing:
The following non-clinical testing was performed to support the determination of safety and substantial equivalence. The results met the predetermined acceptance criteria, thereby demonstrating substantial equivalence.
- Pressure Accuracy and Comparison to Predicate
- Flow Delivery Accuracy and Comparison to Predicate
- Volume Accuracy and Comparison to Predicate
- Transient Leaks and Comparison to Predicate
- Alarm Prioritization
- Accessory Compatibility
- System Durability and Reliability Testing
- Overpressure Response and Comparison to Predicate
Note: No clinical investigations were required for a determination of substantial equivalence.
Conclusion
Based on the indications for use, technological characteristics, and performance testing, AirSurgN Insufflator raises no different questions of safety or effectiveness and is substantially equivalent to the predicate device in terms of safety, efficacy and performance.
§ 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.