Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical device for tissue containment during surgery and does not mention any computational or data-driven features indicative of AI/ML.

Therapeutic

No

The device is intended for the safe containment and removal of tissue during laparoscopic surgery, not for treating a disease or medical condition.

Diagnostic

No
The device is described as a "multiple instrument port and tissue containment system" used during laparoscopic surgery for isolation and containment of tissue during morcellation and removal. Its intended use is to facilitate surgery, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components: a laparoscopic multi-instrument port and a tissue pouch. The performance studies focus on the physical properties and functionality of these hardware components (biocompatibility, shelf life, barrier testing, mechanical strength, etc.). There is no mention of software as a component or its function.

IVD (In Vitro Diagnostic)

Based on the provided information, the PneumoLiner device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for "use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during single-port or multi-site laparoscopic surgery during power morcellation and removal." This describes a surgical tool for containing and removing tissue, not a device used to perform tests on samples taken from the body to diagnose a condition.
Device Description: The description details a laparoscopic multi-instrument port and a tissue pouch. These are physical components used during surgery, not reagents, instruments, or software for performing diagnostic tests.
Performance Studies: The performance studies focus on the physical properties and functionality of the device during simulated and animal/cadaveric surgical procedures (biocompatibility, shelf life, barrier testing, puncture resistance, burst pressure, obstruction, clinical simulation of morcellation, training validation, design validation). They do not involve evaluating the device's ability to detect or measure substances in biological samples for diagnostic purposes.
Lack of Diagnostic Metrics: The "Key Metrics" section explicitly states "Not Found" for metrics like Sensitivity, Specificity, PPV, and NPV, which are standard performance indicators for diagnostic devices. The metrics provided relate to the success or failure of the device's physical function and containment capabilities.

In summary, the PneumoLiner is a surgical device designed for tissue containment and removal during laparoscopic procedures. It does not perform in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The PneumoLiner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during single-port or multi-site laparoscopic surgery during power morcellation and removal. The PneumoLiner is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15 mm and 18 mm in shaft outer diameter and 135 mm and 180 mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation.

Product codes

PMU

Device Description

The PneumoLiner System consists of two main components:

A laparoscopic multi-instrument port
Tissue pouch (PneumoLiner) intended to provide a separately contained space within the abdomen for the safe morcellation of tissue

The laparoscopic multi-instrument port consists of the Retractor, Retractor Introducer and the Boot Assembly. The Retractor Introducer is placed through the abdominal incision (20-25 cm) to deliver the distal ring on the Retractor. The Retractor retracts the incision to allow passage of laparoscopic instruments. The Retractor provides a gas-tight seal between the device and the incision. It also provides an anchor for the Boot Assembly.

The Boot Assembly consists of two insufflation ports and two instrument ports. The insufflation ports are used for the delivery of gas for distension and the venting of smoke during the course of the procedure. The ports consist of a large instrument valve port which is intended for the introduction of the PneumoLiner pouch/Morcellator and a 5 mm valve port which can accommodate a 5 mm instrument such as a laparoscope or grasper. (The large instrument valve also includes a reducer such that the opening can be reduced to 5 mm for smaller instruments.)

The PneumoLiner pouch is preloaded into the Introducer. The PneumoLiner Introducer Shaft is inserted through the Large Instrument Valve in the Boot Assembly. The PneumoLiner Introducer Plunger is then pushed into the Shaft to eject the PneumoLiner pouch into the abdominal cavity. An opening ring on the neck of the PneumoLiner pouch ensures that it is kept open. After the specimen is placed in the PneumoLiner pouch, a tether provides the mechanism for closing the PneumoLiner pouch and exteriorizing the collar section.

The Boot Assembly is reattached inside the exteriorized PneumoLiner pouch enabling inflation of the PneumoLiner pouch and re-establishing pneumoperitoneum. The printed grid pattern allows for distinction between the tissue sample and the retracted viscera. The morcellation can then be conducted under direct visualization.

After morcellation is complete, the PneumoLiner pouch is deflated and the boot assembly is removed. The PneumoLiner pouch is then removed followed by the retractor.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

gynecologic / abdominal cavity

Indicated Patient Age Range

Not Found

Intended User / Care Setting

surgeons with advanced training in laparoscopic techniques; surgeons who have successfully completed the validated training program.
The sale, distribution, and use of the device are restricted to prescription use.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench Studies:

Biocompatibility/Materials: Tests for Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity were conducted according to ISO 10993-1. Results showed the PneumoLiner System is non-cytotoxic, non-sensitizing, and non-irritating.
Shelf Life/Sterility: Sterilization validated per ISO 11137:2006 to achieve a sterility assurance level of 10-6. Accelerated aging simulated 1 year shelf life. Visual inspection per ASTM F1886, Bubble Leak testing per ASTM F2096, and Seal Strength per ASTM F88 were performed with 15, 15, and 60 samples respectively, all passing. Device functionality (35 samples) was assessed through simulated use and leak inspection, followed by bond and material strength testing; all samples met criteria. Supports a 1-year shelf-life.
Barrier Testing:
- Filter Testing: Demonstrated impermeability to human cells using Brevundimonas diminuta. 25 samples tested, no evidence of growth. Repeated with 32 accelerated-aged samples, all passed. Estimated lower bound for passing leakage test is 0.893 (95% CI). Concludes impermeability to cells greater than bacteria size.
- Immersion Testing: Assessed pouch permeability. Initial test using 25 samples showed no B. diminuta growth. Subsequent tests after morcellation (35 samples initially, then an additional 24) involved modifications to the protocol to account for issues with the testing medium and aberrant bacteria. Of 59 total devices tested, 38 samples were included in the final analysis (32 test, 6 controls). No failures were observed, resulting in an upper bound on the 95% confidence interval for failure rate of 0.107 (compared to max allowable of 0.125). Supports that the pouch maintains integrity after morcellation.
Preliminary Bench Testing:
- Laparoscope: Evaluated force to puncture pouch material (minimum force measured was 4 N).
- Tenaculum: Evaluated forces required for grabbing and damaging the material. Two of five tenacula caused damage when open. Most caused damage when scraped.
- Powered Morcellation: Simulated use with 5 different morcellators showed contact with pouch possible at extreme angles not reflective of expected use.
- Pressure/Burst Testing: Evaluated 30 samples. Minimum pressure at failure was 4 kPa.
- Obstruction Testing: 30 samples tested for force required to remove device with a large tissue specimen; no failures at 4 N force.
Design Verification: Nine separate tests were conducted with 30 or more samples each, covering inspection of components, performance and set-up of retractor, set-up and use of boot assembly, set-up and use of PneumoLiner System, inspection of components/assemblies/seams, base retractor assembly, boot assembly, PneumoLiner pouch assembly, and forces required to use the system. All tests passed, with one leakage issue in Test 3 (Leakage rate) that was resolved with a revised design, which then met acceptance criteria.

Animal/Cadaver Studies:

PneumoLiner System Training Validation (Porcine Model):
- Participants: 34 participants (21 experienced, 13 inexperienced) with varying laparoscopic experience.
- Study Design: Participants read IFU, had assisted setup in a training rig, then unassisted setup in training rig, and finally setup/use in a porcine model with beef tongue as specimen.
- Sample Size: At least 3 PneumoLiner Systems used per participant, with a total of 102 systems used.
- Key Results: All users successfully set up and used the system. No observed leaks after water leak test. Users found IFU clear. Lower bound on 95% confidence interval for leakage was 0.898, exceeding the 0.875 limit. Demonstrates successful training for both experienced and inexperienced users.
Design Validation for PneumoLiner System (Porcine Model):
- Participants: 31 participants (21 experienced, 10 inexperienced) from the training validation study.
- Study Design: Each participant used one PneumoLiner System with a beef tongue specimen. A leak test (water fill) was performed after removal.
- Sample Size: 31 PneumoLiner Systems used.
- Key Results: Users were successful; no observed leaks. Lower bound on 95% confidence interval for success was 0.889, exceeding the 0.875 minimum. Confirms device meets design and performance specifications and can be used safely and effectively without leakage.

Clinical Information Summary: Nonclinical testing (bench and animal) is deemed a surrogate for clinical testing to establish reasonable assurance of integrity and prevention of cellular debris transit. These tests assessed the device under worst-case conditions and demonstrated that trained gynecologists could successfully use the device in simulated conditions.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 884.4050 Gynecologic laparoscopic power morcellation containment system.

(a)
Identification. A gynecologic laparoscopic power morcellation containment system is a prescription device consisting of an instrument port and tissue containment method that creates a working space allowing for direct visualization during a power morcellation procedure following a laparoscopic procedure for the excision of benign gynecologic tissue that is not suspected to contain malignancy.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible;
(2) Device components that are labeled sterile must be validated to a sterility assurance level of 10
−6 ;(3) Performance data must support shelf life by demonstrating continued sterility of the device or the sterile components, package integrity, and device functionality over the intended shelf life;
(4) Non-clinical performance data must demonstrate that the device meets all design specifications and performance requirements. The following performance characteristics must be tested:
(i) Demonstration of the device impermeability to tissue, cells, and fluids;
(ii) Demonstration that the device allows for the insertion and withdrawal of laparoscopic instruments while maintaining pneumoperitoneum;
(iii) Demonstration that the containment system provides adequate space to perform morcellation and adequate visualization of the laparoscopic instruments and tissue specimen relative to the external viscera;
(iv) Demonstration that intended laparoscopic instruments and morcellators do not compromise the integrity of the containment system; and
(v) Demonstration that intended users can adequately deploy the device, morcellate a specimen without compromising the integrity of the device, and remove the device without spillage of contents;
(5) Training must be developed and validated to ensure users can follow the instructions for use; and
(6) Labeling must include the following:
(i) A contraindication for use in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy;
(ii) Unless clinical performance data demonstrates that it can be removed or modified, a contraindication for removal of uterine tissue containing suspected fibroids in patients who are: Peri- or postmenopausal, or candidates for en bloc tissue removal, for example, through the vagina or via a mini-laparotomy incision;
(iii) The following boxed warning: “Warning: Information regarding the potential risks of a procedure with this device should be shared with patients. Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer. The use of this containment system has not been clinically demonstrated to reduce this risk.”
(iv) A statement limiting use of device to physicians who have completed the training program; and
(v) An expiration date or shelf life.

Summary

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DE NOVO CLASSIFICATION REQUEST FOR PNEUMOLINER

REGULATORY INFORMATION

FDA identifies this generic type of device as:

Gynecologic Laparoscopic Power Morcellation Containment System: A gynecologic laparoscopic power morcellation containment system is a prescription device consisting of an instrument port and tissue containment method that creates a working space allowing for direct visualization during a power morcellation procedure following a laparoscopic procedure for the excision of benign gynecologic tissue that is not suspected to contain malignancy.

NEW REGULATION NUMBER: 21 CFR 884.4050

CLASSIFICATION: II

PRODUCT CODE: PMU

BACKGROUND

DEVICE NAME: PNEUMOLINER

SUBMISSION NUMBER: DEN150028

DATE OF DE NOVO: JUNE 19, 2015

CONTACT: ADVANCED SURGICAL CONCEPTS UNIT 4 SUNNYBANK CENTRE UPPER DARGLE ROAD BRAY, COUNTY WICKLOW IRELAND

REQUESTER'S RECOMMENDED CLASSIFICATION: II

INDICATIONS FOR USE

The PneumoLiner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during single-port or multi-site laparoscopic surgery during power morcellation and removal. The PneumoLiner is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15 mm and 18 mm in shaft outer diameter and 135 mm and 180 mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation.

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LIMITATIONS

The sale, distribution, and use of the device are restricted to prescription use in accordance with 21 CFR 801.109.

Contraindications

o Do not use on tissue that is known or suspected to contain malignancy.
o Do not use for removal of uterine tissue containing suspected fibroids in patients who are: peri- or post-menopausal; or candidates for en bloc tissue removal, for example, through the vagina or via a mini-laparotomy incision.
o Do not use in women with undiagnosed uterine bleeding.
o Do not use this device on patients with known or suspected allergies to polyurethane.
o Do not use where the abdominal wall thickness is larger than 10 cm.

Boxed Warning

o Information regarding the potential risks of a procedure with this device should be shared with patients. Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer. The use of this containment system has not been clinically demonstrated to reduce this risk.

Warnings

Do not cut, puncture or scrape the PneumoLiner with the morcellator tip or o tenaculum/grasper.
Check for and remove adhesions that may inhibit proper placement of the device O
At all times prior to morcellating, make sure the tenaculum/grasper is within view O when grasping tissue, to prevent it contacting the PneumoLiner.
The tip of the morcellator must be brought into view, prior to and during each o activation to provide confirmation of the position of the morcellator tip and its proximity to the PneumoLiner.
Do not bring the morcellator tip into contact with the PneumoLiner. O
To prevent risk of contamination, do not re-attach the Boot following removal of O the PneumoLiner.
Any abdominal incision introduces a risk of abdominal hernia o
The PneumoLiner must be fully inflated (12 15 mmHg) to minimize the risk of O damage to the bag and adjacent organs during morcellation.
With the tip of the morcellator in view, prior to activating the morcellator, confirm O that the tissue specimen is centered within the PneumoLiner.

Precautions

Device should only be used with 5 mm laparoscopes with >30° lens angle or o deflectable tip
Only use an atraumatic grasper to manipulate the PneumoLiner O

2

Regarding the grasper/tenaculum used, teeth which are curved proximally to shield o their sharp tips may help reduce the risk of damage to the bag from the grasper/tenaculum. However, a lower risk grasper does not alter the risk of damage to the bag from the morcellator tip. Careful adherence to the training provided and the Instructions for Use regarding placement and visualization of the tip remains critical.
To prevent risk of contamination, do not re-use the laparoscope following removal o of the PneumoLiner.
Appropriate pre-operative diagnostic testing should be completed prior to using this o device.
o This device should only be used by surgeons with advanced training in laparoscopic techniques.
This device should only be used by surgeons who have successfully completed the o validated training program.

PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS AND PRECAUTIONS.

DEVICE DESCRIPTION

The PneumoLiner System consists of two main components:

A laparoscopic multi-instrument port ●
Tissue pouch (PneumoLiner) intended to provide a separately contained space within the ● abdomen for the safe morcellation of tissue

As depicted in Figure 1 below, the laparoscopic multi-instrument port consists of the Retractor, Retractor Introducer and the Boot Assembly.

Figure 1: PneumoLiner System Components

3

Image /page/3/Figure/0 description: The image shows five medical instruments labeled with numbers and descriptions. Item 1 is labeled "Retractor Introducer", item 2 is labeled "Retractor", and item 3 is labeled "Boot Assembly". Item 4 is labeled "PneumoLiner Introducer Shaft and Plunger", and item 5 is labeled "PneumoLiner".

The Retractor Introducer is placed through the abdominal incision (20-25 cm) to deliver the distal ring on the Retractor. The Retractor retracts the incision to allow passage of laparoscopic instruments. The Retractor provides a gas-tight seal between the device and the incision. It also provides an anchor for the Boot Assembly.

The Boot Assembly consists of two insufflation ports and two instrument ports. The insufflation ports are used for the delivery of gas for distension and the venting of smoke during the course of the procedure. The ports consist of a large instrument valve port which is intended for the introduction of the PneumoLiner pouch/Morcellator and a 5 mm valve port which can accommodate a 5 mm instrument such as a laparoscope or grasper. (The large instrument valve also includes a reducer such that the opening can be reduced to 5 mm for smaller instruments.)

The PneumoLiner pouch is preloaded into the Introducer. The PneumoLiner Introducer Shaft is inserted through the Large Instrument Valve in the Boot Assembly. The PneumoLiner Introducer Plunger is then pushed into the Shaft to eject the PneumoLiner pouch into the abdominal cavity. As shown in Figure 2, an opening ring on the neck of the PneumoLiner pouch ensures that it is kept open. After the specimen is placed in the PneumoLiner pouch, a tether provides the mechanism for closing the PneumoLiner pouch and exteriorizing the collar section.

4

Figure 2 – Tissue specimen being placed in PneumoLiner pouch

Image /page/4/Figure/1 description: The image shows a medical device, possibly a type of harness or support system. It features a circular band with adjustable straps and a padded section on one side. The device also includes a suspension system with a loop at the top, suggesting it may be designed to provide support or traction to a specific body part.

The Boot Assembly is reattached inside the exteriorized PneumoLiner pouch enabling inflation of the PneumoLiner pouch and re-establishing pneumoperitoneum. The printed grid pattern allows for distinction between the tissue sample and the retracted viscera. The morcellation can then be conducted under direct visualization.

After morcellation is complete, the PneumoLiner pouch is deflated and the boot assembly is removed. The PneumoLiner pouch is then removed followed by the retractor.

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SUMMARY OF NONCLINICAL/BENCH STUDIES

BIOCOMPATIBILITY/MATERIALS

Table 1 - Design Verification

10

1

11

*Due to one observation in which passage of a large instrument through the valve resulted in a leakage rate of(b) (4) (4) Testing repeated on the revised design met the acceptance criteria.

Clinical Simulation of Morcellation

Simulated use testing was conducted to determine the ability of the PneumoLiner pouch to withstand morcellation using animal tissue, and to validate the test method for finding leaks/punctures following use. A total of 34 PneumoLiner pouches and 5 PneumoLiner System boot assembly and retractors were used for the testing along with the following laparoscopic instruments: graspers, trocars, laparoscope, variety of tenacula, and variety of morcellators (including electromechanical and bipolar). (All PneumoLiner pouches were initially checked for leaks as described in Test 2 below.)

In Test 1, simulated use was carried out in a surgical simulation test rig (SSTR). Of the 34 PneumoLiner Systems used. the first ten tests were run using lamb heart as the tissue specimen, and the final twenty-four with beef tongue to assess different tissue characteristics. Morcellation was carried out in the insufflated PneumoLiner pouch using one of three different morcellators. Tissue specimen weights ranged from (b) (4) (b) The time to morcellate ranged (b) (4) . Operator experience and tissue type played a role in the time. The weight of tissue morcellated ranged from(0) (4) the weight remaining in the PneumoLiner pouch was (b) (4)

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The tissue remaining in the PneumoLiner pouch (b) (4)

The largest force measured was (b) (4) This was below the 200N minimum force the bag can withstand.

Test 2 was a leak test. Each of the 34 samples above was cleaned and dried. (b) (4)

r. Each inspection was carried out (b) (4) No bags were noted to have a leak. These samples were then used in the barrier testing previously described.

PERFORMANCE TESTING - ANIMAL &/OR CADAVER

Testing in an animal model was used for training validation and design validation.

PneumoLiner System Training Validation

The training program developed by the device manufacturer was validated through testing in a porcine model, using participants with a range of experience in laparoscopic procedures. The training validation consisted of the following steps:

1. A study coordinator shows and describes use of the PneumoLiner System while participant reads the Instructions for Use (IFU).
1. Assisted device set up and use in which the coordinator assists the participant in set up and use of the PneumoLiner System in the training rig.
Participant sets up and uses the PneumoLiner System without assistance in the 3. training rig.
1. Participant sets up and uses the PneumoLiner System in a porcine model (beef tongue in various sizes used for morcellation specimen).

Thirty-four participants with a range of experience in laparoscopy were recruited. Each participant used at least 3 PneumoLiner Systems in the training. Four different morcellators were used (2 bipolar and 2 electromechanical). The following table, Table 2, provides a breakdown of device usage by operator experience:

Table 2 - Training Validation: Operator Experience

	Experienced	Inexperienced
Mechanical Morcellators	8	5
Bipolar Morcellators	13	8
Total	21	13

All users were able to successfully set up and use the PneumoLiner System.

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Following inspection with a water leak test, no PneumoLiner Systems were observed to have a leak. The users reported that the IFU was clear and understandable; however, there were a few comments provided by the users that were incorporated into the training and a revised IFU for further clarity and emphasis.

With no failures noted in the 34 tests, the estimated lower bound on the 95% confidence interval for leakage is 0.898. This was greater than the 0.875 limit set for passing this test. (Note: A total of 102 PneumoLiner Systems were used in total during this test with no evidence of leak.)

This testing demonstrates that both inexperienced and experienced users can be trained to perform a contained morcellation without compromising the PneumoLiner System and can successfully use the device.

Design Validation for PneumoLiner System

The purpose of the study was to show that the PneumoLiner System can be used safely and effectively. Specifically, the primary outcome was to assess whether surgeons in a clinical setting can damage the PneumoLiner pouch. The secondary outcomes are based on successful set up and use of the device, and that it meets user needs, e.g., it was effective in containing the tissue.

Participants from the training validation study participated in this study, with the exception of 3 subjects from the inexperienced cohort. Each participant (n=31) used one PneumoLiner System in a porcine model with beef tongue for the morcellation specimen. Specimen sizes tested ranged from approximately (b) (4) (4) = with three samples (b) (4) range. Table 3 provides a breakdown of morcellator type by experience level:

	Experienced	Inexperienced
Mechanical Morcellators	8	5
Bipolar Morcellators	13	5
Total	21	10

Table 3 - Design Validation: Operator Experience

Each participant performed set up and use of the morcellator. Following removal, the test coordinator performed a leak test on the PneumoLiner pouch. The PneumoLiner pouch was filled with water (b) (4) and observed for leaks.

In all cases the users were successful in carrying out the procedure. There were no observed leaks following the procedure. There were a few comments from participants that were incorporated into the training and instructions for use for additional clarity.

With no device failures noted in 31 tests, the lower bound on the 95% confidence

14

interval for success was 0.889. This exceeded the minimum value of 0.875 set in the sample size calculation. (As described above for the immersion test, a simple superiority test was set with a value of 0.875 with a 90% power and 0.025 alpha. The difference is that this was described as a test of success whereas the immersion test was described as a test of failure; therefore 0.875 was used here as opposed to the 0.125 used in the immersion test. The same method for determining the target success/failure was used.)

The nonclinical testing conducted on the bench and in an animal model demonstrates that the PneumoLiner System meets its design and performance specifications and can be successfully used by physicians without evidence of leakage.

SUMMARY OF CLINICAL INFORMATION

The nonclinical testing serves as a surrogate for clinical testing for establishing reasonable assurance that the PneumoLiner System will maintain its integrity and will not allow transit of cellular debris following laparoscopic power morcellation procedures. The bench and animal testing provide a rigorous assessment of the design and performance of the device and are adequate to support the use of the device in women who may currently undergo uncontained laparoscopic power morcellation. Because this testing was conducted on the bench and in animal models instead of in humans, the testing conditions could be made more challenging to evaluate the device under worst case conditions. The submission also included testing that demonstrated that gynecologists with varying levels of experience could successfully use the device under simulated use conditions following completion of the training program developed by the sponsor. These tests were adequate to support the use of the device in women who may currently undergo uncontained laparoscopic power morcellation.

LABELING

The labeling meets the requirements of 21 CFR §801.109 for prescription devices.

The PneumoLiner System Instructions for Use address the known hazards and risks of the procedure and incorporate safety statements to mitigate these risks. The labeling includes:

. Information on the types of morcellators, laparoscopes, graspers with which the device has been demonstrated to be compatible.
. The intended use population.
. Safety instructions intended to minimize the risk of contact of surgical instruments with the inside of the PneumoLiner pouch.
Safety instructions emphasizing the importance of visualization of the tenaculum/grasper and morcellator tip at all times.
Risk information in a boxed warning that physicians should share with patients regarding . the potential for uterine tissue to contain an undetected cancer, potential for a

15

laparoscopic power morcellator to spread cancer, and the lack of clinical demonstration of a reduction in risk when using a containment system.

The use of the device requires training of the user. Clinicians using the PneumoLiner System must be physicians who have familiarized themselves with the PneumoLiner System Instructions for Use and have undergone training in the use of the device.
The contraindications identified in the PneumoLiner labeling contribute to the defined indications for use for the PneumoLiner. Removal or modification of any of the contraindications, for new and already cleared devices [see 21 CFR 807.81(a)(3)], will require submission of a premarket notification [510(k)], which includes clinical performance testing to demonstrate that users can use the device to contain the tissue specimen for the intended patient population.

The information in the boxed warning is considered necessary for identifying the benefits and risk of the PneumoLiner procedure.

RISKS TO HEALTH

Table 4 below identifies the risks to health that may be associated with use of the Gynecologic Laparoscopic Power Morcellation Containment System and the measures necessary to mitigate these risks.

Identified Risk	Mitigation Measure
Adverse tissue reaction	Biocompatibility
Infection	Sterilization Validation
Shelf Life Validation
Labeling
Intraperitoneal tissue dissemination (benign or malignant)
Material permeability Improper function of containment device Inadequate material strength Physical trauma to liner caused by contact with morcellator or grasper/tenaculum Damage to liner (intentional or accidental) from instrument inserted through secondary port Tearing during removal with loss of contents into abdominal cavity Use error	Non-clinical Performance Testing (Bench and Animal)
Shelf Life Validation
Labeling
Training

Table 4: Identified Risks to Health and Mitigation Measures

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| Traumatic injury to non-target tissue/organ | Non-clinical Performance Testing
(Bench and Animal) |
|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| • Active end of morcellator or
grasper/tenaculum breaches liner | Labeling |
| • Loss of insufflation | Training |
| • Inadequate space to perform
morcellation | |
| • Inadequate visualization of the
laparoscopic instruments and tissue
specimen relative to the external
viscera | |
| • Use error | |
| Hernia through abdominal wall incision | Labeling |
| | Training |
| Prolongation of procedure and exposure to
Anesthesia | Labeling |
| | Training |

SPECIAL CONTROLS:

In combination with the general controls of the FD&C Act, the Gynecologic Laparoscopic Power Morcellation Containment System is subject to the following special controls:

1. The patient-contacting components of the device must be demonstrated to be biocompatible.
1. Device components that are labeled sterile must be validated to a sterility assurance level of 10-°.
1. Performance data must support shelf life by demonstrating continued sterility of the device or the sterile components, package integrity, and device functionality over the intended shelf life.
1. Non-clinical performance data must demonstrate that the device meets all design specifications and performance requirements. The following performance characteristics must be tested:
- a. Demonstration of the device impermeability to tissue, cells and fluids.
- b. Demonstration that the device allows for the insertion/withdrawal of laparoscopic instruments while maintaining pneumoperitoneum.
- c. Demonstration that the containment system provides adequate space to perform morcellation and adequate visualization of the laparoscopic instruments and tissue specimen relative to the external viscera.
- d. Demonstration that intended laparoscopic instruments and morcellators do not compromise the integrity of the containment system.
- Demonstration that intended users can adequately deploy the device, morcellate a e. specimen without compromising the integrity of the device and remove the device without spillage of contents.
1. Training must be developed and validated to ensure users can follow the instructions for use.
1. Labeling must include:

17

. Contraindication for use in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.
Unless clinical performance data demonstrates that it can be removed or modified, a contraindication for removal of uterine tissue containing suspected fibroids in patients who are: peri- or post-menopausal; or candidates for en bloc tissue removal, for example, through the vagina or via a mini-laparotomy incision.
. The following boxed warning: "Warning: Information regarding the potential risks of a procedure with this device should be shared with patients. Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer. The use of this containment system has not been clinically demonstrated to reduce this risk."
Statement limiting use of device to physicians who have completed the training ● program.
An expiration date or shelf life. ●

BENEFIT/RISK DETERMINATION

The risks of the PneumoLiner System are based on nonclinical laboratory studies (bench and animal). The risks associated with the use of the device include intraperitoneal tissue dissemination, traumatic injury to non-target tissue/organ, infection, hernia through abdominal wall incision, adverse tissue reaction and prolongation of procedure.

The probable benefits of the PneumoLiner System are also based on nonclinical laboratory studies (bench and animal). The benefits of the device include containment of tissue during laparoscopic power morcellation and the associated ability to perform a minimally invasive surgery. The nonclinical testing serves as a surrogate for clinical testing for establishing reasonable assurance that the PneumoLiner System will maintain its integrity and will not allow transit of cellular debris following laparoscopic power morcellation procedures.

The PneumoLiner System also offers the benefit of inflation of the containment system and visualization within the containment system. These two benefits allow for the creation of a working space around the specimen and visualization of the morcellator tip during morcellation. The single port design provides the additional benefits of single site surgery.

In conclusion, given the available information, the data support that when the PneumoLiner System is used in accordance with the intended population identified in the labeling for laparoscopic power morcellators, the probable benefits outweigh the probable risks. The device provides substantial benefits and the risks can be mitigated by the use of general and the identified special controls.

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CONCLUSION

The de novo for the PneumoLiner is granted and the device is classified under the following:

Product Code: PMU Device Type: Gynecologic Laparoscopic Power Morcellation Containment System Class: II Regulation: 21 CFR 884.4050