PNEUMOCLEAR

K201361 · W.O.M. World of Medicine GmbH · HIF · Jul 29, 2020 · Obstetrics/Gynecology

Device Facts

• Record ID: K201361
• Device Name: PNEUMOCLEAR
• Applicant: W.O.M. World of Medicine GmbH
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Jul 29, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 CO2 gas. The Standard, High Flow/Bariatric, Pediatric and Advanced Flow operating mode of the device are indicated to fill and distend a perioneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is indicated for pediatic 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 transanal minimally invasive surgery.

Device Story

Microprocessor-controlled CO2 insufflator; manages cavity distension during endoscopic procedures. Inputs: CO2 gas source; pressure/flow settings via GUI. Operation: Electronic-mechanical system monitors/maintains pressure; features six modes (Standard, High Flow/Bariatric, Pediatric, Advanced Flow, Vessel Harvest, TAMIS). Outputs: Controlled CO2 delivery; optional smoke evacuation/filtration. Used in clinical settings by physicians/trained staff. Enhances visualization/access by creating/maintaining working space; smoke evacuation improves visibility. Integrates with single-use sterile tube sets (with optional heating/humidification).

Clinical Evidence

Bench testing only. No clinical data presented. Verification included electrical safety (AAMI ANSI ES60601-1), EMC (IEC 60601-1-2), packaging/shelf-life (ASTM D642, D999, D4169, D4728, D5276, D6344, F88, F1886, F1929, F1980, F2096, ISO 11607-1, ISO 2233), and simulated use testing for smoke evacuation and sensor sealing.

Technological Characteristics

Microprocessor-controlled insufflator; line-powered. Materials: MABS, PVC, Hydrophobic Glass Fiber, Polyolefin, Silicone, FEP, Polyester, Nylon, Terlux 2802. Features: pressure sensors, venting, suction pump, GUI touch screen. Connectivity: Standalone. Sterilization: EO (tube sets). Software: IEC 62304 compliant. Max flow: 50 l/min; Max pressure: 30 mmHg.

Indications for Use

Indicated for patients undergoing diagnostic/therapeutic endoscopic procedures requiring cavity distension with CO2 gas, including laparoscopic procedures (Standard, High Flow/Bariatric, Pediatric, Advanced Flow modes), pediatric laparoscopic procedures, endoscopic vessel harvesting (saphenous vein or radial artery), and transanal minimally invasive surgery (TAMIS).

Regulatory Classification

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.

Predicate Devices

• PNEUMOCLEAR™ (K170784)

Submission Summary (Full Text)

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July 29, 2020

W.O.M. WORLD OF MEDICINE GmbH Soeren Markworth Head of Regulatory Affairs Salzufer 8 Berlin, Berlin 10587 Germany

Re: K201361 Trade/Device Name: PNEUMOCLEAR™ Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF, OSV Dated: Mav 22, 2020 Received: May 22, 2020

Dear Soeren Markworth:

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.

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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jason R. Roberts, Ph.D. Acting 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K201361

Device Name PNEUMOCLEARTM

#### Indications for Use (Describe)

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 CO2 gas. The Standard, High Flow/Bariatric, Pediatric and Advanced Flow operating mode of the device are indicated to fill and distend a perioneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is indicated for pediatic 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 transanal minimally invasive surgery.

| Type of Use (Select one or both, as applicable) | <span> <input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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Image /page/3/Picture/0 description: The image contains a logo with a circular design and a stylized "WOM" text below it. Underneath the logo and text, the words "PNEUMOCLEAR™" are written. The phrase "510(k) Premarket Notification" is written below the brand name.

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

#### General Information:

| Submitter: | W.O.M. WORLD OF MEDICINE GmbH<br>Salzufer 8<br>10587 Berlin<br>Germany<br>Phone: [phone]<br>Fax: [phone] |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number: | 3001556604 |
| Contact Person: | Dr. Soeren Markworth<br>Head of Regulatory Affairs<br>Salzufer 8<br>10587 Berlin, Germany<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| Date Prepared: | July 24, 2020 |
| Proposed Device: | |
| Trade Name: | PNEUMOCLEAR™ |
| Common Name: | Carbon Dioxide Insufflator for Laparoscopy and Vessel<br>Harvesting |
| Classification Name: | Insufflator, Laparoscopic |
| Regulation Number: | 21 CFR 884.1730 |
| Regulation Name: | Laparoscopic Insufflator |
| Regulatory Class: | II |
| Product Code: | HIF, OSV |
| Predicate Device: | |
| Trade Name: | PNEUMOCLEAR™ |
| 510(k) Number: | K170784 |
| Applicant: | W.O.M. WORLD OF MEDICINE GmbH |
| Regulation Number: | 21 CFR 884.1730 |
| Regulation Name: | Laparoscopic Insufflator |
| Regulatory Class: | II |

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Image /page/4/Picture/1 description: The image shows the logo for WOM, which is a stylized circle with a knot in the middle and a small triangle at the bottom. Below the logo, the text "WOM" is written in a bold sans-serif font. Below that, the text "PNEUMOCLEAR™" is written in a smaller font, followed by "510(k) Premarket Notification".

HIF, OSV Product Code:

The PNEUMOCLEAR™ has not been subject to a design related recall.

#### Device Description:

The PNEUMOCLEAR™ is a microprocessor controlled device that consists of the following major components and features: a casing, a world power supply, pressure reducers, pressure sensors, venting systems, various safety valves, a suction pump, a fluid sensor and a software controlled graphical user interface (GUI) touch screen with various setting keys and display elements. The proposed device offers six operating modes: Standard, High Flow/Bariatric, Pediatric, Advanced Flow, Vessel Harvest, and TAMIS. The PNEUMOCLEAR™is not intended to enter the sterile field and cannot be sterilized. It is to be used with one of the following specially designed, single-use, sterile insufflation tube sets: (1) insufflation tube set with integrated filter, (2) insufflation tube set with integrated filter and heating wire; (3) insufflation tube set with integrated filter, heating wire and humidification media; (4) insufflation and smoke evacuation tube set with integrated filter, heating wire. and humidification media; and (5) insufflation and smoke evacuation tube set with integrated filter. When a smoke evacuation tube set is connected, the PNEUMOCLEAR™ allows for removal and filtration of CO2 and surgical smoke from the abdomen. rectum or colon during laparoscopic and transanal minimally invasive procedures and at the end of a procedure.

### Intended Use / Indication for Use:

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 CO2 gas. The Standard, High Flow/Bariatric, Pediatric and Advanced Flow operating mode 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 transanal minimally invasive surgery.

### Comparison of Technological Characteristics:

The PNEUMOCLEAR™ that is the subject of this 510(k) is substantially equivalent to its predicate, predecessor K170784 PNEUMOCLEAR™. This is a catch-up 510(k) submission intended to update the PNEUMOCLEAR™ record at FDA with the changes that have been implemented for the device. As such, the intended use and indications remain identical to those for the cleared device. Further, the

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Image /page/5/Picture/0 description: The image shows the logo for WOM PNEUMOCLEAR. The logo consists of a circular design with a stylized "W" inside, above the text "WOM". Below that is the text "PNEUMOCLEAR™" and "510(k) Premarket Notification".

implemented changes were primarily to tweak the optional features based on user feedback or internal, routine, developmental updates. These are captured in the comparison table below.

| Substantial Equivalence Comparison Table | | |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Cleared Device: | Subject Device: |
| | PNEUMOCLEAR™ | PNEUMOCLEAR™ |
| | (K170784) | (this submission) |
| Manufacturer | W.O.M.World of Medicine GmbH | Identical |
| Regulation Number | 884.1730 | Identical |
| Regulation Name | Laparoscopic Insufflator | Identical |
| Procodes | HIF, OSV | Identical |
| Indications for Use | The device PNEUMOCLEAR™ is a CO2<br>insufflator intended for use during<br>diagnostic and/or therapeutic<br>endoscopic<br>procedures to distend a cavity by filling it<br>with gas. The Standard, High<br>Flow/Bariatric, Pediatric and Advanced<br>Flow operating mode of the device are<br>indicated to fill and distend a peritoneal<br>cavity with gas during a laparoscopic<br>procedure. The Pediatric operating<br>mode is indicated for pediatric<br>laparoscopic procedures. The Vessel<br>Harvest operating mode is indicated for<br>use during endoscopic vessel harvesting<br>procedures to create a cavity along the<br>saphenous vein or radial artery. The<br>TAMIS operating mode is indicated to fill<br>and distend the rectum and colon using<br>CO2 gas during trans anal minimal<br>invasive surgery. | The device PNEUMOCLEAR™ is a CO₂<br>insufflator intended for use during<br>diagnostic and/or therapeutic endoscopic<br>procedures to distend a cavity by filling it<br>with CO₂ gas. The Standard, High<br>Flow/Bariatric, Pediatric and Advanced<br>Flow operating modes of the device are<br>indicated to fill and distend a peritoneal<br>cavity with gas during a laparoscopic<br>procedure. The Pediatric operating mode is<br>indicated for pediatric laparoscopic<br>procedures. The Vessel Harvest operating<br>mode is indicated for use during<br>endoscopic vessel harvesting procedures<br>to create a cavity along the saphenous vein<br>or radial artery. The TAMIS operating mode<br>is indicated to fill and distend the rectum<br>and colon using CO₂ gas during trans anal<br>minimal invasive surgery. |
| Substantial Equivalence Comparison Table | | |
| | Cleared Device: | Subject Device: |
| | PNEUMOCLEAR™ | PNEUMOCLEAR™ |
| | (K170784) | (this submission) |
| Target Population | Patients undergoing the procedures<br>indicated for the device. | Identical |
| Target Users | For physicians and trained hospital<br>staff. | Identical |
| Power source | Line powered | Identical |
| Mechanism of Action | Insufflation of the target area, which is<br>monitored and maintained by a<br>microprocessor-controlled, electronic-<br>mechanical system | Identical |
| Maximum Flow | 50 l/min | Identical |
| Maximum Pressure | 30 mmHg | Identical |
| Heating Option | Yes | Identical |
| Humidification<br>Option | Yes | Identical |
| Smoke Evacuation<br>Option | Yes | Identical |
| Tube Sets | | |
| Substantial Equivalence Comparison Table | | |
| | Cleared Device: | Subject Device: |
| | PNEUMOCLEAR™<br>(K170784) | PNEUMOCLEAR™<br>(this submission) |
| Model ST295 | Insufflation tube set with integrated filter | Identical |
| Model ST296 | Insufflation tube set with integrated filter and heating wire | Identical<br>Packaging change to address a shipping issue. |
| Model ST297 | Insufflation tube set with integrated filter, heating wire and humidification | Implemented a manufacturing change to better seal a component. |
| Model ST298 | Insufflation and smoke evacuation tube set with integrated filter, heating wire and humidification | • Implemented a manufacturing change to better seal a component.<br>• Implemented a design change to a gas line. |
| Model ST299 | Insufflation and smoke evacuation tube set with integrated filter | Implemented a design change to a gas line. |
| Sterilization Process | EO | Identical |
| Materials | MABS, PVC, Hydrophobic Glass Fiber, Polyolefin, Silicone, FEP, Polyester, Nylon. | Additional Terlux 2802 and fiber materials for the design change to a gas line. |
| Single-Use | Yes | Identical |
| Shelf-life | 3 years | Identical |
| Software | Version 1.0.27 | Version 1.0.34 |

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Image /page/6/Picture/1 description: The image contains a logo with a circular design and a stylized shape inside, along with the text "WOM" below it. Underneath "WOM", the text "PNEUMOCLEAR™" is displayed, followed by "510(k) Premarket Notification". The text is arranged in a clear, hierarchical manner, suggesting a product name and its regulatory status.

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Image /page/7/Picture/1 description: The image shows the logo for WOM, which is a stylized circle with a design inside and the letters "WOM" below it. Below the logo is the text "PNEUMOCLEAR™" and "510(k) Premarket Notification". The text is centered below the logo. The image appears to be a product or company logo with a notification about premarket approval.

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Image /page/8/Picture/0 description: The image shows the logo for WOM PNEUMOCLEAR. The logo consists of a circular design with a stylized figure-eight shape inside, above the text "WOM PNEUMOCLEAR™". Below this is the text "510(k) Premarket Notification".

The differences between the two versions of PNEUMOCLEAR™ do not raise different questions of safety and effectiveness and have been confirmed through testing.

#### Performance Data:

The changes implemented for the PNEUMOCLEAR™ were confirmed using the same guidance/recognized standards that were used for the cleared device. These include:

- Electrical Safety and Electromagnetic Compatibility ●
- o AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012
- IEC 60601-1-2 Edition 4.0 2014-02 O

#### Packaging and Shelf-Life Testing ●

The effectiveness of the tube set barrier provided by the modified packaging was confirmed using the following transportation, packaging and shelf-life standards:

- o ASTM D642 (2015)
- ASTM D999 (2008) O
- ASTM D4169 (2016) O
- ASTM D4728 (2006) O
- ASTM D5276 (1998) O
- ASTM D6344 (2004) O
- ASTM F88 (2015) O
- ASTM F1886 (2016) O
- ASTM F1929 (2015) O
- ASTM F1980 (2016) O
- ASTM F2096 (2011) O
- ISO 11607-1 First Edition 2006-04-15 O
- O ISO 2233 (2001)

#### Software/Bench Testing ●

W.O.M. developed and verified the software in accordance with a major level of concern described in the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and following the IEC 62304 Edition 1.1 2015-06 standard.

The sensor sealing process for tube sets ST297 and ST298 was modified and confirmed through submerged testing. The gas line for the ST297 and ST298 tube sets was modified to improve the surgical smoke evacuation and verified through simulated use testing.

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Image /page/9/Picture/0 description: The image shows the logo for WOM, which is a circle with a design inside and a small red triangle at the bottom. Below the logo is the word "WOM" in large, bold letters. The text "PNEUMOCLEAR™ 510(k) Premarket Notification" is written below the logo and the word WOM.

The complete Version 1.0.34 software and all other changes were bench-tested to confirm that they met their requirements before implementation.

### Conclusion:

The provided performance testing supports a substantial equivalence determination. The subject PNEUMOCLEAR™ is substantially equivalent to its predicate, predecessor K170784 PNEUMOCLEAR™