(68 days)
Not Found
No
The description focuses on microprocessor control, various operating modes, and safety features, with no mention of AI or ML capabilities.
No
The device is used to distend a cavity for diagnostic and/or therapeutic endoscopic procedures, but it does not directly provide therapy itself. It facilitates therapeutic procedures rather than being a therapeutic device.
No
The device is a CO2 insufflator used to distend cavities during endoscopic procedures. It does not perform any diagnostic functions like image processing, data analysis, or measurement to identify or categorize medical conditions or diseases. Its purpose is to facilitate diagnostic and/or therapeutic procedures by creating space.
No
The device description explicitly lists multiple hardware components such as a casing, power supply, pressure reducers, sensors, valves, a suction pump, and a fluid sensor, in addition to the software controlled GUI.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for distending a cavity by filling it with CO2 gas during endoscopic procedures. This is a therapeutic and diagnostic procedure performed in vivo (within the body), not an in vitro (outside the body) test on biological samples.
- Device Description: The description details a device that delivers gas and potentially removes smoke from a body cavity. It does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Providing information about a patient's health status based on laboratory tests.
- Using reagents or calibrators.
- Measuring analytes in biological samples.
The PNEUMOCLEAR™ is a medical device used to facilitate surgical and diagnostic procedures performed directly on the patient.
N/A
Intended Use / Indications 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 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.
Product codes
HIF, OSV
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal cavity, saphenous vein, radial artery, rectum, colon
Indicated Patient Age Range
The Pediatric operating mode is indicated for pediatic laparoscopic procedures.
Intended User / Care Setting
For physicians and trained hospital staff.
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)
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
- 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
- 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:
- ASTM D642 (2015)
- ASTM D999 (2008)
- ASTM D4169 (2016)
- ASTM D4728 (2006)
- ASTM D5276 (1998)
- ASTM D6344 (2004)
- ASTM F88 (2015)
- ASTM F1886 (2016)
- ASTM F1929 (2015)
- ASTM F1980 (2016)
- ASTM F2096 (2011)
- ISO 11607-1 First Edition 2006-04-15
- ISO 2233 (2001)
- The effectiveness of the tube set barrier provided by the modified packaging was confirmed using the following transportation, packaging and shelf-life standards:
- 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.
- The complete Version 1.0.34 software and all other changes were bench-tested to confirm that they met their requirements before implementation.
Key result: The provided performance testing supports a substantial equivalence determination. The subject PNEUMOCLEAR™ is substantially equivalent to its predicate, predecessor K170784 PNEUMOCLEAR™.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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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
Salzufer 8
10587 Berlin
Germany
Phone: +49 30 39981 594
Fax: +49 30 39981 593 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number: | 3001556604 |
| Contact Person: | Dr. Soeren Markworth
Head of Regulatory Affairs
Salzufer 8
10587 Berlin, Germany
Phone: +4930-399 81-594
Fax: +4930-399 81-593
e-mail: soeren.markworth@wom.group |
| Date Prepared: | July 24, 2020 |
| Proposed Device: | |
| Trade Name: | PNEUMOCLEAR™ |
| Common Name: | Carbon Dioxide Insufflator for Laparoscopy and Vessel
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 | |
| 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 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 trans anal minimal | ||
| invasive surgery. | 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 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 | ||
| minimal invasive surgery. | ||
| Substantial Equivalence Comparison Table | ||
| Cleared Device: | Subject Device: | |
| PNEUMOCLEAR™ | PNEUMOCLEAR™ | |
| (K170784) | (this submission) | |
| Target Population | Patients undergoing the procedures | |
| indicated for the device. | Identical | |
| Target Users | For physicians and trained hospital | |
| staff. | Identical | |
| Power source | Line powered | Identical |
| Mechanism of Action | Insufflation of the target area, which is | |
| monitored and maintained by a | ||
| microprocessor-controlled, electronic- | ||
| mechanical system | Identical | |
| Maximum Flow | 50 l/min | Identical |
| Maximum Pressure | 30 mmHg | Identical |
| Heating Option | Yes | Identical |
| Humidification | ||
| Option | Yes | Identical |
| Smoke Evacuation | ||
| Option | Yes | Identical |
| Tube Sets | ||
| Substantial Equivalence Comparison Table | ||
| Cleared Device: | Subject Device: | |
| PNEUMOCLEAR™ | ||
| (K170784) | PNEUMOCLEAR™ | |
| (this submission) | ||
| Model ST295 | Insufflation tube set with integrated filter | Identical |
| Model ST296 | Insufflation tube set with integrated filter and heating wire | Identical |
| 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. |
| • 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.
7
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.
8
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.
9
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™