Renova RP Centesis Pump

K221042 · Gi Supply, Inc. · BTA · Apr 19, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K221042
• Device Name: Renova RP Centesis Pump
• Applicant: Gi Supply, Inc.
• Product Code: BTA · General, Plastic Surgery
• Decision Date: Apr 19, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RenovaRP® Centesis Pump is intended to be used in conjunction with the RenovaRP Tube Set and the RenovaRP Fluid Drainage Bags to remove ascitic fluid from the abdominal cavity for paracentesis, and remove pleural effusion from the thoracic cavity for thoracentesis. The Renova RP Centesis Pump is intended to be used by trained healthcare professionals knowledgeable about paracentesis and thoracentesis.

Device Story

RenovaRP Centesis Pump is a powered peristaltic suction pump; used in hospital/clinic settings by trained healthcare professionals. Device connects to RenovaRP Tube Set and Fluid Drainage Bags to remove ascitic fluid or pleural effusion. Pump operates on AC power (100-230V); provides 700 mL/min flow rate. Healthcare providers use the system to perform paracentesis and thoracentesis procedures. Output is the physical removal of fluid from body cavities into drainage bags. Benefits include efficient, controlled fluid aspiration for patient symptom relief.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified via simulated use, functional testing, distribution testing, and standards compliance (IEC 60601-1, IEC 60601-1-2, EN IEC 62366-1). Biocompatibility testing (ISO 10993-1) and cleaning validation (ISO 17664) performed on components.

Technological Characteristics

Powered peristaltic suction pump; AC-powered (100-230V, 50/60Hz). Flow rate 700 mL/min. Dimensions 33x23x33 cm; weight 8.5 lbs. Class I, Type B electrical safety. Reusable pump; single-patient-use sterile disposable tube sets and drainage bags. Complies with IEC 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for removal of ascitic fluid from the abdominal cavity (paracentesis) and pleural effusion from the thoracic cavity (thoracentesis) in patients requiring fluid drainage. Intended for use by trained healthcare professionals.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Predicate Devices

• RenovaRP® Paracentesis Pump (K970186)

Reference Devices

• RenovaRP® Tube Set and Fluid Drainage Bags (K970187)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 19, 2023

GI Supply, Inc. Thomas Saladin Global Regulatory Lead 5069 Ritter Road Suite 104 Mechanicsburg, Pennsylvania 17055

Re: K221042

Trade/Device Name: Renova RP Centesis Pump Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: BTA Dated: March 20, 2023 Received: March 20, 2023

## Dear Thomas Saladin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm = identifies = combination = product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical

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device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-DICE website assistance/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,

Digitally signed by Mark Mark Trumbore -S -Trumbore -S Date: 2023.04.19 Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K221042

Device Name RenovaRP® Centesis Pump System

Indications for Use (Describe)

The RenovaRP® Centesis Pump is intended to be used in conjunction with the RenovaRP Tube Set and the RenovaRP Fluid Drainage Bags to remove ascitic fluid from the abdominal cavity for paracentesis, and remove pleural effusion from the thoracic cavity for thoracentesis.

The Renova RP Centesis Pump is intended to be used by trained healthcare professionals knowledgeable about paracentesis and thoracentesis.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.2812 2.71875H2.71875C1.52344 2.71875 0.5 3.74219 0.5 4.9375V13.2812C0.5 14.4766 1.52344 15.5 2.71875 15.5H13.2812C14.4766 15.5 15.5 14.4766 15.5 13.2812V4.9375C15.5 3.74219 14.4766 2.71875 13.2812 2.71875ZM13.2812 13.2812H2.71875V4.9375H13.2812V13.2812ZM6.1875 11.0938L2.71875 7.625L4.28125 6.0625L6.1875 7.96875L11.7188 2.4375L13.2812 4L6.1875 11.0938Z" fill="black"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |
| <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <rect height="15" rx="2.5" stroke="black" width="15" x="0.5" y="0.5"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |

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## 510(k) Summary

#### I.SUBMITTER/510(k) SPONSOR

Sponsor/Manufacturer GI Supply, Inc. 5069 Ritter Road Suite 104 Mechanicsburg, PA 17055 USA Phone: [phone]

#### Contact Person

Thomas Saladin Sr. Regulatory Affairs Specialist Phone: [phone] Email: [e-mail]

## Alternate Contact Meghan Moore Manager Regulatory Affairs Email: [e-mail]

## Preparation Date

April 14, 2023

## II. DEVICE NAME/CLASSIFICATION

| Device Trade/Proprietary Name | RenovaRP® Centesis Pump System |
|----------------------------------|--------------------------------|
| Device Common or Usual Name | Suction Pump, Peristaltic Pump |
| Device Regulatory Classification | Class II |
| Device Classification Regulation | 21 CFR 878.4780 |
| Product Code | BTA |
| Submission Type | Traditional 510(k) |
| Classification Panel | General & Plastic Surgery |

#### III. PREDICATE DEVICE

K970186, RenovaRP® Paracentesis Pump System

#### IV. DEVICE DESCRIPTION

The RenovaRP® Centesis Pump is intended to be used in conjunction with the RenovaRP® Tube Set and RenovaRP® Fluid Drainage Bags (provided separately from the pump) to remove fluid from the abdominal cavity for paracentesis, and pleural effusion from the thoracic cavity for thoracentesis.

## V. INTENDED USE / INDICATIONS FOR USE

#### Intended Use / Indications for Use

The RenovaRP® Centesis Pump is intended to be used in conjunction with the RenovaRP Tube Set and the RenovaRP Fluid Drainage Bags to remove ascitic fluid from the abdominal cavity for paracentesis, and remove pleural effusion from the thoracic cavity for thoracentesis.

The Renova RP Centesis Pump is intended to be used by trained healthcare professionals knowledgeable about paracentesis and thoracentesis.

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## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The detailed substantial equivalence comparison of the similarities and differences between the RenovaRP® Centesis Pump System [subject device] and the RenovaRP® Paracentesis Pump (K970186) [predicate device] is provided in the table below. Please note that the devices have the same manufacturer, and only differ with regard to indications for use and proprietary/trade name. The fundamental design and operational and technological characteristics of the subject device remain the same.

No performance data was needed to evaluate the expansion of the indications for use to include thoracentesis. The change of the subject device's indications does not increase risks or impact safety or effectiveness when compared to the predicate device.

| Regulatory | | | Similarities / |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Information | [Subject Device] | [Predicate Device] | Differences |
| Manufacturer | GI Supply, Inc. | GI Supply, Inc. | Same |
| Device Trade or<br>Proprietary Name | RenovaRP® Centesis Pump<br>System | RenovaRP® Paracentesis Pump | Different |
| 510(k) Number | K221042 | K970186 | --- |
| Device Class | Class II | Class II | Same |
| Device<br>Classification<br>Name | General & Plastic Surgery | General & Plastic Surgery | Same |
| Device Common<br>Name | Pump, Portable, Aspiration<br>(Manual or Powered) | Pump, Portable, Aspiration<br>(Manual or Powered) | Same |
| Product Code | BTA | BTA | Same |
| Regulation<br>Number | 21 CFR 878.4780 | 21 CFR 878.4780 | Same |
| | Design Features and Capabilities of the Device | | |
| Indications for Use | The RenovaRP® Centesis Pump is<br>intended to be used in<br>conjunction with the RenovaRP<br>Tube Set and the RenovaRP Fluid<br>Drainage Bags to remove ascitic<br>fluid from the abdominal cavity<br>for paracentesis, and remove<br>pleural effusion from the thoracic<br>cavity for thoracentesis.<br>The Renova RP Centesis Pump is<br>intended to be used by medically<br>trained healthcare professionals<br>knowledgeable about<br>paracentesis and thoracentesis. | The RenovaRP® Paracentesis<br>Pump is intended as a peristaltic<br>pump to remove ascitic fluid<br>from the abdominal cavity in<br>conjunction with the RenovaRP®<br>Paracentesis Kit. The RenovaRP®<br>Paracentesis Pump is intended to<br>be used by medically trained<br>healthcare professionals<br>knowledgeable about<br>paracentesis. | Different |
| Intended Use | Suction pump for removal of<br>fluids | Suction pump for removal of<br>fluids | Same |
| Prescription or<br>Over-the-Counter<br>(OTC) Use | Prescription Use | Prescription Use | Same |
| Use Environment | Hospital / Clinic | Hospital / Clinic | Same |
| Regulatory | [Subject Device] | [Predicate Device] | Similarities /<br>Differences |
| Sterile | Pump is non-sterile.<br>Disposable components are<br>sterile. | Pump is non-sterile.<br>Disposable components are<br>sterile. | Same |
| Disposable versus<br>Non-Disposable | Pump is reusable.<br>Disposable components are<br>single patient use. | Pump is reusable.<br>Disposable components are<br>single patient use. | Same |
| Pump Physical<br>Specifications | 13x9x13 in (33x23x33 cm)<br>8.5 lbs (3.9kg) | 13x9x13 in (33x23x33 cm)<br>8.5 lbs (3.9kg) | Same |
| Pump Power | AC only model | AC only model | Same |
| Pump Input<br>Voltage | 100-230V | 100-230V | Same |
| Pump Input<br>Current | 2.5A | 2.5A | Same |
| Pump Input<br>Frequency | 50/60Hz | 50/60Hz | Same |
| Flow Rate | 700 mL/min | 700 mL/min | Same |
| Pump Electrical<br>Requirements | Class I, Type B | Class I, Type B | Same |
| Packaging | Pump is placed in a polybag in<br>between a top foam and bottom<br>foam insert prior to placement in<br>a 200# shipper box. Power cord<br>and IFU are placed in a polybag<br>on top of the pump under a foam<br>cap prior to box closure.<br><br>Disposable components are<br>provided separately from the<br>pump. Tube sets are individually<br>sterile packaged, with each 200#<br>shipper box containing five (5)<br>tube sets and one (1) IFU. Bags<br>are individually sterile packaged,<br>with each 200# shipper box<br>containing 20 bags. No IFU for<br>the collection bags is required. | Pump is placed in a polybag in<br>between a top foam and bottom<br>foam insert prior to placement in<br>a 200# shipper box. The power<br> | Same |
| Shelf Life | The pump has an expected<br>service life of 7-10 years.<br><br>Tube sets have a shelf life of 24<br>months, while the fluid drainage<br>bags have a shelf life of 25<br>months. | The pump has an expected<br>service life of 7-10 years.<br><br>Tube sets have a shelf life of 24<br>months, while the fluid drainage<br>bags have a shelf life of 25<br>months. | Same |
| Regulatory<br>Information<br>Manufacturer | GI Supply, Inc.<br>Design Features and Capabilities of the Device | GI Supply, Inc.<br>Design Features and Capabilities of the Device | Same |
| Regulatory<br>Information | [Subject Device] | [Predicate Device] | Similarities /<br>Differences |
| RenovaRP® Tube<br>Set and Fluid<br>Drainage Bags | Part of the proposed device;<br>packaged and shipped separately<br>as they are consumables. | N/A | The RenovaRP®<br>Tube Set and<br>Fluid Drainage<br>Bags were cleared<br>via K970187. They<br>are the same as<br>provided under<br>K970187 except<br>the revised<br>labeling for the<br>expanded<br>indication to<br>include<br>thoracentesis.<br>Including the tube<br>set and fluid<br>drainage bags as<br>part of the<br>RenovaRP®<br>Centesis Pump<br>System does not<br>introduce new<br>questions of<br>safety and<br>efficacy. |

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## VII. SUMMARY OF PERFORMANCE DATA AND PERFORMANCE TESTING CONCLUSIONS

The RenovaRP® Centesis Pump system was evaluated using GI Supply's risk management process in accordance with ISO 14971:2019 – Medical devices – Application of risk management to medical devices. All identified risks were adequately mitigated and were previously verified by means of nonclinical performance testing.

No testing was required in support of substantial equivalence to the predicate device as the subject and predicate devices are identical in terms of device design, fundamental technology, physical characteristics, performance, and intended use. The only proposed change to the device is its indications for use, which are being expanded to include thoracentesis.

The expansion of indications did not require any additional nonclinical testing to demonstrate safety and effectiveness nor to support the substantial equivalence to the subject device; however, nonclinical bench testing is being provided as part of this submission to verify device performance and safety.

## Summary of Nonclinical Performance Testing

A series of functional nonclinical performance testing was previously conducted on the RenovaRP® Centesis Pump including simulated use testing, functional testing, and distribution testing. The device was successfully evaluated for standards compliance to IEC 60601-1, Medical electrical equipment – Part 1: General requirements for basic safety and performance and 60601-1-2 – Medical electrical equipment

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– Parts 1-2, General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests. Additionally, usability of the device was assessed by applying the evaluation process specified in EN IEC 62366-1:2015, Medical devices – Part 1: Application of usability engineering to medical devices (Annex C, Evaluation of a user interface of unknown provenance - UOUP).

A series of functional nonclinical performance testing was previously conducted on the RenovaRP® Tube Set including simulated use testing, post-accelerated aging testing, real-time aging, biocompatibility testing (cytotoxicity, irritation, and sensitization per ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing), and distribution testing.

A series of functional nonclinical performance testing was previously conducted on the RenovaRP® Fluid Drainage Bag including graduation mark testing, post-accelerated aging testing, real-time aging, and distribution testing.

## Cleaning Validation

A cleaning validation was conducted per ISO 17664, Processing of healthcare products on the RenovaRP® Centesis Pump.

#### VIII. CONCLUSIONS

The RenovaRP® Centesis Pump System [subject device] is substantially equivalent to the predicate device, RenovaRP® Paracentesis Pump (K970186) and its disposable components (K970187) with respect to device design, fundamental technology, physical characteristics, performance, and intended use for the removal of fluids. Device materials and packaging are identical. The disposable components are provided sterile, while both the subject and predicate pump component of the system are non-sterile, reusable, and have the same expected lifetime.