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 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.

AI/ML Overview

This document is a 510(k) premarket notification for the RenovaRP® Centesis Pump System. It aims to demonstrate substantial equivalence to a predicate device, the RenovaRP® Paracentesis Pump (K970186), for an expanded indication of use to include thoracentesis in addition to paracentesis.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not contain specific acceptance criteria for a new device's performance in terms of clinical outcomes (e.g., success rate of fluid removal, complication rates). Instead, it relies on demonstrating substantial equivalence to a previously cleared predicate device for the expanded indication.

The table below summarizes the technical specifications and aspects of the device that are compared to the predicate, demonstrating their "performance" in terms of equivalence.

Acceptance Criteria/Characteristic	Reported Device Performance (RenovaRP® Centesis Pump System)	Notes
Intended Use	Remove ascitic fluid from abdominal cavity (paracentesis) AND remove pleural effusion from thoracic cavity (thoracentesis).	The key change here is the addition of thoracentesis. The manufacturer states that "No performance data was needed to evaluate the expansion of the indications for use to include thoracentesis" because the fundamental design and operational characteristics remain the same.
Manufacturer	GI Supply, Inc.	Same as predicate.
Device Regulatory Classification	Class II, 21 CFR 878.4780, Product Code BTA	Same as predicate.
Device Common Name	Suction Pump, Peristaltic Pump	Same as predicate.
Prescription or OTC Use	Prescription Use	Same as predicate.
Use Environment	Hospital / Clinic	Same as predicate.
Sterility (Pump)	Non-sterile	Same as predicate.
Sterility (Disposable Components)	Sterile	Same as predicate.
Disposability	Pump is reusable, disposable components are single patient use.	Same as predicate.
Pump Physical Specifications	13x9x13 in (33x23x33 cm), 8.5 lbs (3.9kg)	Same as predicate.
Pump Power	AC only model	Same as predicate.
Pump Input Voltage	100-230V	Same as predicate.
Pump Input Current	2.5A	Same as predicate.
Pump Input Frequency	50/60Hz	Same as predicate.
Flow Rate	700 mL/min	Same as predicate.
Pump Electrical Requirements	Class I, Type B	Same as predicate.
Shelf Life (Pump)	7-10 years	Same as predicate.
Shelf Life (Tube Sets)	24 months	Same as predicate.
Shelf Life (Drainage Bags)	25 months	Same as predicate.
Standards Compliance	IEC 60601-1, 60601-1-2, EN IEC 62366-1:2015, ISO 14971:2019, ISO 17664	Device successfully evaluated for compliance.
Performance Data for Indication Expansion	Not explicitly required or presented for the expanded indication.	The submission explicitly states: "No performance data was needed to evaluate the expansion of the indications for use to include thoracentesis."

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states that no performance data was needed to evaluate the expansion of indications for use to include thoracentesis. The justification for this is that the subject device's fundamental design, operational, and technological characteristics remain identical to the predicate device.

Therefore, there is no "test set" in the sense of a clinical or simulated diagnostic performance dataset with a specified sample size. This submission is based on the substantial equivalence of the physical device and its existing (previously cleared) performance for a very similar procedure (paracentesis vs. thoracentesis).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since no clinical or diagnostic performance test set was used, there were no experts relied upon to establish ground truth for such a dataset. The clearance is based on the technical equivalence and existing safety and effectiveness profile of the predicate device for a related procedure.

4. Adjudication Method for the Test Set

As no test set requiring clinical interpretation or outcome assessment was used, there was no adjudication method applied.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was done. The submission seeks clearance based on substantial equivalence of a physical medical device, not an AI or diagnostic algorithm that would typically be evaluated in an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No standalone performance study of an algorithm was done. The device in question is a physical pump, not a diagnostic algorithm.

7. The Type of Ground Truth Used

Given that no new clinical performance data was explicitly required for the expanded indication, there was no new ground truth established in this submission related to clinical outcomes. The "ground truth" for the device's safety and effectiveness for fluid removal relies on the prior clearance of the predicate device (K970186) and general engineering and safety standards.

8. The Sample Size for the Training Set

This submission is for a physical medical device (a pump), not an AI algorithm requiring a training set. Therefore, there is no training set sample size.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for an AI algorithm, this question is not applicable.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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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: (800)-451-5797

Contact Person

Thomas Saladin Sr. Regulatory Affairs Specialist Phone: (952)-471-6665 Email: tsaladin@laborie.com

Alternate Contact Meghan Moore Manager Regulatory Affairs Email: mmoore@laborie.com

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

V. INTENDED USE / INDICATIONS FOR USE

Intended Use / Indications for Use

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 orProprietary Name	RenovaRP® Centesis PumpSystem	RenovaRP® Paracentesis Pump	Different
510(k) Number	K221042	K970186	---
Device Class	Class II	Class II	Same
DeviceClassificationName	General & Plastic Surgery	General & Plastic Surgery	Same
Device CommonName	Pump, Portable, Aspiration(Manual or Powered)	Pump, Portable, Aspiration(Manual or Powered)	Same
Product Code	BTA	BTA	Same
RegulationNumber	21 CFR 878.4780	21 CFR 878.4780	Same
	Design Features and Capabilities of the Device
Indications for Use	The RenovaRP® Centesis Pump isintended to be used inconjunction with the RenovaRPTube Set and the RenovaRP FluidDrainage Bags to remove asciticfluid from the abdominal cavityfor paracentesis, and removepleural effusion from the thoraciccavity for thoracentesis.The Renova RP Centesis Pump isintended to be used by medicallytrained healthcare professionalsknowledgeable aboutparacentesis and thoracentesis.	The RenovaRP® ParacentesisPump is intended as a peristalticpump to remove ascitic fluidfrom the abdominal cavity inconjunction with the RenovaRP®Paracentesis Kit. The RenovaRP®Paracentesis Pump is intended tobe used by medically trainedhealthcare professionalsknowledgeable aboutparacentesis.	Different
Intended Use	Suction pump for removal offluids	Suction pump for removal offluids	Same
Prescription orOver-the-Counter(OTC) Use	Prescription Use	Prescription Use	Same
Use Environment	Hospital / Clinic	Hospital / Clinic	Same
Regulatory	[Subject Device]	[Predicate Device]	Similarities /Differences
Sterile	Pump is non-sterile.Disposable components aresterile.	Pump is non-sterile.Disposable components aresterile.	Same
Disposable versusNon-Disposable	Pump is reusable.Disposable components aresingle patient use.	Pump is reusable.Disposable components aresingle patient use.	Same
Pump PhysicalSpecifications	13x9x13 in (33x23x33 cm)8.5 lbs (3.9kg)	13x9x13 in (33x23x33 cm)8.5 lbs (3.9kg)	Same
Pump Power	AC only model	AC only model	Same
Pump InputVoltage	100-230V	100-230V	Same
Pump InputCurrent	2.5A	2.5A	Same
Pump InputFrequency	50/60Hz	50/60Hz	Same
Flow Rate	700 mL/min	700 mL/min	Same
Pump ElectricalRequirements	Class I, Type B	Class I, Type B	Same
Packaging	Pump is placed in a polybag inbetween a top foam and bottomfoam insert prior to placement ina 200# shipper box. Power cordand IFU are placed in a polybagon top of the pump under a foamcap prior to box closure.Disposable components areprovided separately from thepump. Tube sets are individuallysterile packaged, with each 200#shipper box containing five (5)tube sets and one (1) IFU. Bagsare individually sterile packaged,with each 200# shipper boxcontaining 20 bags. No IFU forthe collection bags is required.	Pump is placed in a polybag inbetween a top foam and bottomfoam insert prior to placement ina 200# shipper box. The power	Same
Shelf Life	The pump has an expectedservice life of 7-10 years.Tube sets have a shelf life of 24months, while the fluid drainagebags have a shelf life of 25months.	The pump has an expectedservice life of 7-10 years.Tube sets have a shelf life of 24months, while the fluid drainagebags have a shelf life of 25months.	Same
RegulatoryInformationManufacturer	GI Supply, Inc.Design Features and Capabilities of the Device	GI Supply, Inc.Design Features and Capabilities of the Device	Same
RegulatoryInformation	[Subject Device]	[Predicate Device]	Similarities /Differences
RenovaRP® TubeSet and FluidDrainage Bags	Part of the proposed device;packaged and shipped separatelyas they are consumables.	N/A	The RenovaRP®Tube Set andFluid DrainageBags were clearedvia K970187. Theyare the same asprovided underK970187 exceptthe revisedlabeling for theexpandedindication toincludethoracentesis.Including the tubeset and fluiddrainage bags aspart of theRenovaRP®Centesis PumpSystem does notintroduce newquestions ofsafety andefficacy.

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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.

Regulation Number and Section

§ 878.4780 Powered suction pump.

(a)
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.(b)
Classification. Class II.