Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a mechanical pump system for fluid removal and does not mention any AI/ML components or related concepts like algorithms, training data, or performance metrics typically associated with AI/ML.

Therapeutic

Yes
The device is used to remove fluid from the abdominal and thoracic cavities, which is a therapeutic procedure to alleviate symptoms or treat conditions related to fluid accumulation.

Diagnostic

No

The device is intended to remove fluid (ascitic fluid, pleural effusion) from the body, which is a therapeutic rather than a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly refers to a "pump," which is a physical hardware component, and mentions testing related to hardware standards (IEC 60601-1, 60601-1-2) and cleaning validation, indicating it is not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the RenovaRP® Centesis Pump is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The device is intended to remove fluid from the body (ascitic fluid and pleural effusion). It does not perform any testing or analysis on the fluid to diagnose a condition.
Device Description: The description focuses on the mechanical function of removing fluid.
Lack of IVD Characteristics: There is no mention of analyzing samples, using reagents, or providing diagnostic information based on the fluid.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The RenovaRP® Centesis Pump is a therapeutic/procedural device used to remove fluid for patient comfort or other medical reasons, not for diagnostic testing of the fluid itself.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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.

Product codes

BTA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

abdominal cavity, thoracic cavity

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained healthcare professionals knowledgeable about paracentesis and thoracentesis.
Use Environment: Hospital / Clinic

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

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.

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 – 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.

Key Metrics

Not Found

Predicate Device(s)

K970186

Reference Device(s)

K970187

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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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

1

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 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)
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

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
Proprietary Name	RenovaRP® Centesis Pump
System	RenovaRP® Paracentesis Pump	Different
510(k) Number	K221042	K970186	---
Device Class	Class II	Class II	Same
Device
Classification
Name	General & Plastic Surgery	General & Plastic Surgery	Same
Device Common
Name	Pump, Portable, Aspiration
(Manual or Powered)	Pump, Portable, Aspiration
(Manual or Powered)	Same
Product Code	BTA	BTA	Same
Regulation
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
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 medically
trained healthcare professionals
knowledgeable about
paracentesis and thoracentesis.	The RenovaRP® Paracentesis
Pump is intended as a peristaltic
pump to remove ascitic fluid
from the abdominal cavity in
conjunction with the RenovaRP®
Paracentesis Kit. The RenovaRP®
Paracentesis Pump is intended to
be used by medically trained
healthcare professionals
knowledgeable about
paracentesis.	Different
Intended Use	Suction pump for removal of
fluids	Suction pump for removal of
fluids	Same
Prescription or
Over-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 are
sterile.	Pump is non-sterile.
Disposable components are
sterile.	Same
Disposable versus
Non-Disposable	Pump is reusable.
Disposable components are
single patient use.	Pump is reusable.
Disposable components are
single patient use.	Same
Pump Physical
Specifications	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 Input
Voltage	100-230V	100-230V	Same
Pump Input
Current	2.5A	2.5A	Same
Pump Input
Frequency	50/60Hz	50/60Hz	Same
Flow Rate	700 mL/min	700 mL/min	Same
Pump Electrical
Requirements	Class I, Type B	Class I, Type B	Same
Packaging	Pump is placed in a polybag in
between a top foam and bottom
foam insert prior to placement in
a 200# shipper box. Power cord
and IFU are placed in a polybag
on top of the pump under a foam
cap prior to box closure.

Disposable components are
provided separately from the
pump. Tube sets are individually
sterile packaged, with each 200#
shipper box containing five (5)
tube sets and one (1) IFU. Bags
are individually sterile packaged,
with each 200# shipper box
containing 20 bags. No IFU for
the collection bags is required. | Pump is placed in a polybag in
between a top foam and bottom
foam insert prior to placement in
a 200# shipper box. The power
| Same |
| Shelf Life | The pump has an expected
service life of 7-10 years.

Tube sets have a shelf life of 24
months, while the fluid drainage
bags have a shelf life of 25
months. | The pump has an expected
service life of 7-10 years.

Tube sets have a shelf life of 24
months, while the fluid drainage
bags have a shelf life of 25
months. | Same |
| Regulatory
Information
Manufacturer | GI Supply, Inc.
Design Features and Capabilities of the Device | GI Supply, Inc.
Design Features and Capabilities of the Device | Same |
| Regulatory
Information | [Subject Device] | [Predicate Device] | Similarities /
Differences |
| RenovaRP® Tube
Set and Fluid
Drainage Bags | Part of the proposed device;
packaged and shipped separately
as they are consumables. | N/A | The RenovaRP®
Tube Set and
Fluid Drainage
Bags were cleared
via K970187. They
are the same as
provided under
K970187 except
the revised
labeling for the
expanded
indication to
include
thoracentesis.
Including the tube
set and fluid
drainage bags as
part of the
RenovaRP®
Centesis Pump
System does not
introduce new
questions of
safety and
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

7

– 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.