The Aprima Smartesis™ Centesis Pump is a motorized pump to be used in conjunction with the appropriate disposable Aprima Smartesis TM Centesis Collection Tray for paracentesis drainage procedures.

Device Description

The Aprima Smartesis "11 Centesis Pump is a portable, reusable peristaltic suction pump designed for paracentesis procedure in a manner that is both rapid and convenient. The Aprima Pump is comprised of one pump, one power cord, and operating instructions. The Aprima Pump employs peristaltic pump technology to provide displacement of fluid through the centesis tubing set, a component of the Aprima Smartesis Centesis Trav. Operation of the Aprima Pump is initiated with a control knob on the front panel. The Aprima Pump is equipped with a variable speed control of the rollers, thus allowing the operator to control the rate at which the fluid is withdrawn from the patient.

The Aprima Pump is to be used with the Aprima Smartesis Collection Tray only, which includes the needle for access to the abdominal cavity and the connecting tube with attached drainage bags for removal of the fluid during treatment. The Aprima Smartesis™ Centesis Collection Tray and Bags are not included with the Aprima Pump and are packaged and sold individually. No tools are required to load or to remove the tubing and drainage bags.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Aprima Smartesis Centesis Pump, a medical device. This type of document is primarily focused on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with specific acceptance criteria and performance metrics in the way a clinical trial for a novel AI device would.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance (sensitivity, specificity, reader improvement, etc.) is not present for this device. The document focuses on engineering and performance testing to ensure safety and functionality compared to a predicate, not diagnostic accuracy or effectiveness in direct patient outcomes.

However, I can extract information related to the engineering and performance tests that were conducted and their acceptance criteria, as well as the design inputs for the device.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and the Reported Device Performance

The document describes several tests conducted to ensure reliable design and performance, and for each, it states that "The predetermined acceptance criterion was met." However, the specific quantitative acceptance criteria themselves are generally not detailed beyond these statements.

Test Category	Specific Test	Acceptance Criteria (Stated in Document)	Reported Device Performance (Stated in Document)
Electrical Safety	IEC 60101-1 (General requirements for basic safety and essential performance) tests	Compliance with IEC 60101-1 (includes Leakage Currents, Dielectric Strength, Creepage Distances, Spillage, Push, Impact, Drop, Grip/handle Strength, Movable Guards, Audible Acoustic Energy, Maximum Temperature during Normal Use, Instability, Firmware Verification).	"The UL certificate shows that the Aprima Pump complies with the requirements of IEC 60101-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance." (Tests covered by UL certificate include: Leakage Currents Test, Dielectric Strength Test, Creepage Distances Test, Spillage Test, Push Test, Impact Test, Drop Test, Grip/handle Strength Test, Movable Guards Test, Audible Acoustic Energy Test, Maximum Temperature Test during Normal Use, Instability Test, Firmware Verification)
EMC	IEC 60101-1-2 (Electromagnetic disturbances - Requirements and tests) tests	Conformance to IEC 60101-1-2 (includes Harmonic Current Emission, Voltage Fluctuations and Flicker, Power Line Conducted Emissions and Radiated Emissions, Electrostatic Discharge Immunity, Electrical Field Radiated Immunity, Electrical Fast Transient/Burst Immunity, Surge Immunity, Conducted Immunity, Magnetic Field Immunity, Voltage Dips, Short Interruptions and Voltage Variations Immunity).	"Electromagnetic Compatibility Testing was performed to show the device conforms to the requirements of IEC 60101-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests." (Includes: Harmonic Current Emission, Voltage Fluctuations and Flicker, Power Line Conducted Emissions and Radiated Emissions, Electrostatic Discharge Immunity, Electrical Field Radiated Immunity, Electrical Fast Transient/Burst Immunity, Surge Immunity, Conducted Immunity, Magnetic Field Immunity, Voltage Dips, Short Interruptions and Voltage Variations Immunity)
Performance Testing	Simulated Use	"Predetermined acceptance criteria for this study were met." (Implied: users could successfully perform the centesis procedure in accordance with intended use).	"All users were able to use provided components to successfully perform the centesis procedure in accordance with the intended use statement and the predetermined acceptance criteria for this study were met."
	Characterization of Flowrate and Pressure at Different Speed Settings	(Not explicitly stated, but implied to be comparable to predicate or within design spec).	"Testing was performed to characterize the flowrate and pressure for the proposed pump and the predicate pump." (No specific results or comparison values provided in the summary).
	Life Cycle Cleaning Test	"Did not exhibit degradation of electrical safety after the simulation of 1 year life cycle of cleaning."	"The predetermined acceptance criterion was met."
	Wipe Test of Various Labels	"Pump labeling shall be legible after the required number of cleaning cycles."	"The predetermined acceptance criterion was met."
	Aprima Smartesis™ Centesis Pump Distribution Testing	"Pump functions correctly without visible damage before and after distribution cycle testing in packaging."	"The predetermined acceptance criterion was met."

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not specified in the provided summary for any of the performance tests (e.g., number of users for simulated use, number of cleaning cycles for life cycle test, number of distribution tests).
Data Provenance: The tests were conducted internally by Cook Incorporated or by a certified third party (UL certificate implies a third-party evaluation). The data is from prospective testing of the device, not from a retrospective clinical dataset. Country of origin of the data is not explicitly stated beyond Cook Incorporated being located in Indiana, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable to this device's testing. The "ground truth" for these engineering and performance tests is compliance with international standards (IEC) and functional specifications, not clinical diagnostic accuracy requiring expert interpretation. For the "Simulated Use" test, it states "All users were able to use provided components to successfully perform the centesis procedure," implying user feedback rather than expert ground truth establishment for a diagnostic output.

4. Adjudication method

Not applicable. This device is a pump, not an AI diagnostic tool requiring adjudication of results from multiple readers.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document is for a medical device (a pump), not an AI diagnostic algorithm or an AI-assisted tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical pump, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's testing is primarily compliance with established international safety and performance standards (IEC 60101-1, IEC 60101-1-2) and design specifications (e.g., proper function after cleaning, legibility of labels, integrity after distribution, and ability to perform the intended procedure in simulated use).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, this device does not utilize a training set in the context of AI/ML.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 28, 2016

Cook Incorporated Ms. Erum Nasir Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47404

Re: K161002

Trade/Device Name: Aprima Smartesis Centesis Pump Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: BTA Dated: August 31, 2016 Received: September 2, 2016

Dear Ms. Nasir:

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. 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 device reporting (reporting of medical devicerelated adverse events) (21 CFR Part 803); good manufacturing practice requirements as set forth

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in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Christopher J. Ronk -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K161002

Device Name

Aprima Smartesis TM Centesis Pump

Indications for Use (Describe)

The Aprima Smartesis™ Centesis Pump is a motorized pump to be used in conjunction with the appropriate disposable Aprima Smartesis TM Centesis Collection Tray for paracentesis drainage procedures.

Type of Use (Select one or both, as applicable)

[X | Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, block letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, block letters on a darker red background.

510(K) Summary

Aprima Smartesis "11 Centesis Pump (21 CFR §878.4780) Date Prepared: August 31, 2016

Bloomington, IN 47404

(812) 335-3575 x102607

Powered suction pump

Aprima Smartesis™ Centesis Pump

Pump, Portable, Aspiration (Manual or Powered) - General &

(812) 332-0281

Plastic Surgery

21 CFR 8878.4780

Submitted By: Cook Incorporated Applicant: Contact: Erum B. Nasir Applicant Address: Cook Incorporated 750 Daniels Way

Contact Phone Number: Contact Fax Number:

Device Information:

Trade Name: Common Name: Classification Name/Panel:

Regulation Product Code

Predicate Device:

RenovaRP™ Paracentesis Pump (GI Supply, K970186) o
BTA

Device Description:

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Image /page/4/Picture/0 description: The image shows the Cook Medical logo. The logo has a red background with the word "COOK" in white, large, sans-serif font. Below the word "COOK" is a smaller red rectangle with the word "MEDICAL" in white, sans-serif font. The Cook logo is a registered trademark, as indicated by the small "®" symbol next to the word "COOK".

Centesis Collection Tray and Bags are not included with the Aprima Pump and are packaged and sold individually. No tools are required to load or to remove the tubing and drainage bags.

Intended Use:

The Aprima Smartesis™ Centesis Pump is a motorized pump to be used in conjunction with the appropriate disposable Aprima Smartesis Centesis Collection Tray for paracentesis drainage procedures.

Comparison to Predicates:

The Aprima Pump is substantially equivalent to the predicate device, the RenovaRPTM Paracentesis Pump. The devices have the same intended use, operating mechanism, basic design, portability, and function. The minor differences between the subject and the proposed device are presented in the following table and are listed as dimension, weight, input current/voltage, maximum vacuum, AC power operations, and safety features. These minor differences were appropriately assessed and do not raise new questions regarding safety or effectiveness. In addition, the testing performed demonstrates that the proposed device meets the applicable electrical safety requirements, electromagnetic compatibility requirements, and has comparable performance as compared to the predicate device. The comparison table is listed below,

Device	RenovaRP™ Paracentesis Pump(K970186)	Aprima Smartesis™ Centesis Pump(Proposed device)
Regulation	21 CFR §878.4780	21 CFR §878.4780
Classification	Class II	Class II
Product code	BTA - Pump, Portable, Aspiration(manual or powered)	BTA - Pump, Portable, Aspiration(manual or powered)
Intended Use	The GI Supply RenovaRP™Paracentesis Pump is intended as asuction pump to remove ascitic fluidfrom the abdominal cavity inconjunction with the GI SupplyParacentesis Kit.	The Aprima Smartesis™ Pump is amotorized pump to be used inconjunction with the appropriatedisposable Aprima Smartesis™Collection Tray for paracentesisdrainage procedures.
Duration of use	Reusable	Identical
Dimensions	13 x 9 x 13 in(33 x 23 x 33 cm)	10 x 6.8 x 6.3 in(25.6 x 17.2 x 16.0 cm)
Weight	8.5 lbs (3.9 kg)	12.5 lbs (5.7 kg)
Input current	2.5A	2.0A
Input Voltage	100/230V	115/230V
Input Frequency	50/60Hz	Identical
Power Cord	Hospital Grade power cord	Identical
Energy used	AC-powered	Identical

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Image /page/5/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, white, sans-serif letters on a red background. Below the word "COOK" is the word "MEDICAL" in smaller, white, sans-serif letters on a darker red background.

Device		RenovaRPTM Paracentesis Pump(K970186)	Aprima SmartesisTM Centesis Pump(Proposed device)
Type of pump		Peristaltic	Identical
Maximum measuredvacuum (kPa)		-94.2 (used with 7Fr cannula)	-85.7 (used with 5Fr needle)-88.9 (used with 4Fr needle)
Pressure Control		Not controlled	Identical
Speed control		Dial	Identical
Filter		No	Identical
AC power operation		AC power switch is part of the dial	AC on and off switch
Handle fortransporting pump		Yes, portable	Identical
Safetyfeatures	Usability	Safety guard, but device can be runwhile open.	Door acts as a movable guard thatprevents use while open,One-direction flow (clips in the tubingset prevent incorrect installation).
	Electrical	Safety ground	Grounded enclosure

Technological Characteristics:

The following tests have been conducted to ensure reliable design and performance under the specified testing parameters. These tests include:

1. Electrical Safety Testing Cook Inc. holds the UL certificate for the Aprima Pump. The UL certificate shows that the Aprima Pump complies with the requirements of IEC 60101-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. Tests covered by UL certificate include:
- 0 Leakage Currents Test
- Dielectric Strength Test
- Creepage Distances Test ●
- Spillage Test ●
- Push Test ●
- Impact Test ●
- Drop Test
- Grip/handle Strength Test ●
- Movable Guards Test ●
- Audible Acoustic Energy Test ●
- Maximum Temperature Test during Normal Use ●
- Instability Test ●
- Firmware Verification ●

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Image /page/6/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, uppercase letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, uppercase letters on a red background. The logo is simple and clean, with a focus on the company name.

COOK INCORPORATED OLL FREE: 800.457. WW.COOKMEDICAL.COM

1. Electromagnetic Compatibility Testing was performed to show the device conforms to the requirements of IEC 60101-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests, including:
- Harmonic Current Emission
- o Voltage Fluctuations and Flicker
- Power Line Conducted Emissions and Radiated Emissions ●
- Electrostatic Discharge Immunity ●
- o Electrical Field Radiated Immunity
- Electrical Fast Transient/Burst Immunity ●
- Surge Immunity
- Conducted Immunity
- Magnetic Field Immunity .
- Voltage Dips, Short Interruptions and Voltage Variations Immunity o
1. Performance Testing
- 0 Simulated Use - Testing was conducted to obtain clinical opinions on the use of the Aprima Smartesis™ Centesis Pump and Collection Tray. All users were able to use provided components to successfully perform the centesis procedure in accordance with the intended use statement and the predetermined acceptance criteria for this study were met.
- . Characterization of Flowrate and Pressure at Different Speed Settings for the Aprima Smartesis TM Centesis Pump and the RenovaRP™ Paracentesis Pump -Testing was performed to characterize the flowrate and pressure for the proposed pump and the predicate pump.
- Life Cycle Cleaning Test Testing was performed to show that the Aprima . Smartesis 114 Centesis Pump did not exhibit degradation of electrical safety after the simulation of 1 year life cycle of cleaning. The predetermined acceptance criterion was met.
- Wipe Test of Various Labels Testing was performed to show that the pump . labeling shall be legible after the required number of cleaning cycles. The predetermined acceptance criterion was met.
- Aprima Smartesis™ Centesis Pump Distribution Testing Testing was performed . to show that pump functions correctly without visible damage before and after

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Image /page/7/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, bold letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, smaller, bold letters. The logo is simple and clean, with a focus on the company name.

COOK INCORPORATED 750 DANIELS WAY OMINGTON, IN 47404 USA OLL FREE. 800 VW.COOKMEDICAL.COM

distribution cycle testing in packaging. The predetermined acceptance criterion was met.

Conclusion:

The results of these tests support a conclusion that the Aprima Smartesis™ Centesis Pump met the design input requirements based on the intended use and support the conclusion that this device does not raise new questions of safety or effectiveness. The Aprima Smartesis™ Centesis Pump is substantially equivalent to the RenovaRP™ Paracentesis Pump (GI Supply, K970186).

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.