PICO 7Y is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. Appropriate wound types include:

Chronic
Acute
Traumatic
Subacute and dehisced wounds
Partial-thickness burns
Ulcers (such as diabetic or pressure)
Flaps and grafts
Closed Surgical incisions
PICO Systems are suitable for use both in a hospital and homecare setting.

Device Description

PICO 7Y Single Use Negative Pressure Wound Therapy System is a small, lightweight, portable, electro-mechanical pump system connected through a Yshaped tube known as the "Y-Connector" to two super-absorbent, gentle adhesive dressings. Secondary fixation strips are also provided to ensure an adequate seal is achieved. The pump, the dressings and fixation strips are supplied sterile and for single use. PICO 7Y was designed to deliver negative pressure wound therapy to low and moderate exudate levels of acute and chronic wound types. PICO 7Y Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting.

AI/ML Overview

The provided text describes the PICO 7Y Single Use Negative Pressure Wound Therapy System, focusing on performance testing and regulatory clearance. It is important to note that this device is a physical medical device (a powered suction pump) and not an AI device or software. Therefore, the typical acceptance criteria and study designs associated with AI/software devices (e.g., MRMC studies, expert consensus on image interpretation, training/test set ground truth establishment for algorithms) are not applicable here.

However, I can extract the acceptance criteria and study details relevant to this physical medical device based on the information provided in the K182323 submission.

Acceptance Criteria and Device Performance for PICO 7Y Single Use Negative Pressure Wound Therapy System

Given that this is a physical medical device (a Negative Pressure Wound Therapy system) and not an AI or software product, the acceptance criteria and study focus on mechanical and performance-based metrics, rather than diagnostic accuracy or human reader improvement with AI assistance.

1. Table of Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria (Target/Threshold)	Reported Device Performance (Results)
Wound Model Testing (Low Exudate)	Dressings must manage fluid at a flow rate modeling a low exuding wound (0.6 g/cm²/24 hours) for a simulated wound of 25% of the dressing absorbent pad area. Maintained negative pressure within test requirements (-60 mmHg to -100 mmHg) for a minimum of 95% of the test time at the simulated wound base.	All dressings managed fluid at 0.6 g/cm²/24 hours (low exudate). Maintained negative pressure within -60 mmHg to -100 mmHg for a minimum of 95% of the test time at the simulated wound base. Concluded that the device and accessories can be used for their intended purposes.
Wound Model Testing (Moderate Exudate)	Dressings must manage fluid at a flow rate modeling a moderately exuding wound (1.1 g/cm²/24 hours) for a simulated wound of 25% of the dressing absorbent pad area. Maintained negative pressure within test requirements (-60 mmHg to -100 mmHg) for a minimum of 95% of the test time at the simulated wound base.	All dressings managed fluid at 1.1 g/cm²/24 hours (moderate exudate). Maintained negative pressure within -60 mmHg to -100 mmHg for a minimum of 95% of the test time at the simulated wound base. Concluded that the device and accessories can be used for their intended purposes.
Wound Model Testing (No NPWT)	Dressings must manage fluid at a flow rate modeling moderate and low exuding wounds (0.5 g/cm²/24hrs and 0.3g/cm²/24hrs) without negative pressure.	All dressings in vertical position managed fluid at 0.5 g/cm²/24hrs and 0.3g/cm²/24hrs with no NPWT. Concluded that the dressings can handle fluid without the presence of negative pressure.
Functionality Testing (Simultaneous Wounds)	Pump pressure limits between -100 to -60mmHg, cycle of ≥10mmHg, time to reach target negative pressure (<100 seconds) for small (50ml total) and large (600ml total) simulated wounds simultaneously.	Pump pressure limits were recorded between -100 to -60mmHg, had a cycle of ≥10mmHg, and the time taken to reach the target negative pressure was less than 100 seconds (using one 50ml canister and two 300ml canisters). Demonstrated the pump can be used for its intended purpose.
Battery Low State Performance	Device must continue to deliver negative pressure when in a battery low state.	The device continued to deliver negative pressure when in a battery low state. Demonstrated the pump can be used for its intended purpose.
"Check Dressing" Indicator Performance	Indicator successfully activates after 24 hours of use while maintaining negative pressure. After resetting, reactivates after a minimum of 23 hours 45 minutes and a maximum of 24 hours 10 minutes.	The indicator successfully activated after 24 hours of use, while maintaining negative pressure. After resetting, activated after a minimum of 23 hours 45 minutes and a maximum of 24 hours 10 minutes. Concluded that the devices can be used for their intended purposes.
Exudate Management (Blocked Port)	System successfully manages exudate during delivery of negative pressure and following loss of negative pressure (due to port blockage) until the 7-day service life is achieved.	The system successfully manages exudate during the delivery of negative pressure and following the loss of negative pressure until the 7-day service life has been achieved. Concluded that the design acts as an effective primary mitigation for the risk of maceration in a blocked port scenario.
Blocked Port (One Dressing)	When one dressing soft port is blocked, pressure is maintained within the specified range on the non-blocked dressing.	When one dressing soft port is blocked due to oversaturation, the device still delivers acceptable levels of negative pressure to the non-blocked dressing.
Air Leak Testing	Air leak indicators activate at specified time points when high leak rate present, alerting user to inspect and address leak points, ensuring therapeutic negative pressure range (-60mmHg to -100mmHg, target -80mmHg) is achieved and maintained.	Air leak indicator activated at specified time points, consistent with test requirements for initial application to achieve therapeutic range and maintenance of therapeutic range. Concluded the devices can be used for their intended purposes.
Shelf Life	Maintain functionality over 24 months, with dressings managing fluid at specified flow rates and maintaining negative pressure (-60 mmHg to -100 mmHg for ≥95% of time, and no readings < -235mmHg).	All dressings managed fluid at 0.6 g/cm²/24 hours (low) and 1.1 g/cm²/24 hours (moderate). Maintained negative pressure within -60 mmHg to -100 mmHg for ≥95% of test time, with no readings < -235mmHg. All specification test results complied. Concluded that a shelf life of 24 months (2 years) can be applied, and the device and accessories can be used for their intended purposes.
Electromagnetic Compatibility & Electrical Safety	Compliance with AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 62366.	Found to be in compliance with all listed standards.
Human Factors/Usability	Intended users (Lay Users, Healthcare Professionals) can follow IFU, understand safety information, and no unacceptable residual risk due to use errors.	A summative study was carried out in the US. No patterns of use errors resulting in unacceptable residual risk were found. Concluded that the device has appropriate design mitigations and is safe and effective for use by intended users in expected environments.

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

The document does not specify sample sizes in terms of number of devices or number of tests for each "bench test" conducted. The descriptions refer to "all dressings" or "the PICO 7Y device" without quantifying the number of units tested. This is common for this type of K submission where the focus is on demonstrating that the device can meet the specification, rather than statistical significance derived from large sample sizes.

Sample Size: Not explicitly stated for specific tests (e.g., "Wound model testing was conducted on the PICO 7Y system..." implies multiple dressings/tests, but exact number unknown).
Data Provenance: The tests are described as "Non-Clinical Tests (Bench)" indicating laboratory-based testing. A "summative study" for Human Factors was "carried out in the US." The origin of the actual materials used in testing (e.g., simulated wounds) is not detailed. All data appears to be prospective as it was generated specifically for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This section is not applicable to this device. As a powered suction pump, the "ground truth" is based on objective physical measurements (e.g., pressure, flow rate, volume) and engineering standards, not on expert interpretation of medical images or clinical outcomes that require human consensus. No experts were used to establish ground truth in the typical sense for an AI/software device.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are primarily used in studies involving human interpretation (e.g., radiology reads) where there might be inter-reader variability. For objective bench tests of a physical device, results are based on defined measurement protocols and pass/fail criteria, not on human judgment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. An MRMC study is relevant for evaluating the impact of AI/software assistance on human performance (e.g., how AI improves a radiologist's ability to detect disease). This device is a physical therapy system, not a diagnostic or AI-assisted interpretation tool. Therefore, no MRMC study was performed.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device. There is no "algorithm only" component in the sense of a diagnostic or interpretive AI. Its performance is measured directly through its mechanical and functional operation.

7. Type of Ground Truth Used

The ground truth for the performance of the PICO 7Y system was based on:

Engineering Specifications and Benchmarking: Pre-defined ranges for pressure (e.g., -60 to -100 mmHg), flow rates (e.g., 0.6 g/cm²/24 hours), and time intervals (e.g., <100 seconds to reach target pressure, 24-hour indicator activation).
Simulated Clinical Scenarios: Use of simulated wounds (25% of dressing absorbent pad area) and simulated fluid volumes (50ml, 600ml) to mimic real-world conditions in a controlled laboratory environment.
Industry Standards: Compliance with electrical safety and electromagnetic compatibility standards (e.g., IEC 60601 series).

This is analogous to "bench testing" against defined performance parameters and safety standards.

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI model. There is no concept of a "training set" in the context of device development described here.

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

Not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, with the letters "FDA" in a blue box. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 18, 2019

Smith & Nephew Medical Limited % Kulsum Master Director Regulatory Affairs, US Region Smith & Nephew 7000 West William Cannon Drive Austin, Texas 78735

Re: K182323

Trade/Device Name: PICO 7Y Single Use Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: December 19, 2018 Received: December 20, 2018

Dear Kulsum Master:

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kimberly Ferlin -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

510(k) Number (if known)

K182323

Device Name

PICO 7Y Single Use Negative Pressure Wound Therapy System

Indications for Use (Describe)

Chronic
Acute
Traumatic
Subacute and dehisced wounds
Partial-thickness burns
Ulcers (such as diabetic or pressure)
Flaps and grafts
Closed Surgical incisions

PICO Systems are suitable for use both in a hospital and homecare setting.

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)

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510(K) SUMMARY K182323

PICO 7Y Single Use Negative Pressure Wound Therapy System

General Information
Submitter Name/Address:	Smith & Nephew Medical Limited101 Hessle Road,HullHU3 2BNUnited Kingdom
Establishment Registration Number:	8043484
Contact Person:	Shruthi Bhat, Regulatory AffairsSpecialist
Phone Number	+1 512-895-1295
Date Prepared:	August 24, 2018
Application Correspondent:	Smith & Nephew Inc.7000 West William Cannon Drive,Austin,Texas, 78735,USA
Contact Person:	Kulsum Master, Director RegulatoryAffairs, US Region
Phone Number:	+1 512-358-5720
Device Description
Trade Name:	PICO 7Y Single Use Negative PressureWound Therapy System
Common or Usual Name:	Negative Pressure Wound Therapypowered suction pump

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Classification Name:	Powered suction pump (21 CFR 878.4780)
Regulatory Class:	Class II
Product Code:	OMP

Predicate Device Information

510(k) Number:	K180698
Device:	PICO 7 Single Use Negative Pressure Wound Therapy System

Clearance Date:

August 21, 2018

Device Description

Indications for Use

. Chronic
. Acute

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Traumatic .
Subacute and dehisced wounds ●
Partial-thickness burns .
Ulcers (such as diabetic or pressure) ●
Flaps and grafts ●
. Closed Surgical incisions

PICO Systems are suitable for use both in a hospital and homecare setting.

Comparison between subject device and predicate device

The main differences between the cleared PICO 7 System (K180698) and the subject device are as follows:

1. Introduction of a Y connector to the existing PICO 7 pump device (K180698) allowing delivery of negative pressure to two wounds simultaneously. The O-ring component within the pump device has been changed to enable securing the Y Connector within the pump device casing.
1. Extension of the soft port connected to the large multisite dressing kit for use with PICO 7Y Single Use Negative Pressure Wound Therapy System. The dressing components are identical to existing large multisite dressings (20 x 25cm or 7.9 x 9.8 inches); however the soft port has been extended for user convenience so that when using the device on two wounds, use of the extension tubing is not necessary.
Introduction of a new packaging configuration incorporating dimensional 3. changes to accommodate for additional PVC tubing, the instructions for use being presented as booklets, and the "book" style carton used in the predicate device being replaced with a tuck end carton.
1. Replacement of the 'Dressing Full' indicator with the 'Check Dressing' indicator to remind the user to check their dressing every 24hours.

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1. Corresponding changes to the software to accommodate the use of the system on two wounds and replacement of the 'Dressing Full' indicator with 'Check Dressing' indicator.
Replacement of Alkaline batteries with Lithium batteries which are 6. identical to those which were used in a previously cleared version of PICO Single Use Negative Pressure Wound Therapy System (K163387).
Corresponding changes to the instructions for use to reflect the design 7. changes made to the subject device.

The following testing has been completed on the subject device:

Non-Clinical Tests (Bench)

. Wound model testing was conducted on the PICO 7Y system and compatible dressings from the PICO range (10x20cm and 25x25cm dressings) at low and moderate flow rate in vertical and horizontal positions.
The results of the tests showed that all of the dressings managed fluid at a flow rate modelling a low (0.6 g/cm²/24 hours) and a moderately exuding wound (1.1 g/cm²/24 hours) respectively for a simulated wound of 25% of the dressing absorbent pad area. The results also showed that the dressings maintained negative pressure within the test requirements of -60 mmHg to -100 mmHg for a minimum of 95% of the test time at the simulated wound base throughout the test. Based on the results of the tests it can be concluded that the PICO 7Y device and accessories can be used for their intended purposes.
Wound model testing was conducted on the PICO 7Y dressings in the . absence of negative pressure in vertical and horizontal positions. The results of the tests showed that all of the dressings in a vertical position managed fluid at a flow rate modelling moderate and low exuding wounds

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K182323

with no NPWT (0.5 g/cm²/24hrs and 0.3g/cm²/24hrs) for a simulated wound of 25% of the dressing absorbent pad area. Based on the results it can be concluded that the PICO 7Y dressings (large multisite) can handle fluid without the presence of negative pressure.

Functionality testing was conducted on the PICO 7Y device to ● demonstrate that PICO 7Y pump unit has been adequately designed to handle small (minimum total 50ml volume) and large (maximum total 600ml volume) simulated wounds simultaneously. The results of the tests (using one canister of 50ml and two 300ml canisters respectively to simulate small and large wounds) showed that the pump pressure limits were recorded between -100 to -60mmHg and had a cycle of ≥10mmHg and the time taken to reach the target negative pressure was less than 100seconds. This demonstrated the pump can be used for its intended purpose.
The ability of the PICO 7Y device to deliver negative pressure whilst in a . battery low state was assessed. Test results showed that the PICO 7Y device can continue to deliver negative pressure when the device is in a battery low state demonstrating that the pump can be used for its intended purpose.
Check dressing indicator performance testing was conducted on the PICO . 7Y device. The results of the tests showed that the check dressing indicator successfully activated after 24 hours use, while maintaining negative pressure.

After resetting, per the Instructions for Use and Intended Use, the second occurrence of the check dressing indicator activated after a minimum of 23 hours and 45 minutes and a maximum of 24 hours and 10minutes. Based on the test results, it can be concluded that the PICO 7Y devices can be used for their intended purposes.

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K182323

Performance testing was conducted on the PICO 7Y device to . demonstrate that the dressing is able to manage exudate in a scenario when NPWT is lost after the port becomes blocked, thus mitigating risk of maceration. Test results show that the system when tested under the maximum clinically acceptable flow rate successfully manages exudate during the delivery of negative pressure and following the loss of negative pressure until the 7 day service life has been achieved. As such the design of the dressing provides for inherent safety and acts as an effective primary mitigation for the risk that a dressing is left in place after a port blockage scenario has occurred.
Performance bench testing was conducted to confirm system performance ● and demonstrate that when one dressing soft port is blocked, pressure is maintained within the specified range on the non-blocked dressing. The results demonstrate that when one dressing soft port is blocked due to oversaturation of the dressing, the PICO 7Y device is still able to deliver acceptable levels of negative pressure to the non-blocked dressing.
Air leak testing was conducted on PICO 7Y device by introducing . deliberate air leaks into the system to show that when the system has a high leak rate, the leak indicators activate to alert the user to inspect the dressing application and address the point of air ingress/ air leak. Test results showed that air leak indicator was activated at specified time points in line with the test requirements representing the initial application of the system to achieve the therapeutic negative pressure range of -60mmHg to -100mmHg (target -80mmHg); and maintenance of the therapeutic pressure range.

Based on the test results, it can be concluded that the PICO 7Y devices can be used for their intended purposes.

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Electromagnetic Compatibility and Electrical Safety Testing

PICO 7Y Single Use Negative Pressure Wound Therapy System has been tested and assessed respectively and has been found to be in compliance with the following standards:

AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012 C1:2009/(R)2012 . And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment -Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2 Edition 4.0 2014-02 Medical Electrical Equipment Part . 1-2: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
IEC 60601-1-6 Edition 3.1 2016-10 Medical Electrical Equipment Part . 1-6: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Usability
IEC 60601-1-11 Edition 2.0 2015-01 Medical Electrical Equipment Part . 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment
IEC 62366 Medical Devices Application of Usability Engineering to . Medical Devices

Shelf Life

The PICO 7Y system has been evaluated using real time and accelerating ageing challenge conditions and a combination of simulated wound model testing as well as specification testing to demonstrate system functionality over the duration of the shelf life.

Test results showed that all dressings managed fluid at a flow rate modelling a low (0.6 g/cm²/24 hours) and a moderately exuding wound (1.1 g/cm²/24 hours) respectively for a simulated wound of 25% of the dressing absorbent pad area. The results also showed that the dressings maintained negative pressure within

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K182323

the test requirements of -60 mmHg to -100 mmHg for a minimum of 95% of the test time at the simulated wound base throughout the test without any pressure readings being lower than -235mmHg. Furthermore, all specification test results complied with the acceptance criteria as defined within the test requirements. The results of all tests showed that the subject device was able to maintain its functionality over the duration of the ageing study and that a shelf life of 24 months (2 years) can be applied to the PICO 7Y system. Therefore, it can be concluded that the PICO 7Y device and accessories can be used for their intended purposes.

Human Factors/Usability Engineering Testing

A summative study was carried out in the US. Instructions for Use (IFU) validations were also carried out to demonstrate that the intended users (Lay Users, Healthcare Professionals) can follow the instructions as intended and understand information for safety from the instructions for use. The summative study activities did not result in any patterns of use errors that when assessed resulted in an unacceptable residual risk. PICO 7Y system has appropriate design mitigations in order to prevent and control harm occurring due to use error. It was therefore concluded that PICO 7Y system is safe and effective for use by the intended users, for the described uses in the expected environments.

Conclusions

In establishing substantial equivalence to the predicate device, Smith & Nephew Medical Ltd evaluated the indications for use, materials, technology, product specifications and energy requirements of the device. Performance testing, service life testing and electrical safety testing has been completed to demonstrate that the PICO 7Y Single Use Negative Pressure Wound Therapy System is substantially equivalent to predicate device for the intended use.

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.