PICO 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. Examples of 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 Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting.

Device Description

PICO Single Use Negative Pressure Wound Therapy System is a small, lightweight, portable suction device consisting of a electric motor driven, twindiaphragm, vacuum pump connected to a super-absorbent, gentle adhesive dressing. The pump, dressing and secondary fixations strips are supplied sterile and single use. The dressing is applied to the wound and secondary fixation strips are placed over the outside edges to help hold the dressing in place. When the suction pump is turned on, air is pulled out of the dressing creating negative pressure and drawing excess fluid from the wound into the dressing. The pump is battery operated and is supplied with two AA lithium batteries which provide up to 168 hours (7 days) of battery life depending upon leak rate. The batteries can be replaced if required. The pump is programmed to stop working after 168 hours (7 days) of use and will not re-start after this time, even with new batteries. Negative pressure will not be applied at this point. PICO Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting. A carry bag is not provided with the system however will be available to order separately.

AI/ML Overview

The PICO Single Use Negative Pressure Wound Therapy System's acceptance criteria and studies focused on demonstrating biocompatibility and electrical/software safety rather than a comparative effectiveness study with human readers or standalone algorithm performance.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Biocompatibility (ISO 10993 Series)
Cytotoxicity (Dressing)	ISO 10993-5 (Minimum Essential Medium elution assay) standards for non-cytotoxicity.	N to 1:16, all non-cytotoxic (Grade 0)
Cytotoxicity (Fixation Strips)	ISO 10993-5 (elution assay with L-929 mouse fibroblast cells) standards for non-cytotoxicity.	N to 1:16, all non-cytotoxic (Grade 0)
Sensitization (Dressing)	ISO 10993-10 (Guinea Pig Maximisation Test) standards for non-sensitizing.	Non-sensitizing
Sensitization (Fixation Strips)	ISO 10993-10 (Guinea pig maximisation test) standards for non-sensitizing.	Non-sensitizing
Irritation (Dressing)	ISO 10993-10 standards for negligible irritancy.	PII SC = 0.0 (Negligible irritant)
Irritation (Fixation Strips)	ISO 10993-10 standards for negligible irritancy (e.g., Primary Irritation Index below a certain threshold).	PII SC = 0.1; 0.9% NaCl extract: Primary Irritation Index: 0.11 (Negligible)
Ethylene Oxide Residuals (Dressing & Fixation Strips)	ISO 10993-7 requirements for allowable residual limits for Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) for permanent and tolerable contact.	Permanent contact limits: Ethylene Oxide <0.1mg/day (Complies), Ethylene Chlorohydrin <0.4mg/day (Complies). Tolerable contact limits: Ethylene Oxide 10µg²/cm/day (Complies), Ethylene Chlorohydrin 5mg/cm²/day (Implied Complies, as it follows the EO compliance)
Electrical Safety	Compliance with IEC / UL 60601-1; General Requirements for Safety of Electrical Medical Equipment.	Test results conform to IEC / UL 60601-1.
Electromagnetic Safety	Compliance with IEC 60601-1-2; Electromagnetic Safety Requirements For Electrical Medical Equipment.	Test results conform to IEC 60601-1-2.
Software Validation	Compliance with IEC 62304 Software for Medical Devices.	Software validation completed in accordance with IEC 62304.
Substantial Equivalence	Device is substantially equivalent to predicate devices (NPD 1000, Renasys Go, PICO K111170) in design characteristics, functions, intended use, indications, and instructions for use, raising no new safety/effectiveness issues.	The subject device was found substantially equivalent to the predicate devices.

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

The provided documentation does not detail a "test set" in the context of clinical performance or algorithm evaluation with human data. The tests described are primarily non-clinical bench and lab-based studies focused on biocompatibility and safety.

Biocompatibility Tests: These involved laboratory samples of the PICO dressing and secondary fixation strips. The specific "sample sizes" (e.g., number of animals for sensitisation, number of cell cultures for cytotoxicity) are not explicitly stated in the summary, but the methods were conducted in accordance with ISO 10993 standards.
Electrical, Electromagnetic, and Software Tests: These involve testing the physical device and its software, not human data.

Data Provenance: Not applicable in the context of human data. The biocompatibility tests are lab-based, not involving human subjects or real-world clinical data from specific countries.

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

Not applicable. The "ground truth" for these non-clinical tests is established by adhering to international recognized standards (e.g., ISO, IEC protocols) and achieving predefined outcomes (e.g., "non-sensitising," "Grade 0 Cytotoxicity," compliance with electrical safety limits). These are objective measurements rather than expert consensus on a subjective output.

4. Adjudication Method for the Test Set

Not applicable. As the tests are objective measurements against established standards (biocompatibility, electrical safety), an adjudication method for conflicting expert opinions is not relevant.

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

No MRMC comparative effectiveness study was done as this device is a medical device (Negative Pressure Wound Therapy System), not an AI-driven diagnostic or interpretative tool designed to assist human readers. The regulatory submission focuses on the safety and efficacy of the physical device itself.

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

Not applicable. The PICO system is a physical medical device, not a standalone algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests is defined by:

International Standards: Compliance with specific ISO (e.g., 10993 for biocompatibility) and IEC (e.g., 60601 for electrical safety, 62304 for software) standards.
Objective Laboratory Measurements: Results from cytotoxicity assays, sensitization tests (e.g., Guinea Pig Maximisation Test), irritation tests, and residual analyses, all yielding quantitative or qualitative results that are evaluated against pre-defined acceptable limits within the standards.

8. The Sample Size for the Training Set

Not applicable. This device does not employ machine learning or AI algorithms that require a "training set" of data.

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

Not applicable. This device does not employ machine learning or AI algorithms that require a "training set" of data or associated ground truth.

Summary

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K112127

MAY 1 6 2012

510(k) SUMMARY

PICO Single Use Negative Pressure Wound Therapy System

Smith & Nephew, Inc. 1. Submitter: 970 Lake Carillon Drive, Suite 110 St. Petersburg, FL 33716

Contact: Terry McMahon Director of Regulatory Affairs & Quality, North America 727-399-3785 Email: terry.mcmahon@smith-nephew.com
Device name: PICO Single Use Negative Pressure Wound Therapy System Common name: Negative Pressure Wound Therapy powered suction pump Classification name: Powered suction pump (21 CFR 878.4780) Product Classification/Code: Class II, OMP
Date Prepared: May 15, 2012
Predicate Device Information:

NPD 1000 Negative Pressure Wound Therapy System (K080275) Kalypto Medical

6393 Oakgreen Avenue

Hastings, MN 55033

Renasys Go (K083375) Smith & Nephew, Inc.

Rotation Ellipsoid

St. Petersburg, FL

PICO Single Use Negative Pressure Wound Therapy System (K111170) Smith & Nephew, Inc. St. Petersburg, FL

{1}------------------------------------------------

6. Device Description:

7. Intended Use

Examples of appropriate wound types include:

Chronic
Acute ●
Traumatic ●
Subacute and dehisced wounds ●
Partial-thickness burns ●
Ulcers (such as diabetic or pressure)

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Flaps and grafts
Closed surqical incisions

PICO Single Use Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting.

8 Summary of Non-Clinical Testing

The biocompatibility of the PICO Single Use Negative Pressure Wound Therapy System has been demonstrated through assessment according to ISO 10993-1. 2003 In-vivo and in-vitro tests have been conducted on the dressing and fixation strips of finished product. These tests include cytotoxicity, sensitization and irritation. These studies indicated that the PICO Single Use Negative Pressure Wound Therapy System is safe for its intended use. In addition, residual testing has been performed in accordance with ISO 10993-7 which confirms that PICO dressings and fixation strips comply with the allowable residual limits for ethylene oxide (EO) and ethylene chlorohydrin (ECH).

Test	Description of Method	Result
Cytotoxicity	PICO DressingIn order to determine the cytotoxicpotential of the dressing, a MinimumEssential Medium (MEM) elution assaywas conducted in accordance with ISO10993-5.	N to 1:16, all non-cytotoxic(Grade 0)
Cytotoxicity	Secondary Fixation StripsCytotoxicity testing has been performedon the secondary fixation strips, testedin accordance with ISO 10993-5. Thetest article extract was diluted insupplemented EMEM 1X and placedonto triplicate confluent monolayers of	N to 1:16, all non-cytotoxic(Grade 0)
Test	Description of Method	Result
	L-929 mouse fibroblast cells at the100%, 50%, 25% and 5% solutions(v/v)
Sensitisation	PICO DressingA Guinea Pig Maximisation Test wasperformed on the dressing inaccordance with ISO 10993-10.	Non-sensitising
	Secondary Fixation StripsA guinea pig maximisation test wasperformed on the secondary fixationstrips in accordance with ISO 10993-10.	Non-sensitising
Irritation	PICO DressingThe dressing was evaluated for irritationin accordance with ISO 10993-10.Secondary Fixation StripsIrritation testing has been performed onthe secondary fixation strips inaccordance with ISO 10993-10.	PII SC = 0.0PII SC = 0.1Negligible irritant0.9% NaCl extract: PrimaryIrritation Index: 0.11(Negligible)
Ethylene oxideresiduals	PICO Dressing and Fixation StripsThe dressing and strips have beentested in accordance with ISO 10993-7.	Permanent contact limits:Ethylene Oxide <0.1mg/dayCompliesEthylene Chlorohydrin<0.4mg/dayCompliesTolerable contact limits:Ethylene Oxide10µg²/cm/dayCompliesEthylene Chlorohydrin5mg/cm²/day

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Additionally, the effects of the dressing wound contact layer (polyurethane) have been assessed during a wound healing study on ALLEVYN Gentle Border dressings. ALLEVYN Gentle Border dressings are a range of currently marketed (by Smith & Nephew) absorbent foam dressings which incorporate an identical top film layer and wound contact layer as the dressing included in the PICO Single Use Negative

{4}------------------------------------------------

. Pressure Wound Therapy System. The wound healing study report can be found in the Biocompatibility section.

Testing has been completed in accordance with IEC / UL 60601-1; General Requirements for Safety of Electrical Medical Equipment and IEC 60601-1-2; Electromagnetic Safety Requirements For Electrical Medical Equipment. Software validation has been completed in accordance with IEC 62304 Software for Medical Devices. Reports can be found in the Electromagnetic and Electrical Safety section.

9. Conclusion

Based on results of testing performed the subject device is substantially equivalent to the predicate devices NPD 1000 Negative Pressure Wound Therapy System (K080275), PICO Single Use Negative Pressure Wound Therapy System (K111170) and Renasys Go (K083375).

PICO has similar design characteristics and provides similar functions to NPD 1000 Negative Pressure Wound Therapy System (K080275), PICO Single Use Negative Pressure Wound Therapy System (K111170) and Renasys Go (K083375). The intended use, indications and instructions for use for the subject and predicate devices are similar.

PICO does not raise any new issues of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is composed of three thick, curved lines that suggest movement and dynamism. The text is in a simple, sans-serif font and is evenly spaced around the circle.

Public Health Service

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

MAY 1 6 2012

Smith and Nephew, Inc. % Mr. Terry McMahon Director of Regulatory Affairs & Quality, NA 970 Lake Carillon Drive, Suite 110 St. Petersburg, Florida 33716

Re: K112127

Trade/Device Name: PICO 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: May 03, 2012 Received: May 04, 2012

Dear Mr. McMahon:

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

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Page 2 - Mr. Terry McMahon

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth 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 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.html

Sincerely yours.

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure .

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K112127

Dossier Reference: K112127

< smith&nephew

Page 140 of 147

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K112127

Device Name: PICO Single Use Negative Pressure Wound Therapy System

Indications for Use:

PICO is indicated for patients who would benefit from a suction device (negative moderate levels therapy) as it may promote wounderate levels

Examples of 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 Single Use Negative Pressure Wound Therapy System is suitable for use in
both a hospital and homecare setting both a hospital and homecare setting.

Prescription Use

AND/OR

Over-The-Counter

Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)_

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dail Kace for MXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112127

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.