PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System
Device Facts
| Record ID | K203716 |
|---|---|
| Device Name | PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System |
| Applicant | Smith and Nephew Medical Limited |
| Product Code | QFC · General, Plastic Surgery |
| Decision Date | Dec 14, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4783 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K203716 · Dec 14, 2021 | PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System | Smith and Nephew Medical Limited | Published clinical literature (PubMed, EMBASE, Cochrane Library); ClinicalTrials.gov registry data | A systematic literature review and meta-analysis of 25 studies (17 RCTs and 8 prospective observational studies) were used to demonstrate the reduction in surgical site infections (SSI), seroma, and dehiscence in patients with closed surgical incisions compared to standard of care dressings. | Surgical site infection; Seroma; Dehiscence; Meta-analysis; Systematic literature review |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Meta-analysis of PICO Family clinical literature; Systematic literature review and meta-analysis (17 RCTs, 8 prospective observational studies); Follow-up/Duration: At least 30 days post-surgery; Study Period: 2011-2021 | Patients of any age with closed surgical incisions, including high-risk patients; Sample Size: Up to 5,673 patients (2,737 treatment, 2,936 control) | Standard of care (non-NPWT dressings) | Incidence of surgical site infections (SSI), seroma, and dehiscence |
Indications for Use
PICO Single Use Negative Pressure Wound Therapy System 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. PICO Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. 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. When used on closed surgical incisions, PICO Single Use Negative Pressure Wound Therapy System is intended to aid in reducing the incidence of: Superficial and deep incisional surgical site infections for high risk patients in Class II wounds, Post-operative seroma, Dehiscence.
Device Story
PICO family consists of portable, battery-powered, canister-less NPWT systems. Input: wound exudate managed by absorbent dressing. Operation: microprocessor-controlled pump delivers nominal -80mmHg negative pressure to wound site via dressing; fluid managed through dressing absorbency and evaporation. Used in hospital or homecare by healthcare professionals or patients. Output: continuous negative pressure. Clinical impact: promotes healing; reduces incidence of SSI, seroma, and dehiscence in closed surgical incisions. Benefits: portable, disposable, simplifies wound management.
Clinical Evidence
Systematic literature review and meta-analysis of 25 studies (17 RCTs, 8 prospective observational) with up to 5,673 patients. Primary endpoints: incidence of SSI, seroma, and dehiscence. Results showed statistically significant reduction in SSI (OR 0.36, 95% CI 0.27-0.49), seroma (OR 0.37, 95% CI 0.16-0.86), and dehiscence (OR 0.63, 95% CI 0.43-0.92) compared to standard care. Evidence supports safety and effectiveness for closed surgical incisions.
Technological Characteristics
Single-patient, disposable NPWT system. Components: pump, dressing (polyurethane film, polyester spacer, air-laid absorbent, silicone contact layer), fixation strips, PVC tubing, batteries. Pump: electric motor-driven twin-diaphragm (PICO) or voice-coil (PICO 7/7Y/14) controlled by microprocessor. Pressure: nominal -80mmHg. Connectivity: standalone. Sterilization: not specified. Software: microprocessor-controlled.
Indications for Use
Indicated for patients requiring negative pressure wound therapy (NPWT) to promote healing via removal of low to moderate exudate and infectious materials. Suitable for chronic, acute, traumatic, subacute, dehisced wounds, partial-thickness burns, ulcers, flaps, grafts, and closed surgical incisions. When used on closed incisions, aids in reducing incidence of superficial/deep incisional surgical site infections (SSI) in high-risk patients (Class I/II), seroma, and dehiscence. Not indicated for Class III/IV wounds or organ space SSI.
Regulatory Classification
Identification
A negative pressure wound therapy device for reduction of wound complications is a powered suction pump intended for wound management and reduction of wound complications via application of negative pressure to the wound, which removes fluids, including wound exudate, irrigation fluids, and infectious materials. This device type is intended for use with wound dressings classified under § 878.4780. This classification does not include devices intended for organ space wounds.
Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(1) Clinical data must demonstrate that the device performs as intended under anticipated conditions of use and evaluate the following: (i) Wound complication rates; and (ii) All adverse events. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Performance data must demonstrate the sterility of the patient-contacting components of the device. (4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life. (5) Usability testing must demonstrate that intended users can correctly use the device, based solely on reading the instructions for use. (6) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested in a worst-case scenario for the intended use life: (i) Ability to maintain pressure levels at the wound site under a worst-case scenario for the intended use life; (ii) Fluid removal rate consistent with the wound types specified in the indications for use; and (iii) Timely triggering of all alarms. (7) Performance data must demonstrate the electrical safety and electromagnetic compatibility (EMC) of the device. (8) Software verification, validation, and hazard analysis must be performed. (9) Labeling must include the following: (i) Instructions for use; (ii) A summary of the device technical specifications, including pressure settings, modes ( *e.g.,* continuous or intermittent), alarms, and safety features;(iii) Compatible components and devices; (iv) A summary of the clinical evidence for the indications for use; (v) A shelf life for sterile components; and (vi) Use life and intended use environments. (10) For devices intended for use outside of a healthcare facility, patient labeling must include the following: (i) Information on how to operate the device and its components and the typical course of treatment; (ii) Information on when to contact a healthcare professional; and (iii) Use life.
Predicate Devices
- PREVENA 125 and PREVENA PLUS 125 (DEN180013)
Submission Summary (Full Text)
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December 14, 2021
Smith and Nephew Medical Limited Steeve Lamvohee Director, Regulatory Affairs, Advanced Wound Management 101 Hessle Road Hull, Yorkshire HU3 2BN United Kingdom
### Re: K203716
Trade/Device Name: PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4783 Regulation Name: Negative Pressure Wound Therapy Device For Reduction Of Wound Complications Regulatory Class: Class II Product Code: OFC Dated: June 1, 2021 Received: June 14, 2021
Dear Steeve Lamvohee:
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
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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 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-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and 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 DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/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,
for Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) K203716
#### Device Name
PICO Single Use Negative Pressure Wound Therapy System
#### Indications for Use (Describe)
PICO Single Use Negative Pressure Wound Therapy System 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. PICO Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. 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
When used on closed surgical incisions, PICO Single Use Negative Pressure Wound Therapy System is intended to aid in reducing the incidence of:
- · Superficial and deep incisional surgical site infections for high risk patients in Class II wounds
- · Post-operative seroma
- · Dehiscence
Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore. Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol.
| 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
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510(k) Number (if known) K203716
#### Device Name
PICO 7 Single Use Negative Pressure Wound Therapy System
#### Indications for Use (Describe)
PICO 7 Single Use Negative Pressure Wound Therapy System 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. PICO 7 Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. 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
When used on closed surgical incisions, PICO 7 Single Use Negative Wound Therapy System is intended to aid in reducing the incidence of:
- · Superficial and deep incisional surgical site infections for high risk patients in Class II wounds
- · Post-operative seroma
- · Dehiscence
Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore, Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol.
| 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
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510(k) Number (if known) K203716
#### Device Name
PICO 7Y Single Use Negative Pressure Wound Therapy System
#### Indications for Use (Describe)
PICO 7Y Single Use Negative Pressure Wound Therapy System 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. PICO 7Y Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. 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
When used on closed surgical incisions, PICO 7Y Single Use Negative Pressure Wound Therapy System is intended to aid in reducing the incidence of:
- · Superficial incisional surgical site infections for high risk patients in Class I wounds
- · Post-operative seroma
- · Dehiscence
Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class II (Clean/ Contaminated), Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore, Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol.
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
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510(k) Number (if known) K203716
#### Device Name
PICO 14 Single Use Negative Pressure Wound Therapy System
#### Indications for Use (Describe)
PICO 14 Single Use Negative Pressure Wound Therapy System 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. PICO 14 Single Use Negative Pressure Wound Therapy Systems are suitable for use both in a hospital and homecare setting. 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
When used on closed surgical incisions for up to 7 days, PICO 14 Single Use Negative Pressure Wound Therapy is intended to aid in reducing the incidence of:
- · Superficial and deep incisional surgical site infections for high risk patients in Class II wounds
- · Post-operative seroma
- Dehiscence
Note: When used on closed incisions for the reduction of SSI, the safety and effectiveness for Class III (contaminated) and Class IV (Dirty/Infected) wounds have not been demonstrated. Furthermore, Class IV surgical wounds are not expected to be closed primarily. The device has not been demonstrated to reduce organ space surgical site infections. The device is intended to aid in reducing the incidence of, but not treat, seroma, dehiscence, or infected wounds - the use of PICO does not preclude the need to develop and follow a comprehensive infection management protocol.
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
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### 510(k) Summary
| 21 CFR 807.92 (a)(1): Submitter's Information | |
|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Owner Name | Smith & Nephew Medical Ltd |
| Address | 101 Hessle Road, Hull, HU3 2BN, United Kingdom |
| Establishment<br>Registration Number | 8043484 |
| Contact Name | Dr Steeve Lamvohee, Regulatory Affairs Director |
| Date Prepared | 23 Sept 2021 |
| 21 CFR 807.92 (a)(2): Device Information | |
| Device Name<br>(Trade/Proprietary Name) | PICO Single Use Negative Pressure Wound Therapy System<br>PICO 7 Single Use Negative Pressure Wound Therapy System<br>PICO 7Y Single Use Negative Pressure Wound Therapy System<br>PICO 14 Single Use Negative Pressure Wound Therapy System |
| Common Name | Negative pressure wound therapy device for reduction of wound<br>complications |
| Review Panel | General and Plastic Surgery |
| Regulation Number | 21 CFR 878.4783 |
| Regulatory Class | Class II |
| Product Code | QFC |
| 21 CFR 807.92 (a)(3):<br>Legally marketed device to<br>which equivalence is<br>claimed | DeNovo Number: DEN180013<br>Device Name: PREVENATM 125 and PREVENA PLUSTM<br>125 (PREVENA) |
### 21 CFR 807.92 (a)(4): Device Description
The PICO Family of devices, PICO (cleared under K163387), PICO 7 (cleared under K180698), PICO 7Y (cleared under K182323), PICO 14 (cleared under K191760) all have the same main function of management of fluid through dressing absorbency and evaporation with added benefit of negative pressure. The pump provides a -80mmHg nominal pressure under the dressing, applying Negative Pressure Wound Therapy (NPWT) to the wound. The PICO Single Use Negative Therapy Systems consist of:
- PICO Pump
- · Dressing (s)
- · Fixation strips
- · Batteries
- · Connection tubing
- Instructions for Use
The system is a canister-less system - fluid is managed by the dressing. The pump that delivers the NPWT is a portable, battery-powered, software-controlled system that can provide continuous application of negative pressure to the wound as a delivery pressure at a nominal value of -80mmHg. The PICO Systems are designed to be used at home or within a healthcare setting by an appropriate healthcare professional.
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The dressing and amount of negative pressure delivered across all systems remain the same. Table 1 provides details of products within the PICO Family.
In the context of the proposed Indications for Use, see the definitions provided:
According to the latest recommendations (CDC 2020), superficial and deep incisional SSIs are defined as follows:
- A superficial incisional SSI involves only skin and subcutaneous tissue of the incision . and occurs within 30 days after any National Healthcare Safety Network (NHSN) operative procedure.
- A deep incisional SSI involves deep soft tissues of the incision (for example, fascial and . muscle layers) and occurs within 30 or 90 days after the NHSN operative procedure.
Reference:
CDC 2020. SSI – Procedure-associated Module 2020. Available from: https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf. [Accessed 04/11/2020].
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| | PICO<br>(PICO 1.6) | PICO 7 | PICO 7Y | PICO 14 |
|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | PICO Single Use Negative Pressure<br>Wound Therapy System is indicated<br>for patients who would benefit from<br>a suction device (negative pressure<br>wound therapy) as it may promote<br>wound healing via removal of low<br>to moderate levels of exudate and<br>infectious materials. PICO Single<br>Use Negative Pressure Wound<br>Therapy Systems are suitable for use<br>both in a hospital and homecare<br>setting. Appropriate wound types<br>include:<br>• Chronic<br>• Acute<br>• Traumatic<br>• Subacute and dehisced wounds<br>• Partial-thickness burns<br>• Ulcers (such as diabetic or<br>pressure)<br>• Flaps and grafts<br>• Closed surgical incisions<br><br>When used on closed surgical<br>incisions, PICO Single Use<br>Negative Pressure Wound Therapy<br>System is intended to aid in<br>reducing the incidence of:<br>• Superficial and deep<br>incisional surgical site | Same as PICO (PICO 1.6) | PICO 7Y Single Use Negative<br>Pressure Wound Therapy System is<br>indicated for patients who would<br>benefit from a suction device<br>(negative pressure wound therapy)<br>as it may promote wound healing<br>via removal of low to moderate<br>levels of exudate and infectious<br>materials. PICO 7Y Single Use<br>Negative Pressure Wound Therapy<br>Systems are suitable for use<br>both in a hospital and homecare<br>setting. Appropriate wound types<br>include:<br>• Chronic<br>• Acute<br>• Traumatic<br>• Subacute and dehisced wounds<br>• Partial-thickness burns<br>• Ulcers (such as diabetic or<br>pressure)<br>• Flaps and grafts<br>• Closed surgical incisions<br><br>When used on closed surgical<br>incisions, PICO 7Y Single Use<br>Negative Pressure Wound Therapy<br>System is intended to aid in<br>reducing the incidence of:<br>• Superficial incisional surgical site | PICO 14 Single Use Negative<br>Pressure Wound Therapy System is<br>indicated for patients who would<br>benefit from a suction device<br>(negative pressure wound therapy)<br>as it may promote wound healing<br>via removal of low to moderate<br>levels of exudate and infectious<br>materials. PICO 14 Single Use<br>Negative Pressure Wound Therapy<br>Systems are suitable for use<br>both in a hospital and homecare<br>setting. Appropriate wound types<br>include:<br>• Chronic<br>• Acute<br>• Traumatic<br>• Subacute and dehisced wounds<br>• Partial-thickness burns<br>• Ulcers (such as diabetic or<br>pressure)<br>• Flaps and grafts<br>• Closed surgical incisions<br><br>When used on closed surgical<br>incisions for up to 7 days, PICO 14<br>Single Use Negative Pressure<br>Wound Therapy is intended to aid<br>in reducing the incidence of:<br>• Superficial and deep incisional |
| | PICO<br>(PICO 1.6) | PICO 7 | PICO 7Y | PICO 14 |
| | infections for high risk<br>patients in Class I and Class<br>II wounds | | infections for high risk patients in<br>Class I wounds | surgical site infections for high risk<br>patients in Class I and Class II<br>wounds |
| | • Post-operative seroma | | • Post-operative seroma | • Post-operative seroma |
| | • Dehiscence | | • Dehiscence | • Dehiscence |
| | Note: When used on closed<br>incisions for the reduction of SSI,<br>the safety and effectiveness for<br>Class III (contaminated) and Class<br>IV (Dirty/Infected) wounds have<br>not been demonstrated.<br>Furthermore, Class IV surgical<br>wounds are not expected to be<br>closed primarily. The device has not<br>been demonstrated to reduce organ<br>space surgical site infections. The<br>device is intended to aid in reducing<br>the incidence of, but not treat,<br>seroma, dehiscence, or infected<br>wounds - the use of PICO does not<br>preclude the need to develop and<br>follow a comprehensive infection<br>management protocol. | | Note: When used on closed<br>incisions for the reduction of SSI,<br>the safety and effectiveness for<br>Class II (Clean/Contaminated),<br>Class III (contaminated) and Class<br>IV (Dirty/Infected) wounds have<br>not been demonstrated.<br>Furthermore, Class IV surgical<br>wounds are not expected to be<br>closed primarily. The device has not<br>been demonstrated to reduce organ<br>space surgical site infections. The<br>device is intended to aid in reducing<br>the incidence of, but not treat,<br>seroma, dehiscence, or infected<br>wounds - the use of PICO does not<br>preclude the need to develop and<br>follow a comprehensive infection<br>management protocol. | Note: When used on closed<br>incisions for the reduction of SSI,<br>the safety and effectiveness for<br>Class III (contaminated) and Class<br>IV (Dirty/Infected) wounds have<br>not been demonstrated.<br>Furthermore, Class IV surgical<br>wounds are not expected to be<br>closed primarily. The device has not<br>been demonstrated to reduce organ<br>space surgical site infections. The<br>device is intended to aid in reducing<br>the incidence of, but not treat,<br>seroma, dehiscence, or infected<br>wounds - the use of PICO does not<br>preclude the need to develop and<br>follow a comprehensive infection<br>management protocol. |
| Technological<br>principal for<br>delivering the<br>negative pressure<br>wound therapy | Removal of air from<br>dressing and wound creating<br>NPWT effect. Dressing<br>absorbs exudate from wound<br>which then evaporates | Same as PICO (PICO 1.6) | Same as PICO (PICO 1.6) | Same as PICO (PICO 1.6) |
| | PICO<br>(PICO 1.6) | PICO 7 | PICO 7Y | PICO 14 |
| Physical components<br>of the pumps | Electric motor driven twin-diaphragm vacuum pump controlled by Microprocessor | Custom designed "voice-coil" Pump containing a magnet controlled by Microprocessor | Same as PICO 7 | Same as PICO 7 |
| Physical components<br>of Dressing | Dressing: High Moisture Vapor Permeability polyurethane (MVP PU) top film, polyester spacer layer, air laid super absorbent, silicone wound contact layer, Soft Port tube<br>Secondary fixation strips: High MVP film with acrylic adhesive | Same as PICO (PICO 1.6) | Same as PICO (PICO 1.6) | Same as PICO (PICO 1.6) |
| Tubing/Dressing<br>connector | Single – used to connect a single dressing to the device using PVC tubing | Same as PICO (PICO 1.6) | Y shaped - used to connect two dressings to the device using two sets of PVC tubing; same amount of negative pressure delivered to each wound as PICO (PICO 1.6), PICO 7, and PICO 14 | Same as PICO (PICO 1.6) |
| Batteries | AA Lithium (2) | AA Alkaline (2) | Same as PICO (PICO 1.6) | AA Alkaline (2) + 2 spares provided |
| Software Controlled | Yes | Same as PICO (PICO 1.6) | Same as PICO (PICO 1.6) | Same as PICO (PICO 1.6) |
| Dressing Wear Time | Up to 7 Days | Same as PICO (PICO 1.6) | Same as PICO (PICO 1.6) | Same as PICO (PICO 1.6) |
| Pump Lifetime | 7 Days | Same as PICO (PICO 1.6) | Same as PICO (PICO 1.6) | 14 Days |
| User Interface | After dressing application, the user would interact with the pump device that is attached to the dressing via a soft-port. The pump | Same as PICO (PICO 1.6) | Same as PICO (PICO 1.6) | Same as PICO (PICO 1.6) |
| | PICO<br>(PICO 1.6) | PICO 7 | PICO 7Y | PICO 14 |
| | device has a start/stop therapy<br>button and indicators. | | | |
| Electrical Safety and<br>Electro-magnetic<br>Compatibility (EMC) | Complies with IEC 60601-1, IEC<br>60601-1-2, IEC 60601-1-11, IEC<br>60601-1-6, IEC 62366 | Same as PICO (PICO 1.6) | Same as PICO (PICO 1.6)…
