(250 days)
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System and PICO Fluid Management Packs are 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)
- Venous Leg Ulcers - PICO can be used in combination with Graduated Compression Therapy in the management of Venous Leg Ulcers
- Flaps and grafts
- Closed surgical incisions
PICO 7 Single Use Negative Pressure Wound Therapy Systems, PICO 14 Single Use Negative Pressure Wound Therapy Systems and PICO Fluid Management Packs are suitable for use in both a hospital and homecare setting.
The PICO 7 and PICO 14 Single Use Negative Pressure Wound Therapy Systems consist of:
• PICO Pump
• Batteries
• PICO Dressing (s)
• Instructions for Use
• Fixation Strips
PICO Fluid Management Packs consist of 5 individually packaged PICO dressings designed for use with PICO devices.
PICO 7 and PICO 14 are canister-free single use Negative Pressure Wound Therapy Systems and use an absorbent dressing connected to the PICO pump via a tubing and port.
Wound exudate is managed by PICO dressing using a combination of absorption and evaporation. The PICO pump provides the additional benefit of -80mmHg nominal pressure under the dressing, applying Negative Pressure Wound Therapy to the wound.
The provided text does not contain information about acceptance criteria for a device's performance, nor does it detail a study designed to prove the device meets specific performance criteria.
The document is an FDA 510(k) clearance letter and an accompanying 510(k) summary for the PICO 7 and PICO 14 Single Use Negative Pressure Wound Therapy Systems. The primary purpose of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (K202157) for an expanded Indication for Use: the use of PICO in combination with Graduated Compression Therapy in the management of Venous Leg Ulcers.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning the performance of the device itself (e.g., accuracy, sensitivity, specificity for an AI/algorithm-based device), cannot be extracted from this document.
The document does include:
- Clinical information (Page 6-7): References a Randomized Controlled Trial (RCT) by Kirsner et al. (2019) and a Cochrane Review by O'Meara et al. (2012) to demonstrate the safety of PICO when used with compression therapy for Venous Leg Ulcers, especially regarding adverse events (AEs). This is a safety comparison, not a performance study against acceptance criteria.
- Study Design: Randomized, multi-centre, open-label, controlled trial.
- Sample Size: 164 patients for safety analysis. 101 subjects with venous leg ulcers (VLU) and 60 subjects with diabetic foot ulcers were in the ITT population (n=161 total). 80 received PICO treatment, of which 51 (63.8%) had a VLU.
- Data Provenance: Not specified, but likely multi-center, implying various locations. Retrospective or prospective is not explicitly stated, but RCTs are typically prospective.
- Ground Truth: The study evaluated adverse events and their frequency, comparing them to historical controls. The "ground truth" here is the occurrence and classification of adverse events by clinical observation as per the study protocol.
- Acceptance Criteria (Safety): The conclusion drawn is that "PICO used in conjunction with compression therapy does not generate any increased frequency in the number or severity of AEs in patients compared to compression therapy alone." This acts as a comparative safety criterion rather than a performance metric.
- Reported Device Performance (Safety): Percentage of subjects reporting a device-related AE was 13.7% for PICO + 4-Layer Bandage (4LB) group, compared to 31.9% for historical 4LB control.
- Experts, Adjudication, MRMC studies, Standalone Performance, Training Set: These are not relevant to the safety study presented in the document, which focuses on device-related adverse events in patients, not on an algorithmic or AI performance.
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January 5, 2022
Smith Nephew Medical Limited Steeve Lamvohee Director, Regulatory Affairs, Advanced Wound Management 101 Hessle Road Hull, Yorkshire HU3 2BN United Kingdom
Re: K211318
Trade/Device Name: PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: August 18, 2021 Received: August 19, 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.
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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 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 mediation-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.
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211318
Device Name
PICO 7 Single Use Negative Pressure Wound Therapy System PICO 14 Single Use Negative Pressure Wound Therapy System PICO Fluid Management Packs
Indications for Use (Describe)
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System and PICO Fluid Management Packs are 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)
o Venous Leg Ulcers - PICO can be used in combination with Graduated Compression Therapy in the management of Venous Leg Ulcers
- · Flaps and grafts
- · Closed surgical incisions
PICO 7 Single Use Negative Pressure Wound Therapy Systems, PICO 14 Single Use Negative Pressure Wound Therapy Systems and PICO Fluid Management Packs are suitable for use in both a hospital and homecare setting.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Smith Nephew
| 510(k) Summary – K211318 | |
|---|---|
| 21 CFR 807.92 (a)(1): Submitter's Information | |
| 510(k) Owner | Smith & Nephew Medical Ltd |
| Name | |
| Address | 101 Hessle Road, Hull, HU3 2BN, United Kingdom |
| EstablishmentRegistrationNumber | 8043484 |
| Contact Name | Dr Steeve Lamvohee, Regulatory Affairs Director |
| Date Prepared | December 10, 2021 |
| 21 CFR 807.92 (a)(2): Device Information | |
| Device Name(Trade/ProprietaryName) | PICO 7 Single Use Negative Pressure Wound Therapy SystemPICO 14 Single Use Negative Pressure Wound Therapy SystemPICO Fluid Management Packs |
| Common Name | Negative Pressure Wound Therapy Powered Suction Pump |
| Review Panel | General & Plastic Surgery |
| RegulationNumber | 21 CFR 878.4780 |
| Regulatory Class | Class II |
| Product Code | OMP |
| 21 CFR 807.92(a)(3): Legallymarketed device towhich equivalenceis claimed | 510(k) Number: K202157Device Name: PICO 7 Single Use Negative Pressure Wound Therapy System |
| 21 CFR 807.92 (a)(4): Device Description | |
| The PICO 7 and PICO 14 Single Use Negative Pressure Wound Therapy Systems consist of: | |
| • PICO Pump• Batteries | • PICO Dressing (s)• Instructions for Use• Fixation Strips |
PICO Fluid Management Packs consist of 5 individually packaged PICO dressings designed for use with PICO devices.
PICO 7 and PICO 14 are canister-free single use Negative Pressure Wound Therapy Systems and use an absorbent dressing connected to the PICO pump via a tubing and port.
Wound exudate is managed by PICO dressing using a combination of absorption and evaporation. The PICO pump provides the additional benefit of -80mmHg nominal pressure under the dressing, applying Negative Pressure Wound Therapy to the wound.
The subject device is identical to the predicate device (K202157) in terms of it's intended use, operating principles, technological characteristics and design. Clinical information described in next sections demonstrated that the addition to the Indication for Use do not raise different questions of safety or effectiveness.
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21 CFR 807.92 (a)(5): Intended Use / Indications for Use
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System and PICO Fluid Management Packs are 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) ●
- Venous Leg Ulcers PICO can be used in combination with Graduated Compression Therapy in the management of Venous Leg Ulcers
- Flaps and grafts ●
- Closed surgical incisions .
PICO 7 Single Use Negative Pressure Wound Therapy Systems, PICO 14 Single Use Negative Pressure Wound Therapy Systems and PICO Fluid Management Packs are suitable for use both in hospital and homecare setting.
21 CFR 807.92 (a)(6): Comparison of Technological Characteristics between the Subject and Predicate Devices
There subject device is identical to the predicate device (K202157) in terms of its intended use, operating principles, technological characteristics and design. The only difference between the subject and predicate device is the addition to Indications for Use to include the use of PICO in combination with Graduated Compression Therapy in the management of Venous Leg Ulcers.
Clinical information described in next sections demonstrated that the addition to the Indication for Use do not raise different questions of safety or effectiveness.
| Item | Subject Device | Predicate Device (K202157) | Comparison |
|---|---|---|---|
| IntendedUse | For wound management viaapplication of negativepressure to the wound forremoval of low to moderatelevels of levels of exudate andinfectious materials. | For wound management viaapplication of negativepressure to the wound forremoval of low to moderatelevels of levels of exudate andinfectious materials. | Same |
| Indicationsfor Use | PICO 7 Single Use NegativePressure Wound TherapySystem, PICO 14 Single UseNegative Pressure WoundTherapy System and PICOFluid Management Packs areindicated for patients whowould benefit from a suction | PICO 7 Single Use NegativePressure Wound TherapySystem, PICO 14 Single UseNegative Pressure WoundTherapy System and PICOFluid Management Packs areindicated for patients who | Addition of"Venous LegUlcers –PICO can beused incombinationwith |
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Smith Nephew
| device (negative pressurewound therapy) as it maypromote wound healing viaremoval of low to moderatelevels of exudate and infectiousmaterials. Appropriate woundtypes include:• Chronic• Acute• Traumatic• Subacute and dehiscedwounds• Partial-thickness burns• Ulcers (such as diabeticor pressure)• Venous Leg Ulcers –PICO can be used incombination withGraduatedCompression Therapyin the management ofVenous Leg Ulcers• Flaps and grafts• Closed surgicalincisionsPICO 7 Single Use NegativePressure Wound TherapySystems, PICO 14 Single UseNegative Pressure WoundTherapy Systems and PICOFluid Management Packs aresuitable for use both in hospitaland homecare setting. | would benefit from a suctiondevice (negative pressurewound therapy) as it maypromote wound healing viaremoval of low to moderatelevels of exudate and infectiousmaterials. Appropriate woundtypes include:• Chronic• Acute• Traumatic• Subacute and dehiscedwounds• Partial-thickness burns• Ulcers (such as diabeticor pressure)• Flaps and grafts• Closed surgicalincisionsPICO 7 Single Use NegativePressure Wound TherapySystems, PICO 14 Single UseNegative Pressure WoundTherapy Systems and PICOFluid Management Packs aresuitable for use both in hospitaland homecare setting. | GraduatedCompressionTherapy inthemanagementof VenousLeg Ulcers”and“When usingPICO 7,PICO 14with anothertherapy youmust complywithindicationsfor bothproducts.” |
|---|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
in this submission to determine substantial equivalence
Verification and validation activities conducted demonstrate the PICO System continues to perform as intended when used in combination with Graduated Compression Therapy. The principal test methods used to demonstrate performance were simulated wound model tests. Performance data provided in previously cleared 510(k)s for PICO 7, PICO 14, PICO FMP continue to support substantial equivalence and meeting requirements of:
| Biocompatibility | Electrical Safety and EMC | Human Factors andSoftware | Wound ModelTests |
|---|---|---|---|
| ISO 10993-1 | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 | IEC 62304, IEC62366-1 | Wound Exudate,Size |
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21 CFR 807.92 (b)(2): Brief discussion of clinical tests submitted/referenced/ relied on in this submission to determine substantial equivalence
The use of PICO in combination with graduated compression therapy was found to be as safe and effective as predicate device.
Randomized Controlled Study (RCT)
Substantial equivalence is based on a randomized, multi-centre, open-label, controlled trial which investigated PICO in lower extremity ulcers (Kirsner et al 2019). A total of 164 patients were available for safety analysis (safety population) and a total of 101 subjects presenting with venous leg ulcers (VLU) and 60 subjects presenting with diabetic foot ulcer were included in the intentionto-treat (ITT) population (n=161 total). Of these patients, 80 received treatment with PICO (intervention). Of the 80 PICO patients, 51 (63.8%) had a VLU. Patients with VLUs were given multilayered compression bandaging. The primary safety endpoint for the study was the occurrence of an adverse event (AE) followed by an evaluation of the extent of exposure to study therapy.
The Kirsner et al (2019) study reported that in total, 18 of the subjects using PICO on a VLU (35.3%) identified 40 adverse events (AE). No serious device-related AEs were reported. Nine of the 40 AEs (13.7%) were device related. Of the nine device related AEs, the types of harms identified included maceration, ulcer size increase, blistering and irritation.
A Cochrane Review by O'Meara et al (2012) looked at over 40 randomized controlled trials (RCTs) investigating which methods of compression provide the greatest benefit in the management of VLUs. One of the outcomes investigated by the review was the safety profile of compression devices, including the frequency of AEs. As part of the review, an aggregate safety analysis was conducted evaluating the AEs collected from two studies: Franks et al (2004) and Iglesias et al (2004).
The AE results of the PICO (plus compression) arm from the Kirsner et al (2019) study were compared to the aggregate AE frequencies from Franks et al (2004) and Iglesias et al (2004) studies for compression alone (historical control). A summary of this comparison can be seen in below. As seen in the table below, the frequency of device related AEs associated with the use of PICO with multilayer compression is no higher than that observed with multilayer compression alone (13.7% versus 31.9%, respectively). The types of harms identified from the historical control studies include: maceration, pain, eczema, tissue damage (new ulcer), skin excoriation, skin deterioration, ulcer deterioration, bandaging failure, dryness and the requirement for surgical interventions or hospitalization. As noted above, these harms are similar in the type and severity observed with PICO plus compression.
| Percentage frequencies of observed AEs from Kirsner et al (2019) and historical control(s). | ||
|---|---|---|
| Franks et al(2004) | Iglesias et al(2004) | Franks et al(2004) &Iglesias et al(2004) | Kirsner et al(2019) (PICOarm pluscompression) | |
|---|---|---|---|---|
| Percentageofsubjects reportingany AE | SSB: 26.2%4LB: 30.7% | SSB: 53.6%4LB: 47.2% | SSB: 45.3%4LB: 42.6% | SSB: N/A4LB: 35.3% |
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Smith Nephew
| Percentage ofsubjects reporting adevice related AE | SSB: 10.7%4LB: 13.3% | SSB: 47.4%4LB: 39.0% | SSB: 36.2%4LB: 31.9% | SSB: N/A4LB: 13.7% |
|---|---|---|---|---|
| SSB - Short-stretch bandage; 4LB - Four-layer bandage |
It can be concluded from the above findings that PICO used in conjunction with compression therapy does not generate any increased frequency in the number or severity of AEs in patients compared to compression therapy alone.
21 CFR 807.92 (b)(3): Conclusions drawn
Based on the clinical supporting information provided in this submission, the subject device is substantially equivalent to the legally marketed predicate device (K202157) and there are no different questions of safety or effectiveness.
§ 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.