(250 days)
Not Found
No
The document describes a standard negative pressure wound therapy system and does not mention any AI or ML capabilities in its description, intended use, or performance studies.
Yes
The device is indicated for promoting wound healing and is used to remove exudate and infectious materials, which are therapeutic actions.
No
The PICO system is described as a suction device (negative pressure wound therapy) that promotes wound healing by removing exudate and infectious materials. Its function is therapeutic, not diagnostic.
No
The device description explicitly lists hardware components such as a pump, batteries, dressing, instructions for use, and fixation strips. It is a physical negative pressure wound therapy system, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The PICO system is a Negative Pressure Wound Therapy (NPWT) device. It applies suction to a wound to remove exudate and promote healing. This is a therapeutic function, not a diagnostic one.
- Intended Use: The intended use clearly states that the device is a "suction device (negative pressure wound therapy)" to "promote wound healing via removal of low to moderate levels of exudate and infectious materials." This describes a treatment, not a diagnostic test.
- Device Description: The description details a pump, dressing, and tubing, all components of a system that applies negative pressure externally to a wound. There is no mention of analyzing biological samples.
Therefore, the PICO 7 and PICO 14 Single Use Negative Pressure Wound Therapy Systems are therapeutic devices, not in vitro diagnostics.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
OMP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
suitable for use both in hospital and homecare setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 intention-to-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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Percentage of subjects reporting any AE:
- Kirsner et al (2019) (PICO arm plus compression) 4LB: 35.3%
- Franks et al (2004) SSB: 26.2%, 4LB: 30.7%
- Iglesias et al (2004) SSB: 53.6%, 4LB: 47.2%
- Franks et al (2004) & Iglesias et al (2004) SSB: 45.3%, 4LB: 42.6%
Percentage of subjects reporting a device related AE:
- Kirsner et al (2019) (PICO arm plus compression) 4LB: 13.7%
- Franks et al (2004) SSB: 10.7%, 4LB: 13.3%
- Iglesias et al (2004) SSB: 47.4%, 4LB: 39.0%
- Franks et al (2004) & Iglesias et al (2004) SSB: 36.2%, 4LB: 31.9%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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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3
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 |
| Establishment | |
| Registration | |
| Number | 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/Proprietary | |
| Name) | PICO 7 Single Use Negative Pressure Wound Therapy System |
| PICO 14 Single Use Negative Pressure Wound Therapy System | |
| PICO Fluid Management Packs | |
| Common Name | Negative Pressure Wound Therapy Powered Suction Pump |
| Review Panel | General & Plastic Surgery |
| Regulation | |
| Number | 21 CFR 878.4780 |
| Regulatory Class | Class II |
| Product Code | OMP |
| 21 CFR 807.92 | |
| (a)(3): Legally | |
| marketed device to | |
| which equivalence | |
| is claimed | 510(k) Number: K202157 |
| Device 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.
4
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 |
|---|---|---|---|
| Intended | |||
| Use | For wound management via | ||
| application of negative | |||
| pressure to the wound for | |||
| removal of low to moderate | |||
| levels of levels of exudate and | |||
| infectious materials. | For wound management via | ||
| application of negative | |||
| pressure to the wound for | |||
| removal of low to moderate | |||
| levels of levels of exudate and | |||
| infectious materials. | Same | ||
| 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 | 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 | Addition of | ||
| "Venous Leg | |||
| Ulcers – | |||
| PICO can be | |||
| used in | |||
| combination | |||
| with |
5
Smith Nephew
| 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. | 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 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. | Graduated
Compression
Therapy in
the
management
of Venous
Leg Ulcers”
and
“When using
PICO 7,
PICO 14
with another
therapy you
must comply
with
indications
for both
products.” |
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
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 and
Software | Wound Model
Tests |
|------------------|------------------------------------------------|-------------------------------|------------------------|
| ISO 10993-1 | IEC 60601-1, IEC 60601-1-
2, IEC 60601-1-11 | IEC 62304, IEC
62366-1 | Wound Exudate,
Size |
6
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) (PICO
arm plus
compression) |
|--------------------------------------------------|--------------------------|--------------------------|------------------------------------------------------|-----------------------------------------------------------|
| Percentage
of
subjects reporting
any AE | SSB: 26.2%
4LB: 30.7% | SSB: 53.6%
4LB: 47.2% | SSB: 45.3%
4LB: 42.6% | SSB: N/A
4LB: 35.3% |
7
Smith Nephew
| Percentage of
subjects reporting a
device related AE | SSB: 10.7%
4LB: 13.3% | SSB: 47.4%
4LB: 39.0% | SSB: 36.2%
4LB: 31.9% | SSB: N/A
4LB: 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.