(400 days)
No
The summary describes a negative pressure wound therapy device that applies continuous suction and has basic system alarms. There is no mention of AI, ML, image processing, or any data analysis beyond standard statistical methods for clinical study results.
Yes
The device is described as "Therapy Units" and is "intended to aid in reducing the incidence of seroma and, in patients at high risk for post-operative infections, aid in reducing the incidence of superficial surgical site infection." These functions directly relate to treating or preventing medical conditions.
No
Explanation: The device is a therapy unit that applies continuous negative pressure to surgical incisions to aid in reducing the incidence of seroma and superficial surgical site infection. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly states it is a "powered suction pump" and includes physical components like "sterile canisters" and "sterile tubing set," indicating it is a hardware device with potential software control, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes managing the environment of closed surgical incisions and removing fluid. This is a therapeutic and wound management function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a powered suction pump used with dressings to apply negative pressure to an incision. This aligns with a wound care device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition based on such analysis.
The device is clearly intended for direct application to a surgical incision for therapeutic purposes (wound management and aiding in reducing complications).
N/A
Intended Use / Indications for Use
PREVENA 125 and PREVENA PLUS 125 Therapy Units manage the environment of closed surgical incisions and remove fluid away from the surgical incision via the application of -125mmHg continuous negative pressure. When used with legally marketed compatible dressings, PREVENA 125 and PREVENA PLUS 125 Therapy Units are intended to aid in reducing the incidence of seroma and, in patients at high risk for post-operative infections, aid in reducing the incidence of superficial surgical site infection in Class I and Class II wounds.
Product codes
QFC
Device Description
The PREVENA 125 and PREVENA PLUS 125 Therapy Units ("PREVENA pumps") are singleuse, compact and portable powered suction pumps. The therapy units are packaged with compatible sterile canisters (45 ml for PREVENA 125 or 150 ml for PREVENA PLUS 125) and sterile tubing set. The therapy units can be used with compatible, legally marketed wound dressings classified under 21 CFR 878.4780, such as the PEEL & PLACE dressing and the CUSTOMIZABLE dressing, which, when combined are referred to as the PREVENA Incision Management Systems ("PREVENA systems"). The PREVENA Incision Management Systems deliver a pre-set, continuous negative pressure of 125 mmHz to the incision site. The systems are intended to be applied to incision sites immediately after surgery for a minimum of 2 days up to a maximum of 7 days depending on the surgeon's preference. The therapy units can be used up to 192 hours, after which they will automatically shut off.
The subject devices are identical to the currently marketed PREVENA pumps, except for the change in the intended use (reduction in the incidence of wound complications). The PREVENA 125 Therapy Unit was most recently cleared under K161897, and the PREVENA PLUS 125 Therapy Unit was most recently cleared under K173426. There is no change to the user interface, design, mechanisms of operation, and specifications for delivery of negative pressure therapy from the previously marketed PREVENA pumps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Closed surgical incisions, sternotomy, femoral cutdown, common femoral artery
Indicated Patient Age Range
Not Found (Safety and effectiveness in pediatric population (
§ 878.4783 Negative pressure wound therapy device for reduction of wound complications.
(a)
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.(b)
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.
0
DE NOVO CLASSIFICATION REQUEST FOR PREVENA 125 AND PREVENA PLUS 125 THERAPY UNITS
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Negative pressure wound therapy device for reduction of wound complications. 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 21 CFR 878.4780. This classification does not include devices intended for organ space wounds.
NEW REGULATION NUMBER: 21 CFR 878.4783
CLASSIFICATION: Class II
PRODUCT CODE: QFC
BACKGROUND
DEVICE NAME: PREVENA 125 and PREVENA PLUS 125 Therapy Units
SUBMISSION NUMBER: DEN180013
DATE OF DE NOVO: March 15, 2018
- KCI USA. Inc. CONTACT: 6203 Farinon Dr. San Antonio, Tx 78249
INDICATIONS FOR USE
PREVENA 125 and PREVENA PLUS 125 Therapy Units manage the environment of closed surgical incisions and remove fluid away from the surgical incision via the application of -125mmHg continuous negative pressure. When used with legally marketed compatible dressings, PREVENA 125 and PREVENA PLUS 125 Therapy Units are intended to aid in reducing the incidence of seroma and, in patients at high risk for post-operative infections, aid in reducing the incidence of superficial surgical site infection in Class I and Class II wounds.
LIMITATIONS
The sale, distribution, and use of PREVENA 125 and PREVENA PLUS 125 Therapy Units are restricted to prescription use in accordance with 21 CFR 801.109.
1
The device is not intended to treat surgical site infection or seroma.
Safety and effectiveness in pediatric population (35 kg/m². In the treatment group, 6/68 subjects with a BMI >35 kg/m² had an SSI (8.8%) and 10/75 control subiects with a BMI >35 kg/m2 had an SSI (13.3%). Adverse events were reported. See 'Safety' section below for more detail. There were 286 (83.6%) of subjects that experienced at least one adverse event. In the treatment group. 83.8% subjects experienced an adverse event, while 83.4% of the control group subjects experienced an adverse event. There were 18 subjects that experienced a treatment related adverse event. In the treatment group, 16 (9.2%) subjects experienced a treatment related adverse event, while 2 (1.2%) subjects in the control group experienced a treatment related adverse event. There were 118 serious adverse events. In the treatment group. 36.4% of subjects experienced a serious adverse event. while 32.5% of the control subjects experienced a serious adverse event. There were no device-related serious adverse events in either the treatment or control group.
8
Surgical Site Infection (SSI)
Sixteen (16) prospective studies were included in the meta-analyses for SSI, which are summarized in Table 3 below. Nine (9) studies are randomized controlled trials, which are considered level I evidence. The remaining seven (7) studies are considered level II evidence, which include five (5) prospective treatment and historical controls studies and two (2) prospective observational studies that alternated patient assignment into either the treatment or control group (i.e., not randomized).
| Study/ Level
of Evidence* | Study
Design | Surgical
Procedure | Subjects' Risk
Factors | Study
Duration | Incisional
Dressings
Used | No. of
Subjects | Treatment
Duration
(days) |
|--------------------------------|-------------------------------------------|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|------------------------------------------------|--------------------|---------------------------------|
| Cantero 20163
Level II | Prospective
& Historical
Controlled | Diverting loop
ileostomy
reversal | NR | 30 days | PREVENA
IMS | 17 | 5-7 |
| | | | | | Conventional
Wound
Dressing | 43 | 1-2, then daily |
| DiMuzio 20174
Level I | RCT | Elective
vascular
surgery† | BMI> 30kg/m2,
pannus,
immunosuppressant | 30 days | PREVENA
IMS | 59 | NR |
| | | | disorder,
reoperation,
prosthetic graft,
HbA1c>8 | | Standard gauze
dressing | 60 | NR |
| Grauhan 20136
Level II | Prospective
Observational | Median
sternotomy† | BMI Mean
Treatment: 37 kg/m2,
Control: 36 kg/m2;
Diabetes; COPD;
LVEF | 90 days | PREVENA
IMS | 75 | 6-7 |
| | | | | | Conventional
wound
dressings | 75 | 1-2 |
| Grauhan 20147
Level II | Prospective
& Historical
Controlled | Median
sternotomy | NR | 30 days | PREVENA
IMS | 237 | 6-7 |
| | | | | | Conventional
sterile wound
tape dressing | 3508 | 1-2 |
| Gunatilake
20178
Level I | RCT | Cesarean
delivery | BMI Mean
Treatment: 46.3
kg/m2, Control: 46.8
kg/m2; Diabetes | 42 ± 10
days | PREVENA
IMS | 39 | 5-7 |
| | | | | | Steri-strips,
sterile gauze,
Tegaderm | 43 | 1-2 |
| Lavryk 201610
Level II | Prospective
Observational | Reoperative
colorectal
surgery† | Diabetes; Hx of
Smoking | 30 days | PREVENA
IMS | 55 | 7±2 |
| | | | | | Standard gauze
dressing | 101 | NR |
| Lee AJ 201611
Level I | RCT | CABG with
harvesting of
GSV† | Diabetes; Smoking;
COPD; HTN; CHF;
LVD; Aortic
Stenosis; AF; CVD;
Dyslipidemia; CKF;
PVD;
Hypothyroidism;
Arthritis; Gout;
Asthma | 42 days | PREVENA
IMS | 33 | Up to 7 |
| | | | | | Conventional
dry dressing | 27 | NR |
| Table 3. Characteristics of studies included in the SSI meta-analyses | ||
|---|---|---|
9
| Lee K 201712
Level I | RCT | Femoral to
distal artery
bypass; femoral
endarterectomy;
femoral artery
crossover;
other† | BMI Mean
Treatment: 29 kg/m2,
control: 29 kg/m2;
Diabetes; Hx of
Smoking/ COPD;
CAD; LVD; HTN;
CKD;
Anticoagulation;
Ischemic tissue loss | 30 days
and 90
days | PREVENA
IMS
Standard gauze
dressing | 53 | First day of
discharge up to
8 days |
|---------------------------------|-------------------------------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-------------------------------------------|
| Matatov 201313
Level II | Prospective
& Historical
Controlled | Femoral
cutdown for
vascular
procedures | BMI Mean
Treatment: 26 kg/m2,
Control: 27 kg/m2;
Diabetes; Hx of
Smoking/; COPD;
CAD; CHF; HTN;
renal insufficiency,
anemia | 30 days | PREVENA
IMS
Primapore or
Dermabond
Adhesive | 41 (52
wounds) | 5-7 |
| | | | | | | 49 (63
wounds) | 3 |
| NCT01341444
Level I | RCT | Renal
transplant† | BMI Mean
Treatment: 29.05
kg/m2, Control:
28.73; Diabetes;
Tobacco Use; | 30 days | PREVEANA
IMS
Standard
incisional
dressing | 28 | 5 |
| | | | | | | 30 | 3 |
| NCT02195310
Level I | RCT | Median
sternotomy
(elective
cardiac surgery)† | BMI Mean
Treatment: 35.64
kg/m2, Control:
35.27 kg/m2;
Diabetes;
Immunosuppressant
Disorder; Hx of
Smoking; Dialysis;
Planned Bilateral
Mamery Artery;
Chronic Lung
Disease; CKD;
Previous Chest Wall
Radiotherapy; Breast
Size D Age > 75
years; LVEF 4
hours;
chorioamnionitis,
anticoagulation; | 42 days | PREVENA
IMS | 110 | 3 |
| | | | | | Standard
sterile dressing | 209 | NR |
10
*Population or Procedure identified as high-risk for wound complication *Oxford Centre of Evidence-Based Medicine RCT = Randomized Controlled Trial NR= Not Reported IMS= Incision Management System ciNPWT= closed incision Negative Pressure Wound Therapy BMI= Body Mass Index HX= History COPD= Chronic Obstructive Pulmonary Disorder GERD= Gastroesophageal Reflux Disease HTN= Hypertension AF= Atrial Fibrillation CVD= Cardiovascular disease CKF= Chronic kidney failure
PVD= Peripheral vascular disease
LVD= Left ventricle dysfunction
CAD= Coronary artery disease
CKD= Chronic kidney disease
LVEF= Left ventricle ejection fraction
HIV= Human immunodeficiency virus HELLP = Hemolysis, Elevated Liver enzymes, Low Platelet counts
Together, the sixteen (16) studies contained 1,264 evaluable patients receiving the PREVENA Incision Management Systems therapy (treatment group) and 4,923 patients receiving conventional wound dressings (control group). The conventional wound dressings used in each study can be found in Table 3 above and range from occlusive gauze dressings to silverimpregnated dressings. The primary endpoint in the studies was the incidence of surgical site infection in the treatment group compared to the control group for at least four weeks following surgery.
11
The treatment effect for each study was summarized using odds ratio (OR), which was calculated using the following formula:
OR = AD/BC, where
A = the number of subjects with SSI events for the treatment group
B = the number of subjects without SSI events for the treatment group
- C = the number of subjects with SSI events for the control group
D = the number of subjects without SSI events for the control group
An OR of less than 1 suggests a favorable effect by the treatment in reducing SSI, whereas an OR greater than 1 suggests a favorable effect by the conventional wound dressings. The 95% confidence interval (95% CI) for the odds ratio is calculated based on the standard error of Log(OR). The individual study effects for SSI are summarized in Figure 2 below.
| Study or Subgroup | Treatment | Control | Odds Ratio (95% CI) | Odds Ratio (95% CI) | |||||
|---|---|---|---|---|---|---|---|---|---|
| Events | Total | (%) | Events | Total | (%) | ||||
| Cantero 2016 | 0 | 17 | (0.0) | 9 | 43 | (20.9) | 0.10 (0.01, 1.89) | ||
| Dimuzio P 2017 | 6 | 59 | (10.2) | 15 | 60 | (25.0) | 0.34 (0.12, 0.95) | ||
| Grauhan O 2013 | 3 | 75 | (4.0) | 12 | 75 | (16.0) | 0.22 (0.06, 0.81) | ||
| Grauhan O 2014 | 3 | 237 | (1.3) | 119 | 3508 | (3.4) | 0.37 (0.12, 1.16) | ||
| Gunatiliake RP 2017 | 1 | 39 | (2.6) | 4 | 43 | (9.3) | 0.26 (0.03, 2.40) | ||
| Lavryk O 2016 | 7 | 55 | (12.7) | 21 | 101 | (20.8) | 0.56 (0.22, 1.40) | ||
| Lee AJ 2016 | 0 | 27 | (0.0) | 0 | 17 | (0.0) | Not estimable | ||
| Lee K 2017 | 6 | 53 | (11.3) | 9 | 49 | (18.4) | 0.57 (0.19, 1.73) | ||
| Matatov T 2013 | 3 | 52 | (5.8) | 19 | 63 | (30.2) | 0.14 (0.04, 0.51) | ||
| NCT01341444 | 0 | 28 | (0.0) | 2 | 30 | (6.7) | 0.20 (0.01, 4.35) | ||
| NCT02195310 | 13 | 145 | (9.0) | 16 | 154 | (10.4) | 0.85 (0.39, 1.83) | ||
| Newman JM 2017 | 2 | 80 | (2.5) | 12 | 80 | (15.0) | 0.15 (0.03, 0.67) | ||
| Redfern RE 2017 | 2 | 196 | (1.0) | 14 | 400 | (3.5) | 0.28 (0.06, 1.26) | ||
| Ruhstaller K 2017 | 2 | 61 | (3.3) | 4 | 58 | (6.9) | 0.46 (0.08, 2.60) | ||
| Sabat J 2016 | 2 | 30 | (6.7) | 7 | 33 | (21.2) | 0.27 (0.05, 1.39) | ||
| Swift SH 2015 | 3 | 110 | (2.7) | 24 | 209 | (11.5) | 0.22 (0.06, 0.73) | ||
| Total | 1264 | 4923 | 0.37 (0.27, 0.52) | ||||||
| 0.01 | |||||||||
| 0.1 | |||||||||
| 1 | |||||||||
| 10 | |||||||||
| 100 | |||||||||
| Favours [experimental] | |||||||||
| Favours [control] | |||||||||
Figure 2. Forest plot of meta-analysis studies on surgical site infection (SSI)4
Overall, there is an observable trend supporting a favorable effect by the PREVENA system in reducing the incidence of SSI. The SSI rates ranged from 0% to 30.2% for the control group in the individual studies, and the SSI rates in the treatment group ranged from 0% to 12.7%. However, the benefit of the PREVENA systems varies considerably across different studies. possibly due to many confounding factors such as different surgical procedures and patient risk factors, which are further explored in subgroup analyses below. Additionally, there are many inherent limitations associated with meta-analyses and biases with each individual study, which are discussed in the 'Limitations of the Clinical Evidence' section below. Because of these confounding factors and limitations of the studies, statistical significance cannot be reliably inferred for the treatment effect based on the combined results from the sixteen (16) studies.
a One (1) study (Lee AJ 20161) had no events in either the treatment or control group, and an odds ratio cannot be estimated for this study.
12
Subgroup analyses were performed to elucidate potential confounding factors contributing to the heterogeneity in the treatment effect. The subgroup analyses conducted were based on: i) Wound classification, ii) Infection depth (i.e., superficial, deep, organ space), iii) Risk factors for surgical site infection.
i.Wound classification
To analyze the effect of the PREVENA Incision Management Systems on SSI in wounds of different degrees of contamination, a wound classification designation following the Center for Disease Control and Prevention (CDC) guidelines (Table 4) was assigned to each study based on the surgical procedure performed and CDC wound classification definitions. Each study was reviewed, and a CDC wound classification was assigned by two individuals with appropriate medical and clinical trials background. All the same wound types in each study were treated the same unless the publication (e.g., Newman et. al.14) specifically gave guidance that some wounds were more severe in a particular subgroup (e.g., septic revisions). If the publication provided a CDC wound classification, the provided classification was utilized. One study (Lavryk et. al.10) was excluded as only patients with wound classifications of II, III and IV were enrolled and could not be separated into the individual wound classification groups.
| Surgical Wound
| Classification | Definition |
|---|---|
| Class I/Clean | An uninfected operative wound in which no inflammation is encountered and the |
| respiratory, alimentary, genital, or uninfected urinary tract is not entered. In addition, | |
| clean wounds are primarily closed and, if necessary, drained with closed drainage. | |
| Operative incisional wounds that follow nonpenetrating (blunt) trauma should be | |
| included in this category if they meet the criteria. | |
| Class II/Clean- | |
| contaminated | An operative wound in which the respiratory, alimentary, genital, or urinary tracts are |
| entered under controlled conditions and without unusual contamination. Specifically, | |
| operations involving the biliary tract, appendix, vagina, and oropharynx are included in | |
| this category, provided no evidence of infection or major break in technique is | |
| encountered. | |
| Class III/Contaminated | Open, fresh, accidental wounds. In addition, operations with major breaks in sterile |
| technique (e.g., open cardiac massage) or gross spillage from the gastrointestinal tract, | |
| and incisions in which acute, nonpurulent inflammation is encountered are included in | |
| this category. | |
| Class IV/Dirty-infected | Old traumatic wounds with retained devitalized tissue and those that involve existing |
| clinical infection or perforated viscera. This definition suggests that the organisms | |
| causing postoperative infection were present in the operative field before the operation. |
Table 4. Surgical wound classifications and definitions21
Eleven (11) of the sixteen (16) studies were determined to contain only Class I wounds, and these eleven (11) studies consist of approximately 88% of the total patient population for the overall SSI meta-analysis. The subgroup analysis results of Class I wounds (Figure 3) show a reduction in favor of the PREVENA Incision Management Systems therapy and are consistent with the overall reduction in SSI observed in Figure 2.
13
| Treatment | Control | Odds Ratio (95% CI) | Odds Ratio (95% CI) | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Study or Subgroup | Events | Total | (%) | Events | Total | (%) | ||||
| Dimuzio P 2017 | 6 | 59 | (10.2) | 15 | 60 | (25.0) | 0.34 (0.12, 0.95) | |||
| Grauhan O 2013 | 3 | 75 | (4.0) | 12 | 75 | (16.0) | 0.22 (0.06, 0.81) | |||
| Grauhan O 2014 | 3 | 237 | (1.3) | 119 | 3508 | (3.4) | 0.37 (0.12, 1.16) | |||
| Lee AJ 2016 | 0 | 27 | (0.0) | 0 | 17 | (0.0) | Not estimable | |||
| Lee K 2017 | 6 | 53 | (11.3) | 9 | 49 | (18.4) | 0.57 (0.19, 1.73) | |||
| Matatov T 2013 | 3 | 52 | (5.8) | 19 | 63 | (30.2) | 0.14 (0.04, 0.51) | |||
| NCT01341444 | 0 | 28 | (0.0) | 2 | 30 | (6.7) | 0.20 (0.01, 4.35) | |||
| NCT02195310 | 13 | 145 | (9.0) | 16 | 154 | (10.4) | 0.85 (0.39, 1.83) | |||
| Newman JM 2017 | 2 | 80 | (2.5) | 12 | 80 | (15.0) | 0.15 (0.03, 0.67) | |||
| Redfern RE 2017 | 2 | 196 | (1.0) | 14 | 400 | (3.5) | 0.28 (0.06, 1.26) | |||
| Sabat J 2016 | 2 | 30 | (6.7) | 7 | 33 | (21.2) | 0.27 (0.05, 1.39) | |||
| Total | 982 | 4469 | 0.36 (0.24, 0.55) | |||||||
| 0.01 | ||||||||||
| 0.1 | ||||||||||
| 1 | ||||||||||
| 10 | ||||||||||
| 100 | ||||||||||
| Favours [experimental] | ||||||||||
| Favours [control] |
Figure 3. Forest plot of meta-analysis studies on surgical site infection in Class I wounds
Three (3) of the sixteen (16) studies were included in the subgroup analysis for Class II wounds, and these three (3) studies consist of approximately 8% of the total patient population for the overall SSI meta-analysis. The subgroup analysis results of Class II wounds (Figure 4) show a reduction in favor of the PREVENA Incision Management Systems therapy and are consistent with the overall reduction in SSI observed in Figure 2.
Figure 4. Forest plot of meta-analysis studies on surgical site infection in Class II wounds
| Study or Subgroup | Treatment | Control | Odds Ratio (95% CI) | |||||
|---|---|---|---|---|---|---|---|---|
| Events | Total | (%) | Events | Total | (%) | |||
| Gunatiliake RP 2017 | 1 | 39 | (2.6) | 4 | 43 | (9.3) | 0.26 (0.03, 2.40) | |
| Ruhstaller K 2017 | 2 | 61 | (3.3) | 4 | 58 | (6.9) | 0.46 (0.08, 2.60) | |
| Swift SH 2015 | 3 | 110 | (2.7) | 24 | 209 | (11.5) | 0.22 (0.06, 0.73) | |
| Total | 210 | 310 | 0.27 (0.11, 0.68) | |||||
| 0.01 | 0.1 | 1 | 10 100 | |||||
| Favours [experimental] | Favours [control] |
There was only one (1) study identified as having Class III wounds; therefore, a subgroup analysis for Class III wounds was not performed. In this study, no SSI events were reported for the treatment group (0 out of n=17) and nine (9) SSI events were reported for the control group (9 out of n=43). There were no studies containing Class IV wounds that could be isolated for analysis; therefore, a subgroup analysis was not performed for Class IV wounds. It should be noted that the PREVENA systems are intended to be used only on closed incisions. As Class IV wounds are generally not expected to be surgically closed primarily, the PREVENA systems should not be used on Class IV wounds.
ii.Infection depth
Surgical site infection (SSI) can be divided into three (3) subgroups: superficial incisional SSI, deep incisional SSI, and organ space SSI'. Superficial incisional SSI is infection that is limited to the skin or subcutaneous tissue of the surgical incision. Deep incisional SSI is infection that has spread to deep soft tissues such as fascial and muscle layers. Organ space SSI is deeper infection that involves any part of the anatomy that was opened or manipulated during the operation'.
14
Five (5) of the sixteen (16) studies selected for SSI meta-analyses included information to stratify patient SSI events into superficial, deep, and organ space infections. Subgroup analyses examining the effect of the PREVENA systems on different SSI locations were conducted based on these five (5) studies. Among the three subgroups, the PREVENA systems demonstrated the greatest benefit in reducing superficial incisional SSIs (Figure 5). The reduction in superficial SSI appears to be greater than the SSI reduction in the overall data (Figure 2). There was little to no benefit of the PREVENA systems in reducing deep incisional SSIs and organ space SSIs when compared to the control group.
Figure 5. Forest plot of meta-analysis studies on surgical site infection in superficial incisional SSI
| Study or Subgroup | Treatment
Events | Treatment
Total | Treatment
(%) | Control
Events | Control
Total | Control
(%) | Odds Ratio (95% CI) | | | | | |
|-------------------|---------------------|--------------------|------------------|-------------------|------------------|----------------|---------------------|--------------------------------|-----|------------------------|----|-----|
| Grauhan O 2013 | 1 | 75 | (1.3) | 8 | 75 | (10.7) | 0.11 (0.01, 0.93) | | | | | |
| Lavryk O 2016 | 1 | 55 | (1.8) | 12 | 101 | (11.9) | 0.14 (0.02, 1.09) | | | | | |
| Matatov T 2013 | 3 | 52 | (5.8) | 10 | 63 | (15.9) | 0.32 (0.08, 1.25) | | | | | |
| Newman JM 2017 | 0 | 80 | (0.0) | 3 | 80 | (3.8) | 0.14 (0.01, 2.71) | | | | | |
| Redfern RE 2017 | 0 | 196 | (0.0) | 9 | 400 | (2.3) | 0.10 (0.01, 1.81) | | | | | |
| Total | | 458 | | | 719 | | 0.19 (0.08, 0.46) | | | | | |
| | | | | | | | | | | | | |
| | | | | | | | | 0.01
Favours [experimental] | 0.1 | 1
Favours [control] | 10 | 100 |
iii. Risk factors for surgical site infection
Patients having one or more co-morbidities are generally considered to be at higher risk for surgical site complications. High risk patients were defined in the selected studies as having one or more of the following co-morbidities: obesity (body mass index ≥30 kg/m²); diabetes; history of smoking; immune suppression or receiving drugs that can cause immune suppression, such as steroids, chemotherapeutic medications, and/or antimetabolites; malnutrition with a hydrated serum albumin of less than 3.0 grams/deciliter; neutropenia; preeclampsia; patients who have cardiac, pulmonary, liver or renal disease; history of previous surgery or radiation in the treatment area. Subjects' risk factors for each of the sixteen (16) studies are described in Table 3; however, some of the studies contain all comers with only a portion being high-risk patients. Upon further examination, nine (9) studies were determined to contain only high-risk patients. A subgroup analysis was performed on these nine (9) studies (Figure 6). As expected, the incidence of SSI, in both the treatment and control groups, is higher in high-risk patients (5.5% and 12.9%, respectively) compared to the overall study population (4.2% and 5.8%, respectively). Additionally, there appears to be a greater overall percentage reduction in SSI in high risk patients. Thus, while the reduction in SSI, as measured by odds ratio, in high risk patients does not appear to be significantly different than the reduction observed in the overall data (Figure 2), there is a greater clinical benefit of the PREVENA systems in patients at high risk for surgical site infection based on a greater absolute percentage reduction in the incidence of SSI.
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| Study or Subgroup | Treatment | Control | Odds Ratio (95% CI) | |||||
|---|---|---|---|---|---|---|---|---|
| Events | Total | (%) | Events | Total | (%) | |||
| Dimuzio P 2017 | 6 | 59 | (10.2) | 15 | 60 | (25.0) | 0.34 (0.12, 0.95) | |
| Grauhan O 2013 | 3 | 75 | (4.0) | 12 | 75 | (16.0) | 0.22 (0.06, 0.81) | |
| Gunatilake RP 2017 | 1 | 39 | (2.6) | 4 | 43 | (9.3) | 0.26 (0.03, 2.40) | |
| Lee K 2017 | 6 | 53 | (11.3) | 9 | 49 | (18.4) | 0.57 (0.19, 1.73) | |
| NCT01341444 | 0 | 28 | (0.0) | 2 | 30 | (6.7) | 0.20 (0.01, 4.35) | |
| NCT02195310 | 13 | 145 | (9.0) | 16 | 154 | (10.4) | 0.85 (0.39, 1.83) | |
| Newman JM 2017 | 2 | 80 | (2.5) | 12 | 80 | (15.0) | 0.15 (0.03, 0.67) | |
| Ruhstaller K 2017 | 2 | 61 | (3.3) | 4 | 58 | (6.9) | 0.46 (0.08, 2.60) | |
| Swift SH 2015 | 3 | 110 | (2.7) | 24 | 209 | (11.5) | 0.22 (0.06, 0.73) | |
| Total | 650 | 758 | 0.40 (0.27, 0.62) | |||||
| 0.01 | ||||||||
| 0.1 | ||||||||
| 1 | ||||||||
| 10 | ||||||||
| 100 | ||||||||
| Favours [experimental] | ||||||||
| Favours [control] |
Figure 6. Forest plot of meta-analysis studies on surgical site infection in high risk patients
Together, the subgroup analyses on wound classification, infection depth, and patient risk factors for surgical site infection serve as the basis for granting the following Indications for Use:
PREVENA 125 and PREVENA PLUS 125 Therapy Units manage the environment of closed surgical incisions and remove fluid away from the surgical incision via the application of -125mmHg continuous negative pressure. When used with legally marketed compatible dressings, PREVENA 125 and PREVENA PLUS 125 Therapy Units are intended to aid in reducing the incidence of seroma and, in patients at high risk for post-operative infections, aid in reducing the incidence of superficial surgical site infection in Class I and Class II wounds.
Additional subgroup analyses for surgical site infection were performed based on surgical procedure risk factor, combination of surgical procedure and patient risk factors, and incision location. While the results from these subgroup analyses were reviewed, they did not serve as the basis for granting this De Novo request.
Seroma
Seven (7) prospective studies were included in the meta-analysis for seroma, which are summarized in Table 5 below. Five (5) studies are randomized controlled trials, which are level I evidence. The remaining two (2) studies are considered level II evidence, which include one (1) prospective treatment and historical controls study and one (1) prospective observational study that alternated patient assignment into either the treatment or control group (i.e., not randomized).
| Study/ Level of
Evidence* | Study
Design | Surgical
Procedure | Subjects' Risk
Factors | Study
Duration | Incisional
Dressings Used | No. of
Subjects | Treatment
Duration
(days) |
|--------------------------------|-------------------------------------------|-----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|----------------------------------------------------------|--------------------|---------------------------------|
| Ferrando 20175
Level II | Prospective
Observational | Breast conserving
surgery,
oncoplastic
surgery, tissue
sparing, simple
mastectomies† | BMI mean
Treatment: 27
kg/m²; Control: 29.5
kg/m²; Diabetes; Hx
of Smoking; HTN;
Use of
Corticosteroids;
Artery and Liver | 1 year | PREVENA PLUSTM
CUSTOMIZABLE
TM | 17 (25
wounds) | 7 |
| | | | | | Steri-strip skin
adhesive closure | 20 (22
wounds) | 14 |
| | | | Disease;
Chemotherapy;
Radiation; Previous
Surgery; Invasive
surgery | | | | |
| Gunatilake 20178
Level I | RCT | Cesarean delivery | BMI Mean
Treatment: 46.3 kg/m2, Control: 46.8 kg/m2; Diabetes | 42 ± 10 days | PREVENA IMS | 39 | 5-7 |
| | | | | | Steri-strips, sterile gauze, Tegaderm | 43 | 1-2 |
| NCT01341444
Level I | RCT | Renal transplant† | BMI Mean
Treatment: 29.05 kg/m2, Control:
28.73; Diabetes;
Tobacco Use; | 30 days | PREVEANA IMS | 28 | 5 |
| | | | | | Standard incisional dressing | 30 | 3 |
| Pachowsky
201215
Level I | RCT | Total hip arthroplasty | NR | 10 days | PREVENA IMS | 9 | 5 days |
| | | | | | Standard wound dressing | 10 | NR |
| Pauser 201616
Level I | RCT | Hip hemiarthroplasty† | NR | 10 days | PREVENA IMS | 11 | 5 |
| | | | | | Standard wound dressing consisting of dry wound coverage | 10 | NR |
| Pleger 201717
Level I | RCT | Vascular procedures with access in common femoral artery† | BMI Mean
Treatment: 26.7 kg/m2, Control: 27.8 kg/m2; Diabetes; | 30 days | PREVENA IMS | 43 (58 wounds) | 5-7 |
| | | | HX of Smoking/;
COPD; Renal Insufficiency;
Malnutrition; Age >
50 years;
Overweight | | Conventional adhesive plaster | 57 (71 wounds) | 1 |
| Redfern 201718
Level II | Prospective &
Historical
Controlled | Total hip or knee arthroplasty
(elective primary) | BMI Mean
Treatment: 30.5 kg/m2, Control: 30.9 kg/m2; Diabetes; | 60 days | PREVENA IMS | 192 | 6-8 |
| | | | HTN; Hx of
Cancer/Tumor;
Arthritis:
Myocardial
Infarction/Heart
Disease; Tobacco | | Traditional gauze dressing | 400 | Standard |
Table 5. Characteristics of studies included in the Seroma meta-analysis
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*Population or Procedure identified as high-risk for wound complication
*Oxford Centre of Evidence-Based Medicine
- NR= Not Reported
RCT = Randomized Controlled Trial IMS= Incision Management System
ciNPWT= closed incision Negative Pressure Wound Therapy BMI= Body Mass Index HX= History COPD= Chronic Obstructive Pulmonary Disorder GERD= Gastroesophageal Reflux Disease HTN= Hypertension AF= Atrial Fibrillation CVD= Cardiovascular disease CKF= Chronic kidney failure
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Together, the seven (7) studies contained 366 evaluable patients receiving PREVENA Incision Management Systems therapy (treatment group) and 586 patients receiving conventional wound dressings (control group). The conventional wound dressings used in each study can be found in Table 5 above and mostly consist of gauze and occlusive dressings. The primary endpoint in the studies was the incidence of seroma in the treatment group compared to the control group for at least 10 days following surgery.
The treatment effect for each study was summarized using odds ratio (OR), which was calculated using the following formula:
OR = AD/BC. where
A = the number of subjects with seroma events for the treatment group
B = the number of subjects without seroma events for the treatment group
C = the number of subjects with seroma events for the control group
D = the number of subjects without seroma events for the control group
An OR of less than 1 suggests a favorable effect by the treatment in reducing seroma, whereas an OR greater than 1 suggests a favorable effect by the standard of care in reducing seroma. The 95% confidence interval (95% CI) for the odds ratio is calculated based on the standard error of Log(OR). The individual study effects are summarized in Figure 7 below.
| Study or Subgroup | Treatment | Control | Odds Ratio (95% CI) | Odds Ratio (95% CI) | ||||
|---|---|---|---|---|---|---|---|---|
| Events | Total | (%) | Events | Total | (%) | |||
| Ferrando PM 2017 | 1 | 25 | (4.0) | 5 | 22 | (22.7) | 0.14 (0.02, 1.32) | |
| Gunatiliake RP 2017 | 1 | 39 | (2.6) | 2 | 43 | (4.7) | 0.54 (0.05, 6.19) | |
| NCT01341444 | 3 | 28 | (10.7) | 3 | 30 | (10.0) | 1.08 (0.20, 5.85) | |
| Pachowsky M 2012 | 4 | 9 | (44.4) | 9 | 10 | (90.0) | 0.09 (0.01, 1.03) | |
| Pauser J 2014 | 4 | 11 | (36.4) | 8 | 10 | (80.0) | 0.14 (0.02, 1.03) | |
| Pleger SP 2017 | 0 | 58 | (0.0) | 1 | 71 | (1.4) | 0.40 (0.02, 10.05) | |
| Redfern RE 2017 | 0 | 196 | (0.0) | 2 | 400 | (0.5) | 0.41 (0.02, 8.49) | |
| Total | 366 | 586 | 0.31 (0.13, 0.75) | |||||
| 0.01 | ||||||||
| 0.1 | ||||||||
| 1 | ||||||||
| 10 | ||||||||
| Favours [experimental] Favours [control] |
Figure 7. Forest plot of meta-analysis studies for seroma.
Overall, there is an observable trend supporting a favorable effect by the PREVENA systems in reducing the incidence of seroma formation. The seroma rates ranged from 0.5 % to 90 % for the control group in the selected studies, and the seroma rates in the treatment group ranged from 0 % to 44.4 %. However, the benefit of the PREVENA systems in reducing the incidence of seroma formation varies broadly across different studies, possibly due to many confounding factors such as different surgical procedures and patient risk factors. Subgroup analyses for seroma were not conducted as there are only seven (7) studies total and dividing them into subgroups would not result in meaningful analyses. Additionally, there are many inherent limitations associated with meta-analyses and biases with each individual study, which are discussed in the 'Limitations of the Clinical Evidence' section below. Because of these
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confounding factors and limitations, statistical significance cannot be reliably inferred for the treatment effect on seroma rates based on the combined results from the seven (7) studies.
Limitations of the Clinical Evidence
There are many inherent limitations to meta-analyses, such as publication bias and selection bias. In addition, surgical site infection (SSI) and seroma are complex post-operative outcomes that have many potential causes. While efforts were made in the study identification and selection process to ameliorate biases by including both published and unpublished studies and only the highest quality studies, not all aspects of each selected meta-analysis study are identical. First, even though only prospective studies were included in the meta-analyses, these studies often had many potential sources of bias. Bias assessment was conducted using the Cochrane guidelines and focused on randomization, allocation concealment, differences in baseline patient and risk characteristics, blinded assessments, loss to follow up, comparing purpose of study to outcomes reported, and when possible, comparing outcomes to those listed on ClinicalTrials.gov, when available. Fourteen (14) of the twenty (20) meta-analysis studies were identified as high-risk for bias (Cantero 20162, DiMuzio 20174, Ferrando 20175, Gunatilake 2017, Lavryk 201610, Lee AJ 201611, Matatov 201313, NCT013471444, Newman 201714, Pleger 201717, Redfern 201718, Sabat 201620, Swift 201522). One (1) study was assessed as low risk for bias (Lee K 201712). Risk for bias was unclear in the remaining five (5) studies due to the lack of information reported in the studies. Second, the unit of the analysis is not consistent in all studies. Some studies used the wound as the unit of analysis and others used the patient as the unit of analysis. As a result, some of the data used in these analyses were based on wounds and some patients contributed more than one (1) wound to the analyses. Third, the timing of the outcome assessments was not consistent across each of the different studies. For example, although all the SSI studies evaluated SSI events for at least four weeks post-surgery, the duration of some of the studies was much longer. Similarly, although all the seroma studies evaluated the incidence of seroma for at least ten days after surgery, the duration of some of the studies was much longer. Fourth, the reported SSI rates in the metaanalysis studies varied broadly across different studies. It should be noted that the following SSI rates based on wound classification and types of SSI (Table 6) have recently been reported based on a retrospective review of the 2011 American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSOIP) database :
| 30-d postoperative outcomes | Total | Wound Classification | Class I | Class II | Class III | Class IV |
|---|---|---|---|---|---|---|
| Surgical Site Infection (SSI) | 3.4% | 1.8% | 4.8% | 5.6% | 8.5% | |
| Superficial incisional SSI | 1.9% | 1.2% | 2.6% | 2.8% | 2.7% | |
| Deep incisional SSI | 0.6% | 0.4% | 0.6% | 0.8% | 1.5% | |
| Organ space SSI | 1.1% | 0.3% | 1.6% | 2.2% | 4.4% |
| Table 6. Surgical Site Infection (SSI) rates based on ACS NSOIP database's | |||||||
|---|---|---|---|---|---|---|---|
| ---------------------------------------------------------------------------- | -- | -- | -- | -- | -- | -- | -- |
The SSI rates reported in the studies selected for the meta-analysis, even for the control groups, are generally higher than those reported in the literature. Factors contributing to this discrepancy may be surgeon-, procedure-, or patient-dependent, but nevertheless cannot be pinpointed based on the information provided in the studies. Fifth, five (5) of the seven (7) prospective studies included in the meta-analysis for SSI and one (1) prospective study included in the meta-analysis for seroma compared the PREVENA systems to historical
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controls. There have been significant evidence-based changes in patient care to define and reduce the risk for post-operative complications, including surgical site infections. Additionally, surgical site infection reduction measures vary among surgeons, hospitals, and countries. Changes in disease definitions, interventions, and treatment effectiveness over time contribute to non-contemporaneous bias. Results of studies using historical controls should be evaluated with caution.
These limitations should be considered when examining the results from these meta-analyses.
Conclusion
Overall, there appears to be a small but consistent trend supporting the benefit of the PREVENA systems in reducing surgical site infection (SSI) and seroma. However, due to the many limitations of the selected studies in the meta-analyses described above, any statistical inferences based on the combined results of these studies are inherently unreliable. The benefit of the PREVENA systems in reducing SSI and seroma appears to be small in general and varies potentially based on several factors, including wound classification, infection depth, and patient risk factors for post-operative wound complication. Subgroup analyses demonstrated that while the trend observed in the overall data continues to be observed in most subgroup studies, the greatest benefit of the PREVENA system appears to be in reducing superficial SSI in Class I and Class II wounds. Additionally, there is a greater absolute percentage reduction in the incidence of SSI in patients at high risk for post-operative infections, likely because of the higher incidence of SSI in this patient population. Therefore, taken as a whole, the data may not be supportive of routine use of the PREVENA systems for the sole purpose of reducing surgical site infection and seroma; however, as an adjunct therapy to good clinical practice, the PREVENA system has demonstrated to aid in reducing the incidence of seroma and, in patients at high risk for post-operative infections, aid in reducing the incidence of superficial surgical site infection in Class I and Class II wounds. Surgeons should continue to follow the 'Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection'2 and the 'American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines' 1 for best practices in preventing surgical site infection.
Safety
Adverse events (AEs) and Serious Adverse Events (SAEs) were reported in three (3) of the twenty (20) studies included in the meta-analyses [Gunatilake (Cesarean section) 2017°, NCT01341444 (Renal transplant). NCT02195310 (Sternotomy)). There were no treatment related AEs or SAEs reported in the Cesarean section study (Gunatilake 2017°). In the two studies conducted by KCI (NCT01341444 (Renal transplant), NCT02195310 (Sternotomy)), there were no SAEs, and the twenty one (21) reported AEs related or possibly related to the device including pain (5), blisters (4), dehiscence (4), draining/wound secretion (2), erythema (2), skin irritation (2), ecchymosis (1), and hematoma (1), which are known adverse events that may be seen with the use of the device on surgical incisions.
No significant differences were reported in AEs or SAEs between the PREVENA systems (treatment group) and conventional wound dressings (control group). No adverse device events, serious adverse device events, or device failures were reported. These results suggest that the
20
PREVENA systems have a similar safety profile as conventional wound dressing for closed surgical incisions.
Post Market Data
PREVENA 125 and PREVENA PLUS 125 Therapy Units first received 510(k) clearance in 2010 and have been legally marketed globally. Since 2010, there have been (b) (4) units shipped with (b) (4) complaints. The complaint total includes data from both "Non-Harm" and "Alleging Harm" complaints. Post market surveillance data, from Medical Device Reporting (MDR) and Manufacturer and User Facility Device (MAUDE) databases, have been reviewed against the device risk profile and have been determined to be within acceptable limits. Additionally, the post market reports are consistent with the adverse events reported in the metaanalysis studies.
Although Medical Device Reporting (MDR) is a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use. MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time, or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.
Pediatric Extrapolation
In this De Novo request, existing clinical data were not leveraged to support the use of the device in a pediatric population.
LABELING
Device labeling includes a clinician guide and patient labeling. The clinician guide includes a description of the sterile and non-sterile device components, instructions for use, relevant clinical evidence, electromagnetic compatibility information, shelf life, and device disposal instructions.
Patient labeling includes instructions for use and information regarding when the treating physician should be contacted.
RISKS TO HEALTH
The table below identifies the risks to health that may be associated with use of a negative pressure wound therapy system for reduction of wound complications and the measures necessary to mitigate these risks.
21
| Identified Risks to Health | Mitigation Measures |
|---|---|
| Adverse tissue reaction | Biocompatibility evaluation |
| Infection | Sterilization validation |
| Shelf life testing | |
| Labeling | |
| Electrical shock or | |
| electromagnetic interference | |
| with other devices | Electromagnetic compatibility testing |
| Electrical safety testing | |
| Labeling | |
| Damage to underlying tissue | |
| (e.g., wound maceration, | |
| uncontrolled bleeding) due to | Clinical data |
| Non-clinical performance testing | |
| Usability testing | |
| Shelf life testing | |
| Software verification, validation, and hazard analysis | |
| Mechanical failure Software malfunction Use error | Labeling |
| Increase in wound complications | |
| due to use error | Clinical data |
| Usability testing | |
| Labeling |
Table 7. Identified Risks to Health and Mitigation Measures
SPECIAL CONTROLS
In combination with the general controls of the FD&C Act, the negative pressure wound therapy system for reduction of wound complications is subject to the following special controls:
- (1) Clinical data must demonstrate that the device performs as intended under anticipated conditions of use and evaluate the following:
- (a) Wound complication rates; and
- (b) 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:
- (a) Ability to maintain pressure levels at the wound site under a worst-case scenario for the intended use life:
22
- (b) Fluid removal rate consistent with the wound types specified in the indications for use; and
- (c) 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:
- (a) Instructions for use;
- (b) A summary of the device technical specifications, including pressure settings, modes (e.g., continuous or intermittent), alarms, and safety features;
- (c) Compatible components and devices;
- (d) A summary of the clinical evidence for the indications for use;
- (e) A shelf life for sterile components; and
- (f) Use life and intended use environments.
- (10) For devices intended for use outside of a healthcare facility, patient labeling must include the following:
- (a) Information on how to operate the device and its components and the typical course of treatment:
- (b) Information on when to contact a healthcare professional; and
- (c) Use life.
BENEFIT/RISK DETERMINATION
Risks
The risks of the device are based on nonclinical laboratory studies, data collected in clinical studies, and post-market surveillance data described above. Adverse events (AEs) and Serious Adverse Events (SAEs) were reported in three (3) of the twenty (20) studies included in the meta-analyses (Gunatilake (Cesarean section) 20178, NCT01341444 (Renal transplant), NCT02195310 (Sternotomy)). There were no treatment related AEs or SAEs reported in the Cesarean section study (Gunatilake 20178). In the two studies conducted by KCI USA, Inc. (NCT01341444 (Renal transplant), NCT02195310 (Sternotomy)), there were no SAEs, and the twenty-one (21) reported AEs related or possibly related to the device included skin irritation. blisters, erythema, ecchymosis, pain, drainage, hematoma, and dehiscence, which are known adverse events that are anticipated with the use of the device on surgical incisions. Post-market surveillance (PMS) data of seven years also demonstrate the safety of the PREVENA systems. Overall, the risk of the PREVENA systems is low when used on closed surgical incisions. The risks associated with the PREVENA systems have been appropriately mitigated using the identified special controls. Device labeling will help ensure that the end users clearly understand the system description, indications, contraindications, warnings, and instructions for use.
23
Benefits
The probable benefits of the device are based on nonclinical laboratory studies and clinical evidence based on meta-analyses described above. The proposed intended use is supported by a meta-analysis from twenty (20) clinical studies, seven (7) years of post-market surveillance (PMS) data, and preclinical testing: all of which contribute to a favorable benefit risk profile. Overall, the collective clinical evidence demonstrates a small but consistent trend supporting the benefit of the PREVENA systems in reducing surgical site infection (SSI) and seroma. However, due to the many limitations of the selected studies in the meta-analyses, any statistical inferences based on the combined results of these studies are inherently unreliable. The benefit of the PREVENA systems in reducing the incidence of SSI and seroma appears to be small in general and varies potentially based on several factors, including wound classification, infection depth, and patient risk factors for post-operative wound complication. Subgroup analyses demonstrated that while the trend observed in the overall data continues to be observed in most subgroup studies, the greatest benefit of the PREVENA system appears to be in reducing superficial SSI in Class I and Class II wounds. Additionally, there is a greater absolute percentage reduction in the incidence of SSI in patients at high risk for post-operative infections, likely because of the higher incidence of SSI in this patient population. The data, however, do not support the use of the PREVENA systems in reducing surgical site infection and seroma for all surgical procedures and patient populations. Therefore, taken as a whole, the data may not be supportive of routine use of the PREVENA systems for the sole purpose of reducing surgical site infection and seroma; however, as an adjunct therapy to good clinical practice, the PREVENA system has demonstrated to aid in reducing the incidence of seroma and, in patients at high risk for postoperative infections, aid in reducing the incidence of superficial surgical site infection in Class I and Class II wounds. Surgeons should continue to follow the 'Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection'2 and the 'American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines' for best practices in preventing surgical site infection.
Patient Perspectives
This submission did not include specific information on patient perspectives for this device.
Benefit/Risk Conclusion
In conclusion, given the available information above, for the following indication statement:
When used with legally marketed compatible dressings. PREVENA 125 and PREVENA PLUS 125 Therapy Units are intended to aid in reducing the incidence of seroma and, in patients at high risk for post-operative infections, aid in reducing the incidence of superficial surgical site infection in Class I and Class II wounds .
The probable benefits outweigh the probable risks for the PREVENA systems. The device provides benefits and the risk can be mitigated using general controls and the identified special controls.
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CONCLUSION
The De Novo request for the PREVENA 125 and PREVENA PLUS 125 Therapy Units is granted, and the device is classified under the following:
Product Code: QFC Device Type: Negative pressure wound therapy device for reduction of wound complications Class: II
Regulation: 21 CFR 878.4783
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References
-
- Ban, K. A., Minei, J. P., Laronga, C., Harbrecht, B. G., Jensen, E. H., Fry, D. E., . . . Duane, T. M. (2017). American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016 Update. Journal of the American College of Surgeons,224(1), 59-74. doi:10.1016/j.jamcollsurg.2016.10.029
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- Berríos-Torres SI, Umscheid CA, Bratzler DW, et al. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. 2017;152(8):784-791. doi:10.1001/jamasurg.2017.0904
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- Cantero R, Rubio-Perez I, Leon Metal. Negative-Pressure Therapy to Reduce the Risk of Wound Infection Following Diverting Loop Ileostomy Reversal: An Initial Study. Adv Skin Wound Care 2016;29:114-118. doi:10.1097/01.ASW.0000480458.60005.34.
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- DiMuzio P, Staley C, Reiter D et al. RS06: A Randomized Study Evaluating Negative-Pressure Therapy to Decrease Vascular Groin Wound Complications. J Vasc Surg 2017;65:133S.
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- Ferrando, P. M., Ala, A., Bussone, R., Bergamasco, L., Perinetti, F. A., & Malan, F. (2018). Closed incision negative pressure therapy in oncological breast surgery: comparison with standard care dressings. Plastic and Reconstructive Surgery Global Open, 6(6).
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- Grauhan O, Navasardyan A, Hofmann M, Muller P, Stein J, Hetzer R. Prevention of poststernotomy wound infections in obese patients by negative pressure wound therapy. J Thorac Cardiovasc Surg 2013;145:1387-1392.
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- Grauhan, O., Navasardyan, A., Tutkun, B., Hennig, F., Müller, P., Hummel, M., & Hetzer, R. (2014). Effect of surgical incision management on wound infections in a poststernotomy patient population. International wound journal, 11(s1), 6-9.
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- Gunatilake, R. P., Swamy, G. K., Brancazio, L. R., Smrtka, M. P., Thompson, J. L., Gilner, J. B., ... & Heine, R. P. (2017). Closed-incision negative-pressure therapy in obese patients undergoing cesarean delivery: a randomized controlled trial. American Journal of Perinatology Reports, 7(03), e151-e157.
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- Ju, M. H., Cohen, M. E., Bilimoria, K. Y., Latus, M. S., Scholl, L. M., Schwab, B. J., Hall, B. L. (2014). Effect of Wound Classification on Risk Adjustment in American College of Surgeons NSQIP. Journal of the American College of Surgeons,219(3). doi:10.1016/j.jamcollsurg.2014.04.009
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- Lavryk O, Ashburn J, Liska D et al. Incisional negative pressure wound therapy reduces surgical site infections in complex colorectal surgery patients. Dis Colon Rectum 2016;59:e380. doi:1 0.1 097/01 .dcr.0000482708.50838.af.
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- Lee AJ, Sheppard CE, KentWD, Mewhort H, Sikdar KC, Fedak PW. Safety and efficacy of prophylactic negative pressure wound therapy following open saphenous vein harvest in cardiac surgery: a feasibility study. Interactive Cardiovascular and Thoracic Surgery 2017;24:324-328. doi:1 0.1 093/icvts/ivw400.
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- Lee, K., Murphy, P. B., Ingves, M. V., Duncan, A., DeRose, G., Dubois, L., ... & Power, A. (2017). Randomized clinical trial of negative pressure wound therapy for high-risk groin wounds in lower extremity revascularization. Journal of vascular surgery, 66(6), 1814-1819.
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