(296 days)
Not Found
No
The device description details a simple electromechanical pump and dressing system with a fixed operational time limit. There is no mention of adaptive algorithms, learning capabilities, or data processing that would indicate AI/ML. The performance studies focus on biocompatibility, electrical safety, and software validation, not AI/ML performance metrics.
Yes
The device is used for Negative Pressure Wound Therapy (NPWT) to promote wound healing by removing exudate and infectious materials, which is a therapeutic function.
No
This device is a therapeutic device that applies negative pressure to wounds to promote healing by removing exudate and infectious materials. It does not diagnose or detect specific conditions.
No
The device description clearly outlines hardware components including an electric motor driven pump, a dressing, secondary fixation strips, and batteries. While software validation is mentioned, the device is fundamentally a hardware system with embedded software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The PICO Single Use Negative Pressure Wound Therapy System is a therapeutic device. Its function is to apply negative pressure to a wound to promote healing by removing exudate and infectious materials. It does not analyze any biological samples.
- Intended Use: The intended use clearly describes a therapeutic application for wound healing, not a diagnostic one.
Therefore, the PICO Single Use Negative Pressure Wound Therapy System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PICO is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials.
Examples of appropriate wound types include:
- Chronic
- Acute
- Traumatic
- Subacute and dehisced wounds
- Partial-thickness burns
- Ulcers (such as diabetic or pressure)
- Flaps and grafts
- Closed surgical incisions
PICO Single Use Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting.
Product codes
OMP
Device Description
PICO Single Use Negative Pressure Wound Therapy System is a small, lightweight, portable suction device consisting of a electric motor driven, twindiaphragm, vacuum pump connected to a super-absorbent, gentle adhesive dressing. The pump, dressing and secondary fixations strips are supplied sterile and single use. The dressing is applied to the wound and secondary fixation strips are placed over the outside edges to help hold the dressing in place. When the suction pump is turned on, air is pulled out of the dressing creating negative pressure and drawing excess fluid from the wound into the dressing. The pump is battery operated and is supplied with two AA lithium batteries which provide up to 168 hours (7 days) of battery life depending upon leak rate. The batteries can be replaced if required. The pump is programmed to stop working after 168 hours (7 days) of use and will not re-start after this time, even with new batteries. Negative pressure will not be applied at this point. PICO Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting. A carry bag is not provided with the system however will be available to order separately.
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
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)
The biocompatibility of the PICO Single Use Negative Pressure Wound Therapy System has been demonstrated through assessment according to ISO 10993-1. 2003 In-vivo and in-vitro tests have been conducted on the dressing and fixation strips of finished product. These tests include cytotoxicity, sensitization and irritation. These studies indicated that the PICO Single Use Negative Pressure Wound Therapy System is safe for its intended use. In addition, residual testing has been performed in accordance with ISO 10993-7 which confirms that PICO dressings and fixation strips comply with the allowable residual limits for ethylene oxide (EO) and ethylene chlorohydrin (ECH).
Cytotoxicity:
PICO Dressing: Minimum Essential Medium (MEM) elution assay conducted in accordance with ISO 10993-5. Result: N to 1:16, all non-cytotoxic (Grade 0).
Secondary Fixation Strips: Cytotoxicity testing performed in accordance with ISO 10993-5. Test article extract diluted in supplemented EMEM 1X and placed onto triplicate confluent monolayers of L-929 mouse fibroblast cells at 100%, 50%, 25% and 5% solutions (v/v). Result: N to 1:16, all non-cytotoxic (Grade 0).
Sensitisation:
PICO Dressing: Guinea Pig Maximisation Test performed in accordance with ISO 10993-10. Result: Non-sensitising.
Secondary Fixation Strips: Guinea pig maximisation test performed in accordance with ISO 10993-10. Result: Non-sensitising.
Irritation:
PICO Dressing: Evaluated for irritation in accordance with ISO 10993-10. Result: PII SC = 0.0.
Secondary Fixation Strips: Irritation testing performed in accordance with ISO 10993-10. Result: PII SC = 0.1, Negligible irritant, 0.9% NaCl extract: Primary Irritation Index: 0.11 (Negligible).
Ethylene oxide residuals:
PICO Dressing and Fixation Strips: Tested in accordance with ISO 10993-7. Result: Permanent contact limits: Ethylene Oxide
§ 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
K112127
MAY 1 6 2012
510(k) SUMMARY
PICO Single Use Negative Pressure Wound Therapy System
Smith & Nephew, Inc. 1. Submitter: 970 Lake Carillon Drive, Suite 110 St. Petersburg, FL 33716
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Contact: Terry McMahon Director of Regulatory Affairs & Quality, North America 727-399-3785 Email: terry.mcmahon@smith-nephew.com
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Device name: PICO Single Use Negative Pressure Wound Therapy System Common name: Negative Pressure Wound Therapy powered suction pump Classification name: Powered suction pump (21 CFR 878.4780) Product Classification/Code: Class II, OMP
-
Date Prepared: May 15, 2012
-
Predicate Device Information:
NPD 1000 Negative Pressure Wound Therapy System (K080275) Kalypto Medical
6393 Oakgreen Avenue
Hastings, MN 55033
Renasys Go (K083375) Smith & Nephew, Inc.
- Rotation Ellipsoid
St. Petersburg, FL
PICO Single Use Negative Pressure Wound Therapy System (K111170) Smith & Nephew, Inc. St. Petersburg, FL
1
6. Device Description:
PICO Single Use Negative Pressure Wound Therapy System is a small, lightweight, portable suction device consisting of a electric motor driven, twindiaphragm, vacuum pump connected to a super-absorbent, gentle adhesive dressing. The pump, dressing and secondary fixations strips are supplied sterile and single use. The dressing is applied to the wound and secondary fixation strips are placed over the outside edges to help hold the dressing in place. When the suction pump is turned on, air is pulled out of the dressing creating negative pressure and drawing excess fluid from the wound into the dressing. The pump is battery operated and is supplied with two AA lithium batteries which provide up to 168 hours (7 days) of battery life depending upon leak rate. The batteries can be replaced if required. The pump is programmed to stop working after 168 hours (7 days) of use and will not re-start after this time, even with new batteries. Negative pressure will not be applied at this point. PICO Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting. A carry bag is not provided with the system however will be available to order separately.
7. Intended Use
PICO is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials.
Examples of appropriate wound types include:
- Chronic
- Acute ●
- Traumatic ●
- Subacute and dehisced wounds ●
- Partial-thickness burns ●
- Ulcers (such as diabetic or pressure)
2
- Flaps and grafts
- Closed surqical incisions
PICO Single Use Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting.
8 Summary of Non-Clinical Testing
The biocompatibility of the PICO Single Use Negative Pressure Wound Therapy System has been demonstrated through assessment according to ISO 10993-1. 2003 In-vivo and in-vitro tests have been conducted on the dressing and fixation strips of finished product. These tests include cytotoxicity, sensitization and irritation. These studies indicated that the PICO Single Use Negative Pressure Wound Therapy System is safe for its intended use. In addition, residual testing has been performed in accordance with ISO 10993-7 which confirms that PICO dressings and fixation strips comply with the allowable residual limits for ethylene oxide (EO) and ethylene chlorohydrin (ECH).
| Test | Description of Method | Result |
|---|---|---|
| Cytotoxicity | PICO Dressing | |
| In order to determine the cytotoxic | ||
| potential of the dressing, a Minimum | ||
| Essential Medium (MEM) elution assay | ||
| was conducted in accordance with ISO | ||
| 10993-5. | N to 1:16, all non-cytotoxic | |
| (Grade 0) | ||
| Cytotoxicity | Secondary Fixation Strips | |
| Cytotoxicity testing has been performed | ||
| on the secondary fixation strips, tested | ||
| in accordance with ISO 10993-5. The | ||
| test article extract was diluted in | ||
| supplemented EMEM 1X and placed | ||
| onto triplicate confluent monolayers of | N to 1:16, all non-cytotoxic | |
| (Grade 0) | ||
| Test | Description of Method | Result |
| L-929 mouse fibroblast cells at the | ||
| 100%, 50%, 25% and 5% solutions | ||
| (v/v) | ||
| Sensitisation | PICO Dressing | |
| A Guinea Pig Maximisation Test was | ||
| performed on the dressing in | ||
| accordance with ISO 10993-10. | Non-sensitising | |
| Secondary Fixation Strips | ||
| A guinea pig maximisation test was | ||
| performed on the secondary fixation | ||
| strips in accordance with ISO 10993-10. | Non-sensitising | |
| Irritation | PICO Dressing | |
| The dressing was evaluated for irritation | ||
| in accordance with ISO 10993-10. | ||
| Secondary Fixation Strips | ||
| Irritation testing has been performed on | ||
| the secondary fixation strips in | ||
| accordance with ISO 10993-10. | PII SC = 0.0 | |
| PII SC = 0.1 | ||
| Negligible irritant | ||
| 0.9% NaCl extract: Primary | ||
| Irritation Index: 0.11 | ||
| (Negligible) | ||
| Ethylene oxide | ||
| residuals | PICO Dressing and Fixation Strips | |
| The dressing and strips have been | ||
| tested in accordance with ISO 10993-7. | Permanent contact limits: | |
| Ethylene Oxide |