(29 days)
Not Found
No
The document describes a standard negative pressure wound therapy system with an electro-mechanical pump and dressing. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on pressure range and component equivalence, not algorithmic performance.
Yes
The device is clearly indicated for promoting wound healing and is used therapeutically in various wound types.
No.
The device description indicates it is a therapeutic device that applies negative pressure for wound healing, rather than for diagnosing conditions.
No
The device description explicitly states it is an "electro-mechanical pump system connected through a flexible tube to a super-absorbent, gentle adhesive dressing," indicating it includes hardware components beyond just software.
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 description clearly states that the PICO system is a "suction device (negative pressure wound therapy)" that "promote[s] wound healing via removal of low to moderate levels of exudate and infectious materials." It's a therapeutic device applied externally to a wound.
- Lack of Diagnostic Testing: There is no mention of the device analyzing biological samples or providing diagnostic information about a patient's health status. Its purpose is to treat a wound, not to diagnose a condition.
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.
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, electro-mechanical pump system connected through a flexible tube to a super-absorbent, gentle adhesive dressing. Secondary fixation strips are also provided to ensure an adequate seal is achieved. The pump, the dressing and fixation strips are supplied sterile and for single use. PICO was designed to deliver negative pressure wound therapy to low and to moderate exudate levels of acute and chronic wound types. PICO Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting.
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)
Testing demonstrated that the alternative, non-critical components perform equivalently to the current, non-critical components and do not impact device performance. The pumps were able to operate within a pressure range of -60mmHg to -100mmHg (-80mmHg nominal) and remained compliant with IEC requirements as listed above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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.
April 6, 2018
Smith & Nephew Medical Limited % Kulsum Master Director Regulatory Affairs, US Region Smith & Nephew 7000 West William Cannon Drive Austin, Texas 78735
Re: K180614
Trade/Device Name: PICO Single Use Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: March 6, 2018 Received: March 8, 2018
Dear Kulsum Master:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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Page 2 - Kulsum Master
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jennifer R. Stevenson -S3
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180614
Device Name
PICO Single Use Negative Pressure Wound Therapy System
Indications for Use (Describe)
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.
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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
PICO Single Use Negative Pressure Wound Therapy System
| General Information | |
|---|---|
| Submitter Name/Address: | Smith & Nephew Medical Limited 101 Hessle Road, Hull HU3 2BN United Kingdom |
| Establishment Registration Number: | 8043484 |
| Contact Person: | Lavinia Tompkins, Senior Regulatory Affairs Specialist |
| Phone Number | +44 1482 225181 |
| Date Prepared: | March 06, 2018 |
| Application Correspondent: | Smith & Nephew Inc. 7000 West William Cannon Drive, Austin, Texas, 78735, USA |
| Contact Person: | Kulsum Master, Director Regulatory Affairs |
| Phone Number: | 1-512-358-5720 |
| Device Description | |
| Trade Name: | PICO Single Use Negative Pressure Wound Therapy System |
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| Common or Usual Name: | Negative Pressure Wound Therapy
powered suction pump |
|-----------------------|---------------------------------------------------------|
| Classification Name: | Powered suction pump (21 CFR 878.4780) |
| Regulatory Class: | Class II |
| Product Code: | OMP |
| Predicate Device Information |
|---|
| ------------------------------------- |
| 510(k) Number: | K172521 |
|---|---|
| Device: | PICO Single Use Negative Pressure |
| Wound Therapy System | |
| Clearance Date: | September 20, 2017 |
Device Description
PICO Single Use Negative Pressure Wound Therapy System is a small, lightweight, portable, electro-mechanical pump system connected through a flexible tube to a super-absorbent, gentle adhesive dressing. Secondary fixation strips are also provided to ensure an adequate seal is achieved. The pump, the dressing and fixation strips are supplied sterile and for single use. PICO was designed to deliver negative pressure wound therapy to low and to moderate exudate levels of acute and chronic wound types. PICO Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting.
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.
Appropriate wound types include:
- Chronic
- Acute .
- Traumatic .
- Subacute and dehisced wounds .
5
- Partial-thickness burns, Ulcers (such as diabetic or pressure) ●
- Flaps and grafts ●
- Closed surqical incisions .
PICO Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting.
Comparison between New and Predicate Device
The Indications for Use statement of the PICO Single Use Negative Pressure Wound Therapy System is identical to the predicate device. The subject device and the predicate device are the same. The only differences between the subject device and the predicate device are the alternative, equivalent, non-critical components introduced to the printed circuit board assembly to resolve future resourcing issues.
The subject device incorporating the alternative, non-critical components has been tested against for functionality in accordance with the following standards:
- . AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012 – C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
- IEC 60601-1-2 Edition 4.0 2014-02 Medical Electrical Equipment Part 1-2: . General Requirements For Basic Safety And Essential Performance -Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
- . IEC 60601-1-6 Edition 3.1 2016-10 – Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Usability
- IEC 60601-1-11 Edition 2.0 2015-01 Medical Electrical Equipment Part 1-. 11: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment
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Testing demonstrated that the alternative, non-critical components perform equivalently to the current, non-critical components and do not impact device performance. The pumps were able to operate within a pressure range of -60mmHg to -100mmHg (-80mmHg nominal) and remained compliant with IEC requirements as listed above.
Conclusions
In establishing substantial equivalence to the predicate device, Smith & Nephew Medical Ltd evaluated the indications for use, materials, technology, product specifications and energy requirements of the device. As there are no design differences between the subject device and the predicate device, PICO Single Use Negative Pressure Wound Therapy System is substantially equivalent to the predicate for its intended use.