(25 days)
No
The description focuses on the electro-mechanical pump system and dressing for negative pressure wound therapy, with no mention of AI or ML capabilities.
Yes
The device is described as a "Negative Pressure Wound Therapy System" that "may promote wound healing via removal of low to moderate levels of exudate and infectious materials," which directly indicates a therapeutic purpose.
No
The device description and intended use indicate that PICO is a therapeutic device for wound healing (negative pressure wound therapy), not a diagnostic device for identifying or characterizing diseases or 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, the PICO Single Use Negative Pressure Wound Therapy System 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.
- PICO's Function: The description clearly states that PICO is a "suction device (negative pressure wound therapy)" that promotes wound healing by removing exudate and infectious materials directly from the wound. It is a therapeutic device applied externally to the body.
- No Mention of Samples or Testing: The description does not mention the collection or analysis of any biological samples for diagnostic purposes.
Therefore, PICO 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 in both 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)
The subject device has been retested to demonstrate compliance with
- AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,, C1:2009/(R)2012 and . A2:2010/(R)2012
- . IEC60601-1-2 Edition 4 (2014)
- IEC 60601-1-6 Edition 3.1 2013-10, Medical Electrical Equipment Part 1-6: . General Requirements For Basic Safety And Essential Performance -Collateral Standard: Usability. (General I (QS/RM))
- 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. (General II (ES/EMC))
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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15. 2017
Smith & Nephew Medical Limited Samantha Neilson Senior Regulatory Affairs Manager, Advanced Wound Management 101 Hessle Road Hull, HU3 2BN GB
Re: K172519
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: August 18, 2017 Received: August 21, 2017
Dear Samantha Neilson:
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 Actinclude 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 (reporting of medical device-
Image /page/0/Picture/11 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol depicts a stylized human figure in profile, with three overlapping heads, representing the department's focus on health and human well-being.
1
related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K172519
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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! *
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FORM FDA 3881 (8/14)
3
K172519
SECTION 7: 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: | Samantha Neilson, Senior Regulatory Affairs Manager |
| Phone Number | +44 1482 673790 |
| Date Prepared: | August 18, 2017 |
| Device Description | |
| Trade Name: | PICO Single Use Negative Pressure Wound Therapy System |
| 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: | K163387 |
| Device: | PICO Single Use Negative Pressure Wound Therapy System |
| Clearance Date: | April 18, 2017 |
4
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
- 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 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
5
and the predicate device are the same. The only difference between the subject device and the predicate device is the compliance against the requirements of IEC60601.
The subject device has been retested to demonstrate compliance with
- AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,, C1:2009/(R)2012 and . A2:2010/(R)2012
- . IEC60601-1-2 Edition 4 (2014)
- IEC 60601-1-6 Edition 3.1 2013-10, Medical Electrical Equipment Part 1-6: . General Requirements For Basic Safety And Essential Performance -Collateral Standard: Usability. (General I (QS/RM))
- 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. (General II (ES/EMC))
while the predicate device was tested and cleared to the requirements of
- IEC60601-1:2005 + CORR.1 (2006) + CORR.2 (2007) ●
- IEC60601-1-2 Edition 3 (2007) ●
- IEC 60601-1-6: 2010 (Third Edition) Medical electrical equipment Part 1-6: . General requirements for basic safety and essential performance - Collateral standard: Usability)
- IEC 60601-1-11: 2010 (First Edition) 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
The Instructions for Use and the pump label been updated to reflect a change in test house. The cleared device was tested and certified by CSA Group (Canada)
6
whilst the subject device was tested and certified by Intertek Testing Service NA, Inc (USA).
Conclusions
In establishing substantial equivalence to the predicate devices, 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 the intended use.