(25 days)
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.
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.
Here's an analysis of the provided text regarding the PICO Single Use Negative Pressure Wound Therapy System, focusing on acceptance criteria and supporting studies.
Based on the provided K172519 FDA 510(k) summary, the device PICO Single Use Negative Pressure Wound Therapy System is stated to be substantially equivalent to a previously cleared predicate device (K163387). The core of this submission is not about proving new clinical effectiveness or performance claims for a novel device, but demonstrating continued compliance with updated safety and performance standards for an existing design.
Therefore, many of the requested points related to clinical studies (sample size for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to this specific submission. The submission focuses on engineering and regulatory compliance testing, rather than clinical performance evaluation.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria (Compliance with Standards) | Reported Device Performance (Compliance Status) |
|---|---|
| AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,, C1:2009/(R)2012 and . A2:2010/(R)2012 (Medical Electrical Equipment - General requirements for basic safety and essential performance) | Demonstrated compliance |
| IEC60601-1-2 Edition 4 (2014) (Electromagnetic compatibility - Requirements and tests) | Demonstrated compliance |
| 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. | Demonstrated compliance |
| 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. | Demonstrated compliance |
Explanation: The "acceptance criteria" in this context are the updated versions of international safety and performance standards for medical electrical equipment. The "reported device performance" is the assertion by the manufacturer, accepted by the FDA for substantial equivalence, that the device meets these updated standards. No specific numerical performance metrics (e.g., suction pressure, battery life, etc.) are explicitly detailed as "acceptance criteria" distinct from the standards themselves in this document, as the core device design is unchanged from the predicate.
Regarding Clinical Performance Studies:
The document states, "The subject device 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." This means the submission does not include new clinical performance studies to establish efficacy or clinical acceptance criteria beyond what was demonstrated for the predicate device. The focus is on updated safety and usability standards. Therefore, the following points are largely not applicable (N/A) in the context of this specific 510(k) submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This submission focuses on engineering and regulatory compliance testing rather than clinical performance testing with human subjects. The device itself was retested against updated standards, not a clinical "test set" of patients or data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. No clinical "ground truth" was established as part of this submission, as it's not a clinical performance study. The "ground truth" here is the adherence to technical standards, validated by testing laboratories.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No clinical "test set" requiring adjudication methods was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A. This is not an AI-enabled device and no MRMC studies were conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This device does not involve an algorithm or AI that would require standalone performance evaluation in that sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A (for clinical ground truth). The "ground truth" for this submission refers to the specifications and requirements defined by the international medical device standards (e.g., IEC60601 series). Testing houses (CSA Group and Intertek Testing Service NA, Inc) performed evaluations to confirm the device met these technical requirements.
8. The sample size for the training set
- N/A. No training set was used as this is not an AI/ML device or a clinical study requiring data training.
9. How the ground truth for the training set was established
- N/A. No training set and thus no ground truth for a training set was established for this submission.
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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-
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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
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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)
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FORM FDA 3881 (8/14)
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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 |
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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
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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)
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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.
§ 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.