(452 days)
K180698 Smith & Nephew Medical PICO7 Single Use Negative Pressure Wound Therapy System
No
The device description focuses on mechanical negative pressure application and fluid management through absorptive dressing, with no mention of AI or ML capabilities. The performance studies are in vitro tests of mechanical function.
Yes
The device is indicated for promoting wound healing through the removal of excess exudate, infectious material, and tissue debris, which are therapeutic actions.
No
The device is a negative pressure surgical incision management system designed to promote wound healing by removing exudate and maintaining negative pressure; it does not perform diagnostic functions.
No
The device description explicitly states it consists of a non-sterile vacuum chamber, sterile dressing, and tubing kit, which are physical hardware components.
Based on the provided text, the 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 npSIMS Negative Pressure Surgical Incision Management System™ is a device that applies negative pressure to closed surgical incisions to manage exudate and promote healing. It works externally on the body and does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes a wound management system applied to the surface of a closed incision, not a diagnostic test performed on a biological sample.
- Device Description: The description details a physical system with a vacuum chamber, dressing, and tubing, designed for external application.
- Performance Studies: The performance studies mentioned are "in vitro performance tests" evaluating the device's mechanical and fluid management capabilities, not diagnostic accuracy on biological samples.
Therefore, the npSIMS is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Negative Pressure Surgical Incision Management System (npSIMS)™ is indicated for patients who may benefit from wound management via application of negative pressure, as the device may promote wound healing through the removal of excess exudate, infectious material and tissue debris. The npSIMS is indicated for removal of small amounts of exudate from closed surgical incisions.
Product codes (comma separated list FDA assigned to the subject device)
QPX
Device Description
The npSIMS Negative Pressure Surgical Incision Management System™ by Aatru Medical, LLC is a single-use medical device consisting of a non-sterile vacuum chamber and sterile dressing and tubing kit. The npSIMS is intended for use with closed incisions with low exudate up to 10ml, or over a period of up to 7 days. The disposable vacuum chamber initially generates a peak negative pressure of -100±5mmHg at the wound surface, and maintains a continuous, linear rate of pressure decline to -60mmHg over 7 days (nominally, 80mmHg ± 20mmHg). Wound exudate is managed by the absorptive dressing technology. The tubing can be cut to length based upon patient needs. Making use of a fully pre-assembled wound contact dressing, the npSIMS operates silently without the use of an external electromechanical pump nor collection canister, enabling discrete patient portability. The duration of treatment is dependent upon the recommendation of the treating physician. After use, all components of the npSIMS are disposed of as clinical waste in accordance with local protocols and regulations.
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
Not Found
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)
In vitro performance tests of the npSIMS Negative Pressure Surgical Incision Management System™ were carried out to evaluate its ability to meet product performance specifications, including delivery of negative pressure, wound exudate fluid management, and system performance. The test results met all acceptance criteria and ensure the design and construction are suitable for its intended use and as recommended by the Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT) - Class II Special Controls Guidance for Industry and FDA Staff.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K151710 Spiracur SNaP Wound Care System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K180698 Smith & Nephew Medical PICO7 Single Use Negative Pressure Wound Therapy System
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4683 Non-Powered suction apparatus device intended for negative pressure wound therapy.
(a)
Identification. A non-powered suction apparatus device intended for negative pressure wound therapy is a device that is indicated for wound management via application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. It is further indicated for management of wounds, burns, flaps, and grafts.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT).” See § 878.1(e) for the availability of this guidance document.
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August 23, 2021
Aatru Medical, LLC James Rogers Regulatory Affairs and Quality Assurance 1301 East 9th Street, Suite 2700 Cleveland, Ohio 44114
Re: K201400
Trade/Device Name: npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™ Regulation Number: 21 CFR 878.4683 Regulation Name: Non-Powered Suction Apparatus Device Intended For Negative Pressure Wound Therapy Regulatory Class: Class II Product Code: QPX Dated: June 22, 2021 Received: July 1, 2021
Dear James Rogers:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Lixin Liu, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201400
Device Name npSIMS Negative Pressure Surgical Incision Management System™ npSIMSTM
Indications for Use (Describe)
The Negative Pressure Surgical Incision Management System (npSIMS)™ is indicated for patients who may benefit from wound management via application of negative pressure, as the device may promote wound healing through the removal of excess exudate, infectious material and tissue debris. The npSIMS is indicated for removal of small amounts of exudate from closed surgical incisions.
| 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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Image /page/3/Picture/0 description: The image shows a logo with the word "Aatru" in blue, cursive font. To the left of the word is a circular graphic with a white "A" inside. The top half of the circle is gray, while the bottom half is blue. The logo appears to be for a company or organization named Aatru.
510(k) Summary K201400
Prepared in conformance with 21CFR 807.92
| Submitter | Aatru Medical, LLC.
1301 East Ninth Street, Suite 2700
Cleveland, Ohio 44114
http://www.aatru.com |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Primary Contact
James Jochen Rogers
Regulatory Affairs and Quality Assurance
jr@aatru.com
T: 216-303-6063 |
| Date Prepared | August 16, 2021 |
| Trade Name(s) | npSIMS Negative Pressure Surgical Incision Management System™
npSIMS™ |
| Classification | Regulation Number: 21 CFR 878.4683
Regulation Name: Non-Powered suction apparatus device intended for negative
pressure wound therapy.
Regulatory Class: Class II
Product Code/Panel: QPX/General and Plastic Surgery Devices |
| Predicate Device
Reference Device | K151710 Spiracur SNaP Wound Care System
K180698 Smith & Nephew Medical PICO7 Single Use Negative Pressure Wound
Therapy System |
| Device
Description | The npSIMS Negative Pressure Surgical Incision Management System™
by Aatru Medical, LLC is a single-use medical device consisting of a non-sterile
vacuum chamber and sterile dressing and tubing kit. The npSIMS is intended for
use with closed incisions with low exudate up to 10ml, or over a period of up to 7
days. The disposable vacuum chamber initially generates a peak negative
pressure of -100±5mmHg at the wound surface, and maintains a continuous,
linear rate of pressure decline to -60mmHg over 7 days (nominally, 80mmHg ±
20mmHg). Wound exudate is managed by the absorptive dressing technology.
The tubing can be cut to length based upon patient needs. Making use of a fully
pre-assembled wound contact dressing, the npSIMS operates silently without the
use of an external electromechanical pump nor collection canister, enabling
discrete patient portability. The duration of treatment is dependent upon the
recommendation of the treating physician. After use, all components of the
npSIMS are disposed of as clinical waste in accordance with local protocols and
regulations. |
| Indication for Use | The Negative Pressure Surgical Incision Management System (npSIMS)™ is
indicated for patients who may benefit from wound management via application
of negative pressure, as the device may promote wound healing through the
removal of excess exudate, infectious material, and tissue debris. The npSIMS is
indicated for removal of small amounts of exudate from closed surgical incisions. |
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Image /page/4/Picture/1 description: The image contains a logo with the letter A inside of a circle on the left side and the word "Aatru" on the right side. The circle is split into two colors, gray on the top left and blue on the bottom right. The letter A is white and is placed in the center of the circle. The word "Aatru" is written in a cursive font and is blue.
| Technological
Characteristics
Comparison | Subject Device:
npSIMS Negative Pressure Surgical
Incision Management System™
K201400 | Predicate Device:
Spiracur SNaP Wound Care System
K151710 | |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | Regulation Number: 21 CFR 878.4683
Regulation Name: Non-Powered suction
apparatus device intended for negative
pressure wound therapy.
Regulatory Class: Class II | Regulation Number: 21 CFR 878.4683
Regulation Name: Non-Powered
suction apparatus device intended for
negative pressure wound therapy.
Regulatory Class: Class II | |
| Classification | Product Code/Panel: QPX/General and
Plastic Surgery Devices | Product Code/Panel: OKO/General
and Plastic Surgery Devices | |
| Indications for
Use | The Negative Pressure Surgical Incision
Management System (npSIMS)™ is
indicated for patients who may benefit
from wound management via
application of negative pressure, as the
device may promote wound healing
through the removal of excess exudate,
infectious material, and tissue debris.
The npSIMS is indicated for removal of
small amounts of exudate from closed
surgical incisions. | The SNaP® Wound Care System is
indicated for patients who would benefit
from wound management via the
application of negative pressure,
particularly as the device may promote
wound healing through the removal of
excess exudate, infectious material and
tissue debris. The SNaP® Wound Care
System is indicated for removal of small
amounts of exudate from chronic, acute,
traumatic, subacute and dehisced
wounds, partial-thickness burns, ulcers
(such as diabetic, venous or pressure),
surgically closed incisions, flaps and
grafts. | |
| Negative pressure
power source -
vacuum
generating
element | Non-powered negative pressure suction
generated by oxygen scavenger | Non-powered negative pressure suction
generated by mechanical spring | |
| Negative Pressure
Range (high to
low) | Negative pressure between 100mmHg and
60mmHg. | 75mmHg ± variable
100mmHg ± variable
125mmHg ± variable | |
| Exudate
management | Use with low exudate wounds up to 10ml | Use with wounds with low to moderate
exudate up to 60ml | |
| Wear time
(Duration of use) | Up to 7 days | Up to 7 days | |
| Technological
Characteristics
Comparison | Subject Device:
npSIMS Negative Pressure Surgical
Incision Management System™
K201400 | Predicate Device:
Spiracur SNAP Wound Care System
K151710 | |
| Wound interface
elements | Dressing construction:
Absorbent wound dressing Silicone gasket Nominal Pad Size: 3.5x14 cm (1.4x5.6 in) Overall Size: 11.6x22.6 cm (4.6x8.9 in) | Dressing construction:
Occlusive drape with optional foam interface; Hydrocolloid adhesive Overall Size: 10x10cm (2.9x2.9 in) to 15x15cm (5.91x5.91 in) | |
| Tubing Material | Polyvinyl Chloride Elastomer | Polyvinyl Chloride Elastomer | |
| Indicators of
System Status | Indicators:
Slight warming of vacuum chamber Dressing has taut appearance and firmness to touch. Blue sealing flap on top of vacuum chamber is slightly depressed in the vacuum chamber activation slot. Visual change of dressing; Dressing saturation is evident when fluid color permeates the entire dressing or is evident in the tubing | Indicators:
Green capacity indicator moving on side of canister Dressing has a sucked down appearance and feels hard to the touch. Green capacity indicator is visible and stationary. Visual change as dressing becomes flaccid. Red discharge indicator is visible in cartridge. Dressing saturation is evident when fluid color permeates entire dressing. | |
| Sterility; Method
of Sterilization | Yes
Ethylene Oxide | Yes
Radiation | |
| Performance Data
- discussion of
non-clinical tests | The npSIMS Negative Pressure Surgical Incision Management System™ is designed
to, complies with, and has been tested as part of verification and validation
activities to, the FDA Recognized Consensus Standards listed in the table below, as
applicable to device features and components: | | |
| | Requirement | Reference # | Title |
| | Biocompatibility
– Physical/Chemical
Information | ANSI AAMI ISO 10993-1:2018
ISO 10993-1 Fifth edition 2018-08 | Biological evaluation of medical devices -
Part 1: Evaluation and testing within a risk
management process |
| | Biocompatibility
– Cytotoxicity | ANSI AAMI ISO 10993-
5:2009/R2014 | Biological evaluation of medical devices -
Part 5: Tests for in vitro cytotoxicity |
| | Biocompatibility - Sensitization
- Irritation or
Intracutaneous
Reactivity | ANSI AAMI ISO 10993-
10:2010/R2014
ISO 10993-10 Third Edition
2010-08-01 | Biological evaluation of medical devices -
Part 10: Tests for irritation and skin
sensitization. |
| Technological
Characteristics
Comparison | Subject Device:
npSIMS Negative Pressure Surgical
Incision Management System™
K201400 | Predicate Device:
Spiracur SNAP Wound Care System
K151710 | |
| | Biocompatibility - Implantation
Effects | ISO 10993-6 Third edition
2016-12-01 | Biological evaluation of medical devices --
Part 6: Tests for local effects after after
implantation |
| | Biocompatibility - Material Mediated
Pyrogenicity - Acute Systemic
Toxicity - Subacute /
Subchronic Toxicity | ANSI AAMI ISO 10993-11: 2017
ISO 10993-11 Third edition
2017-09 | Biological evaluation of medical devices -
Part 11: Tests for systemic toxicity |
| | Sterility | ISO 11135:2014 + A1:2018 | Sterilization of health-care products -
Ethylene oxide - Requirements for the
development, validation and routine control
of a sterilization process for medical devices |
| | Packaging | ASTM D4169-16: 2016 | Standard Practice for Performance Testing
of Shipping Containers and Systems |
| | Usability | BS EN 62366-1: 2015 + A1:2020
ANSI AAMI IEC 62366-1:2015 +
AMD1:2020
IEC 62366-1 Ed. 1.1: 2020-06 | Medical devices: Part 1: Application of
usability engineering to medical devices |
| | In vitro performance tests of the npSIMS Negative Pressure Surgical Incision
Management System™ were carried out to evaluate its ability to meet product
performance specifications, including delivery of negative pressure, wound exudate
fluid management, and system performance. The test results met all acceptance
criteria and ensure the design and construction are suitable for its intended use
and as recommended by the Non-powered Suction Apparatus Device Intended for
Negative Pressure Wound Therapy (NPWT) - Class II Special Controls Guidance for
Industry and FDA Staff. | | |
| Statement of
Substantial
Equivalence | Based upon technological characteristics, safety and performance testing, and
conformance with voluntary standards, the npSIMS Negative Pressure Surgical
Incision Management System™ by Aatru Medical, LLC is substantially equivalent to
the predicate device, and does not raise any new questions of safety or
effectiveness. | | |
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