npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™

K201400 · Aatru Medical, LLC · QPX · Aug 23, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K201400
• Device Name: npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™
• Applicant: Aatru Medical, LLC
• Product Code: QPX · General, Plastic Surgery
• Decision Date: Aug 23, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4683
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

npSIMS is a single-use, non-powered negative pressure wound therapy (NPWT) system for closed surgical incisions with low exudate (up to 10ml). Device consists of a non-sterile vacuum chamber and sterile dressing/tubing kit. Vacuum generation relies on an internal oxygen scavenger rather than an electromechanical pump. System provides initial peak negative pressure of -100±5mmHg, declining linearly to -60mmHg over 7 days. Tubing is cut to length; dressing is pre-assembled. Device operates silently without external power or collection canisters. Used in clinical or home settings under physician direction. Healthcare providers assess system status via vacuum chamber warming, dressing firmness, and visual inspection of fluid saturation. Benefits include discrete patient portability and promotion of wound healing through exudate removal. After 7-day use, all components are disposed of as clinical waste.

Clinical Evidence

Bench testing only. Performance testing evaluated negative pressure delivery, exudate management, and system performance against product specifications. Biocompatibility testing conducted per ISO 10993-1, -5, -10, -6, and -11. Usability engineering performed per IEC 62366-1. Results met all acceptance criteria.

Technological Characteristics

Non-powered vacuum generation via oxygen scavenger. Materials include PVC elastomer tubing. Dressing includes absorbent material and silicone gasket. Dimensions: 3.5x14 cm pad; 11.6x22.6 cm overall. Sterilization via Ethylene Oxide. Complies with ISO 10993 series (biocompatibility), ISO 11135 (sterilization), ASTM D4169 (packaging), and IEC 62366-1 (usability).

Indications for Use

Indicated for patients requiring wound management via negative pressure to promote healing by removing excess exudate, infectious material, and tissue debris from closed surgical incisions.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Spiracur SNaP Wound Care System (K151710)

Reference Devices

• Smith & Nephew Medical PICO7 Single Use Negative Pressure Wound Therapy System (K180698)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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## 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) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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# 510(k) Summary K201400

Prepared in conformance with 21CFR 807.92

| Submitter | Aatru Medical, LLC.<br>1301 East Ninth Street, Suite 2700<br>Cleveland, Ohio 44114<br>http://www.aatru.com |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Primary Contact<br>James Jochen Rogers<br>Regulatory Affairs and Quality Assurance<br>[e-mail]<br>T: 216-303-6063 |
| Date Prepared | August 16, 2021 |
| Trade Name(s) | npSIMS Negative Pressure Surgical Incision Management System™<br>npSIMS™ |
| Classification | Regulation Number: 21 CFR 878.4683<br>Regulation Name: Non-Powered suction apparatus device intended for negative<br>pressure wound therapy.<br>Regulatory Class: Class II<br>Product Code/Panel: QPX/General and Plastic Surgery Devices |
| Predicate Device<br>Reference Device | K151710 Spiracur SNaP Wound Care System<br>K180698 Smith & Nephew Medical PICO7 Single Use Negative Pressure Wound<br>Therapy System |
| Device<br>Description | The npSIMS Negative Pressure Surgical Incision Management System™<br>by Aatru Medical, LLC is a single-use medical device consisting of a non-sterile<br>vacuum chamber and sterile dressing and tubing kit. The npSIMS is intended for<br>use with closed incisions with low exudate up to 10ml, or over a period of up to 7<br>days. The disposable vacuum chamber initially generates a peak negative<br>pressure of -100±5mmHg at the wound surface, and maintains a continuous,<br>linear rate of pressure decline to -60mmHg over 7 days (nominally, 80mmHg ±<br>20mmHg). Wound exudate is managed by the absorptive dressing technology.<br>The tubing can be cut to length based upon patient needs. Making use of a fully<br>pre-assembled wound contact dressing, the npSIMS operates silently without the<br>use of an external electromechanical pump nor collection canister, enabling<br>discrete patient portability. The duration of treatment is dependent upon the<br>recommendation of the treating physician. After use, all components of the<br>npSIMS are disposed of as clinical waste in accordance with local protocols and<br>regulations. |
| Indication for Use | The Negative Pressure Surgical Incision Management System (npSIMS)™ is<br>indicated for patients who may benefit from wound management via application<br>of negative pressure, as the device may promote wound healing through the<br>removal of excess exudate, infectious material, and tissue debris. The npSIMS is<br>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<br>Characteristics<br>Comparison | Subject Device:<br>npSIMS Negative Pressure Surgical<br>Incision Management System™<br>K201400 | Predicate Device:<br>Spiracur SNaP Wound Care System<br>K151710 | |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | Regulation Number: 21 CFR 878.4683<br>Regulation Name: Non-Powered suction<br>apparatus device intended for negative<br>pressure wound therapy.<br>Regulatory Class: Class II | Regulation Number: 21 CFR 878.4683<br>Regulation Name: Non-Powered<br>suction apparatus device intended for<br>negative pressure wound therapy.<br>Regulatory Class: Class II | |
| Classification | Product Code/Panel: QPX/General and<br>Plastic Surgery Devices | Product Code/Panel: OKO/General<br>and Plastic Surgery Devices | |
| Indications for<br>Use | The Negative Pressure Surgical Incision<br>Management System (npSIMS)™ is<br>indicated for patients who may benefit<br>from wound management via<br>application of negative pressure, as the<br>device may promote wound healing<br>through the removal of excess exudate,<br>infectious material, and tissue debris.<br>The npSIMS is indicated for removal of<br>small amounts of exudate from closed<br>surgical incisions. | The SNaP® Wound Care System is<br>indicated for patients who would benefit<br>from wound management via the<br>application of negative pressure,<br>particularly as the device may promote<br>wound healing through the removal of<br>excess exudate, infectious material and<br>tissue debris. The SNaP® Wound Care<br>System is indicated for removal of small<br>amounts of exudate from chronic, acute,<br>traumatic, subacute and dehisced<br>wounds, partial-thickness burns, ulcers<br>(such as diabetic, venous or pressure),<br>surgically closed incisions, flaps and<br>grafts. | |
| Negative pressure<br>power source -<br>vacuum<br>generating<br>element | Non-powered negative pressure suction<br>generated by oxygen scavenger | Non-powered negative pressure suction<br>generated by mechanical spring | |
| Negative Pressure<br>Range (high to<br>low) | Negative pressure between 100mmHg and<br>60mmHg. | 75mmHg ± variable<br>100mmHg ± variable<br>125mmHg ± variable | |
| Exudate<br>management | Use with low exudate wounds up to 10ml | Use with wounds with low to moderate<br>exudate up to 60ml | |
| Wear time<br>(Duration of use) | Up to 7 days | Up to 7 days | |
| Technological<br>Characteristics<br>Comparison | Subject Device:<br>npSIMS Negative Pressure Surgical<br>Incision Management System™<br>K201400 | Predicate Device:<br>Spiracur SNAP Wound Care System<br>K151710 | |
| Wound interface<br>elements | Dressing construction:<br>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:<br>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<br>System Status | Indicators:<br>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:<br>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<br>of Sterilization | Yes<br>Ethylene Oxide | Yes<br>Radiation | |
| Performance Data<br>- discussion of<br>non-clinical tests | The npSIMS Negative Pressure Surgical Incision Management System™ is designed<br>to, complies with, and has been tested as part of verification and validation<br>activities to, the FDA Recognized Consensus Standards listed in the table below, as<br>applicable to device features and components: | | |
| | Requirement | Reference # | Title |
| | Biocompatibility<br>– Physical/Chemical<br>Information | ANSI AAMI ISO 10993-1:2018<br>ISO 10993-1 Fifth edition 2018-08 | Biological evaluation of medical devices -<br>Part 1: Evaluation and testing within a risk<br>management process |
| | Biocompatibility<br>– Cytotoxicity | ANSI AAMI ISO 10993-<br>5:2009/R2014 | Biological evaluation of medical devices -<br>Part 5: Tests for in vitro cytotoxicity |
| | Biocompatibility<br>- Sensitization<br>- Irritation or<br>Intracutaneous<br>Reactivity | ANSI AAMI ISO 10993-<br>10:2010/R2014<br>ISO 10993-10 Third Edition<br>2010-08-01 | Biological evaluation of medical devices -<br>Part 10: Tests for irritation and skin<br>sensitization. |
| Technological<br>Characteristics<br>Comparison | Subject Device:<br>npSIMS Negative Pressure Surgical<br>Incision Management System™<br>K201400 | Predicate Device:<br>Spiracur SNAP Wound Care System<br>K151710 | |
| | Biocompatibility<br>- Implantation<br>Effects | ISO 10993-6 Third edition<br>2016-12-01 | Biological evaluation of medical devices --<br>Part 6: Tests for local effects after after<br>implantation |
| | Biocompatibility<br>- Material Mediated<br>Pyrogenicity<br>- Acute Systemic<br>Toxicity<br>- Subacute /<br>Subchronic Toxicity | ANSI AAMI ISO 10993-11: 2017<br>ISO 10993-11 Third edition<br>2017-09 | Biological evaluation of medical devices -<br>Part 11: Tests for systemic toxicity |
| | Sterility | ISO 11135:2014 + A1:2018 | Sterilization of health-care products -<br>Ethylene oxide - Requirements for the<br>development, validation and routine control<br>of a sterilization process for medical devices |
| | Packaging | ASTM D4169-16: 2016 | Standard Practice for Performance Testing<br>of Shipping Containers and Systems |
| | Usability | BS EN 62366-1: 2015 + A1:2020<br>ANSI AAMI IEC 62366-1:2015 +<br>AMD1:2020<br>IEC 62366-1 Ed. 1.1: 2020-06 | Medical devices: Part 1: Application of<br>usability engineering to medical devices |
| | In vitro performance tests of the npSIMS Negative Pressure Surgical Incision<br>Management System™ were carried out to evaluate its ability to meet product<br>performance specifications, including delivery of negative pressure, wound exudate<br>fluid management, and system performance. The test results met all acceptance<br>criteria and ensure the design and construction are suitable for its intended use<br>and as recommended by the Non-powered Suction Apparatus Device Intended for<br>Negative Pressure Wound Therapy (NPWT) - Class II Special Controls Guidance for<br>Industry and FDA Staff. | | |
| Statement of<br>Substantial<br>Equivalence | Based upon technological characteristics, safety and performance testing, and<br>conformance with voluntary standards, the npSIMS Negative Pressure Surgical<br>Incision Management System™ by Aatru Medical, LLC is substantially equivalent to<br>the predicate device, and does not raise any new questions of safety or<br>effectiveness. | | |

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