(452 days)
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 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.
The provided text is a 510(k) summary for the npSIMS Negative Pressure Surgical Incision Management System. It primarily focuses on demonstrating substantial equivalence to a predicate device through technological characteristic comparisons and non-clinical performance testing against recognized consensus standards.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a discrete "acceptance criteria" table with corresponding "reported device performance" values for a clinical study comparing an AI device against a specific benchmark. Instead, it refers to non-clinical tests that ensure the device meets product performance specifications and complies with FDA Recognized Consensus Standards.
| Acceptance Criteria Category (from text) | Reported Device Performance / Assessment (from text) |
|---|---|
| Non-Clinical Performance Tests | "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." |
| Delivery of Negative Pressure | "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 Fluid Management | "Use with low exudate wounds up to 10ml." (This is a specification of the device, implying an acceptance criterion for its exudate management capability). |
| System Performance | (General statement that the tests met acceptance criteria for system performance). |
| Biocompatibility | Compliance with ANSI AAMI ISO 10993-1:2018, ISO 10993-5:2009/R2014, ANSI AAMI ISO 10993-10:2010/R2014, ISO 10993-6 Third edition 2016-12-01, ANSI AAMI ISO 10993-11:2017. |
| Sterility | Compliance with ISO 11135:2014 + A1:2018. |
| Packaging | Compliance with ASTM D4169-16: 2016. |
| Usability | Compliance with BS EN 62366-1: 2015 + A1:2020 / ANSI AAMI IEC 62366-1:2015 + AMD1:2020 / IEC 62366-1 Ed. 1.1: 2020-06. |
Important Note: The provided text is for a non-powered medical device (npSIMS Negative Pressure Surgical Incision Management System), not an AI or software as a medical device (SaMD). Therefore, many of the subsequent questions related to AI device evaluation (sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies) are not applicable to this document. The study described is primarily a set of non-clinical functional and safety performance tests.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable. The document describes non-clinical in vitro performance tests and compliance with recognized standards, not a clinical study with human subjects or a test set of data in the context of AI.
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)
- Not applicable. Ground truth in the context of expert consensus is relevant for diagnostic AI/imaging devices. This document describes the performance of a physical medical device. The "ground truth" here would be the physical and chemical properties of the device and its operational parameters, assessed against engineering specifications and regulatory standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 are used for resolving discrepancies among human readers in interpreting data for ground truth establishment, which is not described for this device's evaluation.
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
- Not applicable. This device is not an AI or software assistance tool for human readers. It's a wound care system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical non-powered medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical performance tests, the "ground truth" is defined by engineering specifications, established physical and chemical principles, and the requirements of the referenced FDA Recognized Consensus Standards (e.g., ISO, ASTM standards). For biocompatibility, this involves laboratory tests with established protocols. For negative pressure delivery, it's about meeting specified pressure ranges.
8. The sample size for the training set
- Not applicable. This document describes the evaluation of a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As described above, there is no AI training set for this device.
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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 (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
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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) | |
|---|---|
| ☑ 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 2700Cleveland, Ohio 44114http://www.aatru.com |
|---|---|
| Contact Person | Primary ContactJames Jochen RogersRegulatory Affairs and Quality Assurancejr@aatru.comT: 216-303-6063 |
| Date Prepared | August 16, 2021 |
| Trade Name(s) | npSIMS Negative Pressure Surgical Incision Management System™npSIMS™ |
| Classification | Regulation Number: 21 CFR 878.4683Regulation Name: Non-Powered suction apparatus device intended for negativepressure wound therapy.Regulatory Class: Class IIProduct Code/Panel: QPX/General and Plastic Surgery Devices |
| Predicate DeviceReference Device | K151710 Spiracur SNaP Wound Care SystemK180698 Smith & Nephew Medical PICO7 Single Use Negative Pressure WoundTherapy System |
| DeviceDescription | The npSIMS Negative Pressure Surgical Incision Management System™by Aatru Medical, LLC is a single-use medical device consisting of a non-sterilevacuum chamber and sterile dressing and tubing kit. The npSIMS is intended foruse with closed incisions with low exudate up to 10ml, or over a period of up to 7days. The disposable vacuum chamber initially generates a peak negativepressure 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 fullypre-assembled wound contact dressing, the npSIMS operates silently without theuse of an external electromechanical pump nor collection canister, enablingdiscrete patient portability. The duration of treatment is dependent upon therecommendation of the treating physician. After use, all components of thenpSIMS are disposed of as clinical waste in accordance with local protocols andregulations. |
| Indication for Use | The Negative Pressure Surgical Incision Management System (npSIMS)™ isindicated for patients who may benefit from wound management via applicationof negative pressure, as the device may promote wound healing through theremoval of excess exudate, infectious material, and tissue debris. The npSIMS isindicated for removal of small amounts of exudate from closed surgical incisions. |
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| TechnologicalCharacteristicsComparison | Subject Device:npSIMS Negative Pressure SurgicalIncision Management System™K201400 | Predicate Device:Spiracur SNaP Wound Care SystemK151710 | |
|---|---|---|---|
| Regulation | Regulation Number: 21 CFR 878.4683Regulation Name: Non-Powered suctionapparatus device intended for negativepressure wound therapy.Regulatory Class: Class II | Regulation Number: 21 CFR 878.4683Regulation Name: Non-Poweredsuction apparatus device intended fornegative pressure wound therapy.Regulatory Class: Class II | |
| Classification | Product Code/Panel: QPX/General andPlastic Surgery Devices | Product Code/Panel: OKO/Generaland Plastic Surgery Devices | |
| Indications forUse | The Negative Pressure Surgical IncisionManagement System (npSIMS)™ isindicated for patients who may benefitfrom wound management viaapplication of negative pressure, as thedevice may promote wound healingthrough the removal of excess exudate,infectious material, and tissue debris.The npSIMS is indicated for removal ofsmall amounts of exudate from closedsurgical incisions. | The SNaP® Wound Care System isindicated for patients who would benefitfrom wound management via theapplication of negative pressure,particularly as the device may promotewound healing through the removal ofexcess exudate, infectious material andtissue debris. The SNaP® Wound CareSystem is indicated for removal of smallamounts of exudate from chronic, acute,traumatic, subacute and dehiscedwounds, partial-thickness burns, ulcers(such as diabetic, venous or pressure),surgically closed incisions, flaps andgrafts. | |
| Negative pressurepower source -vacuumgeneratingelement | Non-powered negative pressure suctiongenerated by oxygen scavenger | Non-powered negative pressure suctiongenerated by mechanical spring | |
| Negative PressureRange (high tolow) | Negative pressure between 100mmHg and60mmHg. | 75mmHg ± variable100mmHg ± variable125mmHg ± variable | |
| Exudatemanagement | Use with low exudate wounds up to 10ml | Use with wounds with low to moderateexudate up to 60ml | |
| Wear time(Duration of use) | Up to 7 days | Up to 7 days | |
| TechnologicalCharacteristicsComparison | Subject Device:npSIMS Negative Pressure SurgicalIncision Management System™K201400 | Predicate Device:Spiracur SNAP Wound Care SystemK151710 | |
| Wound interfaceelements | 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 ofSystem 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; Methodof Sterilization | YesEthylene Oxide | YesRadiation | |
| Performance Data- discussion ofnon-clinical tests | The npSIMS Negative Pressure Surgical Incision Management System™ is designedto, complies with, and has been tested as part of verification and validationactivities to, the FDA Recognized Consensus Standards listed in the table below, asapplicable to device features and components: | ||
| Requirement | Reference # | Title | |
| Biocompatibility– Physical/ChemicalInformation | ANSI AAMI ISO 10993-1:2018ISO 10993-1 Fifth edition 2018-08 | Biological evaluation of medical devices -Part 1: Evaluation and testing within a riskmanagement 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 orIntracutaneousReactivity | ANSI AAMI ISO 10993-10:2010/R2014ISO 10993-10 Third Edition2010-08-01 | Biological evaluation of medical devices -Part 10: Tests for irritation and skinsensitization. | |
| TechnologicalCharacteristicsComparison | Subject Device:npSIMS Negative Pressure SurgicalIncision Management System™K201400 | Predicate Device:Spiracur SNAP Wound Care SystemK151710 | |
| Biocompatibility- ImplantationEffects | ISO 10993-6 Third edition2016-12-01 | Biological evaluation of medical devices --Part 6: Tests for local effects after afterimplantation | |
| Biocompatibility- Material MediatedPyrogenicity- Acute SystemicToxicity- Subacute /Subchronic Toxicity | ANSI AAMI ISO 10993-11: 2017ISO 10993-11 Third edition2017-09 | 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 thedevelopment, validation and routine controlof a sterilization process for medical devices | |
| Packaging | ASTM D4169-16: 2016 | Standard Practice for Performance Testingof Shipping Containers and Systems | |
| Usability | BS EN 62366-1: 2015 + A1:2020ANSI AAMI IEC 62366-1:2015 +AMD1:2020IEC 62366-1 Ed. 1.1: 2020-06 | Medical devices: Part 1: Application ofusability engineering to medical devices | |
| In vitro performance tests of the npSIMS Negative Pressure Surgical IncisionManagement System™ were carried out to evaluate its ability to meet productperformance specifications, including delivery of negative pressure, wound exudatefluid management, and system performance. The test results met all acceptancecriteria and ensure the design and construction are suitable for its intended useand as recommended by the Non-powered Suction Apparatus Device Intended forNegative Pressure Wound Therapy (NPWT) - Class II Special Controls Guidance forIndustry and FDA Staff. | |||
| Statement ofSubstantialEquivalence | Based upon technological characteristics, safety and performance testing, andconformance with voluntary standards, the npSIMS Negative Pressure SurgicalIncision Management System™ by Aatru Medical, LLC is substantially equivalent tothe predicate device, and does not raise any new questions of safety oreffectiveness. |
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§ 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.