The ATMOS S041 Wound™ is a suction device intended for aspiration and collection of secretions and body fluids from wounds and is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing. ATMOS S041 is appropriate for use on the following wounds:

· Pressure ulcers
· Diabetic/neuropathic ulcers
· Venous insufficiency ulcers
Traumatic wounds
· Post-operative and dehisced surgical wounds
Explored fistulas
· Skin flaps and grafts

Device Description

The ATMOS S 041 Wound is a device to remove bodily fluids for wound drainage and can be used by patients over an extended period of time as recommended by a physician. The device has a rechargeable battery and therefore is portable. A microprocessor controlled electronic battery charging unit in the suction device guarantees the safe charging of the battery, and overcharging of the battery.
The ATMOS S 041 Wound itself is not a sterile device but can use disposable (sterile) items from other manufacturers but these items are not a part of the S 041, (e.g. various hose sets, containers, trocars and catheters) which have been designed for the wound drainage.

AI/ML Overview

The ATMOS S041 Wound is a medical device designed for wound drainage by removing bodily fluids. The summary provided mainly focuses on demonstrating substantial equivalence to a predicate device (BlueSky VISTA™ Wound Vacuum System) and adherence to various safety and performance standards, rather than proving the device meets specific acceptance criteria based on a clinical study or performance metrics like sensitivity/specificity.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria for device performance (e.g., suction efficiency, battery life in a clinical context, wound healing rates). Instead, the acceptance criteria are related to compliance with safety and performance standards.

Acceptance Criteria (Compliance with Standards)	Reported Device Performance
Adherence to ISO 10993-1:1998 (Biological Compatibility)	No biocompatibility tests needed as no parts touch patient.
Adherence to EN 60601-1-2 (2001) (EMC)	"Software verification and product validation tests were performed and meet the acceptance criterion." (General Statement)
Adherence to EN ISO 61000-3-2 (2000) (Harmonic Current Emissions)	"Software verification and product validation tests were performed and meet the acceptance criterion." (General Statement)
Adherence to EN ISO 61000-3-3 (1995 + A1 2001) (Voltage Fluctuations/Flicker)	"Software verification and product validation tests were performed and meet the acceptance criterion." (General Statement)
Adherence to CEN EN 980:1996+A1:1999+A2:2001 (Graphical Symbols for Labeling)	Implied compliance through successful submission.
Adherence to EN ISO 14971 (03/2001) (Risk Management)	Implied compliance through successful submission.
Adherence to IEC 60601-1 (1988, 1991, 1995) (General Safety)	"Software verification and product validation tests were performed and meet the acceptance criterion." (General Statement)
Software verification and product validation	"Software verification and product validation tests were performed and meet the acceptance criterion."
Does not raise new issues of safety, efficacy, or performance compared to predicate	Statement provided: "does not raise any new issues of safety, efficacy, or performance of the product."
Substantial equivalence to predicate device (BlueSky VISTA™ Wound Vacuum System)	Conclusion: "The 510(k) for the ATMOS S 041 ™ device contains adequate information and data to enable FDA to determine substantial equivalence to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not describe a "test set" in the context of patient data or clinical performance. The "tests" performed are primarily non-clinical safety and performance evaluations against applicable standards. Therefore, information on sample size for patient data or data provenance (country of origin, retrospective/prospective) is not applicable/not provided for this type of submission which focuses on substantial equivalence based on technical characteristics and adherence to standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Since a clinical "test set" with patient data requiring expert ground truth is not described in this document, this information is not applicable/not provided. The ground truth here relates to the adherence of the device to technical standards, which is evaluated through engineering and quality assurance processes.

4. Adjudication Method for the Test Set:

Again, as there is no mention of a "test set" involving patient data and human readers/diagnosticians, an adjudication method is not applicable/not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not mentioned or described. This submission focuses on a 510(k) pathway, demonstrating substantial equivalence to a predicate device, and primarily addresses technical and safety standards. It does not appear to involve a comparative effectiveness study with human readers (AI vs. without AI assistance).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This device (ATMOS S041 Wound) is a physical medical device (a powered suction pump), not an AI algorithm. Therefore, a "standalone algorithm performance" study is not applicable.

7. The Type of Ground Truth Used:

The "ground truth" in this context is the compliance with established national and international safety and performance standards for medical devices (e.g., ISO, EN, IEC standards) and the technical specifications of the device itself. This is assessed through "Software verification and product validation tests" and engineering evaluations.

8. The Sample Size for the Training Set:

This device is not an AI algorithm, so there is no concept of a "training set" in the machine learning sense. The device is validated against engineering specifications and regulatory standards.

9. How the Ground Truth for the Training Set Was Established:

As there is no "training set" for an AI algorithm, this question is not applicable. The ground truth for the device's design and manufacturing is established through the adherence to Quality System Regulations (QSR) and the referenced safety and performance standards.

Summary

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K090130 Page 1/3

510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared:

December 10, 2008

Submitter's Information: 21 CFR 807.92(a)(1) Mr. Marco Schlegel President 3717 Huckleberry Road Allentown, PA 18104 Toll Free: 866-862-8667 Fax: 610-351-6827 Email: MSchlegel@Atmosmed.com

APR - 2 2009

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) ATMOS S041 Wound™ Product Name: Common Name: Powered suction pump pump, portable, aspiration (manual or powered) Classification Name: 878.4780, Class II Product Code: M

Predicate Device: 21 CFR 807. 92(a)(3)

510(k) Number	K061367
Device Name	BlueSky VISTA™ Wound Vacuum System
Applicant	BlueSky Medical Group, Inc.5924 Balfour Ct., Suite 102Carlsbad, CA 92008
Regulation Number	878.4780
Classification Product Code	OMP
Decision Date	08/10/2006
Decision	Substantially equivalent (SE)
Classification Advisory Committee	General & Plastic Surgery

Device Description: 21 CFR 807 92(a)(4)

The ATMOS S 041 Wound itself is not a sterile device but can use disposable (sterile) items from other manufacturers but these items are not a part of the S 041, (e.g. various hose sets, containers, trocars and catheters) which have been designed for the wound drainage.

Indications for Use: 21 CFR 807 92(a)(5)

· Pressure ulcers
· Diabetic/neuropathic ulcers
· Venous insufficiency ulcers
Traumatic wounds
· Post-operative and dehisced surgical wounds
Explored fistulas
· Skin flaps and grafts

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K090130

Image /page/1/Picture/1 description: The image shows the title "510(k) Summary of Safety and Effectiveness". The text is in bold font and is centered on the page. The image is a simple title with no other visual elements.

Contraindications

The use of the ATMOS S 041 WOUND is contraindicated in the presence of:
· Eschar
· Untreated osteomyelitis
· Malignancy in wound (with exception of palliative care to enhance quality of life)
Untreated malnutrition
Exposed arteries, veins or organs
· Necrotic tissue
· Non-enteric unexplored fistulas
· Exposed nerves
· Exposed anastomotic site
· Exposed bone or tendons
Exposed vasculature

The ATMOS S 041 WOUND is not designed for use with emergency medical services.

Not to be used:

• In non-medical applications

· In presence of combustible or explosive fluids or gases

Technological Characteristics: 21 CFR 807 92(a)(6)

The ATMOS S 041 Wound is a small suction unit. The device is operated by an electromotive membrane pump which is maintenance-free. When it operates, the pump creates a vacuum in the hose system and in the collection jar, with the help of which secretions can be sucked off through the set of hoses. The pump switches off after creation of the vacuum and then switches on again when the vacuum lies below a certain value.

The secretion is collected in a collection jar. A hydrophobic bacterial filter prevents the secretion being inadvertently drawn into the pump head. The device is fitted with a rechargeable battery. A microprocessor controlled electronic charging unit in the suction device guarantees the safe charging of the battery, and thus overcharging of the battery is avoided. The electronic unit prevents overheating of the suction device by a high temperature switch. For the mobile use a carrying strap is available. Useful accessories are a shoulder bag and a device support.

The ATMOS S 041™ device are substantially equivalent to other legally marketed devices in the United States and functions in a manner similar and is intended for the same use as the predicate device.

Brief summary of Non-clinical Tests and Results

Software verification and product validation tests were performed and meet the acceptance criterion. The ATMOS S 041™ device have been designed and tested to applicable safety standards (see below) and does not raise any new issues of safety, efficacy, or performance of the product.

Number of standard	Std Date	Title of standard
ISO 10993-1:1998	1998	Biological Compatibility of medical devices - Part 1: Evaluation andTesting1
EN 60601-1-2 (2001)	2001	Medical electrical equipment -- Part 1-2: General requirementsfor safety -Collateral standard: Electromagnetic compatibility -Requirements andtests
EN ISO 61000-3-2 (2000):	2000	Electromagnetic compatibility - Part 3-2: Limits - Limits for Harmoniccurrent emissions (equipment input current < 16A per phase).
EN ISO 61000-3-3 (1995) + A1(2001)	19952001	Electromagnetic compatibility - Part 3: Limits - Section 3: Limitationof voltage fluctuations and flicker in low-voltage supply systems forequipment with rated current < 16A.

1 Result of evaluation: for ATMOS S 041 Wound: No biocompatibility tests are needed because not have parts that would normally touch patient.

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K090130 Page 3/3

510(k) Summary of Safety and Effectiveness

Number of standard	Std Date	Title of standard
CEN EN980:1996+A1:1999+A2:2001	19992001	Graphical symbols for use in the labeling of medical devices
EN ISO 14971	03/2001	Medical devices - application of risk management to medicaldevices
IEC 60601-1	1998,1991,1995	Medical Electrical Equipment - Part 1: General Requirements forSafety, 1988; Amendment 1, 1991-11, Amendment 2,1995. (General)

Conclusion: 21 CFR 807 92(b)(1)

The 510(k) for the ÀTMOS S 041 ™ device contains adequate information and data to enable FDA
to determine substantial equivalence to the predicate device. The device will be accordance with the voluntary standards listed in the enclosed voluntary standard survey.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black against a white background. The overall design is simple and conveys a sense of official authority.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 2 2009

ATMOS, Inc. % TUV Rheinland of North America, Inc. Tamas Borsai 12 Commerce Road Newton, Connecticut 06470

Re: K090130

Trade/Device Name: ATMOS S041 Wound™ Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: OMP Dated: March 19, 2009 Received: March 23, 2009

Dear Tamas Borsai:

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 Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Tamas Borsai

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a logally marketed predicate device results in a classification for your device and thus, permitts your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or a its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K090530

Device Name: ATMOS S041 Wound™

Indications for Use:

· Pressure ulcers
· Diabetic/neuropathic ulcers
· Venous insufficiency ulcers
· Traumatic wounds
· Post-operative and dehisced surgical wounds
· Explored fistulas
· Skin flaps and grafts

Contraindications

The use of the ATMOS $ 041 WOUND is contraindicated in the presence of.

Eschar
· Untreated osteomyelitis
· Malignancy in wound (with exception of palliative care to enhance quality of life)
Untreated malnutrition
· Exposed arteries, veins or organs
· Necrotic tissue
· Non-enteric unexplored fistulas
· Exposed nerves
· Exposed anastomotic site
· Exposed bone or tendons
· Exposed vasculature

The ATMOS S 041 WOUND is not designed for use with emergency medical services.

Not to be used:

· In non-medical applications

· In presence of combustible or explosive fluids or gases
Prescription Use × (Part 21 CFR 801 Subpart D)

No. of the count

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

David Keane BellXU

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number K090130

Regulation Number and Section

§ 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.