Renasys™ GO is indicated for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids including irrigation and body fluids, wound exudates and Infectious materials.

Examples of appropriate wound types include:

Chronic

Acute

Traumatic

Sub-Acute and dehisced wounds

Ulcers (such as pressure or diabetic)

Partial-thickness burns

Flaps and grafts

Device Description

The Renasys GO NPWT device is a lightweight, portable suction device intended to deliver negative pressure to a wound at a range of pressure settings via a tube set connected to a wound dressing. The suction pump creates negative pressure and removes exudates from the wound site to a disposable canister. The device can operate either by a mains power supply or internal battery. Renasys GO is suitable for use in both a hospital and homecare setting and includes a shoulder strap and carry case for portability.

Renasys GO is compatible with existing Smith & Nephew wound dressing kits currently on the market.

AI/ML Overview

The provided text describes the Renasys™ GO Negative Pressure Wound Therapy device and its substantial equivalence to predicate devices. However, it does not include detailed information regarding specific acceptance criteria, a standalone study proving the device meets those criteria, sample sizes for test/training sets, expert qualifications, or multi-reader multi-case studies.

The document states that "Performance testing and electrical safety testing has been successfully completed to demonstrate that tooling and enounced and ally equivalent to the marketed devices and is safe and effective for the intended use." This indicates that some form of testing was performed, but the specifics requested in your prompt are not present.

Therefore, many of the sections below will state "Not provided in the document."

Acceptance Criteria and Device Performance

Acceptance Criteria (Not explicitly stated in the document)	Reported Device Performance (Implied)
(Not explicitly stated, generally involves safety and effectiveness for intended use consistent with predicate devices)	Performance testing and electrical safety testing successfully completed to demonstrate equivalence to marketed devices and safety/effectiveness for intended use.

2. Sample sizes used for the test set and the data provenance

Sample Size for Test Set: Not provided in the document.
Data Provenance: Not provided in the document. The filing is from the USA (Smith & Nephew, Inc., St. Petersburg, FL and Largo, FL). It is a premarket notification for a medical device seeking substantial equivalence, which typically relies on laboratory testing and comparison to predicate devices rather than clinical trials with patient data for this product type. The text mentions "performance testing," which strongly suggests laboratory-based testing rather than clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not provided in the document. Given the description of "performance testing and electrical safety testing," it is unlikely that "ground truth" in the clinical sense (e.g., expert consensus on medical images or pathology) was established for a test set, as this likely refers to engineering and functional performance.

4. Adjudication method for the test set

Not provided in the document.

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

No, an MRMC comparative effectiveness study was not done, nor would it be relevant for this type of device (a negative pressure wound therapy pump). The device is a physical pump, not an AI diagnostic tool that human readers would use.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, implicit in the statement "Performance testing and electrical safety testing has been successfully completed." This refers to the device's functional performance in isolation. The testing would assess parameters like pressure delivery, suction efficacy, battery life, alarm functions, and electrical safety standards without human interaction to "improve" the device's basic function.

7. The type of ground truth used

The "ground truth" for this type of device would likely be engineering specifications, performance standards (e.g., specific pressure levels, flow rates, alarm triggers), and electrical safety standards (e.g., IEC standards). The document implies these were used by stating "Performance testing and electrical safety testing has been successfully completed."

8. The sample size for the training set

Not applicable/Not provided in the document. This device is a hardware product, not a software algorithm that would typically have a "training set" in the machine learning sense. The "training" for such a device would be its iterative design and engineering testing.

9. How the ground truth for the training set was established

Not applicable/Not provided in the document.

Summary

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K683375 Pag

510(k) Summary Renasys™ GO Negative Pressure Wound Therapy

Smith & Nephew, Inc. 1. Submitter: 970 Lake Carillon Drive, Suite 110 St. Petersburg, FL 33716
FEB 2 5 2009
1. Contact: Laura Kreici Requlatory Affairs Manager 727-329-7702
Device Name: Renasys™ GO Negative Pressure Wound Therapy క. Common Name: Powered Suction Pump Classification Name: Powered Suction Pump (21 CFR 878.4780) Product Classification/Code: Class II, JCX
Predicate Device Information: 4.

Renasys TM. EZ Negative Pressure Wound Therapy System Smith & Nephew, Inc. 510(k) #K082426 Largo, FL

Antlia II™ Suction Pump System Innovative Therapies, Inc. Hunt Valley, MD

510(k) #K070904

Medela® INVIA Liberty Secretion & Surgical Aspirator 510(k) #K080357 Medela AG Laettichstrasse, Switzerland

5. Device Description:

Renasys GO is compatible with existing Smith & Nephew wound dressing kits currently on the market.

Intended Use: 6.

Renasvs™ GO is indicated for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wound types include chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.

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K083375 Page(2)

Substantial Equivalence 7.

In establishing substantial equivalence to the current marketed devices, Smith & Nephew, Inc evaluated the indications for use, materials, technology, product specifications and energy requirements of the currently marketed devices. Performance testing and electrical safety testing has been successfully completed to demonstrate that tooling and enounced and ally equivalent to the marketed devices and is safe and effective for the intended use.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with outstretched wings, symbolizing care and protection. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 7 2009

Smith & Nephew, Inc. % Ms. Laura Krejci 970 Lake Carillon Drive, Suite 110 St. Petersburg, Florida 33716

Re: K083375

Trade/Device Name: Renasys™ GO Negative Pressure Wound Therapy Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: December 22, 2008 Received: December 23, 2008

Dear Ms. Krejci:

This letter corrects our substantially equivalent letter of February 25, 2009.

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 (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 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

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Page 2 - Ms. Laura Krejci

limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the 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 at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

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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Indications for Use

510(k) Number (if known): K083375

Device Name: Renasys™ GO Negative Pressure Wound Therapy

Indications for Use:

Examples of appropriate wound types include:

Chronic

Acute

Traumatic

Sub-Acute and dehisced wounds

Ulcers (such as pressure or diabetic)

Partial-thickness burns

Flaps and grafts

Ln. Ahmed

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

510(k) Number K083371

Prescription Use _ X (Part 21 CFR 801 Subpart D)

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 Device Evaluation (ODE)

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.