Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a negative pressure wound therapy dressing kit and its components. There is no mention of AI or ML technology in the intended use, device description, or performance studies.

Therapeutic

Yes
The device is used in conjunction with NPWT systems to promote wound healing via removal of fluids, which is a therapeutic function.

Diagnostic

No

The device is described as a wound dressing kit used in conjunction with negative pressure wound therapy systems to promote wound healing via the removal of fluids. It is a therapeutic device, not a diagnostic one, as it does not diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like foam, gauze, a Softport assembly, film drape, etc., and describes their physical function in negative pressure wound therapy. There is no mention of software as a component or the primary function of the device.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes the device as a wound dressing kit used in conjunction with negative pressure wound therapy systems. Its function is to promote wound healing by removing fluids. This is a therapeutic application, not a diagnostic one.
Device Description: The description details components like foam, gauze, a Softport assembly, and transparent film drape, all designed for wound care and fluid removal. There is no mention of components used for analyzing biological samples in vitro.
Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Using reagents or assays.

The device is a medical device used for wound treatment, falling under the category of therapeutic devices rather than diagnostic ones.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Softport are intended to be used in conjunction with Smith & Nephew NPWT systems. Smith & Nephew NPWT systems are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via the removal of 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.

Product codes (comma separated list FDA assigned to the subject device)

OMP, BTA

Device Description

With the exception of the Softport™ assembly, there are no changes to the components in the currently marketed foam and gauze wound dressing kits. The RENASYS™ Foam and Gauze Wound Dressing Kits with Softport consist of the following components:

Foam Kits: Polyurethane foam wound filler, a Softport assembly and transparent film drape. The foam kits are supplied sterile, single use and are offered in three sizes; small, medium and large.

Gauze Kits: Antimicrobial qauze wound filler, a Softport assembly, non-adherent wound contact layer, transparent film drape, saline bullet, No Sting Skin Prep and wound ruler. The Gauze kits are offered in four sizes: small, medium, large and extra-large. The individual components of the kit are packed sterile and kitted in a non-sterile kit package. The kit is single use.

The Softport assembly attaches to an exudate canister to carry exudate from the wound. The kits are designed specifically for use with the RENASYS EZ / EZ Plus and RENASYS GO negative pressure wound therapy devices and canisters which have been cleared under 510(k) numbers K091470, K102001 and K083375.

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)

The RENASYS Foam and Gauze Wound Dressing Kits with Softport were evaluated under a number of verification and validation tests to ensure performance requirements were met.

The Softport shall serve as a conduit between RENASYS EZ and RENASYS GO NPWT therapy devices and NPWT wound dressings by transmitting negative pressure and collecting exudate flows.
The Softport shall function throughout the recommended maximum elapsed time of 72 . hours between dressing changes.
The Softport will continue to serve as a conduit between RENASYS EZ and RENASYS GO NPWT therapy devices and NPWT wound dressings by transmitting negative pressure and collecting exudate flows when compressed at its terminal end (atop the wound dressing).
The Softport shall incorporate a controlled leak path that does not contribute to RENASYS EZ and RENASYS GO NPWT therapy devices false blockage or leak alarms.

With the exception of the Softport™ assembly, none of the components in the currently marketed foam and gauze dressing kits have changed. Biocompatibility on all components has been successfully completed in accordance with applicable parts of ISO 10993.

The following biocompatibility testing for the Softport assembly has been successfully completed per applicable parts of ISO 10993:

Cytotoxicity
Skin Irritation
Skin Sensitization

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.

K082211, K042134

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.

K091470, K102001, K083375

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

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.

Summary

0

510(k) Summary

RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Softport™ JUN 2 2 2011

Submitter: Smith & Nephew, Inc. 970 Lake Carillon Drive, Suite 110 St. Petersburg, FL 33716
Contact: Laura D. Reynolds, RAC Director Requlatory Affairs 727-329-7702

ന്ന് Date Prepared: May 16, 2011
Device Name: RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Softport 4. Classification Name/Code: Powered Suction Pump / 21 CFR 878.4780 Product Classification: Class II Product Code: OMP

Predicate Device Information: 5.

RENASYS-F NPWT Foam Dressing kits ர்
Smith & Nephew, Inc. b.
510(k) # K082211 C.
Versatile 1 Wound Vacuum System ರ.
BlueSky Medical (Smith & Nephew, Inc.) e.
510(k) #K042134 f.

6. Device Description:

With the exception of the Softport™ assembly, there are no changes to the components in the currently marketed foam and gauze wound dressing kits. The RENASYS™ Foam and Gauze Wound Dressing Kits with Softport consist of the following components:

Foam Kits: Polyurethane foam wound filler, a Softport assembly and transparent film drape. The foam kits are supplied sterile, single use and are offered in three sizes; small, medium and large.

Gauze Kits: Antimicrobial qauze wound filler, a Softport assembly, non-adherent wound contact layer, transparent film drape, saline bullet, No Sting Skin Prep and wound ruler. The Gauze kits are offered in four sizes: small, medium, large and extra-large. The individual components of the kit are packed sterile and kitted in a non-sterile kit package. The kit is single use.

The Softport assembly attaches to an exudate canister to carry exudate from the wound. The kits are designed specifically for use with the RENASYS EZ / EZ Plus and RENASYS GO negative pressure wound therapy devices and canisters which have been cleared under 510(k) numbers K091470, K102001 and K083375.

1

K110647 Page 2/4

7. Intended Use:

The RENASYS™ Foam and Gauze Wound Dressing Kits with Softport are intended to be used in conjunction with Smith & Nephew NPWT systems. Smith & Nephew NPWT systems are indicated for patients who would benefit from a suction device (neqative pressure wound therapy) as it may promote wound healing via the removal of 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.

8. Summary of Non-Clinical Testing:

The RENASYS Foam and Gauze Wound Dressing Kits with Softport were evaluated under a number of verification and validation tests to ensure performance requirements were met.

. The Softport shall serve as a conduit between RENASYS EZ and RENASYS GO NPWT therapy devices and NPWT wound dressings by transmitting negative pressure and collecting exudate flows.
The Softport shall function throughout the recommended maximum elapsed time of 72 . hours between dressing changes.
. The Softport will continue to serve as a conduit between RENASYS EZ and RENASYS GO NPWT therapy devices and NPWT wound dressings by transmitting negative pressure and collecting exudate flows when compressed at its terminal end (atop the wound dressing).
The Softport shall incorporate a controlled leak path that does not contribute to . RENASYS EZ and RENASYS GO NPWT therapy devices false blockage or leak alarms.

With the exception of the Softport™ assembly, none of the components in the currently marketed foam and gauze dressing kits have changed. Biocompatibility on all components has been successfully completed in accordance with applicable parts of ISO 10993.

The following biocompatibility testing for the Softport assembly has been successfully completed per applicable parts of ISO 10993:

. Cytotoxicity
Skin Irritation
Skin Sensitization .

9. Conclusion:

The RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Softport are substantially equivalent in design, materials, technology, function and intended use to the predicate devices named above. Verification and validation testing has been conducted to demonstrate the device is safe and effective for the intended use.

2

K110647 page 34

Renasys Foam and Gauze NPWT Wound Dressing Kits with Softport

Device Comparison Table

| Device: | Smith & Nephew
New Device: | Predicate Device: | Predicate Device: |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Name: | RENASYS™ - Foam
and Gauze Wound
Dressing Kits with
Softport | RENASYS-F NPWT
Foam Dressing kit | Versatile 1 Wound
Vacuum System
(including gauze
wound dressing kits) |
| 510(k): | K110647 | K082211 | K042134 |
| Manufacturer: | Smith & Nephew, Inc. | Smith & Nephew, Inc. | Blue Sky Medical
(Smith & Nephew,
Inc.) |
| Intended Use: | The RENASYS™
Foam and Gauze
NPWT Wound
Dressing Kits with
Softport are Intended
to be used in
conjunction with
Smith & Nephew
NPWT systems.
Smith & Nephew
NPWT systems are
indicated for patients
who would benefit
from a suction device
(negative pressure
wound therapy) as it
may promote wound
healing via the
removal of 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, uicers (such
as pressure or
diabetic), partial-
thickness burns, flaps
and grafts. | Foam dressing kits are
intended to be used in
conjunction with Smith
& Nephew Negative
Pressure Wound
Therapy systems to
deliver negative
pressure to the
wound. Smith &
Nephew NPWT
systems are indicated
for patients who would
benefit from a suction
device particularly as
the device may
promote wound
healing. NPWT 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 | Indicated for
patients who wound
benefit from a
suction device
particularly as the
device may promote
wound healing. |
| Materials: | Wound Filler: | | |
| | Hydrophobic,
Polyurethane foam
or
Antimicrobial Gauze

Softport assembly:
Polyurethane film,
3-D knit polyester
fabric, Polyurethane
foam, Non-woven
polyester,
Polyurethane drape
with adhesive
coating,

Polyurethane drape | Hydrophobic,
Polyurethane foam
Silicone drain
PVC Tube
Polyurethane drape | Antimicrobial Gauze
Silicone drain
PVC Tube
Polyurethane drape |
| Single-use or
Reusable: | Single-use | Single-use | Single-use |
| Method of
Sterilization: | Ethylene Oxide
Or
Individual kit
components individually
sterilized by Ethylene
Oxide or Gamma
Irradiation. | Ethylene Oxide | Individual kit
components
individually sterilized
by Ethylene Oxide or
Gamma Irradiation. |
| Biocompatibility: | All components
comply with ISO
10993 | All components
comply with ISO
10993 | All components
comply with ISO
10993 |
| Packaging: | Components packaged
loose in a pouch then
sterilized
Or
Pre-packaged and
sterilized and placed in
package as a | Components packaged
loose in a pouch then
sterilized | Pre-packaged and
sterilized and placed in
package as a
convenience kit |

3

K 110647 page 4/4

4

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Smith & Nephew, Inc. % Ms. Laura Reynolds Director, Regulatory Affairs 970 Lake Carillon Drive St. Petersburg, Florida 33716

JUN 2 2 2011

Re: K110647

Trade/Device Name: RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Softport" Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: OMP, BTA Dated: June 13, 2011 Received: June 14, 2011

Dear Ms. Reynolds:

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. 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.

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

5

Page 2 - Ms. Laura Reynolds

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

E. Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

6

Indications for Use

510(k) Number (if known): K110647

Device Name: RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Softport™

Indications for Use:

The RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Softport are intended to be used in conjunction with Smith & Nephew NPWT systems. Smith & Nephew NPWT systems are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via the removal of 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.

Prescription Use × (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)

	Daniel Krone for MXM Concurrence of CDRH, Office of Device Evaluation (ODE)
	(Division Sign-Off)
	Division of Surgical, Orthopedic,
	and Restorative Devices

Smith & Nephew - Proprietary Information

510(k) Number K110647