(54 days)
Not Found
No
The description focuses on the mechanical and software control of a suction pump for wound therapy, with no mention of AI or ML capabilities. The performance studies are standard bench testing and electrical/EMC safety, not related to AI/ML model validation.
Yes.
The device is indicated for promoting wound healing and removing fluids, including infectious materials, from wounds.
No
The device description indicates it is a software-controlled suction device designed to provide Negative Pressure Wound Therapy and remove exudate, which are therapeutic actions rather than diagnostic ones.
No
The device description explicitly states it is a "software controlled suction device consisting of an electric motor driven, diaphragm, vacuum pump," indicating it includes significant hardware components beyond just software.
Based on the provided information, the RENASYS EDGE pump is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnostic purposes. This examination is performed outside of the living body (in vitro).
- RENASYS EDGE Function: The RENASYS EDGE pump is a suction device used for Negative Pressure Wound Therapy (NPWT). Its primary function is to apply negative pressure to a wound to remove fluids and promote healing. This is a therapeutic intervention applied directly to the patient's body (in vivo).
- Intended Use: The intended use clearly describes treating wounds and managing abdominal openings, not analyzing biological specimens for diagnostic information.
- Device Description: The description details a suction pump and its mechanism for removing exudate from a wound, not equipment for laboratory analysis of samples.
Therefore, the RENASYS EDGE pump falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The RENASYS EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids, wound exudate and infectious materials. Appropriate wound types include:
- Chronic
- Acute
- · Traumatic
- Sub-acute and dehisced wounds
- · Ulcers (such as pressure or diabetic)
- Partial-thickness burns
- · Flaps
- · Grafts
When used with the RENASYS AB Abdominal Kit with Soft Port, the RENASYS EDGE pump is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary. It is intended to be used in open abdominal wounds with exposed viscera, including but not limited to abdominal compartment syndrome. The use of RENASYS AB Abdominal Kit with Soft Port is intended for use in acute hospital care settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
The RENASYS EDGE device is a software controlled suction device consisting of an electric motor driven, diaphragm, vacuum pump. The device is designed to provide Negative Pressure Wound Therapy at a range of pressure settings between 25-200mmHg to a closed environment over one or two wounds. The device removes exudate from the wound site(s) to a disposable container, which may promote wound healing via removal of fluids, including irrigation of body fluids, wound exudates and infectious materials.
RENASYS EDGE can be operated by either a mains power supply or internal battery. The RENASYS EDGE device is compatible with Smith & Nephew RENASYS Dressing Kits.
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
acute hospital care settings (trauma, general and plastic surgery wards)
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)
Verification activities were conducted which demonstrate the overall system performance of the RENASYS EDGE device. The principal test methods used to demonstrate performance were simulated wound model tests.
- Electrical safety per IEC 60601-1 and IEC 60601-1-11 (home use) ●
- EMC per IEC 60601-1-2
- Human factors per IEC 62366, IEC 60601-1-6 and applicable guidelines listed in FDA ● Guidance Document: Applying Human Factors and Usability Engineering to Medical Devices (FDA 2011-D0469)
- Bench top performance testing including challenge conditions ●
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.
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.
Not Found
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
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right is written in a clear, sans-serif font, with "FDA" in a blue square.
November 22, 2022
Smith & Nephew Medical Limited Zoe Smith Regulatory Affairs Specialist 101 Hessle Road Hull, HU3 2BN United Kingdom
Re: K223041
Trade/Device Name: Renasys Edge (66803126) Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: September 29, 2022 Received: September 29, 2022
Dear Zoe Smith:
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.
1
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.
Julie Morabito, PhD 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
2
Indications for Use
510(k) Number (if known) K223041
Device Name RENASYS EDGE
The RENASYS EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids, wound exudate and infectious materials. Appropriate wound types include:
- Chronic
- Acute
- · Traumatic
- Sub-acute and dehisced wounds
- · Ulcers (such as pressure or diabetic)
- Partial-thickness burns
- · Flaps
- · Grafts
When used with the RENASYS AB Abdominal Kit with Soft Port, the RENASYS EDGE pump is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary. It is intended to be used in open abdominal wounds with exposed viscera, including but not limited to abdominal compartment syndrome. The use of RENASYS AB Abdominal Kit with Soft Port is intended for use in acute hospital care settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.
| 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) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
ditional 510/k) Premarket Notification - K223041
510(k) Summary (K223041)
| 21 CFR 807.92 (a)(1): Submitter's Information | |
|---|---|
| 510(k) Owner | |
| Name | Smith & Nephew Medical Ltd |
| Address | 101 Hessle Road, Hull, HU3 2BN, United Kingdom |
| Establishment | |
| Registration | |
| Number | 8043484 |
| Contact Name | Zoe Smith |
| Telephone Number | +447583672659 |
| Date Prepared | November 21st 2022 |
| 21 CFR 807.92 (a)(2): Device Information | |
| Device Name | |
| (Trade/Proprietary | |
| Name) | RENASYS EDGE |
| Common Name | Negative pressure wound therapy system |
| Review Panel | General and Plastic Surgery |
| Regulation | |
| Number | 21 CFR 878.4783 |
| Regulatory Class | Class II |
| Product Code | OMP |
| 21 CFR 807.92 | |
| (a)(3): Legally | |
| marketed device to | |
| which equivalence | |
| is claimed | 510(k) Number: K181822 |
| Device Name: RENASYS TOUCH | |
| 21 CFR 807.92 (a)(4): Device Description |
The RENASYS EDGE device is a software controlled suction device consisting of an electric motor driven, diaphragm, vacuum pump. The device is designed to provide Negative Pressure Wound Therapy at a range of pressure settings between 25-200mmHg to a closed environment over one or two wounds. The device removes exudate from the wound site(s) to a disposable container, which may promote wound healing via removal of fluids, including irrigation of body fluids, wound exudates and infectious materials.
RENASYS EDGE can be operated by either a mains power supply or internal battery. The RENASYS EDGE device is compatible with Smith & Nephew RENASYS Dressing Kits.
21 CFR 807.92 (a)(5): Intended Use / Indications for Use
The RENASYS EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials. Appropriate wound types include:
4
FNASYS® FDG Traditional 510(k) Premarket Notification – K223041
- Chronic
- . Acute
- Traumatic
- Sub-acute and dehisced wounds .
- Ulcers (such as pressure or diabetic)
- Partial-thickness burns
- . Flaps
- Grafts
When used with the RENASYS AB Abdominal Kit with Soft Port, the RENASYS EDGE pump is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary. It is intended to be used in open abdominal wounds with exposed viscera, including but not limited to abdominal compartment syndrome. The use of RENASYS AB Abdominal Kit with Soft Port is intended for use in acute hospital care settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.
21 CFR 807.92 (a)(6): Comparison of Technological Characteristics between the Subject and Predicate Devices
The RENASYS EDGE device is the next generation in the existing RENASYS family. While there are minor technological differences between the RENASYS EDGE device and predicate device, they have the same requirements and capability with respect to exudate management, therapeutic pressure setting, and operating principles. There minor differences between the devices are to enhance the user experience and do not raise any new or different questions of safety and effectiveness.
| Predicate Device (K181822) | Subject Device (K223041) | Comparison | |
|---|---|---|---|
| Trade Name: | RENASYS TOUCH | RENASYS EDGE | |
| Intended Use: | Same as subject device | Per intended use section | Same, aside from minor |
| formatting change | |||
| Mode of Action | Negative Pressure Wound Therapy | Negative Pressure Wound Therapy | Same |
| Device Operation | Software | Software | Same |
| User Interface | Utilizes a touch screen and tactile buttons | Utilizes tactile buttons with soft key | |
| function | Different, but with no | ||
| impact to therapy | |||
| Single-use or | |||
| Reusable: | Reusable pump unit, Disposable canister | Reusable pump unit, Disposable canister | Same |
| Method of | |||
| Sterilization: | Non-Sterile | Non-Sterile | Same |
| O-Ring | Incorporates O-ring on the device | Incorporates O-ring on the canisters | |
| allowing for a new O-ring with each | |||
| therapy | Similar | ||
| Battery type | Lithium Ion | Lithium Ion | Same |
| Negative Pressure | 25-200mmHg | 25-200mmHg | Same |
| Therapy Mode | Continuous & Intermittent | Continuous & Intermittent | Same |
| Alarms | Device utilizes alarms to notify the user of | ||
| any loss of therapy | Device utilizes alarms to notify the user of | ||
| any loss of therapy | Same | ||
| Auto Restart | N/A | Incorporates an auto-restart function to re- | |
| initiate therapy if the device has been left | |||
| on pause for more than 1 hour | Different, with the | ||
| subject device providing | |||
| an enhanced user | |||
| experience | |||
| Wireless | |||
| Technology | Utilizes wireless data (3G) to enable | ||
| device tracking | Incorporates wireless technology to allow | ||
| for Bluetooth connectivity | Different, but with no | ||
| impact to therapy | |||
| Configurations | 300ml & 800ml canisters available | 300ml & 800ml canisters available | Same |
| Accessories | |||
| Carry Bag | Carry bag for use with device and 300ml | ||
| Canister | Carry bag for use with device and 300ml | ||
| Canister | Same | ||
| Carry Strap | Carry strap fixes to carry strap mounts | Carry strap fixes to carry handle | Similar |
5
raditional 510(k) Premarket Notification – K223041
21 CFR 807.92 (b)(1): Brief discussion of nonclinical tests submitted/referenced/ relied on in this submission to determine substantial equivalence
Verification activities were conducted which demonstrate the overall system performance of the RENASYS EDGE device. The principal test methods used to demonstrate performance were simulated wound model tests.
- Electrical safety per IEC 60601-1 and IEC 60601-1-11 (home use) ●
- EMC per IEC 60601-1-2
- Human factors per IEC 62366, IEC 60601-1-6 and applicable guidelines listed in FDA ● Guidance Document: Applying Human Factors and Usability Engineering to Medical Devices (FDA 2011-D0469)
- Bench top performance testing including challenge conditions ●
21 CFR 807.92 (b)(2): Brief discussion of clinical tests submitted/referenced/ relied on in this submission to determine substantial equivalence
No clinical data were provided to support the demonstration of substantial equivalence.
21 CFR 807.92 (b)(3): Conclusions drawn
In establishing substantial equivalence to the predicate device, Smith & Nephew Medical Ltd evaluated the indications for use, principle of operation, materials, technology, product specifications and energy requirements of the device. Performance testing, software verification testing, electromagnetic compatibility testing and electrical safety testing has been completed to demonstrate that the RENASYS EDGE device is substantially equivalent to the predicate device for the intended use.