(183 days)
The Avance® NPWT system, with associated products 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, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.
Mölnlycke Health Care has developed a Negative Pressure Wound Therapy System in conjunction with Medela AG, which consists of the Avance® NPWT Pump (which is the Medela INVIA Liberty pump cleared under K080357) and the Avance® Foam Dressing Kits (subject of this submission). The Invia Liberty pump will be private labeled with the Avance® NPWT Pump This pump is compatible with the Avance® Foam Dressing Kits described in the branding. below Table. The Avance Foam Dressing Kit is a negative pressure wound therapy device intended to provide negative pressure to the wound bed and thereby transport exudates from the wound. The Avance® Foam Dressing Kit is a combination of different components developed and arranged to meet the needs of the clinical for specific size and types of wounds.
This device is not an AI/ML powered device. It is a Negative Pressure Wound Therapy (NPWT) system. The document does not contain information about acceptance criteria and device performance in the context of AI/ML, human readers, or ground truth establishment.
A table of acceptance criteria and reported device performance cannot be generated in the requested format because the provided document does not specify quantitative acceptance criteria for the Avance® Foam Dressing Kits as they would be for an AI/ML device. Instead, the performance is described qualitatively based on non-clinical tests.
However, based on the provided text, here's a summary of the performance data:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Vacuum Level in Wound Model | Vacuum levels within chosen range, constant and uniform behavior | Measured vacuum levels are within chosen levels and show a constant and uniform behavior. |
| Fluid Transport from Wound Model | Efficient transport without lockage or problems | Fluid was efficiently transported from the wound model without lockage or problems. |
| System Operation Duration | Operation without problems or errors for a specified time period | The system was tested over the time period of 73 hours without any problems or errors. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for each test. The document refers to "the wound model" and "the system" in singular, implying specific setups or instances rather than a large dataset.
- Data Provenance: Not specified, but based on the context, these are likely laboratory or in-vitro tests conducted internally by the manufacturer or a third-party testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/ML device and ground truth in the context of expert review is not relevant for the described performance tests. The performance is based on physical measurements and observation of the device's function.
4. Adjudication method for the test set:
- Not applicable. The performance tests are objective measurements of the device's physical functions, not subject to expert adjudication.
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 is not an AI/ML device, and no MRMC studies are mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device. The "standalone" performance here refers to the device itself operating as intended.
7. The type of ground truth used:
- The "ground truth" for the performance tests described would be based on physical standards and objective measurements of vacuum levels, fluid transport efficiency, and sustained operation, rather than expert consensus, pathology, or outcomes data typically associated with clinical or AI performance.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no training set in that context.
9. How the ground truth for the training set was established:
- Not applicable. No training set for an AI/ML algorithm is involved.
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JAN 1 7 2013 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 21 CFR 807.92(c).
| Date Prepared: | December 18, 2012 |
|---|---|
| Applicant: | Mölnlycke Health Care US, LLC5550 Peachtree Parkway, Suite 500Norcross, GA 30092Registration number:3004763499Owner/Operator Number: 9067000 |
| Official Correspondent: | Angela L. Bunn, RACDirector, Regulatory Affairs of the AmericasTel: 678-250-7930Fax: 678-250-7981e-mail: angela.bunn@molnlycke.com |
| Trade/Proprietary Name: | Avance® Foam Dressing Kits |
| Common Name: | NPWT Dressing Kits |
| Classification Name: | Powered Suction Pump |
| Device Class: | Class II |
| Regulation Number: | 21 CFR 878.4780 |
| Product Code: | OMP |
| Predicate Device Name(s):Description of Device: | RENASYS™ Foam NPWT Dressing Kits with Suction Pad |
Mölnlycke Health Care has developed a Negative Pressure Wound Therapy System in conjunction with Medela AG, which consists of the Avance® NPWT Pump (which is the Medela INVIA Liberty pump cleared under K080357) and the Avance® Foam Dressing Kits (subject of this submission). The Invia Liberty pump will be private labeled with the Avance® NPWT Pump This pump is compatible with the Avance® Foam Dressing Kits described in the branding. below Table.
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| ProductCode | Product Description |
|---|---|
| 662151 | Avance® Foam Dressing Kit incl Transparent Film, Transfer Pad - Small |
| 662251 | Avance® Foam Dressing Kit incl Transparent Film, Transfer Pad - Medium |
| 662351 | Avance® Foam Dressing Kit incl Transparent Film, Transfer Pad - Large |
| 662000 | Avance® Transparent Film |
| 664151 | Avance® Foam Dressing Kit incl Film with Safetac®, Transfer Pad - Small |
| 664251 | Avance® Foam Dressing Kit incl Film with Safetac®, Transfer Pad - Medium |
| 664351 | Avance® Foam Dressing Kit incl Film with Safetac®, Transfer Pad - Large |
| 664000 | Avance® Film with Safetac® Technology |
The Avance Foam Dressing Kit is a negative pressure wound therapy device intended to provide negative pressure to the wound bed and thereby transport exudates from the wound.
The Avance® Foam Dressing Kit is a combination of different components developed and arranged to meet the needs of the clinical for specific size and types of wounds.
The Avance® Foam Dressing Kit is appropriate for use on the following wounds:
- Traumatic .
- Surgical (sterna/abdominal/extremity) .
- Chronic wounds including pressure ulcers, diabetic foot ulcers and venous leg ulcers
- Partial-thickness burns
- Dehisced wounds
- Flaps and grafts
The Avance Foam Dressing Kits will be contraindicated for the following treatment areas:
- Direct positioning of NPWT over exposed organs, large veins and arteries, tendons or . nerves
- Malignant wounds .
- Untreated osteomyelitis
- Non-enteric or unexplored fistulas
- Undebrided wounds with necrotic tissue and eschar present
Intended Use/Indication for Use:
The Avance® NPWT system, with associated products 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, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.
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K122132
Page 393
Performance Data:
The vacuum level values measured in the wound model are within the chosen levels and shows a constant and uniform behavior.
The fluid was efficiently transported from the wound model without lockage or problems.
The system was tested over the time period of 73 hours without any problems or errors.
Clinical Testing:
No clinical data was required.
Conclusion:
Based on the information presented in this submission, it can be concluded that the Avance®
Foam Dressing Kits are equivalent to the RENASYS™ Foam NPWT Dressing Kits with Suc Pad (K110647) predicate with respect to intended use, materials, design, and technological characteristics.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Molnlycke Health Care % Ms. Angela L. Bunn, RAC Director, Regulatory Affairs for the Americas 5550 Peachtree Parkway. Suite 500 Norcross, Georgia 30092
Re: K122132
Trade/Device Name: Avance® Foam Dressing Kits Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: September 15, 2012 Received: December 4, 2012
Dear Ms. Bunn:
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 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
Janaury 17, 2013
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Page 2 - Ms. Angela L. Bunn, RAC
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 yours,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
K122132 510(k) Number (if known):
Device Name: Avance® Foam Dressing Kits
Indications For Use:
The Avance® NPWT system, with associated products 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 Examples of appropriate wound types include: chronic, acute, infectious materials. traumatic, sub-acute and dehisced, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.
Prescription Use _ X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE) .
Jiyoung Dang
(Division-Sign-Off) Division of Surgical Devices 510/k) Number
Page 1 of
§ 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.