(164 days)
No
The summary describes a standard negative pressure wound therapy pump with electronic monitoring and a user interface, but there is no mention of AI or ML capabilities.
Yes
The device is indicated to "help promote wound healing," which is a therapeutic function.
No
The device is used to promote wound healing by drainage and removal of materials under negative pressure, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly details a physical suction pump with a DC-motor, membrane aggregate, and electronic measuring/monitoring system, indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, the Medela® INVIA Wound Therapy device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "help promote wound healing, through means including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressures". This describes a therapeutic intervention applied directly to a wound on a patient's body.
- Device Description: The description details a "suction pump" that applies "negative pressure" to a wound. This is a physical therapy method, not a diagnostic test performed on samples taken from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. The Medela® INVIA Wound Therapy device is a therapeutic device used for wound management.
N/A
Intended Use / Indications for Use
The Medela® INVIA Wound Therapy is indicated to help promote wound healing, through means including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
Product codes
JCX, OMP
Device Description
The Medela® INVIA Liberty pump is an innovative suction pump to help promote wound healing. Its well-proven membrane system guarantees maximum suction performance and quiet, dependable operation. Additional advantages of the Medela® INVIA Liberty are: user friendliness, patient mobility, simple cleaning and integrated safety features. A comprehensive range of accessories makes the Medela® INVIA Liberty ideally suited for Negative Pressure Wound Therapy (NPWT).
The Medela® INVIA Liberty suction pump is an AC/DC powered, maintenance-free aspirator for Negative Pressure Wound Therapy which incorporates a DC-motor with membrane aggregate power actuation in its housing. A user friendly MMI (man machine interface) guides the user through first installation, change of settings, use, data transfer and alarm handling.
The Medela® INVIA Liberty suction pump has an electronic measuring and monitoring system with optical and acoustic status display. It is a "medium vacuum" suction pump and has a suction capacity of 5 liters per minute and a maximum vacuum up to -27 kPa (-200 mmHg). The pump is marked "low flow - medium vacuum".
A variety of reusable and disposable accessories to help promote wound healing are available.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Applicant: Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerland
Contact Person: Bruno Gretler, Tel +41 (41) 769 51 51 ext. 247; Fax +41 (41) 769 51 00
bruno.gretler@medela.ch
Traditional 510(k) Submission for Medela
® INVIA Wound Therapy
JUL 2 4 2008
Section E - 510(k) Summary
This 510(k) summary for the Medela® INVIA Wound Therapy meets the requirements of 21 CFR 807.92.
Sponsor's Name, Address and Contact Person 1
Sponsor: Medela AG Medical Equipment Laettichstrasse 4b 6341 Baar Switzerland Ph: +41 41 769 5151 ext. 247 Fax: +41 41 769 5100
Contact Person Bruno Gretler Manager Regulatory Affairs
Date Summary Prepared: February 06, 2008
2 Name of Device
| Trade Name: | Medela® INVIA Liberty
Secretion & Surgical Aspirator |
|----------------------|--------------------------------------------------------------------------------------------|
| Common Name: | Powered Suction Pump |
| Classification Name: | PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
Classified Class II, per 21 CFR 878.4780 |
| Product Code: | JCX |
3 Name of the predicate Device(s)
- . Medela® Vario 8/18/ci Suction Pumps, by Medela AG K061205
- . KCI V.A.C. Freedom, by KCI KINETIC CONCEPTS, INC. K032310
Section E - 1 of 3
1
K080357 pg 273
Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerland Applicant: Contact Person: Bruno Gretler, Tel +41 (41) 769 51 51 ext. 247; Fax +41 (41) 769 51 00 bruno.gretler@medela.ch Traditional 510(k) Submission for Medela® INVIA Wound Therapy
র্ব Device Description
The Medela® INVIA Liberty pump is an innovative suction pump to help promote wound healing. Its well-proven membrane system guarantees maximum suction performance and quiet, dependable operation. Additional advantages of the Medela® INVIA Liberty are: user friendliness, patient mobility, simple cleaning and integrated safety features. A comprehensive range of accessories makes the Medela® INVIA Liberty ideally suited for Negative Pressure Wound Therapy (NPWT).
The Medela® INVIA Liberty suction pump is an AC/DC powered, maintenance-free aspirator for Negative Pressure Wound Therapy which incorporates a DC-motor with membrane aggregate power actuation in its housing. A user friendly MMI (man machine interface) guides the user through first installation, change of settings, use, data transfer and alarm handling.
The Medela® INVIA Liberty suction pump has an electronic measuring and monitoring system with optical and acoustic status display. It is a "medium vacuum" suction pump and has a suction capacity of 5 liters per minute and a maximum vacuum up to -27 kPa (-200 mmHg). The pump is marked "low flow - medium vacuum".
A variety of reusable and disposable accessories to help promote wound healing are available.
5 Indications for use
The Medela® INVIA Wound Therapy is indicated to help promote wound healing, through means including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
Annotation:
The Medela® INVIA Liberty is used as vacuum source for the Medela® INVIA Wound Therapy in combination with the system components and accessories for Negative Pressure Wound Therapy.
Summary of Technological Characteristics 6
The Medela® INVIA Liberty suction pump is working with a membrane aggregate, an electronic vacuum regulator and has a digital display. It has the identical performance characteristics and is equipped with the identical technology like the predicate devices and other legally marketed devices. The technological features do not affect safety and effectiveness of the device or the application (to help promote wound healing).
2
K0f0357 P3303
Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerland Applicant: Bruno Gretler, Tel +41 (41) 769 51 51 ext. 247; Fax +41 (41) 769 51 00 Contact Person: bruno.gretler@medela.ch Traditional 510(k) Submission for Medela® INVIA Wound Therapy
7 Conclusion
There are no differences in performance or technology which significantly affect the safety and effectiveness of the device or the application "to help promote wound healing". All conclusions are made by the decision making process according to the recommendations in the "510(k) SE Decision Making Process" document.
The Medela® INVIA Liberty suction pump has the identical intended uses and, where applicable, the identical technological characteristics and performance data as the predicate devices.
Based upon the information presented in this submission, it is proven that the proposed Medela® INVIA Liberty powered suction pump is substantially equivalent, safe and effective for the intended use.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR -7 2009
Medela AG % Mr. Scott Cohn 1101 Corporate Drive Mchenry, Illinois 60050
Re: K080357
Trade/Device Name: Medela® INVIA Wound Therapy Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: June 23, 2008 Received: June 17, 2008
Dear Mr. Cohn:
This letter corrects our substantially equivalent letter of July 24, 2008.
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
4
Page 2 - Mr. Scott Cohn
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 you 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
5
Indications for Use
510(k) Number (if known):
Device Name:
Medela® INVIA Wound Therapy
The Medela® INVIA Wound Therapy is indicated to help promote wound healing,
through means including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
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 ANQTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1.
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number
L080357