(15 days)
No
The document describes a mechanical suction pump with no mention of AI or ML technologies. The changes are related to battery type and labeling.
Yes
The device is indicated to "promote wound healing", which is a therapeutic purpose.
No
The device is described as a suction pump used for aspiration and removal of fluids, tissue, and gases, and to create negative pressure for wound healing. Its functions are therapeutic and operative, not diagnostic.
No
The device description clearly details physical components such as a motor, pistons, cylinders, vacuum gauge, and regulator, indicating it is a hardware device with mechanical functions, not software-only.
Based on the provided text, the Medela® Vario 8 and 18 Suction Pumps are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The intended use of the Medela® Vario suction pumps is to aspirate and remove fluids, tissue, gases, and materials directly from or within a patient's body (airway, respiratory system, wounds).
- The device description focuses on the mechanical function of a suction pump. It describes the motor, vacuum regulation, flow rate, and accessories used for aspiration from the patient.
- There is no mention of analyzing or testing biological samples. The purpose is removal, not diagnosis based on analysis of a sample.
Therefore, the Medela® Vario suction pumps are medical devices used for therapeutic and procedural purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Medela® Vario 8 and 18 Suction Pumps are indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from or burgiour from a patient's airway or respiratory support system, either during surgery or at the patient's bedside.
The Medela® Vario 18 c/i Suction Pump is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing. The device is also indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids (including vomit) or infectious materials from a patient's airway or respiratory support system, either during surgery or at the patient's bedside.
Additional indication Wound Healing
It is intended to be used to create localized topical negative pressure when used with the Chariker-Jeter® wound sealing kit to promote wound healing and drainage of fluids and infected materials from the wound into a disposable or reusable canister.
Product codes
BTA, OMP
Device Description
This notification for the Medela® Vario suction pumps is for a change in labeling and to include additional indications (for the Medela® Vario 18 c/i only). There have been no significant modifications or design changes to the currently cleared and marketed Medela® Vario, 510(k) No. K983552.
The only modifications relate to a change from lead acid to NiMH batteries and a more v differentiated trade name - Medela® Vario 8 and Vario 18 instead of Medela® Vario only (the number reflects the flow rate - 8 1/min or 18 l/min).
The Medela® Vario powered suction pump is a further innovative development of Medela's well-proven piston/cylinder system. With its QuatroFlex™ technology, the drive power is transferred to the four piston/cylinder modules by means of high-grade, flexible thin-films hinges. The required suction value is rapidly built-up. High suction performance and low weight are positive features of the Medela® Vario.
It is an AC or AC/DC-powered portable aspirator and incorporates in its medium sized housing an AC respectively DC-motor with a flat belt power transmission to the pistons and cylinders, an ON/OFF-switch, a vacuum gauge in kPa and mmHG and a selfbleeding membrane vacuum regulator.
The Medela® Vario 18 "high vacuum" suction pump has a suction capacity of 18 liters per minute and a maximum vacuum up to -75 kPa (-563 mmHg). The pump is marked "low flow - high vacuum".
The Medela® Vario 18 c/i "medium vacuum" suction pump has a suction capacity of 18 liters per minute and a maximum vacuum up to -55 kPa (-413 mmHg). The pump is marked "low flow – medium vacuum".
The Medela® Vario 8 "low vacuum" suction pump has a suction capacity of 8 liters rne wiedola - 8 a.r.o o maximum vacuum up to -9 kPa (-68 mmHg). The pump is marked "low flow - low vacuum".
A variety of reusable and disposable accessories are available depending on the pump application. An overflow protection device (hydrophobic filter), connection tubing, electric applibation: An oremon participant for the expanded indication of use for wound healing an accessory kit consisting of individually reviewed medical components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's airway or respiratory support system, wounds
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
Medela AG. Laettichstrasse 4b. CH-6341 Baar, Switzerland Applicant: Contact Person: Werner Frei, Tel +41 (41) 769 51 51 ext. 228; Fax +41 (41) 769 51 00 werner.frei@medela.ch Traditional 510(k) Submission for Medela® Vario 18 c/i Suction Pump
Section E - 510(k) Summary
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
This 510(k) summary for the Medela® Vario Powered Suction Pumps 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 +41 41 769 5151 ext. 228 Ph: +41 41 769 5100 Fax:
Contact Person Werner Frei Manager Requlatory Affairs
Date Summary Prepared: February 16, 2006
2 Name of Device
| Trade Name: | Medela® Vario 8 and Vario 18
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: | BTA |
Name of the predicate Device(s) 3
- Medela® Basic, Median, Dominant, Vario Suction Pumps, by Medela Inc. . K983552
- Versatile 1 Wound Vacuum System, by Blue Sky Medical Group Incorporated . K042134
1
Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerland Applicant: Contact Person: Werner Frei, Tel +41 (41) 769 51 51 ext. 228; Fax +41 (41) 769 51 00 werner.frei@medela.ch
Traditional 510(k) Submission for Medela® Vario 18 c/i Suction Pump
Device Description 4
This notification for the Medela® Vario suction pumps is for a change in labeling and to include additional indications (for the Medela® Vario 18 c/i only). There have been no significant modifications or design changes to the currently cleared and marketed Medela® Vario, 510(k) No. K983552.
The only modifications relate to a change from lead acid to NiMH batteries and a more v differentiated trade name - Medela® Vario 8 and Vario 18 instead of Medela® Vario only (the number reflects the flow rate - 8 1/min or 18 l/min).
The Medela® Vario powered suction pump is a further innovative development of Medela's well-proven piston/cylinder system. With its QuatroFlex™ technology, the drive power is transferred to the four piston/cylinder modules by means of high-grade, flexible thin-films hinges. The required suction value is rapidly built-up. High suction performance and low weight are positive features of the Medela® Vario.
It is an AC or AC/DC-powered portable aspirator and incorporates in its medium sized housing an AC respectively DC-motor with a flat belt power transmission to the pistons and cylinders, an ON/OFF-switch, a vacuum gauge in kPa and mmHG and a selfbleeding membrane vacuum regulator.
The Medela® Vario 18 "high vacuum" suction pump has a suction capacity of 18 liters per minute and a maximum vacuum up to -75 kPa (-563 mmHg). The pump is marked "low flow - high vacuum".
The Medela® Vario 18 c/i "medium vacuum" suction pump has a suction capacity of 18 liters per minute and a maximum vacuum up to -55 kPa (-413 mmHg). The pump is marked "low flow – medium vacuum".
The Medela® Vario 8 "low vacuum" suction pump has a suction capacity of 8 liters rne wiedola - 8 a.r.o o maximum vacuum up to -9 kPa (-68 mmHg). The pump is marked "low flow - low vacuum".
A variety of reusable and disposable accessories are available depending on the pump application. An overflow protection device (hydrophobic filter), connection tubing, electric applibation: An oremon participant for the expanded indication of use for wound healing an accessory kit consisting of individually reviewed medical components.
Indications for use 5
The Medela® Vario 8 and 18 Suction Pumps are indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from or burgiour from a patient's airway or respiratory support system, either during surgery or at the patient's bedside.
These indications for use for the Medela® Vario 8 and 18 Suction Pumps are the identical to the ones mentioned for the original Medela® Vario Suction Pumps (K983552).
17
2
Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerland Applicant: Contact Person: Werner Frei. Tel +41 (41) 769 51 51 ext. 228; Fax +41 (41) 769 51 00 werner.frei@medela.ch Traditional 510(k) Submission for Medela® Vario 18 c/i Suction Pump
The Medela® Vario 18 c/i Suction Pump is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing. The device is also indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids (including vomit) or infectious materials from a patient's airway or respiratory support system, either during surgery or at the patient's bedside.
Additional indication Wound Healing
It is intended to be used to create localized topical negative pressure when used with the Chariker-Jeter® wound sealing kit to promote wound healing and drainage of fluids and infected materials from the wound into a disposable or reusable canister.
Contraindications for Wound Healing Application
The Medela® Vario 18 c/i is contraindicated for the following reasons for Wound treatment:
- Presence of Necrotic tissue
- Untreated Osteomyeltitis
- Malignancy (except terminal patients for quality of life issues) •
- Untreated malnutrition
- Use on exposed arteries, veins, or organs .
The Blue Sky Medical Versatile 1 Wound Vacuum System (K042134) is identical to the Medela® Vario 18 c/i suction pump.
Precautions
- patients on anticogagulations or difficult hemostatis ◆
- non-compliant patients .
General Precautions for all indications for use
Health care provider must evaluate patient to insure that use of the Medela® Vario 18 c/i to promote wound healing is an appropriate use for the patient.
3
Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerland Applicant: Werner Frei, Tel +41 (41) 769 51 51 ext. 228; Fax +41 (41) 769 51 00 Contact Person: werner.frei@medela.ch Traditional 510(k) Submission for Medela® Vario 18 c/i Suction Pump
Summary of Technological Characteristics 6
The Medela® Vario 8 and 18 suction pumps are identical in construction and performance to the legally marketed device as submitted under FDA File Number K983552 there are no technical differences which would raise new aspects regarding safety and effectiveness.
The only modifications relate to a change from lead acid to NiMH batteries and a more differentiated trade name - Medela® Vario 8, 8c/i, 18 or 18 c/i instead of Medela® Vario only (the number reflects the flow rate - 18 I/min).
The Blue Sky Medical Versatile 1 Wound Vacuum System (K042134) is identical to the Medela® Vario 18 c/i suction pump. Therefore the indications for use can be adopted.
Conclusion 7
According to the FDA Guidance "Deciding When to Submit a 510(k) for a Change to an Existing Device", the modifications mentioned above do not significantly affect the safety or effectiveness of the device (e.g. a significant change or modification in design, material, chemical composition, energy source or manufacturing process). All conclusions are made by the decision making process in accordance with this guidance document.
Based upon the information presented above and in this 510(k) submission, it is concluded that the proposed Medela® Vario 18 c/i powered suction pump is reliable, safe and effective for the intended use.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol. The symbol is positioned inside a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the circle.
Public Health Service
APR -7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medela AG % Mr. Scott Cohn 1101 Corporate Drive Mchenry, Illinois 60050
Re: K061435
Trade/Device Name: Medela Vario Suction Pumps Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: May 22, 2006 Received: May 24, 2006
Dear Mr. Cohn:
This letter corrects our substantially equivalent letter of June 8, 2006.
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
5
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 (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.
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 yours.
for Natter
Mark N. Natter
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): KO61435
Device Name:
Medela Vario Suction Pumps
Indications For Use:
The Medela Vario 8 and 18 Suction Pumps are indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's air-way or respiratory support system, either during surgery or at the patient's bedside.
The Medela Vario 18 c/i Suction Pump is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing. The device is also indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids (includinc vomit) or infectious materials from a patient's airway or respiratory support system, either during surgery or at the patient's bedside.
| • Prescription Use (Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|---|---|---|
| ------------------------------------------------ | --- | -------- | --------------------------------------------- | -- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Division of General, Restorative,
Concurrenand Neurological Devices Evaluation (ODE)
| 510(k) Number | 4061435 |
|---|---|
| --------------- | --------- |