(183 days)
The Swing™ breastpump is a powered breastpump to be used by lactating women to express and collect milk from their breasts.
The Medela® Swing™ Breastpump is intended to express the mother's milk of a lactating woman. The pumping can be only on one breast at the time. The Swing™ breastpump can operate off common batteries or off an AC/DC power supply. The Swing™ breastpump's drive unit employs a diaphragm-type vacuum pump, powered by a DC-motor, supervised by a microcontroller provides control over motor speed (vacuum creation) and solenoid (vacuum release). The control program resides in a microcontroller, inside the Swing™ breastpump and provides the necessary a) time and b) vacuum parameters. By depressing the vacuum-adjust buttons, the microcontroller changes the vacuum and time parameters of the breast pump is capable of providing vacuum levels from 0 to 250mmHg, with cycling rates up to 130cpm. The program residing on the microcontroller is designed to deliver two pumping curves. All materials with milk contact or components with human breast/skin contact are manufactured from' materials that meet the appropriate FDA and international requlations concerning food contact and/or biocompatibility.
The provided text describes a 510(k) summary for the Medela® Swing™ Breastpump. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study of the device's performance against specific acceptance criteria.
Therefore, many of the requested details about acceptance criteria, study methodologies, and performance metrics are not available in this document. The document states that the "technology of the Medela® Swing™ breastpump is identical to the predicate devices and there are no technical differences which would raise new aspects regarding safety and effectiveness." This implies that the acceptance criteria for this device are met by demonstrating its equivalence to predicate devices that have already met safety and effectiveness standards.
Here's a breakdown of the available information:
-
A table of acceptance criteria and the reported device performance
Acceptance Criteria Reported Device Performance Safety and Effectiveness for Intended Use: The device must be safe and effective for expressing and collecting milk from a lactating woman's breasts. The submission concludes that the Medela® Swing™ breastpump is "safe and effective for the intended use, and is substantially equivalent to the predicate devices." Key technological characteristics include: - Vacuum levels: 0 to 250mmHg - Cycling rates: up to 130cpm - Control: Microcontroller provides control over motor speed and solenoid for vacuum creation and release, delivering two pumping curves. - Material Biocompatibility: All milk-contact or human breast/skin contact components are manufactured from materials meeting appropriate FDA and international regulations for food contact and/or biocompatibility. Substantial Equivalence to Predicate Devices: Technological characteristics, intended use, and performance must be substantially equivalent to legally marketed predicate devices, with no new safety or effectiveness concerns. The document explicitly states: "The technology of the Medela® Swing™ breastpump is identical to the predicate devices and there are no technical differences which would raise new aspects regarding safety and effectiveness." The predicate devices are listed as: - Medela® Symphony® Breastpump (K020518) - Medela® Mini Electric® Breastpump (K901344) The intended use is also stated as identical to the predicate devices. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided in the 510(k) summary. The submission relies on claiming substantial equivalence to predicate devices rather than presenting a new clinical study with a test set.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not provided. As no specific test set study is detailed, there's no mention of experts establishing ground truth.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided.
-
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
- This information is not applicable as the device is a breast pump, not an AI-assisted diagnostic tool involving human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable as the device is a breast pump, not an algorithm. Its operation is standalone in the sense that it functions to express milk, but it doesn't perform diagnostic or analytical tasks that would typically involve "algorithm only" performance evaluation in the context of AI/software.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this type of device, "ground truth" would likely relate to objective measurements of vacuum pressure, cycling rates, and material biocompatibility. The document states the device meets "appropriate FDA and international requlations concerning food contact and/or biocompatibility" and provides specific technical parameters (vacuum levels and cycling rates). This implies that engineering specifications and regulatory compliance serve as the "ground truth" for its performance and safety, validated through direct measurement and adherence to standards rather than expert consensus on a clinical outcome from a test set.
-
The sample size for the training set
- This information is not applicable to a mechanical device like a breast pump in the context of AI/machine learning training sets.
-
How the ground truth for the training set was established
- This information is not applicable.
{0}------------------------------------------------
Section E - 510(k) Summary
2 2006 MAY
Medela® Swing™ Breastpump
1. Sponsor's Name, Address and Contact Person:
Medela AG Laettichstr. 4b 6341 Baar Switzerland +41 (0)41 769 5151 Ph: +41 (0)41 769 5203 Fax:
Contact Person: Werner Frei Manager Requlatory Affairs
Date Summary Prepared: July 20, 2005
2. Name of Device:
Swing™ Trade Name: Common Name: Powered Breast Pump Powered Breast Pump (Classified Class II, per 21 CFR Section 884.5160) Classification Name:
3. Name of Predicate Device:
Medela® Symphony® Breastpump, by Medela AG, K020518 Medela® Mini Electric® Breastpump, by Medela AG, K901344
4. Description of Device:
The Medela® Swing™ Breastpump is intended to express the mother's milk of a lactating woman. The pumping can be only on one breast at the time.
The Swing™ breastpump can operate off common batteries or off an AC/DC power supply. The Swing™ breastpump's drive unit employs a diaphragm-type vacuum pump, powered by a DC-motor, supervised by a microcontroller provides control over motor speed (vacuum creation) and solenoid (vacuum release).
The control program resides in a microcontroller, inside the Swing™ breastpump and provides the necessary a) time and b) vacuum parameters. By depressing the vacuum-adjust buttons, the microcontroller changes the vacuum and time parameters of the breast pump is capable of providing vacuum levels from 0 to 250mmHg, with cycling rates up to 130cpm. The program residing on the microcontroller is designed to deliver two pumping curves.
All materials with milk contact or components with human breast/skin contact are manufactured from' materials that meet the appropriate FDA and international requlations concerning food contact and/or biocompatibility.
{1}------------------------------------------------
5. Intended Use of the Device:
The Medela® Swing™ breastpump is intended to express and collect the mother's milk from the breasts of a lactating woman, thus it is identical to the predicate devices.
6. Summary of Technological Characteristics:
The technology of the Medela® Swing™ breastpump is identical to the predicate devices and there are no technical differences which would raise new aspects regarding safety and effectiveness.
7. Conclusion:
Based upon the information presented above, it is concluded that the proposed Medela® Swing™ breastpump is safe and effective for the intended use, and is substantially equivalent to the predicate devices.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
2 2006 MAY
Medela AG % Mr. Stefan Preiss Responsible Third Party Official TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 25112-1891
Re: K053052
Trade/Device Name: SwingTM Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: April 13, 2006 Received: April 17, 2006
Dear Mr. Preiss:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image shows the FDA Centennial logo. The logo is circular with the words "1906-2006" at the top and "Centennial" in the middle. The words "Protecting and Promoting Public Health" are written in a fancy font below the logo. The logo is black and white.
{3}------------------------------------------------
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); 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 begin 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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) 240-276-0115 |
|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon
Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known):
(if known): K0534
Device Name: Swing™
Indications For Use:
The Swing™ breastpump is a powered breastpump to be used by lactating women to express and collect milk from their breasts.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
e-Counter Use
R 801 Subpart C)
✗
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Bradon
(Division Stan-Division of Reproductive, and Radiological Device 510(k) Number
Page 1 of
§ 884.5160 Powered breast pump.
(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).