The Medela® Pump in Style® Advanced Breastpump is intended to express the mother's milk of a lactating woman. The pumping can be performed on one breast or on both breasts at the same time. The Pump In Style® Advanced Breastpump employs a diaphragm-type vacuum pump, powered by a DC motor supervised by a microcontroller. The microcontroller drives the "H" bridge, providing speed and directional control over the DC motor. The Pump In Style® Advanced Breastpump can be powered by external batteries or a wall plug transformer or by a 12 VDC vehicle lighter adapter.

The control program resides in a microcontroller, inside the Pump In Style® Advanced Breastpump and provides the necessary a) time and b) vacuum parameters. By adjusting the knob, the microcontroller changes the vacuum and time parameters of the suction. The breast pump is capable of providing vacuum levels from 0 to 250mm Hg, with cycling rates up to 120 cycles per minute. The program residing on the microcontroller is designed to deliver two pumpina curves.

All materials with milk contact or components with human breast contact are manufactured from materials that meet the appropriate FDA and international regulations concerning food contact and/or biocompatibility.

AI/ML Overview

This 510(k) premarket notification for the Medela® Pump in Style® Advanced Breastpump does not contain information typically associated with studies proving device performance against acceptance criteria in the context of an AI/ML medical device. Instead, it demonstrates Substantial Equivalence to legally marketed predicate devices.

Therefore, many of the requested fields (e.g., sample sizes, ground truth establishment, MRMC studies, effect sizes) are not applicable to this type of submission.

Here's a breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" and "reported device performance" in this 510(k) focuses on demonstrating that the new device shares fundamental technological characteristics and intended use with previously cleared predicate devices, rather than a specific numerical performance metric benchmarked against a clinical study.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) submission):

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (as stated in 510(k) Summary)
Intended Use Equivalence: The new device must have the same intended use as legally marketed predicate devices.	"The Pump In Style® Advanced 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." (Section 5)
Technological Characteristics Equivalence: The new device must have technological characteristics (e.g., operating principles, materials, energy source) that are the same as, or do not raise new questions of safety and effectiveness from, those of the predicate device.	"The technology of the Pump In Style® Advanced Breastpump is identical to the predicate devices and there are no technical differences which would raise new aspects regarding safety and effectiveness." (Section 6) (Further details on diaphragm-type vacuum pump, DC motor, microcontroller, vacuum levels (0-250mm Hg), cycling rates (up to 120 cycles/minute), and two pumping curves provided in Section 4).
Safety and Effectiveness: Demonstrate that the device is safe and effective for its intended use, based on the equivalence to predicate devices which have already established safety and effectiveness.	"Based upon the information presented above, it is concluded that the proposed Pump In Style® Advanced Breastpump is safe and effective for the intended use, and is substantially equivalent to the predicate devices." (Section 7)
Biocompatibility/Material Safety: Materials in milk/human breast contact must meet appropriate FDA and international regulations.	"All materials with milk contact or components with human breast contact are manufactured from materials that meet the appropriate FDA and international regulations concerning food contact and/or biocompatibility." (Prior to Section 5)

Study Information (Based on 510(k) Context):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. This 510(k) relies on demonstrating substantial equivalence to predicate devices, not on a clinical performance study with a specific test set of data. The "test" is a comparison of the device's design and intended use to existing, cleared devices.
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):
- N/A. Ground truth establishment by experts for a test set is not described in this type of submission for a breast pump. The "ground truth" for substantial equivalence is the regulatory status and established safety/effectiveness of the predicate devices.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No adjudication method for a test set is discussed in this 510(k) submission.
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:
- N/A. This device (a breast pump) is not an AI/ML diagnostic tool, and therefore, an MRMC comparative effectiveness study where human readers improve with AI assistance is entirely irrelevant and not performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a mechanical/electronic breast pump, not an algorithm. Standalone algorithm performance is not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A (in the typical sense of a clinical study). For a 510(k) using substantial equivalence, the "ground truth" is the established regulatory clearance and safety/effectiveness of the predicate devices based on their prior review by the FDA. The new device is compared to these established benchmarks.
The sample size for the training set:
- N/A. There is no "training set" as this is not an AI/ML device.
How the ground truth for the training set was established:
- N/A. Not applicable, as there is no training set for an AI/ML model for this device.

Summary

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Ko31614

Section E - 510(k) Summary

Medela® Pump in Style® Advanced Breastpump

1. Sponsor's Name, Address and Contact Person:

Sponsor: Medela Inc. 1101 Corporate Drive McHenry, IL 60050 (815) 363 1166 ext. 280 Ph: (815) 363 0460 Fax:

Contact Person: Christopher L. Peterson Director Quality Management and Requlatory Affairs

Date Summary Originally Prepared: January 27, 2003

2. Name of Device:

Medela® Pump in Style® Advanced Breastpump Trade Name: Common Name: Powered Breast Pump Classification Name: Powered Breast Pump (Classified Class II, per 21 CFR section 884.5160).

3. Name of Predicate Device(s):

Medela® Symphony® Breast Pump, by Medela Inc., K020518 Medela® Pump in Style® Breastpump, by Medela Inc., K950750

4. Description of Device:

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5. Intended Use of the Device:

The Pump In Style® Advanced 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 Pump In Style® Advanced 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 Pump In Style® Advanced Breastpump is safe and effective for the intended use, and is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or body. The bird is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medela, Inc. % Mr. Stefan Preiss Responsible Third Party TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891

Re: K031614

JUN - 6 2003

Trade/Device Name: Pump in Style® Advanced Breastpump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: 85 HGX Dated: May 23, 2003 Received: May 23, 2003

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 (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); 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.

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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 the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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

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510(k) Number (if known):

Medela® Pump in Style® Advanced Breastpump Device Name:

Indications For Use:

The Pump in Style® Advanced Breastpump is a powered breastpump to be used by lactating women to express and collect milk from their breasts.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Segrom

(Division Sign-Off)

Division of Reproductive. Abdor and Radiological De

510(k) Number K031614

Over-the-Counter Use

Regulation Number and Section

§ 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).