The Symphony Powered Breast Pump 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. A DC motor is employed to drive both diaphragm pumps, one for each breast. The diaphragm pumps create the negative pressure (suction), required to extract the breast milk. Because the motor is controlled by a programmable microcontroller, the mother can potentially select from a number of pumping (suction) programs. The pumping programs are stored on separate pumping cards, which are inserted into the Breast Pump, prior to operating the device. The card is similar in size to a credit card.

The Symphony Powered Breast Pump employs a control knob, for the user to adjust the applied vacuum. The breast pump is capable of providing vacuum levels from 0 to 200 mmHg, constant or variable; 7 to 110 cycles per minute. Configured with a specific pumping card, the breast pump will provide a "Stimulation" mode of fast cycles along with an "Expression" mode of slower cycles.

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

The provided text is a 510(k) submission for the Medela® Symphony® Breastpump, which is a regulatory document seeking clearance for a medical device. This type of document focuses on demonstrating substantial equivalence to existing devices rather than presenting detailed studies with acceptance criteria, sample sizes, and expert adjudications in the way an academic clinical trial report would.

Therefore, the requested information, specifically acceptance criteria for device performance, details of a study proving the device meets those criteria, sample sizes, expert qualifications, and ground truth establishment, is largely not present in this regulatory submission.

However, I can extract what is available and explain why other details are missing.

Here's an attempt to answer your questions based only on the provided text:

1. A table of acceptance criteria and the reported device performance

This document describes the device's technical characteristics and intended use, but does not specify quantifiable acceptance criteria such as performance metrics (e.g., milk expression rate, vacuum stability, noise level) or present a table of reported device performance against such criteria. The submission aims to show substantial equivalence to predicate devices, implying that its performance is comparable, but not necessarily measured against a rigid set of acceptance criteria within this document.

The document mentions:

"The breast pump is capable of providing vacuum levels from 0 to 200 mmHg."
"Configured with a two-phase pumping, the breast pump will provide a "Stimulation" mode of fast cycles along with an "Expression" mode of slower cycles."

These are descriptive features, not acceptance criteria with measured performance data.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not available. The document does not describe a test set or clinical study with sample sizes. It is a technical submission for regulatory clearance based on substantial equivalence.

3. 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)

Not applicable/Not available. There is no mention of a test set requiring expert ground truth establishment for performance evaluation in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not available. As no test set for performance evaluation is described, no adjudication method is mentioned.

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 device is a breast pump, not an AI-assisted diagnostic or imaging device used by human "readers." Therefore, an MRMC comparative effectiveness study is not relevant to this product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a powered breast pump that assists a human user, a lactating woman, in expressing milk. It does not operate as an algorithm-only standalone system in the way a diagnostic AI would. Its performance is inherent in its mechanical operation and interaction with the user.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not available. For a breast pump, "ground truth" would typically relate to its ability to express milk effectively and safely. This document asserts the device's intended use is to "express and collect the mother's milk," and that based on its characteristics, it is "safe and effective for the intended use, and is substantially equivalent to the predicate devices." No specific "ground truth" methodology is detailed in this regulatory filing.

8. The sample size for the training set

Not applicable/Not available. The document does not mention any "training set" as it would be understood for an AI/machine learning device. The design and engineering would have involved typical product development and testing, but not in the format of a training set for an algorithm.

9. How the ground truth for the training set was established

Not applicable/Not available. As no training set is mentioned, this information is not provided.

Summary of what is available: Substantial Equivalence Basis

The core of this 510(k) submission is to demonstrate substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical trial.

Predicate Devices:
- Medela® Classic™ Breast Pump, by Medela Inc., K801862
- Egnell Elite Breast Pump, by Ameda Medizintechnik AG (Hollister Inc.), K950531
Conclusion: "Based upon the information presented above, it is concluded that the proposed Medela Symphony® breast pump is safe and effective for the intended use, and is substantially equivalent to the predicate devices."
Technological Characteristics: "The technology of the Symphony® powered breast pump is identical to the predicate devices and the minor differences in technology do not raise new aspects regarding safety and effectiveness." (Note: The provided text has a typo, saying "perceive areast particle" instead of "powered breast pump" in this section, but the intent is clear from context).
Intended Use: "The Symphony Powered Breast Pump is intended to express and collect the mother's milk from the breasts of a lactating woman, thus identical to the predicate devices."

The regulatory clearance (K020518 letter) confirms that the FDA reviewed the submission and found the device "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This substantial equivalence finding allows the device to be marketed without requiring a Pre-Market Approval (PMA), which would typically involve more extensive clinical trials and explicit acceptance criteria demonstration.

Summary

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KO20518

MAR

7 2002 MAR

Medela Inc., 1101 Corporate Drive, McHenry, IL 60050 Applicant: Marcel Felber, Tel (815) 363 1166 ext. 423; Fax (815) 363 1246 Contact Person: marcel.felber@medelainc.com 510(k) Submission for Medela® Symphony® Breastpump

Medela Powered Breast Pump Symphony®

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

Sponsor: Medela Inc. 1101, Corporate Drive McHenry, IL 60050 (815) 363 1166 ext. 423 Ph: (815) 363 0460 Fax:

Contact Person: Marcel Felber Vice President Quality Management

Correspondent: Medela AG Medical Equipment Laettichstrasse 4b 6341 Baar Switzerland +41 41 769 52 28 Ph: Fax: +41 41 769 51 01

Contact Person Wemer Frei Manager Regulatory Affairs

Date Summary Prepared: October 31st, 2001

2. Name of Device:

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

3. Name of Predicate Device(s):

Medela® Classic™ Breast Pump, by Medela Inc., K801862 .
Egnell Elite Breast Pump, by Ameda Medizintechnik AG (Hollister Inc.), . K950531

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K020518

4. Description of Device:

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5. Intended Use of the Device:

The Symphony Powered Breast Pump is intended to express and collect the mother's milk from the breasts of a lactating woman, thus identical to the predicate devices.

6. Summary of Technological Characteristics:

The technology of the Symphony® powered breast pump is identical to the predicate The lectinology of the Oymphony® perceive areast particle would raise new aspects regarding safety and effektiveness.

7. Conclusion:

Based upon the information presented above, it is concluded that the proposed Dased upon the information 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 is a black and white circular seal. The seal contains a symbol in the center that resembles three curved lines stacked on top of each other. The text "HEALTH & HUMAN SERVICES" is arranged around the top half of the circle, and the text "U.S. DEPARTMENT OF" is arranged around the bottom half of the circle.

Food and Drug Administration 00 Corporate Boulevard Rockville MD 20850

7 2002 MAR

Medela, Inc. % Mr. Mark Job Program Manager TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891

Re: K020518

Trade/Device Name: Medela Symphony Electrically Powered Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: 85 HGX Dated: February 12, 2002 Received: February 19, 2002

Dear Mr. Job:

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 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:

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" (21 CFR Part 807.97). 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

Nancv 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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Page 1 _ of 1

510(k) Number (if known): KC20516

Device Name: Symphony

Indications For Use:

The Symphony breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breast.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

(Division Sign-Off) o
Division of Reproductive,
and Radiological Devices
510(k) Number K020518

(Optional Format 3-10-98)

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).