The Whisper Wear Breast Pump is a self-contained, battery-operated device that is worn under and held in place by everyday clothing. A DC motor imparts motion to a silicone diaphragm that develops a negative pressure that expresses milk from the breast to a collection bag.

AI/ML Overview

The provided text describes the Whisper Wear Breast Pump and its regulatory submission, but it does not contain the detailed information requested regarding specific acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/ML-driven device.

This document is a 510(k) premarket notification for a traditional medical device (a breast pump), and therefore, the typical performance criteria and study designs associated with AI/ML devices are not applicable. The core of this submission is demonstrating substantial equivalence to a predicate device, not establishing novel performance characteristics through a detailed clinical or algorithmic study as would be required for an AI/ML product.

Here's a breakdown of what the document does provide, and why it doesn't fit the requested format for acceptance criteria and dedicated studies:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Mentioned: The document states the device "complies with the following standards, practices, and guidances:"
- 10993-1, Biological Evaluation-Part 1: Guidance on Selection of Tests
- 10993-5, Biological Evaluation-Part 5: Tests for Cytotoxicity: In Vitro Methods
- 10993-10, Biological Evaluation-Part 10: Tests for irritation and sensitization
- UL 1431, Personal Hygiene and Health Care Appliances
- UL 2601-1, Medical Electrical Equipment, Part 1: General Requirements for Safety
Reported Device Performance: The document vaguely states, "This has been demonstrated through a series of bench tests including vacuum and cycle rate performance." It also mentions, "The tissue contact and milk contact materials used to fabricate the Whisper Wear Breast Pump and Collection Bags have a long history of safe usage."
Missing from the Request: The document does not provide specific quantitative acceptance criteria (e.g., "vacuum pressure must be > X kPa and < Y kPa") nor does it provide a table with measured performance metrics against such criteria. The "performance" is primarily described as meeting general standards and being "essentially identical to the predicate device."

2. Sample Size for Test Set and Data Provenance:

Not Applicable/Not Provided: This type of information (sample size for a test set, data provenance) is typically associated with studies involving data analysis, often for AI/ML algorithms. For a breast pump, performance is demonstrated through engineering bench tests and material biocompatibility. No "test set" in the context of data is mentioned.

3. Number of Experts and Qualifications:

Not Applicable/Not Provided: This relates to expert review of data for ground truth. Not relevant for a breast pump's physical performance evaluation.

4. Adjudication Method:

Not Applicable/Not Provided: Not relevant for a breast pump's physical performance evaluation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not Applicable/Not Provided: This is specific to diagnostic or interpretive AI/ML systems where human readers might improve with AI assistance. Not relevant for a breast pump.

6. Standalone (Algorithm Only) Performance:

Not Applicable/Not Provided: There is no algorithm; this is a mechanical device.

7. Type of Ground Truth Used:

Implicitly "Bench Test Standards" and "Predicate Device Characteristics": The "ground truth" for this device's performance would be the specifications and performance of the predicate device (Medela Mini Electric® Breastpump) and compliance with relevant safety and biological standards (ISO, UL). There isn't "ground truth" derived from expert consensus, pathology, or outcomes data in the way it's used for AI/ML models.

8. Sample Size for Training Set:

Not Applicable/Not Provided: No training set for an algorithm is involved.

9. How Ground Truth for Training Set was Established:

Not Applicable/Not Provided: No training set or associated ground truth establishment process is described, as it's not an AI/ML device.

In summary, the provided document details a 510(k) submission for a non-AI/ML breast pump, focusing on substantial equivalence to a predicate device and compliance with general safety and performance standards. It does not contain the specific types of data and study details that would be present for an AI/ML device seeking regulatory approval.

Summary

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Summary of Safety and Effectiveness for the Whisper Wear Breast Pump

submitted by Whisper Wear, Inc. 2221 Newmarket Parkway, Suite 136 Marietta, GA 30067 Phone: (770) 984-0905

Contact Person:	Al Weisenborn
Device Trade Name:	Whisper Wear Breast Pump
Common Name:	Breast Pump
Classification Name:	Powered Breast Pump per 21 CFR § 884.5160

Identification of a Legally Marketed Predicate Device

The Whisper Wear, Inc. Breast Pump is substantially equivalent to the Medela Mini Electric® Breastpump, which is legally marketed and distributed by Medela, Inc. pursuant to 510(k) K901344.

Device Description

Intended Use

The Whisper Wear Powered Breast Pump is intended for use by lactating women to express and collect breast milk.

Summary of Technological Characteristics

Thirteen (13) technological characteristics of the Whisper Wear, Inc. Breast Pump were compared to those of predicate device and found to be equivalent.

Summary of Performance Data

The Whisper Wear, Inc. Breast Pump complies with the following standards, practices, and guidances:

10993-1, Biological Evaluation-Part 1: Guidance on Selection of Tests
10993-5, Biological Evaluation-Part 5: Tests for Cytotoxicity: In Vitro Methods

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10993-10, Biological Evaluation-Part 10: Tests for irritation and sensi-● tization
UL 1431, Personal Hygiene and Health Care Appliances ●
UL 2601-1, Medical Electrical Equipment, Part 1: General Requirements ● for Safety

The Whisper Wear, Inc. Breast Pump is substantially equivalent to the Medela Mini Electric® Breastpump, which is legally marketed and distributed by Medela, Inc. pursuant to 510(k) K901344. This has been demonstrated through a series of bench tests including vacuum and cycle rate performance.

The tissue contact and milk contact materials used to fabricate the Whisper Wear Breast Pump and Collection Bags have a long history of safe usage. Since the Whisper Wear Breast Pump and Collection Bags meet the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device. The Whisper Wear Breast Pump and Collection Bags will be manufactured per specifications and good manufacturing practices that ensure the device is safe and effective for its intended use.

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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 consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 0 2002

Whisper Wear Incorporated c/o Mr. Al Weisenborn Certified Quality Engineer 19526 East Lake Drive MIAMI FL 33015

Re: K022140

Trade /Device Name: Whisper Wear Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: 85 HGX Dated: July 1, 2002 Received: July 2, 2002

Dear Mr. Weisenborn:

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 10 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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Page 2

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 Chroydon

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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Indications for Use

Page 1 of 1

510(k) Number (if known): __ KO22

Device Name: Breast Pump

Indications for Use:

The Whisper Wear Powered Breast Pump is intended for use by lactating women to express and collect breast milk.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __________	OR
(Per 21 CFR 801.109)
(Optional Format 1-2-96)

Over-The-Counter Use__X_

David G. Dyson

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

Whisper Wear, Inc.

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).