(90 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical components and standard safety testing, with no mention of AI or ML.
No
A breast pump, while used for a health-related purpose, is generally considered a device for supporting a physiological process (lactation and milk expression) rather than directly treating a disease, disorder, or injury.
No
The device is a breast pump, which is used to express milk. Its intended use and description do not indicate that it diagnoses any medical condition.
No
The device description explicitly states it is a "self-contained, battery-operated device" with a "DC motor" and "silicone diaphragm," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "express and collect breast milk" from lactating women. This is a physical process performed on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a mechanical device that uses negative pressure to extract milk. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing diagnostic information about a disease or condition
The device is clearly a medical device, but its function is related to physical expression of a bodily fluid, not in vitro analysis for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Whisper Wear Powered Breast Pump is intended for use by lactating women to express and collect breast milk.
Product codes (comma separated list FDA assigned to the subject device)
85 HGX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
lactating women
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)
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
- 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
This has been demonstrated through a series of bench tests including vacuum and cycle rate performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
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.
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
1
- 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.
2
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.
3
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
4
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.