(128 days)
Powered Breast Pump used to express milk from lactating women
Not Found
This document is a 510(k) clearance letter from the FDA for a powered breast pump, the Whittlestone Expresser (K051112).
This type of document (510(k) clearance) primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device, rather than requiring a device to meet specific acceptance criteria through extensive clinical studies like those needed for a PMA (Premarket Approval) application or for devices with higher risk classifications.
Therefore, the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.
Specifically, the document lacks:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size.
- Standalone (algorithm only) performance study details.
- Type of ground truth used.
- Training set sample size.
- How ground truth for the training set was established.
The FDA letter simply states that the device has been reviewed and determined to be substantially equivalent to predicate devices, allowing it to be marketed under general controls. It does not provide details of any performance studies that would typically include acceptance criteria and proof of meeting them, as would be found in a more rigorous clinical trial report or a PMA.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an image of an abstract caduceus. The caduceus is a symbol of medicine and health, featuring a staff with a serpent coiled around it.
Public Health Service
SEP - 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Glenn M. Thibault Official Contact VP Whittlestone, Inc. 602 B Stone Road BENICIA CA 94510
Re: K051112
Trade/Device Name: Whittlestone Expresser Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: August 2, 2005 Received: August 2, 2005
Dear Mr. Thibault:
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.
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) I his letter will anow you to begin manceling of substantial equivalence of your device to a legally premarket nothication. The PDA munig or bassimine of the experience 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 If you desire specific advice for your downer on bees, 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 Also, please note the regulation entired, "Thisorananting on your responsibilities under the Act from the 807.97). You may obtain other general mismal and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
050-2011 of (2a.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
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Indications for Use
KOS III2 510(k) Number (if known):
Device Name: Whittlestone Expresser
Indications For Use: Powered Breast Pump used to express milk from lactating women
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Image /page/2/Picture/6 description: The image shows the text "Over-The-Counter Use (21 CFR 801 Subpart C)" along with a check mark. The text indicates that the product is intended for over-the-counter use and complies with the regulations outlined in 21 CFR 801 Subpart C. The check mark is located to the right of the text. The check mark is black and bold.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
lancuc brogdon
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K051112
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§ 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).