(128 days)
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No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
No
A breast pump is used to express milk, which is not a therapeutic function for treating a disease or condition.
No
A powered breast pump is used to express milk, which is a therapeutic or supportive function, not a diagnostic one. It does not identify or detect a medical condition.
No
The intended use describes a "Powered Breast Pump," which is a hardware device. The summary does not provide a device description, but the intended use strongly suggests a physical device, not software alone.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Powered Breast Pump used to express milk from lactating women." This describes a device that physically interacts with the body to collect a biological fluid.
- Definition of IVD: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to analyze these samples.
A breast pump does not perform any diagnostic testing on a sample. It is a device used for collection.
N/A
Intended Use / Indications for Use
Powered Breast Pump used to express milk from lactating women
Product codes
HGX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
0
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.
1
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
2
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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