(46 days)
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Not Found
No
The 510(k) summary describes a manual breast pump and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No.
The device is used to sustain lactation and collect milk, which are not therapeutic purposes. While it can relieve engorgement and sore nipples, these are symptoms rather than diseases or conditions being treated by the device itself.
No
A breast pump is used for milk collection and relief of breast discomfort, not for diagnosing medical conditions.
No
The device is described as a "Mini Manual Breast Pump," which is a physical hardware device, not software.
Based on the provided information, the White River Mini Manual Breast Pump is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states the device is a breast pump used for physical actions related to breastfeeding (sustaining lactation, milk collection, relief of engorgement and sore nipples). It does not involve testing samples from the body.
Therefore, the White River Mini Manual Breast Pump falls outside the scope of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The White River Mini Manual Breast Pump is used to sustain lactation, milk collection, relief of breast engorgement, and for relief of sore or cracked nipples.
Product codes
85 HGY
Device Description
White River Mini Manual Breast Pump
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
Breast
Indicated Patient Age Range
Mothers who are breastfeeding
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 884.5150 Nonpowered breast pump.
(a)
Identification. A nonpowered breast pump is a manual suction device used to express milk from the breast.(b)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9, if the device is using either a bulb or telescoping mechanism which does not develop more than 250 mm Hg suction, and the device materials that contact breast or breast milk do not produce cytotoxicity, irritation, or sensitization effects.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 9 1997 MAY
K971231 Re:
White River Concepts % Smith Associates Attn: Mr. E.J. Smith P.O. Box 4341 Crofton, Maryland 21114
Mini Manual Breast Pump Dated: April 3, 1997 Received: April 3, 1997 Regulatory Class: I 21 CFR 884.5150/Procode: 85 HGY
Dear Mr. Smith:
We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
hiikai Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat/ and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
Page 1 of 1
510(k) Number (if known):
Device Name: White River Mini Manual Breast Pump
Classification Panel: 85HGY
Indications for Use:
The White River Mini Manual Breast Pump is used to sustain lactation, milk collection, relief of breast engorgement, and for relief of sore or cracked nipples.
Mothers who are breastfeeding Target Population:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Anthony
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number _
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use A