(201 days)
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Not Found
No
The summary describes a vacuum-powered breast pump with a vacuum regulator and a single-use set. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML functionality. The description focuses on the mechanical aspects of the device.
No.
A breast pump is used to express milk and does not treat a disease, injury, or condition.
No
The device is described as a "vacuum powered suction device used to express milk from the breast," which is a therapeutic or supportive function, not a diagnostic one.
No
The device description explicitly states it consists of two physical parts: a vacuum regulator and a breast pump set. This indicates it is a hardware device, not software-only.
Based on the provided information, the White River Automatic Breast Pump is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- The description of the White River Automatic Breast Pump clearly states its intended use is to "express milk from the breast." This is a physical process performed on the body, not an examination of a specimen outside the body.
Therefore, the device falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The White River Automatic Breast Pump is a vacuum powered suction device used to express milk from the breast. It is intended to be used in the hospital setting where wall vacuum systems are available. The device consists of two parts: (1) a vacuum regulator, and; (2) a single patient use breast pump set, which ensures a consistent, clean method of emptying breast milk.
Product codes
HGX
Device Description
The White River Automatic Breast Pump is a vacuum powered suction device used to express milk from the breast. It consists of two parts: (1) a vacuum regulator, and; (2) a single patient use breast pump set, which ensures a consistent, clean method of emptying breast milk.
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
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Intended User / Care Setting
Used in the hospital setting where wall vacuum systems are available.
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 features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 100 1997
White River Concepts % Mr. E.J. Smith Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114 Re: K964679
White River Automatic Breast Pump, Model 2000 Intermittent Wall Suction Breast Pump Regulator Dated: March 13, 1997 Received: March 13, 1997 Regulatory class: II 21 CFR §884.5160/Product code: 85 HGX
参 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 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 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" (2) 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,
Nilian Yi
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throath 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 Automatic Breast Pump
80KDP, 85HGX Classification Panel:
Indications for Use:
The White River Automatic Breast Pump is a vacuum powered suction device used to express milk from the breast. It is intended to be used in the hospital setting where wall vacuum systems are available. The device consists of two parts: (1) a vacuum regulator, and; (2) a single patient use breast pump set, which ensures a consistent, clean method of emptying breast milk.
Target Population: Mothers who are breast feeding in the hospital setting.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Kar R. Sterling
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K964674
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use
OB
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