(103 days)
Not Found
Not Found
No
The summary describes a standard electrically operated breast pump and contains no mention of AI, ML, or related concepts.
No
A breast pump is used to express and collect milk, which is not considered a therapeutic function. Therapeutic devices are typically used to treat or manage a disease or medical condition.
No
Explanation: The device is described as an electrically operated suction device used to express and collect milk, which is a therapeutic or assistive function, not a diagnostic one. There is no mention of identifying, analyzing, or diagnosing any medical condition.
No
The device description explicitly states it is an "electrically operated suction device," indicating it includes hardware components beyond just software.
Based on the provided information, the SimplyGo™ Breast Pump Kit is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- SimplyGo™ Breast Pump Kit Function: The intended use clearly states that the device is used to "express and collect milk from the breast(s) of lactating women." This is a physical process of extracting a bodily fluid, not a diagnostic test performed on a specimen.
The device description and intended use align with a medical device used for a therapeutic or collection purpose, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The SimplyGo™ Breast Pump Kit is an electrically operated suction device used to express and collect milk from the breast(s) of 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
breast(s)
Indicated Patient Age Range
Not Found
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
Not Found
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.
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Don Huber Director Product Integrity Evenflo Company, Inc. 225 Byers Road MIAMISBURG OHIO 45342
DEC 2 2 2010
Re: K102600 Trade/Device Name: SimplyGo™ Breast Pump Kit Regulation Number: 21 CFR $884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: November 23, 2010 Received: November 24, 2010
Dear Mr. Huber:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting of medical device-related
1
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adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 1 5809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFFR, Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default:htm.
Sincerely yours,
Hluber Lemur MD
ferbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
evenflo Best
for
Baby
Evenflo Company, Inc. 225 Byers Road Miamisburg, Ohio 45342 (937) 415-3300 Registration No. 9046462
SPECIAL 510(K): PREMARKET NOTIFICATION SIMPLYGO™ BREAST PUMP 510(k) NUMBER K___
STATEMENT FOR INDICATIONS FOR USE
Device Name: SimplyGo™ Breast Pump Kit
510(k) Number: K1002600
DEC 2 2 2010
STATEMENT FOR INDICATIONS OF USE: The SimplyGo™ Breast Pump Kit is an electrically operated suction device used to express and collect milk from the breast(s) of lactating women.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert Klein
ision Sign-Off of Reproductive. C
| Over-the-Counter Use |
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Evenflo Company. Inc.
CONFIDENTIAL
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