(72 days)
Not Found
No
The description details a microcontroller-supervised DC motor and diaphragm pump with manual vacuum level selection, with no mention of AI/ML terms or functionalities.
No
A breast pump is intended to express breast milk, which is a functional process rather than treating or preventing a disease or condition. Therapeutic devices generally aim to cure, mitigate, or prevent illness, or restore function in the context of disease.
No
Explanation: The device is intended to express breast milk, which is a therapeutic or assistive function, not a diagnostic one. It does not identify or detect any medical conditions.
No
The device description clearly outlines hardware components such as a diaphragm-type vacuum pump, DC-motor, and microcontroller, indicating it is a physical medical device with integrated software, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "express breast milk from the breast of a lactating woman." This is a physical process performed on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a mechanical pump that creates vacuum to extract milk. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing diagnostic information about a disease or condition
The Unimom Allegro is a medical device, specifically a breast pump, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Unimom Allegro is intended to express breast milk from the breast of a lactating woman.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The Unimom Allegro electric breast pump is intended to express the mother's milk of a lactating woman. The pumping can be only on one breast at the time. The Unimom Allegro electric breast pump can operate off common batteries or off a DC POWER supply. The Unimom Allegro electric breast pump's drive unit employs a diaphragmtype vacuum pump, powered by a DC-motor, supervised by a microcontroller. Passing through an air tubing to breastshield, the vacuum is used to comfortably draw out the breast milk. This device is designed with 7 vacuum levels by pressing button.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 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
K100929
pg. 1 of 2
Image /page/0/Picture/1 description: The image shows the logo for Blue Egg. The words "Blue Egg" are written in a bold, sans-serif font. To the right of the word "Blue" is a stylized image of an egg. The egg is outlined in black, and the inside of the egg is also black.
JUN 1 6 2010
Blue Egg Co.
510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
Submission Information
Sponsor:
US Agent:
Official Correspondent: Hong Jung Hyun (Mr.)
216-5 Yongmoon-Dong, Seo-Ku, Daejon, Korea Blue Egg Co. 216-5 Yongmoon-Dong, Seo-Ku, Daejon, Korea
Manufacturing Site
Blue Egg Co. 216-5 Yongmoon-Dong, Seo-Ku, Daejon, Korea
Device Identification
| Proprietary Name: | Unimom Allegro |
|---|---|
| Common/Usual Name: | Powered Breast Pump |
| Classification Name: | Powered Breast Pump per 21 CFR § 884.5160 |
| Product Code: | HGX |
Substantially Equivalent Predicate Legally Marketed Device
The subject device, Unimom Allegro, is substantially equivalent in technical characteristics and intended used to:
| Device Name | Medela
SwingTM Breastpump | Medela
Mini Electric |
|---------------|------------------------------|-------------------------|
| 510(k) Number | K053052 | K901344 |
Device Description
The Unimom Allegro electric breast pump is intended to express the mother's milk of a lactating woman. The pumping can be only on one breast at the time. The Unimom Allegro electric breast pump can operate off common batteries or off a DC POWER supply. The Unimom Allegro electric breast pump's drive unit employs a diaphragmtype vacuum pump, powered by a DC-motor, supervised by a microcontroller. Passing
1
Image /page/1/Picture/0 description: The image shows the logo for Blue Egg. The word "Blue" is written in a bold, sans-serif font on the left side of the image. To the right of the word "Blue" is a stylized image of an egg, with the letters "gg" written in a cursive font to the right of the egg.
Blue Egg Co.
through an air tubing to breastshield, the vacuum is used to comfortably draw out the breast milk. This device is designed with 7 vacuum levels by pressing button.
Indications for Use
The Unimom Allegro is intended to express breast milk from the breast of lactating woman.
Comparison to leally marketed predicate device
The Unimom Allegro has the same intended use and similar technological characteristics as the predicate device. Thus, we are claiming that the Unimom Allegro is substantially equivalent to the predicate device.
Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Blue Egg Co. concludes that the Unimom Allegro are safe and effective and substantially equivalent to predicate devices as described herein.
Blue Egg Co. will update and include in this summary any other information deemed reasonably necessary by the FDA.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Blue Egg Co. c/o Marc M. Mouser Office Coordinator Underwriters Laboratories, Inc. 2600 NW Lake Road CAMAS WA 98607
JUN 1 6 2010
Re: K100929
Trade Name: Unimom Allegro Regulation Number: 21 CFR § 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: May 25, 2010 Received: June 3, 2010
Dear Mr. Mouser:
:
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 I hat 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
3
Page 2 -
adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the auverse events) (21 CFR 000), good 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 11 you desire specific ad rive to: your downtersOffices/CDRH/CDRHOffices/ucm115809.htm for go to mtp.//www.radiological Health's (CDRH's) Office of Compliance Also, please the Center for DOTioes and Radiologiding by reference to premarket notification" (21CFR Part hote the regulation officies, winestanters 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 I ou may other other generational 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,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
Unimom Allegro
Indications for Use:
The Unimom Allegro is intended to express breast milk from the breast of a lactating woman.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __ (21 CFR 801 Subpart C)
. ٻُ
1: 1. -, ph
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | 3-1 |
|---|---|
| --------------------- | ----- |
Division of Reproductive, Abdominal, and
Radiological Devices
| 510(k) Number | K100929 |
|---|---|
| --------------- | --------- |