(199 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts, and the device description is consistent with a standard powered breast pump.
No
The device is a breast pump, which is used to express and collect milk, not to treat a disease or medical condition. While it aids in a biological process, it isn't considered a therapeutic device in the medical sense of treating or curing an ailment.
No
The device is a breast pump, used to express and collect milk, which is a therapeutic or supportive function, not a diagnostic one.
No
The device description explicitly states it is a "powered breast pump with accessories," indicating it is a hardware device, not software-only.
Based on the provided information, the EnDeare™ Breast Pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- The EnDeare™ Breast Pump is used to express and collect milk from the breasts of lactating women. This is a physical process involving the body directly, not an examination of a specimen outside the body for diagnostic purposes.
The description clearly indicates its function is to physically extract milk, not to analyze a biological sample for diagnostic information.
N/A
Intended Use / Indications for Use
The EnDeare™ Breast Pump is indicated to express and collect milk from the breasts of lactating women
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The product is a powered breast pump with accessories that is used to express and collect milk from the breasts of lactating women
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
breasts
Indicated Patient Age Range
lactating women
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)
Performance testing and device comparison demonstrate that the subject device is substantially equivalent to the predicate device, and is safe and effective for the intended use
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
510(k) Summary
| General Information | |
|---|---|
| Submitters Name/Address: | Hygeia Medical, Inc |
| 6353 Corte del Abeto, Suite 102 | |
| Carlsbad, CA 92011 | |
| Establishment Registration Number: | 3006774448 |
| Contact Person: | Jasper Benke |
| Phone Number: | (760) 918-0339 |
| Date Prepared: | June 30, 2008 |
| Device Description | |
| Trade Name: | EnDeare™ Breast Pump |
| Generic/Common Name: | Breast Pump and Accessories |
| Classification Name | Powered Breast Pump (21 CFR |
| 884 5160, Product Code HGX) |
Predicate Device Information
Medela Lactina® Breastpump (K875300)
Medela Pump-in-Style® (K950750)
Ameda Purely Yours (K973501))
Product Description
The product is a powered breast pump with accessories that is used to express and collect milk from the breasts of lactating women
Intended Use
The EnDeare™ Breast Pump is indicated to express and collect milk from the breasts of lactating women
Substantial Equivalence
In establishing substantial equivalence to the predicate device. Hygeia Medical evaluated the indications for use, materials, technology, product specifications, and energy requirements of the system Performance testing has been completed to demonstrate the safe and effective use of the EnDeare™ Breast Pump for the intended use
Summary of Safety and Effectiveness
Performance testing and device companson demonstrate that the subject device is substantially equivalent to the predicate device, and is safe and effective for the intended use
1
Image /page/1/Picture/1 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)". The symbol in the center appears to be a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2009
Mr Jasper Benke Vice President. Quality and Regulatory Affairs Hygera Medical, Inc 6353 Del Abeto, Suite 102 CARLSBAD CA 92011
Re K081932
Trade/Device Name EnDeare™ Breast Pump Regulation Number, 21 CFR §884 5160 Regulation Name Powered breast pump Regulatory Class II Product Code HGX Dated December 3, 2008 Received December 5, 2008
Dear Mr Benke
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 pror 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 (PMA), 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
2
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
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification The FDA finding os 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter
| 21 CFR 876 xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884 xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892 xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464 You may obtain other general information on your responsibilities under the Act from the Drivision of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http //www.fda gov/cdrh/industry suppot/index.html
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
3
Indications for Use
K081932 510(k) Number
EnDeare™ Breast Pump Device Name
Indications for Use
The EnDeare™ Breast Pump is indicated to express and collect milk from the breasts of lactating women
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
X Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off)
(Division Sign-Off) Division of Reproad : tive, Abdominal and Radiological Device 510(k) Number 1
Page 1 of ____________________________________________________________________________________________________________________________________________________________________