The provided text is a 510(k) summary for the EnDeare™ Breast Pump. It does not contain any information about acceptance criteria or a study proving that the device meets those criteria, as it is a breast pump, not a diagnostic or AI-powered device.

Therefore, I cannot provide the requested information in the format specified. The document primarily focuses on demonstrating substantial equivalence to predicate breast pumps for regulatory clearance, rather than presenting performance data against a set of acceptance criteria.

Summary

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K081932

510(k) Summary

General Information
Submitters Name/Address:	Hygeia Medical, Inc6353 Corte del Abeto, Suite 102Carlsbad, 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 CFR884 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

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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

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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

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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

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Regulation Number and Section

§ 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).