(101 days)
No
The summary describes a standard electric breast pump and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is intended to express and collect milk, alleviate engorgement, and maintain lactation, which are physiological support functions rather than therapeutic interventions for a disease or condition. While it can alleviate discomfort (engorgement), its primary purpose isn't to treat a disease, but to facilitate a natural bodily process and improve comfort.
No
Explanation: The device's intended use is to express and collect milk, alleviate engorgement, maintain lactation, and provide milk for future feedings. It does not mention any diagnostic capabilities or functions.
No
The device description explicitly states it is an "electric breast pump" and mentions "bench tests to demonstrate the Ameda Platinum breast pump performs within its specifications, included vacuum and life cycling," indicating it is a hardware device with electrical and mechanical components, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Ameda Platinum Breast Pump's intended use is to express and collect milk directly from the mother's breast. It does not analyze any bodily fluids or tissues in vitro (outside the body).
- Intended Use: The stated intended uses (expressing milk, alleviating engorgement, maintaining lactation, providing milk for feeding) are all related to the physical process of milk extraction and collection, not diagnostic testing.
Therefore, based on the provided information, the Ameda Platinum Breast Pump is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Ameda Platinum Breast Pump is intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The Ameda Platinum electric breast pump is a simple and effective system for expressing milk from a mother's lactating breast(s). The Ameda Platinum Breast Pump is electric or battery operated. The Ameda Platinum Breast Pump utilizes the separately supplied predicate device. the Ameda HygieniKit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mother's breast
Indicated Patient Age Range
Lactating women
Intended User / Care Setting
Hospitals, institutions and home
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)
We have performed bench tests to demonstrate the Ameda Platinum breast pump performs within its specifications, included vacuum and life cycling. There are no differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.
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.
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
Premarket Notification 510(k) Section 5 - 510(k) Summary
Eventlo
510(k) Summary Page 1 of 2 12-Feb-2010
$\overline{K100435}$
MAY 2 8 2010
Evenflo Company, Inc. 225 Byers Road Miamisburg, OH 45342
Tel – (937) 415-3215 Fax - (937) 859-7561
Powered breast pump
Amy Neff -- Associate General Counsel
Proprietary or Trade Name:
Ameda Platinum Breast Pump
Classification Name:
Common/Usual Name:
Official Contact:
Powered breast pump HGX - CFR 884.5760
Predicate Devices:
K020518 - Medela Symphony K950531 - Ameda Elite breast pump K052909 - Evenflo Elan breast pump K011519 - Ameda HygieniKit
Device Description:
The Ameda Platinum electric breast pump is a simple and effective system for expressing milk from a mother's lactating breast(s). The Ameda Platinum Breast Pump is electric or battery operated. The Ameda Platinum Breast Pump utilizes the separately supplied predicate device. the Ameda HygieniKit.
Indications for Use:
The Ameda Platinum Breast Pump is intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs.
Patient Population: . Lactating women
Environment of use:
None
Environment of use:
Hospitals, institutions and home
Contraindications:
1
Premarket Notification 510(k) Section 5 - 510(k) Summary
510(k) Summary Page 2 of 2 12-Feb-2010
| Attribute | Ameda Platinum |
|---|---|
| Intended Use | Express milk |
| Patient population | Lactating women |
| Environment of use | Hospital, institutions and home |
| Power Source | AC |
| Battery | |
| Pump Style | Piston |
| Single/double Pumping | Both |
| Adjustable Suction Levels | Yes |
| Cycle Speed | 30 - 80 |
| Overflow Protection | No |
| Vacuum range - (mmHg) | 30 - 250 |
| Uses HygieniKit | Yes |
| Software | Yes |
The Ameda Platinum breast pump is viewed as substantially equivalent to the predicate devices because:
Indications -
Similar to predicates – Medela Symphony (K020518) breast pump and Ameda Elite (K950531) and Evenflo Elan (K052909) breast pumps
Technology -
Similar to predicates – Ameda Elite (K950531) and Evenflo Elan (K052909) breast pumps
Materials -
Materials in contact with the user and expressed milk are identical to predicate – Ameda HygieniKit (K011519)
Environment of Use -
Identical to predicates - Medela Symphony (K020518) breast pump and Ameda Elite (K950531) and Evenflo Elan (K052909) breast pumps
Patient Population -
Identical to predicates - Medela Symphony (K020518) breast pump and Ameda Elite (K950531) and Evenflo Elan (K052909) breast pumps
Performance Testing and Differences
We have performed bench tests to demonstrate the Ameda Platinum breast pump performs within its specifications, included vacuum and life cycling. There are no differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three bars representing the agency's commitment to health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are 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
MAY 2 8 2010
Mr. Steve Nowak Engineering Manager, Ameda Breastfeeding products Evenflo Company, Inc. 225 Byers Road MIAMISBURG OH 45342
Re: K100435
Trade/Device Name: Ameda Platinum Breast Pump Regulation Number: 21 CFR §884.5160 Regulation Name: Powered breast pumps Regulatory Class: II Product Code: HGX Dated: April 29, 2010 Received: April 30, 2010
Dear Mr. Nowak:
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
3
Page 2 -
adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ucm115809.htm 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" (21CFR 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/Resourcesfor You/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 Statement
Page 1 of 1
510(k) Number:
K100435 (To be assigned)
Device Name:
Ameda Platinum Breast Pump
Indications for Use:
The Ameda Platinum Breast Pump is intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs.
Prescription Use or (Part 21 CFR 801 Subpart D)
Over-the-counter use XX (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)
Sh. Lhe
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ K100435
Page 4.2