(48 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description is also not available.
No
The device is a breast pump, which is used for expressing and collecting milk from the breast, not for treating a disease, injury, or other medical condition.
No
The device is described as a breast pump designed to express and collect milk, which is a functional purpose, not a diagnostic one. Diagnostic devices are used to identify or detect medical conditions or diseases.
No
The device is described as a "double electric breast pump," which is a hardware device. The summary does not mention any software component as the primary or sole function.
Based on the provided information, the Memory Pump is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "express and collect milk from the breast." This is a physical process involving the body, not a diagnostic test performed on samples taken from the body.
- Device Description: While the description is "Not Found," the intended use clearly points away from diagnostic testing.
- Mentions image processing, AI, DNN, or ML: These are often associated with advanced diagnostic techniques, and their absence further supports that this is not an IVD.
- Input Imaging Modality: "Not Applicable" confirms it doesn't use imaging for diagnostic purposes.
- Anatomical Site: "breast" is the site of the physical action, not a sample being analyzed.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The Memory Pump's function is purely mechanical and related to collecting a bodily fluid for consumption, not for diagnostic analysis.
N/A
Intended Use / Indications for Use
The Memory Pump (double electric breast pump) is a single user device designed to express and collect milk from the breast.
Product codes
HGX
Device Description
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 30, 2013
TOMY International, Inc. % Mr. Jeff D. Rongero Senior Project Engineer Underwriters Laboratories, LLC 12 Laboratory Drive RESEARCH TRIANGLE PARK NC 27709
Re: K131027
Trade/Device Name: Memory Pump Electric / Battery Breast Pump Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: May 15, 2013 Received: May 17, 2013
Dear Mr. Rongero:
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.
1
Page 2 - Mr. Jeff D. Rongero
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 (reporting of medical device-related 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/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/ReportalProblem/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.
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Memory Pump™ Electric / Battery Breast Pump TRADITIONAL 510(k) PREMARKET NOTIFICATION TOMY International Inc.
Section 4 - Indications for Use Statement
Indication For Use
510K(k) Number (if known): K131027
Device Name: Memory Pump Electric / Battery Breast Pump
Indication for Use: The Memory Pump (double electric breast pump) is a single user device designed to express and collect milk from the breast.
Prescription Use: (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use: X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert Lerner-S
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K131027 510(k) Number
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