(583 days)
Not Found
No
The description details a microcontroller-based device with user-adjustable settings and electronic memory, but there is no mention of AI or ML algorithms for adapting or learning from data.
No.
The primary purpose of the device is to express and collect milk, not to treat or cure a disease or condition. While it alleviates engorgement, this is an effect of milk removal rather than a direct therapeutic action on a disease state.
No
The device is an Electric Breast Pump used to express and collect milk. It does not perform any diagnostic function to identify or characterize a disease or condition.
No
The device description explicitly mentions hardware components like a Single-Chip Microcontroller, control knobs, a front panel, and an LCD screen, and the performance studies include testing of hardware aspects like biocompatibility, EMC, electrical safety, and vacuum pressure/cycle rate.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Electric Breast Pump, model PJ2012, is a mechanical device used to physically express and collect milk from the breast. It does not perform any tests on biological samples to diagnose or monitor a condition.
- Intended Use: The intended use is to alleviate engorgement, maintain lactation, and provide milk for feeding. These are physical actions and not diagnostic procedures.
Therefore, the function and intended use of this device clearly fall outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Electric Breast Pump, model PJ2012 is used to express and collect milk from the breast to alleviate engorgement of the breast, maintain the ability of lactation and provide mother's milk for future feeding when separation of mother and baby occurs. The device is intended for multiple uses.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The Electric Breast Pump, model PJ2012 is designed and manufactured by Limerick, Inc. It is intended to express and collect milk from a lactating woman's breast. This action helps to alleviate engorgement of the breast, maintain the woman's ability to lactate, and provide a mother's milk for future feedings when separation of the mater and baby occur.
The product uses a Single-Chip Microcontroller to imitate a baby's suckling action. The device is ergonomically designed to create comfortable milk stimulation, massage, and suction from the breast. There are 80 vacuum levels and 30 speeds available to imitate the rhythm and action of a baby's suckling. Selection of the vacuum and speed is made by adjusting the control knobs on the front panel of the pump. The control panel is soft and viewing is provided by a LCD screen. Once programmed, the pump's electronic memory stores the selected rhythm and intensity of the device.
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)
The sponsor has performed bench testing to demonstrate the electric breast pump performs within the specifications:
PJ's Serenity Model number PJ2012 Vacuum levels 15-270 mm Hg. Cycles/min
PJ's Serenity Model number PJ2012 has met acceptance criteria of performance testing including: biocompatibility (in vivo cytotoxicity, irritation, and sensitization testing), software validation, EMC, electrical safety, and vacuum pressure / cycle rate testing.
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.
K051926, PJ's Comfort breast pump, K012275, PJ's Comfort portable breast pump
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. In the center of the circle is an abstract symbol that resembles an eagle or other bird with outstretched wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 20, 2015
Limerick, Inc. Patricia Kelly 2150 N. Glenoaks Blvd. Burbank, CA 91504
K132220 Re: Trade/Device Name: PJ's Serenity Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: February 2, 2015 Received: February 6, 2015
Dear Patricia Kelly,
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
Page 2 - Patricia Kelly
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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Benjamin R. Fisher -S
Beniamin 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132220
Device Name
PJ's Screnity
Indications for Use (Describe)
The Electric Breast Pump, model PJ2012 is used to express and collect milk from the breast to alleviate engorgement of the breast, maintain the ability of lactation and provide mother's milk for future feeding when separation of mother and baby occurs. The device is intended for multiple uses.
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Submission Number K13220/S004
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
:
| Date: | 2014/06/13 |
|---|---|
| Submitter: | Limerick, Inc. |
| Primary Contact Person: | Patricia Kelly |
| President | |
| Limerick, Inc. | |
| Tel: (818) 566-3060 | |
| Fax: (818) 566-1260 | |
| Secondary Contact Person: | Joan Ortiz |
| Vice President | |
| Limerick, Inc. | |
| Tel: (818) 566-3060 | |
| Fax: (818) 566-1260 | |
| Device:Trade Name: | PJ's Serenity Model PJ2012 |
| Common/Usual Name: | Powered breast pump |
| Classification Names: | Powered breast pump |
| Regulation Number: | CFR884.5160 |
| Product Code: | HGX |
| Predicate Device(s) | K051926, PJ's Comfort breast pump |
| K012275, PJ's Comfort portable breast pump | |
| Device Description: | The Electric Breast Pump, model PJ2012 |
| is designed and manufactured by Limerick, Inc. It is | |
| intended to express and collect milk from a lactating | |
| woman's breast. This action helps to alleviate | |
| engorgement of the breast, maintain the woman's | |
| ability to lactate, and provide a mother's milk for | |
| future feedings when separation of the mater and | |
| baby occur. |
The product uses a Single-Chip Microcontroller to
imitate a baby's suckling action. The device is
ergonomically designed to create comfortable milk
stimulation, massage, and suction from the breast.
There are 80 vacuum levels and 30 speeds available
to imitate the rhythm and action of a baby's
suckling. Selection of the vacuum and speed is
made by adjusting the control knobs on the front
panel of the pump. The control panel is soft and
viewing is provided by a LCD screen. Once
programmed, the pump's electronic memory stores
the selected rhythm and intensity of the device. |
| Indications for Use: | The Electric Breast Pump, model PJ2012 is
used to express and collect milk from the breast to
alleviate engorgement of the breast, maintain the
ability of lactation and provide mother's milk for
future feeding when separation of mother and baby
occurs. The device is intended for multiple users. |
| Technology: | The Electric Breast Pump, model PJ2012
is designed to mechanically interface with a
mother's breast via breast shield and withdraw, ther
collect, the breast milk. The device incorporates a
microcontroller with embedded firmware. The
microcontroller is a Microchip PIC18F26K22. The
firmware was developed using MicroEngineering
Labs PICBasic Pro. The device incorporates a
pump driven by an electric motor to produce a
vacuum. The device incorporates an air valve to
selectively allow air into the vacuum system. The
device incorporates an LCD display to provide
information to the user. The firmware provides a
means for the user to start and stop pump operation. |
4
:
5
While in operation, it provides a means for the user to adjust the speed of the pump motor and adjust the maximum vacuum level reached. The motor speed is controlled using pulse width modulation of the power applied to the motor. The maximum vacuum level is controlled by monitoring the output of a vacuum sensor and comparing the vacuum level with the user setting. When the level is reached, the air valve is opened. The LCD display shows the settings for the motor speed and vacuum levels using an arbitrary numeric scale, such as 1 to 30. The LCD also shows an elapsed time in minutes from the start of pump cycling.
| Specification | Predicate Device | Predicate Device | Proposed Device | Discussion of
Differences |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | PJ's Comfort | PJ's Comfort portable | PJ's Serenity | |
| K Number | K051926 | K012275 | K132220 | |
| Indications for
Use | The intended use of the
electrically powered
(diaphragm type)
suction device is to
express milk from the
breast of lactating
women. | The intended use of the
electrically powered
(diaphragm type)
suction device is to
express milk from the
breast of lactating
women. | The Electric Breast
Pump, model PJ2012 is
used to express and
collect milk from the
breast to alleviate
engorgement of the
breast, maintain the
ability of lactation and
provide mother's milk
for future feeding when
separation of mother
and baby occurs. The
device is intended for
multiple users. | The
Indications
for Use
statements
between the
subject and
predicate
devices are
not identical,
but the
intended use
of the
devices-to
express milk
from the
breast of
lactating
women-is
the same. |
| Patient
Population | Breastfeeding
Women | Breastfeeding
Women | Breastfeeding
Women | Same |
| Pump Type | Diaphragm | Diaphragm | Diaphragm | Same |
| Vacuum Range | 40-270mm Hg | 150-220 mm Hg | 15-270
mm Hg. | Similar |
| Cycle Levels | 16-70 cycles/min. | 30-45 cycles/min. | 15- 275 cycles/min | The
difference in
cycle rate
between the |
| | | | | subject and
predicate
devices does
not represent
new
technology,
and raises no
new types of
safety and
effectiveness
questions. |
| Filter Between
kit and pump | Yes | Yes | Yes | Same |
| Adjustable
Suction Levels | Yes | Yes | Yes | Same |
| Software | Yes | Yes | Yes | Same |
| Anatomical
Sites | Breast | Breast | Breast | Same |
| Energy Used
And/or delivered | AC
Battery
Car adapter | AC
Battery
Car adapter | AC | No battery
No Car
adapter for
PJ's Serenity
as it is only
used in
hospital |
| Designed and
Materials | All food or human
contact components
are manufactured
from materials that
meet FDA food
additive criteria as
set forth in 21 Code
of Federal
Regulations Part 176,
177 and 178. | All food or human
contact components
are manufactured
from materials that
meet FDA food
additive criteria as set
forth in 21 Code of
Federal Regulations
Part 176, 177 and
178. | All food or human
contact components
are manufactured
from materials that
meet FDA food
additive criteria as set
forth in 21 Code of
Federal Regulations
Part 176, 177 and
178. | Same |
| Performance | Stimulation, suction
and collect | Stimulation, suction
and collect | Stimulation, suction
and collect | Same |
| Standards Met | IEC60601-1 2005,
3rd Edition
IEC60601-2: 2007,
3rd Edition
ISO 10993-1
ISO 10993-5
ISO 10993-10 | IEC60601-1 2005, 3rd
Edition
IEC60601-2: 2007,
3rd Edition
ISO 10993-1
ISO 10993-5
ISO 10993-10 | IEC60601-1 2005, 3rd
Edition
IEC60601-2: 2007,
3rd Edition
ISO 10993-1
ISO 10993-5
ISO 10993-10 | Same |
| Biocompatibility | Not cytotoxic
irritating or dermal
sensitizer | Not cytotoxic
irritating or dermal
sensitizer | Not cytotoxic
irritating or dermal
sensitizer | Same |
| Mechanical
Safety | Electromechanical
cycling suction
regulator | Electromechanical
cycling suction
regulator | Electromechanical
cycling suction
regulator | Same |
| Operating
Temperature | 5-40 degree C | 5-40 degree C | 5-40 degree C | Same |
| Electrical Safety | | | | |
| Bench Test | Performs within
specifications | Performs within
specifications | Performs within
specifications | Same |
| 1-Micron filter | Provides a barrier.
against bacteria, fluid
and virus from
entering the pump | Provides a barrier
against bacteria, fluid
and virus from
entering the pump | Provides a barrier
against bacteria, fluid
and virus from
entering the pump | Same |
| Accessory Kit | 2 silicone breast cups
2 braces
2 bottle caps
2 silicone gaskets
2 storage containers
2 tubes with "Y"
adapter
2 tube connectors
1 filter
1clamp | 2 silicone breast cups
2 braces
2 bottle caps
2 silicone gaskets
2 storage containers
2 tubes with "Y"
adapter
2 tube connectors
1 filter
1clamp | 2 silicone breast cups
2 braces
2 bottle caps
2 silicone gaskets
2 storage containers
2 tubes with "Y"
adapter
2 tube connectors
1 filter
1clamp | Same |
| Packaging | Corrugated | Corrugated | Corrugated | Same |
Determination of Substantial Equivalence:
6
7
Submission Number K13220/S004
Summary of non-clinical tests:
The sponsor has performed bench testing to demonstrate the electric breast pump performs within the specifications:
PJ's Serenity Model number PJ2012 Vacuum levels 15-270 mm Hg. Cycles/min
PJ's Serenity Model number PJ2012 has met acceptance criteria of performance testing including: biocompatibility (in vivo cytotoxicity, irritation, and sensitization testing), software validation, EMC, electrical safety, and vacuum pressure / cycle rate testing.
Conclusion:
Limerick, Inc considers the PJ's Serenity electric breast pump to be substantially equivalent to the predicated devices.