(147 days)
Not Found
No
The device description details a microprocessor-controlled system with user-selectable settings for vacuum and cycle speed, similar to a predicate device using discrete components. There is no mention of learning, adaptation, or data-driven decision-making characteristic of AI/ML.
No.
The intended use of the device is to express milk from the breast for lactating women, which is not considered a therapeutic function.
No
The device description clearly states its intended use is to express milk from the breast, and it describes its mechanical operation (variable speed, vacuum levels) for this purpose. There is no mention of it being used to diagnose any medical condition, only to collect breast milk. The indicator lights are for device function/malfunction, not for patient diagnosis.
No
The device description clearly outlines hardware components such as a DC motor, vacuum pump, microprocessor, solenoid valve, control panel, indicator lights, and power options (AC/DC converter, battery pack, vehicle adapter). While it mentions firmware, the device is fundamentally a physical, electrically powered suction device with integrated control electronics, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "express milk from the breast" for "lactating women." This is a physical process performed on the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a mechanical pump with controls for vacuum and cycling. It does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Reagents or assays
- Measurement of biomarkers or analytes
- Interpretation of results for diagnosis, monitoring, or screening
- Use with biological specimens
The device is clearly a medical device intended for a therapeutic or supportive purpose (expressing milk), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The intended use of the electrically powered suction device is to express milk from the breast.
The intended use of the electrically powered suction device is to lactating women.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The pj's comfort jr® Portable Electric Breast Pump is powered by a variable speed DC motor that drivos a high op that has 510(k) approval # to that used in the pj's comfort® breast pump that has 510(k) approval # to that used in the pro creates the negative pressure required to KUTZZ7J. The vaouall partip article the vacuum pump is extract breast milk. In the presont upplied on controller circuit, and a interconnected with a PIC 16F872 microprocessor controller circuit, and a interconnected with a PTO-101 or an also pacuum cycling rates, from 16 solenoid valve that provide variable speed vacuum charather control panol solehold valve that vanable opera vacating your of the control panel.
A second knob located on the front panel provides for user selection of A second Kriob located on the from levels from 90 to 270 mm Hg. infinitely vanable maximum vaodam is always 40 mm Hg. The vacuum is the same for single and double pumping.
When the cycle knob and the vacuum knob are both set at maximum the vinen the cycle Rhob and the rate rated in the cycle speed is 16 cycles per minute.
When the cycle knob is set at maximum and the vacuum knob is set at vinen the cycle knob is sot at mapproximately 90 mm Hg. and the cycle speed is 70 cycles per minute.
When the cycle knob is set at minimum, and the vacuum knob is set at maximum, the maximum vacuum is approximately 270 mm Hg. and the cycle speed is 16 cycles per minute.
oyole opeod is the vacuum knob are both set at minimum, the When the cycle knob and the vacuality the back only and the cycle speed is 36 cycles per minute.
The controller contains firmware, loaded at the factory in non-volatile memory, and requires no software to be loaded at each startup. The pj's memory, and requires no sonward to sortwall # K012275 uses a comfort ® bleast pump with o ro(it) approvide components to carry out similar control functions.
out Simillar Sentrel for for the pj's confort the pj's confort jr.® to mimic
The above controls allow the user of the information movimize The above controls allow the uccling of their infant, and to maximize the speed and strength of Subking of the Hg. is applied to one or both comfort. A maximum vacuum of 276 mm . Ignes applied by way of flexible tubing to the breast cup(s).
The pj's comfort jr® front control panel also has a set of indicator lights also The pJ's comfort IN® front control particular ression. These lights also that show the time remaining in the pumping session. These lights also of that show the time remaining in the pamping outtern in case of pump failure.
- Top three lights flashing: Excess vacuum level; not user repairable, return to factory for repair.
- tubing or replace filter.
- tubing of replace litter.
- Bottom three lights flashing: Pump overheated: turn pump off and Bottom three lights hashing. T ump overnounce, If this happens often, return pump to factory for repair.
The pi's comfort jr® Portable Electric Breast Pump can be operated by l he pJ's comfort JN® Portable Liecthe Broad. Punp .
use of either an AC/DC wall converter, a 12-Volt battery pack or a 12 volt motor vehicle adapter.
All materials used in the manufacturing of this device that have contact All matehals used in the manafacturements of the FDA and with food or numan tissue mect requirements of and or biocompatability.
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)
Not Found
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
Name of Company: Limerick Inc. Premarket Notification - 510(k) # K051926 Fremarket Notifoution - onfort jr.® Portable Electric Breast Pump
EXHIBIT #1 Page 1 Of 4
510(K) SUMMARY
This summary of 510 (k) safety and effectiveness information is being submitted This summary of 510 (K) Safety and Sheet. SMDA 1990 and 21 CFR 807.92.
in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K051926
Submitter's Identification: 1.
Limerick Inc. 2150 North Glenoaks Boulevard Burbank, CA 91504
Date Summary Revised: December 7, 2005
Name of the Device: 2.
pj's comfort jr.® Portable Electric Breast Pump
Predicate Devices Information:
pj's comfort ® Portable Breast Pump K012275 Medela Pump In Style Breast Pump (510 (k) not known) Medela Pump in Style Breast Pamp (616 (4) 1133 - 113 (1) 1133 - 11 Premier Powered Breast pump K973501
Device Description: ను
The pj's comfort jr® Portable Electric Breast Pump is powered by a The pJ s comfort fre Portable Elocalle Discussion pump similar variable speed DC motor that drivos a high op that has 510(k) approval #
to that used in the pj's comfort® breast pump that has 510(k) approval # to that used in the pro creates the negative pressure required to KUTZZ7J. The vaouall partip article the vacuum pump is extract breast milk. In the presont upplied on controller circuit, and a
interconnected with a PIC 16F872 microprocessor controller circuit, and a interconnected with a PTO-101 or an also pacuum cycling rates, from 16
solenoid valve that provide variable speed vacuum charather control panol solehold valve that provide vanable opera vacating your of the control panel.
A second knob located on the front panel provides for user selection of A second Kriob located on the from levels from 90 to 270 mm Hg. infinitely vanable maximum vaodam is always 40 mm Hg. The vacuum is the same for single and double pumping.
When the cycle knob and the vacuum knob are both set at maximum the vinen the cycle Rhob and the rate rated in the cycle speed is 16 cycles per minute.
When the cycle knob is set at maximum and the vacuum knob is set at vinen the cycle knob is sot at mapproximately 90 mm Hg. and the cycle speed is 70 cycles per minute.
1
Name of Company: Limerick Inc. Name of Sotification -- 510(k) # K051926 Premarket Notification = STo(it) if Roo rozle Electric Breast Pump
EXHIBIT #1 Page 2 of 4
When the cycle knob is set at minimum, and the vacuum knob is set at When the cycle Knob is set at minimam, and the volume.
maximum, the maximum vacuum is approximately 270 mm Hg. and the cycle speed is 16 cycles per minute.
oyole opeod is the vacuum knob are both set at minimum, the When the cycle knob and the vacuality the back only and the cycle speed is 36 cycles per minute.
The controller contains firmware, loaded at the factory in non-volatile The controller contains limitware, to be loaded at each startup. The pj's
memory, and requires no software to be loaded at each startup. The pj's memory, and requires no sonward to sortwall # K012275 uses a comfort ® bleast pump with o ro(it) approvide components to carry out similar control functions.
out Simillar Sentrel for for the pj's confort the pj's confort jr.® to mimic
The above controls allow the user of the information movimize The above controls allow the uccling of their infant, and to maximize the speed and strength of Subking of the Hg. is applied to one or both comfort. A maximum vacuum of 276 mm . Ignes applied by way of flexible tubing to the breast cup(s).
The pj's comfort jr® front control panel also has a set of indicator lights also The pJ's comfort IN® front control particular ression. These lights also
that show the time remaining in the pumping session. These lights also of that show the time remaining in the pamping outtern in case of pump failure.
- Top three lights flashing: Excess vacuum level; not user repairable, 1. return to factory for repair.
- tubing or replace filter.
- tubing of replace litter.
- Bottom three lights flashing: Pump overheated: turn pump off and Bottom three lights hashing. T ump overnounce, If this happens often, return pump to factory for repair.
The pi's comfort jr® Portable Electric Breast Pump can be operated by l he pJ's comfort JN® Portable Liecthe Broad. Punp .
use of either an AC/DC wall converter, a 12-Volt battery pack or a 12 volt motor vehicle adapter.
All materials used in the manufacturing of this device that have contact All matehals used in the manafacturements of the FDA and with food or numan tissue mect requirements of and or biocompatability.
2
Name of Company: Limerick Inc. Name of Company - 510(k) # K051926 Premarket Notification = 310(K) # R001620
Name of Device: pj's comfort jr.® Portable Electric Breast Pump
EXHIBIT #1 Page 3 of 4
Intended Use: 4.
The intended use of the electrically powered suction device is to express milk from the breast.
Comparison to Predicate Devices: 5.
Table of Comparison to Legally Marketed Devices:
Below is a comparison chart outlining differences and similarities between the Below is a comparison crart outlining unterences ails comfort(@Rortable Electric
pj's comfort jr® Portable Electric Breast Pump, pji's comfort @ Portable Electric pj's comfort JR® Portable Electric Breast Pump, pJ 0 Common Collection
Breast Pump, the Medela Pump In Style, and the Ameda Expresse and Premier breast pumps:
| | Current
device | Predicate devices | | | |
|---------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Character-
istics | Limerick
pj's comfort jr® | Limerick
pj's comfort® | Medela Pump In
Style-K unknown | Ameda Expresse
K973501 | Ameda Premier
K973501 |
| Intended Use | As described in 21
CFR 884.5160 | As described in 21
CFR 884.5160 | As described in 21
CFR 884.5160 | As described in 21
CFR 884.5160 | As described in 21
CFR 884.5160 |
| Suction
Levels | 40-270 mm Hg. | 20-240 mm Hg. | 80-240 mm Hg. |