(583 days)
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.
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.
The provided document is a 510(k) summary for the PJ's Serenity Electric Breast Pump, Model PJ2012. It details the device's characteristics and compares them to predicate devices, but it does not contain a clinical study with detailed acceptance criteria, sample sizes, expert ground truth, or MRMC studies for AI performance. This document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices through bench testing and compliance with recognized standards.
Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria cannot be extracted from this document, as such a study (as described by your prompts) was not performed or reported in this 510(k) summary.
However, I can provide information based on the "bench testing" mentioned, which serves as the "study" demonstrating the device meets its specifications (acceptance criteria).
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly defines the "acceptance criteria" through the device specifications that are compared to predicate devices. The "reported device performance" is stated as performing "within specifications."
| Acceptance Criteria (Specification) | Reported Device Performance (PJ's Serenity Model PJ2012) |
|---|---|
| Vacuum Range | 15-270 mm Hg |
| Cycle Levels | 15-275 cycles/min |
| Filter Between kit and pump | Yes (Provides a barrier against bacteria, fluid and virus from entering the pump) |
| Adjustable Suction Levels | Yes |
| Software | Yes (validated) |
| Anatomical Sites | Breast |
| Energy Used | AC |
| 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. |
| Performance | Stimulation, suction and collect |
| Standards Met | IEC60601-1 2005, 3rd Edition; IEC60601-2: 2007, 3rd Edition; ISO 10993-1; ISO 10993-5; ISO 10993-10 |
| Biocompatibility | Not cytotoxic, irritating or dermal sensitizer |
| Mechanical Safety | Electromechanical cycling suction regulator |
| Operating Temperature | 5-40 degree C |
| Electrical Safety | (Implied by meeting IEC60601-1/2) |
| Bench Test | Performs within specifications |
| 1-Micron filter | Provides a barrier against bacteria, fluid and virus from entering the pump |
| 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, 1 clamp |
| Packaging | Corrugated |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The summary states "the sponsor has performed bench testing to demonstrate the electric breast pump performs within the specifications." This implies testing of the device itself, but the number of units tested is not stated.
- Data Provenance: Not specified, but generally, bench tests are performed by the manufacturer in their own facilities. It is inherently "prospective" in the sense that the testing is done to approve the specific device for market.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. This is a breast pump, not an AI diagnostic device. Bench testing typically relies on instrument measurements against engineering specifications, not expert interpretation or ground truth establishment in the clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept is for diagnostic interpretation, not mechanical device performance.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI-powered device. The device does have a microcontroller with embedded firmware, but its performance is measured against physical parameters (vacuum, cycle rate) rather than an algorithm's standalone diagnostic accuracy.
7. The type of ground truth used:
- Engineering Specifications / Recognized Standards: The "ground truth" for this device's performance is its adherence to predefined engineering specifications (e.g., specific vacuum range, cycle rates) and compliance with recognized safety and biocompatibility standards (e.g., IEC60601-1, ISO 10993 series).
8. The sample size for the training set:
- Not applicable. As this is not an AI/machine learning device, there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable.
In summary: The provided document is a 510(k) summary for a powered breast pump. It describes the device and its compliance with established performance specifications and standards through bench testing. It does not involve AI or diagnostic interpretations that would require clinical studies with human readers, expert ground truth, or MRMC analyses.
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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
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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
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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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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 pumpK012275, PJ's Comfort portable breast pump |
| Device Description: | The Electric Breast Pump, model PJ2012is designed and manufactured by Limerick, Inc. It isintended to express and collect milk from a lactatingwoman's breast. This action helps to alleviateengorgement of the breast, maintain the woman'sability to lactate, and provide a mother's milk forfuture feedings when separation of the mater andbaby occur.The product uses a Single-Chip Microcontroller toimitate a baby's suckling action. The device isergonomically designed to create comfortable milkstimulation, massage, and suction from the breast.There are 80 vacuum levels and 30 speeds availableto imitate the rhythm and action of a baby'ssuckling. Selection of the vacuum and speed ismade by adjusting the control knobs on the frontpanel of the pump. The control panel is soft andviewing is provided by a LCD screen. Onceprogrammed, the pump's electronic memory storesthe selected rhythm and intensity of the device. |
| Indications for Use: | The Electric Breast Pump, model PJ2012 isused to express and collect milk from the breast toalleviate engorgement of the breast, maintain theability of lactation and provide mother's milk forfuture feeding when separation of mother and babyoccurs. The device is intended for multiple users. |
| Technology: | The Electric Breast Pump, model PJ2012is designed to mechanically interface with amother's breast via breast shield and withdraw, thercollect, the breast milk. The device incorporates amicrocontroller with embedded firmware. Themicrocontroller is a Microchip PIC18F26K22. Thefirmware was developed using MicroEngineeringLabs PICBasic Pro. The device incorporates apump driven by an electric motor to produce avacuum. The device incorporates an air valve toselectively allow air into the vacuum system. Thedevice incorporates an LCD display to provideinformation to the user. The firmware provides ameans for the user to start and stop pump operation. |
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:
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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 ofDifferences |
|---|---|---|---|---|
| Device Name | PJ's Comfort | PJ's Comfort portable | PJ's Serenity | |
| K Number | K051926 | K012275 | K132220 | |
| Indications forUse | The intended use of theelectrically powered(diaphragm type)suction device is toexpress milk from thebreast of lactatingwomen. | The intended use of theelectrically powered(diaphragm type)suction device is toexpress milk from thebreast of lactatingwomen. | The Electric BreastPump, model PJ2012 isused to express andcollect milk from thebreast to alleviateengorgement of thebreast, maintain theability of lactation andprovide mother's milkfor future feeding whenseparation of motherand baby occurs. Thedevice is intended formultiple users. | TheIndicationsfor Usestatementsbetween thesubject andpredicatedevices arenot identical,but theintended useof thedevices-toexpress milkfrom thebreast oflactatingwomen-isthe same. |
| PatientPopulation | BreastfeedingWomen | BreastfeedingWomen | BreastfeedingWomen | Same |
| Pump Type | Diaphragm | Diaphragm | Diaphragm | Same |
| Vacuum Range | 40-270mm Hg | 150-220 mm Hg | 15-270mm Hg. | Similar |
| Cycle Levels | 16-70 cycles/min. | 30-45 cycles/min. | 15- 275 cycles/min | Thedifference incycle ratebetween the |
| subject andpredicatedevices doesnot representnewtechnology,and raises nonew types ofsafety andeffectivenessquestions. | ||||
| Filter Betweenkit and pump | Yes | Yes | Yes | Same |
| AdjustableSuction Levels | Yes | Yes | Yes | Same |
| Software | Yes | Yes | Yes | Same |
| AnatomicalSites | Breast | Breast | Breast | Same |
| Energy UsedAnd/or delivered | ACBatteryCar adapter | ACBatteryCar adapter | AC | No batteryNo Caradapter forPJ's Serenityas it is onlyused inhospital |
| Designed andMaterials | All food or humancontact componentsare manufacturedfrom materials thatmeet FDA foodadditive criteria asset forth in 21 Codeof FederalRegulations Part 176,177 and 178. | All food or humancontact componentsare manufacturedfrom materials thatmeet FDA foodadditive criteria as setforth in 21 Code ofFederal RegulationsPart 176, 177 and178. | All food or humancontact componentsare manufacturedfrom materials thatmeet FDA foodadditive criteria as setforth in 21 Code ofFederal RegulationsPart 176, 177 and178. | Same |
| Performance | Stimulation, suctionand collect | Stimulation, suctionand collect | Stimulation, suctionand collect | Same |
| Standards Met | IEC60601-1 2005,3rd EditionIEC60601-2: 2007,3rd EditionISO 10993-1ISO 10993-5ISO 10993-10 | IEC60601-1 2005, 3rdEditionIEC60601-2: 2007,3rd EditionISO 10993-1ISO 10993-5ISO 10993-10 | IEC60601-1 2005, 3rdEditionIEC60601-2: 2007,3rd EditionISO 10993-1ISO 10993-5ISO 10993-10 | Same |
| Biocompatibility | Not cytotoxicirritating or dermalsensitizer | Not cytotoxicirritating or dermalsensitizer | Not cytotoxicirritating or dermalsensitizer | Same |
| MechanicalSafety | Electromechanicalcycling suctionregulator | Electromechanicalcycling suctionregulator | Electromechanicalcycling suctionregulator | Same |
| OperatingTemperature | 5-40 degree C | 5-40 degree C | 5-40 degree C | Same |
| Electrical Safety | ||||
| Bench Test | Performs withinspecifications | Performs withinspecifications | Performs withinspecifications | Same |
| 1-Micron filter | Provides a barrier.against bacteria, fluidand virus fromentering the pump | Provides a barrieragainst bacteria, fluidand virus fromentering the pump | Provides a barrieragainst bacteria, fluidand virus fromentering the pump | Same |
| Accessory Kit | 2 silicone breast cups2 braces2 bottle caps2 silicone gaskets2 storage containers2 tubes with "Y"adapter2 tube connectors1 filter1clamp | 2 silicone breast cups2 braces2 bottle caps2 silicone gaskets2 storage containers2 tubes with "Y"adapter2 tube connectors1 filter1clamp | 2 silicone breast cups2 braces2 bottle caps2 silicone gaskets2 storage containers2 tubes with "Y"adapter2 tube connectors1 filter1clamp | Same |
| Packaging | Corrugated | Corrugated | Corrugated | Same |
Determination of Substantial Equivalence:
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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.
§ 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).