(206 days)
The Freemie breast pump collection system is intended to be used in conjunction with an approved powered breast pump for the purpose of expressing human milk.
The device is to be used by connection to an approved breast pump, and will be used in place of the pump's original breast milk collection equipment. The device has a funnel-shaped breast funnel, internal valve assembly and enclosing reservoir shaped like a bowl. Additional accessories, associated with the device to replicate the functional and performance characteristics necessary for use with some pump brands, will be sold separately but in conjunction with the sale of the Freemie when those specific brands are identified by the user. The Freemie device is designed to be supported within a woman's ordinary or nursing brassiere, and held in place there while the lactating woman is pumping. When the pump extracts milk, the milk flows out through the end of the funnel and enclosing valve system, where it gathers and is collected in the cup. When the lactating woman is done pumping, she turns off the pump, removes the Freemie from her brassiere and transfers the milk to a storage container for later use.
The Freemie device is available with two cup variations. The first (identified as "Round" or "Standard") is similar in shape to the predicate Freemie (K111411). The second (referred to as "Shaped" or "Natural" or "Formed") is a shaped cup that is intended to approximate a shape that, for aesthetic purposes, more resembles the natural shape of a breast supported by an ordinary brassiere. Both variants are made from the same materials, function identically and use the same valve and funnel assembly and will be chosen by the user based on individual preference. The interfaces where the cup and cone variants attach to each other are identical.
The Freemie will also be available in 3 funnel variants, a 25mm (similar to the predicate Freemie), identified by DAO Health as FG008 (Standard) and FG011 (Form Shape), and larger 28mm (FG009 for the Standard and FG012 for the Form Shape) and 32mm (FG010 for Standard and FG013 for the Form Shape) funnels. All funnel sizes are made from the same material, fit with either of the cup variants and use the same universal valve assembly.
The Freemie® Breast Pump Collection System, as described in the provided 510(k) summary, demonstrates its acceptance through various performance tests, primarily focusing on demonstrating equivalence to predicate devices and ensuring safety and effectiveness.
Here's an breakdown outlining the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
Since the provided text does not explicitly detail a "table of acceptance criteria" with numerical targets and direct comparisons, I will synthesize the information to create a table based on the various performance testing categories mentioned and the general conclusion of equivalence.
| Acceptance Criteria Category | Reported Device Performance (Summary from Submission) |
|---|---|
| Biocompatibility | Passed all biocompatibility testing. |
| Breast Funnel Design | Demonstrated equivalence to the predicate device and other marketed accessories. (Implies meeting functional and safety aspects of design). |
| Compatible Pumps | Demonstrated compatibility with approved breast pumps, with accessories available to replicate functional and performance characteristics for specific pump brands. |
| Vacuum Performance | Bench testing demonstrated equivalence to the predicate device. (Implies maintaining effective vacuum for milk expression). |
| Capacity | Bench testing demonstrated equivalence to the predicate device. (Implies holding an appropriate volume of milk without issue). |
| Freedom from Leakage | Bench testing demonstrated equivalence to the predicate device. (Implies no leaks during use, ensuring proper milk collection). |
| Ability to be Supported | Bench testing demonstrated equivalence to the predicate device. (Implies stable and secure placement within a brassiere during pumping). |
| Material Equivalence | Constructed of similar materials as the Predicate Device(s) and other currently marketed accessories. |
| Design Equivalence | Similar design to the Predicate Device(s) and other currently marketed accessories. |
| Indications for Use | Same indications as the Predicate Device(s) and other currently marketed accessories, i.e., "intended to be used in conjunction with an approved powered breast pump for the purpose of expressing human milk." |
| General Safety & Effectiveness | Bench and biocompatibility testing have demonstrated equivalence and the safety and effectiveness of the device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states that "Performance testing was conducted to demonstrate Safety and Effectiveness and for comparison to the predicate device."
The specific sample sizes for tests such as Breast Funnel Design, Compatible Pumps, Vacuum Performance, Capacity, Freedom from Leakage, and Ability to be Supported are not explicitly mentioned in the provided summary.
The data provenance is not stated, but the testing would typically be conducted by the manufacturer or contracted labs within the country of origin (USA, based on the submitter's address). The nature of the performance tests (bench testing) suggests that this was likely prospective testing designed specifically for this submission, rather than retrospective analysis of existing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The provided information does not specify the number of experts or their qualifications used to establish ground truth. The tests described are primarily engineering/bench performance tests rather than clinical evaluations requiring expert interpretation. For biocompatibility, certified labs and toxicologists would establish "ground truth" through adherence to established standards (e.g., ISO 10993).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Given that the tests described are bench performance and biocompatibility evaluations, an "adjudication method" in the sense of clinical human-reader consensus (e.g., 2+1 for image interpretation) is not applicable or described. The results of bench tests are typically objective measurements against predefined specifications or comparison points.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of data, often with AI assistance. The Freemie Breast Pump Collection System is a mechanical device for milk expression, not a diagnostic tool, and involves no AI component or human readers in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Freemie Breast Pump Collection System is a physical medical device, not a software algorithm. Therefore, "standalone algorithm performance" is not relevant to this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance tests mentioned (Breast Funnel Design, Compatible Pumps, Vacuum Performance, Capacity, Freedom from Leakage, Ability to be Supported), the 'ground truth' was based on:
- Predicate device performance: direct comparison to the established characteristics of the legally marketed predicate device (Freemie Breast Pump Collection System K111411 and Medela® Pump in Style Advanced® Breastpump K031614).
- Established engineering specifications/standards: adherence to functional and safety requirements for breast pumps, even if no formal performance standards are promulgated (as stated, "Performance standards have not been promulgated for powered breast pumps," but general engineering principles and safety considerations would apply).
- Biocompatibility standards: meeting established international standards for biological evaluation of medical devices (e.g., ISO 10993 series).
8. The sample size for the training set
Not applicable. This device is hardware and does not utilize a training set in the context of machine learning or AI models.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
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| Submitter | DAO Health1345 Easy LnEl Dorado Hills, California, 95762 | Device Description | The device is to be used by connection to an approved breast pump, andwill be used in place of the pump's original breast milk collectionequipment. The device has a funnel-shaped breast funnel, internal valveassembly and enclosing reservoir shaped like a bowl. Additionalaccessories, associated with the device to replicate the functional andperformance characteristics necessary for use with some pump brands,will be sold separately but in conjunction with the sale of the Freemiewhen those specific brands are identified by the user. The Freemiedevice is designed to be supported within a woman's ordinary or nursingbrassiere, and held in place there while the lactating woman is pumping.When the pump extracts milk, the milk flows out through the end of thefunnel and enclosing valve system, where it gathers and is collected inthe cup. When the lactating woman is done pumping, she turns off thepump, removes the Freemie from her brassiere and transfers the milk toa storage container for later use.The Freemie device is available with two cup variations. The first(identified as "Round" or "Standard") is similar in shape to the predicateFreemie (K111411). The second (referred to as "Shaped" or "Natural"or "Formed") is a shaped cup that is intended to approximate a shapethat, for aesthetic purposes, more resembles the natural shape of a breastsupported by an ordinary brassiere. Both variants are made from thesame materials, function identically and use the same valve and funnelassembly and will be chosen by the user based on individual preference.The interfaces where the cup and cone variants attach to each other areidentical.The Freemie will also be available in 3 funnel variants, a 25mm (similarto the predicate Freemie), identified by DAO Health as FG008(Standard) and FG011 (Form Shape), and larger 28mm (FG009 for the |
|---|---|---|---|
| Date Prepared | April 1, 2013 (original)August 8, 2013 (S002) | Standard and FG012 for the Form Shape) and 32mm (FG010 forStandard and FG013 for the Form Shape) funnels. All funnel sizes aremade from the same material, fit with either of the cup variants and usethe same universal valve assembly. | |
| Contact Person | Dan GarbezPhone: 916-339-7388FAX: 877-869-1973e-mail: dan@daohealth.com | Biocompatibility | The Freemie Breast Pump Collection System has passed allbiocompatibility testing. |
| Device Trade Name | Freemie® Breast Pump Collection System | Performance Data | Performance testing was conducted to demonstrate Safety andEffectiveness and for comparison to the predicate device.Testing included: Breast Funnel Design, Compatible Pumps, VacuumPerformance and Capacity and Freedom from Leakage, Ability to beSupported. |
| Classification Name | Powered Breast Pump | Summary | The Freemie Breast Pump Collection System is constructed of similarmaterials, has a similar design and the same indications as the PredicateDevice(s) and other currently marketed accessories for powered breastpumps. Bench and biocompatibility testing have demonstratedequivalence and the safety and effectiveness of the device. |
| Device Classification | Regulatory Class: Class II (two)Product Code: 85 HGX884.5160 | Conclusion | The Freemie Breast Pump Collection System is substantially equivalentto the predicate devices and other currently marketed accessories forpowered breast pumps. |
| Predicate Device(s) | Freemie Breast Pump Collection System (K111411)Medela® Pump in Style Advanced® Breastpump (K031614) | ||
| Performance Standards | Performance standards have not been promulgated for powered breastpumps. | ||
| Intended Use | The Freemie breast pump collection system is intended to be used inconjunction with an approved powered breast pump for the purpose ofexpressing human milk. |
510(k) Summary - Freemie® Breast Pump Collection System
SEP 06 2013
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 6. 2013
DAO Health % Dan Garbez Manager 1345 Easy Ln El Dorado Hills, CA 95762
Re: K130349
Trade/Device Name: Freemie Breast Pump Collection System Regulation Number: 21 CFR$ 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: August 8. 2013 Received: August 13, 2013
Dear Dan Garbez,
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.
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Page 2 - Dan Garbez
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/ucm 1 15809.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,
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
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Indications for Use
510(k) Number (if known): K130349
Device Name: Freemie® Breast Pump Collection System
| Freemie Catalog/Model Number | Cup Type | Funnel Size |
|---|---|---|
| FG008 | Standard | 25mm |
| FG009 | Standard | 28mm |
| FG010 | Standard | 32mm |
| FG011 | Form Shape | 25mm |
| FG012 | Form Shape | 28mm |
| FG013 | Form Shape | 32mm |
Indications For Use: The Freemie breast pump collection system is intended to be used in conjunction with an approved powered breast pump for the purpose of expressing human milk.
Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Herbert P. Lerner -S
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§ 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).