(257 days)
The Freemie milk collection system is intended to be used in conjunction with an approved electric 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 adapter, internal valve assembly and enclosing reservoir shaped like a bowl. Variations of the device incorporate minor differences to replicate the functional and performance characteristics necessary for use with additional pump brands. Additionally, smaller and larger breast adapter and milk collection sizes will be available, as is the practice with predicate devices. 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 provided document describes the Freemie® Breast Pump Collection System and its 510(k) submission (K111411) for market clearance. The study aimed to demonstrate substantial equivalence to predicate devices.
1. Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical acceptance criteria in the format of sensitivity, specificity, AUC, or similar AI-specific metrics, as it predates the widespread use of AI in medical devices and focuses on mechanical performance and safety. Instead, the acceptance criteria are based on demonstrating equivalence in key functional and safety attributes to predicate devices. The study proves the device meets these criteria through comparative performance testing and biocompatibility assessments.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Passed all biocompatibility testing. This suggests adherence to recognized standards for materials in contact with human tissue and milk. |
| Performance - Breast Adapter Design | Testing was conducted to demonstrate the design features. The report mentions "variations of the device incorporate minor differences to replicate the functional and performance characteristics necessary for use with additional pump brands." This implies successful adaptation. |
| Performance - Compatible Pumps | Testing was conducted to demonstrate compatibility. The device is intended to be used by connection to an "approved breast pump" and in place of "the pump's original breast milk collection equipment," implying successful integration and function with various pumps. |
| Performance - Vacuum Performance | Testing was conducted to demonstrate vacuum performance. This is crucial for effective milk expression and implies performance comparable to existing collection systems. |
| Performance - Capacity | Testing was conducted to demonstrate capacity. The report mentions "smaller and larger breast adapter and milk collection sizes will be available, as is the practice with predicate devices." This suggests a range of capacities similar to market standards. |
| Materials and Design Equivalence | Constructed of similar materials, has a similar design, and the same indications as predicate devices and other currently marketed accessories. Bench testing demonstrated equivalence. |
| Safety and Effectiveness | Bench and biocompatibility testing demonstrated the safety and effectiveness of the device. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an AI/ML algorithm with data provenance like country of origin or retrospective/prospective data. The performance testing described (Breast Adapter Design, Compatible Pumps, Vacuum Performance, and Capacity) appears to be bench testing (laboratory-based evaluations) rather than clinical studies with human subjects. Therefore, the "sample size" would likely refer to the number of units or configurations tested in the lab, which is not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a mechanical breast milk collection system, and its evaluation does not involve establishing ground truth from expert interpretation of medical images or clinical outcomes in the way an AI diagnostic tool would. The "ground truth" for its performance is determined by physical measurements and functional testing against engineering specifications and predicate device performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for the same reasons as point 3.
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-assisted diagnostic device, so MRMC studies and the concept of human reader improvement with AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance would be the direct measurements from the bench testing (e.g., vacuum pressure readings, milk volume collected, compatibility with various pump models) and adherence to material safety standards (biocompatibility testing results). It is based on engineering specifications and direct experimental measurements rather than clinical or pathological ground truth.
8. The sample size for the training set
Not applicable. This device does not involve an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not involve an AI/ML algorithm.
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| Submitter: | DAO Health2526 Capitol AvenueSacramento, CA 95816 |
|---|---|
| Date Prepared: | May 18, 2011 |
| Contact Person: | Dan GarbezPhone: 916-339-7388FAX: 877-869-1973e-mail: dan@daohealth.com |
| Device Trade Name | Freemie® |
| Device Common Name | Freemie® Breast Pump Collection System |
| Classification Name | Powered Breast Pump |
| Device Classification | Regulatory Class: Class II (two)Product Code: 85 HGX884.5160 |
| Predicate Device(s) | Medela® Pump in Style® Advanced Breastpump (K031614)Learning Curve Brands miPump™ (K082802) |
| Performance Standards | Performance standards have not been promulgated for powered breast pumps. |
| Intended Use | The Freemie milk collection system is intended to be used in conjunction with an approved electric breast pump for the purpose of expressing human milk. |
| Device Description | 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 adapter, internal valve assembly and enclosing reservoir shaped like a bowl. Variations of the device incorporate minor differences to replicate the functional and performance characteristics necessary for use with additional pump brands. Additionally, smaller and larger breast adapter and milk collection sizes will be available, as is the practice with predicate devices. 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. |
| Biocompatibility | The Freemie Breast Pump Collection System has passed all biocompatibility testing. |
| Performance Data | Performance testing was conducted to demonstrate Safety andEffectiveness and for comparison to the predicate device.Testing included: Breast Adapter Design, Compatible Pumps, VacuumPerformance and Capacity. |
| Summary | The Freemie Breast Pump Collection System is constructed of similarmaterials, has a similar design and the same indications as the PredicateDevices and other currently marketed accessories for powered breastpumps. Bench and biocompatibility testing have demonstratedequivalence and the safety and effectiveness of the device. |
| Conclusion | The Freemie Breast Pump Collection System is substantially equivalentto the predicate devices and other currently marketed accessories forpowered breast pumps. |
510(k) Summary - Freemie® Breast Pump Collection System
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB - 1 2012
Mr. Dan Garbez Manager DAO Health 2526 Capitol Avenue SACRAMENTO CA 95816
Re: K111411
Trade/Device Name: Freemie® Breast Pump Collection System (Freemie) Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: January 24, 2012 Received: January 27, 2012
Dear Mr. 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 your 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 1 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
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/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.
Sincerély vours,
Sincerely yours,
Benjamin K. Ticho
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 Statement
510(k) Number (if known): K111411
Device Name: Freemie Breast Pump Collection System (Freemie)
Indications for Use:
The Freemie breast pump collection system is intended to be used in conjunction with an approved electric breast pump for the purpose of expressing human milk.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The- Counter
(Optional Format 1-1-96)
Benjamin R. Toth
§ 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).