(206 days)
Not Found
No
The device description focuses on mechanical components and their function in collecting breast milk. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a breast milk collection system to be used with an approved powered breast pump for expressing human milk. It functions to collect milk, rather than to treat or cure a disease or condition.
No
The device is a breast pump collection system used to express human milk. Its function is to collect milk, not to diagnose any condition or disease.
No
The device description explicitly details physical components such as funnels, valves, reservoirs, and cups, and mentions performance testing related to these physical attributes (vacuum performance, leakage, support). There is no mention of software as a component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the purpose of expressing human milk." This is a physical process of collecting a biological fluid, not a diagnostic test performed on a biological sample to determine a medical condition or state.
- Device Description: The description details a system for collecting milk, including funnels, valves, and reservoirs. It does not mention any components or processes related to analyzing the milk itself for diagnostic purposes.
- Lack of Diagnostic Language: The document does not use any language typically associated with IVDs, such as "diagnosis," "detection," "measurement," "analysis," "assay," or "in vitro."
- Performance Studies: The performance studies focus on the physical function of the device (vacuum performance, capacity, leakage, support) rather than the accuracy or reliability of a diagnostic test.
In summary, the Freemie breast pump collection system is a device for collecting human milk, which is a physical process, not an in vitro diagnostic procedure.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
85 HGX
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Performance testing was conducted to demonstrate Safety and Effectiveness and for comparison to the predicate device. Testing included: Breast Funnel Design, Compatible Pumps, Vacuum Performance and Capacity and Freedom from Leakage, Ability to be Supported.
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.
Freemie Breast Pump Collection System (K111411), Medela® Pump in Style Advanced® Breastpump (K031614)
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).
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| Submitter | DAO Health
1345 Easy Ln
El Dorado Hills, California, 95762 | 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 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 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | April 1, 2013 (original)
August 8, 2013 (S002) | | 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. |
| Contact Person | Dan Garbez
Phone: 916-339-7388
FAX: 877-869-1973
e-mail: dan@daohealth.com | Biocompatibility | The Freemie Breast Pump Collection System has passed all
biocompatibility testing. |
| Device Trade Name | Freemie® Breast Pump Collection System | Performance Data | Performance testing was conducted to demonstrate Safety and
Effectiveness and for comparison to the predicate device.
Testing included: Breast Funnel Design, Compatible Pumps, Vacuum
Performance and Capacity and Freedom from Leakage, Ability to be
Supported. |
| Classification Name | Powered Breast Pump | Summary | The Freemie Breast Pump Collection System is constructed of similar
materials, has a similar design and the same indications as the Predicate
Device(s) and other currently marketed accessories for powered breast
pumps. Bench and biocompatibility testing have demonstrated
equivalence and the safety and effectiveness of the device. |
| Device Classification | Regulatory Class: Class II (two)
Product Code: 85 HGX
884.5160 | Conclusion | The Freemie Breast Pump Collection System is substantially equivalent
to the predicate devices and other currently marketed accessories for
powered 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 breast
pumps. | | |
| Intended 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. | | |
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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