(121 days)
Not Found
No
The summary describes a standard powered breast pump with a mobile app for control. There is no mention of AI, ML, or any features that would suggest the use of such technologies for analysis, prediction, or adaptation.
No.
A therapeutic device is one that treats or prevents a disease or condition. A breast pump assists in milk expression and collection, which is a supportive function rather than a treatment or prevention of a medical condition.
No
The device is a breast pump used to express and collect milk, not to diagnose a medical condition.
No
The device description clearly outlines hardware components including a main enclosure, electrical components, pneumatic components, a rechargeable battery, and tubing. While it includes a mobile app for control, it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The Pump by Babyation is a mechanical device designed to physically express and collect milk from a lactating woman's breasts. It does not perform any diagnostic tests on biological samples.
- Intended Use: The intended use is to "express and collect milk from their breasts," which is a physical process, not a diagnostic one.
The device description and performance studies focus on the mechanical and electrical performance of the pump, safety, and usability, not on analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Pump by Babyation is a powered breast pump to be used by lactating women in the hospital or home setting to express and collect milk from their breasts. The Pump by Babyation can be used by multiple users.
Product codes
HGX
Device Description
The Pump by Babyation is a multiple-user powered breast pump system that allows lactating women to discreetly express and collect milk. It is powered by a rechargeable lithium ion battery. Users have the option of single or double pumping. The device has two phases of pumping, stimulation and expression. Stimulation phase is characterized by faster cycle times and lower suction levels and is used to initiate milk letdown. Expression phase is characterized by slower cycle times and higher suction levels and is used after milk letdown has occurred. The device consists of a main enclosure which houses all of the electrical components that control the system and the pneumatic components that generate suction at vacuum levels up to 250mmHg. The main enclosure also provides an insulated storage area for one ice pack, milk collection bottles, breast shields, and the necessary tubing for the system. The device also includes a mobile app that connects to the device via Bluetooth and allows the user to control the pump.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breasts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Lactating women in the hospital or home setting
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)
Non-clinical testing was conducted to verify that The Pump by Babyation met all design specifications, demonstrated safety based on current industry standards, and is substantially equivalent to the predicate. The following tests were performed:
- A. Cleaning: The reusable components were subjected to cleaning and reprocessing using methods outlined in AAMI TIR30 A compendium of processes, materials, test methods, and acceptance criteria/or cleaning reusable medical devices.
- B. Biocompatibility: Patient contacting material was subjected to biocompatibility testing in compliance with ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10) and irritation (ISO 10993-10).
- C. Software Verification: The software development and testing was executed with consideration to IEC 62304 Medical device software - Software life cycle processes. Software documentation was provided in accordance with FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005.
- D. Electromagnetic Compatibility, Electrical Safety, and Battery Safety: The subject device was tested in compliance with the following:
- i. ANSI/AAMI ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- ii. IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-11 Medical electrical equipment Part 1-11: General requirements iii. for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 62133-2 Secondary cells and batteries containing alkaline or other non-acid İV. electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
- E. Wireless Coexistence: The subject device was tested in compliance with ANSI C63.27 American National Standard for Evaluation of Wireless Coexistence, KDB 447498 RF Exposure Procedures and Equipment Authorization Policies for Mobile and Portable Devices
- F. Performance Testing: Bench testing was conducted to demonstrate pump performance (vacuum performance, speed verification, milk collection in the worst case scenario), battery performance, backflow control, and cross contamination were tested using internal test protocols.
- G. Usability: Usability testing was performed in compliance with IEC 62366 Medical devices - Part 1: Application of usability engineering to medical devices and IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 4, 2018
Babyation, LLC % Allison Komiyama Principal Consultant Acknowledge Regulatory Strategies, LLC 2834 Hawthorn Street San Diego, California 92104
Re: K173699 Trade/Device Name: The Pump by Babyation Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: Class II Product Code: HGX Dated: March 1, 2018 Received: March 5, 2018
Dear Allison Komiyama:
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 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);
1
Page 2 - Allison Komiyama
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joyce M. Whang -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
2
Indications for Use
510(k) Number (if known) K173699
Device Name The Pump by Babyation
Indications for Use (Describe)
The Pump by Babyation is a powered breast pump to be used by lactating women in the hospital or home setting to express and collect milk from their breasts. The Pump by Babyation can be used by multiple users.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary K173699
DATE PREPARED
March 14, 2018
MANUFACTURER AND 510(k) OWNER
Babyation LLC 911 Washington Avenue, Suite 427 St. Louis, MO 63101, USA Telephone: +1 (844) 744-7867 Official Contact: Jared Miller, CTO/COO
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 208-7888 Email: akomiyama@acknowledge-rs.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | The Pump by Babyation |
|---|---|
| Common Name: | Powered breast pump |
| Regulation Number: | 21 CFR 884.5160 |
| Class: | II |
| Product Code: | HGX (pump, breast, powered) |
| Review Panel: | Obstetrics/Gynecology |
PREDICATE DEVICE IDENTIFICATION
| 510(k) Number: | K160511 |
|---|---|
| Device Name: | Naya Breast Pump System |
| Manufacturer: | Naya Health, Inc. |
The predicate device has not been subject to a design related recall.
DEVICE DESCRIPTION
The Pump by Babyation is a multiple-user powered breast pump system that allows lactating women to discreetly express and collect milk. It is powered by a rechargeable lithium ion battery. Users have the option of single or double pumping. The device has two phases of pumping, stimulation and expression. Stimulation phase is characterized by faster cycle times and lower suction levels and is used to initiate milk letdown. Expression phase is characterized by slower cycle times and higher suction levels and is used after milk letdown has occurred.
4
The device consists of a main enclosure which houses all of the electrical components that control the system and the pneumatic components that generate suction at vacuum levels up to 250mmHg. The main enclosure also provides an insulated storage area for one ice pack, milk collection bottles, breast shields, and the necessary tubing for the system. The device also includes a mobile app that connects to the device via Bluetooth and allows the user to control the pump.
INDICATIONS FOR USE
The Pump by Babyation is a powered breast pump to be used by lactating women in the hospital or home setting to express and collect milk from their breasts. The Pump by Babyation can be used by multiple users.
PREDICATE COMPARISON
The following table compares The Pump by Babyation to the predicate device with respect to the indications for use and technological characteristics:
| Device &
Predicate Device | Subject Device
Babyation LLC / The Pump by Babyation
(K173699) | Predicate Device
Naya Health Inc. / Naya Breast Pump System
(K160511) |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Pump by Babyation is a powered breast
pump to be used by lactating women in the
hospital or home setting to express and collect
milk from their breasts. The Pump by
Babyation can be used by multiple users. | The Naya Breast Pump System is a powered
breast pump to be used by lactating women in the
hospital or home setting to express and collect
milk from their breasts. |
| Single/Multiple | Multiple users | Multiple users |
| Environment of
Use | Hospital, Home | Hospital, Home |
| Power Source | Input: 100-240 VAC, 50/60Hz, 0.7-0.35A
Rechargeable Li-Ion Battery (7.2 V / 2200 mAh) | Input: 100-240 VAC, 50/60Hz, 2.1A
Rechargeable Li-ion Battery (1 x 14.8V / 3200 mAh) |
| Pump Type | Reciprocating diaphragm pump | Reciprocating diaphragm pump |
| User Interface | Hardware interface, mobile app | Hardware interface, mobile app |
| User Control | Power Button
Control Wheel / Button Mobile App | Power Button
Touch Wheel / Button Mobile App |
| Software | Yes | Yes |
| Mobile App | Yes | Yes |
| Single/double | Both | Both |
| Adjustable
Suction Levels | 10 levels | 10 levels |
| Cycle Speed
(cycles /min) | 30 - 120 | 34 - 120 |
5
| Device &
Predicate Device | Subject Device
Babyation LLC / The Pump by Babyation
(K173699) | Predicate Device
Naya Health Inc. / Naya Breast Pump System
(K160511) |
|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Backflow
Protection
(prevention of
backflow of
liquid into
pump/tubing) | Yes (filter, sensor) | Yes (diaphragm) |
| Overflow
Protection (stops
pumping when
the bottle is full
to prevent
overflow) | Yes (sensor) | |
| Vacuum range -
double / single
(mmHg) | 50-250 / 50-250 | 50-250 / 50-260 |
| Cycling/Suction
Control
Mechanism | Microprocessor | Microprocessor |
| Design Features | Reciprocating diaphragm vacuum pumpPortable, battery poweredPump controlled by interface on unit or by mobile appAir-based silicone flange (i.e., breast shield)Expressed milk flows from the flanges to the bottles through tubing | Reciprocating diaphragm vacuum pumpPortable, battery poweredPump controlled by interface on unit or by mobile appWater-based silicone flangeMilk expressed directly in collection cups attached to the flanges |
The Pump by Babyation has the same intended use but different technological characteristics compared to the predicate device. The differences in technological characteristics do not raise different questions of safety and effectiveness.
SUMMARY OF NON-CLINICAL TESTING
Non-clinical testing was conducted to verify that The Pump by Babyation met all design specifications, demonstrated safety based on current industry standards, and is substantially equivalent to the predicate. The following tests were performed:
- A. Cleaning: The reusable components were subjected to cleaning and reprocessing using methods outlined in AAMI TIR30 A compendium of processes, materials, test methods, and acceptance criteria/or cleaning reusable medical devices.
6
- B. Biocompatibility: Patient contacting material was subjected to biocompatibility testing in compliance with ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10) and irritation (ISO 10993-10).
- C. Software Verification: The software development and testing was executed with consideration to IEC 62304 Medical device software - Software life cycle processes. Software documentation was provided in accordance with FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005.
- D. Electromagnetic Compatibility, Electrical Safety, and Battery Safety: The subject device was tested in compliance with the following:
- i. ANSI/AAMI ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- ii. IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-11 Medical electrical equipment Part 1-11: General requirements iii. for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 62133-2 Secondary cells and batteries containing alkaline or other non-acid İV. electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
- E. Wireless Coexistence: The subject device was tested in compliance with ANSI C63.27 American National Standard for Evaluation of Wireless Coexistence, KDB 447498 RF Exposure Procedures and Equipment Authorization Policies for Mobile and Portable Devices
- F. Performance Testing: Bench testing was conducted to demonstrate pump performance (vacuum performance, speed verification, milk collection in the worst case scenario), battery performance, backflow control, and cross contamination were tested using internal test protocols.
7
- G. Usability: Usability testing was performed in compliance with IEC 62366 Medical devices - Part 1: Application of usability engineering to medical devices and IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
CLINICAL PERFORMANCE DATA
Not Applicable
CONCLUSION
Based on the comparison and analysis above, The Pump by Babyation is substantially equivalent to the predicate device.