(147 days)
Not Found
No
The description focuses on basic electronic controls for vacuum intensity, suction rate, and massage unit speed/location. There is no mention of AI, ML, or any features that would suggest adaptive or learning capabilities based on user input or data. The software mentioned likely controls the basic functions and user interface.
No.
A breast pump is used to express milk and does not treat or prevent any medical condition or disease.
No
Explanation: The Annabella Breast Pump is used to express and collect milk. It does not analyze patient data or provide information about a patient's health status or disease.
No
The device description clearly states it is comprised of a vacuum unit, tubing, massage unit, breast shield, bottle lids, and a charger, all of which are hardware components. While it contains software, it is not a software-only device.
Based on the provided information, the Annabella Breast Pump is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "express and collect milk from their breasts." This is a physical process involving the body directly, not a test performed on a sample taken from the body to diagnose a condition or provide information about a physiological state.
- Device Description: The description details a mechanical device that applies vacuum and massage to the breast. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing diagnostic information
- Using reagents or assays
The Annabella Breast Pump is a medical device, specifically a breast pump, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Annabella Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Annabella Breast Pump is intended for a single user.
Product codes
HGX
Device Description
The Annabella Breast Pump is a single, electric breast pump system intended to express and collect milk from the breasts of lactating women. It is comprised of a vacuum unit including tubing and a massage unit that mimics the baby's sucking motions. The user employs buttons on the vacuum unit to control the vacuum intensity levels, suction rate as well as the massage unit speed and location on the breast. The device is supplied with a reusable, washable and adjustable breast shield, a bottle lids and a charger. The Annabella is a rechargeable Li-ion battery operated device that contains software. The device cannot be operated while connected to the mains AC Power core.
The battery compartment is at the bottom of the pump motor unit and is covered by a battery door. The runtime of the removable lithium-ion battery is influenced by the number and duration of pumping sessions and lasts usually for one day.
The device is to be used in the home.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breasts
Indicated Patient Age Range
Lactating women
Intended User / Care Setting
Home
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 tests were conducted to verify that the subject device met all design specifications to be considered substantially equivalent to the predicate device.
Electrical Safety and Electromagnetic Compatibility:
- Electrical Safety Testing was performed in accordance with IEC 60601-1:2005 (3rd Edition)
- Electrical safety testing for use in home was performed in accordance with IEC 60601-1-11:2015, General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- Battery safety testing was performed in accordance with the applicable standards for Lithium-ion batteries: Cell and pack: 62133-2:2017-02: Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
- Electromagnetic compatibility testing was performed in accordance with IEC 60601-1-2:2021. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
Software Verification:
Software Verification was performed in accordance with IEC 62304:2015 Ed.1.1: Medical Device Software – Software Life Cycle Processes and according to the FDA Guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.
Biocompatibility:
Biocompatibility evaluation was performed according to the following requirements of ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process for patient-contacting components of the subject device as follow:
- Cytotoxicity testing per ISO 10993-5:2009
- Guinea Pig Maximization Sensitization testing per ISO 10993-10:2010
- Irritation testing per ISO 10993-10:2010
Non-clinical Performance Testing:
- Vacuum level/suction strength of subject devices was tested for each mode/ cycle.
- Backflow protection testing was conducted to ensure that even if the bottle is over-filled, no liquid will backflow into the tubing, and therefore no liquid can backflow into the pump motor.
- Cycle speed of subject devices was tested.
- Battery performance testing was conducted to demonstrate that the battery remains functional during its stated use-life.
- Battery status indicator testing was conducted to demonstrate that the battery status indicator remains functional during its stated battery life.
- Device use life to demonstrate that the device maintains its specifications throughout its proposed use life.
Key results: The results of the performance testing described above demonstrate that the Annabella Breast Pump is as safe and effective as the predicate device and supports a determination of substantial equivalence.
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.
August 4, 2023
Annabella Ltd. % Dalia Dickman, Ph.D. Regulatory Consultant Dalia Dickman Consulting Manof Misgav, 20184 Israel
Re: K230672 Trade/Device Name: Annabella Breast Pump Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: July 6, 2023 Received: July 7, 2023
Dear Dalia Dickman:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Monica D. Garcia -S
Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230672
Device Name Annabella Breast Pump
Indications for Use (Describe)
The Annabella Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Annabella Breast Pump is intended for a single user.
| 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
Annabella Tech Ltd's Annabella Breast Pump
Submitter
Annabella Tech Ltd. 23/5 Hataas KFAR SABA, 4442525 Israel. +972-9-8845513
Contact Person: Dalia Dickman, PhD. Date Prepared: August 2, 2023
Device Name: Annabella Breast Pump
Common or Usual Name: Powered breast pump
Regulation Number: 21 CFR 884.5160
Regulation Name: Powered breast pump
Regulatory Class: II
Product Code: HGX (Powered, Breast, Pump)
Predicate Device
Medela Freestyle (K150499)
The predicate device has not been subject to a design-related recall.
Device Description
The Annabella Breast Pump is a single, electric breast pump system intended to express and collect milk from the breasts of lactating women. It is comprised of a vacuum unit including tubing and a massage unit that mimics the baby's sucking motions. The user employs buttons on the vacuum unit to control the vacuum intensity levels, suction rate as well as the massage unit speed and location on the breast. The device is supplied with a reusable, washable and adjustable breast shield, a bottle lids and a charger. The Annabella is a rechargeable Li-ion battery operated device that contains software. The device cannot be operated while connected to the mains AC Power core.
The battery compartment is at the bottom of the pump motor unit and is covered by a battery door. The runtime of the removable lithium-ion battery is influenced by the number and duration of pumping sessions and lasts usually for one day.
The device is to be used in the home.
4
Intended Use / Indications for Use
The Annabella Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Annabella Breast Pump is intended for a single user.
Predicate Device Comparison
The table below compares the intended use and technological characteristics of the subject and predicate device.
| Device Name | Annabella
Breast Pump | Predicate Device:
FreeStyle;
K150499 | Discussion |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Annabella
Breast Pump is a
powered breast
pump to be used
by lactating women
to express and
collect milk from
their breasts. The
Annabella Breast
Pump is intended
for a single user. | The Freestyle® is a
powered breast
pump to be used by
lactating women to
express and collect
milk from their
breasts. The
Freestyle® is
intended for a
single user. | Identical |
| Intended Use | Express and
collect milk | Express and collect
milk | Identical |
| Single User Device | Yes | Yes | Identical |
| Environment of
Use | Home | Home | Identical |
| Over the Counter | Yes | Yes | Identical |
| User Interface
Hardware Interfaces | | | |
| User Control | • On-off switch
• Vacuum
adjustment
Control
• Cycle-
adjustment
Control
• Tongue
mechanism | On-off switch
Vacuum/Cycle-
adjustment
control | Different -
Annabella has
two independent
controls
for vacuum and
cycles.
Freestyle® uses
a single
control to adjust
vacuum
and cycles
together. |
| | control (height
and pace) | | |
| Visual Indicator | 7 Segment
Display and LED
Indications | LCD Display | Different - Both
provide indications
display |
| Pumping
Options | Single only | Single or Double | Different -
Pumping
mechanism is the
same |
| Accessories | A variety of
accessories for:
• Collection of
milk
• Storage of milk
• Breast care
• Providing
Power | A variety of
accessories for:
• Collection of milk
• Storage of milk
• Breast care
• Providing Power
• Carrying
• Cleaning
• Feeding | Different - both
systems come
with or make
available a
variety of
accessories that
can be used with
the pump for
collection and
storage of
breast milk,
providing
power and breast
pump. Freestyle®
has
additional
accessories for
carrying and
cleaning its
components
and feeding
stored milk. |
| Media Separation | Yes | Yes | Identical |
| Specifications | | | |
| Power Supply | • Li-Ion battery or
• AC adaptor
provided | • Li-Ion battery or
• AC adaptor
provided | Identical |
| Suction Levels
(stimulation) | 27-105 mmHg | 40 - 140 mmHg | Different |
| Cycles per second
(stimulation) | 1.66-2.0 | 1.7-1.93 | Different |
| Suction Levels | 26-217 mmHg | 45 – 245 mmHg | Different |
| (expression) | | | |
| Cycles per second
(expression) | 0.8-1.44 | 0.83-1.36 | Different |
| Maximum Vacuum | 250 mmHg | 270 mmHg | Different |
| Suction Settings | 9 | 9 | Identical |
| Adjustable Suction
Levels | Yes | Yes | Identical |
| Let-Down Button | Yes | Yes | Identical |
| Massage (Tongue
Mechanism) | - 4 cams rotating at a
typical angular
speed of 0-40rpm
- 9 levels of speed
- 9 levels for location on
the breast (distance
from the breast center) | NA | Annabella has an
additional massage unit –
both the speed and location on
the breast is controlled by the
user for maximum
comfort; the user can stop its
operation at any time. The
addition of the massage unit
does not raise different
questions of safety and
effectiveness. |
| Cycling Control
Mechanism | Microcontroller | Microcontroller | Identical |
| Back Flow
Protection | Yes | Yes | Identical |
| 2-phase
expression | Yes | Yes | Equivalent. Both
devices offer an initial
simulation phase that moves
to expression phase
after two |
5
6
7
| minutes. | |||
|---|---|---|---|
The indications for use of the subject and predicate devices are identical and they have the same intended use (i.e., the collection of breast milk from the breasts of lactating women).
The subject and predicate devices have different technological features, including differences in the pumping options, cycle speeds, vacuum strengths, visual indicators, and the inclusion of a massage unit in the subject device. The different technological characteristics of the subject device, as compared to the predicate device, do not raise different questions of safety and effectiveness.
Performance Data
Non-clinical tests were conducted to verify that the subject device met all design specifications to be considered substantially equivalent to the predicate device.
Electrical Safety and Electromagnetic Compatibility:
- -Electrical Safety Testing was performed in accordance with IEC 60601-1:2005 (3rd Edition)
- | Electrical safety testing for use in home was performed in accordance with IEC 60601-1-11:2015, General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- -Battery safety testing was performed in accordance with the applicable standards for Lithium-ion batteries: Cell and pack: 62133-2:2017-02: Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
- Electromagnetic compatibility testing was performed in accordance with IEC | 60601-1-2:2021. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
Software Verification:
Software Verification was performed in accordance with IEC 62304:2015 Ed.1.1: Medical Device Software – Software Life Cycle Processes and according to the FDA Guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.
Biocompatibility:
8
Biocompatibility evaluation was performed according to the following requirements of ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process for patient-contacting components of the subject device as follow:
- -Cytotoxicity testing per ISO 10993-5:2009
- -Guinea Pig Maximization Sensitization testing per ISO 10993-10:2010
- -Irritation testing per ISO 10993-10:2010
Non-clinical Performance Testing:
- Vacuum level/suction strength of subject devices was tested for each mode/ cycle.
- -Backflow protection testing was conducted to ensure that even if the bottle is over-filled, no liquid will backflow into the tubing, and therefore no liquid can backflow into the pump motor.
- -Cycle speed of subject devices was tested.
- Battery performance testing was conducted to demonstrate that the battery | remains functional during its stated use-life.
- -Battery status indicator testing was conducted to demonstrate that the battery status indicator remains functional during its stated battery life.
- | Device use life to demonstrate that the device maintains its specifications throughout its proposed use life.
Conclusions
The results of the performance testing described above demonstrate that the Annabella Breast Pump is as safe and effective as the predicate device and supports a determination of substantial equivalence.