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.

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.

AI/ML Overview

The Annabella Breast Pump is a powered breast pump intended for lactating women to express and collect milk. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device (Medela Freestyle, K150499) rather than presenting a standalone efficacy study with acceptance criteria in the traditional sense of medical device performance for diagnosis or treatment. Therefore, the information typically found for such a study (like effect size for AI assistance, expert qualifications, adjudication methods, ground truth types for test/training sets, and large sample sizes for studies proving efficacy) is not applicable here.

The "acceptance criteria" for this submission are primarily demonstrating safety and performance equivalence to the predicate device through non-clinical testing. The "study" proving this involves various non-clinical performance data and compliance with relevant standards.

Here's a breakdown of the requested information based on the provided text, with explicit notes where information is not applicable or not provided for this type of device and submission:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by adherence to standards and comparison to the predicate. The "performance" is reported as having successfully met these standards and demonstrating functionality similar to the predicate, accounting for differences.

Acceptance Criteria (Implied)	Reported Device Performance
Electrical Safety (IEC 60601-1, IEC 60601-1-11)	Testing performed in accordance; device meets requirements.
Battery Safety (62133-2:2017-02)	Testing performed in accordance; device meets requirements.
Electromagnetic Compatibility (EMC) (IEC 60601-1-2:2021)	Testing performed in accordance; device meets requirements.
Software Verification (IEC 62304:2015 Ed.1.1, FDA Guidance)	Verification performed in accordance; device software meets requirements.
Biocompatibility (ISO 10993-1, -5, -10)	Cytotoxicity, Sensitization, and Irritation testing performed; device meets requirements for patient-contacting components.
Vacuum level/suction strength (each mode/cycle)	Tested and verified. Specific quantitative values are compared to predicate (see table in original text).
Backflow protection	Tested and verified to prevent liquid backflow into tubing/motor.
Cycle speed (each mode/cycle)	Tested and verified. Specific quantitative values are compared to predicate (see table in original text).
Battery performance (functional during use-life)	Tested and verified to demonstrate functionality throughout stated use-life.
Battery status indicator (functional during battery life)	Tested and verified to remain functional.
Device use life (maintains specifications throughout life)	Tested and verified to maintain specifications.
Substantial Equivalence (Overall)	The results demonstrate the device is as safe and effective as the predicate.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of a clinical study for diagnostic/treatment efficacy. The "test set" here refers to the actual devices used for non-clinical performance and safety testing. The number of physical units tested is not specified but would typically be a small number of production or representative samples.
Data Provenance: Not applicable for typical device testing. The tests are conducted in a controlled laboratory environment by the manufacturer or a contracted testing facility. No patient data or geographical origin is relevant for these types of non-clinical tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable. Ground truth, in this context, refers to engineering specifications and regulatory standards for safety and performance testing (e.g., electrical safety, EMC, biocompatibility). These are objective measurements against established criteria, not subjective expert interpretations for clinical diagnosis.
Qualifications of Experts: Not applicable. The "experts" would be qualified engineers and technicians performing the tests according to defined protocols and standards, not clinical radiologists or similar.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements in subjective interpretations (e.g., expert reads of medical images). For objective non-clinical performance and safety testing, measurements either meet or do not meet a predefined standard; there's no subjective difference to adjudicate.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done?: No. An MRMC study is typically for evaluating the diagnostic performance of a medical imaging device or AI algorithm with human readers. This device is a breast pump, not an imaging device or an AI diagnostic tool.
Effect Size of Human Readers Improvement with AI: Not applicable, as there is no AI assistance for human readers in the context of a breast pump.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Standalone Performance Done?: No, not in the sense of a standalone diagnostic algorithm. The device does contain software, and its performance was verified as part of the software verification testing (IEC 62304). However, this refers to the pump's operational software, not a standalone diagnostic algorithm being evaluated for clinical accuracy.

7. Type of Ground Truth Used

Type of Ground Truth: For the non-clinical performance and safety tests, the "ground truth" consists of established engineering specifications, recognized national and international safety standards (e.g., IEC, ISO), and regulatory requirements set by agencies like the FDA. For example:
- Electrical Safety: Standards like IEC 60601-1 define acceptable leakage currents, insulation breakdown, etc.
- Biocompatibility: ISO 10993 standards define acceptable levels of cytotoxicity, irritation, and sensitization.
- Device Performance: Internal design specifications for vacuum levels, cycle speeds, and battery life, which are then compared against objective measurements.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a physical medical device, not an AI/ML diagnostic algorithm that requires a "training set" of data in the typical sense. While products undergo design and development, which can be seen as an iterative "training" process for engineering, it's not a data-driven training set like for AI.

9. How the Ground Truth for the Training Set was Established

How Ground Truth for Training Set Established: Not applicable. As there's no "training set" in the AI/ML context, there's no need to establish ground truth for it. The design and development process for a physical device relies on engineering principles, materials science, user needs, and regulatory requirements rather than training data with established ground truth.

Summary

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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.

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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

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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)
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Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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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 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.

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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	AnnabellaBreast Pump	Predicate Device:FreeStyle;K150499	Discussion
Indications for Use	The AnnabellaBreast Pump is apowered breastpump to be usedby lactating womento express andcollect milk fromtheir breasts. TheAnnabella BreastPump is intendedfor a single user.	The Freestyle® is apowered breastpump to be used bylactating women toexpress and collectmilk from theirbreasts. TheFreestyle® isintended for asingle user.	Identical
Intended Use	Express andcollect milk	Express and collectmilk	Identical
Single User Device	Yes	Yes	Identical
Environment ofUse	Home	Home	Identical
Over the Counter	Yes	Yes	Identical
User InterfaceHardware Interfaces
User Control	• On-off switch• VacuumadjustmentControl• Cycle-adjustmentControl• Tonguemechanism	On-off switchVacuum/Cycle-adjustmentcontrol	Different -Annabella hastwo independentcontrolsfor vacuum andcycles.Freestyle® usesa singlecontrol to adjustvacuumand cyclestogether.
	control (heightand pace)
Visual Indicator	7 SegmentDisplay and LEDIndications	LCD Display	Different - Bothprovide indicationsdisplay
PumpingOptions	Single only	Single or Double	Different -Pumpingmechanism is thesame
Accessories	A variety ofaccessories for:• Collection ofmilk• Storage of milk• Breast care• ProvidingPower	A variety ofaccessories for:• Collection of milk• Storage of milk• Breast care• Providing Power• Carrying• Cleaning• Feeding	Different - bothsystems comewith or makeavailable avariety ofaccessories thatcan be used withthe pump forcollection andstorage ofbreast milk,providingpower and breastpump. Freestyle®hasadditionalaccessories forcarrying andcleaning itscomponentsand feedingstored milk.
Media Separation	Yes	Yes	Identical
Specifications
Power Supply	• Li-Ion battery or• AC adaptorprovided	• Li-Ion battery or• AC adaptorprovided	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 SuctionLevels	Yes	Yes	Identical
Let-Down Button	Yes	Yes	Identical
Massage (TongueMechanism)	- 4 cams rotating at atypical angularspeed of 0-40rpm- 9 levels of speed- 9 levels for location onthe breast (distancefrom the breast center)	NA	Annabella has anadditional massage unit –both the speed and location onthe breast is controlled by theuser for maximumcomfort; the user can stop itsoperation at any time. Theaddition of the massage unitdoes not raise differentquestions of safety andeffectiveness.
Cycling ControlMechanism	Microcontroller	Microcontroller	Identical
Back FlowProtection	Yes	Yes	Identical
2-phaseexpression	Yes	Yes	Equivalent. Bothdevices offer an initialsimulation phase that movesto expression phaseafter two

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			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:

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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.

Regulation Number and Section

§ 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).