(30 days)
Not Found
No
The description focuses on mechanical and electrical functions, user control via buttons, and standard software verification. There is no mention of AI, ML, or related concepts like learning, adaptation, or data-driven decision making.
No
The device is a breast pump, not a therapeutic device. It helps express and collect milk but does not treat a disease or condition. Its purpose is for milk expression and collection, which is a supportive function rather than a therapeutic intervention.
No
Explanation: The device is a breast pump used to express and collect milk, and its description and intended use do not mention any diagnostic capabilities or functions.
No
The device description clearly outlines multiple hardware components including a vacuum unit, tubing, massage units, breast shield, bottle, bottle lids, charger, and a rechargeable Li-ion battery. While it contains software, it is an integral part of a physical medical device.
No, the Annabella Double Breast Pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Annabella Double Breast Pump Function: The Annabella Double Breast Pump is used to express and collect milk directly from the breast of a lactating woman. This is a physical process performed on the body, not a diagnostic test performed on a specimen.
- Intended Use: The intended use clearly states it's for expressing and collecting milk, not for diagnosing any condition or analyzing a biological sample for diagnostic purposes.
- Device Description: The description details the mechanical and electrical components used for suction and massage, not for analyzing biological samples.
- Performance Studies: The performance studies focus on electrical safety, software verification, biocompatibility of materials in contact with the user, and the mechanical performance of the pump (vacuum level, battery life, etc.). These are all related to the safe and effective operation of a physical device, not the accuracy of a diagnostic test.
Therefore, based on the provided information, the Annabella Double Breast Pump is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Annabella Double Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Annabella Double Breast Pump is intended for a single user.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The Annabella Double Breast Pump is a double, electric breast pump system intended to express and collect milk from the breasts of lactating women. Each pump is comprised of a vacuum unit including tubing (connected to a hybrid cable with a "Y" connector) and a massage unit (tongue mechanism) that mimics the baby's sucking motions. The Y hybrid cable delivers the vacuum from the vacuum unit through the Y splitter to both massage units. 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 and adjustable breast shield, a bottle, 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 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.
- 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 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, " Content of Premarket Submissions for Device Software Functions," dated June, 2023.
- The materials of all parts that are in contact with the user remain the same for the Annabella Double Breast Pump as was tested for the Annabella Breast Pump, therefore, testing from the predicate device was leveraged to support the biocompatibility of the subject device.
- Vacuum level/suction strength of subject devices was tested for each mode/ cycle.
- 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.
The results of the performance testing described above demonstrate that the Annabella Double 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): 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.
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).
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 27, 2024
Annabella Tech % Dalia Dickman Regulatory Consultant Dalia Dickman Consulting Caesarea ISRAEL
Re: K241506
Trade/Device Name: Annabella Double Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: Mav 23, 2024 Received: May 28, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
K241506 - Dalia Dickman
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
2
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
3
Indications for Use
510(k) Number (if known) K241506
Device Name Annabella Double Breast Pump
Indications for Use (Describe)
The Annabella Double Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Annabella Double 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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4
510(k) SUMMARY - K241506
Annabella Tech Ltd's Annabella Double Breast Pump
Submitter
Annabella Tech Ltd. 23/5 Hataas KFAR SABA, 4442525 Israel. +972-9-8845513
Contact Person: Dalia Dickman, PhD. Date Prepared: May 23, 2023
Device Name: Annabella Double 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
Annabella Breast Pump (K230672)
The predicate device has not been subject to a design-related recall.
Device Description
The Annabella Double Breast Pump is a double, electric breast pump system intended to express and collect milk from the breasts of lactating women. Each pump is comprised of a vacuum unit including tubing (connected to a hybrid cable with a "Y" connector) and a massage unit (tongue mechanism) that mimics the baby's sucking motions. The Y hybrid cable delivers the vacuum from the vacuum unit through the Y splitter to both massage units. 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 and adjustable breast shield, a bottle, 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.
5
Intended Use / Indications for Use
The Annabella Double Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Annabella Double 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.
| | Subject Device:
Annabella Double
Breast Pump | Predicate Device:
Annabella Breast
Pump (K230672) | Discussion |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/
Indication for use | The Annabella Double
Breast Pump is a
powered breast pump
to be used by lactating
women to express and
collect milk from their
breasts. The
Annabella is intended
for a single user. | The Annabella is a
powered breast pump to
be used by lactating
women to express and
collect milk from their
breasts. The Annabella
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/Cycle-
adjustment control.
Massage adjustment
control- speed and
location relative to the
breast center. | On-off switch
Vacuum/Cycle-
adjustment control.
Massage adjustment
control- speed and
location relative to the
breast center. | Identical |
| Visual Indicator | 7 Segment Display
and LED Indications | 7 Segment Display and
LED Indications | Identical |
| Pumping options | Single or double | Single | Different – The
subject device
has two single
and pumping
options. The
pumping
mechanism is the
same for both
devices. |
| Media Separation | Yes | Yes | Identical |
| Specifications | | | |
| Power Supply | Li-Ion rechargeable
battery | Li-Ion rechargeable
battery | Identical |
| Suction Levels | Stimulation: 30 - 122 | Stimulation: 35 - 130 | Different; there |
| | Subject Device:
Annabella Double_
Breast Pump | Predicate Device:
Annabella Breast
Pump (K230672) | Discussion |
| | mmHg | mmHg | are minor |
| | Expression: 39 -250
mmHg | Expression: 33 -250
mmHg | differences in
suction levels.i |
| Cycles per Second | Stimulation: 1.66- 2.0
Expression: 0.7-1.44 | Stimulation: 1.66- 2.0
Expression: 0.8-1.44 | Different; there are minor
differences in
cycle speeds. |
| Maximum vacuum | 250 mmHg | 250 mmHg | Identical |
| Suction setting | 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 0-60rpm, 9 levels
for speed.
9 levels for location on
the breast (distance
from the breast center) | 4 cams rotating at a
typical angular speed of
0-60rpm, 9 levels for
speed.
9 levels for location on
the breast (distance
from the breast center) | Identical |
| Cycling Control
Mechanism | Microcontroller | Microcontroller | Identical |
| Back Flow
Protection | Yes | Yes | Identical |
| 2-phase expression | Yes | Yes | Identical |
6
7
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, with minor differences in the pumping options, cycle speeds, and vacuum strengths. 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.
- 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, " Content of Premarket Submissions for Device Software Functions," dated June, 2023.
Biocompatibility:
The materials of all parts that are in contact with the user remain the same for the Annabella Double Breast Pump as was tested for the Annabella Breast Pump, therefore, testing from the predicate device was leveraged to support the biocompatibility of the subject device.
Non-clinical Performance Testing:
- Vacuum level/suction strength of subject devices was tested for each mode/ cycle.
- 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
8
Double Breast Pump is as safe and effective as the predicate device and supports a determination of substantial equivalence.