(262 days)
Not Found
No
The 510(k) summary describes a standard electric breast pump with various modes and adjustable settings. There is no mention of AI, ML, or any features that would suggest the use of such technologies for optimizing pumping, analyzing milk flow, or any other function. The performance studies focus on standard device safety and functionality testing.
No.
The device is a breast pump used to express and collect milk, not for therapeutic purposes.
No
The device is described as a powered breast pump used to express and collect milk, not to diagnose any condition.
No
The device description explicitly lists numerous hardware components (flange, breast shield body, main body, battery, AC adapter, etc.) and describes its function as a powered breast pump, which is a physical device. While software is mentioned as being evaluated, the core device is hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- VIVACE's Function: The VIVACE is a breast pump. Its function is to physically express and collect milk from a lactating woman's breast. It does not analyze any biological specimens to provide diagnostic information.
- Intended Use: The intended use clearly states it's for "lactating women to express and collect milk from their breast." This is a mechanical function, not a diagnostic one.
The description of the device and its intended use clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The VIVACE is a powered breast pump to be used by lactating women to express and collect milk from their breast. The VIVACE is intended for a single user.
Product codes
HGX
Device Description
VIVACE is an electric breast pump intended to express and collect milk from the breasts of lactating women. The device is intended for daily use in a home environment by a single user. VIVACE is both AC-powered/battery-powered. The AC adapter uses a 100-240 V a.c, 50/60Hz, 1.0A adapter, and the battery is a rechargeable Li-ion battery with specifications of 11.1V, 2200mAh, 24.4Wh. VIVACE is comprised of a flange, breast shield body, wide adapter, diaphragm, diaphragm cover, white valve, bottle cover, cap, disk, bottle, adapter, air tube, main body, nipple, and instruction manual. VIVACE supports a single pumping mode in which only one breast is expressed and a double pumping mode in which both breasts are expressed. The double pumping mode is divided into a synchronous mode that expresses at the same time and an alternative mode that expresses on both sides alternately. The vacuum provided covers a range of pressures from 50 mmHg, and cycle speeds (cycles/min) from 20 to 80 cycles/min. The device is provided non-sterile.
Unimom VIVACE provides the following features:
- LCD display shows the current status such as Mode (single, synchronous, alternative, massage, expression), cycle level and vacuum level of both breasts and mood light.
- -Expression can be performed on one breast only (single mode), on both sides simultaneously (synchronous), or on both sides alternately (alternative).
- -Expression mode: 1-12 level (50-280 mmHg), cycle speeds (28, 31, 34, 37, 40)
- -Massage mode: 1-6 level (60-160 mmHg), cycle speeds (40, 50, 60, 70, 80)
The breast pump expresses breast milk by creating a seal around the nipple using a flange and applying and releasing suction to the nipple. The milk is collection container, which can be used for storage. To prevent millt from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Lactating women / home environment
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.
Biocompatibility:
Per the 2023 FDA guidance document, Use of International Standard ISO 10993-1, "Biological evaluation of medical – Part 1: Evaluation and testing within a risk management process", the following tests were performed on the direct user contacting device materials:
- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2021)
- Irritation (ISO 10993-23:2021)
The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing.
Electrical Safety:
Testing was conducted in accordance with IEC 60601-1:2005 + A1:2012 + A2:2020 (3.2 Edition) Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, IEC 60601-1-11:2015+A1:2020 (2.1 Edition) Medical electrical equipment – Part 1-11: 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, and IEC 62133-2 Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems.
Electromagnetic Compatibility:
Testing was conducted in accordance with IEC 60601-1-2:2014 + AMD 1:2021 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
Software:
Software was evaluated as recommended in the 2023 FDA guidance document, Content of Premarket Submissions for Software Functions.
Performance Testing:
Other performance testing was conducted to show that the device meets its design requirements and performs as intended. The performance tests include:
- Vacuum level verification testing at each mode/cycle demonstrated that the devices meet mode/cycle specifications.
- Backflow protection testing was conducted to verify liquid does not backflow into the tubing.
- Use life testing was conducted to demonstrate that the device maintains its specifications throughout its proposed use life.
- Battery performance testing was conducted to demonstrate that the battery remains functional during its stated battery use-life.
- Battery status indicator testing was conducted to demonstrate that the battery status indicator remains functional during its stated battery life.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
March 28, 2024
Unimom.Co % Jong-Hyun Kim CEO Global Medical Standard Consulting Co., Ltd. 66, Cheongcho-ro, Deogyang-gu, Goyang-si Gyeonggi-do, 10543 KOREA, South
Re: K232047
Trade/Device Name: VIVACE Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: March 4, 2024 Received: March 4, 2024
Dear Jong-Hyun Kim:
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
(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 Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
2
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,
Michael T. Bailey -S
For 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) K232047
Device Name VIVACE
Indications for Use (Describe)
The VIVACE is a powered breast pump to be used by lactating women to express and collect milk from their breast. The VIVACE is intended for a single user.
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 K232047
1. Submitter Information
| Applicant: | Unimom Co. |
|---|---|
| Contact: | Yeong-Bin, Chon |
| Phone: | +82-70-8798-5577 |
| Email: | infounimom@naver.com |
| Address: | 110-19, Gajangsaneopseobuk-ro, Osan-si |
| Gyeonggi-do, Republic of Korea | |
| [Zip.18102] |
2. Correspondent Information
| Contact: | Jong-Hyun Kim
CEO |
|----------|------------------------------------------------|
| Firm: | Global Medical Standard Consulting Co.
Ltd. |
| Phone: | +82-02-2135-9540 |
| Email: | fda@gmsc.kr |
3. Date prepared: March 28, 2024
4. Device Information
| Device Name: | VIVACE |
|---|---|
| Common Name: | Powered breast pump |
| Regulation Number: | 21 CFR 884.5160 |
| Regulation Name: | Powered Breast Pump |
| Product Code: | HGX (Pump, Breast, Powered |
| Regulatory Class: | Class II |
5. Predicate Device Information
| Device Name: | OPERA, OPERA eco |
|---|---|
| 510(k) Number: | K190810 |
| Manufacturer: | Unimom Co. |
The predicate device has not been subject to a design-related recall.
6. Device Description
VIVACE is an electric breast pump intended to express and collect milk from the breasts of lactating women. The device is intended for daily use in a home environment by a single user. VIVACE is both AC-powered/batterypowered. The AC adapter uses a 100-240 V a.c, 50/60Hz, 1.0A adapter, and the battery is a rechargeable Li-ion battery with specifications of 11.1V, 2200mAh, 24.4Wh. VIVACE is comprised of a flange, breast shield body, wide adapter, diaphragm, diaphragm cover, white valve, bottle cover, cap, disk, bottle, adapter, air tube, main body, nipple, and instruction manual. VIVACE supports a single pumping mode in which only one breast is expressed and a double pumping mode in which both breasts are expressed. The double pumping mode is divided into a synchronous mode that expresses at the same time and an alternative mode that expresses on both sides
5
alternately. The vacuum provided covers a range of pressures from 50 mmHg, and cycle speeds (cycles/min) from 20 to 80 cycles/min. The device is provided non-sterile.
Unimom VIVACE provides the following features:
- LCD display shows the current status such as Mode (single, synchronous, alternative, massage, expression), cycle level and vacuum level of both breasts and mood light.
- -Expression can be performed on one breast only (single mode), on both sides simultaneously (synchronous), or on both sides alternately (alternative).
- -Expression mode: 1-12 level (50-280 mmHg), cycle speeds (28, 31, 34, 37, 40)
- -Massage mode: 1-6 level (60-160 mmHg), cycle speeds (40, 50, 60, 70, 80)
The breast pump expresses breast milk by creating a seal around the nipple using a flange and applying and releasing suction to the nipple. The milk is collection container, which can be used for storage. To prevent millt from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.
7. Indications for Use
The VIVACE is a powered breast pump to be used by lactating women to express and collect milk from their breast. The VIVACE is intended for a single user.
8. Comparison of Intended Use and Technological Characteristics with the Predicate Device
The table below compares the intended use and technological characteristics of the subject and predicate device.
| | Subject Device
K232047 | Predicate Device
K190810 | Comparison |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | VIVACE | OPERA, OPERA eco | - |
| Product Code | HGX | HGX | Same |
| Regulation
Number | 21 CFR 884.5160 | 21 CFR 884.5160 | Same |
| Regulatory Class | Class II | Class II | Same |
| Patient Population | Lactating Women | Lactating Women | Same |
| Indications for Use | The VIVACE is a powered breast
pump to be used by lactating
women to express and collect milk
from their breast. The VIVACE is
intended for a single user. | The OPERA & OPERA eco are
multiple user, powered breast
pumps intended to express and
collect milk from the breasts of
lactating women | Different.
The predicate
device can be used
by multiple users,
while the subject
device is only for
use by a single user.
This difference does
not represent a new
intended use, as
both are used to
express and collect
milk from the |
| | | | breasts of lactating
women. |
| Pump Options | Single or Double | Single or Double | Same |
| Suction modes | Massage, expression | Massage, expression | Same |
| Backflow
Protection | Yes | Yes | Same |
| Indicators | Yes, LCD | Yes, LCD | Same |
| Single User | Yes | No, Multiple users | Different
The subject device
is only for use by a
single user. This
difference does not
raise different
questions of safety
and effectiveness. |
| Power supply | Li-ion battery: Rechargeable
battery (11.1 V, 2200mAh,
24.4Wh)
AC adapter:
-Input: 100-240 Va.c., 50/60 Hz,
1.0A
-Output: 14.0 Vd.c, 2.0A, 28.0W | Li-ion battery:
Rechargeable Lithium Polymer
battery (only for OPERA)
AC/DC Adapter
- Rated input: AC 100~240V,
50/60Hz - Rated output: DC14V, 2A | Same |
| Suction levels
(massage) | 60 - 160 mmHg, 6 levels | 45-280 mmHg (510(k) Summary
doesn't specify between massage
and expression modes), 5 levels | Different.
Differences in
massage suction
levels do not raise
different questions
of safety and
effectiveness. |
| Suction levels
(expression) | 50 - 280 mmHg, 12 levels | 45-280 mmHg (510(k) Summary
doesn't specify between massage
and expression modes), 8 levels | Different.
Differences in
expression suction
levels do not raise
different questions
of safety and
effectiveness. |
| Cycles per minute
(massage) | 40-80 cycles per minute, 5 levels | 60-100 cycles per minute, 5 levels | Different.
Differences in
massage cycle
speeds do not raise
different questions
of safety and
effectiveness. |
| Cycles per minute
(expression) | 28-40 cycles per minute
(synchronous), 44-60 cycles per
minute (alternative), 5 levels | 26-42 cycles per minute, 5 levels | Different.
Differences in
expression cycle
speeds do not raise
different questions
of safety and
effectiveness. |
| User Interface | LCD display for battery status,
mode, and vacuum level.
Button for on/off. | Switch control - Power, Vacuum / Cycle Up or
Down - Mode switch | Similar |
| | Buttons for increase/decrease
vacuum for each pump.
Buttons for increase/decrease
Cycle.
Buttons for change mood light. | LCD Display | |
| Adjustable Suction
Levels | Yes | Yes | Same |
| Pump type | Diaphragm | Diaphragm | Same |
Table 1: Comparator Table for Subject and Predicate Devices
6
7
The indications for use of the subject and predicate device are not identical as shown in the table above; however, they have the same intended use (i.e., for collection of breast milk from the breasts of lactating women).
The subject and predicate devices have similar technological features, including pumping options, control mechanism, user interface, backflow protection, and device indicators. However, as shown in the table above, there are technological differences between the subject and predicate device, including different vacuum and cycle specifications and vacuum levels. The different technological characteristics of the subject device, as compared to the predicate device, do not raise different questions of safety and effectiveness.
9. Summary of Non-Clinical Performance Testing
Non-clinical tests were conducted to verify that the subject device met all design specifications to be considered substantially equivalent to the predicate device.
Biocompatibility
Per the 2023 FDA guidance document, Use of International Standard ISO 10993-1, "Biological evaluation of medical – Part 1: Evaluation and testing within a risk management process", the following tests were performed on the direct user contacting device materials:
- . Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2021) ●
- Irritation (ISO 10993-23:2021)
The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing.
Electrical Safety
Testing was conducted in accordance with IEC 60601-1:2005 + A1:2012 + A2:2020 (3.2 Edition) Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, IEC 60601-1-11:2015+A1:2020 (2.1 Edition) Medical electrical equipment – Part 1-11: 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, and IEC 62133-2 Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems.
Electromagnetic Compatibility
Testing was conducted in accordance with IEC 60601-1-2:2014 + AMD 1:2021 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
8
Software
Software was evaluated as recommended in the 2023 FDA guidance document, Content of Premarket Submissions for Software Functions.
Performance Testing
Other performance testing was conducted to show that the device meets its design requirements and performs as intended. The performance tests include:
- Vacuum level verification testing at each mode/cycle demonstrated that the devices ● meet mode/cycle specifications.
- . Backflow protection testing was conducted to verify liquid does not backflow into the tubing.
- . Use life testing was conducted to demonstrate that the device maintains its specifications throughout its proposed use life.
- . Battery performance testing was conducted to demonstrate that the battery remains functional during its stated battery use-life.
- . Battery status indicator testing was conducted to demonstrate that the battery status indicator remains functional during its stated battery life.
10. Conclusion
The results of the performance testing described above demonstrate that VIVACE is as safe and effective as the predicate device and supports a determination of substantial equivalence.