(450 days)
Not Found
No
The summary describes a standard powered breast pump with user-selectable settings and no mention of AI/ML capabilities or related components like image processing or training data.
Yes
The device is a powered breast pump intended to express and collect milk from lactating women, which is a therapeutic function.
No
Explanation: The device is a powered breast pump intended to express and collect milk. Its function is to facilitate milk expression, not to diagnose any medical condition.
No
The device description clearly outlines physical hardware components including a motor unit, expression kits, a silicone vacuum tube, and power supply options (AC and battery). The performance studies also include testing related to hardware (biocompatibility, electrical safety, electromagnetic compatibility, battery performance).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "express and collect milk from the breasts of lactating women." This is a physical process performed on the body, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The description details a mechanical pump with components for expressing and collecting milk. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic, monitoring, or screening information
- Using reagents or assays
- Measuring analytes
The device is clearly a medical device, but its function is to physically extract milk, not to perform an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Powered Breast Pump (Models 7V and 7X) is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The Powered Breast Pump (Models 7V and 7X) is a powered breast pump that is intended to express and collect milk from the breasts of lactating women. The device is intended for a single user and can be used in home and professional healthcare environments.
The subject device can be used for single or double breast pumping and consists of the following key components: a motor unit with a press-button user interface, expression kits (NexusFit™ Cap, Diaphragm, Pump Body, Breast Shield, and Valve; areola shield; milk collection kit), and a silicone vacuum tube.
The Powered Breast Pump (Models 7V and 7X) has two operational modes (massage and expression), with user-selectable vacuum and cycle levels in each mode (levels are shown in Section 7 of the summary). Both device models are powered by an external AC power supply, while all 7V and select 7X models can be operated using an internal rechargeable lithium-ion battery. The device is provided nonsterile.
All milk contacting components are compliant with 21 CFR 174-179
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 and professional healthcare environments.
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)
Biocompatibility:
- Study Type: Biocompatibility testing in accordance with ISO 10993-1.
- Key Results: The patient-contacting device materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing.
Electrical Safety:
- Study Type: Electrical safety testing in accordance with AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-11:2015, and IEC 62133-2:2017.
- Key Results: Not explicitly stated, but implies compliance with standards.
Electromagnetic Compatibility:
- Study Type: Electromagnetic compatibility testing in accordance with IEC 60601-1-2:2014.
- Key Results: Not explicitly stated, but implies compliance with standards.
Software:
- Study Type: Software evaluation in accordance with the 2005 FDA guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
- Key Results: Not explicitly stated, but implies compliance with guidance.
Performance Testing:
- Study Type: Performance testing was conducted to demonstrate pump performance met established specifications.
- Key Results:
- 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.
- Battery charging testing to demonstrate the duration of time needed to fully recharge the battery.
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 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" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
June 29, 2022
Haenim Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt. STE 200 Irvine, CA 92620
Re: K211016
Trade/Device Name: Powered Breast Pump (Models 7V and 7X) Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: Mav 25, 2022 Received: May 31, 2022
Dear Priscilla Chung:
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,
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
2
Indications for Use
510(k) Number (if known) K211016
Device Name Powered Breast Pump (Models 7V and 7X)
Indications for Use (Describe)
The Powered Breast Pump (Models 7V and 7X) is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary K211016
Date: June 28, 2022
1. Applicant / Submitter:
| Applicant: | Haenim Co., Ltd. |
|---|---|
| Address: | 15, Saryeom-ro 21beon-gil, Seo-gu, Incheon |
| South Korea, 22742 | |
| Contact: | Dae Won Kim |
| Tel: | +82-32-324-6614 |
Submission Correspondent: 2.
| Contact: | Priscilla Chung |
|---|---|
| Address: | LK Consulting Group USA, Inc. |
| 1150 Roosevelt STE 200, | |
| Irvine CA 92620 | |
| Phone: | 714-202-5789 |
| Fax: | 714-409-3357 |
| Email: | juhee.c@lkconsultinggroup.com |
3. Subject Device:
| Proprietary Name: | Powered Breast Pump (Models 7V and 7X) |
|---|---|
| Common Name: | Powered breast pump |
| Regulation Name: | Powered breast pump |
| Regulation Number | 21 CFR 884.5160 |
| Product Code: | HGX (pump, breast, powered) |
| Regulatory Class: | Class II |
Predicate Device: 4.
| Proprietary Name: | Hi bebesuper (Models BT-150S and BT-150L) |
|---|---|
| 510(k) Number: | K200675 |
The predicate device has not been subject to a design-related recall.
Device Description: 5.
The Powered Breast Pump (Models 7V and 7X) is a powered breast pump that is intended to express and collect milk from the breasts of lactating women. The device is intended for a single user and can be used in home and professional healthcare environments.
The subject device can be used for single or double breast pumping and consists of the following key components: a motor unit with a press-button user interface, expression kits (NexusFit™ Cap,
4
Diaphragm, Pump Body, Breast Shield, and Valve; areola shield; milk collection kit), and a silicone vacuum tube.
The Powered Breast Pump (Models 7V and 7X) has two operational modes (massage and expression), with user-selectable vacuum and cycle levels in each mode (levels are shown in Section 7 of the summary). Both device models are powered by an external AC power supply, while all 7V and select 7X models can be operated using an internal rechargeable lithium-ion battery. The device is provided nonsterile.
All milk contacting components are compliant with 21 CFR 174-179
6. Indications for Use:
The Powered Breast Pump (Models 7V and 7X) is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women.
Comparison of Intended Use and Technological Characteristics with the 7. Predicate Device
The table below compares the intended use and technological characteristics of the subject and predicate device.
| | Powered Breast Pump (Models 7V
and 7X)
K211016 | Hi bebesuper (Models BT-150S and
BT-150L)
K200675 | Comparison | |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Haenim Co., Ltd. | Bistos Co., Ltd. | | |
| Indications for Use | The Powered Breast Pump (7V and
7X) is a single-user, powered breast
pump intended to express and collect
milk from the breasts of lactating
women. | Hi bebesuper (Models BT-150S and
BT-150L) is intended to be used by
lactating women for expressing and
collecting breast milk. It is intended
for a single user. | The subject and
predicate device
indications for use
statements are not
identical; however,
their intended uses
are the same (i.e.,
for collection of
milk from the
breasts of lactating
women). | |
| Pump Options | Single or Double | Single or Double | Same | |
| Suction Modes | Massage Mode and Expression Mode | Massage Mode and Expression Mode | Same | |
| Pump Type | Diaphragm | Unknown | Different: The
pump type of the
predicate device is
not known;
however,
differences in the
pump type do not
raise different | |
| | | | | |
| | | | | questions of safety
and effectiveness. |
| Visual
Indicator | LED-light display | | Liquid-crystal display | Different: The
subject and
predicate devices
have different
display types.
Differences in
visual indicators do
not raise different
questions of safety
and effectiveness. |
| User Control | Power | | Power | Same |
| | Memory
Lamp brightness
Mode change
Decrease vacuum
Increase vacuum
Decrease speed
Increase speed | | Memory
Lamp brightness
Mode change
Decrease vacuum
Increase vacuum
Decrease speed
Increase speed | |
| Accessories | NexusFitTM Breast Shield
Areola shield 21mm
Bottle Stand
NexusFitTM Cap
NexusFitTM Pump Body
NexusFitTM Diaphragm
NexusFitTM Valve
Tubing
Nipple
Bottle Disk
Bottle Cap
Bottle
Dual Connector
Adaptor | | Funnel (21/24/27/32 mm)
Funnel Block Funnel cap
Diaphragm Top, Diaphragm and
Diaphragm Bottom
Air tube and air tube connector
Nipple
Bottle
Bottle cap
Bottle cover and bottle disc | Different: The
subject device has
different packaged
components than
the predicate
device. Differences
in device
components do not
raise different
questions of safety
and effectiveness. |
| Power | 7V:
- AC
Adaptor input
AC100~240V
50/60Hz
Adaptor output
DC5V 2.0A - Battery
Li-ion 3.7V
2600mAh | 7X:
1.AC
Adaptor input
AC100~240V
50/60Hz
Adaptor output
DC12V 2.0A - Battery
Li-ion 7.4V
2200mAh | Battery power only:
7.4V Li-ion Polymer 2200 mA | Different: The
subject device
operates under both
AC and battery
power, while the
predicate is only
battery powered.
Differences in
power supply do
not raise different
questions of safety
and effectiveness. |
| Maximum
Vacuum
Pressure | -290 mmHg | | -290 mmHg | Same |
| Cycle Speed | 7V
Expression
Mode: 30-50
cycle/min | 7X
Expression
Mode: 34-55
cycle/min | Expression Mode: 35/40/45/50/55/60
Cycle/Min.
Massage Mode: 70/80/90 Cycle/Min | Different: The
differences in
specifications do
not raise different |
| | | | | |
| | Massage Mode:
70-90 cycle/min
Expression
Mode: 5 levels | Massage Mode:
70-105 cycle/min
Expression
Mode: 6 levels | Expression Mode: 6 levels
Massage Mode: 3 levels | questions of safety
and effectiveness. |
| | Massage Mode: 5 levels | Massage Mode: 5 levels | | |
| Vacuum Range
(mmHg) | 7V
Single pumping:
Massage mode: -50 to -120 mmHg ±
20%
Expression mode: -50 to -250 mmHg ± 20%
Double pumping:
Massage mode: -30 to -70 mmHg ±
20%
Expression mode: -40 to -180 mmHg ± 20% | Single pumping:
Massage mode: -50 to -140 mmHg ±
20% Expression mode: -50 to -250
mmHg ± 20%
Double pumping:
Massage mode: -30 to -80 mmHg ±
20%
Expression mode: -40 to -190 mmHg ± 20% | Single pumping:
Massage mode: -50 to -230 mmHg ±
20%
Expression mode: -50 to -250 mmHg ± 20%
Double pumping:
Massage mode: -30 to -150 mmHg ±
20%
Expression mode: -30 to -200 mmHg ± 20% | Different: The
differences in
specifications do
not raise different
questions of safety
and effectiveness. |
| Adjustable
Vacuum
Levels | 7V
12 levels | 7X
15 levels | 16 levels | Different: The
difference in the
number of suction
levels do not raise
different questions
of safety and
effectiveness. |
| Backflow
Protection | Diaphragm construction acts as a
media separation and prevents milk
from going into the pump in case of a
milk overflow into the vacuum tubes. | | Diaphragm construction acts as a
media separation and prevents milk
from going into the pump in case of a
milk overflow into the vacuum tubes. | Same |
| Nursing Night
Lamp | Yes | | Only applicable to BT-150L | Different:
Differences in
device versions
with and without
nursing night lamps
do not raise
different questions
of safety and
effectiveness. |
5
6
7
The subject and predicate device do not have identical indications for use statements; however, they do have the same intended use, i.e., for collection of breast milk from the breasts of lactating women.
The subject and predicate device have different technological features, including the user interface, pump, vacuum range, cycle speed/range, and power sources. These technological differences do not raise different questions of safety and effectiveness.
Summary of Non-Clinical Performance Testing 8.
Biocompatibility
Biocompatibility testing was performed in accordance with the 2020 FDA guidance Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process." Testing included the following:
- Cytotoxicity (ISO 10993-5:2009) ●
- . Sensitization (ISO 10993-10:2010)
- . Irritation (ISO 10993-10:2010)
The testing supports the biocompatibility of the patient-contacting device materials that were shown to be non-cytotoxic, non-irritating, and non-sensitizing.
Electrical Safety
Testing was conducted in accordance with:
- AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, Medical electrical equipment Part 1: ● General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- · IEC 60601-1-11:2015. 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.
- IEC 62133-2:2017, 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 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 in accordance with the 2005 FDA guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Performance Testing
8
Performance testing was conducted to demonstrate pump performance met established specifications in the following areas:
- 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.
- . Battery charging testing to demonstrate the duration of time needed to fully recharge the battery.
Conclusion 9.
The performance testing described above demonstrates that the subject devices are as safe and effective as the predicate device and support a determination of substantial equivalence.