(311 days)
Not Found
No
The description details various pumping modes and suction levels controlled by user input via buttons, without mentioning any adaptive or learning capabilities. The performance studies focus on standard electrical, mechanical, and software verification tests, not AI/ML performance metrics.
No
The device is described as an Electric Breast Pump used to express and collect milk from the breast, which is a supportive function rather than a therapeutic treatment for a medical condition.
No
Explanation: The device is an electric breast pump intended for expressing and collecting milk from lactating women. Its purpose is mechanical milk expression, not the diagnosis of any medical condition.
No
The device description clearly outlines physical components like a pump unit, tubing sets, breast shield assemblies, and bottles, indicating it is a hardware device with integrated software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Electric Breast Pump's intended use is to express and collect milk from a lactating woman's breast. It is a mechanical device that interacts with the body externally to facilitate a physiological process (milk expression).
- Lack of Diagnostic Purpose: The device does not analyze any biological sample or provide any diagnostic information about the user's health or condition. It simply aids in the physical act of collecting breast milk.
Therefore, the Electric Breast Pump falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Electric Breast Pump (Models 918, HF918) is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Electric Breast Pump is intended for a single user.
Product codes
HGX
Device Description
The Electric Breast Pump (Model 918 and HF918) are powered breast pumps intended to express and collect milk from a lactating woman's breast. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The Electric Breast Pump is provided non-sterile and should be cleaned and disinfected according to the instructions for use prior to first use. The user employs buttons on the pump unit to select the pumping mode and vacuum level.
The Electric Breast Pump has five basic modes: Stimulation mode, Expression mode, Two-in-one mode, Dual-Frequency mode, and Simulation mode has 5 suction levels (vacuum levels: 60-217.5 +/- 20 mmHg; cycle speed: 39-123 +/- 5 cycles/min), expression mode (vacuum levels: 105-285 +/- 20 mmHg; cycle speed: 24-84 +/- 5 cycles/min), dual-frequency mode (vacuum levels: 67.5-277.5 +/- 20 mmHg; cycle speed: 39-85 +/- 5 cycles/min), and two-in-one mode (vacuum levels: 75-285 +/- 20 mmHg; cycle speed: 59-123 +/- 5 cycles/min) have seven suction levels, and simulation mode (vacuum levels: 187.5 +/- 20 mmHg; cycle speed: 14 +/- 5 cycles/min) has one suction level. Stimulation mode is for massaging the breast to stimulate breast milk secretion. Expression mode is for pumping breast milk. Dual Frequency mode is for cycling between strong and weak pumping strengths. Two-in-One mode cycles between massaging for 5 cycles and expressing breast milk for 1 cycle. Simulation mode operates at a single suction level to stimulate milk secretion.
The subject devices are available in two models: 918 and HF918. The hands-free (HF) model (HF918) is designed to be placed inside a user's bra and connect to the external pump unit. The milk collection cup is located on the breast. The HF model (HF918) includes breast shield assemblies, milk collection cups, single and double tubing sets, a bottle set, power adapter, and a pump unit. The non-HF model (918) includes a breast shield connected to a milk bottle. The non-HF model includes breast shield assemblies, bottles, bottle stands, single and double tubing sets, power adapter, and a pump unit.
The Electric Breast Pumps are intended for a single user.
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
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 tests were conducted including IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012, IEC 60601-1-2:2014, A IEC 60601-1-11:2010, AMD1:2013, and IEC 62133:2012.
Biocompatibility testing was conducted in accordance with FDA guidance "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" dated September 4, 2020, including Cytotoxicity per ISO 10993-5:2009 and Sensitization and Irritation per ISO 10993-10:2010.
Software Verification was conducted in accordance with the FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005.
Additionally, the following non-clinical tests were conducted:
- Suction strength of subject devices was tested. All the test results complied with the design specifications of the subject device throughout the use life.
- Backflow 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. The test results showed that there was no backflow during the test.
- Cycle speed of subject devices was tested. All the test results complied with the design specifications of the subject devices throughout the use life.
- 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.
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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 11, 2022
Shantou Huihengqi Electronic Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, Shanghai 200120 China
Re: K211024
Trade/Device Name: Electric Breast Pump (Models 918, HF918) Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: January 8, 2022 Received: January 11, 2022
Dear Diana Hong:
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211024
Device Name Electric Breast Pump (Models 918, HF918)
Indications for Use (Describe)
The Electric Breast Pump (Models 918, HF918) is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Electric 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 K211024
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR 807.92.
- Date of 510(k) Summary Preparation: February 10, 2022 1.
-
- Sponsor Identification
Shantou Huihengqi Electronic Technology Co., Ltd.
501, 5/F, Block C, 14A Industrial Zone, Longhu District, Shantou, 515000, China
Establishment Registration Number: Not registered
Contact Person: Gensong Yang Position: Quality Supervisor Tel: +86-0754-88893348 Email: 357732164@qq.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Tingting Su (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
4
Page 2
Trade Name: Electric Breast Pump (Models 918, HF918) Common Name: Electric Breast Pump Models: 918, HF918
Regulatory Information Classification Name: Powered Breast Pump Product Code: HGX: Classification: II Regulation Number: 21 CFR 884.5160
- Identification of Predicate device న్.
510(k) Number: K201903 Product Name: Electric breast pump (Models: RH-228 and RH-338)
The predicate device has not been subject to a design-related recall.
Device Description: 6.
The Electric Breast Pump (Model 918 and HF918) are powered breast pumps intended to express and collect milk from a lactating woman's breast. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The Electric Breast Pump is provided non-sterile and should be cleaned and disinfected according to the instructions for use prior to first use. The user employs buttons on the pump unit to select the pumping mode and vacuum level.
The Electric Breast Pump has five basic modes: Stimulation mode, Expression mode, Two-in-one mode, Dual-Frequency mode, and Simulation mode has 5 suction levels (vacuum levels: 60-217.5 ± 20 mmHg; cycle speed: 39-123 ± 5 cycles/min), expression mode (vacuum levels: 105-285 ± 20 mmHg; cycle speed: 24-84 ± 5 cycles/min), dual-frequency mode (vacuum levels: 67.5-277.5 ± 20 mmHg; cycle speed: 39-85 ± 5 cycles/min), and two-in-one mode (vacuum levels: 75-285 ± 20 mmHg; cycle speed: 59-123 ± 5 cycles/min) have seven suction levels, and simulation mode (vacuum levels: 187.5 ± 20 mmHg; cycle speed: 14 ± 5 cycles/min) has one suction level. Stimulation mode is for massaging the breast to stimulate breast milk secretion. Expression mode is for pumping breast milk. Dual Frequency mode is for cycling between strong and weak pumping strengths. Two-in-One mode cycles between massaging for 5 cycles and expressing breast milk for 1 cycle. Simulation mode operates at a single suction level to stimulate milk secretion.
The subject devices are available in two models: 918 and HF918. The hands-free (HF) model (HF918) is designed to be placed inside a user's bra and connect to the external pump unit. The milk collection
5
cup is located on the breast. The HF model (HF918) includes breast shield assemblies, milk collection cups, single and double tubing sets, a bottle set, power adapter, and a pump unit. The non-HF model (918) includes a breast shield connected to a milk bottle. The non-HF model includes breast shield assemblies, bottles, bottle stands, single and double tubing sets, power adapter, and a pump unit.
The Electric Breast Pumps are intended for a single user.
-
- Indication for Use:
The Electric Breast Pump (Models 918, HF918) is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Electric Breast Pump is intended for a single user.
- Indication for Use:
-
Comparison of Technological Characteristics 8.
| ITEM | Subject Device
Electric Breast Pump (918, HF918)
K211024 | Predicate Device
Electric Breast Pump (Models:
RH-228, RH-338)
K201903 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | HGX | HGX |
| Class | II | II |
| Regulation No. | 21 CFR 884.5160 | 21 CFR 884.5160 |
| Indication for Use | The Electric Breast Pump (Models 918,
HF918) is a powered breast pump to be
used by lactating women to express
and collect milk from their breast. The
Electric Breast Pump is intended for a
single user. | The Electric breast pump is intended
to be used by lactating women to
express and collect milk from their
breasts. It is intended for a single
user. |
| Patient Population | Breastfeeding women | Breastfeeding women |
| Anatomical Sites | Breast | Breast |
| Single User | Yes | Yes |
| Provided Non-sterile | Yes | Yes |
| Direct user contact | Yes | Yes |
| Re-usable | Yes | Yes |
Table 1 General Comparison
Table 2 Technological Comparison
| ITEM | Subject Device | Predicate Device |
|---|---|---|
| Electric Breast Pump (918, | ||
| HF918) | Electric Breast Pump (Models: | |
| K211024 | RH-228, RH-338) | |
| K201903 |
6
| Pump Type | Diaphragm | Diaphragm | |
|---|---|---|---|
| Pumping Options | Single and Double Pumping | Single Pumping | |
| Visual Indicator | 918 & HF918: LED | RH-228: LED | |
| RH-338: LCD | |||
| Backflow Protection | Yes | Yes | |
| Suction | |||
| strength | Stimulation mode | 918 & HF918: 60-217.5 | RH-228:60-150 |
| RH-338: 45-165 | |||
| Expression mode | 918 & HF918: 105-285 | RH-228:120-275 | |
| RH-338: 110-300 | |||
| Two-in One mode | 918 & HF918: 75-285 | N/A | |
| Dual-frequency mode | 918 & HF918: 67.5-277.5 | N/A | |
| Simulation mode | 918 & HF918:187.5 | N/A | |
| Suction level | Massage mode | N/A | RH-338: 135-255 |
| Stimulation mode | 918 & HF918: 5 levels | RH-228: 5 levels | |
| RH-338: 9 levels | |||
| Expression mode | 918 & HF918: 7 levels | RH-228: 4 levels | |
| RH-338: 9 levels | |||
| Two-in One mode | 918 & HF918: 7 levels | N/A | |
| Dual-frequency mode | 918 & HF918: 7 levels | N/A | |
| Simulation mode | 918 & HF918: 1 level | N/A | |
| Cycling Speed | Massage mode | N/A | RH-338: 9 levels |
| Stimulation mode | 918 & HF918: 39-123 | RH-228: 58-90 | |
| RH-338: 115-155 | |||
| Expression mode | 918&HF918: 24-84 | RH-228: 28-52 | |
| RH-338: 25-52 | |||
| Two-in One mode | 918 & HF918: 59-123 | N/A | |
| Dual-frequency mode | 918 & HF918: 39-85 | N/A | |
| Simulation mode | 918 & HF918:14 | N/A | |
| Massage mode | N/A | RH-338: 56-72 | |
| Power Source | 3.7 V, Lithium ion battery | 3.7 V, Lithium ion battery | |
| User Control | On pump body | On pump body |
The subject and predicate device have same indications for use statements, and the same intended use. They are both used to express and collect milk from a lactating woman's breast.
The differences between the subject devices and the predicate devices are pumping options, suction levels, suction strength, and cycle speed. These differences do not raise different questions of safety and effectiveness.
7
Non-Clinical Testing 9.
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
-
IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012, Medical electrical equipment -Part 1: General requirements for basic safety, and essential performance.
-
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility
- A IEC 60601-1-11:2010, AMD1:2013, 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 62133:2012, 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
Biocompatibility testing in accordance with the FDA guidance "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" dated September 4, 2020. Testing included the following assessments:
- A Cytotoxicity per ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
-
Sensitization and Irritation per ISO 10993-10:2010 Biological evaluation of medical devices --Part 10: Tests for irritation and skin sensitization
Software Verification
- ▲ Software verification in accordance with the FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005.
Additionally, the following non-clinical tests were conducted:
Suction strength of subject devices was tested. All the test results complied with the design specifications of the subject device throughout the use life.
Backflow 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. The test results showed that there was no backflow during the test.
8
Cycle speed of subject devices was tested. All the test results complied with the design specifications of the subject devices throughout the use life.
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.
-
- Conclusion
The comparison and analysis above demonstrate that the Electric Breast Pump (Models 918, HF918) is as safe and effective as the predicate device and supports a determination of substantial equivalence to the predicate device
- Conclusion